VALTREX TABLETS 500 MG

Israel - English - Ministry of Health

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Active ingredient:
VALACICLOVIR AS HYDROCHLORIDE
Available from:
GLAXO SMITH KLINE (ISRAEL) LTD
ATC code:
J05AB11
Pharmaceutical form:
FILM COATED TABLETS
Composition:
VALACICLOVIR AS HYDROCHLORIDE 500 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
GLAXO WELLCOME SA, SPAIN
Therapeutic group:
VALACICLOVIR
Therapeutic area:
VALACICLOVIR
Therapeutic indications:
Varicella zoster virus (VZV) infections – herpes zoster:Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults.Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression.Herpes simplex virus (HSV) infections:Valtrex is indicated for the treatment and suppression of HSV infections of the skin and mucous membranes including- treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults- treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults- suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adultsTreatment and suppression of recurrent ocular HSV infections in immunocompetent adults and adolescents and in immunocompromised adults Clinical studies have not been conducted in HSV-infected patients immunocompromised for other cau
Authorization number:
100 39 28426 00
Authorization date:
2011-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

19-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

06-05-2020

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with a physician’s prescription

only

Valtrex Tablets 500 mg

Each tablet contains 500 mg valaciclovir (as

hydrochloride)

The list of additional ingredients is detailed in section 6.

Read the leaflet carefully in its entirety before using

the medicine. This leaflet contains concise information

about the medicine. If you have further questions, refer to

the physician or pharmacist.

This medicine has been prescribed to treat your illness. Do

not pass it on to others. It may harm them, even if it seems

to you that their illness is similar.

1. WHAT IS THE MEDICINE INTENDED fOR?

Valtrex works by killing or stopping the growth of viruses

called herpes simplex (HSV), varicella zoster (VZV) and

cytomegalovirus (CMV).

Valtrex is intended to:

Treat shingles in adults.

Treat VZV infections of the eye (ophthalmic zoster) in

adults with a weakened immune system.

Treat HSV infections of the skin (e.g., cold sores) and

genital herpes in adults and adolescents. It is also used

to help prevent recurrence of these infections.

Treat and prevent recurrence of HSV infections of the eye

in adults and adolescents.

Prevent infection with CMV after organ transplants in

adults and adolescents.

Therapeutic group: Valtrex belongs to a group of medicines

called antivirals.

2. BEfORE USING THE MEDICINE

Do not use the medicine if:

You are sensitive (allergic) to valaciclovir or aciclovir or to

any of the additional ingredients contained in the medicine

(as detailed in section 6).

Special warnings regarding use of the medicine

Before treatment with Valtrex, tell the physician if:

You have kidney problems.

You have liver problems.

You are over 65 years of age.

Your immune system is weak.

Prevent passing genital herpes on to others

If you are taking Valtrex to treat or prevent genital

herpes, or you have had genital herpes in the past,

you should still practice safe sex, including the use

of condoms. This is important to prevent you from

passing the infection on to others. If you have genital

sores or blisters, you should avoid having sex.

Drug interactions:

If you are taking, or have recently taken, other

medicines, including non-prescription medicines,

nutritional supplements and herbal medicines, tell the

physician or pharmacist. Tell the physician or pharmacist

if you are taking any other medicines that affect the kidneys.

These include:

Aminoglycosides, organoplatinum compounds, iodinated

contrast media, methotrexate, pentamidine, foscarnet,

cimetidine, probenecid, ciclosporin, tacrolimus.

Pregnancy and breastfeeding

Valtrex is not usually recommended for use during pregnancy.

If you are pregnant, or think you could be pregnant, or if you

are planning to become pregnant, do not take Valtrex without

consulting with your physician. Your physician will weigh up

the benefit of you taking Valtrex against the risk to your baby

while you are pregnant or breastfeeding.

Driving and using machines

Valtrex can cause side effects that may affect your ability to

drive (e.g., dizziness).

3. HOW SHOULD YOU USE THE MEDICINE?

Always use the preparation according to the physician’s

instructions.

Check with the physician or pharmacist if you are uncertain

regrading the preparation dosage and treatment regimen.

The dosage and treatment regimen will be determined by

the physician only. The usual dosage is generally:

Treatment of shingles (Herpes zoster) in adults

The usual dosage is 1,000 mg (two 500 mg Valtrex tablets),

three times a day.

You should take Valtrex for seven days.

Treatment of cold sores in adults and adolescents (from

age 12 and above)

The usual dosage is 2,000 mg (four 500 mg Valtrex

tablets), twice a day.

The second dose should be taken 12 hours (no sooner

than 6 hours) after the first dose.

You should take Valtrex for one day (two doses) only.

Treatment of HSV infections of the skin and genital herpes

in adults and adolescents (from age 12 and above)

The usual dosage is one 500 mg Valtrex tablet, twice a

day.

For the first infection, you should take Valtrex for five days

or for up to ten days, if your physician instructs you to. For

recurrent infection, the duration of treatment is normally

5 days.

Helping to prevent HSV infections from returning in adults

and adolescents (from age 12 and above)

The usual dosage is one 500 mg Valtrex tablet, once a

day.

You should take Valtrex until your physician tells you to

stop.

Treatment of CMV (Cytomegalovirus) infection in adults and

adolescents (from age 12 and above)

The usual dosage is 2,000 mg (four 500 mg Valtrex

tablets), four times a day.

You should take each dose separately, 6 hours apart.

You will usually start taking Valtrex as soon as possible

after your surgery.

You should take Valtrex for around 90 days after your

surgery, until your physician tells you to stop.

Your physician may adjust the dosage of Valtrex if:

You are over 65 years of age.

You have a weak immune system.

You have kidney problems.

→ Talk to your physician before taking Valtrex if any of the

above apply.

Do not exceed the recommended dose.

Taking this medicine:

Take this medicine by mouth.

Swallow the tablets whole with a drink of water.

There is no information regarding crushing/halving/

chewing.

Take Valtrex at the same time each day.

Take Valtrex according to the instructions from your

pharmacist or physician.

People over 65 years of age or with kidney problems

It is very important while you are taking Valtrex that

you drink water regularly during the day.

This will help reduce side effects that may affect the kidney

or nervous system. Your physician will closely monitor you

for these signs. Nervous system side effects might include

feeling confused or agitated, or feeling unusually sleepy

or drowsy.

If you accidentally take a higher dosage

Valtrex is not usually harmful, unless you take too much

over several days. If you take too many tablets, you may

feel nauseous, vomit, get kidney problems, be confused,

agitated, feel less aware, see things that do not exist, or

become unconscious.

If you took an overdose or if a child has accidentally

swallowed the medicine, refer immediately to a physician

or proceed to a hospital emergency room, and bring the

package of the medicine with you.

If you forget to take the medicine

If you forgot to take Valtrex, take it as soon as you remember.

However, if it is nearly time for your next dose, skip the

missed dose.

Do not take a double dose to make up for a forgotten dose.

Adhere to the treatment regimen as recommended by the

physician.

Do not take medicines in the dark! Check the label and

the dose each time you take medicine. Wear glasses

if you need them.

If you have further questions regarding use of the

medicine, consult the physician or pharmacist.

4. SIDE EffECTS

As with any medicine, use of Valtrex may cause side effects

in some users. Do not be alarmed by reading the list of side

effects. You may not suffer from any of them.

Side effects requiring special attention

Discontinue use and refer to a physician immediately upon

onset of:

Severe allergic reactions (anaphylaxis). These are rare

reactions in people taking Valtrex. Rapid development of

symptoms including:

Flushing, itchy skin rash

Swelling of the lips, face, neck and throat, causing difficulty

in breathing (angioedema)

Fall in blood pressure leading to collapse

Very common side effects - effects occurring in more than

one user in ten:

Headache

Common side effects - effects occurring in 1-10 in 100 users:

Nausea

Dizziness

Vomiting

Diarrhea

Skin reaction after exposure to sunlight (photosensitivity)

Rash

Itching

Uncommon side effects - effects occurring in 1-10 in 1,000

users:

Feeling confused

Seeing or hearing things that do not exist (hallucinations)

Feeling very drowsy

Tremors

Feeling agitated

These nervous system side effects usually occur in people

with kidney problems, the elderly or in organ transplant

patients taking high dosages of 8 grams or more of Valtrex

a day. These effects get better when Valtrex treatment is

stopped or the dose reduced.

Other uncommon side effects:

Shortness of breath (dyspnea)

Stomach discomfort

Rash, sometimes itchy, hive-like rash (urticaria)

Lower back pain (kidney pain)

Blood in urine (hematuria)

Uncommon side effects that may show up in blood tests:

Reduction in the number of white blood cells (leucopenia)

Reduction in the number of blood platelets which help the

blood to clot (thrombocytopenia)

Increase in levels of substances produced by the liver

Rare side effects - effects occurring in 1-10 in 10,000 users:

Unsteadiness when walking and lack of coordination

(ataxia)

Slow, slurred speech (dysarthria)

Fits (convulsions)

Altered brain function (encephalopathy)

Unconsciousness (coma)

Confused or disturbed thoughts (delirium)

These nervous system side effects usually occur in people

with kidney problems, the elderly or in organ transplant

patients taking high dosages of 8 grams or more of Valtrex

a day. These effects get better when Valtrex treatment is

stopped or the dose reduced.

Other rare side effects:

Kidney problems where you pass little or no urine

If a side effect occurs, if one of the side effects worsens,

or if you are suffering from a side effect not mentioned

in the leaflet, consult with the physician.

Reporting side effects

Side effects can be reported to the Ministry of Health by

clicking on the link “Report Side Effects of Drug Treatment”

found on the Ministry of Health homepage (www.health.gov.il)

that directs you to the online form for reporting side effects,

or by entering the link:

https://sideeffects.health.gov.il

5. HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine and any other medicine

should be kept in a closed place out of the reach and sight

of children and/or infants in order to avoid poisoning. Do

not induce vomiting unless explicitly instructed to do so by

the physician.

Do not use the medicine after the expiry date (exp. date)

that appears on the package. The expiry date refers to the

last day of that month.

Store below 30°C.

6. ADDITIONAL INfORMATION

In addition to the active ingredient, the medicine also

contains:

Microcrystalline cellulose

Crospovidone

Povidone, K90

White Colour Concentrate YS-1-18043

(Methylhydroxypropylcellulose, Titanium dioxide,

Polyethylene Glycol 400, Polysorbate 80)

Magnesium stearate

Colloidal Anhydrous Silica

Carnauba wax.

What the medicine looks and the contents of the

package:

Valtrex Tablets are packaged in blister packs. Valtrex

Tablets 500 mg are provided in cartons containing 2, 10,

or 42 film-coated tablets. They are white and marked with

“GX CF1” on one side.

Not all packages may be marketed.

Manufacturer: Glaxo Wellcome, S.A., Burgos, Spain.

License Holder: GlaxoSmithKline (Israel) Ltd., 25 Basel St.,

Petach Tikva.

The format of this leaflet was determined by the Ministry

of Health and its content was checked and approved by

the Ministry of Health in July 2019, and was updated

in accordance with the Ministry of Health guidelines in

February 2020.

Registration number of the medicine in the National Drug

Registry of the Ministry of Health:

100-39-28426-00.

Trade marks are owned by or licensed to the GSK group

of companies.

©2020 GSK group of companies or its licensor.

Val PT v5B

Val PT v5B

لمعتسم نم رثكأ ىدل رهظت ضارعأ ـ (very common)

ادج ةعئاش ةيبناج ضارعأ :ةرشع نم دحاو عادص :100 نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ - (common) ةعئاش ةيبناج ضارعأ نايثغ راود ؤيقت لاهسإ

(ءوضلل ةطرفم ةيساسح) سمشلا ءوضل ضرعتلا دعب يدلج لعف در حفط ةكح نم نيلمعتسم 1-10 ىدل رهظت ضارعأ ـ (uncommon) ةعئاش ريغ ةيبناج ضارعأ :1,000 نيب كابترلإاب روعشلا

(ةسوله) ةدوجوم ريغ ءايشأ عامس وأ ةيؤر ساعنلاب روعشلا

ةفجر ءودهلا مدعب روعشلا

يف لكاشم مهيدل صاخشأ ىدل ةداع ثدحت ،يبصعلا زاهجلا يف ةيبناجلا ضارعلاا هذه ـ سكرتلاﭬ نم ةيلاع ةيئاود ةعرج نولوانتي نيذلا ،ءاضعلأا يعراز وأ نينسملا ،ةيلكلا وأ سكرتلاﭬ ـب جلاعلا نع فقوتلا دنع ضارعلأا هذه نسحتت .مويلا يف رثكأ وأ مارغ 8 .ةيئاودلا ةعرجلا ضيفخت :ةعئاش ريغ ةيفاضإ ةيبناج ضارعأ (dyspnea) سفنتلا يف قيض نطبلا يف جاعزنإ

urticaria

) ىرشلاب هيبش حفط ،

انايحأ كاح ،حفط (ةيلكلا يف ملأ) رهظلا لفسأ ملأ

(hematuria) لوبلا يف مد :مدلا صوحف يف رهظت دق ةعئاش ريغ ةيبناج ضارعأ (leucopenia) ءاضيبلا مدلا ايلاخ ددع يف ضافخنإ

(thrombocytopenia) مدلا رثخت ىلع دعاست يتلا ةيومدلا تاحيفصلا ددع يف ضافخنإ

دبكلا جتاون ىوتسم عافترإ

:10,000 نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ - (rare)ةردان ةيبناج ضارعأ (ataxia) قسانتلا مدعو يشملا دنع رارقتسلاا مدع (dysarthria) حضاو ريغ ،ءيطب ملاك (تاجنشت) تابون (encephalopathy) غامدلا ةفيظو يف ريغت (تابس) يعولا نادقف (delirium) ةجعزم وأ ةتتشم راكفأ

،ىلكلا يف لكاشم مهيدل صاخشأ ىدل ةداع ثدحت ،يبصعلا زاهجلا يف ةيبناجلا ضارعلأا هذه يف رثكأ وأ مارغ 8 ـ سكرتلاﭬ نم ةيلاع ةعرج نولوانتي نيذلا ءاضعلأا يعراز وأ نينسملا .ةيئاودلا ةعرجلا ضيفخت وأ سكرتلاﭬ ـب جلاعلا نع فقوتلا دنع نسحتت ضارعلأا هذه .مويلا :ىرخأ ةردان ةيبناج ضارعأ

ادبأ لوبتت لا وأ

لايلق لوبتت اهيف ثيح ةيلكلا يف لكاشم

نم يناعت امدنع وأ ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسإ كيلع ،ةرشنلا هذه يف ركذي مل يبناج ضرع ةيبناج ضارعأ نع غيلبتلا نع غيلبت« طبارلا ىلع طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب ةحصلا ةرازو عقومل ةيسيئرلا ةحفصلا ىلع دوجوملا »يئاود جلاع بقع ةيبناج ضارعأ ،ةيبناج ضارعأ نع غيلبتلل رشابملا جذومنلا ىلإ كهجوي يذلا (www.health.gov.il) :طبارلا حفصت قيرط نع وأ

https://sideeffects.health.gov.il

؟ءاودلا نيزخت ةيفيك )5 لوانتم نع

اديعب قلغم ناكم يف رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت ؤيقتلا ببست لا .ممستلاب مهتباصإ يدافتل كلذو عضرلا وأ/و لافطلأا ةيؤر لاجمو يديأ .بيبطلا نم ةحيرص تاميلعت نودب ىلع رهظي يذلا (exp. date) ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لامعتسإ زوجي لا .رهشلا سفن نم ريخلأا مويلا ىلإ ةيحلاصلا ءاهتنإ خيرات ريشي .ةبلعلا رهظ .ةيوئم هجرد 30 نود نيزختلا بجي ةيفاضإ تامولعم )6

:

ً

اضيأ ةلاعفلا ةداملل ةفاضلإاب ءاودلا يوتحي

Microcrystalline cellulose

Crospovidone

Povidone, K90

White Colour Concentrate YS-1-18043

(Methylhydroxypropylcellulose, Titanium dioxide, Polyethylene

Glycol 400, Polysorbate 80)

Magnesium stearate

Colloidal Anhydrous Silica

Carnauba wax.

:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك رفوتت غلم 500 صارقأ سكرتلاﭬ .(رتسيلب) تاحيول نمض ةأبعم سكرتلاﭬ صارقأ

ةملعم ضيبأ اهنول .

ايلطم

اصرق 42 وأ 10 ،2 ىلع يوتحت يتلا نوترك بلع نمض .دحاو بناج يف "GX CF1" ـب .تاوبعلا ةفاك ق

وست لاأ زئاجلا نم

.اينابسإ ،سوچروب ،S.A. ماكليو وسكلاچ :جتنملا

. اڤكت حتيپ ، 25 لزاب عراش ، . ض.م ( ليئارسإ ) نيلاكثيمسوسكلاچ :زايتملإا بحاص خيرات يف اهلبق نم صخ

رو صح

ف اهاوتحمو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ

.2020 طابش خيراتب ةحصلا ةرازو تاميلعت بجومب اهثيدحت متو ،2019 زومت :ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر

.100-39-28426-00

نم مغرلا ىلع .ركذملا ةغيصب ةرشنلا هذه ةغايص تمت ،ةءارقلا نيوهتو ةلوهس لجأ نم .نيسنجلا لاكل صصخم ءاودلا نإف ،كلذ .GSK تاكرش ةعومجم زايتمإب وأ ةيكلمب يه ةيراجتلا تاملاعلا .اهب صاخلا زايتملإا بحاص وأ GSK تاكرش هعومجم 2020©

Page 1 of 14

VALTREX TABLETS 500 MG

1.

NAME OF THE MEDICINAL PRODUCT

VALTREX TABLETS 500MG

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains valaciclovir (as hydrochloride) equivalent to 500 mg valaciclovir

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Film-coated tablets

500 mg tablet

White, biconvex, elongated tablet with a white to off-white core, engraved “GX CF1” on one side.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Varicella zoster virus (VZV) infections – herpes zoster

Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in

immunocompetent adults (see section 4.4).

Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate

immunosuppression (see section 4.4).

Herpes simplex virus (HSV) infections

Valtrex is indicated

for the treatment and suppression of HSV infections of the skin and mucous membranes

including:

treatment of first-episode of genital herpes in immunocompetent adults and

adolescents and in immunocompromised adults.

treatment of recurrences of genital herpes in immunocompetent adults and

adolescents, and in immunocompromised adults.

suppression of recurrent genital herpes in immunocompetent adults and adolescents

and in immunocompromised adults.

Treatment and suppression of recurrent ocular HSV infections in immunocompetent adults

and adolescents and in immunocompromised adults (see section 4.4)

Clinical studies have not been conducted in HSV-infected patients immunocompromised for other

causes than HIV-infection (see section 5.1).

Cytomegalovirus (CMV) infections

Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ

transplantation in adults and adolescents (see section 4.4).

Page 2 of 14

4.2

Posology and method of administration

Varicella zoster virus (VZV) infections – herpes zoster and ophthalmic zoster

Patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster.

There are no data on treatment started more than 72 hours after onset of the zoster rash.

Immunocompetent Adults

The dose in immunocompetent patients

is 1000 mg three times daily for seven days (3000 mg total

daily dose). This dose should be reduced according to creatinine clearance (see Renal impairment

below).

Immunocompromised Adults

The dose in immunocompromised patients is 1000 mg three times daily for at least seven days

(3000 mg total daily dose) and for 2 days following crusting of lesions. This dose should be reduced

according to creatinine clearance (see Renal impairment below).

In immunocompromised patients, antiviral treatment is suggested for patients presenting within one

week of vesicle formation or at any time before full crusting of lesions.

Treatment of herpes simplex virus (HSV) infections in adults and adolescents (≥12 years):

Immunocompetent Adults and Adolescents (≥12 years)

The dose is 500 mg of valtrex to be taken twice daily (1000 mg total daily dose).

This dose should be reduced according to creatinine clearance (see Renal impairment below).

For recurrent episodes treatment should be 5 days. For initial episodes, which can be more severe,

treatment may have to be extended to ten days.

Dosing should begin as early as possible. For recurrent episodes of herpes simplex, this should

ideally be during the prodromal period or immediately upon appearance of the first signs or

symptoms. Valtrex can prevent lesion development, when taken at the first signs and symptoms of

an HSV recurrence.

Herpes labialis

For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment

in adults and adolescents. The second dose should be taken about 12 h (no sooner than 6 h) after the

first dose. This dose should be reduced according to creatinine clearance (see Renal impairment

below). When using this dosing regimen, treatment should not exceed one day, since this has been

shown not to provide additional clinical benefit. Therapy should be initiated at the earliest symptom

of a cold sore (e.g. tingling, itching or burning).

Immunocompromised Adults

For the treatment of HSV in immunocompromised adults, the dosage is 1000 mg twice daily for at

least 5 days, following assessment of the severity of the clinical condition and immunological status

of the patient. For initial episodes, which can be more severe, treatment may have to be extended to

ten days. Dosing should begin as early as possible. This dose should be reduced according to

creatinine clearance (see Renal impairment below). For maximum clinical benefit, the treatment

should be started within 48 hours. A strict monitoring of the evolution of lesions is advised.

Suppression of recurrences of herpes simplex virus (HSV) infections

in adults and adolescents

(≥12 years)

Page 3 of 14

Immunocompetent Adults and Adolescents (≥12 years):

The dose is 500 mg of Valtrex to be taken once daily. Some patients with very frequent recurrences

10/year in absence of therapy) may gain additional benefit from the daily dose of 500 mg being

taken as a divided dose (250 mg twice daily). This dose should be reduced according to creatinine

clearance (see Renal impairment below).Treatment should be re-evaluated after 6 to 12 months of

therapy.

Immunocompromised Adults

The dose is 500 mg of Valtrex twice daily. This dose should be reduced according to creatinine

clearance (see Renal impairment below). Treatment should be re-evaluated after 6 to 12 months of

therapy.

Prophylaxis of cytomegalovirus (CMV) infection and disease in adults and adolescents (≥12 years)

The dosage is 2000 mg four times a day, to be initiated as early as possible post-transplant. This

dose should be reduced according to creatinine clearance (see Renal impairment below).

The duration of treatment will usually be 90 days, but may need to be extended in high-risk patients.

Special populations

children

:

The efficacy of Valtrex in children below the age of 12 years has not been evaluated.

Elderly:

The possibility of renal impairment in the elderly must be considered and the dose should be

adjusted accordingly (see Renal impairment below). Adequate hydration should be maintained.

Renal impairment:

Caution is advised when administering Valtrex to patients with impaired renal function. Adequate

hydration should be maintained. The dose of Valtrex should be reduced in patients with impaired

renal function as shown in Table 1 below.

In patients on intermittent haemodialysis, the Valtrex dose should be administered after the

haemodialysis has been perfomed.

The creatinine clearance should be monitored frequently, especially during periods when renal

function is changing rapidly e.g. immediately after renal transplantation or engraftment. The

Valtrex dosage should be adjusted accordingly.

Hepatic impairment

Studies with a 1000 mg dose of valaciclovir in adult patients show that dose modification is not

required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained).

Pharmacokinetic data in adult patients with advanced cirrhosis, (impaired hepatic synthetic function

and evidence of portal-systemic shunting) do not indicate the need for dose adjustment; however,

clinical experience is limited. For higher doses (4000 mg or more per day), see section 4.4.

Page 4 of 14

Table 1: DOSAGE ADJUSTMENT FOR RENAL IMPAIRMENT

Therapeutic indication

Creatinine clearance

(mL/min

Valaciclovir Dosage

a

Varicella-Zoster Virus (VZV)

Infections

Treatment of herpes zoster

(shingles)

in immunocompetent and

immunocompromised adults

30 to 49

10 to 29

1000 mg three times daily

1000 mg twice daily

1000 mg once daily

500 mg once daily

Herpes Simplex Virus

(HSV) Infections

Treatment of HSV infections

- immunocompetent adults

and adolescents

< 30

500 mg twice daily

500 mg once daily

- immunocompromised adults

< 30

1000 mg twice daily

1000 mg once daily

Treatment of herpes labialis

(cold sores) in

immunocompetent adults and

adolescents

(alternative 1-day regimen)

30 to 49

10 to 29

<10

2000mg twice in one day

1000 mg twice in one day

500 mg twice in one day

500 mg single dose

uppression of HSV infections

- immunocompetent adults and

adolescents

< 30

500 mg once daily

250 mg once daily

-immunocompromised adults

< 30

500 mg twice daily

500 mg once daily

Cytomegalovirus (CMV)

Infections

CMV prophylaxis in solid organ

transplant recipients in adults

and adolescents

50 to <75

25 to <50

10 to <25

<10 or on dialysis

2000 mg four times daily

1500 mg four times daily

1500 mg three times daily

1500 mg twice daily

1500 mg once daily

For patients on intermittent haemodialysis, the dose should be given after dialysis on dialysis

days.

For HSV suppression in immunocompetent subjects with a history of

10 recurrences/year, better

results may be obtained with 250 mg twice daily.

4.3 Contraindications

Hypersensitivity to valaciclovir or aciclovir or any of the excipients listed in section 6.1.

Page 5 of 14

4.4

Special warnings and precautions for use

Hydration status

Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration

particularly the elderly.

Use in patients with renal impairment and in elderly patients

Aciclovir is eliminated by renal clearance, therefore the dose of valaciclovir must be reduced in

patients with renal impairment (see section 4.2). Elderly patients are likely to have reduced renal

function and therefore the need for dose reduction must be considered in this group of patients. Both

elderly patients and patients with renal impairment are at increased risk of developing neurological

side-effects and should be closely monitored for evidence of these effects. In the reported cases,

these reactions were generally reversible on discontinuation of treatment (see section 4.8).

Use of higher doses of valaciclovir in hepatic impairment and liver transplantation

There are no data available on the use of higher doses of valaciclovir ( 4000 mg or more per day) in

patients with liver disease. Specific studies of valaciclovir have not been conducted in liver

transplantation, and hence caution should be exercised when administering daily doses greater than

4000 mg to these patients.

Use for zoster treatment

Clinical response should be closely monitored, particularly in immunocompromised patients.

Consideration should be given to intravenous antiviral therapy when response to oral therapy is

considered insufficient.

Patients with complicated herpes zoster, i.e. those with visceral involvement, disseminated zoster,

motor neuropathies, encephalitis and cerebrovascular complications should be treated with

intravenous antiviral therapy.

Moreover, immunocompromised patients with ophthalmic zoster or those with a high risk for

disease dissemination and visceral organ involvement should be treated with intravenous antiviral

therapy.

Transmission of genital herpes

Patients should be advised to avoid intercourse when symptoms are present even if treatment with

an antiviral has been initiated. During suppressive treatment with antiviral agents, the frequency of

viral shedding is significantly reduced. However, the risk of transmission is still possible. Therefore,

in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices.

Use in ocular HSV infections

Clinical response should be closely monitored in these patients. Consideration should be given to

intravenous antiviral therapy when response to oral therapy is unlikely to be sufficient.

Use in CMV infections

Data on the efficacy of valaciclovir from transplant patients (~200) at high risk of CMV disease

(e.g. donor CMV-positive/recipient CMV negative or use of anti-thymocyte globulin induction

therapy) indicate that valaciclovir should only be used in these patients when safety concerns

preclude the use of valganciclovir or ganciclovir.

Page 6 of 14

High dose valaciclovir as required for CMV prophylaxis may result in more frequent adverse

events, including CNS abnormalities, than observed with lower doses administered for other

indications (see section 4.8). Patients should be closely monitored for changes in renal function, and

doses adjusted accordingly (see section 4.2).

4.5

Interaction with other medicinal products and other forms of interaction

The combination of valaciclovir with nephrotoxic medicinal products should be made with caution,

especially in subjects with impaired renal function, and warrants regular monitoring of renal

function. This applies to concomitant administration with aminoglycosides, organoplatinum

compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, and

tacrolimus.

Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion.

Following 1000 mg valaciclovir, cimetidine and probenecid reduce aciclovir renal clearance and

increase the AUC of aciclovir by about 25% and 45%, respectively, by inhibition of the active renal

secretion of aciclovir. Cimetidine and probenecid taken together with valaciclovir increased

aciclovir AUC by about 65%. Other medicinal products (including e.g. tenofovir) administered

concurrently that compete with or inhibit active tubular secretion may increase aciclovir

concentrations by this mechanism. Similarly, valaciclovir administration may increase plasma

concentrations of the concurrently administered substance.

In patients receiving higher aciclovir exposures from valaciclovir (e.g., at doses for zoster treatment

or CMV prophylaxis), caution is required during concurrent administration with drugs which which

inhibit active renal tubular secretion.

Increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an

immunosuppressant agent used in transplant patients, have been shown when the drugs are co-

administered. No changes in peak concentrations or AUCs are observed with co-administration of

valaciclovir and mycophenolate mofetil in healthy volunteers. There is limited clinical experience

with the use of this combination.

