VECTOR PLUS 16012.5

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
HYDROCHLOROTHIAZIDE; VALSARTAN
Available from:
UNIPHARM LTD, ISRAEL
ATC code:
C09CA03
Pharmaceutical form:
TABLETS
Composition:
VALSARTAN 160 MG; HYDROCHLOROTHIAZIDE 12.5 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
Therapeutic group:
VALSARTAN
Therapeutic area:
VALSARTAN
Therapeutic indications:
For the treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy. This fixed combination should be used as second-line therapy.
Authorization number:
146 06 33406 00
Authorization date:
2016-04-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

22-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

09-07-2020

11C19

119858010

مييقت نكمي لا( ةفورعم ريغ اهراشتنا ةريتو ةيبناج ضارعأ :)ةرفوتملا تامولعملا ىلإ ادانتسا راشتنلاا ىوتسم ;لوبلا جاتنإ يف ريبك ضافخنا

ُّ

فنتلا يف تابوعص ىلإ يدؤت دق( مدلا يف مويدوصلا نم ةضفخنم تايوتسم يف تابون وأ/و تلاضعلا يف تاجنشت ،كابترا ،بعت مدلا يف مويساتوبلا نم ةضفخنم تايوتسم ;)ةداح تلااح ةريتوو ،تلاضعلا صلقت ،تلاضعلا فعض انايحأ اهقفاري( مدلا تايرك نم ةضفخنم تايوتسم ;)ةميلس ريغ بلق مظن يف ملأ ،ةيدلج تاثولت ،ىم

ح :لاثم ،تاملاع اهقفارت( ءاضيبلا عافترا ;)فعضو ،تاثولت ببسب مفلا يف تاحرقت ،ةرجنحلا ىلإ ةريطخ تلااح يف يدؤي دق( مدلا يف نيبوريليبلا ىوتسم ايرويلا نيجورتين تايوتسم عافترا ;)نينيعلاو دلجلا رارفصا ىلإ تايوتسملا هذه ريشت دق( نينتايركلاو ) BUN ( مدلا يف ضمح تايوتسم عافترا ;)ىلكلا ءادأ يف ررض ثودح طيشنت ىلإ ةريطخ تلااح يف يدؤي دق يذلا( مدلا يف كيرويلا .ءامغإ ;))Gout( سرقنلا ءاد لامعتسا دنع ةيلاتلا ةيبناجلا ضارعلأا نع غلابلإا مت وأ ناتراسلاڨ نم لك نمضتت ىرخأ تارضحتسم :ةدح ىلع ديزايثورولكورديه :ناتراسلاڨ 1 ىتح ىدل رهظت ضارعأ( ةعئاش تسيل ةيبناج ضارعأ :)لمعتسم 100 نيب نم .نطبلا يف ملأ ;راودلاب روعشلا مييقت نكمي لا( ةفورعم ريغ اهراشتنا ةريتو ةيبناج ضارعأ :)ةرفوتملا تامولعملا ىلإ ادانتسا اهراشتنا ةريتو ،]Dermatitis[ دلجلا باهتلا ىلإ ريشت ةملاع( ةيدلج تارثب ضعب هقفاري ،ةكح نود نم وأ عم ،يدلج حفط ;)يسيكلا ملأ ،لصافملا يف ملأ ،ىم

ح :ةيلاتلا ضارعلأا وأ تاملاعلا ةهيبش تاملاع وأ/و ةيوافمللا د

علا مروت ،تلاضعلا يف ةكحو ،ىم

ح ،ءارمح - ةيجسفنب عقب ،حفط ;ازنولفنلإاب ىوتسم ;)ةيومدلا ةيعولأا يف باهتلا ىلإ ريشت تاملاع( فيزن عم انايحأ رهظت( ةيومدلا حئافصلا نم ضفخنم مدلا يف مويساتوبلا نم ةيلاع تايوتسم ;)ةيئانثتسا تامدكو ;)ةمظتنم ريغ بلق ةريتو ،تلاضعلا جنشت عم انايحأ رهظت( ،ىرش ،ةكح ،حفط :لاثم ،تاملاع هقفارت( يجرأ لعافت اميس لا ،مروت ;)ةخود ،علاتبلاا وأ س

