Serc Flas 24 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Serc Flas 24mg orodispersible tablets EFG

Betahistine dihydrochloride

Please read all of this leaflet carefully before you start taking this medicine, as 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, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

The full name of the medicine is Serc Flas 24 mg orodispersible tablets EFG. In this leaflet, the abbreviated name is Serc Flas.

Leaflet Contents

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

1. What Serc Flas is and what it is used for

What Serc Flas is

Serc Flas contains betahistine. Serc Flas is a type of medicine called a “histamine analogue”.

What Serc Flas is used for

Ménière's disease, whose symptoms include:

• dizziness (vertigo) and discomfort (nausea or vomiting)
• ringing in the ears (tinnitus)
• hearing loss or difficulty hearing.

Dizziness: occurs when the part of the inner ear that controls balance is not functioning properly (this is known as “vestibular vertigo”).

How Serc Flas works

Serc Flas works by improving blood flow in the inner ear. The inner ear is one of the organs responsible for balance.

2. What you need to know before taking Serc Flas

Do not take Serc Flas:

• If you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6)
• If your doctor has told you that you have a tumour of the adrenal gland (called “pheochromocytoma”).

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• If you have or have ever had a stomach ulcer.
• If you have asthma.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking betahistine. Your doctor may wish to monitor you more closely while you are taking betahistine.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age.

Taking Serc Flas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Antihistamines: these may (theoretically) reduce the effect of this medicine. In addition, betahistine may reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAOIs), which may be used to treat depression or Parkinson’s disease. These may increase exposure to betahistine.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

Taking Serc Flas with food and drink

You may take betahistine with or without food. However, this medicine may cause mild stomach problems (mentioned in section 4). Taking betahistine with food may help reduce stomach problems.

Pregnancy, breast-feeding and fertility

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

It is not known whether betahistine affects newborns:

• If you are pregnant, think you may be pregnant, or plan to become pregnant, stop taking betahistine and inform your doctor.
• Do not take betahistine if you are pregnant unless your doctor has decided it is necessary.

In humans, it is unknown whether betahistine is excreted in breast milk:

• Do not breast-feed your baby if you are taking betahistine unless your doctor tells you to do so.

Driving and using machines

This medicine is unlikely to affect your ability to drive or operate tools or machinery.

However, remember that the conditions for which you are taking this medicine may cause dizziness or discomfort and may affect your ability to drive and use machines.

This medicine contains

• 3.4 mg of aspartame (E951) in each tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
• Sucrose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Serc Flas

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

• Your doctor will adjust the dose according to your progress.
• Continue taking the medicine. The medicine may take some time to start working.

How to take it

• Place one tablet on the tongue and wait for it to dissolve before swallowing, with or without water (according to your preference).
• You may take the tablet with or without food. However, betahistine may cause moderate stomach problems (listed in section 4). Taking betahistine with food may help reduce stomach discomfort.

How much to take

Your doctor will adjust the dose according to your response to treatment, from an initial dose of one 24 mg tablet once daily to a maximum dose of 48 mg (a 24 mg tablet twice daily).

Distribute the tablets evenly throughout the day. For example, take one tablet in the morning and one at night.

Try to take the tablet at the same time every day. This will ensure a consistent amount of the medicine in your body. Taking the medicine at the same time each day will also help you remember to take the tablets.

If you take more Serc Flas 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.

If you take more Serc Flas than you should, you may experience discomfort (nausea), drowsiness, or stomach pain. If you are concerned about this, consult your doctor.

If you forget to take Serc Flas

• If you miss a dose, skip the missed dose. Take the next dose at the regular scheduled time.
• Do not take a double dose to make up for the missed dose.

If you stop taking Serc Flas

Do not stop taking betahistine without consulting your doctor, even if you start to feel better.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine:

Allergic reactions

If you have an allergic reaction, stop taking this medicine and consult a doctor or go immediately to a hospital. These symptoms may include:

• rash with redness of the skin, rash with raised areas on the skin, or inflamed and itchy skin
• swelling of the face, lips, tongue, or neck
• drop in blood pressure
• loss of consciousness
• difficulty breathing.

If you experience any of the symptoms listed above, stop taking this medicine and consult a doctor or go immediately to a hospital.

Other adverse effects are:

Frequent (may affect up to 1 in 10 people)

• feeling unwell (nausea)
• indigestion (dyspepsia)
• headache.

Other adverse effects reported with the use of betahistine

• Moderate stomach problems such as feeling unwell (vomiting), stomach pain, stomach swelling (abdominal distension), and inflammation. Taking betahistine with food may help reduce stomach problems.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect 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 effects, you can help provide more information on the safety of this medicine.

5. Storage of Serc Flas

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you have any questions, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.**

6. Contents of the pack and other information

Composition of Serc Flas

The active substance is betahistine dihydrochloride. Each tablet contains 24 milligrams (mg) of betahistine dihydrochloride. The other components of Serc Flas are microcrystalline cellulose, crospovidone (type A), anhydrous citric acid, anhydrous colloidal silica, talc, aspartame E951, potassium acesulfame E950, peppermint flavor, artificial flavoring (sucrose, aspartame E951, acesulfame potassium E950).

Appearance of Serc Flas and contents of the pack

• Serc Flas 24 mg orodispersible tablets EFG are round, flat, white to slightly yellowish in color, uncoated, with beveled edges and no engravings. They have a diameter of approximately 9 mm.
• Serc Flas is available in packs containing 20, 30, 50, 60 or 100 tablets. It is packaged in blisters made of polyamide/aluminum/PVC and sealed with an aluminum foil.
• Only certain pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain S.L.U.

Av. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Manufacturer

DELPHARM L’AIGLE

Zone Industrielle Nº1

Route de Crulai

61300 L’Aigle

France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium Betaserc Instant 24 mg orodispersible tablet

Spain Serc Flas 24 mg orodispersible tablets EFG

Finland Betahistin Mylan 24 mg orodispersible tablets

Luxembourg Betaserc Instant 24 mg orodispersible tablet

Date of the most recent revision of this leaflet: October 2020

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