Alergoliber 1 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Alergoliber 1 mg/ml oral solution
Rupatadine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. 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, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Alergoliber is and what it is used for
- What you need to know before taking Alergoliber
- How to take Alergoliber
- Possible side effects
- How to store Alergoliber
- Contents of the pack and other information
1. What Alergoliber is and what it is used for
Alergoliber contains the active substance rupatadine, which is an antihistamine.
Alergoliber oral solution is indicated for the relief of symptoms of allergic rhinitis such as sneezing, runny nose, nasal congestion, and itching of the nose and eyes in children aged 2 to 11 years.
Alergoliber is also indicated for the relief of symptoms associated with urticaria (allergic skin rash), such as itching and skin wheals (redness and swelling of the skin), in children aged 2 to 11 years.
2. What you need to know before taking Alergoliber
Do not take Alergoliber:
- If you are allergic (hypersensitive) to rupatadine or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Alergoliber.
If you have renal or hepatic impairment, consult your doctor. The use of Alergoliber is currently not recommended in patients with renal or hepatic impairment.
If you have low blood potassium levels and/or if you have a certain abnormal heart rhythm pattern (known QTc interval prolongation on ECG) that may occur in certain heart conditions, consult your doctor.
Children
This medicine must not be used in children under 2 years of age or weighing less than 10 kg.
Other medicines and Alergoliber
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking Alergoliber, do not take medicines containing ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).
If you are taking central nervous system depressants, statins (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Alergoliber.
Taking Alergoliber with food, drinks, and alcohol
Alergoliber can be taken with or without food.
Do not take Alergoliber together with grapefruit juice, as it may increase the level of rupatadine in your body.
Alergoliber at the 10 mg dose does not increase drowsiness caused by alcohol.
Pregnancy and breastfeeding
Do not use Alergoliber during pregnancy or breastfeeding unless your doctor considers it essential.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
The recommended dose of Alergoliber is not expected to affect your ability to drive vehicles or operate machinery. However, when you first start using Alergoliber, you should take caution and observe how the treatment may affect you before driving or operating machinery.
Alergoliber contains sucrose, methyl parahydroxybenzoate, and propylene glycol.
If your doctor has advised you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. It may cause dental caries.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.
This medicine contains 200 mg of propylene glycol in each ml.
If your child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if using other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless your doctor recommends it. Your doctor may perform additional monitoring while you are taking this medicine.
If you have liver or kidney disease, do not take this medicine unless your doctor recommends it. Your doctor may perform additional monitoring while you are taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per ml, i.e., essentially "sodium-free".
3. How to take Alergoliber
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Alergoliber oral solution is administered orally.
Dosage in children weighing 25 kg or more: 5 ml (5 mg of rupatadine) of oral solution once daily, taken with or without food.
Dosage in children weighing 10 kg or more and less than 25 kg: 2.5 ml (2.5 mg of rupatadine) of oral solution once daily, taken with or without food.
Your doctor will determine the duration of your treatment with Alergoliber.
Instructions for use
- To open the bottle, press down on the cap and turn it counterclockwise.
- Insert the syringe into the hole in the pierced cap and invert the bottle.
- Fill the syringe with the prescribed dose.
- Administer directly using the dosing syringe.
- Wash the syringe after each use.
If you take more Alergoliber than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number 915\ 620\ 420, indicating the medicine and the amount ingested.
If you forget to take Alergoliber
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, Alergoliber oral solution may produce adverse effects, although not everyone experiences them.
Frequent adverse effects (may affect up to 1 in 10 patients) are headache and somnolence.
Uncommon adverse effects (may affect up to 1 in 100 patients) are influenza, nasopharyngitis, upper respiratory tract infections, increased eosinophils, decreased neutrophils, dizziness, nausea, eczema, night sweats, and fatigue.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Alergoliber
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated. The expiry date of the medicine after first opening is the same as that indicated on the carton and on the label of the bottle.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Alergoliber
- The active substance is rupatadine. Each ml contains 1 mg of rupatadine (as fumarate).
- The other components are: propylene glycol (E-1520), anhydrous citric acid, anhydrous disodium phosphate, sodium saccharin, sucrose, methylparaben (E-218), quinoline yellow (E-104), banana flavor, and purified water. See section 2 “Alergoliber contains sucrose, methylparaben and propylene glycol”.
Appearance of the product and contents of the pack
Alergoliber is a yellow, clear solution.
Alergoliber is available in amber plastic bottles fitted with an integrated perforated closure and a child-resistant cap. Each pack contains a bottle with 120 ml of oral solution and includes a 5 ml oral syringe graduated in 0.25 ml increments.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Urquima, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)
Manufacturer
Italfarmaco, S.A.
San Rafael, 3
Pol. Ind. Alcobendas
E-28108 Alcobendas (Spain)
Or
NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)
Further information on this medicinal product can be requested from the local representative of the Marketing Authorization Holder:
Zentiva Spain S.L.U.
Avenida de Europa, 19, Edificio 3, Planta 1
28224 Pozuelo de Alarcón
Madrid, Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Alergoliber 1mg/ml oral solution Spain
Urtimed 1mg/ml oral solution Germany
Pafinur 1mg/ml oral solution Italy
Date of the most recent revision of this leaflet: 08/2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es