Rinialer 1 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rinialer 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, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- 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 could harm them.
- 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 Rinialer is and what it is used for
- What you need to know before taking Rinialer
- How to take Rinialer
- Possible side effects
- How to store Rinialer
- Contents of the pack and other information
1. What Rinialer is and what it is used for
Rinialer contains the active substance rupatadine, which is an antihistamine.
Rinialer oral solution is indicated for the relief of symptoms of allergic rhinitis such as sneezing, nasal discharge, nasal congestion, itching of the nose and eyes in children aged 2 to 11 years.
Rinialer 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 starting to take Rinialer
Do not take Rinialer
- If you are allergic to rupatadine or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Rinialer.
If you have renal or hepatic impairment, consult your doctor. The use of Rinialer is currently not recommended in patients with renal or hepatic impairment.
If you have low blood potassium levels and/or a known abnormal heart rhythm pattern (prolonged QTc interval 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 Rinialer
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking Rinialer, 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 Rinialer.
Taking Rinialer with food, drinks and alcohol
Rinialer may be taken with or without food.
Do not take Rinialer together with grapefruit juice, as it may increase the level of rupatadine in your body.
Rinialer, at the 10 mg dose, does not increase the drowsiness caused by alcohol.
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.
Driving and using machines
Rinialer is not expected to affect your ability to drive vehicles or operate machinery at the recommended dose. However, when you first start using Rinialer, you should take caution and observe how the treatment affects you before driving or operating machinery.
Rinialer contains sucrose, methyl parahydroxybenzoate, and propylene glycol
If your doctor has informed you of 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 per 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 advised by your doctor. 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 advised by your doctor. 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 Rinialer
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Rinialer oral solution is administered orally.
Dosing in children weighing 25 kg or more: 5 ml (5 mg of rupatadine) of oral solution once daily, taken with or without food.
Dosing in children weighing 10 kg or more but 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 Rinialer.
Instructions for use
- To open the bottle, press down on the cap and turn it counterclockwise.
- Insert the syringe into the pierced opening of the cap and invert the bottle.
- Draw up the prescribed dose into the syringe.
- Administer directly using the dosing syringe.
- Wash the syringe after each use.
If you take more Rinialer than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, indicating the medicine and the amount ingested.
If you forget to take Rinialer
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequent adverse effects (may affect up to 1 in 10 people) are headache and somnolence.
Uncommon adverse effects (may affect up to 1 in 100 people) are influenza, nasopharyngitis, upper respiratory tract infections, increased eosinophils, decreased neutrophils, dizziness, nausea, eczema, night sweats, and fatigue.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may 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. Rinialer Storage
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 following 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 stated on the carton and on the label of the bottle.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Rinialer
- 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, methyl 4-hydroxybenzoate (E-218), quinoline yellow (E-104), banana flavour and purified water. See section 2 “Rinialer contains sucrose, methyl 4-hydroxybenzoate and propylene glycol”.
Presentation of the product and pack contents
Rinialer is a yellow, clear solution.
Rinialer is available in amber plastic bottles fitted with an integrated perforated stopper and child-resistant cap. Each pack contains one bottle with 120 ml of oral solution and includes a 5 ml oral syringe graduated in 0.25 ml increments.
Marketing Authorisation Holder
NOUCOR HEALTH, 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 about this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder:
Laboratorios BIAL, S.A.
C/ Alcalá 265, Edificio 2, Planta 2ª
28027 Madrid (Spain)
Date of the most recent revision of this leaflet: November 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