ALYR 10MG TBL N7

ATC code: R06AE07 

Active substances: Cetirizinum

Vendor, principal: Pharmaswiss Ceska Republika S.r.o. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ALYR 10MG N7

Package leaflet: Information for the patient

Alyr, 10 mg, film-coated tablets

Cetirizini dihydrochloridum

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 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 is in this leaflet:

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

1. WHAT ALYR IS AND WHAT IT IS USED FOR

Cetirizine dihydrochloride is active ingredient of Alyr.
Alyr is an antiallergic medication.

In adults and children aged 6 years and above, Alyr is indicated:

-   for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
-   for the relief of urticaria.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALYR Do not take Alyr

-   if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6) or to hydroxizine or to piperazine derivatives (closely related active ingredients of other medicines)
-   if you have severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min)
-   if you have rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Warnings and precautions

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 Alyr with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop taking Alyr 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 Alyr

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

Alyr with food and drink

Food does not affect absorption of Alyr.

Pregnancy, breast-feeding and fertility

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.
Alyr should be avoided in pregnant women. Accidential 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 passess into breast milk. Therefore, you should not take Alyr 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 Alyr at the recommended dose.
You should closely observe your response to the drug after you have taken Alyr if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
Alyr 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 ALYR

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.
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 as a half tablet twice daily.

Patients with renal impairment:

Patients with moderate renal impairment are recommended to take 5 mg (1/2 tablet) 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 Alyr 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 Alyr than you should

If you think you have taken the overdose of Alyr, 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 Alyr

Do not take a double dose to make up for a forgotten dose.
If you have any futher 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 people):
-   somnolence (sleepiness)
-   dizziness, headache
-   pharyngitis, rhinitis (in children)
-   diarrhea, nausea, dry mouth
-   fatigue
Uncommon side effects (may affect up to 1 in 100 people):
-   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 people):
-   allergic reactions, sometimes severe (very rare)
-   depression, hallucinations, aggression, confusion, insomnia
-   convulsions
-   tachycardia (heart beating too    fast)
-   abnormal liver function
-   urticaria (hives)
-   oedema (swelling)
-   weight increase
Very rare side effects (may affect up to 1 in 10,000 people):
-   thrombocytopenia (low level of blood platelets)
-   tics (habit spasms)
-   syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)
-   blurred vision, accomodation 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 urination (bed wetting, pain and/or difficulty passing urine)
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)
-   memory loss, memory impairment
-   vertigo (sensation of rotation or movement)
-   urinary retention (inability to completely empty the urinary bladder)

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 ALYR
Keep this medicine out of the sight and reach of children.
Store below 25°C. Store in the original package to protect from light.
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.
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 Alyr contains
-   The active substance of Alyr is: cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine dihydrochloride.
-   The other ingredients are: lactose monohydrate, microcrystalline celulose, colloidal anhydrous silica, magnesium stearate, coating Opadry Y-1-7000 white: hypromellose, titanium dioxide (E 171), macrogol 400.
What Alyr looks like and contents of the pack
Alyr is white or almost white, round, biconvex film-coated tablets of 7.0-7.2 mm, with a score line on one side.
Available packaging: 7, 10 film-coated tablets in AL/PVC/PVDC foil blister in a cardboard box.
Not all pack sizes may be marketed.

Manufacturing Authorisation Holder

PharmaSwiss Česka republika s.r.o.
Jankovcova 1569/2c 170 00 Prague 7 Czech Republic

Manufacturer

ICN Polfa Rzeszow S.A. ul. Przemyslowa 2 35-959 Rzeszow
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
PharmaSwiss Eesti OÜ Tammsaare tee 47 11316 Tallinn Phone: 682 7400

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

names: Estonia	ALYR
Latvia	ALYR 10 mg apvalkotās tabletes
Lithuania	ALYR 10 mg plevele dengtos tabletes
Poland	CetAlergin Ten
Germany	Cetirizin Dr. Mann 10 mg Filmtabletten
Slovakia	Izatexi 10 mg

The leaflet was last revised in July 2016.

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