BETAHISTINE CINFA 16 mg TABLETS

Introduction

Package Leaflet: Information for the User

betahistina cinfa 16 mg tablets EFG

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

1. What is betahistina cinfa and what is it used for

Betahistina cinfa belongs to a group of medications called anti-vertigo medications, and its active ingredient is betahistine dihydrochloride.

Betahistine is used to treat Meniere's Syndrome, a disorder characterized by the following symptoms:

• vertigo (with nausea and vomiting),
• hearing loss, and
• a sensation of noise inside the ear (tinnitus).

The active ingredient of this medication is a histamine analogue 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 cinfa

Do not take betahistina cinfa

• If you are allergic to betahistine dihydrochloride or any of the other components of this medication (listed in section 6).
• If your doctor has told you that you have a certain type of adrenal gland cancer called pheochromocytoma.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take betahistina cinfa

• If you have bronchial asthma.
• If you have or have had stomach ulcers.
• If you suffer from skin rashes and intense itching (urticaria), skin eruptions (exanthema), or hay fever.

Children and Adolescents

Betahistine is not recommended for use in children and adolescents under 18 years of age due to the lack of experience in these age groups.

Taking betahistina cinfa with other medications

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

Taking betahistina cinfa at the same time as antiallergic medications such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medications.

Taking betahistina cinfa at the same time as monoamine oxidase inhibitors (MAOIs) (used to treat Parkinson's disease) may increase the effect of betahistine.

Taking betahistina cinfa with food, drinks, and alcohol

It is recommended to take betahistina cinfa during or after meals to avoid stomach upset.

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, so betahistine should not be taken during pregnancy, unless your doctor considers it necessary.

It is unknown whether this medication passes into breast milk, so if you are taking betahistine, you should not breastfeed your child.

Driving and Using Machines

Betahistine is indicated for 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, betahistine had no effects or were insignificant.

betahistina cinfa 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 cinfa

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

Your doctor will adjust the dose based on your response to treatment, from an initial dose of half a 16 mg tablet three times a day to a full 16 mg tablet three times a day (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 a day.

The tablets should be taken with water.

The 16 mg tablets are scored to allow them to be divided into two equal halves and facilitate taking half the dose (8 mg) when necessary.

The tablet can be split into equal doses.

In some cases, improvement may not begin to become apparent until two weeks after starting treatment. The optimal result is obtained after several months of treatment.

The tablets can 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 problems.

Use in Children and Adolescents

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

If you take more betahistina cinfa 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.

You may experience the following symptoms due to an overdose: nausea, drowsiness, abdominal pain. You may also experience rapid heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), and fluid accumulation in the tissues (edema).

Seizures can occur after taking very high doses.

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

If you forget to take betahistina cinfa

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, wait until the next dose and continue with your usual treatment.

If you stop taking betahistina cinfa

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

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 will experience them.

The classification by frequency is as follows:

Very common: may affect more than 1 in 10 patients.

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

Rare: may affect up to 1 in 1,000 patients.

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

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

In clinical trials, the following side effects were found:

Gastrointestinal disorders

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

Nervous system disorders

Common: headache.

After marketing and in the scientific literature, the following side effects have been reported with an unknown frequency:

Immune system disorders

Hypersensitivity reactions, such as anaphylaxis.

Gastrointestinal disorders

Mild stomach problems (such as vomiting, gastrointestinal pain, distension, and abdominal bloating). These effects can usually be treated by taking the medication during meals or reducing the dose.

Skin and subcutaneous tissue disorders

Hypersensitivity reactions of the skin and subcutaneous tissue, in particular, angioedema (swelling of the skin and mucous membranes, especially of the face, mouth, tongue, and hands), urticaria, skin eruptions, and itching (pruritus).

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 cinfa

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

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging 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 packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of betahistina cinfa

• The active ingredient is betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride.
• The other components are: lactose monohydrate, microcrystalline cellulose (E-460i), povidone K-90 (E-1201), colloidal anhydrous silica, crospovidone, stearic acid, and talc.

Appearance of the Product and Package Contents

Cylindrical tablets, white in color, with a score line on one side and marked with the code "B16" on the other.

The tablets are presented in PVC/PVDC blister packs of 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

KERN PHARMA, S.L.

Venus, 72. Poligono Industrial Colon II.

08228 Tarrasa, Spain

Date of the Last Revision of this Package Leaflet:July 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74833/P_74833.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74833/P_74833.html