BETAHISTINE STADA 24 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Betahistina Stada 24 mg Tablets EFG

Betahistina Dihydrochloride

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 Stada and what is it used for
2. What you need to know before taking Betahistina Stada
3. How to take Betahistina Stada
4. Possible side effects
5. Storage of Betahistina Stada
6. Package Contents and Additional Information

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

Betahistina Stada contains betahistina dihydrochloride. This medication belongs to a group of medications called antivertigo preparations: preparations against vertigo and is a type of medication called a histamine analog.

It is used for the treatment of Meniere's Syndrome, the symptoms of which include:

• Dizziness with nausea and vomiting (vertigo)
• Feeling of noise inside the ear (tinnitus)
• Hearing loss

This medication works by improving circulation in the inner ear and thereby reducing pressure. The inner ear is one of the organs responsible for the sense of balance.

2. What you need to know before taking Betahistina Stada

Do not take Betahistina Stada

• if you are allergic to betahistina or any of the other components of this medication (listed in section 6).

• if you have a type of adrenal gland cancer called pheochromocytoma.

Do not take this medication if you suffer from any of the above-mentioned symptoms and consult your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take betahistina:

• if you have or have had stomach ulcers,
• if you have bronchial asthma,

• if you suffer from skin rashes and intense itching (urticaria), skin rash (exanthema) or nasal discharge caused by an allergy (hay fever), as these symptoms may worsen.

• if you have low blood pressure

Your doctor will indicate if it is safe to start taking this medication. Your doctor may also want to monitor your asthma while taking this medication.

Children and Adolescents

This medication is not recommended for use in children and adolescents under 18 years of age. There is no experience with safety and efficacy in these patients.

Other Medications and Betahistina Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take other medications, including those purchased without a prescription.

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

• antihistamines (especially H1 antagonists), betahistina may decrease the effect of antihistamines.
• MAO inhibitors (including selective MAO-B, such as selegiline), may inhibit the metabolism of betahistina.
• monoamine oxidase inhibitors (IMAO), used to treat depression or Parkinson's disease. These may increase the amount of betahistina in your body.

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.

Do not take betahistina if you are pregnant unless your doctor considers it absolutely necessary. Consult your doctor.

Do not breastfeed your child while using this medication unless your doctor indicates it. It is unknown if betahistina passes into breast milk.

Driving and Using Machines

This medication is indicated in Meniere's Syndrome. This disease can negatively affect the ability to drive and use machines. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistina had no effects or were insignificant.

Betahistina Stada contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Betahistina Stada

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

Posology

The recommended dose is:

Adults

• The recommended starting dose is 24 mg once a day.
• Maximum daily dose: the patient can increase the dose to 24 mg taken twice a day (48 mg divided into two doses). Maintenance dose: it will be established based on the response to treatment until the minimum effective dose is reached.

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

It is best to take the tablets with food.

Based on your response, your doctor will indicate the maintenance dose.

The effect of the medication usually does not manifest until after a few weeks.

Use in Children and Adolescents

Betahistina is not recommended for use in children and adolescents, as its safety and efficacy have not been established.

If you take more Betahistina Stada than you should

If you or others take too many betahistina tablets (overdose), you may experience nausea, drowsiness, or abdominal pain. You may also experience rapid heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), or fluid accumulation in the tissues (edema). Seizures can occur after taking very high doses. Symptomatic treatment is recommended, as there is no specific antidote. Talk to your doctor or go to the hospital immediately. Bring the betahistina package with you.

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 forget to take Betahistina Stada

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

If you stop taking Betahistina Stada

Continue taking the tablets until your doctor indicates that you should stop.

Even when you start to feel better, your doctor may indicate that you continue taking the tablets for a while to ensure that the medication has had its full effect.

If you have any other 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 experiences them.

The following serious side effects can occur during treatment with betahistina:

Allergic reactions such as:

• redness or bumps on the skin, skin rash or itching of inflamed skin
• swelling of the face, lips, tongue, or throat
• difficulty breathing

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

Other side effects include:

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

• discomfort (nausea)
• indigestion (dyspepsia)
• headache
• occasional drowsiness
• Mild stomach discomfort such as discomfort (vomiting), gastrointestinal pain, abdominal distension, and bloating.

Taking betahistina during meals can help reduce stomach problems.

Frequency not known (frequency cannot be estimated from available data)

Itching, rash, urticaria, abnormal heartbeats (palpitations).

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is 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 contribute to providing more information on the safety of this medication.

5. Storage of Betahistina Stada

Keep this medication out of sight and reach of children.

Do not store above 25°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Betahistina Stada 24 mg Tablets:

• The active ingredient is betahistina dihydrochloride. Each tablet contains 24 mg of betahistina dihydrochloride.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone, anhydrous colloidal silica, crospovidone, talc, and stearic acid.

Appearance of the Product and Package Contents

White, round tablets with a notch on one side and a "K" engraved on the other side.

The notch is only for breaking the tablet if you find it difficult to swallow it whole.

Betahistina 24 mg is presented in PVC/PVDC/aluminum blisters in packages of 30 and 60 tablets.

Only some package 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

Kern Pharma, S.L.

Polígono Industrial Colón II

C/Venus 72

08228 Terrassa (Barcelona)

Spain

This package leaflet was approved in:November 2021

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