ZYRTEC TBL 10MG N30

ATC code: R06AE07 

Active substances: Cetirizini Dihydrochloridum

Vendor, principal: Ucb Pharma Oy. 

 Prescription drug (℞) 

ZYRTEC 10MG N10

Package leaflet: Information for the user

Zyrtec 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 have 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 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 is in this leaflet:

1.   What Zyrtec is and what it is used for
2.   What you need to know before you take Zyrtec
3.   How to take Zyrtec
4.   Possible side effects
5.   How to store Zyrtec
6.   Content of the pack and further information

1. What Zyrtec is and what it is used for

Cetirizine dihydrochloride is the active ingredient of Zyrtec.
Zyrtec is an antiallergic medication.
In adults and children aged 6 years and above, Zyrtec 10 mg film-coated tablets are indicated
-   for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
-   for the relief of urticaria.

2. What you need to know before you take Zyrtec Do not take Zyrtec

-   if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min);
-   if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active ingredients of other medicines).

Warning and precautions

Ask your doctor or pharmacist for advice before taking Zyrtec.
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 have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 per mille (g/l) corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking Zyrtec with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Zyrtec for several days before testing. This medicine may affect your allergy test results.

Children

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

Other medicines and Zyrtec

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

Zyrtec with food and drink

Food does not affect absorption of Zyrtec.

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 for advice before taking this medicine.
Zyrtec 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 medicine should only be administered if necessary and after medical advice.
Cetirizine passes into breast milk. Therefore, you should not take Zyrtec during breast-feeding unless you have contacted a doctor.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zyrtec at the recommended dose.
You should closely observe your response to the drug after you have taken Zyrtec if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
Zyrtec film-coated tablets 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 Zyrtec

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.
The tablets need to be swallowed with a glass of liquid.
The tablet can be divided into 2 equal doses.

Adults and adolescents above 12 years old:

The recommended dose is 10 mg once daily as 1 tablet.

Use in children between 6 and 12 years old:

The recommended dose is 5 mg twice daily as a half tablet twice daily.

Patients with renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.
If you suffer from severe kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly.
If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child’s needs.
If you feel that the effect of Zyrtec 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. Please ask your doctor or pharmacist for advice.

If you take more Zyrtec than you should

If you think you have taken an overdose of Zyrtec 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 Zyrtec

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

If you stop taking Zyrtec

Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Zyrtec.
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.

The following side effects are rare or very rare, but you must stop taking the medicine and speak to your doctor straight away if you notice them:

-   Allergic reactions, including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat).
These reactions may start soon after you first take the medicine, or it might start later.
Common side effects (may affect up to 1 in 10 patients)
-   Somnolence (sleepiness)
-   Dizziness, headache
-   Pharyngitis, rhinitis (in children)
-   Diarrhea, nausea, dry mouth
-   Fatigue
Uncommon side effects (may affect up to 1 in 100 patients)
-   Agitation
-   Paresthesia (abnormal feelings of the skin)
-   Abdominal pain
-   Pruritus (itchy skin), rash
-   Asthenia (extreme fatigue), malaise
Rare side effects (may affect up to 1 in 1,000 patients)
-   Allergic reactions, some severe (very rare)
-   Depression, hallucination, aggression, confusion, insomnia
-   Convulsions
-   Tachycardia (heart beating too fast)
-   Liver function abnormal
-   Urticaria (hives)
-   Oedema (swelling)
-   Weight increased
Very rare side effects (may affect up to 1 in 10,000 patients)
-   Thrombocytopenia (low levels of blood    platelets)
-   Tics (habit spasm)
-   Syncope, dyskinesia (involuntary movements),    dystonia (abnormal prolonged muscular
contractions), tremor, dysgeusia (altered taste)
-   Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes having uncontrolled circular movements)
-   Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption
-   Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)
Not known frequency of side effects (frequency cannot be estimated from the available data)
-   Increased appetite
-   Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmares
-   Amnesia, memory impairment
-   Vertigo (sensation of rotation or movement)
-   Urinary retention (inability to completely empty the urinary bladder)
-   Pruritus (intense itching) and/or urticaria upon discontinuation
-   Joint pain
-   Pustular rash
-   Hepatitis (inflammation of the liver).

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 www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zyrtec

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 box and blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Zyrtec contains

-   The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine dihydrochloride.
-   The other ingredients are microcrystalline cellulose, lactose-monohydrate, colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000 (hydroxypropylmethylcellulose (E 464), titanium dioxide (E 171), macrogol 400).

What Zyrtec looks like and contents of the pack

White, oblong, film-coated tablet, with breakline and Y-Y logo.
Pack with 1, 4, 5, 7, and 10 tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
UCB Pharma Oy Finland Bertel Jungin aukio 5 02600 Espoo Finland
Manufacturers:
Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza (TO), Italy UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom Phoenix Pharma Polska Sp. z o.o., ul. Oplotek 26, 01-940 Warsaw, Poland ExtractumPharma Co. Ltd., 6413 Kunfeherto, IV. körzet 6., Hungary
Movianto Polska Sp. z o.o, ul. Artura i Franciszka Radziwillow 5, 05-850 Ozarow Mazowiecki, Poland

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

Austria: Zyrtec 1 mg/ml - orale Lösung
Belgium: Zyrtec
Cyprus: Zyrtec
Denmark: Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Zyrtec
Ireland: Zirtek oral solution 1 mg/ml
Italy: Zirtec 1 mg/ml soluzione orale
Latvia: Zyrtec
Lithuania: Zyrtec
Luxemburg: Zyrtec
Malta: Zyrtec
Netherlands: Zyrtec
Noray: Zyrtec
Poland: Zyrtec
Portugal: Zyrtec
Slovenia: Zyrtec 1 mg/ml peroralna raztopina Spain: Zyrtec 1 mg/ml solucion oral Sweden: Zyrlex
United Kingdom: Zirtek allergy solution
This leaflet was last revised in June 2018.
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