CETIRIZINE MABO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine MABO 10mg film-coated tablets EFG

cetirizine dihydrochloride

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Cetirizine MABO and what is it used for
2. What you need to know before taking Cetirizine MABO
3. How to take Cetirizine MABO
4. Possible side effects
5. Storage of Cetirizine MABO
6. Contents of the pack and further information

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

The active substance of this medication is cetirizine dihydrochloride.

This medication is an antiallergic medication.

This medication is indicated in adults and children from 6 years of age for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of urticaria

2. What you need to know before taking Cetirizine MABO

Do not take Cetirizine MABO

• if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min);
• if you are allergic to cetirizine dihydrochloride, to any of the other ingredients of this medication (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances to other medications).

Warnings and precautions

Consult your doctor or pharmacist before taking this medication:

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

• if you are an epileptic patient or a patient at risk of convulsions, 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 safety data available when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.

If you are scheduled 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 of age, as this formulation does not allow for the necessary dose adjustment.

Taking Cetirizine MABO with other medications

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

Taking Cetirizine 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of this medication should be avoided in pregnant women. Accidental use of the medication in pregnant women should not produce any harmful effect on the fetus. However, the medication should only be administered if necessary and after consulting with the doctor.

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

Driving and using machines

Clinical studies have not shown evidence that this medication produces alterations in attention, decreased reaction capacity, and ability to drive 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.

Cetirizine MABO contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Cetirizine MABO contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Cetirizine MABO

Follow the administration instructions of this medication exactly as indicated 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 of age

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 of age

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.

Patient with renal insufficiency

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

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 notice that the effect of this medication 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.

If you take more Cetirizine MABO than you should

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 medication and the amount ingested.

After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, tingling, irritation, sedation, somnolence, stupor, abnormally fast heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine MABO

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

If you stop taking Cetirizine MABO

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects are rare or very rare, but you should stop taking the medication 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 medication for the first time or may start later.

Common: may affect up to 1 in 10 patients

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

Uncommon: may affect up to 1 in 100 patients

• Abdominal pain
• Asthenia (extreme fatigue), malaise
• Paresthesia (abnormal skin sensation)
• Agitation
• Itching,rash

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

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

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

• Thrombocytopenia (low platelet count in blood)
• Accommodation disorders (difficulty fixing gaze), blurred vision, ocular gyration (eyes have 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 lack of control when urinating (bedwetting, pain and/or difficulty urinating)

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

• Increased appetite
• Suicidal thoughts (recurrent or obsessive thoughts of suicide), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to empty the bladder completely)
• Itching (intense itching) and/or urticaria after stopping treatment
• Joint pain
• Blistering rash
• Hepatitis (inflammation of the liver)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cetirizine MABO

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and blister after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cetirizine MABO

• The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients 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 pack contents

White, biconvex, film-coated tablets with a score line on one side and a smooth surface on the other. The tablet can be divided into equal doses.

Pack containing 20 tablets.

Marketing authorization holder

MABO-FARMA, S.A.

Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid (Spain)

Date of last revision of this package leaflet: November 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/