Rupatadine bluefish

Package leaflet: Information for the user

Rupatadine Bluefish, 10 mg, tablets
Rupatadinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Rupatadine Bluefish contains rupatadine fumarate, an active substance with antihistaminic properties.
Rupatadine Bluefish is used in adults and adolescents aged over 12 years to relieve symptoms of allergic rhinitis, such as sneezing, runny nose, and itching of the eyes and nose.
Rupatadine Bluefish is also used in adults and adolescents aged over 12 years to relieve symptoms associated with urticaria (allergic skin rash), such as itching and hives.

2. Important information before taking Rupatadine Bluefish

When not to take Rupatadine Bluefish

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

Warnings and precautions
Before starting to take Rupatadine Bluefish, discuss this with your doctor,
pharmacist, or nurse.
In particular, tell your doctor, pharmacist, or nurse if:

• the patient has impaired kidney or liver function,
• the patient has low potassium levels,
• the patient currently has or has ever had heart disease in the past,
• the patient is over 65 years of age.

Children and adolescents
The use of Rupatadine Bluefish is not recommended in children and adolescents under 12 years of age.
Rupatadine Bluefish with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take, including those obtained without a prescription.
Do not take medicines containing ketoconazole or erythromycin, as this may
increase the concentration of rupatadine in the body.
If the patient is taking medicines that depress the central nervous system or statins,
they should consult their doctor before using Rupatadine Bluefish.
Rupatadine Bluefish with food, drink, and alcohol
Do not take Rupatadine Bluefish with grapefruit juice, as this may
increase the concentration of rupatadine in the body.
Rupatadine at the recommended dose of 10 mg does not increase alcohol-induced drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Rupatadine Bluefish must not be used during pregnancy unless clearly necessary.
The use of Rupatadine Bluefish is not recommended during breastfeeding.
Driving and using machines
It is unlikely that Rupatadine Bluefish will affect the ability to drive or
operate machinery. However, before driving or operating machinery, ensure that
these tablets do not cause drowsiness or dizziness.
Rupatadine Bluefish contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult their doctor before taking this medicine.

3. How to take Rupatadine Bluefish

This medicine should always be taken as directed by a doctor. If in doubt, consult a doctor or pharmacist.
Adults and adolescents aged 12 years and above
The recommended dose is one tablet (10 mg) once daily.
The tablet should be swallowed with water, with or without food.
The doctor will inform the patient how long treatment with Rupatadine Bluefish should continue.
Use in children and adolescents
Rupatadine Bluefish is not recommended for use in children and adolescents under 12 years of age.
Taking more Rupatadine Bluefish than recommended
If a patient has taken too many tablets, they should contact a doctor immediately.
Missing a dose of Rupatadine Bluefish
Do not take a double dose to make up for a missed tablet.
Take the next dose according to the recommended dosing schedule.
Stopping Rupatadine Bluefish
Inform the doctor if the patient wishes to stop taking Rupatadine Bluefish before the end of the treatment course.
If the patient stops taking Rupatadine Bluefish earlier than planned, symptoms may return.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately and stop taking Rupatadine Bluefish if the patient experiences:

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

Common adverse reactions (may occur in up to 1 in 10 patients):

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

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• Sore throat
• Dryness of the throat mucosa
• Runny nose
• Increased appetite
• Difficulty concentrating
• Nosebleeds
• Dryness of the nasal mucosa
• Cough
• Nausea
• Abdominal pain
• Diarrhea
• Indigestion
• Vomiting
• Constipation
• Rash
• Back pain
• Joint pain
• Muscle pain
• Increased thirst
• General malaise
• Fever
• Irritability
• Abnormal liver function test results
• Weight gain

Rare adverse reactions (may occur in up to 1 in 1,000 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rupatadine Bluefish

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store the blister pack in the original packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Rupatadine Bluefish contains

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

What Rupatadine Bluefish looks like and contents of the pack
Rupatadine Bluefish tablets are round, biconvex, smooth on both sides, and light purple in colour.
Blister pack made of PVC/PVDC/Aluminium 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: