Serc 16 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Serc 16 mg tablets

Betahistine dihydrochloride

Read the entire 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, consult 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. It may harm them.

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

Contents of the leaflet:

1. What Serc is and what it is used for
2. What you need to know before taking 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 sensation of ringing or noise in the ear (tinnitus).

The active substance in 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 ingredients 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 hives and intense itching (urticaria), skin rash (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 baby.

Driving and use of machines

Betahistine is indicated for Ménière's syndrome. This condition 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 effects were negligible.

3. How to take Serc

Follow exactly the instructions for using 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 half a 16 mg tablet three times daily up to one 16 mg tablet three times daily (maximum dose). The maintenance dose will be adjusted according to your response, the minimum effective dose being half a 16 mg tablet three times daily.

The tablets should be taken with water. The 16 mg tablets are scored so they can be divided into two equal halves, facilitating administration of a half dose (8 mg) when necessary.

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

The tablets may be taken with or without food. However, if taken without 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 limited data on safety and efficacy.

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: 91.562.04.20, indicating the medicine and the amount ingested.

You may experience the following symptoms due to an overdose: nausea, drowsiness, abdominal pain. You may also develop a rapid heartbeat (tachycardia), low blood pressure (hypotension), breathing difficulty with a sensation 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 can cause adverse effects, although not everyone will experience them.

The classification by frequency is as follows:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data

In clinical trials, the adverse effects observed were:

Gastrointestinal disorders

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

Disorders of the nervous system

Common: headache.

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

Immune system disorders

Hypersensitivity reactions, for example anaphylaxis.

Gastrointestinal disorders

Mild gastric discomfort (e.g., vomiting, gastrointestinal pain, abdominal distension, and bloating). These effects can usually be managed by taking the medicine with food 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 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Serc

Keep this medicine out of 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 packaging and on the blister after EXP.. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Serc 16 mg tablets:

• The active substance is betahistine dihydrochloride. Each tablet contains 16 mg of betahistine as dihydrochloride.

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

Appearance of the product and contents of the pack

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

Other pack sizes:

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