Betahistina bluefish

Package leaflet: Information for the user

Betahistyna Bluefish, 8 mg, tablets
Betahistyna Bluefish, 16 mg, tablets
Betahistyna Bluefish, 24 mg, tablets
Betahistini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your 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 (a 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 to 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 to take Betahistyna Bluefish, discuss this with your doctor.
Before starting to take Betahistyna Bluefish, talk to your doctor or
pharmacist.

• if the patient has a peptic ulcer (gastric 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

Use of Betahistyna Bluefish is not recommended in children.

Betahistyna Bluefish and other medicines

Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for future use.

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 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 discontinue taking Betahistyna Bluefish and consult a doctor.
• Betahistyna Bluefish must not be taken during pregnancy unless explicitly authorized by a doctor.

It is not known whether betahistine passes into breast milk.

• Breastfeeding must not be undertaken during treatment with Betahistyna Bluefish unless authorized by a doctor.

Driving and operating machinery

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

3. How to take Betahistyna Bluefish

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

• The doctor will adjust the dose according to 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 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:
Tablets, 8 mg: one or two tablets, three times a day.
Tablets, 16 mg: half a tablet or one tablet, three times a day.
Always follow the doctor's instructions, as the 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 consistent level of medicine in the body. Taking the tablets at the same time each day will also help 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 abdominal pain may occur. In case of doubt, consult the 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 the doctor, even if the patient feels better.
If you have any further doubts regarding 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 will experience them.
Allergic reactions
If an allergic reaction occurs (frequency unknown), treatment with Betahistyna Bluefish should be discontinued and you should contact your 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,
• breathing difficulties.

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

• headache,
• nausea,
• indigestion.

Unknown (frequency cannot be determined from available data):

• mild gastrointestinal disturbances 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betahistyna Bluefish

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the carton after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system 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 8 mg, 16 mg and 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
8 mg: white, round, flat, uncoated tablets with dimensions of 6.9 mm – 7.1 mm, smooth on both sides.
16 mg: white, round, biconvex, uncoated tablets with dimensions of 8.6 mm – 8.8 mm, with an embossed break line on one side and the marking "I" on both sides of the break line, and smooth on the other side.
24 mg: white, round, biconvex, uncoated tablets with dimensions of 9.9 mm – 10.1 mm, with an embossed break line on one side and the marking "II" 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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names: