Cetirizine Aurovitas 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cetirizine Aurovitas 10 mg film-coated tablets EFG Cetirizine dihydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Cetirizina Aurovitas is and what it is used for

The active substance of Cetirizina Aurovitas is cetirizine dihydrochloride. Cetirizina Aurovitas is an antiallergic medicine.

Cetirizina Aurovitas 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 Aurovitas

Do not take Cetirizine Aurovitas

• if you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances in other medicines closely related to this one);
• if you have severe renal disease requiring dialysis.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Cetirizine Aurovitas.

If you are a patient with renal impairment, 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, 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 mille (g/l), corresponding to one glass of wine) and the use of cetirizine 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 Aurovitas with alcohol. If you are scheduled to undergo allergy testing, consult your doctor whether you should stop taking Cetirizine Aurovitas 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.

Other medicines and Cetirizine Aurovitas

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

Taking Cetirizine Aurovitas with food and drinks

Food does not affect the absorption of cetirizine.

Pregnancy, breastfeeding, and fertility

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

The use of Cetirizine Aurovitas should be avoided in pregnant women. Accidental use of the medicine during pregnancy is not expected to cause harmful effects on the fetus. However, the medicine should only be administered if necessary and after consultation with the doctor.

Cetirizine is excreted in breast milk. The risk of adverse effects in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine Aurovitas during breastfeeding unless advised by your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine causes impairment of attention, alertness, or driving ability at the recommended dose.

After taking Cetirizine Aurovitas, you should carefully monitor your response to the medicine if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cetirizine Aurovitas contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Cetirizine Aurovitas contains sodium

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

3. How to take Cetirizine Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets should be swallowed with a glass of liquid.

The tablets may be divided into two 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.

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 Cetirizine Aurovitas 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 Aurovitas than you should

If you think you have taken an overdose of Cetirizine Aurovitas, inform your doctor. Your doctor will decide, if necessary, what measures should be taken.

In case of overdose or accidental ingestion, contact 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, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence (drowsiness), stupor, abnormally increased heart rate, tremor and urinary retention (difficulty completely emptying the bladder).

If you forget to take Cetirizine Aurovitas

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

If you stop taking Cetirizine Aurovitas

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

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 may cause adverse effects, although not everyone will experience them.

The following adverse effects are rare or very rare, but you must 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 causing swelling of the face or throat).

These reactions may begin shortly after taking the medicine for the first time, or they may start later.

Frequent (may affect up to 1 in 10 people):

• Somnolence (drowsiness).
• Dizziness, headache.
• Pharyngitis (sore throat), rhinitis (runny or nasal congestion) (in children).
• Diarrhea, nausea, dry mouth.
• Fatigue.

Uncommon (may affect up to 1 in 100 people):

• Agitation.
• Paresthesia (abnormal sensation of the skin).
• Abdominal pain.
• Pruritus (itching), rash.
• Asthenia (extreme fatigue), malaise (feeling unwell).

Rare (may affect up to 1 in 1,000 people):

• Allergic reactions, some of which may be severe (very rare).
• Depression, hallucination, aggression, confusion, insomnia.
• Seizures.
• Tachycardia (heart beating too fast).
• Abnormal liver function.
• Urticaria (hives).
• Edema (swelling).
• Weight gain.

Very rare (may affect up to 1 in 10,000 people):

• Thrombocytopenia (low platelet levels in blood).
• Tics (spasms).
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disturbance).
• Blurred vision, accommodation disorders (difficulty focusing vision), ocular rotation (eyes have uncontrolled circular movement).
• Angioedema (severe allergic reaction causing swelling of the face or throat), drug rash (drug allergy).
• Abnormal urination (bedwetting, pain and/or difficulty urinating).

Frequency not known (cannot be estimated from available data):

• Increased appetite.
• Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares.
• Amnesia (memory loss), 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.
• Arthralgia (joint pain), myalgia (muscle pain).
• Generalized bullous exanthematous pustulosis (rash with pus-filled blisters).
• 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging 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 containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cetirizina Aurovitas

• The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hypromellose (5 cp), titanium dioxide (E 171), macrogol 400.

Appearance of the product and contents of the pack

Film-coated tablet.

Film-coated tablets, white to almost white, rectangular, engraved with "10" on one side and smooth on the other. With a notch between "1" and "0". The tablet can be divided into equal doses.

Cetirizina Aurovitas film-coated tablets are available in blister packs and high-density polyethylene (HDPE) bottles.

Pack sizes:

Blister packs: 20 film-coated tablets.

HDPE bottles: 30 and 1000 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Cetirizina Aurovitas 10 mg film-coated tablets EFG

Italy: Cetirizina Aurobindo 10 mg, compresse rivestite con film

Malta: Cetirizine Aurobindo 10 mg film-coated tablets

Portugal: Cetirizina Aurobindo

Date of the most recent review of this leaflet: September 2023

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