Betahistina Bluefish

Leaflet attached to the packaging: information for the user

Betahistyne Bluefish, 8 mg, tablets

Betahistyne Bluefish, 16 mg, tablets

Betahistyne Bluefish, 24 mg, tablets

Betahistini dihydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 labyrinthine origin, tinnitus, hearing loss with accompanying nausea, balance disorders and (or) headache:

• vertigo of labyrinthine origin (feeling of spinning). The medicine improves blood flow in the inner ear. This leads to a reduction in increased pressure.
• tinnitus,
• hearing loss.

2. Important information before taking Betahistyne Bluefish

When not to take Betahistyne Bluefish

• if the patient is allergic to betahistyne 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 should not be used if the patient has any of these conditions. Before starting to take Betahistyne Bluefish, the patient should talk to their doctor or pharmacist.

Warnings and precautions

Before starting to take Betahistyne Bluefish, the patient should discuss it with their doctor.
Before starting to take 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 should not be used if the patient has any of these conditions (or is unsure). Before starting to take 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 use in children.

Betahistyne Bluefish and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, as well as any medicines they plan to 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 disorders (see section 4). Taking Betahistyne Bluefish with food may help reduce stomach disorders.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist 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 should not be taken during pregnancy, unless the doctor advises it.

It is not known whether betahistyne passes into breast milk.

• Betahistyne Bluefish should not be taken while breastfeeding, 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 dizziness and nausea, which may affect the ability to drive or use machines.

3. How to take Betahistyne Bluefish

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The doctor will adjust the dose individually for each patient.

• The doctor will adjust the dose depending on 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 disorders (listed in section 4). Taking Betahistyne Bluefish with food may help reduce stomach disorders.

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.
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 space out the tablets evenly throughout the day.
The patient should try to take the tablet at the same time every day. This will help ensure that a steady amount of the medicine is in the body. Taking the tablets at the same time will also help the patient remember to take them.

Taking more than the recommended dose of Betahistyne Bluefish

If the patient takes too many Betahistyne Bluefish tablets, they may experience nausea, drowsiness, or stomach pain. In case of doubt, the patient should consult 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 to take the next dose. The patient should not take a double dose to make up for the missed tablet.

Stopping Betahistyne Bluefish

The patient should not stop taking Betahistyne Bluefish without consulting their doctor, even if they feel better.
In case of any further doubts about the use of this medicine, the patient should consult 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:

• 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 occur in up to 1 in 10 people):

• headache,
• nausea,
• indigestion.

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

• mild stomach disorders, 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 tell 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 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information 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 storing the medicine.
The medicine should not be used after the expiry date stated on the carton after "Expiry date (EXP)". 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 that are no longer needed. 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 what the pack contains

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 leaflet:December 2021