Betahistine bluefish

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Betahistyna Bluefish (Beta-histina Bluefish), 16 mg, tablets
Betahistini dihydrochloridum
Betahistyna Bluefish and Beta-histina Bluefish are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Betahistyna Bluefish is and what it is used for
2. Important information before taking Betahistyna Bluefish
3. How to take Betahistyna Bluefish
4. Possible side effects
5. How to store Betahistyna Bluefish
6. Contents of the pack and other information

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

The active substance in Betahistyna Bluefish is betahistine dihydrochloride. This medicine is known as a "histamine analogue". It is used to treat symptoms of Ménière’s disease, such as vestibular vertigo, tinnitus, hearing loss accompanied by nausea, hearing disturbances and (or) headache:

• Vestibular vertigo (sensation of spinning). The medicine improves blood flow in the inner ear, thereby reducing elevated pressure;
• Tinnitus;
• Hearing loss.

2. Information before taking Betahistyna Bluefish

When not to take Betahistyna 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 caused by an adrenal gland tumour (pheochromocytoma).

This medicine must not be used if the patient has any of these conditions. Before starting
treatment with Betahistyna Bluefish, consult a doctor or
pharmacist.
Warnings and precautions
Before starting treatment with Betahistyna Bluefish, discuss this with a doctor.
Before starting treatment with Betahistyna Bluefish, talk to your doctor or
pharmacist.

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

This medicine must not be used if the patient has any of these conditions (or if the patient is unsure). Before starting treatment with Betahistyna Bluefish, consult a doctor or pharmacist. Close monitoring of the patient's condition may be necessary during treatment with Betahistyna Bluefish.
Children
Betahistyna Bluefish is not recommended for use in children.
Betahistyna Bluefish and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• Antihistamines – these may (theoretically) reduce the effect of Betahistyna Bluefish. Also, Betahistyna Bluefish may reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAO inhibitors), used in the treatment of Parkinson's disease. These may enhance the effect of Betahistyna Bluefish.

Betahistyna Bluefish with food and drink
Betahistyna Bluefish may be taken with or without food. However, Betahistyna Bluefish may cause mild gastrointestinal discomfort (see section 4). Taking Betahistyna Bluefish with food may help reduce gastrointestinal symptoms.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
It is not known whether Betahistyna Bluefish affects the unborn child:

• If the patient is pregnant or suspects she may be pregnant, she should stop taking Betahistyna Bluefish and consult a doctor.
• Betahistyna Bluefish must not be taken during pregnancy unless advised by a doctor.

It is not known whether betahistine passes into breast milk.

• Breastfeeding must not be undertaken while taking Betahistyna Bluefish unless advised by a doctor.

Driving and operating machinery
It is unlikely that Betahistyna Bluefish affects the ability to drive or operate tools and machinery. However, it should be noted that the conditions treated with Betahistyna Bluefish (dizziness, tinnitus and hearing loss associated with Ménière's disease) may cause vertigo and nausea, which could affect the ability to drive and operate machinery.

3. How to take Betahistyna Bluefish

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. The doctor will adjust the dose individually for
each patient.
Betahistyna Bluefish is available in the following strengths: 8 mg, 16 mg, 24 mg.

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

How to take Betahistyna Bluefish

• Swallow the tablet with water.
• The tablet can be taken with or without food. However, Betahistyna Bluefish may cause mild gastrointestinal discomfort (listed in section 4). Taking Betahistyna Bluefish with food may help reduce gastrointestinal discomfort.

How much Betahistyna Bluefish to take
The usual recommended dose is: half a tablet or one tablet, three times daily.
Always follow your doctor's instructions, as your doctor may adjust the dose.
If the patient takes more than one tablet per day, the doses should be evenly spaced
throughout the day.
Try to take the tablet at the same time each day. This will help ensure a constant level of medicine in the body. Taking the tablets at the same time every day will also help you remember to take them.
Taking more Betahistyna Bluefish than recommended
If the patient has taken too many Betahistyna Bluefish tablets, symptoms such as nausea, drowsiness,
or stomach pain may occur. In case of doubt, consult your doctor.
Missing a dose of Betahistyna Bluefish
If the patient forgets to take a tablet, skip that dose. Wait until the next scheduled dose. Do not take a double dose to make up for the missed tablet.
Stopping Betahistyna Bluefish
Do not stop taking this medicine without consulting your doctor, even if the patient feels better.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions
If an allergic reaction occurs (frequency unknown), stop taking Betahistyna Bluefish and contact a doctor or go immediately to the nearest hospital. Symptoms may include:

• red or bumpy skin rash or inflammatory skin condition with itching,
• swelling of the face, lips, tongue or neck,
• decreased blood pressure,
• loss of consciousness,
• difficulty breathing.

Other adverse reactions may include:
Common (may occur in up to 1 in 10 people):

• headache,
• nausea,
• dyspepsia.

Unknown (frequency cannot be determined from available data):

• mild gastrointestinal discomfort such as: vomiting, abdominal pain, bloating and gas.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Reporting adverse reactions helps to obtain more information on the safety of using the medicine.

5. How to store Betahistyna Bluefish

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Betahistyna Bluefish contains

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

What Betahistyna Bluefish looks like and contents of the pack
White, round, biconvex, uncoated tablets of 8.6 mm – 8.8 mm in size, with a central break line on one side and the mark "I" on both sides of the break line, and smooth on the other side.
PVC/PVDC/Aluminium blisters: 20, 30, 50, 60, 90 and 100 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Portugal, 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 in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Number in Portugal, country of export: 5681846
Parallel Import Authorisation Number: 398/24
This medicinal product is authorised in the Member States of the European Economic Area under the following names: