Betahistine Stada 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betahistina Stada 16 mg tablets EFG

Betahistine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people,

even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are

effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

Betahistine belongs to a group of medicines called antivertigo agents.

Betahistine is used for the treatment of Ménière's syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and the sensation of noise in the ear (tinnitus).

The active substance in this medicine is an analogue of histamine that acts by improving circulation in the inner ear, 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 the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if your doctor has told you that you have a certain type of adrenal gland cancer called phaeochromocytoma.

Warnings and precautions

Talk to your doctor or pharmacist before taking Betahistina Stada:

• if you have bronchial asthma
• if you have or have had a stomach ulcer
• if you suffer from skin hives and intense itching (urticaria), skin rash (exanthema), or hay fever
• if you have low blood pressure

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.

Concomitant administration of betahistina with antiallergic medicines such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medicines.

Use of Betahistina Stada with food, drinks and alcohol

It is recommended to take betahistina during or after meals to avoid gastric discomfort.

Pregnancy, breastfeeding and fertility

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

It is unknown whether this medicine affects the fetus; therefore, betahistina should not be taken during pregnancy unless your doctor considers it necessary.

It is unknown whether this medicine passes into breast milk; therefore, if you are taking betahistina, you should not breastfeed your child.

Driving and using machines

Betahistina is indicated for Ménière's syndrome. This condition may negatively affect your ability to drive or operate machinery. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistina had no effects or effects were negligible.

Betahistina Stada contains lactose

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

3. How to take Betahistina Stada

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

Your doctor will adjust the dose according to your response to treatment, starting from an initial dose of half a 16 mg tablet three times daily up to one 16 mg tablet three times daily (maximum dose). The maintenance dose will be adjusted based on your response, with the minimum effective dose being half a 16 mg tablet three times daily.

In some cases, improvement may not become evident until two weeks after starting treatment. Optimal results are achieved after several months of treatment.

The tablets should be taken with water. Tablets may be taken with or without food. However, if taken without food, they may cause mild stomach problems (listed in section 4). Taking the tablets with food may help reduce stomach discomfort.

The tablet can be divided into equal doses.

Use in children and adolescents

Betahistina is not recommended for use in children and adolescents under 18 years of age due to limited data on safety and efficacy.

If you take more Betahistina Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

You may experience the following symptoms due to an overdose: nausea, drowsiness, abdominal pain. You may also develop rapid heartbeat (tachycardia), low blood pressure (hypotension), breathing difficulty with a sensation of suffocation (bronchospasm), and fluid accumulation in tissues (edema). Seizures may occur after taking very high doses.

Symptomatic treatment is recommended, as there is no specific antidote.

If you forget to take Betahistina Stada

Do not take a double dose to make up for missed doses. If you forget a dose, wait until your next scheduled dose and continue your treatment as normal.

If you stop taking Betahistina Stada

You should take betahistine for as long as your doctor recommends. Do not stop treatment prematurely, as the expected results will not be achieved.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The frequency classification is as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Frequency not known: frequency cannot be estimated from the available data

In clinical trials, the adverse effects observed were:

Gastrointestinal disorders

Common: nausea and dyspepsia (discomfort in the upper abdomen with a feeling of bloating).

Nervous system disorders

Common: headache

After marketing and reported in the scientific literature, the following adverse effects have been reported with a frequency not known:

Immune system disorders

Hypersensitivity reactions, for example anaphylaxis.

Gastrointestinal disorders

Mild gastrointestinal discomfort (e.g., vomiting, gastrointestinal pain, bloating, and abdominal swelling). These effects can usually be managed by taking the medicine during meals or by reducing the dose.

Disorders of the skin and subcutaneous tissue

Cutaneous and subcutaneous hypersensitivity reactions, particularly angioneurotic edema (swelling of the skin and mucous membranes, especially of the face, mouth, tongue, and hands), urticaria, skin rash, and itching (pruritus).

Reporting of adverse reactions:

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

5. Storage of Betahistina Stada

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

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Betahistina Stada:

• The active substance is betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride.
• The other components (excipients) are monohydrate lactose, microcrystalline cellulose (E-460i), povidone (E-1201), colloidal anhydrous silica, crospovidone, stearic acid and talc.

Appearance of the medicinal product and contents of the pack

Betahistina STADA is presented as white, round tablets, with a score on one side and the letter "K" on the other.

Each pack contains 30 tablets.

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

Date of the most recent revision of this package leaflet: August 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.