MIZOLLEN TABLETS 10 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

MIZOLASTINE

Fáanlegur frá:

PHARMA SHALOM

ATC númer:

R06AX25

Lyfjaform:

FILM COATED TABLETS

Samsetning:

MIZOLASTINE 10 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

SANOFI WINTHROP INDUSTRIE, FRANCE

Meðferðarhópur:

MIZOLASTINE

Lækningarsvæði:

MIZOLASTINE

Ábendingar:

Symptomatic treatment of seasonal allergic rhinoconjuctivitis (hay fever), perennial allergic rhino-conjuctivitis and urticaria.

Leyfisdagur:

2014-06-30

Upplýsingar fylgiseðill

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 FOLLO

Vara einkenni

1
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
or
suspected
QT
prolongation
or
with
electrolyte
imbalance,
in
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.
2
Due to the presence of lactose, patients with rare
hereditary problems of galactose intolerance, total lactase
deficiency or glucose-galacto