Package Leaflet: Information for the User

Betahistina cinfa 16 mg EFG Tablets

Betahistine dihydrochloride

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Betahistina cinfa belongs to a group of medications known as antivertiginous medications and its active ingredient is dihydrochloride of betahistina.

Betahistina is used for the treatment of Meniere's Syndrome, which is 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 and thereby reducing pressure. The inner ear is one of the organs responsible for the sense of balance.

Do not take betahistina cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistina cinfa.betahistina cinfa

• If you have bronchial asthma.
• If you have or have had a stomach ulcer.
• If you suffer from skin rashes and intense itching (urticaria), skin eruption (exantema) 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.

Use of betahistina cinfa with other medications

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

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

The administration at the same time as betahistina with monoamine oxidase inhibitors (MAOIs), (used for the treatment of Parkinson's disease), may increase the effect of betahistina.

Use of betahistina cinfa with food, drinks and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The effects of this medication on the fetus are unknown, so betahistina should not be taken during pregnancy, unless your doctor considers it necessary.

The effects of this medication on breast milk are unknown, so if you are taking betahistina, do not breastfeed your child.

Driving and operating machinery

Betahistina is indicated for Meniere's syndrome. This disease may negatively affect the ability to drive and operate machinery. In clinical trials specifically designed to investigate the ability to drive or operate machinery, betahistina 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.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 tablet of 16 mg three times a day to a tablet of 16 mg three times a day (maximum dose). The maintenance dose will be adjusted based on your response, with the minimum effective dose being half a tablet of 16 mg 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 the taking of half a dose (8 mg) when necessary.

The tablet can be split into equal doses.

In some cases, improvement may not 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 you take them 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

Betahistina is not recommended for use in children and adolescents under 18 years due to the scarcity 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 Toxicological 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 heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing with a sensation of choking (bronchospasm), accumulation of fluid in tissues (edema).

Seizures may occur after taking very high doses.

It is recommended that you receive symptomatic treatment since there is no specific antidote.

If you forget to take betahistina cinfa

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, wait until the next scheduled dose and continue with the usual treatment.

If you interrupt treatment with betahistina cinfa

You should take betahistina for as long as your doctor recommends. Do not interrupt treatment prematurely, as you will not achieve the expected results.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The classification by frequencies is as follows:

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

Frequent: may affect up to 1 in 10 patients.

Infrequent: 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 available data.

In clinical trials, the adverse effects found were:

Gastrointestinal disorders

Frequent: nausea and dyspepsia (upper abdominal discomfort with a feeling of bloating).

Nervous system disorders

Frequent: headache.

After its commercialization and in scientific literature, the following adverse effects with an unknown frequency have been reported:

Immunological system disorders

Hypersensitivity reactions, for example anaphylaxis.

Gastrointestinal disorders

Mild gastric discomfort (for example vomiting, gastrointestinal pain, distension, and abdominal bloating). These effects can usually be treated by taking the medication with meals or reducing the dose.

Skin and subcutaneous tissue disorders

Hypersensitivity skin and subcutaneous reactions, particularly angioneurotic edema (skin and mucous membrane swelling, especially on the face, mouth, tongue, and hands), urticaria, skin rash, and pruritus.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.esBy reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Betahistina cinfa composition

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

Appearance of the product and contents of the packaging

Cylindrical tablets, white in color, with a groove on one face and marked with the code “B16” on the other.

The tablets are presented in PVC/PVDC blister packaging with 30 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible 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

Last review date of this leaflet:July 2020

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning the QR code included in the 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 link to:https://cima.aemps.es/cima/dochtml/p/74833/P_74833.html