Betahistine bluefish

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Betahistyna Bluefish (Beta-histina Bluefish), 24 mg, tablets
Betahistini dihydrochloridum
Betahistyna Bluefish and Beta-histina Bluefish are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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”. The medicine is used in the treatment of:
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. This leads to a reduction in 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 any of these conditions apply to the patient. Before starting
treatment with Betahistyna Bluefish, talk to your doctor or
pharmacist.
Warnings and precautions
Talk to your doctor before starting treatment with Betahistyna Bluefish.
Before starting treatment with Betahistyna Bluefish, talk to your doctor or
pharmacist.

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

This medicine must not be used if any of these conditions apply to the patient (or if the patient is
unsure). Before starting treatment with Betahistyna Bluefish, talk to your 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
child, she should consult her 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 her 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 using machines
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 may be taken with or after 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, taken twice daily.
Always follow your doctor's instructions, as your doctor may adjust the dose.
If you are taking 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 consistent level of medicine in the body. Taking the tablets at the same time each day will also help you remember to take them.
Taking more Betahistyna Bluefish than prescribed
If you have taken too many Betahistyna Bluefish tablets, you may experience nausea, drowsiness,
or abdominal pain. If in doubt, consult your doctor.
If you forget to take Betahistyna Bluefish
If you forget to take a tablet, skip that dose. Wait until it is time to take the next 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 you feel better.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• red or lumpy rash or inflamed itchy skin,
• swelling of the face, lips, tongue or neck,
• low blood pressure,
• loss of consciousness,
• difficulty breathing.

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

• headache,
• nausea,
• indigestion.

Unknown (frequency cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 enables better assessment of the safety of this medicine.

5. How to store Betahistyna Bluefish

Keep this medicine out of the sight and reach of children.
No special storage instructions are required.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Betahistyna Bluefish contains

• The active substance is 24 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 9.9 mm – 10.1 mm in size, with a central breakline on one side and engraved with the mark "II" on both sides of the breakline, 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: 5681861
Parallel Import Authorisation Number: 404/24
This medicinal product is authorised in the European Economic Area countries under the following names: