Prospect: information for the user

Alerlisin 10mg/ml oral drops in solution

cetirizine dihydrochloride

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

1.What Alerlisin is and for what it is used

2.What you need to knowbeforestarting totake Alerlisin

3.How to take Alerlisin

4.Possible adverse effects

5.Storage of Alerlisin

6.Contents of the package andadditional information

The active ingredient of Alerlisin is cetirizine dihydrochloride.

Alerlisin is an antihistamine medication.

Alerlisin 10mg/ml oral drops in solution is indicated in adults and pediatric patients aged 2 years and above, for:

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

Do not take Alerlisin

-if you have severe kidney disease (severe renal insufficiency with a creatinine clearance below 10ml/min);

• if you are allergic to the active ingredient, to any of the other components of this medication (listed in section 6), to hydroxyzine, or to piperazine derivatives (closely related active ingredients in other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alerlisin

• if you have renal insufficiency, 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 seizures, consult your doctor.

No significant interactions have been observed between alcohol (with a blood level of 0.5per 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 alcohol consumption during treatment.

Children

Do not recommend the use of the medication in children under 2years.

Taking Alerlisin with other medications

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

Due to the profile of cetirizine, no interactions with other medications are expected.

Taking Alerlisin with food and beverages

Food does not significantly affect the absorption of cetirizine.

Pregnancy and breastfeeding

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.

Alerlisin should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harm to the fetus. However, administration of the medication should be discontinued.

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

Driving and operating machinery

Clinical studies have not shown evidence that Alerlisin produces attention alterations, reaction capacity reduction, and driving ability at the recommended dose.

If you intend to drive, perform potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You must closely observe your response to the medication.

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

Alerlisin containsparahydroxybenzoate methyl ester (E-218) and parahydroxybenzoate propyl ester (E-216), propylene glycol (E-1520) and sodium

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

This medication contains 350 mg of propylene glycol per ml (equivalent to 20 drops).

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Adults and adolescents 12 years and older

10 mg once a day as 20 drops.

Use in children 6 to 12 years

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

Use in children 2 to 6 years

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

Patients with moderate to severe renal insufficiency

Patients with moderate renal insufficiency are recommended to 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.

Treatment duration

The duration of treatment will depend 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 reported include confusion, diarrhea, dizziness, fatigue, weakness, headache, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal heart rate, tremor, and urinary retention.

Inform 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Alerlisin

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

If you interrupt treatment with Alerlisin

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 have been reported in post-marketing experience:

Frequent: may affect up to 1 in 10 people

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

Infrequent: may affect up to 1 in 100 people

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

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

• Tachycardia (heart beats too quickly)
• 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 platelet count in blood)
• Accommodation disorders, blurred vision, nystagmus (eyes have an uncontrolled circular movement)
• Syncope, tremor, dysgeusia (taste disorder)
• Tic
• Abnormal urination
• Edema, drug-induced rash

At the first signs of hypersensitivity, stop taking Alerlisin.

Your doctor will evaluate the severity and decide on the necessary measures.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly to theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alerlisin

-The active ingredient is cetirizine dihydrochloride. One milliliter (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.

• The other components 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 contents of the packaging

Alerlisin is supplied as a transparent and colorless liquid.

Original packaging with a 10, 15, 20, or 30 ml solution bottle.

Not all packaging sizes may be marketed.

Marketing Authorization Holder

RETRAIN, S.A.U.

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

Responsible for manufacturing

LABORATORIOS MENARINI, S.A.

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

LABORATORIOS MENARINI, S.A.

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

This medication is authorized in the member states of the European Economic Area, with the following names:

Austria: Zyrtec 10 mg/ml – Drops

Belgium: Ceterizine-UCB, Zyrtec, Virlix

Bulgaria: Zyrtec

Czech Republic: Zyrtec

Denmark: Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Virlix, Zyrtec

Germany: Zyrtec P drops, Zyrtec drops

Greece: Ziptek

Hungary: Zyrtec drops

Italy: Formistin, Zirtec 10 mg/ml oral drops solution

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Virlix, Zyrtec, Cetirizina-UCB

Norway: Zyrtec

Poland: Zyrtec

Portugal: Zyrtec

Romania: Zyrtec

Slovakia: Zyrtec drops for 10 mg/ml

Slovenia: Zyrtec 10 mg/ml oral drops, solution

Spain: Alerlisin, Virdos, Zyrtec oral drops in solution

Sweden: Zyrlex

Last review date of this leaflet: January 2020

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