GAMALATE B (6) FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

GAMALATE B6coated tablets

BGM/GABA/GABOB/Hydrochloride of pyridoxine

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What GAMALATE B6 coated tablets are and what they are used for
2. What you need to know before taking GAMALATE B6 coated tablets
3. How to take GAMALATE B6 coated tablets
4. Possible side effects
5. Storage of GAMALATE B6 coated tablets
6. Package Contents and Additional Information

1. What GAMALATE B6 coated tablets are and what they are used for

GAMALATE B6 coated tablets belong to the group of drugs called psychostimulants and nootropics.

GAMALATE B6 coated tablets are indicated for:

Complementary treatment of patients with mild-moderate cognitive disorders, who have learning problems due to attention and memory difficulties, and behavioral problems, such as hyperactivity or irritability.

2. What you need to know before taking GAMALATE B6 solution

Do not take GAMALATE B6

• If you are allergic to the active substances or to any of the other components of this medication (listed in section 6).
• If you have Parkinson's disease and are being treated with Levodopa.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take GAMALATE B6.

Pyridoxine has a potential risk of photosensitivity, which manifests in the skin as a rash, blisters, and vesicles.

Children and Adolescents

Safety and efficacy in children under 6 years of age have not been established. Gamalate should not be administered to children under 6 years of age.

Other Medications and GAMALATE B6coated tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

GAMALATE B6 may enhance the effects of central nervous system depressant drugs such as hypnotics (sleep-inducing medications), sedatives, anxiolytics (tranquilizing medications), and analgesics (pain medications).

Consuming alcohol may enhance the effect of Gamalate B6, so it is not recommended.

If you have Parkinson's disease and are being treated with Levodopa, you should not take this medication.

Taking GAMALATE B6coated tablets with Food, Drinks, and Alcohol

The effects of alcohol may be enhanced by the magnesium glutamate hydrobromide.

GAMALATE B6 coated tablets can be taken both before and after meals.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

The sedative properties of the drug may lead to a decrease in reflexes, and caution should be exercised in patients who drive vehicles or operate machinery.

GAMALATE B6coated tablets contain sucrose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take GAMALATE B6 coated tablets

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

This medication is administered orally. It can be administered before or after the main meals.

The recommended dose in adults and children over 6 years of age is 2 tablets every 8 hours.

This dose may be modified at the discretion of your doctor. The dose should not exceed 6 tablets per day.

Use in Children

The use of Gamalate in children under 6 years of age is not recommended.

In children from 6 years of age, the recommended dose is the same as for adults.

If you take more GAMALATE B6coated tablets than you should

Doses of pyridoxine higher than the therapeutic doses administered over long periods of time may be associated with neurotoxicity (sensory symptoms and neuropathic pain).

In cases of overdose, treatment should be discontinued, and symptomatic treatment should be initiated.

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 medication and the amount ingested).

If you forget to take GAMALATE B6coated tablets

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The frequency of side effects of this medication is not known. The following may occur: Nervous system disorders: drowsiness, restlessness, sedation, insomnia, or disorientation.

Respiratory disorders: difficulty breathing.

Gastrointestinal disorders: nausea, vomiting, occasional diarrhea, constipation, stomach and abdominal discomfort.

Skin and subcutaneous tissue disorders: skin redness, urticaria, appearance of red spots on the skin, eczema.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of GAMALATE B6 coated tablets

This medication does not require special storage conditions.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of GAMALATE B6coated tablets per tablet:

• The active ingredients are: Magnesium glutamate hydrobromide (BGM) 75 mg; Gamma-aminobutyric acid (GABA) 75 mg; Gamma-amino beta-hydroxybutyric acid (GABOB) 37 mg; Pyridoxine hydrochloride 37 mg.
• The other ingredients (excipients) are: Sucrose, approximately 210 mg; colloidal silica; polyvinylpyrrolidone (E-1201); carboxymethylcellulose; magnesium stearate; talc (E-553b); cornstarch; titanium dioxide (E-171); magnesium carbonate (E504i); indigotine; Eudragit E; arabic gum (E-414); propylene glycol (E-1520), and carnauba wax (E903)

Appearance of the Product and Package Contents

Blue, round, coated tablets, packaged in aluminum/PVC blisters.

Box containing 60 tablets.

Other Presentations

GAMALATE B6 oral solution. Containers containing 80 ml of solution.

Marketing Authorization Holder and Manufacturer

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Date of the Last Revision of this Package Leaflet:May 2022.

Other Sources of Information

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

This information is intended only for healthcare professionals.