SERC 16 mg TABLETS

Introduction

Package Leaflet: Information for the User

Serc 16 mg Tablets

Betahistine Dihydrochloride

Read all of this leaflet carefully before you start takingthe medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet:

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

1. What is Serc and what is it used for

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

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

The active ingredient 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 you take Serc

Do not take Serc

• If you are allergic to the active ingredient 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

Talk to your doctor or pharmacist before taking 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 eruptions (exanthema), or hay fever.

Using Serc with other medicines:

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

Taking Serc at the same time as antiallergic medicines such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medicines.

Taking Serc at the same time as monoamine oxidase inhibitors (MAOIs) (used to treat Parkinson's disease) may increase the effect of Serc.

Using Serc with food, drinks, and alcohol

It is recommended to take Serc during or after meals to avoid stomach upset.

Children and adolescents

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

Betahistine is indicated for Meniere's syndrome. This disease may negatively affect the ability to drive and use machines. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistine had no effects or they were insignificant.

3. How to take Serc

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 16 mg tablet three times a day to a maximum dose of one 16 mg tablet three times a day. The maintenance dose will be adjusted based on your response, with the minimum effective dose being half a 16 mg tablet 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 administration of half the 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 taken 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 of age due to the 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 medicine and the amount taken.

You may experience the following symptoms due to an overdose: nausea, drowsiness, abdominal pain. You may also experience rapid heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), and fluid accumulation in the tissues (edema). Seizures may occur after taking very high doses.

Symptomatic treatment is recommended since there is no specific antidote.

If you forget to takeSerc

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

If you stop taking Serc

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

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

4. Possible side effects

Like all medicines, Serc can cause side effects, although not everybody gets them.

The classification by frequency is as follows:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: 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 not known: frequency cannot be estimated from the available data

In clinical trials, the following side effects were found:

Gastrointestinal disorders

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

Nervous system disorders

Common: headache.

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

Immune system disorders

Hypersensitivity reactions, such as anaphylaxis.

Gastrointestinal disorders

Mild stomach problems (such as vomiting, gastrointestinal pain, abdominal distension, and bloating). These effects can usually be treated by taking the medicine during meals or reducing the dose.

Skin and subcutaneous tissue disorders

Hypersensitivity reactions of the skin and subcutaneous tissue, in particular angioneurotic edema (swelling of the skin and mucous membranes, especially of the face, mouth, tongue, and hands), urticaria, skin eruptions, and itching (pruritus).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, 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.

Keep in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Serc16 mg tablets:

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

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

Appearance of the product and pack contents

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

Other presentations:

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

Serc 8 mg/ml oral solution is presented in the form of an oral solution in a 60 ml brown 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 authorisation holder and manufacturer

Marketing authorisation 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)

This leaflet was last revised inAugust 2015

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