ُّ

فنتلا يف تابوعص ءادأ صوحف جئاتن عافترا ;ةكح ،حفط :ةرجنحلاو هجولا يف ايلاخ ةبسن ضافخناو نيبولغوميهلا تايوتسم ضافخنا ;دبكلا يف ضافخنلاا يدؤي دق ،ةريطخلا تلااحلا يف( ءارمحلا مدلا ةضفخنم تايوتسم ;يولك لشف ;)مدلا رقف ىلإ نيتلاحلا اتلك تاجنشت ،كابترا ،بعت ىلإ يدؤت دق( مدلا يف مويدوصلا نم .)ةريطخ تلااح يف تابون وأ/و تلاضعلا يف :ديزايثورولكورديه نم رثكأ ىدل رهظت ضارعأ( ادج ةعئاش ةيبناج ضارعأ :(نيلمعتسم 10 نيب 1 لمعتسم .مدلا تاينهد عافترا ;مدلا يف مويساتوبلا نم ةضفخنم تايوتسم 1 لمعتسم ىتح ىدل رهظت ضارعأ( ةعئاش ةيبناج ضارعأ :)نيلمعتسم 10 نيب تايوتسم ;مدلا يف مويدوصلا نم ةضفخنم تايوتسم ضمح نم ةيلاع تايوتسم ;مدلا يف مويسنغملا نم ةضفخنم نم ةفلتخم لاكشأ وأ ةكح هقفارت حفط ;مدلا يف كيرويلا دنع ءامغإ ،ةخود ;ؤيقتو فيفط نايثغ ;ةيهشلا نادقف ;حفطلا ىلإ لصوتلا ىلع ةردقلا صقن ;فوقولا ةيعضو ىلإ لاقتنلاا .هيلع ظافحلا وأ باصتنلاا 1 لمعتسم ىتح ىدل رهظت ضارعأ( ةردان ةيبناج ضارعأ :)لمعتسم 1,000 نيب نم ;)سمشلل دلجلا ةيساسح ةدايز ببسب( ةيدلج تارثبو مروت نم ةيلاع تايوتسم ;مدلا يف مويسلاكلا نم ةيلاع تايوتسم تاذ ةيبلاقتسلاا ةلاحلا مقافت ;لوبلا ركس ;مدلا يف ركسلا ،نطبلا يف جاعزنا ،لاهسإ ،كاسمإ ;يركسلاب ةلصلا ;دلجلاو نينيعلا رارفصا هقفاري دق يذلا ،دبكلا يف بارطضا ;مونلا يف تابارطضا ;عادص ;ةمظتنم ريغ بلق مظن ةريتو حئافصلا نم ةضفخنم تايوتسم ;)بائتكا( ضفخنم جازم ;)دلجلا تحت تامدك وأ فيزن عم انايحأ ثدحت( ةيومدلا .ةيؤرلا يف تابارطضا ;ساسحلإا نادقف وأ تاعسل ;ةخود لمعتسم ىتح ىدل رهظت ضارعأ( ادج ةردان ةيبناج ضارعأ :)لمعتسم 10,000 نيب نم 1 عقب ،حفط :لاثم ،ضارعأ عم ةيومدلا ةيعولأا يف تاثولت ،ىرش ،ةكح ،حفط ;) vasculitis ( ىمح ،ءارمح - ةيجسفنب طرف لعف دودر( ةخود ،علاتبلااو س

ُّ

فنتلا يف تابوعص يف بارطضا ،لصافملا يف ملأ ،هجولا يف حفط ;)سسحتلا نطبلا يف داح ملأ ;)ةبئذلل ةلمتحم تاملاع( ىمح ،تلاضعلا ،ىمح عم سفنتلا يف تابوعص ;)سايركنبلا باهتلا( ةيولعلا نمضتت ةيسفنت ةقئاض( سفنتلا يف قيض ،ريفص ،لاعس يف قيض ،بعت ،بحاش دلج ;)ةيوئر ةمذوو نيتئرلا باهتلا ;)يللاحنلاا مدلا رقفل ةلمتحم تاملاع( نكاد لوب ،سفنتلا تايركلا ةلق( تاثولتلا ةجيتن تاحرقت وأ ةرجنحلا يف ملأ ،ىمح ،تلاضعلا يف تاصلقتو تاجنشت ،بعت ،كابترا ;)ضيبلا جتانلا ،)alkalosis) ءلاقلل ةلمتحم تاملاع( عيرس سفنت .)مدلا يف ديرولكلل ةضفخنم تايوتسم نع مييقت نكمي لا( ةفورعم ريغ اهراشتنا ةريتو ةيبناج ضارعأ :)ةرفوتملا تامولعملا ىلإ ادانتسا اهراشتنا ةريتو ىوتسم ;)يجسنتلالا مدلا رقف( ةرركتم تاثولتو تامدك ،فعض ةلمتحم تاملاع( لوبلا جاتنإ يف ريطخ ضافخنا رارمحا ،حفط ;)يولكلا لشفلل وأ ىلكلا يف تابارطضلا ،دلجلا ر

