RINIALER 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rinialer 10mg Tablets

Rupatadine

Read all of this 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rinialer and what is it used for

2. What you need to know before you take Rinialer

3. How to take Rinialer

4. Possible side effects

5. Storage of Rinialer

6. Contents of the pack and further information.

1. What is Rinialer and what is it used for

Rupatadine is an antihistamine.

Rinialer is indicated for the relief of symptoms of allergic rhinitis such as sneezing, runny nose, itchy eyes and nose.

Rinialer is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and hives (redness and swelling of the skin).

2. What you need to know before you take Rinialer

Do not take Rinialer:

• If you are allergic to rupatadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Rinialer.

If you have kidney or liver problems, consult your doctor. The use of Rinialer is not currently recommended in patients with kidney or liver problems.

If you have low potassium levels in your blood and/or if you have a certain abnormal heart rhythm (known prolongation of the QTc interval in the ECG) that may occur in certain heart diseases, consult your doctor.

If you are over 65 years old, consult your doctor or pharmacist.

Children

This medicine must not be used in children under 12 years of age.

Other medicines and Rinialer

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking Rinialer, do not take medicines that contain ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).

If you are taking medicines that depress the central nervous system, medicines with 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

Do not take Rinialer in combination with grapefruit juice as it may increase the level of rupatadine in your body.

Rinialer, at the recommended dose of 10 mg, does not increase the drowsiness produced by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that at the recommended dose Rinialer will have an effect on your ability to drive or use machines. However, when you first start taking Rinialer, you should be careful to see how you react to the treatment before driving or using machines.

Rinialer contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Rinialer

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Rinialer is administered in adolescents (from 12 years of age) and adults. The recommended dose is one tablet (10 mg of rupatadine) once a day with or without food. Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water).

Your doctor will indicate the duration of your treatment with Rinialer.

If you take more Rinialer than you should

In case of accidental ingestion of high doses of the medicine, consult your doctor or pharmacist immediately or the Toxicology Information Service, telephone 915 620 420.

If you forget to take Rinialer

Take your dose as soon as possible and 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, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people) are drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

Uncommon side effects (may affect up to 1 in 100 people) are increased appetite, irritability, difficulty concentrating, nosebleeds, dry nose, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, malaise, fever, abnormal liver function tests and weight gain.

Rare side effects (may affect up to 1 in 1,000 people) are palpitations, increased heart rate and allergic reactions (itching, urticaria and swelling of the face, lips, tongue or throat).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rinialer

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.

Store in the outer carton to protect the tablets from light.

Medicines should not be disposed of via wastewater or household waste. Return the carton and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rinialer

The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate). The other ingredients are pregelatinized maize starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate and magnesium stearate. See section 2, “Rinialer contains lactose”.

Appearance and packaging:

Rinialer are light salmon-colored, round tablets and are available in unit dose blisters containing 15 or 20 tablets. Not all pack sizes are marketed.

Marketing authorisation holder

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Manufacturer

Bial-Portela & Cía. S.A.

Av. Da Siderurgia Nacional; 4745-457S- Mamede do Coronado (Portugal)

Or

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid (Spain)

Date of last revision of this leaflet:November 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es