Prospect: information for the user

Cetirizine MABO 10mg film-coated tablets EFG

cetirizine dihydrochloride

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

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

2.What you need to knowbeforestarting totake Cetirizine MABO

3.How to take Cetirizine MABO

4.Possible adverse effects

5.Storage of Cetirizine MABO

6.Contents of the pack and additional information

The active ingredient of this medication is cetirizine dihydrochloride.

This medication is an antihistamine.

This medication 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 ofurticaria

Do not take Cetirizina MABO

-if you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10ml/min);

• if 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 drugs).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have renal insufficiency, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.
• If you have difficulty urinating (such as spinal cord problems or prostate or bladder problems), please consult your doctor.

• if you are an epileptic patient or a patient at risk of seizures, consult your doctor.

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

If you are planning to undergo an allergy test, consult your doctor if you should stop taking cetirizine a few days before the test. This medication may affect the results of your allergy tests.

Children

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

Taking Cetirizina MABOwith othermedications

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

Taking Cetirizina MABO with food and drinks

Food does not affect the absorption of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any 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 is a risk of adverse reactions in infants. Therefore, do not take this medication during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that this medication produces attention impairments, reaction ability decrease, and driving ability at the recommended dose.

If you intend to drive, perform potentially hazardous activities, or use machinery, do not exceed the recommended dose. You should observe your response to the medication.

Cetirizina MABO contains lactose

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

Cetirizina MABO contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed with a glass of liquid.

The tablets can be divided into equal doses.

Adults and adolescents over 12 years old

The recommended dose is 10 mg once a day as 1 tablet.

Other forms of this medication may be more suitable for children: ask your doctor or pharmacist.

Use in children between 6 and 12 years old

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

Other forms of this medication may be more suitable for children: ask your doctor or pharmacist.

Patients with renal insufficiency

Patients with moderate renal insufficiency should take 5 mg once a day.

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

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

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

Treatment duration

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

If you take more Cetirizina MABO than you should

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.

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, weakness, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention.

If you forgot to take Cetirizina MABO

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

If you interrupt treatment with Cetirizina MABO

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

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

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

The following side effects are rare or very rare, but you should stop taking the medicine and tell your doctor immediately if you notice any of them:

- Allergic reactions, including severe reactions and angioedema (severe allergic reaction that causes swelling of the face or throat).

These reactions can start soon after taking the medicine for the first time, or they can start later.

Frequent: can affect up to 1 in 10 patients

• Fatigue
• Diarrhea, dry mouth, nausea
• Dizziness, headache
• Drowsiness (drowsiness)
• Pharyngitis, rhinitis(in children)

Less frequent: can affect up to 1 in 100 patients

• Abdominal pain
• Extreme fatigue, discomfort
• Paraesthesia (abnormal skin sensation)
• Agitation
• Pruritus, rash

Rare: can affect up to 1 in 1,000 patients

• Tachycardia (heart beats too quickly)
• Edema (swelling)
• Allergic reactions, some severe (very rare)
• Abnormal liver function
• Weight gain
• Seizures
• Aggression, confusion, depression, hallucination, insomnia
• Urticaria (hives)

Very rare: can affect up to 1 in 10,000 patients

• Thrombocytopenia (low platelet count in blood)
• Accommodation disorders (difficulty focusing vision), blurred vision, nystagmus (eyes have an uncontrolled circular movement)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Tic (spasms)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Difficulty or inability to urinate (wetting the bed, pain, and/or difficulty urinating)

Side effects of unknown frequency (frequency cannot be estimated from available data)

• Increased appetite
• Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares
• Amnesia, memory deterioration
• Dizziness (sensation of spinning or movement)
• Urinary retention (inability to completely empty the urinary bladder)
• Pruritus (intense itching) and/or urticaria after treatment suspension
• Joint pain
• Rash with blisters that have pus
• Hepatitis (inflammation of the liver)

Reporting of 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reachof children.

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

No special storage conditions are required.

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

Composition of Cetirizina MABO

• The active ingredient is cetirizine dihydrochloride. Each coated tablet contains 10mg of cetirizine dihydrochloride.
• The other components are:
• Core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica, sodium croscarmellose.
• Coating (Opadry white Y-1-7000): hypromellose, macrogol 400, titanium dioxide (E171).

Appearance of the product and content of the packaging

Coated tablets with a film coating, white, biconvex, scored on one side and smooth on the other. The tablet can be divided into equal doses.

Packaging with 20 tablets.

Holder of the marketing authorization

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid (Spain)

Last review date of this leaflet: November 2021

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