4.6

Fertility, pregnancy and lactation

Pregnancy

A limited amount of data on the use of valaciclovir and a moderate amount of data on the use of

aciclovir in pregnancy is available from pregnancy registries (which have documented the

pregnancy outcomes in women exposed to valaciclovir or to oral or intravenous aciclovir, the active

metabolite of valaciclovir); 111 and 1246 outcomes (29 and 756 exposed during the first trimester

of pregnancy, respectively) and postmarketing experience indicate no malformative or

foeto/neonatal toxicity. Animal studies do not show reproductive toxicity for valaciclovir (see

section 5.3). Valaciclovir should only be used in pregnancy if the potential benefits of treatment

outweigh the potential risk.

Breastfeeding

Aciclovir,

principle

metabolite

valaciclovir,

excreted

breast

milk.

However,

therapeutic doses of valaciclovir, no effects on the breastfed newborns/infants are anticipated since

the dose ingested by the child is less than 2% of the therapeutic dose of intravenous aciclovir for

treatment of neonatal herpes (see Section 5.2).

Valaciclovir should be used with caution during breast feeding and only when clinically indicated.

Page 7 of 14

Fertility:

Valaciclovir did not affect fertility in rats dosed by the oral route. At high parenteral doses of

aciclovir testicular atrophy and aspermatogenesis have been observed in rats and dogs. No human

fertility studies were performed with valaciclovir, but no changes in sperm count, motility or

morphology were reported in 20 patients after 6 months of daily treatment with 400 to 1000 mg

aciclovir.

4.7

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. The clinical

status of the patient and the adverse reaction profile of valtrex should be borne in mind when

considering the patient’s ability to drive or operate machinery. Further, a detrimental effect on such

activities cannot be predicted from the pharmacology of the active substance.

4.8

Undesirable effects

The most common adverse reactions (ARs) reported in at least one indication by patients treated

with Valtrex in clinical trials were headache and nausea. More serious ARs such as thrombotic

thrombocytopenic purpura/haemolytic uraemic syndrome, acute renal failure and neurological

disorders are discussed in greater detail in other sections of the label.

Undesirable effects are listed below by body system organ class and by frequency.

The following frequency categories are used for classification of adverse

effects:

Very common

1/10,

Common

1/100 to < 1/10,

Uncommon

1/1,000 to < 1/100,

Rare

1/10,000 to < 1/1000,

Very rare

< 1/10,000

Clinical trial data have been used to assign frequency categories to ARs if, in the trials, there was

evidence of an association with valaciclovir. For ARs identified from postmarketing experience, but

not observed in clinical trials, the most conservative value of point estimate (“rule of three”) has

been used to assign the AR frequency category. For ARs identified as associated with valaciclovir

from post-marketing experience, and observed in clinical trials, study incidence has been used to

assign the AR frequency category. The clinical trial safety database is based on 5855 subjects

exposed to valaciclovir in clinical trials covering multiple indications (treatment of herpes zoster,

treatment/suppression of genital herpes & treatment of cold sores).

Clinical Trial Data

Nervous system disorders

Very common: Headache

Page 8 of 14

Gastrointestinal disorders

Common: Nausea.

Post Marketing Data

Blood and lymphatic system disorders

Uncommon:

Leukopenia, thrombocytopenia.

Leucopenia is mainly reported in immunocompromised patients.

Immune system disorders

Rare: Anaphylaxis.

Psychiatric and nervous system disorders

Common:

Dizziness,

Uncommon: Confusion, hallucinations, decreased consciousness, agitation, tremor.

Rare:

Ataxia, dysarthria, psychotic symptoms, convulsions, encephalopathy, coma,

delirium.

Neurological disorders, sometimes severe, may be linked to encephalopathy and include confusion,

agitation, convulsions, hallucinations, coma. These events are generally reversible and usually seen

in patients with renal impairment or with other predisposing factors (see section 4.4). In organ

transplant patients receiving high doses (8000 mg daily) of Valtrex for CMV prophylaxis,

neurological

reactions

occurred

more

frequently

compared

with

lower

doses

used

other

indications

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea .

Gastrointestinal disorders

Common:

Vomiting, diarrhoea.

Uncommon : Abdominal discomfort.

Hepato-biliary disorders

Uncommon: Reversible increases in liver function tests (e.g. bilirubin, liver enzymes).

Skin and subcutaneous tissue disorders

Common: Rashes including photosensitivity, pruritus.

Uncommon: Urticaria

Rare: Angioedema.

Renal and urinary disorders

Uncommon: Renal pain, haematuria (often associated with other renal events).

Rare:

Renal impairment

acute renal failure(especially in elderly patients or in patients

with renal impairment receiving higher than the recommended doses).

Renal pain may be associated with renal failure.

Intratubular precipitation of aciclovir crystals in the kidney has also been reported. Adequate fluid

intake should be ensured during treatment (see section 4.4).

Page 9 of 14

Additional information on special populations

There have been reports of renal insufficiency, microangiopathic haemolytic anaemia and

thrombocytopenia (sometimes in combination) in severely immunocompromised adult patients,

particularly those with advanced HIV disease, receiving high doses (8000 mg daily) of valaciclovir

for prolonged periods in clinical trials. These findings have been observed in patients not treated

with valaciclovir who have the same underlying or concurrent conditions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected

adverse events should be reported to the Ministry of Health according to the National Regulation by

using an online form

/https://sideeffects.health.gov.il

Additionally, you should also report to GSK Israel (il.safety@gsk.com).

4.9

Overdose

Symptoms and signs

Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation,

decreased consciousness and coma, have been reported in patients receiving overdoses of

valaciclovir. Nausea and vomiting may also occur. Caution is required to prevent inadvertent

overdosing. Many of the reported cases involved renally impaired and elderly patients receiving

repeated overdoses, due to lack of appropriate dosage reduction.

Treatment

Patients should be observed closely for signs of toxicity. Haemodialysis significantly enhances the

removal of acyclovir from the blood and may, therefore, be considered a management option in the

event of symptomatic overdose.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Antivirals for systemic use

Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors,

ATC code: J05A B11.

Mechanism of Action

Valaciclovir, an antiviral, is the L-valine ester of acyclovir. Acyclovir is a purine (guanine)

nucleoside analogue.

Valaciclovir is rapidly and almost completely converted in man to aciclovir and valine, probably by

the enzyme referred to as valaciclovir hydrolase.

Aciclovir is a specific inhibitor of the herpes viruses with in vitro activity against herpes simplex

viruses (HSV) type 1 and type 2, varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-

Barr Virus (EBV) and human herpes virus 6 (HHV-6). Aciclovir inhibits herpes virus DNA

synthesis once it has been phosphorylated to the active triphosphate form.

Page 10 of 14

The first stage of phosphorylation requires the activity of a virus-specific enzyme. In the case of

HSV, VZV and EBV this enzyme is the viral thymidine kinase (TK), which is only present in virus-

infected cells. Selectivity is maintained in CMV with phosphorylation, at least in part, being

mediated through the phosphotransferase gene product of UL97. This requirement for activation of

aciclovir by a virus- specific enzyme largely explains its selectivity.

The phosphorylation process is completed (conversion from mono- to triphosphate) by cellular

kinases. Acyclovir triphosphate competitively inhibits the virus DNA polymerase and incorporation

of this nucleoside analogue results in obligate chain termination, halting virus DNA synthesis and

thus blocking virus replication.

Pharmacodynamic Effects

Resistance to aciclovir is normally due to a thymidine kinase deficient phenotype which results in a

virus which is disadvantaged in the natural host. Reduced sensitivity to aciclovir has been described

as a result of subtle alterations in either the virus thymidine kinase or DNA polymerase. The

virulence of these variants resembles that of the wild-type virus.

Monitoring of clinical HSV and VZV isolates from patients receiving aciclovir therapy or

phophylaxis has revealed that virus with reduced sensitivity to aciclovir is extremely rare in the

immunocompetent host and is found infrequently in severely immunocompromised individuals e.g.

organ or bone marrow transplant recipients, patients receiving chemotherapy for malignant disease

and people infected with the human immunodeficiency virus (HIV).

Clinical studies

Varicella Zoster Virus Infection

Valtrex accelerates the resolution of pain: it reduces the duration of and the proportion of patients

with zoster-associated pain, which includes acute and, in patients older than 50 years, also post-

herpetic neuralgia. Valtrex reduces the risk of ocular complications of ophthalmic zoster.

Intravenous therapy generally is considered standard for zoster treatment in immunocompromised

patients; however, limited data indicate a clinical benefit of valaciclovir in the treatment of VZV

infection (herpes zoster) in certain immunocompromised patients, including those with solid organ

cancer, HIV, autoimmune diseases, lymphoma, leukaemia and stem cell transplants.

Herpes Simplex Virus Infection

Valaciclovir for ocular HSV infections should be given according to applicable treatment

guidelines.

Studies of valaciclovir treatment and suppression for genital herpes were performed in HIV/HSV

coinfected patients. with a median CD4 count of > 100cells/mm3. Valaciclovir 500 mg twice daily

was superior to 1000 mg once daily for suppression of symptomatic recurrences Valaciclovir 1000

mg twice daily for treatment of recurrences was comparable to oral aciclovir 200 mg five times

daily on herpes episode duration. Valaciclovir has not been studied in patients with severe immune

deficiency.

The efficacy of valaciclovir for the treatment of other HSV skin infections has been documented.

Valaciclovir has shown efficacy in the treatment of herpes labialis (cold sores), mucositis due to

chemotherapy or radiotherapy, HSV reactivation from facial resurfacing, and herpes gladiatorum.

Based on historical aciclovir experience, valaciclovir appears to be as effective as aciclovir for the

treatment of erythema multiforme, eczema herpeticum and herpetic whitlow.

Page 1 of 14

ראורבפ

2020

: ןודנה

Valtrex Tablets 500 mg

תוילבט סקרטלו

500

ג"מ

Valaciclovir (As Hydrochloride) 500 mg

ה/דבכנ ה/אפור

,ה/דבכנ ת/חקור

( מ"עב לארשי ןיילקתימסוסקלג תרבח

GSK

לע עידוהל תשקבמ )

אפורל ןולעה ןוכדע ןכרצל ןולעהו

לש

רישכתה

.Valtrex Tablets 500 mg

:ללוכ ןודעה

ולע םינ רשואש

ו

העמטהל ראוניב

2020

תואירבה דרשמ ידי לע

(

לע ססובמ ןולע מ רשואמ ילוי

2019

)

:

ןונימ רטשמ ןוכדעו היוותה יוניש םיללוכ םינולעב םינוכדעה

התשענש היצזינומרה יפ לע( ןוכדעה תרגסמב . )הפוריאב

ץומיא השענ רל ( ילגנאה ןולעה לש )ןכרצלו אפו רבעמו

ל

טמרופ ינכדעה ןכרצל ןולעה לש

לארשיב

-

ולעה ךכמ האצותכ םינ

כ

ללו םי

םייוניש םיבר

.

לממ ונא םינולעה תא אורקל םיצי

םיפרוצמה אלמ ןפואב

ו

ןויעב

בר

.

יצקיפיטונ ןוכדע

ה

ראורבפמ

2020

ססובמ(

לע הילגנא לש אפורל ןולע ינוימ

2019

)

.

יתוהמה םייונישה םילולכ וז העדוהב .דבלב םי

םינמוסמה םינוכדעל ארקמ

רסוהש עדימ

הצוח םודא וקב ןמוסמ

תפסות

בתכ לוחכ

הרמחה תפסות

בתכ לוחכ

רקרמ בוהצב ןמוסמ

רישכתל םינכדועמה ןונימה רטשמו היוותהה

לארשיב

:

:אפורל ןולעב

4.1 Therapeutic indications:

4.1

Therapeutic indications

Varicella zoster virus (VZV) infections – herpes zoster

Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in

immunocompetent adults.

Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate

immunosuppression.

Herpes simplex virus (HSV) infections

Valtrex is indicated

Page 2 of 14

for the treatment and suppression of HSV infections of the skin and mucous

membranes including:

treatment of first-episode of genital herpes in immunocompetent adults and

adolescents and in immunocompromised adults.

treatment of recurrences of genital herpes in immunocompetent adults and

adolescents, and in immunocompromised adults.

suppression of recurrent genital herpes in immunocompetent adults and

adolescents and in immunocompromised adults.

Treatment and suppression of recurrent ocular HSV infections in immunocompetent

adults and adolescents and in immunocompromised adults.

Clinical studies have not been conducted in HSV-infected patients immunocompromised for other

causes than HIV-infection.

Cytomegalovirus (CMV) infections:

Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ

transplantation in adults and adolescents.

4.2 Posology and method of administration:

Varicella zoster virus (VZV) infections – herpes zoster and ophthalmic zoster

Patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster.

There are no data on treatment started more than 72 hours after onset of the zoster rash.

Immunocompetent Adults

The dose in immunocompetent patients is 1000 mg three times daily for seven days (3000 mg total

daily dose). This dose should be reduced according to creatinine clearance (see Renal impairment

below).

Immunocompromised Adults

The dose in immunocompromised patients is 1000 mg three times daily for at least seven days

(3000 mg total daily dose) and for 2 days following crusting of lesions. This dose should be reduced

according to creatinine clearance (see Renal impairment below).

In immunocompromised patients, antiviral treatment is suggested for patients presenting within

one week of vesicle formation or at any time before full crusting of lesions.

Treatment of herpes simplex virus (HSV) infections in adults and adolescents (≥12 years):

Immunocompetent Adults and Adolescents (≥12 years)

The dose is 500 mg of valtrex to be taken twice daily (1000 mg total daily dose).

This dose should be reduced according to creatinine clearance (see Renal impairment below).

Page 3 of 14

For recurrent episodes treatment should be 5 days. For initial episodes, which can be

more severe, treatment may have to be extended to ten days.

Dosing should begin as early as possible. For recurrent episodes of herpes simplex,

this should ideally be during the prodromal period or immediately upon appearance of

the first signs or symptoms. Valtrex can prevent lesion development, when taken at

the first signs and symptoms of an HSV recurrence.

Herpes labialis

For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment

in adults and adolescents. The second dose should be taken about 12 h (no sooner than 6 h) after

the first dose. This dose should be reduced according to creatinine clearance (see Renal

impairment below). When using this dosing regimen, treatment should not exceed one day, since

this has been shown not to provide additional clinical benefit. Therapy should be initiated at the

earliest symptom of a cold sore (e.g. tingling, itching or burning).

Immunocompromised Adults

For the treatment of HSV in immunocompromised adults, the dosage is 1000 mg twice daily for at

least 5 days, following assessment of the severity of the clinical condition and immunological

status of the patient. For initial episodes, which can be more severe, treatment may have to be

extended to ten days. Dosing should begin as early as possible. This dose should be reduced

according to creatinine clearance (see Renal impairment below). For maximum clinical benefit, the

treatment should be started within 48 hours. A strict monitoring of the evolution of lesions is

advised.

Suppression of recurrences of herpes simplex virus (HSV) infections in adults and adolescents (≥12

years)

Immunocompetent Adults and Adolescents (≥12 years):

The dose is 500 mg of Valtrex to be taken once daily. Some patients with very frequent recurrences

10/year in absence of therapy) may gain additional benefit from the daily dose of 500 mg being

taken as a divided dose (250 mg twice daily). This dose should be reduced according to creatinine

clearance (see Renal impairment below).Treatment should be re-evaluated after 6 to 12 months of

therapy.

Immunocompromised Adults

The dose is 500 mg of Valtrex twice daily. This dose should be reduced according to creatinine

clearance (see Renal impairment below). Treatment should be re-evaluated after 6 to 12 months

of therapy.

Prophylaxis of cytomegalovirus (CMV) infection and disease in adults and adolescents (≥12 years)

The dosage is 2000 mg four times a day, to be initiated as early as possible post-

transplant. This dose should be reduced according to creatinine clearance (see Renal

impairment below).

Page 4 of 14

The duration of treatment will usually be 90 days, but may need to be extended in high-risk

patients.

Special populations

children:

The efficacy of Valtrex in children below the age of 12 years has not been evaluated.

Elderly:

The possibility of renal impairment in the elderly must be considered and the dose should be

adjusted accordingly (see Renal impairment below). Adequate hydration should be maintained.

Renal impairment:

Caution is advised when administering Valtrex to patients with impaired renal

function. Adequate hydration should be maintained. The dose of Valtrex should be

reduced in patients with impaired renal function as shown in Table 1 below.

In patients on intermittent haemodialysis, the Valtrex dose should be administered

after the haemodialysis has been perfomed.

The creatinine clearance should be monitored frequently, especially during periods when renal

function is changing rapidly e.g. immediately after renal transplantation or engraftment. The

Valtrex dosage should be adjusted accordingly.

Hepatic impairment

Studies with a 1000 mg dose of valaciclovir in adult patients show that dose modification is not

required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained).

Pharmacokinetic data in adult patients with advanced cirrhosis, (impaired hepatic synthetic

function and evidence of portal-systemic shunting) do not indicate the need for dose adjustment;

however, clinical experience is limited. For higher doses (4000 mg or more per day), see section

4.4.

Page 5 of 14

Table 1: DOSAGE ADJUSTMENT FOR RENAL IMPAIRMEN

Therapeutic indication

Creatinine clearance (mL/min)

Valaciclovir Dosage

a

Varicella-Zoster Virus (VZV) Infections

Treatment of herpes zoster (shingles)

in immunocompetent and

immunocompromised adults

30 to 49

10 to 29

1000 mg three times daily

1000 mg twice daily

1000 mg once daily

500 mg once daily

Herpes Simplex Virus (HSV)

Infections

Treatment of HSV infections

- immunocompetent adults and

adolescents

< 30

500 mg twice daily

500 mg once daily

- immunocompromised adults

< 30

1000 mg twice daily

1000 mg once daily

Treatment of herpes labialis

(cold sores) in

immunocompetent adults and

adolescents

(alternative 1-day regimen)

30 to 49

10 to 29

<10

2000mg twice in one day

1000 mg twice in one day

500 mg twice in one day

500 mg single dose

Suppression of HSV infections

- immunocompetent adults and

adolescents

< 30

500 mg once daily

250 mg once daily

-immunocompromised adults

< 30

500 mg twice daily

500 mg once daily

Cytomegalovirus (CMV) Infections

CMV prophylaxis in solid organ

transplant recipients in adults and

50 to <75

2000 mg four times daily

1500 mg four times daily

Page 6 of 14

adolescents

25 to <50

10 to <25

<10 or on dialysis

1500 mg three times daily

1500 mg twice daily

1500 mg once daily

For patients on intermittent haemodialysis, the dose should be given after dialysis on dialysis

days.

For HSV suppression in immunocompetent subjects with a history of

recurrences/year, better results may be obtained with 250 mg twice daily.

ןכרצל ןולעב

:

1

.

?הפורתה תדעוימ המל

ידי לע לעופ סקרטלו ידג תריצע וא הליטק ארקנה םיפיגנ לש הל סקלפמיס ספרה םי

(HSV)

הלצירו , וז רטס

(VZV)

ולגמוטיצו

סוריו

(CMV)

ל תדעוימ סקרטלו

תרגוח תקבלשב לופיט

םירגובמב

םימוהיזב לופיט

מ םיעבונה םייניע סוריו

ophthalmic zoster

םירגובמב ) .תשלחומ ןוסיח תכרעמ םע

לופיט ימוהיזב

סקלפמיס ספרה

רועה לש )רוק יעצפ המגודל ומכ( ספרהו ילטינג רגובמב תמו םי םירגב

עייסל ידכ םג תשמשמ איה

תעינמב תונשיה

לש .הלא םימוהיז

ימוהיז תונשיה תעינמו לופיט

סקלפמיס ספרה

ןיעה לש ) םירגובמב

ירגבתמו

והיז תעינמ

םירביא תלתשה רחאל

םירגבתמו םירגובמב

יטיופרת הצובק

סקרטלו םילאריויטנא תארקנה תופורת תצובקל תכייש

3

.

תב שמתשת דציכ ?הפור

תב שמתשהל שי הב דימת רישכ .אפורה תוארוהל םאת

רה םע קודבל ךילע .רישכתב לופיטה ןפואו ןונימל עגונב חוטב ךניא םא חקורה וא אפו

.דבלב אפורה ידי לע ועבקי לופיטה ןפואו ןונימה ללכ ךרדב לבוקמה ןונימה

:אוה

ב לופיט תרגוח תקבלש

Herpes zoster

םירגובמב

מה ןונימה אוה לבוק

1000

ג"מ

יתש תוילבט

סקרטלו לש

)ג"מ

םימעפ שולש םויב

סקרטלו תחקל ךילע

ךשמב העבש

.םימי

לופיט רוק יעצפב

Cold sore

ליגמ( םירגבתמבו םירגובמב

)הלעמו

Page 7 of 14

אוה לבוקמה ןונימה

2000

( ג" עברא תוילבט סקרטלו לש

)ג"מ םויב םיימעפ ,

ירצ הינשה הנמה חקליהל הכ

תוע מ תוחפ אל(

)תועש

רחאל

הנושארה הנמה

תונמ יתש( דחא םוי ךשמב סקרטלו תחקל ךילע .דבלב )

ימוהיזב לופיט

ילטינג ספרהו רועה ל

ליגמ( םירגבתמבו םירגובמב

)הלעמו

ןונימה קמה לבו

אוה

( ג"מ הילבט

לש תחא

)ג"מ

םויב םיימע

והיזה רובע

ןושארה

תחקל ךילע

סקרטלו ךשמב השימח

םימי

םא םימי הרשע דע וא ללכ ךרדב אוה לופיטה ךשמ רזוח םוהיזל .ךתוא החנה ךלש אפורה

.םימי

ימוהיז לש םתרזח תעינמב עויס

ליגמ( םירגבתמבו םירגובמב

עמו )הל

ןונימה אוה לבוקמה

הילבט

סקרטלו לש תחא

ג"מ

םויב םעפ

סקרטלו תחקל ךילע מוא ךלש אפורהש דע .קיספהל ךל ר

לופיט

םוהיז

לש

ולגמוטיצ(

)סוריו

ליגמ( םירגבתמבו םירגובמב

)הלעמו

אוה לבוקמה ןונימה

2000

( ג"מ עברא תוילבט

רטלו לש

)ג"מ

מעפ עברא .םויב םי

לש חוורמב דרפנב הנמ לכ תחקל ךילע

.תועש

ת ללכ ךרדב התא חת לי סקרטלו תחקל ירשפאה םדקהב

.ךלש חותינה רחאל

ךשמב סקרטלו תחקל ךילע

ךרעב

ךל רמוא ךלש אפורהש דע ,ךלש חותינה רחאל םימי .קיספהל

יושע ךלש אפורה םיאתהל

:םא סקרטלו לש ןונימה תא

ליג לעמ התא

םינ

השלח תינוסיח תכרעמ ךל שי

.הילכ תויעב ךל שי

םע רבד פורה לש א חקיתש ינפל ך סקרטלו ח הלאמ דחא םא .ךילע ל

תצלמומה הנמה לע רובעל ןיא

.

