CETIRIZINE AUROVITAS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine Aurovitas 10 mg Film-Coated Tablets EFGCetirizine Dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Cetirizine Aurovitas is indicated in adults and children aged 6 years and above for:

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

2. What you need to know before you take Cetirizine Aurovitas

Do not take Cetirizine Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine Aurovitas.

If you have renal insufficiency, consult your doctor; if necessary, a lower dose will be taken. Your doctor will determine the new dose.

If you have problems 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 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, 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 going to have an allergy test, consult your doctor if 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

Tell your doctor or pharmacist if you are taking, have recently taken or might 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Cetirizine Aurovitas should be avoided in pregnant women. Accidental use of the medicine in pregnant women should not produce any harmful effects on the fetus. However, the medicine should only be administered if necessary and after consulting a doctor.

Cetirizine is excreted in breast milk. The risk of side effects in breastfed babies cannot be excluded. Therefore, you should not take Cetirizine Aurovitas during breastfeeding, unless you have consulted your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine produces alterations in attention, alertness, and ability to drive at the recommended dose.

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

Cetirizine Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Cetirizine Aurovitas contains sodium

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

3. How to take Cetirizine Aurovitas

Follow exactly the administration instructions of this medicine given 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 2 equal doses.

Adults and adolescents over 12 years:

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:

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 insufficiency

Patients with moderate renal insufficiency are recommended to take 5 mg once daily. If you have severe kidney disease, please contact your doctor or pharmacist, who may adjust the dose accordingly.

If your child has 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 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 what measures to take, if necessary.

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 medicine 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, malaise, pupil dilation, pruritus, restlessness, sedation, somnolence, stupor, abnormal increase in heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Aurovitas

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

If you stop taking Cetirizine Aurovitas

It may rarely happen that pruritus and/or urticaria reappear if you stop taking Cetirizine Aurovitas.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side 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 serious and angioedema (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 may start later.

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

• Somnolence (drowsiness).
• Dizziness, headache.
• Pharyngitis (sore throat), rhinitis (runny, stuffy nose) (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.

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

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

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

• Thrombocytopenia (low platelet count in blood).
• Tics (involuntary muscle contractions).
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder).
• Blurred vision, accommodation disorders (difficulty focusing), ocular gyration (uncontrolled circular eye movement).
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash.
• Abnormal urine elimination (bedwetting, pain and/or difficulty urinating).

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

• Increased appetite.
• Suicidal thoughts (recurring or obsessive thoughts of suicide), nightmares.
• Amnesia (memory loss), memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to empty the bladder completely).
• Pruritus and/or urticaria after treatment discontinuation.
• Arthralgia (joint pain), myalgia (muscle pain).
• Acute generalized exanthematous pustulosis (rash with pus-filled blisters).
• Hepatitis (inflammation of the liver).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cetirizine Aurovitas

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

Appearance of the product and pack contents

Film-coated tablet.

White to off-white, rectangular film-coated tablets, scored with "10" on one side and smooth on the other. The tablet can be divided into two equal doses.

Cetirizine 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised 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 last revision of this leaflet: September 2023

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