MIZOLLEN TABLETS 10 MG

Israel - English - Ministry of Health

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Active ingredient:
MIZOLASTINE
Available from:
SANOFI - AVENTIS ISRAEL LTD
ATC code:
R06AX25
Pharmaceutical form:
FILM COATED TABLETS
Composition:
MIZOLASTINE 10 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
SANOFI WINTHROP INDUSTRIE, FRANCE
Therapeutic group:
MIZOLASTINE
Therapeutic area:
MIZOLASTINE
Therapeutic indications:
Symptomatic treatment of seasonal allergic rhinoconjuctivitis (hay fever), perennial allergic rhino-conjuctivitis and urticaria.
Authorization number:
114 94 29697 00
Authorization date:
2014-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

18-12-2019

This patient package insert was reviewed and approved by the

Ministry of Health in February 2015, and revised in May 2019 in

accordance with Ministry of Health guidelines.

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with a doctor’s prescription only

MIZOLLEN TABLETS 10 mg

Film-coated tablets

Active ingredient: Mizolastine 10 mg.

Inactive ingredients: See Section 6.

Read this leaflet carefully in its entirety before using the medicine.

Keep this leaflet as you may need to read it again.

This leaflet contains concise information about the medicine.

If you have further questions, refer to the doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to

others. It may harm them even if it seems to you that their medical

condition is similar.

This medicine is intended for adults and children above the age of 12.

1. WHAT IS THE MEDICINE INTENDED FOR?

Mizollen is intended for treatment of symptoms of:

Runny nose and conjunctivitis due to seasonal allergy (hay fever).

Runny nose and conjunctivitis due to a chronic allergy.

Urticaria (an itchy skin rash).

Therapeutic group: Antihistamine.

2. BEFORE USING THE MEDICINE

Do not use the medicine if:

You are sensitive (allergic) to the active ingredient mizolastine or

to any other ingredient of the medicine (see Section 6).

You are taking a macrolide antibiotic, such as erythromycin,

clarithromycin, azithromycin.

You are taking an imidazole antifungal preparation, such as

ketoconazole, fluconazole, itraconazole.

You suffer from liver problems.

You suffer from heart problems.

You have a history of irregular heartbeat or a slow heart rate.

Your ECG (electrical recording of cardiac activity) test results are

abnormal.

You are being treated with medicines for heart rhythm disorders.

You suffer from electrolyte imbalance, particularly a low blood

level of potassium (hypokalaemia).

Special warnings regarding use of the medicine:

In the elderly - Mizollen can make some people feel drowsy and

cause a fast heartbeat or heart rhythm disturbances. These effects

are more common in the elderly.

Tests and follow-up

During the course of treatment you may be referred for blood tests

and other tests to check how the medicine is affecting you.

This is more likely if:

You suffer from diabetes (your blood sugar levels are not in order).

The levels of salt substances in your blood sometimes change

(electrolyte imbalance).

You have problems with your heart beat (cardiac arrhythmias).

Drug interactions:

If

you

are

taking

or

if

you

have

recently

taken,

other

medicines including non-prescription medicines and nutritional

supplements, inform the doctor or pharmacist.

Do not take the following medicines together with Mizollen:

Macrolide

antibiotics

such

erythromycin,

clarithromycin,

azithromycin.

Antifungals from the imidazole group such as ketoconazole,

fluconazole, itraconazole.

Especially inform the doctor or pharmacist if you are taking or have

recently taken:

cimetidine (for stomach ulcer).

ciclosporin (an immunosuppressant).

nifedipine (for treatment of high blood pressure or heart conditions).

Since these drugs can affect the levels of Mizollen (mizolastine) in

your blood.

Using the medicine and food

Mizollen can be taken with food or between meals.

Use of the medicine and alcohol consumption

Mizollen does not change the effect of alcohol. However, as with

any other medicine, you should not consume alcohol in excessive

quantities when taking the medicine.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before you take any medicine.

Pregnancy

The safety of taking Mizollen during pregnancy is not known.

