Leaflet: information for the user

Cetirizine Aurovitas 10 mg film-coated tablets EFG
Cetirizine dihydrochloride

Read this 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, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.Seesection4.

The active ingredient of Cetirizina Aurovitas is cetirizine dihydrochloride.
Cetirizina Aurovitas is an antihistamine medication.

Cetirizina Aurovitas is 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 take Cetirizina Aurovitas

• if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medication (listed in section 6), to hydroxyzine or to piperazine derivatives (active ingredients of other closely related medications);
• if you have severe kidney disease that requires dialysis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizina Aurovitas.

If you are a patient with kidney 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 Aurovitas with alcohol.

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

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

Taking Cetirizina 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

The use of Cetirizina Aurovitas should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harm to the fetus. However, the medication should only be administered if necessary and after consulting with the doctor.

Cetirizine is excreted in breast milk. The risk of secondary effects in breastfeeding infants cannot be ruled out. Therefore, do not take Cetirizina Aurovitas during breastfeeding, unless you consult your doctor.

Driving and operating machinery

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

After taking Cetirizina Aurovitas, you should closely observe your response to the medication if you intend to drive, perform potentially hazardous activities, or operate machinery; do not exceed the recommended dose.

Cetirizina Aurovitas contains lactose

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

Cetirizina Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication as 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.

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 Cetirizina Aurovitas is too weak or too strong, consult your doctor.

Treatment duration:

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 Aurovitas than you should

If you think you have taken an overdose of Cetirizina Aurovitas, inform your doctor. Your doctor will decide, if necessary, what measures to take.

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 adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, discomfort (feeling unwell), dilated pupil, itching, restlessness, sedation, drowsiness (drowsiness), stupor, abnormal increase in heart rate, tremor, and urinary retention (difficulty emptying the bladder) have been reported.

If you forgot to take Cetirizina Aurovitas

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

If you stop takingCetirizina Aurovitas

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

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 (severe allergic reaction that causes swelling of the face or throat).

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

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

• Drowsiness (drowsiness).
• Dizziness, headache.
• Pharyngitis (sore throat), rhinitis (runny, congested nose) (in children).
• Diarrhea, nausea,drynessofthemouth.
• Fatigue.

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

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

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

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

• Thrombocytopenia (low platelet count in the blood).
• Tics (spasms).
• Syncope (fainting), 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 eruption (allergic reaction to the drug).
• Abnormal urination (bedwetting, pain, 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 deterioration.
• Dizziness (sensation of spinning or movement).
• Urinary retention (inability to completely empty the bladder).
• Pruritus (intense itching) and/or urticaria after treatment discontinuation.
• Arthralgia (joint pain), myalgia (muscle pain).
• Generalized acute pustular exanthema (rash with pus-filled blisters).
• Hepatitis (inflammation of the liver).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Cetirizina Aurovitas

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

Appearance of the product and contents of the packaging

Film-coated tablet.

Film-coated tablets, white to off-white in color, rectangular, marked 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 (PEAD) bottles.

Packaging sizes:

Blister packs : 20 film-coated tablets.

PEAD bottles : 30 and 1000 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: September 2023

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