ALERLISIN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Alerlisin 10mg film-coated tablets

cetirizine 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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Alerlisin and what is it used for

The active substance of Alerlisin is cetirizine dihydrochloride.

Alerlisin is an antiallergic medicine.

Alerlisin is indicated in adults and children over 6 years for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before you take Alerlisin

Do not take Alerlisin

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

Do not take Alerlisin 10 mg film-coated tablets:

• if you have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Warnings and precautions

Consult your doctor or pharmacist before taking Alerlisin

• if you have kidney problems, consult your doctor; if necessary, a lower dose will be taken. Your doctor will determine the new dose.

• if you are an epileptic patient or a patient at risk of convulsions, consult your doctor.

No significant interactions have been observed between alcohol (with a blood level of 0.5 per thousand, corresponding to a glass of wine) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid concurrent consumption of alcohol during treatment.

Children

This medicine is not recommended for children under 6 years, as this formulation does not allow for appropriate dose adjustments.

Taking Alerlisin with other medicines

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

Due to the profile of cetirizine, interactions with other medicines are not expected.

Taking Alerlisin with food and drinks

Food does not significantly affect the degree of absorption of cetirizine.

Pregnancy and breastfeeding

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.

As with other medicines, the use of Alerlisin should be avoided in pregnant women. Accidental use of the medicine in pregnant women should not produce any harmful effect on the fetus. However, treatment with the medicine should be discontinued.

Do not take Alerlisin during breastfeeding, as cetirizine is excreted in breast milk.

Driving and using machines

Clinical studies have not shown evidence that Alerlisin produces 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, do not exceed the recommended dose. You should closely observe your response to the medicine.

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants may further affect your attention and reaction capacity.

Alerlisin contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Alerlisin

Follow exactly the administration instructions of this medicine indicated 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.

Adults and adolescents over 12 years

10 mg once a day as 1 tablet.

Use in children between 6 and 12 years

5 mg twice a day, as half a tablet twice a day.

Patient with moderate to severe renal impairment

It is recommended that patients with moderate renal impairment take 5 mg once a day.

If you notice that the effect of Alerlisin 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 Alerlisin than you should

After an overdose, the following adverse effects 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.

Tell your doctor if you think you have taken an overdose of Alerlisin.

Your doctor will then decide what measures should be taken.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alerlisin

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

If you stop taking Alerlisin

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 have been reported in the post-marketing experience:

Common: may affect up to 1 in 10 people

• Fatigue
• Diarrhea, dry mouth, nausea
• Dizziness, headache
• Somnolence
• Pharyngitis, rhinitis

Uncommon: may affect up to 1 in 100 people

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

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

• Tachycardia (heart beats too fast)
• Edema (swelling)
• Allergic reactions, some severe (very rare)
• Abnormal liver function
• Weight gain
• Seizures, movement disorders
• Aggression, confusion, depression, hallucination, insomnia
• Urticaria

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

• Thrombocytopenia (low blood platelet count)
• Accommodation disorders, blurred vision, eye rolling (eyes have an uncontrolled circular movement)
• Syncope, tremor, dysgeusia (taste disorder)
• Tic
• Abnormal urine elimination
• Edema, drug rash

At the first symptoms of hypersensitivity, stop taking Alerlisin.

Your doctor will assess the severity and decide on the measures to be taken.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alerlisin

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 and blister after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alerlisin

• The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are:
• Core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica.
• Coating: hypromellose (E-464), macrogol 400, titanium dioxide (E-171).

Appearance of the product and pack contents

White, oblong, scored film-coated tablets with the logo Y-Y.

Pack sizes: 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

RETRAIN, S.A.U.

Alfons XII, 587 – 08918 Badalona (Barcelona) – Spain

Manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) – Spain

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) – Spain

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

Austria: Zyrtec 10 mg - Filmtabletten

Belgium: Reactine, Cetirizine-UCB, Zyrtec

Bulgaria: Zyrtec

Cyprus: Zyrtec

Czech Republic: Zyrtec, Reactine

Denmark: Benaday, Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Reactine 10 mg film-coated tablet, Virlix, Cetirizine UCB 10 mg, Zyrtec, Actifed Allergie cetirizine 10 mg film-coated tablet, Zyrtecset

Germany: Zyrtec, Zyrtec P, Reactine

Greece: Ziptek

Hungary: Zyrtec filmtabletta, Zyrtec start filmtabletta

Ireland: Zirtek tablets, Reactine 10 mg tablets

Italy: Formistin, Reactidiem "10 mg film-coated tablets", Zirtec 10 mg film-coated tablets

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Reactine, Zyrtec, Cetirizine-UCB

Malta: Zyrtec

Netherlands: Reactine tablets 10 mg, Zyrtec

Norway: Reactine, Zyrtec

Poland: Reactine, Virlix, Zyrtec, Zyrtec UCB

Portugal: Zyrtec, Virlix

Romania: Zyrtec

Slovakia: Zyrtec tbl flm 10 mg, Reactine 10 mg

Slovenia: Zyrtec 10 mg filmsko oblozene tablete

Spain: Alerlisin, Virlix, Reactine 10 mg tablets, Zyrtec film-coated tablets

Sweden: Zyrlex

United Kingdom: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets, Zirtek allergy tablets

Date of last revision of this leaflet: January 2020

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