ALERLISIN 10 mg/ml ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

Alerlisin 10mg/ml Oral Drops 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, as 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 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 further 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 10 mg/ml oral drops solution is indicated in adults and pediatric patients from 2 years of age, 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 (active substances closely related to other medicines).

Warnings and precautions

Consult your doctor or pharmacist before taking Alerlisin

• if you have kidney insufficiency, 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

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

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.

Taking Alerlisin with food and drinks

Food does not significantly affect the 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.

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, administration of the medicine should be discontinued.

You should 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, reduction of 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 concurrent use of alcohol or other central nervous system depressants may further affect your attention and ability to react.

Alerlisin containsmethyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216), propylene glycol (E-1520) and sodium

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

This medicine contains 350 mg of propylene glycol in each ml (equivalent to 20 drops).

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

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.

Adults and adolescents from 12 years of age

10 mg once a day as 20 drops.

Use in children between 6 and 12 years of age

5 mg twice a day, as 10 drops twice a day.

Use in children between 2 and 6 years of age

2.5 mg twice a day administered as 5 drops twice a day.

Patient with moderate to severe renal insufficiency

It is recommended that patients with moderate renal insufficiency take 5 mg as 10 drops 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, weakness, headache, pupil dilation, paresthesia, irritation, sedation, somnolence, stupor, abnormal tachycardia, 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 levels)
• Accommodation disorders, blurred vision, ocular nystagmus (eyes have 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: 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 on the bottle after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 further information

Composition of Alerlisin

• The active substance is cetirizine dihydrochloride. One ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
  • The other ingredients are glycerol (E-422), propylene glycol (E-1520), sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium acetate, acetic acid, purified water.

Appearance of the product and pack contents

Alerlisin is supplied as a clear and colorless liquid.

Original pack with a bottle of 10, 15, 20 or 30 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 10 mg/ml – Tropfen

Belgium: Ceterizine-UCB, Zyrtec, Virlix

Bulgaria: Zyrtec

Czech Republic: Zyrtec

Denmark: Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Virlix, Zyrtec

Germany: Zyrtec P Tropfen, Zyrtec Tropfen

Greece: Ziptek

Hungary: Zyrtec cseppek

Italy: Formistin, Zirtec 10 mg/ml gocce orali soluzione

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Virlix, Zyrtec, Cetirizina-UCB

Norway: Zyrtec

Poland: Zyrtec

Portugal: Zyrtec

Romania: Zyrtec

Slovakia: Zyrtec gtt por 10 mg/ml

Slovenia: Zyrtec 10 mg/ml peroralne kapljice, raztopina

Spain: Alerlisin, Virdos, Zyrtec gotas orales en solución

Sweden: Zyrlex

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/