Package Leaflet: Information for the User

Serc 16 mg Tablets

Betahistine Dihydrochloride

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

Package Leaflet Contents:

1. What Serc is and what it is used for
2. What you need to know before you start taking Serc
3. How to take Serc
4. Possible side effects
5. Storage of Serc
6. Contents of the pack and additional information

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

Serc 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 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 a stomach ulcer.
• 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.

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.

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

Serc 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 Serc 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 as there is no specific antidote.

If you forget to takeSerc

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 Serc

You should take Serc 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, pharmacist, or nurse.

Like all medications, Serc may produce adverse effects, although not all people will 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 unknown: the frequency cannot be estimated from the available data

In clinical trials, the adverse effects found were:

Gastrointestinal disorders

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

Nervous system disorders

Frequent: headache.

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

Immune 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 that does not appear 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 in the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through thedrains 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.

Composition of Serc16 mg tablets:

• The active ingredient is dihydrochloride of betahistine. Each tablet contains 16 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 16 mg is presented in the form of round, scored, white tablets. Each package contains 30 tablets.

Other presentations:

Serc 8 mg is presented in the form of round white tablets. Each package contains 60 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 a maximum capacity of approximately 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/