Alerlisin 10 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Alerlisin 10 mg film-coated tablets
cetirizine dihydrochloride
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
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If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Alerlisin is and what it is used for
- What you need to know before taking Alerlisin
- How to take Alerlisin
- Possible adverse effects
- How to store 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 medicine.
Alerlisin is indicated in adults and children aged 6 years and older 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).
You must not take Alerlisin 10 mg film-coated tablets:
- if you have hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alerlisin
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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.
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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 6 years of age, as this formulation does not allow appropriate dose adjustments.
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 drinks
Food does not significantly affect the extent of 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.
As with other medicines, 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. However, treatment with the medicine should be discontinued.
You must not take Alerlisin while breastfeeding, as cetirizine is excreted in breast milk.
Driving and using machines
Clinical studies have not shown evidence that Alerlisin causes impairment of attention, reduced reaction ability, or impaired driving 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 observe 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 affect your attention and your ability to react.
Alerlisin contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Alerlisin
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The tablets must be swallowed with a glass of liquid.
Adults and adolescents over 12 years of age
10 mg once daily as 1 tablet.
Use in children between 6 and 12 years of age
5 mg twice daily, as half a tablet twice daily.
Patients with moderate to severe renal impairment
Patients with moderate renal impairment are advised to take 5 mg 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, headache, weakness, pupillary dilation, tingling, irritation, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and urinary retention.
Inform your doctor if you think you have taken an overdose of Alerlisin.
Your doctor will then decide which measures should be taken.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at 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 taking 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 may 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 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 platelet levels in blood)
- Accommodation disorders, blurred vision, ocular nystagmus (eyes have uncontrolled circular movement)
- Syncope, tremor, dysgeusia (taste disturbance)
- Tic
- Abnormal urination
- Edema, drug-induced rash
If you experience the first symptoms of hypersensitivity, stop taking Alerlisin.
Your doctor will assess the severity and decide on the necessary measures to take.
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 through the Spanish Pharmacovigilance System for Human Medicines: 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 blister pack after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Alerlisin
- The active substance is cetirizine dihydrochloride. Each coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other components are:
- Core: microcrystalline cellulose, monohydrate lactose, magnesium stearate, anhydrous colloidal silica.
- Coating: hypromellose (E-464), macrogol 400, titanium dioxide (E-171).
Appearance of the product and contents of the pack
Film-coated tablets, white, oblong, scored, with the logo Y-Y.
Pack containing 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90 or 100 tablets.
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 more information about this medicinal product, 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 Member States of the European Economic Area under the following names:
Austria: Zyrtec 10 mg - Filmtabletten
Belgium: Reactine, Cetirizine-UCB, Zyrtec
Bulgaria: Zyrtec
Cyprus: Zyrtec
Czech Republic: Zyrtec, Reactine
Denmark: Benaday, Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Reactine 10 mg comprimé pelliculé sécable, Virlix, Cetirizine UCB 10 mg, Zyrtec, Actifed Allergie cetirizine 10 mg comprimé pelliculé sécable, Zyrtecset
Germany: Zyrtec, Zyrtec P, Reactine
Greece: Ziptek
Hungary: Zyrtec filmtabletta, Zyrtec start filmtabletta
Ireland: Zirtek tablets, Reactine 10 mg tablets
Italy: Formistin, Reactidiem “10 mg compresse rivestite con film”, Zirtec 10 mg compresse rivestite con film
Latvia: Zyrtec
Lithuania: Zyrtec
Luxembourg: Reactine, Zyrtec, Cetirizine-UCB
Malta: Zyrtec
Netherlands: Reactine tabletten 10 mg, Zyrtec
Norway: Reactine, Zyrtec
Poland: Reactine, Virlix, Zyrtec, Zyrtec UCB
Portugal: Zyrtec, Virlix
Romania: Zyrtec
Slovakia: Zyrtec tbl flm 10 mg, Reactine 10 mg
Slovenia: Zyrtec 10 mg filmsko obložene tablete
Spain: Alerlisin, Virlix, Reactine 10 mg comprimidos, Zyrtec comprimidos recubiertos con película
Sweden: Zyrlex
United Kingdom: Benadryl one a day, Benadryl one a day relief, Zirtek allergy relief tablets, Zirtek allergy tablets
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/