Serc 8 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Serc 8 mg tablets

Betahistine dihydrochloride

Read all of 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of this leaflet

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

1. What Serc is and what it is used for

Serc belongs to a group of medicines called anti-vertigo medications, and its active ingredient is betahistine dihydrochloride.

Serc is used to treat Ménière's syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and the sensation of noise in the ear (tinnitus).

The active substance of this medicine is a histamine analogue that acts by improving circulation in the inner ear, thereby reducing pressure. The inner ear is one of the organs responsible for the sense of balance.

2. What you need to know before taking Serc

Do not take Serc

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

• If your doctor has told you that you have a certain type of adrenal gland cancer called phaeochromocytoma.

Warnings and precautions

Consult your doctor or pharmacist before starting 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 eruptions (exanthema), or hay fever.

Taking Serc with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Concomitant administration of Serc with antiallergic medicines such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medicines.

Concomitant administration of Serc with monoamine oxidase inhibitors (MAOIs) (used in the treatment of Parkinson's disease) may increase the effect of Serc.

Taking Serc with food, drinks and alcohol

It is recommended to take Serc during or after meals to avoid gastric 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, lactation and fertility

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

It is unknown whether this medicine affects the fetus, therefore Serc should not be taken during pregnancy unless your doctor considers it necessary.

It is unknown whether this medicine passes into breast milk, therefore if you are taking Serc you should not breastfeed your child.

Driving and use of machines

Betahistine is indicated for Ménière's syndrome. This condition may negatively affect the ability to drive or operate machinery. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistine had no effects or effects were negligible.

3. How to take Serc

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose according to your response to treatment, starting from an initial dose of 1 tablet of 8 mg three times daily up to 2 tablets of 8 mg three times daily (maximum dose). The maintenance dose will be adjusted based on your response, with the minimum effective dose being 1 tablet of 8 mg three times daily.

The tablets should be taken with water.

In some cases, improvement may not become evident until two weeks after starting treatment. Optimal results are achieved after several months of treatment.

The tablets may be taken with or without food. However, if taken in the absence of food, they may cause mild stomach problems (listed in section 4). Taking the tablets with food may help reduce stomach discomfort.

Use in children and adolescents

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

If you take more Serc than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 develop rapid heartbeat (tachycardia), low blood pressure (hypotension), breathing difficulty with a feeling of suffocation (bronchospasm), and fluid accumulation in tissues (edema). Seizures may occur after taking very high doses.

Symptomatic treatment is recommended, as there is no specific antidote.

If you forget to take Serc

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 your treatment as normal.

If you stop taking Serc

You should take Serc for as long as your doctor recommends. Do not stop treatment prematurely, as the expected results will not be achieved.

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

4. Possible adverse effects

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

The frequency classification is as follows:

Gastrointestinal disorders

Common: nausea and dyspepsia (discomfort in the upper abdomen with a sensation of bloating).

Nervous system disorders

Common: headache.

Following marketing and reported in the scientific literature, the following adverse reactions have been reported with unknown frequency:

Immune system disorders

Hypersensitivity reactions, for example anaphylaxis.

Gastrointestinal disorders

Mild gastric discomfort (e.g. vomiting, gastrointestinal pain, distension and abdominal swelling). These effects can usually be managed by taking the medicine during meals or by reducing the dose.

Skin and subcutaneous tissue disorders

Cutaneous and subcutaneous hypersensitivity reactions, particularly angioneurotic edema (swelling of the skin and mucous membranes, especially of the face, mouth, tongue and hands), urticaria, skin rash and itching (pruritus).

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Serc

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

This medicine does not require any special storage conditions.

Store in the original packaging.

Do not use Serc after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Serc 8 mg tablets:

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

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

Appearance of the product and contents of the pack

Serc 8 mg is presented as white, round tablets. Each pack contains 60 tablets.

Other pack sizes:

Serc 16 mg is presented as white, round, scored tablets. Each pack contains 30 tablets.

Serc 8 mg/ml oral solution is presented as an oral solution in a 60 ml amber glass bottle with a dosing syringe. The syringe has markings at 1, 2, and 3 ml and a maximum capacity of approximately 3.5 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970- Sant Joan Despí

Barcelona - Spain

Manufacturer

Mylan Laboratories SAS

Route de Belleville, Lieu dit Maillard

01400 Châtillon sur Chalaronne (France)

The most recent revision of this leaflet was in August 2015

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/