Rupatadine Bluefish

Package Leaflet: Information for the User

Rupatadine Bluefish, 10 mg, tablets

Rupatadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Rupatadine Bluefish and what is it used for
• 2. Important information before taking Rupatadine Bluefish
• 3. How to take Rupatadine Bluefish
• 4. Possible side effects
• 5. How to store Rupatadine Bluefish
• 6. Contents of the pack and other information

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

Rupatadine Bluefish contains rupatadine fumarate, which is an antihistamine.
Rupatadine Bluefish is used in adults and adolescents over 12 years of age to relieve symptoms of allergic rhinitis, such as sneezing, runny or itchy nose, and itchy eyes.
Rupatadine Bluefish is also used in adults and adolescents over 12 years of age to relieve symptoms of urticaria (allergic skin rash), such as itching and hives.

2. Important information before taking Rupatadine Bluefish

When not to take Rupatadine Bluefish

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

Warnings and precautions

Before taking Rupatadine Bluefish, talk to your doctor, pharmacist, or nurse.
Especially, tell your doctor, pharmacist, or nurse if:

• you have kidney or liver problems,
• you have low potassium levels,
• you have a heart condition,
• you are over 65 years old.

Children and adolescents

Rupatadine Bluefish should not be used in children and adolescents under 12 years of age.

Rupatadine Bluefish with other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription.
Do not take medicines containing ketoconazole or erythromycin, as this may increase the levels of rupatadine in your body.
If you are taking medicines that affect the central nervous system or statins, you should consult your doctor before taking Rupatadine Bluefish.

Rupatadine Bluefish with food, drink, and alcohol

Do not take Rupatadine Bluefish with grapefruit juice, as this may increase the levels of rupatadine in your body.
Rupatadine at the recommended dose of 10 mg does not increase drowsiness 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.
Rupatadine Bluefish should not be used during pregnancy, unless necessary.
Rupatadine Bluefish should not be used during breastfeeding.

Driving and using machines

It is unlikely that Rupatadine Bluefish will affect your ability to drive or use machines. However, before driving or using machines, check that these tablets do not make you feel drowsy or dizzy.

Rupatadine Bluefish contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Rupatadine 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) once daily.
Swallow the tablet with water, with or without food.
Your doctor will tell you how long you should take Rupatadine Bluefish.

Use in children and adolescents

Rupatadine Bluefish is not recommended for use in children and adolescents under 12 years of age.

Overdose of Rupatadine Bluefish

If you take more tablets than you should, contact your doctor immediately.

Missed dose of Rupatadine Bluefish

Do not take a double dose to make up for a forgotten tablet.
Take the next dose at the usual time.

Stopping treatment with Rupatadine Bluefish

Tell your doctor if you want to stop taking Rupatadine Bluefish before completing the treatment course.
If you stop taking Rupatadine Bluefish too early, your symptoms may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rupatadine Bluefish can cause side effects, although not everybody gets them.

Stop taking Rupatadine Bluefish and contact your doctor immediately if you experience:

The following:

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

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

• Drowsiness
• Headache
• Dizziness
• Dry mouth
• Feeling weak
• Feeling tired

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

• Sore throat
• Dryness of the throat
• Common cold
• Increased appetite
• Difficulty concentrating
• Nosebleeds
• Dryness of the nose
• Cough
• Nausea
• Abdominal pain
• Diarrhea
• Indigestion
• Vomiting
• Constipation
• Rash
• Back pain
• Joint pain
• Muscle pain
• Increased thirst
• General feeling of being unwell
• Fever
• Irritability
• Abnormal liver function tests
• Weight gain

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

• Palpitations
• Fast heartbeat
• Allergic reactions (itching, hives, swelling of the face, lips, tongue, or throat)

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported to the national reporting system listed below.
You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rupatadine 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 carton and blister after “EXP”. The expiry date refers to the last day of that month.
Store the blister in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rupatadine Bluefish contains

• The active substance is rupatadine fumarate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, red iron oxide (E 172), yellow iron oxide (E 172).

What Rupatadine Bluefish looks like and contents of the pack

Rupatadine Bluefish tablets are round, biconvex, smooth on both sides, light orange in color.
PVC/PVDC/Aluminium blister in a cardboard box. The pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer/Importer

Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: