Betahistine CINFA 8 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

betahistina cinfa 8 mg tablets EFG

Betahistina dihydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What betahistina cinfa is and what it is used for
2. What you need to know before taking betahistina cinfa
3. How to take betahistina cinfa
4. Possible adverse effects
5. How to store betahistina cinfa

Pack contents and other information

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

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

Betahistina is used to treat Ménière's syndrome, a disorder characterized by the following symptoms:

• vertigo (with nausea and vomiting),
• hearing loss, and
• ringing or noise sensation in the ear (tinnitus).

The active substance in this medicine is a histamine analogue that works 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 starting betahistina cinfa

Do not take betahistina cinfa

• If you are allergic to betahistine dihydrochloride 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

Consult your doctor or pharmacist before starting betahistina cinfa

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

Children and adolescents

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

Taking betahistina cinfa with other medicines

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.

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

Concomitant administration of betahistina with monoamine oxidase inhibitors (MAOIs) (used in the treatment of Parkinson's disease) may increase the effect of betahistina.

Taking betahistina cinfa with food, drinks and alcohol

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

Pregnancy and breastfeeding

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 considered necessary by your doctor.

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 Menière'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, betahistina had no effects or effects were negligible.

betahistina cinfa contains lactose

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

3. How to take betahistine cinfa

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

Your doctor will adjust your dose according to your response to treatment, starting from an initial dose of one 8 mg tablet three times daily up to two 8 mg tablets three times daily (maximum dose). The maintenance dose will be adjusted according to your response, with the minimum effective dose being one 8 mg tablet three times daily.

The tablets should be taken with water.

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

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

Use in children and adolescents

Betahistine 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 betahistine cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 ingestion of very high doses.

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

If you forget to take betahistine cinfa

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

If you stop taking betahistine cinfa

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 or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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: cannot be estimated from the available data.

In clinical trials, the following adverse effects were observed:

Gastrointestinal disorders

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

Disorders of the nervous system

Common: headache.

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

Skin and subcutaneous tissue disorders

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 effects

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

5. Storage of betahistine cinfa

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 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. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of betahistina cinfa

• The active substance is betahistine dihydrochloride. Each tablet contains 8 mg of betahistine dihydrochloride.
• The other components are: monohydrate lactose, microcrystalline cellulose (E-460i), povidone K-90 (E-1201), colloidal anhydrous silica, crospovidone, stearic acid and talc.

Appearance of the product and contents of the pack

Cylindrical white tablets marked with the code “B8”.

The tablets are presented in PVC/PVDC blister packs containing 60 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 most recent revision of this leaflet: July 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74830/P_74830.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74830/P_74830.html