CETIRIZINE TARBIS FARMA 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Cetirizine Tarbis Farma 10 mg film-coated tablets EFG

Cetirizine dihydrochloride

Read the entire leaflet carefully before starting to take this medication, as 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 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 leaflet. See section 4.

Contents of the leaflet

1. What Cetirizine Tarbis Farma is and what it is used for
2. What you need to know before taking Cetirizine Tarbis Farma
3. How to take Cetirizine Tarbis Farma
4. Possible side effects
5. Storage of Cetirizine Tarbis Farma
6. Package contents and additional information

1. What Cetirizine Tarbis Farma is and what it is used for

The active ingredient of Cetirizine Tarbis Farma is cetirizine dihydrochloride.

Cetirizine is an antiallergic medication.

Cetirizine 10 mg film-coated tablets are indicated for adults and children over 6 years 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 Tarbis Farma

Do not use Cetirizine Tarbis Farma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizine.

If you have kidney impairment, 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 Tarbis Farma 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, as this formulation does not allow for the necessary dose adjustment.

Other medications and Cetirizine Tarbis Farma

Tell your doctor or pharmacist if you are using or have recently used, or may need to use, any other medication.

Taking Cetirizine Tarbis Farma with food, drinks, and alcohol

Food does not affect the absorption of Cetirizine.

Pregnancy and breastfeeding

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

The use of Cetirizine 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 your doctor.

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

Driving and using machines

Clinical studies have not shown evidence that Cetirizine causes 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, you should not exceed the recommended dose. You should closely observe your response to the medication.

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.

This medication contains sodium

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

3. How to take Cetirizine Tarbis Farma

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. If in doubt, consult your doctor or pharmacist again.

The tablets should be swallowed with a glass of liquid.

The tablets can be divided into 2 equal doses.

Adults and adolescents over 12 years:

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:

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 impairment:

Patients with moderate renal impairment are recommended to 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 Cetirizine is too weak or 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 Tarbis Farma 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 taken.

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, abnormal increased heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Tarbis Farma

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

If you stop taking Cetirizine Tarbis Farma

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

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 serious 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 side effects (may affect up to 1 in 10 patients)

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

Uncommon side effects (may affect up to 1 in 100 patients)

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

Rare side effects (may affect up to 1 in 1,000 patients)

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

Very rare side effects (may affect up to 1 in 10,000 patients)

• Thrombocytopenia (low platelet count in blood)
• Tics (spasms)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty fixing gaze), ocular gyration (eyes have an uncontrolled circular movement)
• 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, pharmacist, or nurse, even if they are not listed in this 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 Tarbis Farma

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cetirizine Tarbis Farma

The active ingredient is cetirizine dihydrochloride.

Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.

The other ingredients are:

Lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The tablets are coated with:

Hypromellose, polydextrose, titanium dioxide (E171), macrogol 400.

Appearance of the product and package contents

Film-coated tablet

White to off-white film-coated tablets, capsule-shaped, with a score line on one side. Dimensions (Length: 9.60 mm ± 0.30 mm and width: 4.60 mm ± 0.30 mm). The tablet can be divided into 2 equal doses.

Cetirizine Tarbis Farma is presented in PVC/PVDC-Alu blisters of 20 tablets.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Date of last revision of this 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.