شقت ،مفلا وأ ،نينيعلا ،نيتفشلا يف روثب ،دلجلا صلقت ;)لاكشلأا ةددعتم ىمامحل ةلمتحم تاملاع( ىمحو ناطرس ;فعض ;)مسجلا ةرارح عافترا( ى

ح ;تلاضعلا .)امونلايم سيل عون نم دلجلا ناطرس( نيتفشلاو دلجلا ،ةيبناجلا ضارعلأا نم

ٌّ

يأ مقافت اذإ ،يبناج ضراع رهظ اذإ كيلع ،ةرشنلا يف ر

َ

كذ

ُ

ي مل

ّ

يبناج ض

ِ

راع نم تيناع اذإ وأ .بيبطلا ةراشتسا ةيبناجلا ضارعلأا نع غلابلإا طغضلا ربع ةيبناجلا ضارعلأاب ة

حصلا ةرازو غلابإ نكمي جلاعلا ببسب ةيبناجلا ضارعلأا نع غلابلإا" طبار ىلع ةرازو عقومل ةيسيئرلا ةحفصلا يف دوجوملا ،"يئاودلا ىلإ كهجوي يذلا (

www.health.gov.il

حصلا وأ ةيبناجلا ضارعلأا نع غلابلإل تنرتنلإا ىلع ةرامتسا :طبارلا ىلإ لوخدلا ربع

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

."ض.م مرافينوي" ةكرش غلابإ نكمي ،ةفاضلإاب

5

.

؟ءاودلا ن

ّ

زخ

ُ

ي فيك

يف ،رخآ ءاود

لكو ،ءاودلا اذه ظفح بجي !م

مستلا ب

نجت دلاولأا ةيؤر لاجمو يديأ لوانتم نع ا

ديعب ،قلغم ناكم نود ؤيقتلا ببست لا .م

مستلا ب

نجتت اذكهو ،لافطلأا وأ/و .بيبطلا نم ةحيرص تاميلعت

exp.) ةيحلاصلا ءاهتنا خيرات دعب ءاودلا لوانت عنم

بسن

ي ة

يحلاصلا ءاهتنا خيرات

وبعلا ىلع رهاظلا )date .رهشلا سفن نم ريخلأا مويلا ىلإ

25 نم لقأ ةرارح ةجردب

فاج ناكم يف نيزختلا بجي .ةيوئم ةجرد

.ةررضتم هتوبع تناك اذإ ءاودلا لامعتسا عنم

لس يف وأ

حصلا فرصلا هايم يف صارقلأا ءاقلإ عنم

ةيودلأا نم صلختت فيك يلديصلا لأسا .تيبلا يف تلامهملا .ةئيبلا ةدوج ىلع اظافح كلذو ،دعب اهيلإ جاتحت لا يتلا

6

.

ة

ّ

يفاضإ تامولعم :ىلع ا

ً

ضيأ ،ءاودلا يوتحي ،ةلا

ّ

عفلا داوملا ىلإ ةفاضلإاب

lactose monohydrate, microcrystalline

cellulose,

crospovidone,

magnesium

stearate, colloidal silicon dioxide, opadry

)orange, yellow(.

ّ

وبعلا يوحت اذامو ءاودلا ودبي فيك ةوبع نمض )تارتسيلب( تاحيول لخاد أبعم سولپ روتكڨ .اصرق 28 ةوبع لك نمضتت .ةينوترك ةبدحم ،ةريدتسم ة

يلطم صارقأ نع ةرابع وه سولپ روتكڨ يف رطشلل اطخ نمضتتو ،يلاقترب اهنول ،نيبناجلا لاك نم .دحاو بناج ، 10 ، 5 نمضتت سولپ روتكڨل ةفلتخم تاوبع ماجحأ كانه .اصرق 30 و 28 ، 20 ، 15 ، 14 .تاوبعلا ماجحأ لك ق

وس

ت لا دق

Patient leaflet in accordance with the

Pharmacists’ Regulations (Preparations)

- 1986

This medicine is dispensed with a doctor’s

prescription only

VECTOR PLUS

80/12.5

Film-coated tablets

Composition:

Each tablet contains:

Valsartan 80 mg

Hydrochlorothiazide 12.5 mg

VECTOR PLUS

160/12.5

Film-coated tablets

Composition:

Each tablet contains:

Valsartan 160 mg

Hydrochlorothiazide 12.5 mg

VECTOR PLUS

160/25

Film-coated tablets

Composition:

Each tablet contains:

Valsartan 160 mg

Hydrochlorothiazide 25 mg

Inactive ingredients: See section 6:

Additional information’.

