Package Insert: Information for the User

Serc 24 mg Tablets

Betahistina (dihidrochloride of betahistina)

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor, or pharmacist, even if they are not listed in this package insert. See section 4.

Serc 24 mg tabletsbelongs to a group of medications called antivertiginous: preparations against dizziness and its active ingredient is dihydrochloride of betahistine.

Serc 24 mg tabletsis used for the treatment of Meniere's Syndrome, a disorder that is characterized by the following symptoms: dizziness (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 therefore reduces pressure. The inner ear is one of the organs responsible for the sense of balance.

Do not takeSerc 24 mg:

• if you are allergic to the active ingredient betahistina or to any of the other components of this medication (listed in section 6)
• if you have a cancer of the adrenal glands called phaeochromocytoma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistina:

• 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 (exanthema) or hay fever.

Patients should be carefully monitored by the doctor during treatment with this medication.

Children and adolescents

Serc 24 mgis not recommended for use in children and adolescents under 18 years of age due to lack of experience in these age groups.

Use ofSerc 24 mgwith other medications:

Inform your doctor or pharmacist if you are using, have used recently or may have to use other medications, even those obtained without a prescription.

The simultaneous administration of this medication with antiallergic medications such as antihistamines (especially H1 antagonists) may reduce the efficacy of both medications.

Caution is recommended when using betahistina simultaneously with MAO inhibitors (including selective MAO-B inhibitors, such as selegiline), as it may cause inhibition of betahistina metabolism.

The simultaneous administration of this medication with monoamine oxidase inhibitors (MAOIs), (used for the treatment of Parkinson's disease), may increase the effect of betahistina.

Use ofSerc 24 mgwith food and beverages:

It is recommended to takeSerc 24 mgwith or after meals to avoid gastrointestinal discomfort.

Pregnancy, breastfeeding and fertility

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, soSerc 24 mgshould 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 takingSerc 24 mgyou should not breastfeed your child.

No data are available on the effect of this medication on fertility.

Driving and operating machinery

Serc 24 mgis 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.

Serc 24 mg contains lactose:

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him 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.

The dosage varies according to individuals and their response to treatment.

The recommended initial dose is 24 mg once a day.

Maximum daily dose: the patient may increase the dose to 24 mg taken twice a day (48 mg divided into two doses).

Maintenance dose: it will be established according to the response to treatment until the minimum effective dose is reached.

It is best to take the tablets with food.

Depending on your response, your doctor will indicate the maintenance dose.

The effect of the medication usually does not manifest until two weeks have passed.

You should takeSerc 24 mgfor as long as your doctor recommends, so do not interrupt the treatment beforehand, as the expected results will not be obtained.

Use in children and adolescents

This medication should not be used in children and adolescents since its safety and efficacy have not been established.

If you take moreSerc 24 mgthan 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 fluids 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 forgot to takeSerc 24 mg:

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 the treatment withSerc 24 mg:

You should take Serc 24 mg for as long as your doctor recommends. Do not interrupt the treatment beforehand, as the expected results will not be obtained.

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 will experience them.

During treatment with betahistina, the following severe adverse effects may occur:

Allergic reactions such as: Swelling of the face, lips, tongue, or neck. This may cause breathing difficulties.

Red rash on the skin, inflammation, and itching on the skin.

If any of these adverse effects occur, you should stop treatment immediately and contact your doctor.

Frequent Adverse Effects (may affect up to 1 in 10 people)

Headache, occasional drowsiness, nausea, mild stomach upset such as vomiting, stomach pain, and bloating.

Taking betahistina with food may help reduce these stomach problems.

Unknown Frequency (frequency cannot be estimated from available data)

Itching, rash, urticaria, abnormal heartbeats (palpitations).

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 website: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 Serc 24 mg tablets

• The active ingredient is betahistine in the form of dihydrochloride of betahistine.
• 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 content of the packaging

Serc 24 mg tablets are presented in the form of biconvex tablets (Snap-Tab), with a marking line on one of the faces, and white in color.

The tablets can be divided into equal doses.

Packaging of 30 or 60 tablets, in PVC/PVDC/aluminum blister.

Other presentations:

Betahistina Qualigen 16 mg tablets. Packaging of 30 tablets.

Betahistina Qualigen 8 mg tablets. Packaging of 60 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

Catalent Germany Schorndorf GmbH

Steinbeisstrasse 2, D-73614 Schorndorf

Germany

Ó

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Last review date of this leaflet: June 2021

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