As with any medicine, you should avoid taking Mizollen during

pregnancy, particularly during the first three months of pregnancy.

Breastfeeding

Mizolastine passes into breast milk, therefore, Mizollen should not

be used during breastfeeding.

Driving and using machines

You may feel sleepy after taking the medicine. If this happens, do

not drive or use machines.

Important information about some of the ingredients in the

medicine:

Mizollen contains lactose - If your doctor has told you that you

are sensitive to some sugars, consult your doctor before taking

this medicine.

Mizollen also contains hydrogenated castor oil, which may cause

abdominal pain and diarrhea.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor’s instructions. Check with the

doctor or pharmacist if you are not sure about your dose and how

you should take this medicine.

The dosage and manner of use will be determined by the doctor only.

The usual dosage is generally:

Adults, including the elderly, and children above 12 years of age:

one 10 mg tablet per day.

Swallow the medicine with a lot of water. Do not exceed the

recommended dose.

Do not crush/halve/chew the tablets because they are film-coated.

If you have accidentally taken too high dosage

If you have accidentally taken higher dosage or if a child has

accidentally swallowed the medicine, refer immediately to a doctor

or proceed to a hospital emergency room, and bring the package of

the medicine with you.

If you forgot to take the medicine

If you forgot to take the medicine at the required time, do not take a

double dose. Take the next dose at the scheduled time and consult

with the doctor. Be sure to adhere to the treatment as recommended

by the doctor.

If you stop taking the medicine

Inform your doctor if you intend to stop taking Mizollen before

completion of the recommended course of treatment.

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

each time you take a medicine. Wear glasses if you need them.

If you have further questions regarding use of the medicine,

consult the doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Mizollen may cause side effects in

some users. Do not be alarmed by the list of side effects. You may

not suffer from any of them.

Stop treatment with Mizollen and contact the doctor immediately

if you experience any of the following side effects: Dizziness,

swelling of the face, lips, tongue or throat and difficulty breathing -

these may be symptoms of a serious allergic reaction.

Common side effects (occurring in 1 to 10 patients in 100):

dry mouth, headache, dizziness, drowsiness, weakness.

diarrhea, nausea.

abdominal pain, indigestion.

increased appetite associated with weight gain.

Uncommon side effects (occurring in 1 to 10 patients in 1,000):

anxiety, depression.

changes in the results of blood tests for liver function (increased

liver enzymes).

low blood pressure, rapid or irregular heartbeat.

joint and muscle pain.

Very rare side effects (occurring in less than 1 in 10,000 patients):

decreased white blood cell count, which increases the risk of

infections.

serious allergic reaction, which can cause dizziness, swelling of

the face, lips, tongue or throat, and difficulty breathing.

generalized skin rash (urticaria), itching.

fainting.

Side effects of unknown frequency (effects whose frequency has

not been established yet):

vomiting.

Patients having taken Mizollen have also reported: difficulty in

breathing or wheezing, worsening of their asthma or slight changes

in blood sugar and salts levels. Your doctor may order blood tests

to monitor your condition.

Some antihistamines (anti-allergy medicines) have been associated

with abnormal ECG results (electrical recording of cardiac activity),

and increased risk of irregular heart rhythm.

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

suffer from a side effect not mentioned in this leaflet, consult the

doctor.

You can report side effects to the Ministry of Health by following the

link ‘Reporting Side Effects of Medication’ 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

5. HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine and any other medicine should be

kept in a safe place out of sight and reach of children and/or infants

in order to avoid poisoning.

Do not induce vomiting unless explicitly instructed to do so by the

doctor.

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

on the package/blister tray. The expiry date refers to the last day

of that month.

Storage: At a temperature not above 25°C.

Do not use Mizollen if you notice that the tablets are discolored.

6. FURTHER INFORMATION

In addition to the active ingredient, Mizollen also contains:

In the tablets: lactose monohydrate, hydrogenated castor oil,

microcrystalline cellulose, tartaric acid, povidone, magnesium

stearate, anhydrous colloidal silica, purified water.

In the coating: hypromellose, titanium dioxide (E171), propylene

glycol.

