Package Insert: Information for the Patient

Rupatadina Bluefish 10 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Rupatadina Bluefish

4. Possible adverse effects

5. Storage of Rupatadina Bluefish

6. Contents of the package and additional information

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, nasal and ocular itching.

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

Do not take Rupatadina Bluefish

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

Warnings and precautions

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

Inform your doctor, pharmacist, or nurse if:

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

Children and adolescents

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

Other medications and Rupatadina Bluefish

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

Do not take medications containing ketoconazole or erythromycin, which may increase the level of rupatadina in your body.

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

Taking Rupatadina Bluefish with food and drinks

Do not take Rupatadina Bluefish in combination with grapefruit juice, as it may increase the level of rupatadina in your body.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

It is not recommended to take Rupatadina Bluefish during breastfeeding.

Driving and operating machinery

It is not expected that Rupatadina Bluefish will affect your ability to drive vehicles or operate machinery. However, check that these tablets do not 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 some sugars, consult your doctor before taking Rupatadina Bluefish.

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

Adults and adolescents 12 years of age and older

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

Swallow the tablet with water, with or without food.

Your doctor will inform you of 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 have taken more tablets than you should.

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

If you forget to take Rupatadina Bluefish

Do not take a double dose to compensate for the missed dose.

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

If you interrupt treatment with Rupatadina Bluefish

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

If you stop taking Rupatadina Bluefish before the planned time, your symptoms may subside.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

Frequent Adverse Effects(may affect up to 1 in 10 patients)

• Drowsiness
• Headache
• Dizziness
• Dry mouth
• Sensation of weakness
• Fatigue.

Infrequent Adverse Effects(may affect up to 1 in 100 patients)

• Sore throat
• Throat dryness
• Runny nose
• Increased appetite
• Difficulty concentrating
• Nasal bleeding
• Nasal dryness
• Cough
• Nausea
• Abdominal pain
• Diarrhea
• Indigestion
• Vomiting
• Constipation
• Rash
• Back pain
• Joint pain
• Muscle pain
• Thirst
• Discomfort
• 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 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Rupatadina Bluefish

The active ingredient is rupatadine fumarate.

The other components are:

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

Appearance of the product and content of the container

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

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Responsible for manufacturing

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:May 2017

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es