Rupatadine Normon 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rupatadina Normon 10 mg tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Rupatadina Normon is and what it is used for
2. What you need to know before taking Rupatadina Normon
3. How to take Rupatadina Normon
4. Possible adverse effects
5. How to store Rupatadina Normon
6. Contents of the pack and other information

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

Rupatadine, the active substance in Rupatadina Normon, is an antihistamine.

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

Rupatadina Normon is indicated for the relief of symptoms associated with urticaria (allergic skin rash), such as itching and skin wheals (redness and swelling of the skin).

2. What you need to know before taking Rupatadina Normon

Do not take Rupatadina Normon:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

If you have renal or hepatic impairment, consult your doctor. The use of Rupatadina Normon is not currently recommended in patients with renal or hepatic impairment.

If you have low blood potassium levels and/or if you have a certain abnormal heart rhythm pattern (known QTc interval prolongation on ECG), which may occur in certain heart conditions, consult your doctor.

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

Children

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

Taking Rupatadina Normon with other medicines

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

If you are taking Rupatadina Normon, do not take medicines containing ketoconazole or erythromycin.

If you are taking central nervous system depressants or statin-containing medicines, consult your doctor before taking Rupatadina Normon.

Taking Rupatadina Normon with food, drinks and alcohol

Do not take Rupatadina Normon together with grapefruit juice, as it may increase the level of rupatadine in your body.

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

Pregnancy and breastfeeding

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

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

The recommended dose of Rupatadina Normon is not expected to affect your ability to drive or operate machinery. However, when you first start using Rupatadina Normon, you should observe how the treatment affects you before driving or operating machinery.

Rupatadina Normon contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Rupatadina Normon

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will determine the duration of your treatment with Rupatadina Normon.

If you take more Rupatadina Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rupatadina Normon

Take your dose as soon as possible and then continue taking your tablets at the usual times. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Uncommon adverse effects (may affect up to 1 in 100 people):

Increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, rinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, malaise, fever, abnormal liver function tests, and weight gain.

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

Palpitations, increased heart rate, and allergic reactions (itching, hives, and swelling of the face, tongue or throat).

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rupatadina Normon

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rupatadina Normon

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).

• The other components are monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, red iron oxide, yellow iron oxide and magnesium stearate.

Appearance of the product and contents of the pack

Rupatadina Normon are round, flat, light salmon-coloured tablets, printed with "R10" on one side, and packed in blisters containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

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

Date of latest revision of the leaflet: July 2018

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address:

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