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SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS

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About the medicine

How to use SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Serc Flas 24mg Orodispersible Tablets EFG

Betahistine Dihydrochloride

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

  • Keep this leaflet, 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 signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The full name of this medicine is Serc Flas 24 mg Orodispersible Tablets EFG. In this leaflet, the shorter name Serc Flas is used.

Contents of the pack

  1. What Serc Flas is and what it is used for
  2. What you need to know before you take Serc Flas
  3. How to take Serc Flas
  4. Possible side effects
  5. Storing 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 nausea (or vomiting)
  • ringing in the ears (tinnitus)
  • hearing loss or difficulty hearing.

Dizziness: this occurs when the part of the inner ear that controls balance does not function properly (this is called "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.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Serc Flas

Do not take Serc Flas:

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

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

If any of the above circumstances apply to your case (or if you are not sure), consult your doctor or pharmacist before taking betahistine. Your doctor may want 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 take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • Antihistamines: they may (in theory) reduce the effect of this medicine. Also, betahistine may reduce the effect of antihistamines.
  • Monoamine oxidase inhibitors (MAOIs) may be used to treat depression or Parkinson's disease. They may increase exposure to betahistine.

If any of the above circumstances apply to your case (or if you are not sure), consult your doctor or pharmacist before taking this medicine.

Taking Serc Flas with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

It is not known if 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 that it is necessary.

In humans, it is not known if betahistine is excreted in breast milk:

  • Do not breastfeed your child if you are taking betahistine, unless your doctor tells you to.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use tools or machines.

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

This medicine contains

  • 3.4 mg of aspartame (E951) in each tablet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.
  • Sucrose. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Serc Flas

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

How to take it

  • Place a tablet on the tongue and wait for it to dissolve before swallowing it with or without water (as you prefer).
  • You can take the tablet with or without food. However, betahistine may cause mild stomach problems (indicated in section 4). Taking betahistine with food may help reduce stomach problems.

How much to take

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

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

Try to take the tablet at the same time every day. This will ensure that there is a steady amount of the medicine in your body. Taking the medicine at the same time 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Serc Flas

  • If you forget a dose, skip the forgotten dose. Take the next dose at the usual time.
  • Do not take a double dose to make up for the forgotten 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 on the use of this medicine, ask your doctor or pharmacist.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can occur with this medicine:

Allergic reactions

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

  • skin rash with redness, skin rash with swelling, or inflamed and itchy skin
  • swelling of the face, lips, tongue, or throat
  • low blood pressure
  • loss of consciousness
  • difficulty breathing.

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

Other side effects are:

Common(may affect up to 1 in 10 people)

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

Other side effects that have been reported with the use of betahistine

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Serc Flas

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.
  • This medicine does not require any special storage conditions.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Serc Flas contains

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

Appearance of Serc Flas and pack contents

  • Serc Flas 24 mg Orodispersible Tablets EFG are round, flat, white to yellowish in color, uncoated, with a beveled edge, and without any markings. 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 polyamide/aluminum/PVC blisters and aluminum foil lidding.
  • Not all 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 medicine 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 suussa hajoavat tabletit

Luxembourg Betaserc Instant 24 mg orodispersible tablet

Date of last revision of this leaflet:October 2020

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

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Frequently Asked Questions

Is a prescription required for SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS?
SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS?
The active ingredient in SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS is betahistine. This information helps identify medicines with the same composition but different brand names.
How much does SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS cost in pharmacies?
The average pharmacy price for SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS is around 8.18 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS?
SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS is manufactured by Neuraxpharm Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SERC FLAS 24 mg ORALLY DISINTEGRATING TABLETS?
Other medicines with the same active substance (betahistine) include BETAHISTINE ACCORD 24 mg TABLETS, BETAHISTINE AUROVITAS 16 mg TABLETS, BETAHISTINE AUROVITAS 8 mg TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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