What the medicine looks like and the contents of the package:

White, oblong, film-coated tablets with a score line on one side and

a mark “MZI10” on the reverse side.

The tablets are packed in trays (blisters) made of aluminum/(oPA/

Al/PVC). Each package contains 15 tablets.

This leaflet does not contain all the information about the

medicine. If you have any questions or are not sure about

anything, please ask your doctor.

License holder and address: Sanofi-Aventis Israel ltd., 10 Benny

Gaon Street, Netanya.

Manufacturer and address: Sanofi-Winthrop Industrie, France.

Registration number of the medicine in the National Drug Registry of

the Ministry of Health: 114-94-29697-00

.ءاملا نم ريثكلا عم ءاودلا علب بجي .هب ىصوملا ةعرجلا زواجت عنمي

يلطم صارقأ اهنوك ببسب ،ءاودلا غضم /رطش /قحس عنم

ربكأ ةعرج أطخلاب تلوانت اذإ وأ بــيبطلا ىــلإ

لااــح هــجوت ءاودــلا نــم أــطخلاب لــفط عــلب اذإ وأ رــبكأ ةــعرج أــطخلاب تــلوانت اذإ .ءاودــلا ةــبلع كــعم رــضحأو ىفــشتسملا يــف ئراوــطلا ةــفرغل ءاودلا لوانت تيسن اذإ لواــنت .ةــفعاضم ةــعرج لواــنت عــنمي ،بوــلطملا تــقولا يــف ءاودــلا اذــه لواــنت تيــسن اذإ اــمك جاــعلا ىــلع ةــبظاوملا بــجي .بــيبطلا رــشتسإو يداــيتعلإا تــقولا يــف ةــمداقلا ةــعرجلا .بــيبطلا هــب ىــصوأ ءاودلا لوانت نع كفقوت لاح يف .اهب ىصوملا ةرتفلا ةياهن لبق نيلوزيم لوانت نع فقوتلا يونت تنك اذإ كبيبط غلب لك يــف ةــعرجلا نــم دــكأتلاو ءاودــلا عــباط صيخــشت بــجي !ماــظلا يــف ةــيودلأا لواــنت عــنمي .اــهيلا ةــجاحب تــنك اذإ ةــيبطلا تاراــظنلا عــض .ءاود اــهيف لواــنتت ةرــم .يلديصلا وأ بيبطلا رشتسا ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ

.

ةيبناجلا ضارعلأا لا .نيلمعتــسملا ضــعب دــنع ةــيبناج

اــضارعأ ببــسي دــق نــيلوزيم لامعتــسإ نإ ،ءاود لكــب اــمك .اــهنم

اــيأ يــناعت لاأ زــئاجلا نــم .ةــيبناجلا ضارــعلأا ةــمئاق نــم شــهدنت ضارــعلأا ىدــحإب رعــشت تــنك اذإ بــيبطلا ىــلإ

ً

لااــح هــجوتو نــيلوزيم ـــب جاــعلا نــع فــقوت ـــــ ســفنتلا يــف تاــبوعصو ةرــجنحلا وأ ناــسللا ،نيتفــشلا ،هــجولا خاــفتنإ ،راود :ةــيلاتلا ةــيبناجلا .رــيطخ يــسسحت لــعف درــل ضارــعأ هذــه نوــكت دــق :(١۰۰ نيب نم نيجلاعم ١۰ - ١ ىدل رهظت( ةعئاش ةيبناج ضارعأ

.فع

ض ،ساعن ،راود ،عادص ،مفلا فافج

.نايثغ ،لاهسإ

.مضهلا يف تابوعص ،نطب عاجوأ

.نزولا يف ةدايز هقفار

ي ماعطلل ةيهشلا ةدايز :(١،۰۰۰ نيب نم نيجلاعم ١۰ - ١ ىدل رهظت( ةعئاش ريغ ةيبناج ضارعأ

.بائتكإ ،قلق

.)دبكلا تاميزنإ عافترإ( دبكلا لمع ءادأ ىلإ ريشت يتلا مدلا تاصوحف جئاتن يف تارييغت

.بلقلا تابرض ماظتنإ مدع وأ عرست ،مدلا طغض ضافخنإ

.تاضعلاو لصافملا يف ملاآ :)نيجلاعم ١۰،۰۰۰ نيب نم ١ نم لقأ ىدل رهظت(

ً

ادج ةردان ةيبناج ضارعأ

.تاثولت ثودح ةيناكمإ ةدايزل يدؤت يتلا ءاضيبلا مدلا اياخ ةيمك صقانت

ةرــجنحلا وأ ناــسللا ،نيتفــشلا ،هــجولا خاــفتنإ ،راود :ببــسي دــق يذــلا رــيطخ يــسسحت لــعف در .ســفنتلا يــف تاــبوعصو

.ةكح ،)ىرش( لماش يدلج حفط

.ءامغإ :)دعب اهرتاوت ديدحت

متي مل ة

يبناج ضارعأ( ةفورعم ريغ اهعويش ةبسن ة

ّ

يبناج ضارعأ

.تاؤيقت ،رــيفص وأ ســفنتلا يــف ةــبوعص :ثودــح نــع

اــضيأ نــيلوزيم اوــلوانت نــيذلا صاخــشلأا غــلب دــقل كــهجوي نأ لــمتحملا نــم .مدــلا يــف حاـ ـملأاو ركــسلا ةبــسنب ةــفيفط تارــيغت وأ وــبرلا يــف مــقافت .كــتلاح ةــبقارمو ةــعباتم لــجأ نــم مد تاــصوحف ءارــجلإ كــبيبط ةميلــس رــيغ جــئاتنب ةــقاع اــهل )ةيــساسحلل ةداــضم ةــيودأ( نيماتــسيهلا تاداــضم ضــعب نأ دـ ـج

.ميلــس رــيغ بــلق مــظن رــطخ دــيزت يــتلا ،)بــلقلل يــئابرهكلا طاــشنلا طــيطخت( ECG ـــلا يــف ضرــع نــم يــناعت تــنك اذإ وأ ،ةــيبناجلا ضارــعلأا یدــحإ تــمقافت اذإ ،يــبناج ضرــع رــهظ اذإ .بــيبطلا ةراـ ـشتسإ كــيلع ،ةرــشنلا هذــه يــف رــكذي مـ ـل يــبناج غــيلبتلا" طــبارلا ىــلع طــغضلا لاـ ـخ نــم ةــ

يبناج ضارــعأ نــع ةــ

حصلا ةرازو غــيلبت نــكمملا نــم ةرازو عــقوم" يــف ةيــسيئرلا ةــحفصلا ىــلع دوــجوملا "يــئاود جاــعل ةــجيتن ةــ

يبناج ضارــعأ نــع نــع غــيلبتلل تــنرتنلإا رــبع ةرامتــسإ ىــلإ كــل

وحي يذــلا )www.health.gov.il( ةــ

حصلا :طــبارلا لوــخد رــبع وأ ،ةــ

يبناجلا ضارــعلأا

https://sideeffects.health.gov.il

.

؟ءاودلا نيزخت ةيفيك يدــيأ لواــنتم نــع

ادــيعب قــلغم ناكــم يــف رــخآ ءاود لكو ءاودــلا اذــه ظــفح بــجي !ممــستلا بــنجت .ممــستلاب مهتباصإ يداــفتل كــلذو ،مــهتيؤر لاــجم نــعو عــضرلا وأ/و لاــفطلأا .بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ببست لا ىــلع رــهظي يذــلا )exp. date( ةــيحاصلا خــيرات ءاــضقنإ دــعب ءاودــلا لامعتــسإ زوــجي لا .رهــشلا ســفن نــم رــيخلأا موــيلا ىــلإ ةــيحاصلا خــيرات ريــشي .)رتــسيلب( ةــحيوللا/ةبلعلا رــهظ .ةيوئم ةجرد ۲٥ نع ديزت لا ةرارح ةجرد يف :نيزختلا .اهنول ريغت صارقلأا نأ تظحلا اذإ نيلوزيم لمعتست لا

.

