Cetirizine dihydrochloride 10mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cetirizine dihydrochloride

Available from:

Chefaro Ireland DAC

ATC code:

R06AE; R06AE07

INN (International Name):

Cetirizine dihydrochloride

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

7, 14 or 30 film-coated tablets

Prescription type:

Product not subject to medical prescription

Manufactured by:

Chanelle Medical

Therapeutic group:

Piperazine derivatives

Therapeutic area:

Piperazine derivatives; cetirizine

Therapeutic indications:

In adults and paediatric patients 6 year and above: it is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of symptoms of chronic idiopathic urticaria.

Authorization status:

Not marketed

Authorization date:

2006-05-26

Patient Information leaflet

CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS
(cetirizine dihydrochloride)
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
•
This medicine is available without a prescription, however you still
need to use Cetirizine
Dihydrochloride 10mg Film-coated Tablets carefully to get the best
results from them.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact your doctor if your symptoms change, worsen or do not
improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
1. WHAT THIS MEDICINE IS FOR
Cetirizine Dihydrochloride 10mg Film-coated Tablets contain cetirizine
dihydrochloride, which
belongs to a group of drugs called antihistamines. These medicines
help to relieve the symptoms of
some allergies.
This medicine is used to relieve:
• symptoms of hayfever and other allergies such as sneezing, runny
nose and burning, itchy eyes
• symptoms of skin allergies such as rash, itching or urticaria
(hives).
2. BEFORE YOU TAKE THE MEDICINE
This medicine can be taken by adults, and children aged 6 years and
over. Some people should not
take this medicine or should talk to their pharmacist or doctor first.
DO NOT TAKE IF YOU:
•
Are allergic (hypersensitive) to cetirizine dihydrochloride or any of
the other ingredients in the
medicine, listed in section 6.
•
Have serious kidney problems
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE IF YOU:
•
Have epilepsy or are at risk of convulsions.
•
Have problems passing urine (like spinal cord problems, prostate or
bladder problems)
TAKING THIS MEDICINE WITH FOOD AND DRINK
•
Avoid alcoholic drink while you are taking this medicine.
PREGNANCY AND BREAST-FEEDING
•
DO NOT TAKE if you are pregnant or breast-feeding.
DRIVING AND USING MACHINES
•
Tests have shown that this medicine does not cause drowsiness in the
vast major

Summary of Product characteristics

HealthProductsRegulatoryAuthority
08June2021
CRN00CDDH
Page1of7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetirizinedihydrochloride10mgFilm-coatedTablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EachtabletcontainsCetirizinedihydrochloride10mg.
Alsocontainslactose
Forafulllistofexcipientssee6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet.
Whitecircularbiconvexfilm-coatedtablets,embossed`A`ononesideandadeepscoreontheother.
Thetabletcanbedividedintoequalhalves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Inadultsandpaediatricpatients6yearandabove:
-Cetirizineisindicatedforthereliefofnasalandocularsymptomsofseasonalandperennial
allergicrhinitis.
-Cetirizineisindicatedforthereliefofsymptomsofchronicidiopathicurticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Childrenaged from6 to 12 years:_
5mgtwicedaily(ahalftablettwicedaily).
_Adults and adolescentsover 12 years of age:_
10mgoncedaily(1tablet).
_Elderly patients:_
Datadonotsuggestthatthedoseneedstobereducedinelderlysubjectsprovidedthattherenalfunctionisnormal.
_Patients with moderate to severe renal impairment:_
Therearenodatatodocumenttheefficacy/safetyratioinpatientswithrenalimpairment.Sincecetirizineismainlyexcretedvia
renalroute(seesection5.2),incasesnoalternativetreatmentcanbeused,thedosingintervalsmustbeindividualized
accordingtorenalfunction.Refertothefollowingtableandadjustthedoseasindicated.Tousethisdosingtable,anestimate
ofthepatient'screatinineclearance(CLcr)inml/mi