Cetirizine Mabo 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cetirizine MABO 10 mg film-coated tablets EFG

cetirizine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

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

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

The active substance in this medicine is cetirizine dihydrochloride.

This medicine is an antiallergic medicine.

This medicine 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 starting to take Cetirizine MABO

Do not take Cetirizine MABO

• if you have severe renal disease (severe renal insufficiency with creatinine clearance below 10 ml/min);
  • 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 (active substances closely related to other drugs).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• 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 problems urinating (such as spinal cord, 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 one glass of wine) and cetirizine used at the recommended dose. However, safety data are not available when higher doses of cetirizine and alcohol are taken 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 about whether you should stop taking cetirizine a few days before the test. This medicine may affect the results of your allergy tests.

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 MABO with other medicines

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

Taking Cetirizine MABO with food and drink

Food does not affect the absorption of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of this medicine should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to produce any 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 this medicine during breastfeeding unless advised by your doctor.

Driving and using machines

Clinical studies have not shown evidence that this medicine causes disturbances in attention, reduced reaction capacity, or impaired driving ability at the recommended dose.

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

Cetirizine MABO contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Cetirizine MABO contains sodium

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

3. How to take Cetirizina MABO

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets must 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 daily as 1 tablet.

Other forms of this medicine 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 daily, as half a tablet twice daily.

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

Patients with renal impairment

Patients with moderate renal impairment are advised to take 5 mg once daily.

If you suffer from severe kidney disease, please contact your doctor or pharmacist, who can appropriately adjust the dose.

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

If you notice that the effect of this medicine 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 Cetirizina MABO than you should

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

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

If you forget to take Cetirizina MABO

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

If you stop taking Cetirizina MABO

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

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

4. Possible adverse effects

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

The following adverse effects are rare or very rare, but you must stop taking the medicine and inform your doctor immediately if you experience any of them:

• Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat).

These reactions may start soon after first taking the medicine, or may begin later.

Frequent: 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 sensation of the skin)
• Agitation
• Pruritus, rash

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

• Tachycardia (heart beating 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 levels in blood)
• Accommodation disorders (difficulty focusing vision), blurred vision, ocular rotation (eyes have uncontrolled circular movement)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disturbance)
• Tic (spasms)
• Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced rash
• Difficulty or loss of control in urination (bedwetting, pain and/or difficulty urinating)

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

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

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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine MABO

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and any unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of any packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cetirizine MABO

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

Appearance of the product and contents of the pack

Film-coated tablets, white, biconvex, scored on one side and smooth on the other. The tablet can be divided into equal doses.

Pack containing 20 tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid (Spain)

Date of the most recent review of this leaflet: November 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/