iMeds.se

Cetirizin Sandoz

Information för alternativet: Cetirizin Sandoz 10 Mg Filmdragerad Tablett, visa andra alternativ
Document: Cetirizin Sandoz film-coated tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER


Cetirizin Sandoz 10 mg film-coated tablets


Cetirizine dihydrochloride


Read all of this leaflet carefully before you start taking 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 has told you.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

- You must talk to a doctor if you do not feel better or if you feel worse after 3 days.


What isinthis leaflet:

1. What Cetirizin Sandoz is and what it is used for

2. What you need to know before you take Cetirizin Sandoz

3. How to take Cetirizin Sandoz

4. Possible side effects

5. How to store Cetirizin Sandoz

6. Contents of the pack and other information


1. What Cetirizin Sandoz is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Cetirizin Sandoz. Cetirizin Sandoz is an antiallergic medication.


In adults and children aged 6 years and above, Cetirizin Sandoz is indicated

- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis

- for the relief of chronic nettle rash (chronic idiopathic urticaria).


2. What you need to know before you take Cetirizin Sandoz

Do not take Cetirizin Sandoz

- if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min);

- if you are allergic tocetirizine dihydrochloride, to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).


Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizin Sandoz.


If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.


If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.


If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.


If you plan having an allergy skin test made. The use of Cetirizin Sandoz should be interrupted at least 3 days prior to skin tests.


No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses. However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.


Other medicines and Cetirizin Sandoz

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.


Cetirizin Sandoz with food and drink

Food does not affect noticeabily the absorbtion of cetirizine.


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.

As with other drugs, use of Cetirizin Sandoz should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the administration of the medicine should be discontinued.


You should not take Cetirizin Sandoz during breast feeding because cetirizine passes into breast milk.


Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizin Sandoz at the recommended dose.


If you are intending 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.

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.


Cetirizin Sandoz contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.


3. How to take Cetirizin Sandoz

How and when should you take Cetirizin Sandoz?

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


Tablets need to be swallowed with a glass of liquid.

Adults and adolescents above 12 years old

10 mg once daily as 1 tablet


Children between 6 and 12 years old

5 mg twice daily as a 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 Cetirizin Sandoz is too weak or too strong, please consult your doctor.


Duration of treatment

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


If you take more Cetirizin Sandoz than you should

If you think you have taken an overdose of Cetirizin Sandoz please inform your doctor.


Your doctor will then decide what measures, if any, should be taken.


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


If you forget to take Cetirizin Sandoz

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


If you stop taking Cetirizin Sandoz

If you have any further questions on the use of this medicine, 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 Cetirizin Sandoz and seek for medical attention without delay if you experience symptoms like:

The symptoms can be signs of hypersensitivityreactions, anaphylactic shock and angiooedema. These reactions are rare (may affect up to 1 in 1,000 people).


The following outline contains further side effects listed by their frequency:


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


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


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


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

thrombocytopenia (low blood platelets count manifested by bleeding or bruising more easily than normal)

accommodation disorder, blurred vision, oculogyric crisis (eyes having uncontrolled circular movements)

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

If you feel this way, stop taking the tablets and see your doctor.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.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 Cetirizin Sandoz


Keep this medicine out of the sightand reachof children.


Do not use Cetirizin Sandoz after the expiry date which is stated on the box and blister. The expiry date refers to the last day of that month


This medicine does not require any special storage conditions.


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


6. Contents of the pack and other information


What Cetirizin Sandoz contains

The active substance of Cetirizin Sandoz is cetirizine dihydrochloride


One film-coated tablet contains 10 mg cetirizine dihydrochloride.


The other ingredients are:

Tablet core:cellulose, microcrystalline, lactose monohydrate, magnesium stearate (Ph.Eur.), colloidal anhydrous silica

Tablet coat:hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E 171)


What Cetirizin Sandoz looks like and contents of the pack

White, oblong film-coated tablet with a score on one side


PVC blister with aluminium foil lidding: 7, 10, 14, 20, 21, 28, 30, 50, 60, 98 and 100 and 50 (50x1) unit-dose.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


[To be completed nationally]


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


[To be completed nationally]


This leaflet was last revised in 2014-11-12