Label: information for the user

Cetirizine Viatris 10 mg film-coated tablets EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6. Contents of the pack and additional information

The active ingredient of Cetirizina Viatris is cetirizine dihydrochloride. Cetirizina Viatris is an antihistamine medication.

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

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

Do not takeCetirizina Viatris:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizina Viatris:

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

Skin test

If a skin test (allergy test) is to be performed, inform your doctor that you are taking this medication, as these medications may affect the results of the skin tests. You will need to discontinue treatment three days before undergoing the test.

Children

Do not administer this medication to children under 6 years old, as this formulation does not allow for the necessary dose adjustment.

TakingCetirizina Viatriswith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Cetirizina Viatriswith 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, there is no data on the safety of taking high 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Cetirizine should be avoided in pregnant women. Accidental use of this medication in pregnant women should not cause harm to the fetus.However, the medication should only be administered if necessary and after consulting with your doctor.

Cetirizine passes into breast milk. It cannot be ruled out that there may be a risk of adverse reactions in infants. Therefore, do not take cetirizine during breastfeeding, unless you consult your doctor.

Driving and operating machinery

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

You should closely monitor your response to the medication after taking cetirizine if you plan to drive, engage in potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cetirizina Viatris contains lactose

If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated 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 the treatment with cetirizine may not be fully effective. The tablets must 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 a day, as a tablet.

Use in children between 6 and 12 years:

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

Patients with renal insufficiency:

Patients with moderate renal insufficiency are recommended to take 5 mg once a day.

If you have severe kidney disease, please contact your doctor, who may adjust the dose appropriately.

If your child has 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 discomfort 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 such as confusion, diarrhea, dizziness, fatigue, headache, general malaise, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and difficulty fully emptying the bladder have been reported.

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

If you forgot to take Cetirizine Viatris

Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Cetirizine Viatris

In rare cases, intense itching and/or urticaria may recur if you stop taking cetirizine.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious:

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

• Sudden signs of allergy such as skin rash, itching or hives 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.

Unknown(the frequency cannot be estimated from the available data)

• Thoughts of suicide.
• Inability to completely empty the bladder.

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

Other possible side effects:

Frequent(may affect up to 1 in 10 people)

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

Occasional(may affect up to 1 in 100 people)

• Weakness.
• General discomfort.
• Tingling or numbness of hands or feet.
• Restlessness.
• Itching.
• Hives.
• Stomach pain.

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

• Tachycardia (heart beats too quickly).
• Abnormal liver function tests.
• Weight gain.
• Seizures (attacks).
• 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).
• Hives.
• 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, the eyes have an uncontrolled circular movement.
• Accommodation disorders (difficulty focusing the gaze)
• Syncope.
• Tremors.
• Alteration or loss of taste.
• Involuntary body movements.
• Involuntary muscle contractions
• Difficulty, pain or loss of control when urinating.

Unknown(the frequency cannot be estimated from the available data)

• Memory loss.
• Deterioration of memory
• Increased appetite.
• Dizziness (sensation of rotation), nightmares.
• Itching (intense itching) and/or hives after stopping treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalized acute pustular exanthema (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 appear more frequently and may affect up to 1 in 10 people:

• Nasal discharge or blocked nose.

• Diarrhea.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

Blister packs - No special storage conditions are required.

Bottles – Do not store at a temperature above 25 °C.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Cetirizine Viatris Composition

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

Appearance of the product and contents of the package

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

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

Only some package 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,

Netherlands

Or

Mylan Hungary Ltd.

Mylan utca 1.

Komarom, 2900

Hungary

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 – Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

DenmarkCetirizin Mylan

SpainCetirizine Viatris 10 mg film-coated tablets EFG

ItalyCetirizine Mylan Generics 10 mg film-coated tablets

NorwayCetirizin Mylan

NetherlandsCetirizine diHCl Mylan 10 mg film-coated tablets

PortugalCetirizine Mylan

United KingdomCetirizine 10 mg Film-coated Tablets

SwedenCetirizin Mylan 10 mg film-coated tablet

Last review date of this leaflet:May 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/