MELGAMA 300 MG FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the Patient

Melgama 300mg film-coated tablets

benfotiamine

Read this package leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

Contents of the package leaflet

1. What is Melgama and what is it used for
2. What you need to know before taking Melgama
3. How to take Melgama
4. Possible side effects
5. Storage of Melgama
6. Package contents and additional information

1. What is Melgama and what is it used for

Melgama contains benfotiamine, which is a derivative of vitamin B1 that, after ingestion, is converted into vitamin B1.

Most people get enough vitamin B1 from their diet, but you may not absorb enough vitamin B1 if you have had stomach surgery, are on hemodialysis, have certain intestinal diseases, follow a restrictive diet, have diabetes or alcoholism, or are elderly.

Benfotiamine is used in adults in the following situations:

Treatment and prevention of vitamin B1 deficiency, if it cannot be controlled with an adequate diet.

This medicine is indicated for use in adults.

The tablets can be taken as long as symptoms persist or a dietary supplement is required; follow the recommendations of your doctor or pharmacist.

You should consult a doctor if it worsens or does not improve.

2. What you need to know before taking Melgama

Do not take Melgama

If you are allergic to benfotiamine, thiamine, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Melgama.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age, as the safety and benefits of this medicine in people under 18 years of age are not yet known.

Other medicines and Melgama

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

5-fluorouracil, which is a chemotherapy medicine used to treat cancer, may reduce the action of vitamin B1.

Taking Melgama with food and drinks

There are no data on the influence of food on this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Do not use this medicine unless it is prescribed by a doctor. Your doctor will only prescribe this medicine after carefully considering the risks and benefits. Your doctor will also consider other forms of vitamin B1 supplementation you may be taking (such as multivitamins before conception and during pregnancy).

The influence of benfotiamine on fertility is unknown.

Driving and using machines

Melgama has no significant influence on the ability to drive and use machines.

Melgama contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially "sodium-free".

3. How to take Melgama

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Use in adults

Prevention:usually, half a tablet or one whole film-coated tablet (150-300 mg) once a day.

Treatment:1 film-coated tablet (300 mg) once a day.

Use in children and adolescents

This medicine is not suitable for use in children and adolescents under 18 years of age.

Elderly patients

The same dose as for adults is applied.

Renal impairment

In patients with kidney problems, this medicine can be used at the normal dose.

Hepatic impairment

It is unknown whether this medicine can be taken safely if you have liver problems. Consult your doctor if you have any liver problems.

Method of administration:

Oral use.

The tablet should be swallowed with a glass of water before meals.

The tablet can be divided into equal doses.

If you take more Melgama than you should

If you take more of this medicine than you should, consult your doctor or pharmacist, who will advise you on the necessary measures. No cases of benfotiamine overdose have been reported. In general, excess water-soluble vitamins, such as vitamin B1, are easily excreted in the urine, so no toxic effects of doses higher than recommended are expected.

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 forget to take Melgama

Do not take a double dose to make up for forgotten doses.

If you stop taking Melgama

You should always consult your doctor or pharmacist before stopping treatment.

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

4. Possible side effects

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

Frequency not known (cannot be estimated from the available data):

• Allergic reactions (rash, itching, skin allergic reactions)
• Nausea or other stomach or intestinal disorders

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System, www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Melgama

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Melgama

• The active ingredient is benfotiamine. Each tablet contains 300 mg of benfotiamine.
• The other ingredients are: microcrystalline cellulose, talc, povidone K30, colloidal anhydrous silica, high-partial-glycerides, and sodium croscarmellose in the tablet core; and hypromellose 15 mPa·s, talc, titanium dioxide (E 171), hypromellose 3 mPa·s, hypromellose 6 mPa·s, hypromellose 50 mPa·s, macrogol 3350, and sodium saccharin in the film coating.

Appearance of the product and package contents

White, oblong, film-coated tablets with a break line on both sides (approx. dimensions 18.5 mm x 6.5 mm).

Melgama is available in blister packs (PVC/PVDC/Al) in a carton.

Packs of 1, 10, 30, 60, 90, or 100 film-coated tablets.

Clinical packs of 500, 1,000, or 5,000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

AAA-Pharma GmbH

Flugfeld-Allee 24

71034 Böblingen

Germany

Manufacturer

Dragenopharm Apotheker Püschl GmbH

Göllstraße 1

84529 Tittmoning

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria milgamma protect 300 mg Filmtabletten

Spain Melgama 300 mg film-coated tablets

Date of the last revision of this package leaflet:03.2025.

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