Betahistine Stada 24 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Betahistina Stada 24 mg tablets EFG

Betahistine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Betahistina Stada contains betahistine dihydrochloride. This medicine belongs to a group of medicines known as anti-vertigo agents: preparations for the treatment of vertigo, and is a type of medicine called a histamine analogue.

It is used to treat Ménière's syndrome, the symptoms of which include:

• Dizziness with nausea and vomiting (vertigo)
• sensation of noise in the ear (tinnitus)
• hearing loss

This medicine 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 betahistine or to any of the other ingredients of this medicine (listed in section 6).

• if you have a tumor of the adrenal glands called phaeochromocytoma.

Do not take this medicine if you have any of the conditions mentioned above and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistine:

• if you have or have had stomach ulcer,

• if you have bronchial asthma,

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

• if you have low blood pressure

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

Children and adolescents

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

Other medicines and Betahistina Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

• antihistamines (especially H1 antagonists), as betahistine may reduce the effect of antihistamines.
• MAO inhibitors (including selective MAO-B inhibitors such as selegiline), which may cause inhibition of betahistine metabolism.
• 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take betahistine during pregnancy unless your doctor considers it absolutely necessary. Consult your doctor.

You should not breastfeed your child while using this medication unless your doctor instructs you otherwise. It is unknown whether betahistine passes into breast milk.

Driving and use of machines

This medication is indicated for Ménière's syndrome. This condition may negatively affect the ability to drive and use machines. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistine had no effects or the effects were insignificant.

Betahistina Stada contains lactose

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

3. How to take Betahistina Stada

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is:

Adults

• The recommended starting dose is 24 mg once daily.
• Maximum daily dose: the patient may increase the dose to 24 mg taken twice daily (48 mg divided into two doses). Maintenance dose: will be established according to the response to treatment, up to the lowest effective dose.

Always follow your doctor's instructions, as he or she is the one who can adjust your dose.

It is best to take the tablets with food.

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

The effect of the medicine usually does not become apparent until after about two 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), nausea, drowsiness, or abdominal pain may occur. Other possible symptoms include increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a sensation of suffocation (bronchospasm), and fluid accumulation in tissues (edema). Seizures may occur after ingestion of very high doses. Symptomatic treatment is recommended, as there is no specific antidote. Speak to your doctor or go immediately to a hospital. Bring the betahistina packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Betahistina Stada

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

If you stop taking Betahistina Stada

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

Even when you start to feel better, your doctor may advise you to continue taking the tablets for some time to ensure the medicine has achieved its full effect.

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

4. Possible adverse effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.

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

Allergic reactions such as:

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

If you experience any of these side effects, you must 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 gastric discomfort such as discomfort (vomiting), gastrointestinal pain, bloating and abdominal swelling.

Taking betahistine with meals may help reduce stomach problems.

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

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistine Stada

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betahistina Stada 24 mg tablets:

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

Appearance of the product and contents of the pack

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

The score line is intended only to divide the tablet if you find it difficult to swallow whole.

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

Only certain 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

Kern Pharma, S.L.

Polígono Industrial Colón II

C/Venus 72

08228 Terrassa (Barcelona)

Spain

This leaflet was approved in: November 2021

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