CETIRIZINE VIATRIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine Viatris 10 mg Film-Coated Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

Contents of the pack

1. What is Cetirizine Viatris and what is it used for
2. What you need to know before you take Cetirizine Viatris
3. How to take Cetirizine Viatris
4. Possible side effects
5. Storage of Cetirizine Viatris

1. Contents of the pack and further information

1. What is Cetirizine Viatris and what is it used for

The active substance of Cetirizine Viatris is cetirizine dihydrochloride. Cetirizine Viatris is an antiallergic medicine.

Cetirizine Viatris is indicated in adults and children aged 6 years and above for:

• Relief of symptoms of seasonal and perennial allergic rhinitis and chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before you take Cetirizine Viatris

Do not takeCetirizine Viatris:

• If you have severe kidney disease.
• If you know that you are allergic to cetirizine dihydrochloride or 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

Consult your doctor or pharmacist before taking Cetirizine Viatris:

• If you have kidney problems. You may need to take a lower dose. Your doctor will determine the new dose.
• If you have problems urinating (such as spinal cord or prostate or bladder problems), consult your doctor.
• If you are an epileptic patient or a patient at risk of convulsions (seizures).

Skin test

If you are to undergo a skin test (allergy test), inform your doctor that you are taking this medicine, as these medicines may affect the result of the skin test. You will need to stop treatment three days before undergoing the test.

Children

Do not give this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.

Taking Cetirizine Viatris with other medicines

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

Cetirizine Viatris with food, drinks, and alcohol

Food does not affect the absorption of cetirizine.

No clinically significant interactions have been observed between alcohol (blood levels of 0.5 per thousand (g/l) corresponding to a glass of wine) and cetirizine at recommended doses. However, no data are available on safety when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.

Pregnancy and breastfeeding

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

Cetirizine should be avoided in pregnant women. Accidental use of this medicine in pregnant women should not produce harmful effects on the fetus. However, the medicine should only be administered if necessary and after consulting a doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take cetirizine during breastfeeding, unless you have consulted your doctor.

Driving and using machines

There is no evidence of altered attention, alertness, and driving ability after taking cetirizine at the recommended dose.

You should carefully observe your response to the medicine after taking cetirizine if you intend to drive, perform potentially hazardous activities, or use machinery. Do not exceed the recommended dose.

Cetirizine Viatris contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Cetirizine Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How and when to take cetirizine

These recommendations apply unless your doctor has given you different instructions on how to take Cetirizine Viatris.

Follow these instructions; otherwise, treatment with cetirizine may not be fully effective. The tablets should be swallowed with a glass of liquid.

The tablets can be divided into two equal parts.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once daily, as one tablet.

Use in children between 6 and 12 years:

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

Patients with renal insufficiency:

It is recommended that patients with moderate renal insufficiency take 5 mg once daily.

If you suffer from severe kidney disease, please contact your doctor, who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor, who may adjust the dose according to your child's needs.

If you notice that the effect of cetirizine is too weak or too strong, consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of your symptoms and will be determined by your doctor or pharmacist.

If you take more Cetirizine Viatris than you should

If you think you have taken more cetirizine than you should, inform your doctor. Your doctor will then decide what measures should be taken.

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, dilation of the pupils, tingling, irritation, sedation, somnolence, stupor, abnormally fast heart rate, tremor, and difficulty emptying the bladder completely have been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Cetirizine Viatris

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

If you stop taking Cetirizine Viatris

Rarely, itching (intense itching) and/or urticaria may reappear if you stop taking cetirizine.

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.

Some side effects can be serious:

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

• Sudden signs of allergy such as skin rash, itching, or urticaria on the skin, swelling of the face, lips, tongue, or throat, or any other part of the body, shortness of breath, wheezing, or difficulty breathing.

Not known(frequency cannot be estimated from the available data)

• Suicidal thoughts.
• Inability to empty the bladder completely.

If you experience any of the above, stop taking this medicine and inform your doctor immediately.

Other possible side effects:

Common(may affect up to 1 in 10 people)

• Fatigue.
• Dry mouth.
• Malaise.
• Dizziness.
• Headache.
• Somnolence.
• Sore throat and discomfort when swallowing.

Uncommon(may affect up to 1 in 100 people)

• Weakness.
• Malaise.
• Tingling or numbness of hands or feet.
• Agitation.
• Itching.
• Rash.
• Stomach pain.

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

• Tachycardia (heart beats too fast).
• Abnormal liver function tests.
• Weight gain.
• Seizures (fits).
• Aggression.
• Confusion.
• Depression.
• Seeing, feeling, or hearing things that are not there.
• Insomnia.
• Hypersensitivity (usually appears with skin reactions such as rash, redness with itching).
• Urticaria.
• Inflammation, fluid retention (edema).

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

• Bleeding or bruising more easily than normal.
• Tics (spasms).
• Blurred vision, the eyes have an uncontrolled circular movement.
• Accommodation disorders (difficulty fixing the gaze).
• Fainting.
• Tremors.
• Alteration or loss of taste.
• Involuntary body movements.
• Involuntary muscle contractions.
• Difficulty, pain, or lack of control when urinating.

Not known(frequency cannot be estimated from the available data)

• Memory loss.
• Memory impairment.
• Increased appetite.
• Dizziness (feeling of spinning), nightmares.
• Itching (intense itching) and/or urticaria after stopping treatment.
• Arthralgia (joint pain), myalgia (muscle pain).
• Acute generalized exanthematous pustulosis (rash with blisters containing pus).
• Hepatitis (inflammation of the liver).

Side effects in children and adolescents

In children and adolescents, the following side effects may occur more frequently and may affect up to 1 in 10 people:

• Nasal secretion or stuffy nose.

• Diarrhea.

Reporting of side effects:

If you experience 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 Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Viatris

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 is the last day of the month stated.

Blister packs - No special storage conditions required.

Bottles – Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Cetirizine Viatris

• The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: lactose monohydrate (see section 2 "Cetirizine Viatris contains lactose"), corn starch pregelatinized, povidone, magnesium stearate, hypromellose (E464), macrogol, titanium dioxide (E171), and talc.

Appearance and packaging

Cetirizine Viatris is presented in the form of white, capsule-shaped, film-coated tablets, scored and marked with "CZ" and "10" on one side and "G" on the other.

It is available in bottles of 30, 100, and 250 film-coated tablets and blister packs containing 2, 7, 10, 14, 15, 20, 30, 50, 60, 90, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan B.V.

Krijgsman 20,

Amstelveen, 1186DM,

Netherlands

Or

Mylan Hungary Ltd.

Mylan utca 1.

Komarom, 2900

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 – Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark Cetirizin Mylan

Spain Cetirizine Viatris 10 mg film-coated tablets EFG

Italy Cetirizina Mylan Generics 10 mg film-coated tablets

Norway Cetirizin Mylan

Netherlands Cetirizine diHCl Mylan 10 mg film-coated tablets

Portugal Cetirizina Mylan

United Kingdom Cetirizine 10 mg Film-coated Tablets

Sweden Cetirizin Mylan 10 mg film-coated tablets

Date of last revision of this leaflet:May 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/