Betahistina Bluefish

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Betahistyne Bluefish (Beta-histamine Bluefish), 24 mg, tablets

Betahistini dihydrochloride
Betahistyne Bluefish and Beta-histamine Bluefish are different trade names for the same drug.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Leaflet

• 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, hearing disturbances, 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

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.
Before taking Betahistyne Bluefish, talk to your doctor or pharmacist.

Do not take this medicine if you have any of these conditions (or are unsure). 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, have recently taken, or might take.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• 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.
It is not known whether Betahistyne Bluefish affects the unborn child:

• do not take Betahistyne Bluefish during pregnancy, unless your doctor advises you to.

It is not known whether betahistyne passes into breast milk.

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

Driving and using machines

It is unlikely that Betahistyne Bluefish will affect your ability to drive or use tools and machines. However, remember that the diseases 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.
Betahistyne Bluefish is available in the following strengths: 8 mg, 16 mg, 24 mg.

• Your doctor will adjust the dose according to 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: half a tablet or one tablet, 2 times a day.
Always follow your doctor's advice, as they may adjust the dose.
If you take more than one tablet a day, take the tablets evenly 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, consult 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 the medicine without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, 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,
• decrease in blood pressure,
• loss of consciousness,
• difficulty breathing.

Other side effects may include:

Frequent(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 any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Betahistyne Bluefish

Keep the medicine out of the sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 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

White, round, biconvex, uncoated tablets, 9.9 mm - 10.1 mm in size, with a dividing line on one side and "II" on both sides of the dividing line and smooth on the other side.
PVC/PVDC/Aluminum blisters: 20, 30, 50, 60, 90, and 100 tablets.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

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

Manufacturer:

Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Portugal, the country of export:5681861

Parallel import authorization number: 404/24

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of approval of the leaflet: 20.11.2024