RUPATADINE BLUEFISH 10 mg TABLETS

Introduction

Patient Information Leaflet

Rupatadina Bluefish 10 mg tablets EFG

Read 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Rupatadina Bluefish is and what it is used for
2. What you need to know before you take Rupatadina Bluefish
3. How to take Rupatadina Bluefish
4. Possible side effects
5. Storage of Rupatadina Bluefish
6. Contents of the pack and further information

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

Rupatadina Bluefish contains rupatadine fumarate, which is an antihistamine.

Rupatadina Bluefish is indicated in adults and adolescents over 12 years of age for the relief of symptoms of allergic rhinitis such as sneezing, runny nose, itchy nose, and itchy eyes.

Rupatadina Bluefish is indicated in adults and adolescents over 12 years of age for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and skin hives

2. What you need to know before you take Rupatadina Bluefish

Do not take Rupatadina Bluefish

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Rupatadina Bluefish.

Tell your doctor, pharmacist, or nurse if:

• you have liver or kidney problems
• you have low potassium levels in your blood
• you have or have had heart disease
• you are over 65 years old

Children and adolescents

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

Other medicines and Rupatadina Bluefish

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

Do not take medicines that contain ketoconazole or erythromycin, as they may increase the level of rupatadine in your body.

If you are taking medicines that depress the central nervous system or statins, consult your doctor before taking Rupatadina Bluefish.

Taking Rupatadina Bluefish with food and drinks

Do not take Rupatadina Bluefish 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 somnolence caused by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Rupatadina Bluefish if you are pregnant, unless it is necessary.

It is not recommended to take Rupatadina Bluefish during breastfeeding.

Driving and using machines

Rupatadina Bluefish is unlikely to affect your ability to drive or use machines. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or using machines.

Rupatadina Bluefish contains lactose

Rupatadina Bluefish contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking Rupatadina Bluefish.

3. How to take Rupatadina Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Adults and adolescents over 12 years of age

The recommended dose is one tablet (10 mg of rupatadine) once a day.

Swallow the tablet with water, with or without food.

Your doctor will tell you how long to take Rupatadina Bluefish.

Use in children and adolescents

Rupatadina Bluefish is not recommended for children and adolescents under 12 years of age.

If you take more Rupatadina Bluefish than you should

Contact your doctor immediately if you have taken more tablets than you should.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 0420, indicating the medicine and the amount taken.

If you forget to take Rupatadina Bluefish

Do not take a double dose to make up for forgotten doses.

Take your dose as soon as possible and continue with your tablets at the usual times.

If you stop taking Rupatadina Bluefish

Tell your doctor if you want to stop taking Rupatadina Bluefish before you have finished your treatment.

If you stop taking Rupatadina Bluefish before you have finished your treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Rupatadina Bluefish if you experience:

• Swelling of the face, lips, tongue, or throat, and difficulty breathing, this may be symptoms of a severe allergic reaction (may affect up to 1 in 1000 patients)

Common side effects(may affect up to 1 in 10 patients)

• Somnolence
• Headache
• Dizziness
• Dry mouth
• Feeling of weakness
• Fatigue

Uncommon side effects(may affect up to 1 in 100 patients)

• Sore throat
• Dry throat
• Rhinitis
• Increased appetite
• Difficulty concentrating
• Nasal bleeding
• Dry nose
• Cough
• Nausea
• Abdominal pain
• Diarrhea
• Indigestion
• Vomiting
• Constipation
• Rash
• Back pain
• Joint pain
• Muscle pain
• Thirst
• Malaise
• Fever
• Irritability
• Abnormal liver function tests
• Weight gain

Rare side effects(may affect up to 1 in 1000 patients)

• Palpitations
• Increased heart rate
• Allergic reactions (including anaphylactic reactions, angioedema, and urticaria)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rupatadina Bluefish

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

Do not use this medicine after the expiry date which is stated on the pack and blister after EXP. The expiry date is the last day of the month stated.

Store the blister in the outer packaging to protect it from light

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rupatadina Bluefish

The active substance is rupatadine fumarate.

The other ingredients are:

microcrystalline cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch (maize), red iron oxide (E172), yellow iron oxide (E172)

Appearance and packaging

Rupatadina Bluefish 10 mg are round, salmon-colored, biconvex, and flat on both sides.

PVC/PVDC/Aluminum blister packs in packs of 20, 30, 50, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Local Representative:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

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

Date of last revision of this leaflet:May 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es