Read the entire leaflet carefully before

you start using this medicine. This leaflet

contains

concise

information

about

this

medicine. If you have any further questions,

consult your doctor 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 to yours.

1.

What is this medicine intended for?

For the treatment of hypertension in patients

who need combined therapy with two active

ingredients.

Vector Plus contains two active ingredients

called

valsartan

hydrochlorothiazide.

Both of these components help to control

high blood pressure (hypertension).

Valsartan belongs to a group of medicines

known

“angiotensin

receptor

antagonists”

)blocking

receptor(,

which help to control high blood pressure.

Angiotensin II is a

substance in your body

that causes blood vessels to tighten, and

this causes your blood pressure to rise.

Valsartan works by blocking the effect of

angiotensin II. As a result, blood vessels

relax and blood pressure is lowered.

Hydrochlorothiazide belongs to a group

medicines

called

thiazide

diuretics.

Hydrochlorothiazide increases urine output,

which helps to lower blood pressure.

Vector Plus is used to treat high blood

pressure which is not adequately controlled

by a single substance alone.

High blood pressure increases the workload

of the heart and arteries. If not treated, it

can damage the blood vessels of the brain,

heart, and kidneys, and may result in a

stroke, heart failure or kidney failure. High

blood pressure increases the risk of heart

attacks. Lowering your blood pressure to

normal reduces the risk of developing these

disorders.

Therapeutic group: A combination of an

angiotensin

receptor

antagonist

with

thiazide diuretic.

2. Before using this medicine

Do not use this medicine if:

you are sensitive )allergic( to valsartan,

hydrochlorothiazide,

sulfonamide

derivatives

(substances

chemically

related

hydrochlorothiazide)

other

ingredients

this

medicine (listed in section 6)

you are more than 3 months pregnant (it

is also better to avoid Vector Plus in early

pregnancy - see the section ‘Pregnancy,

breastfeeding, and fertility’)

have

severe

liver

disease

with

destruction of the small bile ducts within

liver

(biliary

cirrhosis)

leading

build-up of bile in the liver )cholestasis(

you are unable to produce urine (anuria)

the levels of potassium or sodium in

your blood are lower than normal, or the

level of calcium in your blood is higher

than normal despite treatment

you have gout

you have diabetes or impaired kidney

function

(GFR<30ml/min/1.73m

being

treated

with

blood

pressure lowering medicine containing

aliskiren

If any of the above apply to you, inform

your doctor and do not take Vector Plus.

Special warnings about using this medicine:

Before taking Vector Plus, tell your

doct

or if:

taking

potassium-sparing

medicines, potassium supplements, salt

substitutes containing potassium or other

medicines that increase the amount of

potassium in your blood such as heparin.

Your

doctor

check

levels

potassium in your blood regularly

you have low levels of potassium in your

blood

you have diarrhea or severe vomiting

you are taking high doses of diuretics

you have severe heart disease

you have heart failure or have experienced

heart

attack.

Carefully

follow

your

doctor‘s instructions for the starting dose.

Your doctor may also check your kidney

function

you have a narrowing of the kidney artery

you have recently had a kidney transplant

have

disease

called

hyperaldosteronism. This is a disease

in which your adrenal glands make too

much of the hormone aldosterone. If this

applies to you, the use of Vector Plus is

not recommended

you have liver or kidney disease

you have ever experienced swelling of

the tongue and face caused by an allergic

reaction called angioedema when taking

other medicines )including ACE inhibitors(,

tell your doctor. If these symptoms occur

when you are taking Vector Plus, stop

taking

Vector

Plus

immediately

and

never

take

Vector

Plus

again.

section 4: ‘Side effects

have

fever,

rash,

joint

pain,

which may be signs of systemic lupus

erythematosus (an autoimmune disease)

you have diabetes, gout, high levels of

cholesterol or triglycerides in your blood

you have had an allergic reaction with

the use of other blood pressure-lowering

medicines of the same type (angiotensin II

receptor antagonists) or if you have allergy

or asthma

you experience eye pain or a decrease

in vision. These could be symptoms of

increased pressure in your eye that can

happen within hours to a week of taking

Vector Plus. This can lead to permanent

vision loss, if not treated. If you have ever

had an allergy to penicillin or sulfonamide

you are at a high risk of developing this

effect

you are taking any of the following

medicines

used

to

treat

high

blood

pressure:

ACE inhibitors )for example enalapril,

lisinopril, ramipril(, in particular if you

have diabetes-related kidney problems

aliskiren

have

ever

skin

cancer

develop

unexpected

skin

lesion while using this medicine. Using

hydrochlorothiazide may increase your

risk of developing skin or lip cancer (a

type of skin cancer that is not melanoma(,

particularly with long-term use of high

doses

Protect your skin from exposure to the

sun and ultraviolet (UV) rays while using

Vector Plus.

