Prospecto: information for the user

Alerlisin 1mg/ml oral 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 is Alerlisin 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 is indicated in adults and children aged 2 years and above, for:

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

Do not take Alerlisin

• if you have a 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 any piperazine derivative (closely related active principles of other drugs).

You should not take Alerlisin 1mg/ml oral solution if:

• if you have rare hereditary fructose intolerance problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alerlisin

• if you are a patient with 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 clinically significant interactions have been observed between alcohol (with a blood level of 0.5per thousand) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid the joint consumption of alcohol during treatment.

Alerlisin use with other medications

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

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

Children

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

Alerlisin use with food and beverages

The 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 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 does not produce any harmful effects on the fetus. However, treatment with the medication should be interrupted.

Alerlisin should not be taken 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 decrease, and ability to drive at the recommended dose.

If you intend to drive, perform potentially hazardous activities, or use machinery, you should 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 contains sorbitol (E-420), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), and sodium

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

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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

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

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.

The solution can be taken as is.

Adults and adolescents 12 years and older

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

Use in children 6 to 12 years

5 mg twice a day, as 5 ml (one full teaspoon) twice a day.

Use in children 2 to 6 years

2.5 mg twice a day as 2.5 ml of oral solution (half a teaspoon) twice a day.

Patients with moderate to severe renal insufficiency

Patients with moderate renal insufficiency are recommended to take 5 mg 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 following adverse effects may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, weakness, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget 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 bottle after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or 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 Alerlisin1mg/ml oral solution

• The active ingredient is cetirizine dihydrochloride. 10ml (equivalent to 2 teaspoons) contain 10mg of cetirizine dihydrochloride.
• The other components are 70 % (non-crystallized) 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 of the product and contents of the package

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

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

Not all package 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

For more information about this medication, please contact 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 1mg/ml – oral solution

Belgium: Zyrtec

Cyprus: Zyrtec

Denmark: Benaday, Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Virlix, Zyrtec

Germany: Zyrtec syrup, cetirizin allergy syrup

Hungary: Zyrtec solution

Ireland: Zyrtek oral solution 1mg/ml

Italy: Zirtec 1mg/ml oral solution

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Zyrtec

Malta: Zyrtec

Netherlands:Zyrtec

Norway: Zyrtec

Poland: Virlix, Zyrtec

Portugal: Zyrtec, Virlix

Slovenia: Zyrtec 1mg/ml peroral solution

Spain: Alerlisin, Virlix, Reactine 5mg/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 1mg/ml

Last review date of this leaflet: January 2020

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/