Betahistina Bluefish

Package Leaflet: Information for the User

Betahistyne Bluefish, 8 mg, tablets

Betahistyne Bluefish, 16 mg, tablets

Betahistyne Bluefish, 24 mg, tablets

Betahistini dihydrochloride

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 or pharmacist.
• This medicine has been prescribed for you. 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 those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Betahistyne Bluefish and what is it used for
• 2. Important information before taking Betahistyne Bluefish
• 3. How to take Betahistyne Bluefish
• 4. Possible side effects
• 5. How to store Betahistyne Bluefish
• 6. Package contents and other information

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

The active substance in Betahistyne Bluefish is betahistini dihydrochloride. This medicine is called a "histamine analogue". It is used to treat:

• symptoms of Meniere's disease, such as vertigo of vestibular origin, tinnitus, hearing loss with accompanying nausea, balance disorders and/or headache:
• vertigo of vestibular origin (feeling of spinning). The medicine improves blood flow in the inner ear. This reduces increased pressure.
• tinnitus,
• hearing loss.

2. Important information before taking Betahistyne Bluefish

When not to take Betahistyne Bluefish

• if you are allergic to betahistyne or any of the other ingredients of this medicine (listed in section 6);
• if you have high blood pressure caused by a tumor of the adrenal gland (pheochromocytoma).

Do not take this medicine if you have any of these conditions. Before taking Betahistyne Bluefish, talk to your doctor or pharmacist.

Warnings and precautions

Before taking Betahistyne Bluefish, discuss it with your doctor.

• if you have a stomach ulcer (peptic ulcer);
• if you have asthma.

Do not take this medicine if you have any of these conditions (or are not sure). Before taking Betahistyne Bluefish, talk to your doctor or pharmacist. It may be necessary to closely monitor your condition while taking Betahistyne Bluefish.

Children

Betahistyne Bluefish is not recommended for children.

Betahistyne Bluefish and 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.

• Antihistamines - they may (theoretically) reduce the effect of Betahistyne Bluefish. Betahistyne Bluefish may also reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAOIs) used to treat Parkinson's disease. They may enhance the effect of Betahistyne Bluefish.

Betahistyne Bluefish with food and drink

Betahistyne Bluefish can be taken with or without food. However, Betahistyne Bluefish may cause mild stomach upset (see section 4). Taking Betahistyne Bluefish with food may help reduce stomach upset.

Pregnancy, breastfeeding, and fertility

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.

• If you are pregnant or think you may be pregnant, stop taking Betahistyne Bluefish and consult your doctor.
• Do not take Betahistyne Bluefish during pregnancy, unless your doctor advises you to do so.

It is not known whether betahistyne passes into breast milk.

• Do not breastfeed while taking Betahistyne Bluefish, unless your doctor advises you to do so.

Driving and using machines

It is unlikely that Betahistyne Bluefish will affect your ability to drive or use machines. However, remember that the diseases being treated with Betahistyne Bluefish (vertigo, tinnitus, and hearing loss associated with Meniere's disease) can cause dizziness and nausea, which may affect your ability to drive or use machines.

3. How to take Betahistyne Bluefish

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will adjust the dose individually for each patient.

• Your doctor will adjust the dose depending on your condition.
• Continue taking the medicine. It may take some time for the medicine to start working.

How to take Betahistyne Bluefish

• Swallow the tablet with water.
• The tablet can be taken with or after food. However, Betahistyne Bluefish may cause mild stomach upset (listed in section 4). Taking Betahistyne Bluefish with food may help reduce stomach upset.

How much Betahistyne Bluefish to take

The recommended dose is:

Tablets, 8 mg:one or two tablets, 3 times a day.

Tablets, 16 mg:half a tablet or one tablet, 3 times a day.

Always follow your doctor's advice, as your doctor may adjust the dose. If you take more than one tablet a day, take the tablets at evenly spaced intervals throughout the day. Try to take the tablet at the same time each day. This will help keep a steady amount of medicine in your body. Taking the tablets at the same time will also help you remember to take them.

Taking more than the recommended dose of Betahistyne Bluefish

If you take too many Betahistyne Bluefish tablets, you may experience nausea, drowsiness, or stomach pain. If you are unsure, ask your doctor.

Missing a dose of Betahistyne Bluefish

If you forget to take a tablet, skip that dose. Wait until it is time for your next dose. Do not take a double dose to make up for a missed tablet.

Stopping Betahistyne Bluefish treatment

Do not stop taking Betahistyne Bluefish without talking to your doctor, even if you feel better.

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

4. Possible side effects

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

Allergic reactions

If you experience an allergic reaction (frequency not known), stop taking Betahistyne Bluefish and contact your doctor or go to the nearest hospital immediately. Symptoms may include:

• red or lumpy skin rash or skin inflammation with itching,
• swelling of the face, lips, tongue, or throat,
• low blood pressure,
• loss of consciousness,
• difficulty breathing.

Other side effects may include:

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

• headache,
• nausea,
• indigestion.

Unknown(frequency cannot be estimated from the available data):

• mild stomach upset, such as vomiting, stomach pain, bloating, and gas.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Betahistyne Bluefish

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

There are no special storage instructions for this medicine.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

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

6. Package contents and other information

What Betahistyne Bluefish contains

• The active substance is 8 mg, 16 mg, and 24 mg of betahistini dihydrochloride.
• The other ingredients are citric acid, microcrystalline cellulose (PH 102), mannitol (E 421), colloidal anhydrous silica, and talc.

What Betahistyne Bluefish looks like and contents of the pack

8 mg: white, round, flat, uncoated tablets, 6.9 mm - 7.1 mm in size, smooth on both sides.

16 mg: white, round, biconvex, uncoated tablets, 8.6 mm - 8.8 mm in size, with a scored line on one side and "I" marking on both sides of the score line and smooth on the other side.

24 mg: white, round, biconvex, uncoated tablets, 9.9 mm - 10.1 mm in size, with a scored line on one side and "II" marking on both sides of the score line and smooth on the other side.

PVC/PVDC/Aluminum blisters: 20, 30, 50, 60, 90, and 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet:December 2021