Cetirizine Viatris 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cetirizina 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Cetirizina Viatris

3. How to take Cetirizina Viatris

4. Possible side effects

5. How to store Cetirizina Viatris

6. Contents of the pack and other information

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

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

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

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

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

Do not take Cetirizine Viatris:

• If you have severe kidney disease.
• If you are allergic to cetirizine dihydrochloride, to any of the other components of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (closely related active substances in other medicines).

Warnings and precautions

Talk to 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 appropriate dose.
• If you have difficulty urinating (such as due to spinal, prostate, or bladder problems), consult your doctor.
• If you are an epileptic patient or a patient at risk of seizures (fits).

Skin testing

If you need to undergo a skin allergy test, inform your doctor that you are taking this medicine, as antihistamines may interfere with the results of skin tests. You will need to stop treatment three days before 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 mille (g/l), equivalent to one glass of wine) and cetirizine at recommended doses. However, safety data are lacking when higher doses of cetirizine and alcohol are taken 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Cetirizine should be avoided in pregnant women. Accidental use of this medicine during pregnancy is not expected to cause harmful effects on the fetus. However, the medicine should only be administered if necessary and after consulting with your doctor.

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

Driving and using machines

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

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

Cetirizine Viatris contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Cetirizine Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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. Tablets must be swallowed with a glass of liquid.

The tablets may be divided into two equal parts.

Adults and adolescents over 12 years of age:

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

Use in children between 6 and 12 years of age:

The recommended dose is 5 mg twice daily, as half a 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 renal disease, please contact your doctor, who may appropriately adjust the dose.

If your child suffers from renal 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 adverse effects described below may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, malaise, pupillary dilation, tingling, irritation, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and difficulty completely emptying the bladder.

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

If you forget to take Cetirizine Viatris

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

If you stop treatment with Cetirizine Viatris

In rare cases, pruritus (intense itching) and/or urticaria may reappear if you stop taking cetirizine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse 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 hives, swelling of the face, lips, tongue or throat, or other parts of the body, shortness of breath, wheezing or difficulty breathing.

Not known (frequency cannot be estimated from available data)

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

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

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Fatigue.
• Dry mouth.
• Malaise.
• Dizziness.
• Headache.
• Drowsiness.
• Sore throat and difficulty swallowing.

Uncommon (may affect up to 1 in 100 people)

• Weakness.
• General malaise.
• Tingling or numbness in hands or feet.
• Restlessness.
• Pruritus.
• 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.
• Swelling, 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, eyes have uncontrolled circular movements.
• Accommodation disorders (difficulty focusing vision).
• Syncope.
• Tremors.
• Disturbance 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 available data)

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

Adverse effects in children and adolescents

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

• Runny or blocked nose.
• Diarrhea.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Blister packs – No special storage conditions required.

Bottles – Do not store above 25 ºC.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cetirizine Viatris

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

Nature of the product and pack contents

Cetirizine Viatris is available as white, capsule-shaped, film-coated tablets, scored on one side 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 in blisters containing 2, 7, 10, 14, 15, 20, 30, 50, 60, 90 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan B.V.

Krijgsman 20,

Amstelveen, 1186DM,

The Netherlands

Or

Mylan Hungary Ltd.

Mylan utca 1.

Komarom, 2900

Hungary

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 – Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark Cetirizin Mylan

Spain Cetirizina Viatris 10 mg film-coated tablets EFG

Italy Cetirizina Mylan Generics 10 mg compresse rivestite con film

Norway Cetirizin Mylan

The Netherlands Cetirizine diHCl Mylan 10 mg filmomhulde tabletten

Portugal Cetirizina Mylan

United Kingdom Cetirizine 10 mg Film-coated Tablets

Sweden Cetirizin Mylan 10 mg filmdragerad tablett

Date of the most recent review of this leaflet: May 2024

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