Rupatadine Bluefish 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rupatadina Bluefish 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Rupatadina Bluefish

Do not take Rupatadina Bluefish

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Rupatadina Bluefish.

Inform your doctor, pharmacist, or nurse if:

• you have problems with liver or kidney function
• you have low levels of potassium in your blood
• you have or have ever had a heart condition
• you are over 65 years of age

Children and adolescents

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

Other medicines and Rupatadina Bluefish

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

Do not take medicines containing ketoconazole or erythromycin, as these may increase the level of rupatadine in your body.

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

Taking Rupatadina Bluefish with food and drink

Do not take Rupatadina Bluefish 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Rupatadina Bluefish if you are pregnant unless considered necessary by your doctor.

Rupatadina Bluefish is not recommended during breastfeeding.

Driving and using machines

Rupatadina Bluefish is unlikely to affect your ability to drive or operate machinery. However, you should check whether these tablets make you feel drowsy or dizzy before driving or operating machinery.

Rupatadina Bluefish contains lactose.

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

3. How to take Rupatadina Bluefish

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

Adults and adolescents aged 12 years and older

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

Take the tablet with water, with or without food.

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

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 take more tablets than you should.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 0420, indicating the medicine and the amount ingested.

If you forget to take Rupatadina Bluefish

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

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

If you stop taking Rupatadina Bluefish

Inform your doctor if you wish to stop taking Rupatadina Bluefish before completing your treatment.

If you stop taking Rupatadina Bluefish earlier than planned, your symptoms may return.

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

4. Possible adverse effects

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

Immediately inform your doctor and stop taking Rupatadina Bluefish if you experience:

• Swelling of the face, lips, tongue or throat and difficulty breathing – these may be symptoms of a severe allergic reaction (may affect up to 1 in 1,000 patients)

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

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

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

• Sore throat
• Dry throat
• Rhinitis
• Increased appetite
• Difficulty concentrating
• Nosebleed
• 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 adverse effects (may affect up to 1 in 1,000 patients)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rupatadine Bluefish

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.

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

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

6. Contents of the pack and other information

Composition of Rupatadina Bluefish

The active substance is rupatadine fumarate.

The other components are:

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

Appearance of the product and contents of the pack

Rupatadina Bluefish 10 mg are round, salmon-coloured, biconvex tablets, flat on both sides.

PVC/PVDC/Aluminium blisters in packs of 20, 30, 50 and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Local Representative:

Bluefish Pharma S.L.U.,

P.O. Box 36007

2832094 Madrid, Branch 36

This medicinal product is authorised in the European Economic Area countries under the following names:

Date of last revision of this leaflet: May 2017

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