BETAHISTINE BLUEFISH 16 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina Bluefish 16 mg Tablets EFG

Dihydrochloride of Betahistine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Betahistina Bluefish and what is it used for
2. What you need to know before taking Betahistina Bluefish
3. How to take Betahistina Bluefish
4. Possible side effects
5. Storage of Betahistina Bluefish
6. Contents of the pack and further information

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

Betahistina Bluefish contains betahistine dihydrochloride. This medication is a type of medication called a "histamine analogue". It is used to treat:

Ménière's Syndrome.

The symptoms of Ménière's Syndrome may include vertigo, tinnitus, hearing loss associated with nausea, otology and/or headache.

• Vertigo (feeling of dizziness). This medication works by improving circulation in the inner ear and thus reducing pressure.
• Tinnitus (ringing in the ears).
• Hearing loss or difficulty hearing.

2. What you need to know before taking Betahistina Bluefish

Do not take Betahistina Bluefish:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6),
• If you have hypertension due to a certain type of adrenal gland cancer called pheochromocytoma.

Do not take this medication if you suffer from any of the above-mentioned symptoms, consult your doctor or pharmacist before taking betahistine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have stomach ulcers (peptic ulcers).
• If you have asthma.

If you suffer from any of the above-mentioned symptoms (or if you are unsure), consult your doctor or pharmacist before taking betahistine tablets. These patient groups should be monitored by a doctor during treatment.

Children and adolescents

Betahistine is not recommended for children.

Taking Betahistina Bluefish with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

In particular, tell your doctor or pharmacist if you are taking any of the following medications:

• Antihistamines: this is because, in theory, it may reduce the effect of betahistine. Additionally, betahistine may reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. They may increase the effect of betahistine.

Taking Betahistina with food, drinks, and alcohol

Betahistine can be taken with or without food. However, this medication may cause mild stomach problems (see Section 4). Taking betahistine with food can help reduce stomach problems.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is unknown whether this medication affects the fetus:

• Stop taking betahistine and inform your doctor if you are pregnant or plan to become pregnant.
• Do not take betahistine if you are pregnant unless your doctor advises you to do so.

It is unknown whether betahistine passes into breast milk:

• Do not breastfeed while taking betahistine tablets unless your doctor advises you to do so.

Driving and using machines

Betahistina Bluefish is unlikely to affect your ability to drive or use machines or tools. However, remember that the disease for which you are being treated with this medication (vertigo, tinnitus, and hearing loss associated with Ménière's Syndrome) may make you feel dizzy or sick, affecting your ability to drive and use machines.

3. How to take Betahistina Bluefish

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Your doctor will adjust the dose based on your progress.
• Continue taking your medication. The medication may take some time to start working.

How to take Betahistina Bluefish

• The tablets should be taken with water.
• Take the tablet during or after a meal. Betahistina Bluefish may cause mild stomach problems (see Section 4). Taking this medication with food can help reduce stomach problems.

How much Betahistina Bluefish to take

The initial dose is:

In 16 mg tablets: one to two tablets three times a day.

Always follow your doctor's instructions, as they can adjust your dose.

If you take more than one tablet per day, space your tablets evenly throughout the day.

Try to take the tablet at the same time each day. This will ensure that there is a constant amount of medication in your body. Taking the tablets at the same time each day will help you remember to take them.

If you take more Betahistina Bluefish than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you or others take too many betahistine tablets, you may experience nausea, drowsiness, abdominal pain. Talk to your doctor or go to the hospital immediately. Bring the betahistine packaging with you.

If you forget to take Betahistina Bluefish

Wait until the next dose. Do not take a double dose to make up for the missed doses.

If you stop taking Betahistina Bluefish

Do not stop taking this medication without talking to your doctor, even when you start to feel better.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The following serious side effects may occur during treatment with betahistine:

Allergic reactions:

If you experience any of these side effects (frequency not known), you should stop treatment immediately and talk to your doctor or go to the hospital immediately. The symptoms include:

• Redness or bumps on the skin, rash, or itching of inflamed skin.
• Swelling of the face, lips, tongue, or throat.
• Decrease in blood pressure.
• Loss of consciousness.
• Difficulty breathing.

Other side effects include:

Common (may affect up to 1 in 10 patients):

• Headache.
• Nausea.
• Indigestion (dyspepsia).

Unknown(frequency cannot be estimated from the available data)

• Mild stomach problems such as vomiting, stomach pain, and bloating.

Taking Betahistina with food can help reduce stomach problems.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Betahistina Bluefish

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging and blister pack after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Betahistina Bluefish

• The active ingredient is betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride.
• The other ingredients (excipients) are: citric acid, microcrystalline cellulose (PH 102), mannitol (E421), colloidal anhydrous silica, and talc.

Appearance of the product and contents of the pack

Uncoated tablet, white, round, and biconvex on both sides (diameter 8.6 mm-8.8 mm).

Al/PVC/PVdC blisters: 20, 30, 50, 60, 90, and 100 tablets.

HDPE bottles: 20, 30, 50, 60, 90, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer:

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet:January 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/