Package Insert: Information for the Patient

Rupatadina Stada 10 mg Tablets EFG

Read this entire 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 only for you, 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.

1. What is Rupatadina Stada and what is it used for

2. What you need to know before starting to take Rupatadina Stada

3. How to take Rupatadina Stada

4. Possible adverse effects

5. Storage of Rupatadina Stada

6. Contents of the package and additional information

Rupatadina, the active substance of Rupatadina Stada, is an antihistamine.

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

Rupatadina Stada 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 Rupatadina Stada:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rupatadina Stada.

If you have kidney or liver insufficiency, consult your doctor. The use of rupatadina 10 mg tablets 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 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 and adolescents

This medication should not be used in children under 12 years of age.

Other medications and Rupatadina Stada

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

If you are taking rupatadina, do not take medications that contain ketoconazole or erythromycin.

If you are taking central nervous system depressants or statin medications, consult your doctor before taking rupatadina.

Taking Rupatadina Stada with food and drinks

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

Pregnancy and breastfeeding

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

Do not take rupatadina during pregnancy and breastfeeding unless your doctor clearly indicates otherwise.

Consult your doctor or pharmacist before taking any 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. Nevertheless, when you first use rupatadina, you should exercise caution to see how the treatment may affect you before driving or operating machinery.

Rupatadina Stada 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 or pharmacist. 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 Stada.

If you take more Rupatadina Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeRupatadina Stada

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.

Thefrequent adverse effects(may affect up to 1 in 10 people) are:

Drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

Theinfrequent adverse effects(may affect up to 1 in 100 people) 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.

Therare adverse effects(may affect up to 1 in 1,000 people) are:

Palpitations, increased heart rate, and allergic reactions (including anaphylactic reactions, angioedema, and urticaria).

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 on 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 blister after CAD.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rupatadina Stada

• The active ingredient is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other components are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized cornstarch, red iron oxide, yellow iron oxide, and magnesium stearate.

Appearance of the product and contents of the package

Rupatadina Stada are round tablets, of a light salmon color and are presented in blisters containing 20, 30, 50 and 100 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares (Madrid)

Spain

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

Martin Dow Pharmaceuticals

Goualle Le Puy, Champ de Lachaud,

Meymac, 19250,

France

This medicine is authorized in the Member States of the European Economic Area with the following names:

Belgium: Rupatadine EG 10 mg tabletten

Germany: Rupatadin AL 10 mg Tabletten

Italy: Rupatadina EG 10 mg, compresse

Netherlands: Rupatadine CF 10 mg, tabletten

Slovakia: Rupastad 10 mg tablety

Spain: Rupatadina Stada 10 mg comprimidos EFG

Last review date of the leaflet:August 2018

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