ALERLISIN 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Alerlisin 1mg/ml Oral Solution

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. This includes any possible side effects 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 from 2 years of age, for:

• relief of nasal and ocular symptoms associated with 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 any piperazine derivative (closely related active substances of other medicines).

Do not take Alerlisin 1 mg/ml oral solution if:

• you have rare hereditary problems of fructose intolerance.

Warnings and precautions

Consult your doctor or pharmacist before taking Alerlisin

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

• 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) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid consuming alcohol during treatment.

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, no interactions with other medicines are expected.

Children

The use of the medicine is not recommended in children under 2 years of age.

Taking Alerlisin with food and drinks

Food does not 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.

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

Alerlisin should not be taken 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 ability to react, 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 ability to react.

Alerlisin contains sorbitol (E-420), methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216), propylene glycol (E-1520) and sodium

This medicine contains 450 mg of sorbitol (E-420) in each ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder, in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

It can cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine contains 50 mg of propylene glycol (E-1520) in each ml.

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

3. How to take Alerlisin

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

The solution can be taken as is.

Adults and adolescents from 12 years of age

10 mg once a day as 10 ml of oral solution (2 full tablespoons).

Use in children between 6 and 12 years of age

5 mg twice a day, as 5 ml (1 full tablespoon) twice a day.

Use in children between 2 and 6 years of age

2.5 mg twice a day as 2.5 ml of the oral solution (half a tablespoon) 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 adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, tingling, irritation, sedation, somnolence, stupor, abnormal increase in 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 sensation of the skin)
• 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
• Aggressiveness, confusion, depression, hallucination, insomnia
• Urticaria

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

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

At the first signs 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: 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 bottle after EXP. The expiry date refers to 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 Alerlisin 1 mg/ml oral solution

• The active substance is cetirizine dihydrochloride. 10 ml (equal to 2 tablespoons) contain 10 mg of cetirizine dihydrochloride.
• The other ingredients are 70% non-crystallizing sorbitol solution (E-420), glycerol (E-422), propylene glycol (E-1520), sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), flavoring agent, sodium acetate, acetic acid, purified water.

Appearance and packaging of the product

Clear and colorless liquid with a slight sweet taste and banana flavor.

Original packaging with a bottle of 60, 75, 100, 125, 150 or 200 ml of solution.

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 request more information about this medicine by contacting 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, with the following names:

Austria: Zyrtec 1 mg/ml oral solution

Belgium: Zyrtec

Cyprus: Zyrtec

Denmark: Benaday, Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Virlix, Zyrtec

Germany: Zyrtec syrup, cetirizine allergy syrup

Hungary: Zyrtec solution

Ireland: Zyrtek oral solution 1 mg/ml

Italy: Zirtec 1 mg/ml oral solution

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Zyrtec

Malta: Zyrtec

Netherlands: Zyrtec

Norway: Zyrtec

Poland: Virlix, Zyrtec

Portugal: Zyrtec, Virlix

Slovenia: Zyrtec 1 mg/ml oral solution

Spain: Alerlisin, Virlix, Reactine 5 mg/ml oral solution, Zyrtec oral solution

Sweden: Zyrlex

United Kingdom: Benadryl allergy oral syrup, Benadryl for children allergy solution, Zirtek allergy relief for children, Zirtek allergy solution 1 mg/ml

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 Health Products (AEMPS) http://www.aemps.gob.es/