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Cetimax

Document: Cetimax film-coated tablet ENG PL change

Package leaflet: information for the user


Cetimax 10 mg film-coated tablets

cetirizine dihydrochloride


Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.


What is in this leaflet

1. What Cetimax is and what it is used for

2. What do you need to know before you take Cetimax

3. How to take Cetimax

4. Possible side effects

How to store Cetimax

6. Contents of the pack and other information


What Cetimax is and what it is used for


Cetirizine dihydrochloride is the active substance of Cetimax. Cetimax belongs to the group of medicines called antihistamines for systemic use, which are used against allergy (hypersensitivity).


In adults and children aged 6 year and above, Cetimax is used


What you need to know before you take Cetimax


Do not take Cetimax

  • if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6)

  • if you are allergic to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines)

  • if you have a severe kidney disease


Warnings and precautions

Talk to your doctor or pharmacist before using Cetimax if;

  • you have impaired renal function. If necessary, your dose will be adjusted. The new dose will be determined by your doctor.

  • you have problems passing urine (like spinal cord problems or prostate or bladder problems).

  • you have epilepsy or are prone to convulsions.

  • you are going to have an allergy skin test made. Cetimax use should be stopped three days before tests are performed.


Children

Do not give this medicine to children below the age of 6 because the tablet formulation does not allow the necessary dose adjustments.


Other medicines and Cetimax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


Due to the profile of cetirizine, no interactions with other drugs are expected.


Cetimax with food, drink and alcohol

The absorption of cetirizine is hardly affected by food.


There is no evidence of interactions between alcohol (at a blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine at normal doses. In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance, although Cetimax does not increase the effect of alcohol. As with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.


Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


The use of Cetimax should be avoided in pregnant women. Accidental use of the drug is not believed to cause any harmful effects on the foetus. Nevertheless, the medicine should only be administered if necessary and after medical advice.

The active substance cetirizine passes into breast milk. Therefore, you should not take Cetimax during breast-feeding unless your doctor has told you to do so.


Driving and using machines

Clinical studies reveal no evidence of impaired attention, alertness and driving capabilities after taking Cetimax at the recommended dose.

If you intend to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose. You should closely observe your response to the drug.


How to take Cetimax


How and when should you take Cetimax

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


The tablets should be swallowed with a glass of liquid.

The tablet can be divided into two equal doses.


Adults and adolescents above 12 years old:

The recommended dose is: 10 mg (1 tablet) once daily.


Use in children between 6 and 12 years old:

The recommended dose is: 5 mg (half tablet) twice daily.


Patients with moderate to severe renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.


If you feel that the effect of Cetimax is too weak or too strong, please consult your doctor.


Duration of treatment

The duration of treatment depends on the type, duration and cause of your complaints and is determined by your doctor.


If you take more Cetimax than you should

If you have taken more Cetimax than you should, or if a child has taken medicine by accident, you should contact your doctor or the nearest hospital casualty department for advice.


After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, malaise, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and difficulty to urinate have been reported.


If you forget to take Cetimax

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


If you stop taking Cetimax

If you have any further questions on the use of this product, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Stop taking Cetimaxand contact a doctor or go to the nearest emergency department immediately if you experience any of the following symptoms: swelling in your mouth, face and/or throat, difficulties in breathing (chest tightness or wheezing), sudden drop in your blood pressure with subsequent fainting or shock.

The symptoms can be signs of a very serious allergic reaction (angioedema) or anaphylactic shock. The reactions are very rare (may affect up to 1 in 10,000 users).

Other possible side effects are:


Common (may affect up to 1 in 10 users):


Uncommon (may affect up to 1 in 100 users):


Rare (may affect up to 1 in 1,000 users):


Very rare (may affect up to 1 in 10,000 users):

fixed drug eruption


Frequency not known (cannot be estimated from the available data):


Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Cetimax


Keep this medicine out of the sight and reach of children.


Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.


Store below 25 C.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment.


6. Contents of the pack and other information


What Cetimax contains



What Cetimax looks like and contents of the pack


Appearance:

A white, round, convex one-side scored tablet with logo “5”. Diameter is 7 mm.


Pack sizes:

7, 10, 14, 20, 30, 50 and 100 tablets (PVC/PVdC/Al blister with carton).


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


Vitabalans Oy

Varastokatu 8

FI-13500 Hämeenlinna

FINLAND

Tel: +358 (3) 615600

Fax: +358 (3) 6183130


This medicinal product is authorised in the Member States of the EEA under the following names:

Cetimax (DK, FI, HU, NO, SE)

Cetrix (EE, LV, LT, PL)

Cetixin (CZ, DE, SI, SK)


This leaflet was last revised in 15thJanuary 2016


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