BETAHISTINE STADAGEN 16 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Betahistina Stadagen8 mg tablets EFG

Betahistina Stadagen 16 mg tablets EFG

Betahistina Stadagen 24 mg tablets EFG

betahistine dihydrochloride

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

• Keep this package leaflet, as you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Betahistine, the active substance of Betahistina Stadagen, is similar to histamine, a substance that occurs naturally in the human body.

It is used to treat Meniere's syndrome, whose symptoms may include:

• dizziness (vertigo)
• ringing in the ears (tinnitus)
• hearing loss

This medicine improves blood flow in the inner ear. This reduces the accumulation of pressure.

2. What you need to know before taking Betahistina Stadagen

Do not take Betahistina Stadagen

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you have a tumor of the adrenal gland (pheochromocytoma)

If any of the above applies to you, do not take this medicine and talk to your doctor.

Warnings and precautions

Talk to your doctor before starting to take betahistine if:

• you have or have had a stomach ulcer (peptic ulcer). Treatment with betahistine may cause indigestion
• you suffer from a chronic respiratory disease (bronchial asthma)
• you suffer from hives, skin rash, or nasal discharge caused by an allergy (allergic rhinitis) - your symptoms may worsen when taking betahistine
• you have low blood pressure

Your doctor will tell you if it is safe for you to start taking this medicine. Your doctor may also want to monitor your asthma while taking this medicine.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

Other medicines and Betahistina Stadagen

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

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

• antihistamines - these may (theoretically) decrease the effect of betahistine. Also, betahistine may reduce the effect of antihistamines.
• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. These may increase the amount of betahistine in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take betahistine if you are pregnant unless your doctor has decided that it is absolutely necessary. Talk to your doctor.

Do not breastfeed while using betahistine unless your doctor tells you to do so. It is not known if betahistine passes into breast milk.

Driving and using machines

Betahistine is unlikely to affect your ability to drive or use tools or machines. However, remember that the diseases for which you are being treated with betahistine may make you feel dizzy or sick, and may affect your ability to drive or use machines.

3. How to take Betahistina Stadagen

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

Dosage

The recommended dose is

Adults

• The initial recommended dose is 16 mg three times a day (48 mg).
• Maintenance doses are 24 to 48 mg per day, divided into 2 or 3 doses.
• Your doctor may reduce your dose to 8 mg three times a day (24 mg).

Always follow your doctor's instructions, as they may adjust your dose. The daily dose should not exceed 48 mg.

Use in children and adolescents

Betahistine is not recommended for use in children and adolescents.

Method of administration

• swallow the tablets with water
• take the tablet during or after a meal. Betahistine may cause mild stomach problems (listed in section 4); taking it with food may help reduce the likelihood of these problems occurring.
• try to take the tablet at the same time every day. This will ensure that there is a constant amount of the medicine in your body. Following a schedule will also help you remember to take your tablets.

Betahistina Stadagen 16 mg tablets EFG

The tablet can be divided into equal doses.

Betahistina Stadagen 24 mg tablets EFG

The score line is only for breaking and facilitating swallowing.

Duration of treatment

Continue taking your medicine until your doctor tells you to stop. The medicine may take some time to start working.

If you take more Betahistina Stadagen than you should

If you or someone else takes too much betahistine (overdose), you may feel sick (nausea), sleepy, or have stomach pain. Other symptoms of betahistine overdose are vomiting, indigestion (dispepsia), ataxia (difficulty controlling movements/alteration in coordination), and convulsions. More serious complications (convulsions, respiratory or cardiac problems) have been observed in cases of intentional betahistine overdose, especially in combination with other medicines with overdose.

Talk to a doctor or go to a hospital immediately. Bring the medicine pack with you.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Betahistina Stadagen

Wait until it is time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Betahistina Stadagen

Continue taking your tablets until your doctor tells you to stop.

Even when you start to feel better, your doctor may want you to continue taking the tablets for some time to make sure the medicine has worked completely.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following serious side effects may occur during treatment with betahistine:

Allergic reactions such as:

• a red or lumpy skin rash or inflamed skin with itching
• swelling of the face, lips, tongue, or throat
• a drop in blood pressure
• loss of consciousness
• difficulty breathing

If any of these side effects occur, you must stop treatment immediately and contact your doctor.

Other side effects include:

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

• feeling sick (nausea)
• indigestion (dispepsia)
• headache

Other side effects that have been reported with the use of betahistine

Mild stomach problems such as feeling sick (vomiting), stomach pain, stomach swelling (abdominal distension), and bloating. Taking betahistine with food may help reduce stomach problems.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistina Stadagen

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from moisture.

Medicines should 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 further information

Composition of Betahistina Stadagen

• the active substance is betahistine dihydrochloride.

Each tablet contains 8 mg of betahistine dihydrochloride.

Each tablet contains 16 mg of betahistine dihydrochloride.

Each tablet contains 24 mg of betahistine dihydrochloride.

• the other ingredients are microcrystalline cellulose, mannitol (E 421), povidone, crospovidone, citric acid, colloidal anhydrous silica, talc, and stearic acid.

Appearance of the product and pack contents

Betahistina Stadagen 8 mg tablets EFG

White or almost white, flat, round tablets (approximate diameter of 7 mm), engraved with "JI" on one side and smooth on the other.

Betahistina Stadagen 16 mg tablets EFG

White or almost white, biconvex, round tablets (approximate diameter of 9 mm), engraved with "J2" on one side and smooth on the other.

The tablet can be divided into equal doses.

Betahistina Stadagen 24 mg tablets EFG

White or almost white, biconvex, round tablets (approximate diameter of 10 mm), engraved with "J4" on one side and smooth on the other.

The score line is only for breaking and facilitating swallowing.

Betahistina Stadagen 8 mg tablets EFG are available in PVC/PVDC-Aluminum blister packs of 20, 30, 50, 60, 84, 90, 100 tablets.

Betahistina Stadagen 16 mg tablets EFG are available in PVC/PVDC-Aluminum blister packs of 20, 30, 42, 50, 60, 84, 100 tablets.

Betahistina Stadagen 24 mg tablets EFG are available in PVC/PVDC-Aluminum blister packs of 20, 30, 50, 60, 90, 100, 180 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Betahistin AL 8 mg Tablets

Betahistin AL 16 mg Tablets

Betahistin AL 24 mg Tablets

Belgium: Betahistine Eurogenerics 8 mg tablets

Betahistine Eurogenerics 16 mg tablets

Betahistine Eurogenerics 24 mg tablets

Denmark: Menisy

Spain: Betahistina Stadagen 8 mg tablets EFG

Betahistina Stadagen 16 mg tablets EFG

Betahistina Stadagen 24 mg tablets EFG

Finland: Menisy 8 mg/ 16 mg/ 24 mg tablets

France: BETAHISTINE EG LABO 8 mg, tablet

BETAHISTINE EG LABO 24 mg, tablet

Hungary: Betahistin-STADA

Iceland: Menisy 8 mg/ 16 mg/ 24 mg tablets

Luxembourg: Betahistine Eurogenerics 8 mg tablets

Betahistine Eurogenerics 16 mg tablets

Betahistine Eurogenerics 24 mg tablets

Czech Republic: Betahistin STADA

Sweden: Menisy 8 mg/ 16 mg/ 24 mg tablets

Date of last revision of this package leaflet:January 2025

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