Patient Information

Rupatadina Normon 10 mg Tablets

Read this entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do 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 Rupatadina Normon and what it is used for

2. What you need to know before taking Rupatadina Normon

3. How to take Rupatadina Normon

4. Possible side effects

5. Storage of Rupatadina Normon

6. Contents of the pack and additional information

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

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

Rupatadina Normon 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 Normon:

- 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 this medication.

If you have kidney or liver insufficiency, consult your doctor. The use of Rupatadina Normon 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

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

Taking Rupatadina Normon with other medications

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 Normon, 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 Normon.

Taking Rupatadina Normon with food, drinks, and alcohol

Do not take Rupatadina Normon 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 the drowsiness caused by alcohol.

Pregnancy and breastfeeding

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

Do not take Rupatadina Normon during pregnancy and breastfeeding unless clearly indicated by your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

It is not expected that the recommended dose of Rupatadina Normon will affect your ability to drive vehicles or operate machinery. However, when you first use Rupatadina Normon, you should observe how the treatment affects you before driving or operating machinery.

Rupatadina Normon contains lactose.

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

If you take more Rupatadina Normon 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 take Rupatadina Normon

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 dose.

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

Frequent Adverse Effects(may affect up to 1 in 10 patients) are:

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

Less Frequent 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, increased heart rate, and allergic reactions (itching, urticaria, and swelling of the face, 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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. 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 Normon

- 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, yellow iron oxide, and magnesium stearate.

Appearance of the product and contents of the packaging

Rupatadina Normon are round, flat, light salmon-colored tablets, printed with “R10” on one of their faces and packaged in blisters containing 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6, 28760 Tres Cantos (Madrid)- Spain

Date of the last review of the prospectus: July 2018

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/83302/P_83302.html