Vector Plus may cause increased sensitivity

of the skin to sun.

Tell your doctor if you think you are (or

might become) pregnant. Vector Plus is not

recommended in early pregnancy, and must

not be taken when more than three months

pregnant, as it may cause serious harm to

your baby if it is used during this stage of

pregnancy

(see

section

Pregnancy,

breastfeeding, and fertility’).

Tests and follow-up:

Your doctor may refer you to tests for kidney

function, blood pressure, and the levels of

electrolytes (e.g. potassium) in your blood

regularly during the course of this treatment.

See additional information under the section

Do not use this medicine if’.

Children and adolescents: Use of Vector

Plus in children and adolescents (under 18

years old) is not recommended.

Other medicines and Vector Plus

If you are taking or have recently taken

other medicines, including nonprescription

medications and dietary supplements, tell

your doctor or pharmacist. The effect of the

treatment can be influenced if Vector Plus is

taken together with certain other medicines.

It may be necessary to change your dose,

to take

other precautions, or in some cases

stop

taking

medicines.

particular, tell your doctor or pharmacist if

you are taking medicines that belong to any

of the following groups:

lithium, a medicine used to treat some

types of psychiatric disorders

edicines or substances that may increase

the levels of potassium in your blood.

These

include

potassium

supplements

or salt substitutes containing potassium,

potassium sparing medicines, and heparin

medicines that may reduce the levels of

potassium in your blood such as diuretics,

corticosteroids, laxatives, carbenoxolone,

amphotericin, or penicillin G

certain

antibiotics

)rifamycin

group(,

medicine used to protect against transplant

rejection )cyclosporine( or an antiretroviral

medicine used to treat HIV/AIDS infection

(ritonavir). These medicines may increase

the effect of Vector Plus

medicines that may cause heart rhythm

disorders

such

antiarrhythmics

(medicines used to treat heart problems)

and antipsychotics

medicines that may reduce the levels

sodium

your

blood,

such

antidepressants,

antipsychotics,

antiepileptics

medicines for the treatment of gout, such

as allopurinol, probenecid, sulfinpyrazone

vitamin D and calcium supplements

medicines for the treatment of diabetes

)oral

agents

like

metformin,

insulin

injections(

other

medicines

lowering

blood

pressure,

including

methyldopa,

inhibitors (such as enalapril, lisinopril( or

aliskiren (see additional information under

the headings ‘Do not use this medicine

if’ and ‘Special warnings about using

this medicine’)

medicines that raise your blood pressure

such as noradrenaline or adrenaline

digoxin

other

digitalis

glycosides

(medicines used to treat heart problems)

medicines that may increase blood sugar

levels, such as diazoxide or beta blockers

cytotoxic

medicines

(used

treat

cancer(,

such

methotrexate

cyclophosphamide

pain killers such as non-steroidal anti-

inflammatory medicines )NSAIDs(, including

selective

cyclooxygenase-2-inhibitors

)COX-2 inhibitors( and acetylsalicylic acid

(aspirin) over 3g

muscle

relaxing

medicines,

such

tubocurarine

anti-cholinergic

medicines

)medicines

used to treat a variety of disorders such

gastrointestinal

cramps,

urinary

bladder spasm, asthma, motion sickness,

muscular

spasms,

Parkinson’s

disease

and as an aid to anesthesia)

amantadine

medicine

used

treat

Parkinson‘s disease and treat or prevent

certain viral diseases)

colestyramine and colestipol (medicines

used mainly to treat high levels of fats in

the blood)

cyclosporine, a medicine used for organ

transplant to prevent organ rejection

alcohol,

sleeping

pills

anesthetics

(medicines

with

sleeping

painkilling

effect used for example during surgery)

iodine contrast media (substances used

for imaging examinations)

Using Vector Plus and alcohol

consumption:

Avoid drinking alcohol until you have talked

to your doctor. Alcohol may make your blood

pressure fall more and/or may increase your

risk of getting dizzy or fainting.

Using Vector Plus and food:

You can take this medicine with or without

food.

Pregnancy, breastfeeding, and fertility:

You

must

tell

your

doctor

if

you

think that you are (or might become)

pregnant. Your doctor will advise you

to stop taking Vector Plus before you

become pregnant or as soon as you know

you are pregnant, and will advise you to

use a different treatment instead of Vector

Plus. Vector Plus is not recommended in

early pregnancy, and must not be taken

when more than 3 months pregnant, as it

may cause serious harm to your baby if it

is used after the third month of pregnancy.

