Package Insert: Information for the User

Rupatadina Mabo 10 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Rupatadina is an antihistamine.

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

Rupatadina 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 takeRupatadina Mabo

If you are allergic to rupatadina 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 rupatadina:

• If you have kidney or liver insufficiency. In this case, consult your doctor. The use of rupatadina 10 mg tablets is not currently recommended for patients with kidney or liver insufficiency.
• If you have low potassium levels in your 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 Rupatadina Mabo

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

• When taking rupatadina, do not take medications containing ketoconazole or erythromycin.
• If you are taking central nervous system depressants or statin medications, consult your doctor before taking rupatadina.

Taking Rupatadina Mabo with food, drinks, and alcohol

Do not take this medication in combination with grapefruit juice as it may increase the level of rupatadina in your body.

Rupatadina, at the recommended dose of 10 mg, does not increase drowsiness caused by alcohol.

Pregnancy and breastfeeding

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

Driving and operating machinery

It is not expected that the recommended dose of rupatadina will affect your ability to drive vehicles or operate machinery. However, when you first use rupatadina, you should be cautious and see how it affects you before driving or operating machinery.

Rupatadina Mabo contains lactose.

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them 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.

Rupatadina is administered to adolescents (12 years of age and older) and adults. The recommended dose is one tablet (10 mg of rupatadina) 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 rupatadina.

If you take more Rupatadina Mabo 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 forgot to take Rupatadina Mabo

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.

Frequent Adverse Effects (may affect up to 1 in 10 patients):are drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

Possible 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.

Rare Adverse Effects (may affect up to 1 in 1,000 patients): are palpitations and 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 that does not appear in the 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 packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Keep the blister pack in the outer packaging to protect it from light.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rupatadina Mabo

• The active ingredient is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other components are lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, red iron oxide (E.172), yellow iron oxide (E-172), and magnesium stearate.

Appearance of the product and contents of the packaging

Rupatadina Mabo are round, biconvex, smooth, uncoated, salmon-colored tablets, packaged in blisters containing 20 tablets.

Packaging size: 20 tablets.

Holder of the marketing authorization

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor

28821 Coslada (Madrid)

Spain

Responsible for manufacturing

APL Swift Services (Malta) LTD.

HF26, Hal Fal Industrial Estate

Hal Far, Birzebbugia 3000, Malta

Last review date of this leaflet:September 2020

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