וז הפורת תליטנ

.הפה ךרד וז הפורת תחקל שי

תוילבטה תא עולבל שי

ןתומלשב .םימ תיתש םע

.הסיעל/היצח/השיתכ יבגל עדימ ןיא

.םוי לכב ןמז ותואב סקרטלו תחקל

רה תוארוהל םאתהב סקרטלו תחקל שי .ךלש אפורה וא חקו

Page 8 of 14

ליג לעמ םישנא

65

הילכ תויעב םע וא םינש

התאש ןמזבש דואמ בושח לטונ

עובק ןפואב םימ התשת סקרטלו .םויה ךלהמב

יאוול תועפות תיחפהל רוזעי הז תולולעש

עה תכרעמ לע וא הילכה לע עיפשהל רטני ךלש אפורה .םיבצ ןפואב ךתוא

ב יאוול תועפות .הלא םינמיסל קודה םיבצעה תכרעמ לולע תו

ובלב תשוחת לולכל וא ל .ןפוד תואצוי םונמנ וא תוינונשי תשוחת וא ,תונבצע

םא תלטנ רתוי הובג ןונימ תועטב

הקיזמ הניא סקרטלו

התא ןכ םא אלא ,ללכ ךרד לטונ

א .םימי המכ ךשמב ידמ רתוי

לוטית

ידמ רתוי ל לולע התא תוילבט תוילכב תויעב ,האקה ,הליחב שיגרה

,לובלב

קש רס

תוחפ שיגרהל עדומ

היאר וא םימייק םניאש םירבד לש .הרכה דוביא

םילוח תיב לש ןוימ רדחל וא אפורל דימ הנפ ,הפורתה ןמ דלי עלב תועטב םא וא רתי תנמ תחקל םא .ךתיא הפורתה תזירא אבהו

א

ם

תחכש לוטיל הפורתה תא

,סקרטלו לוטיל תחכש ם .רכזנ התאש עגרב חק

הז םא ,םלוא מה דעומל בורק הנ

לע גלד ,ךלש האבה .הצמחוהש הנמה

.החכשנש הנמ לע תוצפל ידכ הלופכ הנמ לוטיל ןיא

.אפורה ידי לע ץלמוהש יפכ לופיטב דימתהל שי

הנמהו תיוותה קודב !ךשוחב תופורת לוטיל ןיא כב

ל

םעפ

ה .הפורת לטונ ךנהש ךנה םא םייפקשמ בכר .םהל קוקז

תופסונ תולאש ךל שי םא תב שומישל עגונב .חקורב וא אפורב ץעוויה ,הפור

Page 9 of 14

םייתוהמ םינוכדע

נ

םיפסו

ושענ

ב

םיאבה םיפיעס

ב

:אפורל ןולע

4.4 Special warnings and precautions for use

....

Use for zoster treatment

Clinical response should be closely monitored, particularly in immunocompromised

patients. Consideration should be given to intravenous antiviral therapy when response

to oral therapy is considered insufficient.

Patients with complicated herpes zoster, i.e. those with visceral involvement,

disseminated zoster, motor neuropathies, encephalitis and cerebrovascular

complications should be treated with intravenous antiviral therapy.

Moreover, immunocompromised patients with ophthalmic zoster or those with a high

risk for disease dissemination and visceral organ involvement should be treated with

intravenous antiviral therapy.

Transmission of genital herpes

Patients should be advised to avoid intercourse when symptoms are present even if

treatment with an antiviral has been initiated. During suppressive treatment with

antiviral agents, the frequency of viral shedding is significantly reduced. However, the

risk of transmission is still possible. Therefore, in addition to therapy with valaciclovir, it

is recommended that patients use safer sex practices.

Use in ocular HSV infections

Clinical response should be closely monitored in these patients. Consideration should

be given to intravenous antiviral therapy when response to oral therapy is unlikely to be

sufficient.

Use in CMV infections

Data on the efficacy of valaciclovir from transplant patients (~200) at high risk of CMV

disease (e.g. donor CMV-positive/recipient CMV negative or use of anti-thymocyte

globulin induction therapy) indicate that valaciclovir should only be used in these

patients when safety concerns preclude the use of valganciclovir or ganciclovir.

High dose valaciclovir as required for CMV prophylaxis may result in more frequent

adverse events, including CNS abnormalities, than observed with lower doses

administered for other indications (see section 4.8). Patients should be closely

monitored for changes in renal function, and doses adjusted accordingly (see section

4.2).

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions have been identified.

The combination of valaciclovir with nephrotoxic medicinal products should be made

with caution, especially in subjects with impaired renal function, and warrants regular

monitoring of renal function. This applies to concomitant administration with

aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate,

pentamidine, foscarnet, ciclosporin, and tacrolimus.

Page 10 of 14

Acyclovir Aciclovir is eliminated primarily unchanged in the urine via active renal tubular

secretion. Any drugs administered concurrently that compete for this route of

elimination may increase plasma acyclovir concentrations following valaciclovir

administration.

Following 1g 1000 mg valaciclovir, cimetidine and probenecid reduce aciclovir renal

clearance and increase the AUC of acyclovir aciclovir by about 25% and 45%,

respectively, by inhibition of the active renal secretion of aciclovir. by this mechanism,

and reduce acyclovir renal clearance. However, no dosage adjustment is necessary

because of the wide therapeutic index of acyclovir. Cimetidine and probenecid taken

together with valaciclovir increased aciclovir AUC by about 65%. Other medicinal

products (including e.g. tenofovir) administered concurrently that compete with or inhibit

active tubular secretion may increase aciclovir concentrations by this mechanism.

Similarly, valaciclovir administration may increase plasma concentrations of the

concurrently administered substance.

4.8 Undesirable effects

Clinical Trial Data

Nervous system disorders

Very common: Headache

Gastrointestinal disorders

Common: Nausea.

Post Marketing Data

Blood and lymphatic system disorders

Very rare Uncommon:

Leukopenia, thrombocytopenia.

Leukopenia is mainly reported in immunocompromised patients.

Immune system disorders

Very rare Rare: Anaphylaxis.

Psychiatric and nervous system disorders

Rare Common: Dizziness,

Uncommon: Confusion, hallucinations, decreased consciousness, agitation, tremor.

Very rare Rare: Agitation, tremor, Ataxia, dysarthria, psychotic symptoms, convulsions,

encephalopathy, coma, delirium

Neurological disorders, sometimes severe, may be linked to encephalopathy and

include confusion, agitation, convulsions, hallucinations, coma. The above These

events are generally reversible and usually seen in patients with renal impairment or

with other predisposing factors (see Warning and Precautions section 4.4). In organ

transplant patients receiving high doses (8g 8000 mg daily) of Valaciclovir Valtrex for

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