Rinialer 10 mg tablets. Antihistamine
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist (see section 4)
In this leaflet
1. What Rinialer is, and what it is used for
2. Before you take Rinialer
3. How to take Rinialer
4. Possible side effects
5. How to store Rinialer
6. Further information
1. WHAT RINIALER IS AND WHAT IT IS USED FOR?
Rupatadine is an antihistamine.
Rinialer relieves the symptoms of allergic rhinitis such as sneezing, runny nose, itching in the eyes and nose.
Rinialer is also used to relieve the symptoms associated with urticaria (an allergic skin rash)
such as itching and hives (localized skin redness and swelling).
2. BEFORE YOU TAKE RINIALER
Do not take Rinialer
- If you are allergic (hypersensitive) to rupatadine or any of the other ingredients of Rinialer.
Take special care with Rinialer
If you suffer from kidney or liver insufficiency, ask your doctor for advice. The use of Rinialer
10 mg tablets is at present not recommended in patients with impaired kidney or liver functions.
If you have low blood levels of potassium and/or if you have a certain abnormal pattern to your heart beat (known prolongation of the QTc interval on the ECG) which can occur in some forms of heart disease, ask your doctor for advice.
This medicine is not for use in children under 12 years of age. If you are older than 65, ask your doctor or your pharmacist.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
If you are taking Rinialer do not take medicines containing ketoconazole or erythromycin.
If you are taking central nervous system depressant medicines or statin medicines, ask your doctor for advice before taking Rinialer.
Taking Rinialer with food and drink
Rinialer should not be taken in combination with grapefruit juice, as this may increase the level of rupatadine in your body.
Rinialer, at recommended dose (10 mg), does not increase the drowsiness produced by alcohol.
Pregnancy and breast-feeding
Do not take Rinialer during pregnancy and breast-feeding, unless clearly indicated by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
At the recommended dosage, Rinialer is not expected to influence your ability to drive or use machinery. However, when you first start taking Rinialer you should take care to see how the treatment affects you before driving or using machines.
Important information about some of the ingredients of Rinialer
This medicinal product contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE RINIALER
Always take Rinialer exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Rinialer is for adolescents (from 12 years and older) and adults. The recommended dose is one tablet (10 mg of rupatadine) once daily with or without food. Swallow the tablet with a sufficient quantity of liquid (e. g. one glass of water).
Your doctor will tell you how long your treatment with Rinialer will last.
If you take more Rinialer than you should
If you have accidentally taken a high dose of your medicine, talk to your doctor or pharmacist immediately or contact the Servicio de Información Toxicológica (Poison Information Centre), Phone 915 620 420.
If you forget to take Rinialer
Take your dose as soon as possible and then continue with your tablets at the usual times. Do not take a double dose to make up for forgotten doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rinialer can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people) are sleepiness, headache, dizziness, dry mouth, sensation of weakness and fatigue. Uncommon side effects (may af fect up to 1 in 100 people) are increased appetite, irritability, difficulty concentration, nosebleed, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhoea, i ndigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, general discomfort, fever, abnormal liver function test and increased weight.
Rare side effects (may affect up to 1 in 1,000 people are palpitations and increase d heart rate.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor orpharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via Sistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es. By reporting side effects you can help
provide more information on the safety of this medicine.
5. HOW TO STORE RINIALER
Keep out of the reach and sight of children.
Do not use Rinialer after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Keep the blisters in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Del iver containers and medicines no longer used at a Used Medicines Collection Point (known in Spain as Punto
) in a pharmacy. In case of doubt ask your pharmacist how to throw away containers
and medicines no longer used. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Rinialer contains
- The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
- The other ingredients are pregelatinised maize starch, microcrystalline celllulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate and magne sium stearate.
What Rinialer looks like and contents of the pack
Rinialer are round, light salmon coloured tablets packed in unit blister doses of 15 or 20 tablets. Not all pack sizes may be marketed.
This leaflet was last approved in 05/2014
J. Uriach & Cía, S.A.
Av. Camí Reial 51-57 08184 Palau-solita i Plegamans (Barcelona-España)