ةيفاضإ تامولعم

اضيأ ةلاعفلا ةداملل ةفاضلإاب نيلوزيم يوتحي

:صرقلا يف

lactose

monohydrate,

hydrogenated

castor

oil,

microcrystalline

cellulose, tartaric acid, povidone, magnesium stearate, anhydrous

colloidal silica, purified water.

:ءاطلا يف

hypromellose, titanium dioxide (E171), propylene glycol.

طــخ تاذ ،ةــلواطم نوــللا ءاــضيب ةــيلطم صارــقأ :ةــبلعلا ىوــتحم وــه اــمو ءاودــلا ودــبي فــيك .يــناثلا بــناجلا نــم "MZI10" اــهيلع عوــبطمو دــحاو بــناج نــم روــفحم .Aluminium/(oPA/Al/PVC( نــم ةــعونصم )رتــسيلب( ةــحيول ةــبلع نــمض ةأــبعم صارــقلأا

اــصرق ١٥ ىــلع ةــبلع لك يوــتحت وأ لاؤــس يأ كــيدل رــفوت اذإ .رضحتــسملا نــع تاــمولعملا ةــفاك ىــلع يوــتحت لا ةرــشنلا هذــه .بــيبطلا ةــعجارم ءاــجرلا ،اــم رــمأ نــم

ً

اــقثاو نــكت مــل اذإ .ايناتن ،١۰ نوؤاچ ينب عراش ،.ض.م ليئارسإ سيتنڤأ ـ يفوناس :هناونعو ليجستلا بحاص .اسنرف ،تاعانصلل پورتنيو - يفوناس :هناونعو جتنملا مسإ ١١٤-٩٤-۲٩٦٩٧-۰۰ :ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجست مقر نــم مــغرلا ىــلع .رــكذملا ةــغيصب ةرــشنلا هذــه ةــغايص تــمت ،ةءارــقلا نــيوهتو ةلوهــس لــجأ نــم .نيــسنجلا اكــل صــصخم ءاودــلا نإــف ،كــلذ

The content of this leaflet was approved by the Ministry of

Health in February 2015 and updated according to the

guidelines of Ministry of Health in May 2019.

MIZOLLEN TABLETS

SUMMARY OF PRODUCT CHARACTERISTICS

1.

Name of The Medicinal Product

MIZOLLEN tablets 10 mg, film-coated tablets

2.

Qualitative and Quantitative Composition

Mizolastine 10mg per tablet.

Excipients with known effect:

Lactose monohydrate (125mg/tablet)

Hydrogenated castor oil (25mg/tablet)

Propylene glycol (0.45mg/tablet)

For the full list of excipients, see section 6.1

3.

Pharmaceutical Form

Modified-release tablet.

Oblong, white tablets with a scored line on one side and a mark "MZI 10" on the reverse side.

4.

Clinical Particulars

4.1

Therapeutic indications

Mizolastine is a long acting H1- antihistamine indicated for the symptomatic treatment of seasonal allergic

rhinoconjunctivitis (hay fever), perennial allergic rhinoconjunctivitis and urticaria.

4.2

Posology and method of administration

Adults, including the elderly, and children 12 years of age and over:

The recommended daily dose is one 10mg tablet

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Concomitant administration with macrolide antibiotics or systemic imidazole antifungals.

Significantly impaired hepatic function.

Clinically significant cardiac disease or a history of symptomatic arrhythmias.

Patients

with

known

suspected

prolongation

with

electrolyte

imbalance,

particular

hypokalaemia.

Clinically significant bradycardia.

Medicinal products known to prolong the QT interval, such as Class I and III anti-arrhythmics.

4.4

Special warnings and precautions for use

Mizolastine has a weak potential to prolong the QT interval in a few individuals. The degree of prolongation is

modest and has not been associated with cardiac arrhythmias.

The elderly may be particularly susceptible to the

sedative effects of mizolastine and the potential effects of

the medicinal product on cardiac repolarisation.

Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, total lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

Mizolastine contains hydrogenated castor oil which can cause stomach upset and diarrhoea.

4.5

Interactions with other medicinal products and other forms of Interaction

Although the bioavailability of mizolastine is high and the medicinal product is principally metabolised by

glucuronidation, systemically administered ketoconazole and erythromycin moderately increase the plasma

concentration of mizolastine and their concurrent use is contraindicated.

Concurrent use of other potent inhibitors or substrates of hepatic oxidation (cytochrome P450 3A4) with

mizolastine should be approached with caution. These would include cimetidine, ciclosporin, and nifedipine.

Alcohol: In studies with mizolastine, no potentiation of the sedation and the alteration in performance caused

by alcohol has been observed.

4.6

Fertility, pregnancy and lactation

Pregnancy

The safety of mizolastine for use in human pregnancy has not been established. The evaluation of

experimental animal studies does not indicate direct or indirect harmful effects with respect to the

development of the embryo or foetus, the course of gestation and peri- and post-natal development. However,

as with all medicinal products, mizolastine should be avoided in pregnancy, particularly during the first

trimester.

Breast feeding

Mizolastine is excreted into breast milk, therefore its use by lactating women is not recommended.

4.7

Effects on ability to drive and use machines

Most patients taking mizolastine may drive or perform tasks requiring concentration. However, in order to

identify sensitive people who have unusual reactions to medicinal products, it is advisable to check the

individual response before driving or performing complicated tasks.

4.8

Undesirable effects

Gastro-intestinal disorders:

Common: dry mouth, diarrhoea, abdominal pain (including dyspepsia), nausea.

Not known: vomiting.

Central nervous system disorders and psychiatric disorders:

Common: drowsiness often transient, headache, dizziness,

Uncommon: anxiety and depression.

Liver disorders:

Uncommon: raised liver enzymes.

Hematological disorders:

Very rare: low neutrophil count.

Body as a whole:

Common: asthenia often transient, increased appetite associated with weight gain.

Very rare: allergic reactions including anaphylaxis,

angioedema, generalized rash/urticaria, pruritus and

hypotension.

Cardiovascular disorders:

Uncommon: hypotension, tachycardia, palpitations.

Very rare: vasovagal attack

Musculoskeletal disorders:

Uncommon: arthralgia and myalgia.

Description of selected adverse reactions

There were reports of bronchospasm and aggravation of asthma but in view of the high frequency of asthma

in the patient population being treated, a causal relationship remains uncertain.

Treatment with certain antihistamines has been associated with QT interval prolongation increasing the risk of

serious cardiac arrhythmias in susceptible subjects.

Minor changes in blood sugar and electrolytes have been observed rarely. The clinical significance of these

changes in otherwise healthy individuals remains unclear. Patients at risk (diabetics, those susceptible to

electrolyte imbalance and cardiac arrhythmias) should be monitored periodically.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il

4.9

Overdose

In cases of overdose, general symptomatic surveillance with cardiac monitoring including QT interval and

cardiac rhythm for at least 24 hours is recommended, along with standard measures to remove any

unabsorbed medicinal product.

Studies in patients with renal insufficiency suggest that haemodialysis does not increase clearance of the

medicinal product.

5.

Pharmacological Properties

5.1

Pharmacodynamic properties

Antihistamines for systemic use (ATC code: R06AX25)

Mechanism of action

Mizolastine possesses antihistamine and antiallergic properties due to a specific and selective antagonism of

peripheral histamine H

receptors. It has also been shown to inhibit histamine release from mast cells (at 0.3

mg/kg orally) and the migration of neutrophils (at 3 mg/kg orally) in animal models of allergic reactions.

Clinical efficacy and safety

In man, histamine-induced wheal and flare studies have shown that mizolastine 10 mg is a rapid, potent (80 %

inhibition

after

hrs)

sustained

(24hr)

antihistamine.

tachyphylaxis

occurred

after

long-term

administration.

In both preclinical and clinical studies, no anticholinergic effect has been demonstrated.

