Package Insert: Information for the User

Serc 8 mg Tablets

Betahistine Dihydrochloride

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4

Serc belongs to a group of medications known as antivertiginous medications and its active ingredient is dihydrochloride of betahistine

Sercis 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 Serc

• If you are allergic to the active ingredient 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 betahistine:

• If you have bronchial asthma.

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

Use of Serc with other medications:

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

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

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

Use of Sercwith food, drinks and alcohol

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

Children and adolescents

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

Pregnancy, breastfeeding and fertility

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

The effects of this medication on the fetus are unknown, so Serc 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 Serc, do not breastfeed your child.

Driving and operating machinery

Betahistine 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, betahistine had no effects or were insignificant.

Follow exactly the administration instructions for this medication 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, starting from an initial dose of 1 tablet of 8 mg three times a day up to two tablets of 8 mg three times a day (maximum dose). The maintenance dose will be adjusted based on your response, with the minimum effective dose being one tablet of 8 mg three times a day.

Tablets should be taken with water.

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

Tablets can be taken with or without food. However, if taken without food, they may cause mild stomach problems (listed in section 4). Taking tablets with food may help reduce stomach problems.

Use in children and adolescents

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

If you take more Sercthan 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 heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing with a sensation of choking (bronchospasm), fluid accumulation in tissues (edema). Seizures may occur after taking very high doses.

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

If you forget to takeSerc

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

If you interrupt treatment with Serc

You should take Serc for as long as your doctor recommends. Do not interrupt treatment prematurely, as this may not produce the expected results.

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

Like all medications, Serc may cause adverse effects, although not everyone will experience them.

The frequency classification is as follows:

Gastrointestinal disorders

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

Nervous system disorders

Frequent: headache.

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

Immune system disorders

hypersensitivity reactions, for example anaphylaxis.

Gastrointestinal disorders

Mild gastric discomfort (e.g. 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.es. By 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.

This medication does not require special storage conditions.

Store in the original packaging.

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

Medications should not be disposed of through thedrains or trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Serc8 mg tablets:

• The active ingredient is dihydrochloride of betahistine. Each tablet contains 8 mg of betahistine as dihydrochloride.

- The other components are microcrystalline cellulose, mannitol, citric acid monohydrate, anhydrous colloidal silica, and talc.

Appearance of the product and contents of the packaging

Serc 8 mg is presented in the form of round white tablets. Each package contains 60 tablets.

Other presentations:

Serc 16 mg is presented in the form of round, scored, white tablets. Each package contains 30 tablets.

Serc 8 mg/ml oral solution is presented in the form of an oral solution in a 60 ml amber glass bottle with a dosing syringe. The syringe has markings of 1.2 and 3 ml and an approximate maximum capacity of 3.5 ml.

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

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

01400 Châtillon sur Chalaronne (France)

Last review of this leaflet was inAugust 2015

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/