Leaflet: Information for the user

Rinialer 10mg tablets

Rupatadina

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Rinialer and what it is used for

2.What you need to know before you start taking Rinialer

3.How to take Rinialer

4.Possible side effects

5.Storage of Rinialer

6.Content of the pack and additional information.

Rupatadine is an antihistamine.

Rinialer is indicated for the relief of symptoms of allergic rhinitis such as: sneezing, runny nose, eye and nasal itching.

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

Do not take Rinialer:

- If you are allergic to rupatadine or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rinialer.

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

If you have low potassium levels in the blood and/or if you have a certain abnormal heart rhythm pattern (prolongation of the QTc interval on 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 medication should not be used in children under 12 years of age.

Other medications and Rinialer

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you are taking Rinialer, do not take medications that contain ketoconazole (antifungal medication) or erythromycin (bacterial infection medication).

If you are taking central nervous system depressants, statin medications (used to treat high cholesterol levels) or midazolam (sedation medication for short duration), 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 caused by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No significant effect on your ability to drive vehicles or operate machinery is expected at the recommended dose of Rinialer. However, when you first use Rinialer, be cautious and see how it affects you before driving or operating machinery.

Rinialer contains lactose.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Rinialer is administered in adolescents (12 years of age and older) 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 inform you of 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 medication, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 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 compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequent adverse effects (may affect up to 1 in 10 patients) are drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

The infrequent adverse effects (may affect up to 1 in 100 patients) are increased appetite, irritability, difficulty concentrating, nasal bleeding, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, discomfort, fever, abnormal liver function tests, and weight gain.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and the blister pack. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the box and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Rinialer

The active ingredient is rupatadina. Each tablet contains 10mg of rupatadina (as fumarate). The other components are: pregelatinized cornstarch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate, and magnesium stearate. See section 2, “Rinialer contains lactose”.

Appearance of the product and contents of the packaging:

Rinialer are round, salmon-colored tablets and are presented in blister packs containing 15 or 20tablets. Not all packaging is marketed.

Marketing Authorization Holder

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Responsible for manufacturing

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)

Further information about this medicine can be requested from the local representative of the marketing authorization holder:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid (Spain)

Last review date of this leaflet:November 2020

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es