Betahistina Bluefish

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Betahistyne Bluefish (Betahistine Bluefish), 16 mg, Tablets

Betahistini Dihydrochloride
Betahistyne Bluefish and Beta-histina Bluefish are different trade names for the same medicine.

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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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". The medicine 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 (a 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 the patient is allergic to betahistine or any of the other ingredients of this medicine (listed in section 6);
• If the patient has high blood pressure due to a tumor of the adrenal gland (pheochromocytoma).

This medicine must not be taken if the patient has any of these conditions. Before taking Betahistyne Bluefish, the patient should talk to their doctor or pharmacist.

Warnings and Precautions

Before taking Betahistyne Bluefish, the patient should discuss it with their doctor.
Before taking Betahistyne Bluefish, the patient should talk to their doctor or pharmacist.

• If the patient has a stomach ulcer (peptic ulcer);
• If the patient has bronchial asthma.

This medicine must not be taken if the patient has any of these conditions (or is unsure). Before taking Betahistyne Bluefish, the patient should talk to their doctor or pharmacist. It may be necessary to closely monitor the patient's condition while taking Betahistyne Bluefish.
Children
Betahistyne Bluefish is not recommended for children.

Betahistyne Bluefish and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
In particular, the patient should inform their doctor or pharmacist if they 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, Breast-feeding, and Fertility

If the patient is pregnant or breast-feeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.
It is not known whether Betahistyne Bluefish affects the unborn child:

• If the patient is pregnant or thinks they may be pregnant, they should stop taking Betahistyne Bluefish and consult their doctor.
• Betahistyne Bluefish must not be taken during pregnancy, unless the doctor advises it.

It is not known whether betahistine passes into breast milk.

• Betahistyne Bluefish must not be taken during breast-feeding, unless the doctor advises it.

Driving and Using Machines

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

3. How to Take Betahistyne Bluefish

This medicine should always be taken exactly as advised by the doctor or pharmacist. If the patient has any doubts, they should ask their doctor or pharmacist. The doctor will adjust the dose individually for each patient.
Betahistyne Bluefish is available in the following strengths: 8 mg, 16 mg, 24 mg.

• The doctor will adjust the dose according to the patient's condition.
• The patient should continue taking the medicine. It may take some time for the medicine to start working.

How to Use 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, 3 times a day.
The patient should always follow the doctor's advice, as the doctor may adjust the dose.
If the patient takes more than one tablet a day, they should spread the tablets evenly throughout the day.
The patient should try to take a tablet at the same time every day. This will help ensure that a steady amount of medicine is in the body. Taking the tablets at the same time will also help the patient remember to take them.

Taking More Betahistyne Bluefish Than Recommended

If the patient takes too many Betahistyne Bluefish tablets, they may experience nausea, drowsiness, or stomach pain. If the patient has any doubts, they should ask their doctor.

Missing a Dose of Betahistyne Bluefish

If the patient forgets to take a tablet, they should skip that dose. They should wait until it is time for their next dose. The patient should not take a double dose to make up for a missed tablet.

Stopping Betahistyne Bluefish Treatment

The patient should not stop taking Betahistyne Bluefish without consulting their doctor, even if they feel better.
If the patient has any further doubts about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible Side Effects

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

Allergic Reactions

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

• A red or lumpy skin rash or skin inflammation with itching;
• Swelling of the face, lips, tongue, or throat;
• A decrease in 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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, more information can be gathered on the safety of the medicine.

5. How to Store Betahistyne Bluefish

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Betahistyne Bluefish Contains

• The active substance is 16 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 What the Package Contains

White, round, biconvex, uncoated tablets, 8.6 mm - 8.8 mm in size, with a score line on one side and the marking "I" on both sides of the score line and a smooth surface on the other side.
PVC/PVDC/Aluminum blisters: 20, 30, 50, 60, 90, and 100 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the 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:5681846

Parallel Import Authorization Number: 398/24

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Approval of the Leaflet: 19.11.2024