Tell your doctor if you are breastfeeding

or plan to breastfeed.

Vector Plus is not recommended during

breastfeeding, and your doctor may choose

another

treatment

wish

to breastfeed, especially if your baby is

newborn, or was born prematurely.

Driving and using machines:

Before you drive a vehicle, use tools or

operate

machines,

carry

other

activities that require concentration, make

sure you know how Vector Plus affects

you. Like many other medicines used to

treat high blood pressure, Vector Plus may

occasionally cause dizziness and affect your

ability to concentrate.

Important information about some of this

medicine’s ingredients:

This medicine contains lactose (see section

6: ‘Additional information’). If you have

been told by your doctor that you have an

intolerance to certain sugars, consult your

doctor before taking this medicine.

3. How to use this medicine?

Always use this medicine according to your

doctor’s

instructions.

This

will

help

to get the best results and lower the risk

of side effects. Check with your doctor or

pharmacist if you are not sure about your

dose or about how to take this medicine.

People with high blood pressure often do not

notice any signs of this problem. Many may

feel quite normal. This makes it all the more

important for you to keep your appointments

with your doctor even if you are feeling well.

Only your doctor will determine your dose

and how you should take this medicine.

Your doctor will tell you how many tablets of

Vector Plus to take.

Depending

respond

treatment, your doctor may suggest a higher

or lower dose of medicine.

The recommended dose of Vector Plus is

one tablet once a day

Do not change the dose or stop taking the

medicine without consulting your doctor

Take this medicine at the same time each

day, preferably in the morning hours

You can take Vector Plus with or without

food

Swallow the tablet with a glass of water

necessary,

split

tablet

immediately before taking it. There is no

information about crushing or chewing the

tablet

Do not exceed the recommended dose.

If you have accidentally taken a higher

dose

If you experience severe dizziness and/or

fainting, lie down and contact your doctor

immediately. If you have taken an overdose,

or if a child has accidentally swallowed some

medicine, immediately see a doctor or go to

a hospital emergency room and bring the

medicine package with you.

If you forget to take Vector Plus

forget

take

your

dose

scheduled

time,

take

soon

remember. However, if it is almost time for

your next dose, skip the dose you missed.

take

double

dose.

Take

next dose at the usual time and consult

your

doctor. Adhere

treatment

recommended by your doctor.

Even if your health improves, do not stop

taking this medicine without consulting your

doctor.

If you stop taking this medicine

Stopping your treatment with Vector Plus

may cause your high blood pressure to get

worse. Do not stop taking your medicine

unless your doctor tells you to.

Do not take medicines in the dark! Check

the label and dose every time you take

medicine. Wear glasses if you need them.

If you have any further questions about

using this medicine, consult your doctor

or pharmacist.

4. Side effects

Like with all medicines, using Vector Plus

may cause side effects in some users. Do

not be alarmed by this list of side effects; you

may not experience any of them.

Some side effects can be serious and

need immediate medical attention:

Consult your doctor immediately if:

experience

symptoms

angioedema, such as:

swollen face, tongue or throat

difficulty in swallowing

hives and difficulty in breathing

severe

skin

disease

that

causes

rash,

skin redness, blistering of the lips, eyes or

mouth, skin peeling, fever (toxic epidermal

necrolysis)

decrease in vision or pain in your eyes due

to high blood pressure (possible signs of

acute angle-closure glaucoma(

fever, sore throat, more frequent infections

(agranulocytosis)

These are very rare side effects and their

frequency is not known.

If you notice any of these symptoms,

stop

taking

Vector

Plus

and

consult

your doctor immediately (see under the

section

‘Special

warnings

about

using

this medicine’).

Additional side effects:

Uncommon side effects (may affect up to 1

in 100 users):

Cough; low blood pressure; light-headedness;

dehydration )with symptoms such as thirst,

dry mouth and tongue, low urine output,

dark colored urine, dry skin(; muscle pain;

tiredness;

tingling

numbness;

blurred

vision; noises )hissing, buzzing( in ears.

Very rare side effects (may affect up to 1 in

10,000 users(:

Dizziness; diarrhea; joint pain.

