Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet, you may need to read it again
- If you have further questions, please ask your doctor or pharmacist
- This medicine has been prescribed for you personally and you should not pass
it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet
1. What RINIALER 10 mg Tablets is, and what it is used for
2. Before you take RINIALER 10 mg Tablets
3. How to take RINIALER 10 mg Tablets
4. Possible side effects
5. Storing RINIALER 10 mg Tablets
The active substance of RINIALER 10 mg Tablets is rupatadine (INN). Each tablet
contains 10 mg rupatadine (INN) as fumarate.
The other excipients are pregelatinised maize starch, microcrystalline cellulos,
red iron oxide (E.172), yellow iron oxide (E-172), lactose monohydrate and magnesium
1. WHAT RINIALER 10 mg Tablets IS AND WHAT IT IS USED FOR?
RINIALER is available as tablets. Each box contains 20 tablets.
Rupatadine belongs to the pharmacotherapeutic group of non-sedating antihistamines.
RINIALER 10 mg Tablets is indicated for the relief of allergic rhinitis symptoms,
seasonal or perennial. These symptoms include sneezing, rhinorrhea, watering
eyes, eyes, nose and throat irritation.
2. BEFORE YOU TAKE RINIALER 10mg Tablets
Do not take RINIALER 10 mg Tablets:
If you are allergic to rupatadine or to any of the other ingredients of RINIALER
10 mg Tablets.
This medicine is not indicated for children less than 12 years old age.
Take special care with RINIALER 10 mg Tablets:
If you have renal or hepatic impairment. If it is the case consult your doctor.
II you are older than 65 years of age consult your doctor or pharmacist.
Pregnancy and breast-feeding:
Do not use RINIALER 10 mg Tablets during pregnancy and lactation, except when
the doctor considers it as essential. Consult your doctor or pharmacist belore
taking this medicine.
Driving and using machines:
It is not expected that the recommended dose of RINIALER 10 mg Tablets has any
effect on the ability to drive and use machines.
Important information about some of the ingredients of RINIALER 10 mg
If your doctor has told you that you have intolerance to some sugars, consult
your doctor belore start taking this medicine.
Taking other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken
any other medicines, even those not prescribed.
When taking RINIALER 10 mg Tablets do not take medicines containing ketoconazole,
erythromycin or Central Nervous System depressants.
3. HOW TO TAKE RINIALER 10 mg Tablets
Always take RINIALER 10 mg Tablets as your doctor instructed.
RINIALER 10 mg Tablets is administed orally. It is indicated in adults and adolescents
(aged over 12). The recommended dose is 1 tablet (rupatadine 10 mg) once daily,
with or without a meal. Take it with enough quantity of liquid (e.g. water).
Your doctor will tell you how long will the treatment with RINIALER 10 mg Tablets
last. Do not stop the treatment in advance as symptoms may not disappear.
If you take more tablets of RINIALER 10 mg Tablets than you should:
In case of accidental ingestion of high doses of this medicine, contact immediately
your doctor or pharmacist or the Toxicology Information Centre (Servicio de
Información Toxicológica) 915 620 420.
If you forget to take RINIALER 10 mg Tablets:
II you forget to take a dose 10 RINIALER 10 mg Tablets take it as soon as possible
and continue your regular dosing schedule. Do not take a double dose to make
up lor lorgotten individual doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines RINIALER 10 mg Tablets can have side effects.
The commonest are somnolence, asthenia, and fatigue. Less frequent adverse effects
are dry mouth, inflammation of pharyngeal or nostrils mucosas, dyspepsia and
increased appetite. If you notice any side effects not mentioned in this leallet,
please inform your doctor or pharmacist.
5.STORING RINIALER 10 mg TABLETS
Keep out of the reach and sight of children
Keep the container in the outer carton to protect tablets from light.
Do not use RINIALER 10 mg Tablets alter the exprirydate stated on the carton.
Text approved: June 2004
(A new updated leaflet of "Rinialer 10 mg tablets" is available)
Laboratorios Bial - Portela & Cia, S.A.
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado (Portugal)