5.2

Pharmacokinetic properties

Following oral administration mizolastine is rapidly absorbed. Peak plasma concentration is reached at a

median time of 1.5 hours.

Bioavailability is 65% and linear kinetics have been demonstrated.

The mean elimination half-life is 13.0 hours with plasma protein binding of 98.4%.

hepatic

insufficiency

absorption

of mizolastine is slower and the distribution phase longer,

with a resulting moderate increase in AUC of 50%.

The principal metabolic pathway is glucuronidation of the parent compound. The cytochrome P

enzyme system is involved in one of the additional metabolic pathways with formation of the hydroxylated

metabolites of mizolastine. None of the identified metabolites contribute to the pharmacological activity of

mizolastine.

An increase in mizolastine plasma levels, observed with systemic ketoconazole and erythromycin, led to

concentrations equivalent to those obtained after a 15 to 20 mg dose of mizolastine alone.

In studies carried out in healthy volunteers, no clinically significant interaction has been recorded with food,

warfarin, digoxin, theophylline, lorazepam, or diltiazem.

5.3

Preclinical safety data

Pharmacological studies in several species have shown an effect on cardiac repolarisation at doses in excess

of 10-20 times the therapeutic dose. In conscious dogs, mizolastine has shown pharmacological interactions

with ketoconazole at the electrocardiographic level at 70 times the therapeutic dose.

6.

Pharmaceutical Particulars

6.1

List of excipients

Core: lactose monohydrate, hydrogenated castor oil, microcrystalline cellulose, tartaric acid, povidone,

magnesium stearate, anhydrous colloidal silica, purified water.

Film-coating: hypromellose, titanium dioxide (E171), propylene glycol, purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Aluminium/(oPA/Aluminum/PVC) blisters: Pack of 15 tablets.

6.6 Special precautions for disposal

Tablets should not be taken if they become discoloured.

7. Marketing Authorization Holder

Sanofi-aventis Israel ltd., 10 Beni Gaon, P.O.B. 8090, Netanya, 4250499, Israel

8. Manufacturer

Sanofi Winthrop Industrie, France

Mizo -13.0

וא יפונאס

ןואג ינב 'חר ,לארשי סיטנ

ופ קראפ , ,גל .ד.ת

8090

םורד הינתנ ,

42504

לט

09-8633700

סקפ

09-8851444

יאמ

2019

Mizollen tablets 10mg film coated tablets

:ליעפ רמוח

Mizolastine 10mg

ה היוותהה תרשואמ

:

Mizolastine is a long acting H1- antihistamine indicated for the symptomatic treatment of

seasonal allergic rhinoconjunctivitis (hay fever), perennial allergic rhinoconjunctivitis and

urticaria.

סיטנווא יפונאס תרבח מ"עב לארשי ןולעה ןוכדע לע עידוהל תשקבמ

אפורל

ןכרצל ןולעהו

יאמ

2019

ןלהל םיטרופמ קר יתת

ושענ םהב םיפיעס ינוכדע

תוחיטבה

ולעב .אפורל ןולעבו ןכרצל ן

ב ןמוסמ ףסוותהש עדימ בוהצ

:ןכרצל ןולעב ןוכדע

4

.

:יאוול תועפות

....

:)העבקנ םרט ןתוחיכשש תועפות( העודי הניא ןתוחיכשש יאוול תועפות

תואקה

:אפורל ןולעב ןוכדע

4.8

Undesirable effects

Gastro-intestinal disorders:

Not known: vomiting.

ולעה םינ

כדועמה םינ

חלשנ

לבקל ןתינו תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל

ספדומ םי

לע םושירה לעבל היינפ ידי יפונאס ,

סיטנווא

ןואג ינב 'חר ,מ"עב לארשי

: ןופלטב וא הינתנ

8633700

ןלהל :תואירבה דרשמ רתאל רושיקה

https://data.health.gov.il/drugs/index.html#/byDrug

,הכרבב

רביולטוג הירוטקיו

ידדה

הנוממ תחקור

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