Alerlisin 10 mg/ml oral solution drops
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Alerlisin 10mg/ml oral drops solution
cetirizine dihydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Alerlisin is and what it is used for
- What you need to know before taking Alerlisin
- How to take Alerlisin
- Possible adverse effects
- Storage of Alerlisin
- Contents of the pack and other information
1. What Alerlisin is and what it is used for
The active substance in Alerlisin is cetirizine dihydrochloride.
Alerlisin is an antiallergic medicinal product.
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 taking 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 drugs).
Warnings and precautions
Talk to your doctor or pharmacist before taking Alerlisin
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if you have renal impairment; consult your doctor. If necessary, you will be given a lower dose. Your doctor will determine the new dose.
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if you are an epileptic patient or a patient at risk of seizures, consult your doctor.
No interactions likely to have a significant impact have been observed between alcohol (with a blood level of 0.5 per mille, corresponding to one glass of wine) and the use of cetirizine at normal doses. However, as with all antihistamines, it is recommended to avoid concomitant alcohol consumption during treatment.
Children
The use of this medicine is not recommended in children under 2 years of age.
Taking Alerlisin with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Due to the profile of cetirizine, interactions with other drugs are not expected.
Taking Alerlisin with food and drink
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 become pregnant, consult your doctor or pharmacist before using this medicine.
The use of Alerlisin should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to cause any harmful effects on the fetus. Nevertheless, administration of the medicine should be discontinued.
You must not take Alerlisin during breastfeeding, as cetirizine is excreted in breast milk.
Driving and using machines
Clinical studies have not shown evidence that Alerlisin causes disturbances in attention, reduced reaction capacity, or impaired driving ability at the recommended dose.
If you intend to drive, perform potentially hazardous activities, or operate machinery, you must not exceed the recommended dose. You should closely monitor your response to the medicine.
If you are a sensitive patient, you may find that the concomitant use of alcohol or other central nervous system depressants may further impair your attention and reaction capacity.
Alerlisin contains methylparahydroxybenzoate (E-218) and propylparahydroxybenzoate (E-216), propylene glycol (E-1520), and sodium
May cause allergic reactions (possibly delayed) as it contains methylparahydroxybenzoate (E-218) and propylparahydroxybenzoate (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; hence, it is essentially “sodium-free”.
3. How to take Alerlisin
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults and adolescents aged 12 years and older
10 mg once daily as 20 drops.
Use in children between 6 and 12 years of age
5 mg twice daily, as 10 drops twice daily.
Use in children between 2 and 6 years of age
2.5 mg twice daily administered as 5 drops twice daily.
Patients with moderate to severe renal impairment
It is recommended that patients with moderate renal impairment take 5 mg as 10 drops once daily.
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 increased intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, weakness, headache, pupil dilation, tingling, irritation, sedation, somnolence, stupor, abnormal tachycardia, 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 at telephone number 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 missed doses.
If you stop treatment with Alerlisin
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse 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
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 beating 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 platelet levels in blood)
- Accommodation disorders, blurred vision, ocular flutter (eyes exhibit uncontrolled circular movement)
- Syncope, tremor, dysgeusia (taste disturbance)
- Tic
- Abnormal urination
- Edema, drug-induced rash
At the first signs of hypersensitivity, stop taking Alerlisin.
Your doctor will assess the severity and decide on the necessary measures.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other 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 components are glycerol (E-422), propylene glycol (E-1520), sodium saccharin, methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), sodium acetate, acetic acid, purified water.
Appearance of the product and contents of the pack
Alerlisin is supplied as a clear, colourless liquid.
Original packaging containing 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
LABORATORIOS MENARINI, S.A.
Alfons XII, 587 – 08918 Badalona (Barcelona) – Spain
This medicinal product is authorized in the European Economic Area member states under 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 the most recent review of this leaflet: January 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/