Package Leaflet: Information for the User

Serc Flas 24mg buccal dispersible tablets EFG

Betahistina dihidrocloruro

Read 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

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

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

2.What you need to know before you start taking Serc Flas

3.How to take Serc Flas

4.Possible side effects

5.Storage of Serc Flas

6.Contents of the pack and additional information

What is Serc Flas

Serc Flas contains betahistina. Serc Flas is a type of medication known as a “histamine analogue”.

What is Serc Flas used for

Ménière's disease, whose symptoms include:

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

Vertigo: occurs when the part of the inner ear that controls balance does not function correctly (this is known as “vestibular vertigo”).

How Serc Flas works

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

Do not take Serc Flas:

• If you are allergic to betahistine or any of the other components of this medication (listed in section6)
• If your doctor has informed you that you have a tumor in the adrenal gland (known as “pheochromocytoma”).

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

Warnings and precautions

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

• If you have or have had any stomach ulcers.
• If you have asthma.

If any of the above circumstances apply to your case (or if you are unsure), 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 administer this medication to children or adolescents under 18years of age.

Taking Serc Flas with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. In particular, inform your doctor or pharmacist if you are taking any of the following medications:

• Antihistamines: they may (in theory) reduce the effect of this medication. Additionally, betahistine may reduce the effect of antihistamines.
• MAOIs (monoamine oxidase inhibitors) 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 unsure), consult your doctor or pharmacist before taking this medication.

Taking Serc Flas with food and drinks

You can take betahistine with or without food. However, this medication may cause moderate stomach problems (listed in section4). 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 plan to become pregnant, consult your pharmacist before using this medication.

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 unknown 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 operating machinery

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

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

This medication contains

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, you must consult your doctor or pharmacist again.

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

How to take it

• Place a tablet on the tongue and wait for it to dissolve before swallowing it with or without water (according to your preference).
• You can take the tablet with or without food. However, betahistina may cause moderate stomach problems (indicated in section 4). Taking betahistina 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 (two 24 mg tablets per day).

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

Try to take the tablet every day at the same time. This will ensure that there is a balanced amount of the medication in your body. Taking the medication 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you take more Serc Flas than you should, you may feel unwell (nausea), drowsy, or have stomach pain. If you are concerned about this, consult your doctor.

If you forget to take Serc Flas

• If you forget a dose, omit the missed dose. Take the next dose at the usual time.
• Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Serc Flas

Do not stop taking betahistina without consulting your doctor, even if you start feeling better.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them. With this medication, the following adverse effects may occur:

Allergic Reactions

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

• skin eruption with redness, skin eruption with swelling or inflamed skin and itching
• swelling of the face, lips, tongue, or neck
• drop in blood pressure
• loss of consciousness
• difficulty breathing.

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

Other adverse effects are:

Frequent(may affect up to 1 in 10people)

• feeling of discomfort (nausea)
• indigestion (dyspepsia)
• headache.

Other adverse effects reported with the use of betahistina

• Moderate gastrointestinal problems such as discomfort (vomiting), stomach pain, stomach inflammation (abdominal distension) and inflammation. Taking betahistina with food may help reduce gastrointestinal problems.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Serc Flas

The active principle is betahistina dihidrocloruro. Each tablet contains 24milligrams (mg) of betahistina dihidrocloruro. The other components of Serc Flas are microcrystalline cellulose, crospovidone (typeA), anhydrous citric acid, anhydrous colloidal silica, talc, aspartame E951, potassium acesulfame E950, peppermint essence, artificial sweetener (sucrose, aspartame E951, potassium acesulfame E950).

Appearance of Serc Flas and content of the container

• Serc Flas 24mg orodispersible tablets EFG are round, flat, white to yellowish in color, without coating, with beveled edge and without inscriptions. They have a diameter of approximately 9mm.
• Serc Flas is available in containers that contain 20, 30, 50, 60 or 100 tablets. It is packaged in polyamide/aluminum/PVC blisters and aluminum foil seal.
• Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Neuraxpharm Spain S.L.U.

Av. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Responsible for manufacturing

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 with the following names:

BélgicaBetaserc Instant 24 mg orodispersible tablet

SpainSerc Flas 24mg orodispersible tablets EFG

FinlandBetahistin Mylan 24 mg suussa hajoavat tabletit

LuxembourgBetaserc Instant 24 mg orodispersible tablet

Date of the last review of this prospectus:October 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.