Side

effects

with

unknown

frequency

(frequency cannot be estimated from the

available data):

Breathing

difficulty;

severely

decreased

urine output; low levels of sodium in the

blood

)may

induce

tiredness,

confusion,

muscle spasms and/or convulsions in acute

cases(; low levels of potassium in the blood

)sometimes with muscle weakness, muscle

spasms, abnormal heart rhythm(; low levels

of white blood cells (with symptoms such

fever,

skin

infections,

sore

throat

mouth-ulcers due to infections, weakness(;

increase in levels of bilirubin in your blood

)which can, in severe cases, cause yellow

skin and eyes(; increase in the levels of urea

nitrogen (BUN) and creatinine in blood (may

indicate impaired kidney function(; increase

in the levels of uric acid in your blood (which

can, in severe cases, trigger gout(; fainting.

The

following

side

effects

have

been

reported

with

other

products

which

contain valsartan or hydrochlorothiazide

alone:

Valsartan:

Uncommon side effects (may affect up to 1

in 100 users):

Spinning sensation; abdominal pain.

Side

effects

with

unknown

frequency

(frequency cannot be estimated from the

available data):

Blisters on the skin (sign of bullous skin

inflammation [dermatitis[(; skin rash with

or without itching together with some of the

following signs or symptoms: fever, joint

pain, muscle pain, swollen lymph nodes

and/or flu-like symptoms; rash, purplish-

spots,

fever,

itching

)symptoms

inflammation

blood

vessels(;

level of blood platelets (sometimes with

unusual bleeding or bruising(; high levels

of potassium in the blood (sometimes with

muscle spasms, abnormal heart rhythm(;

allergic reaction (with symptoms such as

rash, itching, hives, difficulty breathing or

swallowing, dizziness(; swelling mainly of

the face and throat, rash, itching; elevation

liver

function

values;

decrease

levels of hemoglobin and the percentage

of red blood cells in the blood (both can, in

severe cases, cause anemia(; kidney failure;

levels

sodium

blood

(may

induce tiredness, confusion, muscle spasms

and/or convulsions in acute cases).

Hydrochlorothiazide:

Very common side effects (may affect more

than 1 in 10 users):

levels

potassium

blood;

increase of lipids in the blood.

Common side effects (may affect up to 1 in

10 users):

Low levels of potassium in the blood; low

levels

magnesium

blood;

high

levels of uric acid in the blood; itchy rash or

other types of rash; reduced appetite; mild

nausea and vomiting; dizziness, fainting on

standing up; inability to achieve or maintain

an erection.

Rare side effects (may affect up to 1 in 1,000

users):

Swelling and blistering of the skin (due to

increased sensitivity to sun(; high levels of

calcium in the blood; high levels of sugar

in the blood; sugar in the urine; worsening

diabetic

metabolic

state;

constipation,

diarrhea,

abdominal

discomfort,

liver

disorder which may occur with yellowing

of the skin and eyes(; irregular heart beat;

headache; sleep disturbances; sad mood

)depression(; low levels of blood platelets

(sometimes

with

bleeding

bruising

underneath the skin(; dizziness; tingling or

numbness; vision disturbances.

Very rare side effects (may affect up to 1 in

10,000 users(:

Infection of blood vessels with symptoms

such

rash,

purplish-red

spots,

fever

)vasculitis(; rash, itching, hives, difficulty

breathing

swallowing,

dizziness

)hypersensitivity reactions(; facial rash, joint

pain, muscle disorder, fever )possible signs

of cutaneous lupus erythematosus(; severe

upper stomach pain )pancreatitis(; difficulty

breathing with fever, coughing, wheezing,

breathlessness (respiratory distress including

pneumonia and pulmonary edema(; pale

skin, tiredness, breathlessness, dark urine

(possible signs of hemolytic anemia(; fever,

sore

throat

ulcers

infections

(leucopenia(; confusion, tiredness, muscle

twitching

spasms,

rapid

breathing

(possible signs of alkalosis as a result of low

levels of chlorine in the blood).

Side

effects

with

unknown

frequency

(frequency cannot be estimated from the

available data):

Weakness, bruising, and frequent infections

)aplastic anemia(; severely decreased urine

output (possible signs of kidney disorder or

kidney failure(; rash, skin redness, blistering

of the lips, eyes or mouth, skin peeling, fever

(possible

signs

erythema

multiforme(;

muscle spasm; fever )pyrexia(; weakness;

cancer of the skin and lips (skin cancer that

is not melanoma).

If

you

experience

any

side

effect,

if

any

side

effect

gets

worse,

or

if

you

experience a side effect not mentioned in

this leaflet, consult your doctor.

Reporting side effects

You can report side effects to the Ministry of

Health by following the link ‘Reporting Side

Effects of Drug Treatment’ on the Ministry

of Health home page (www.health.gov.il)

which

links to an online form for reporting

side effects. You can also use this link:

https://sideeffects.health.gov.il

In addition, you can also report to Unipharm Ltd

5. How to store the medicine?

Prevent poisoning! To prevent poisoning,

keep this, and all other medicines, in a closed

place, out of the reach and sight of children

and/or infants. Do not induce vomiting unless

explicitly instructed to do so by a doctor.

