PATIENT INFORMATION LEAFLET

Betahistina Qualigen 16mg tablets EFG

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 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 Qualigen belongs to a group of medications called anti-vertigo preparations.

Betahistina Qualigen is used for the treatment of Meniere's Syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and tinnitus (sensation of noise within the ear).

Do not take Betahistina Qualigen:

• if you are allergic to betahistina or to any of the other ingredients of this medication (listed in section 6).
• if you have a condition called phaeochromocytoma.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Betahistina Qualigen:if you have bronchial asthma,
• if you have or have had stomach ulcers.

Other medications and Betahistina QualigenInform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

No interactions between betahistina and other medications are known to date.

Taking Betahistina Qualigen with food and drinks:

Foods do not affect the effect of Betahistina Qualigen, so it can be taken before, during or after meals.

If any type of stomach discomfort occurs, it is recommended to take Betahistina Qualigen during meals.

Children and adolescentsIt is not recommended for use in children under 18 years.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Betahistina Qualigen should not be taken during pregnancy, unless your doctor considers it necessary.

Betahistina Qualigen should not be taken during breastfeeding.

Driving and operating machinery

Betahistina Qualigen does not affect your ability to drive or operate machinery.

Betahistina Qualigen 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 for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

The effect of the medication usually does not manifest until after about two weeks.

The dosage varies according to individuals and how they respond to treatment. However, in general, an initial dose of 16 mg (1 tablet), taken three times a day, is recommended, which means a maximum daily dose of 48 mg (3 tablets) divided into 3 doses.

Your doctor will indicate the maintenance dose based on your response.

Tablets can be taken with meals.

You should take Betahistina Qualigen for as long as your doctor recommends, and do not interrupt treatment prematurely, as you will not achieve the expected results.

The groove is only for breaking the tablet if it is difficult to swallow whole.

If you take more Betahistina Qualigen than you should:

Consult your doctor, pharmacist, or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone: 91.562.04.20

In case you take more Betahistina Qualigen than you should, symptomatic treatment is recommended, as there is no specific antidote.

If you forget to take Betahistina Qualigen:

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 normal treatment.

If you interrupt treatment with Betahistina Qualigen:

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

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

The adverse effects observed frequently (in at least 1 of every 100 patients) are nausea and dyspepsia.

In some cases (the frequency of these adverse effects is unknown), cases of anaphylaxis (severe general allergic reaction) have been reported.

In some cases, (the frequency of these adverse effects is also unknown), mild stomach discomfort, such as vomiting, stomach pain, and abdominal swelling, which may be alleviated by taking the medication with meals, have occurred.

Very rarely, skin allergic reactions, such as angioneurotic edema (violent and brief swelling), itching, urticaria (skin eruption), and rash (generalized skin eruption and itching), have been observed.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children. Store below 25°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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Betahistina Qualigen 16mg tablets

• The active ingredient is betahistina in the form of dihydrochloride of betahistina.
• The other components are: povidone K90 (E-1201), microcrystalline cellulose (E-460i), lactose monohydrate, anhydrous colloidal silica, crospovidone and stearic acid (E-570).

Appearance of the product and contents of the packaging

Betahistina Qualigen 16mg is presented in the form of white, round, biconvex tablets, marked with B16 on oneface and scoredon the other.

Each package contains 30 tablets.

Other presentations

Betahistina Qualigen 8mg tabletsPackages of 60 tablets.

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Last review date of this leaflet: May 2021

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