Package Insert: Information for the Patient

Cetirizine Tarbis Farma 10 mg Film-Coated Tablets

Cetirizine dihydrochloride

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

• Keep this package insert, 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 must not give it to others 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, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Cetirizine Tarbis Farma

3. How to take Cetirizine Tarbis Farma

4. Possible side effects

5. Storage of Cetirizine Tarbis Farma

6. Contents of the pack and additional information

The active ingredient of Cetirizina Tarbis Farma is cetirizine dihydrochloride.

Cetirizine is an antihistamine medication.

Cetirizine 10 mg film-coated tablets are 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 urticaria.

Do not use Cetirizina Tarbis Farma

• if you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10 ml/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 medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizina.

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 taking together higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Tarbis Farma with alcohol.

If you are scheduled to undergo an allergy test, consult your doctor if you should interrupt taking Cetirizina 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.

Other medications and Cetirizina Tarbis Farma

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

Taking Cetirizina Tarbis Farma with food, drinks, and alcohol

Food does not affect the absorption of Cetirizina.

Pregnancy and breastfeeding

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

Cetirizina should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harmful effects 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 infants cannot be ruled out. Therefore, do not take Cetirizina during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that Cetirizina produces attention alterations, reaction ability decrease, and driving ability impairment at the recommended dose.

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

This medication contains lactose

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

This medication contains sodium

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

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

The tablets must 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.

Patients with renal insufficiency:

Patients with moderate renal insufficiency 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 too strong, consult your doctor.

Treatment duration:

The duration of treatment depends on the type, duration, and course of your discomfort 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 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 Cetirizine Tarbis Farma:

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

If you stop taking Cetirizine Tarbis Farma:

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, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 (a 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 side effects (may affect up to 1 in 10 patients)

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

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

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

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

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Seizures
• Tachycardia (heart beats too quickly)
• 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 focusing), nystagmus (uncontrolled eye movement)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Difficulty or inability to urinate (bedwetting, pain, and/or difficulty urinating)

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about 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 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Composition of Cetirizina Tarbis Farma

The active ingredient is cetirizine dihydrochloride.

Each coated tablet contains 10 mg of cetirizine dihydrochloride.

The other components are:

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

The tablets are coated with:

Hydroxypropyl methylcellulose, maltodextrin, titanium dioxide (E171), macrogol 400.

Appearance of the product and contents of the packaging

Coated tablet

Coated tablets of white to off-white color, in capsule shape, with a notch on one of the faces. Dimension (Length: 9.60 mm ± 0.30 mm and width: 4.60 mm ± 0.30 mm). The tablet can be divided into 2 equal doses.

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

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Date of the last review 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