Do not use the medicine after the expiry

date (exp. date) which is stated on the

package. The expiry date refers to the last

day of that month.

Store in a dry place below 25°C.

Do not use if the medicine’s package is

damaged.

Do not discard the tablets in the drain or your

household waste. Ask your pharmacist how

to dispose of medicines you no longer need.

This will help protect the environment.

6. Additional information

In addition to the active ingredients, this

medicine also contains:

lactose monohydrate, microcrystalline cellulose,

crospovidone, magnesium stearate, colloidal

silicon dioxide, Opadry )orange, yellow(.

What the medicine looks like and contents

of the pack:

Vector Plus is packaged in blister trays

placed

cardboard

box.

Each

pack

contains 28 tablets.

Vector Plus tablets are round, biconvex,

orange film-coated tablets with a score line

on one side.

Vector Plus is available in pack sizes of 5,

10, 14, 15, 20, 28, and 30 tablets.

Not all pack sizes may be marketed.

Registration holder: Unipharm Ltd.,

POB 21429, Tel Aviv 6121301.

Manufacturer: Unipharm Ltd., Mevo Carmel

Industrial Park.

This leaflet, dated January 2020, is formatted

according to Ministry of Health guidelines and

its content matches the original medicinal

product leaflet reviewed and approved by the

Ministry of Health in March 2019.

Registration number of the medicine in the

Ministry of Health’s National Drug Registry:

VECTOR PLUS 80/12.5: 145 46 33145 01

VECTOR PLUS 160/12.5: 146 06 33406 01

VECTOR PLUS 160/25: 145 47 33146 01

لت ، 21429 ب.ص ،.ض.م مرافينوي :ليجستلا بحاص . 6121301 بيبأ ."لمركلا وڨام" ةعانصلا كراپ ،.ض.م مرافينوي

ِ

تن

ُ

ملا ةغيصلل اقفو يه 2020 يناثلا نوناك خيرات نم ةرشنلا هذه ةرشنل مئلام اهنومضمو ةحصلا ةرازو لبق نم تد

ح يتلا نم اهيلع ةقداصملاو اهصحف

مت يتلا يلصلأا رضحتسملا .2019 راذا خيرات يف ةحصلا ةرازو لب

ةرازو يف يمسرلا ةيودلأا لجس يف ءاودلا ليجست مقر :ةحصلا 145 46 33145 01 : 80/12.5 سولپ روتكڨ 146 06 33406 01 : 160/12.5 سولپ روتكڨ 145 47 33146 01 : 160/25 سولپ روتكڨ ةغيصب

صنلا درو اهليهستو ةرشنلا هذه ةءارق طيسبتل .نيسنجلا لاكل

دعم ءاودلاف اذه عم .ر

كذملا

DOR-Vec-plu-PIL-0120-08

סמ סמ

V

V

ecPlus

ecPlus

-4

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העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

)תוחיטב )תוחיטב ךיראת

___

___

28.05.2012

__________

םש

רישכת

תילגנאב

Vector Plus 80/12.5; 160/12.5; 160/25

רפסמ

__םושיר

33145

33406

33146

םש

לעב

__םושירה

U nipharm Ltd

.

_____

םייונישה

ןולעב

םינמוסמ

לע

עקר

בוהצ ןכרצל ןולעב ןכרצל ןולעב קרפ

ןולעב יתמ

ןיא שמתשהל ?רישכתב

סרה םע הרומח דבכ תלחממ ת/לבוס ךניה םא - )הרמ תמחש( דבכב םינטקה הרמה תורוניצ לש .)סיזאטסלוכ( דבכב הרמ תורבטצהל ליבומה

סרה םע הרומח דבכ תלחממ ת/לבוס ךניה םא - )הרמ תמחש( דבכב םינטקה הרמה תורוניצ לש .)סיזאטסלוכ( דבכב הרמ תורבטצהל ליבומה תדרוהל תופורתב לפוטמו תרכוסמ לבוס ךניה םא - .ןריקסילא תוליכמה םד ץחל

תובוגת

ןיב תויתפורת

:תואבה תוצובקהמ תופורת יבגל דחוימב תופורת תדרוהל

ץחל

םד

:תואבה תוצובקהמ תופורת יבגל דחוימב ;)םד ץחל תדרוהל( ןריקסילא תופורת תופסונ תדרוהל

ץחל

םד

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