GAMALATE B (6) ORAL SOLUTION

Introduction

Leaflet: information for the user

GAMALATE B6oral solution

BGM/GABA/GABOB/Hydrochloride of pyridoxine

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

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

If you have any doubts, 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, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What GAMALATE B6 solution is and what it is used for
2. What you need to know before taking GAMALATE B6 solution
3. How to take GAMALATE B6 solution
4. Possible side effects
5. Storage of GAMALATE B6 solution
6. Package contents and additional information

1. What is GAMALATE B6 solution and what it is used for

GAMALATE B6 solution belongs to the group of drugs called psychostimulants and nootropics.

GAMALATE B6 solution is 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 ingredients or 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 on 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 B6solution

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-relieving medications).

Alcohol consumption 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 B6solution with food, drinks, and alcohol

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

GAMALATE B6 solution 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 B6solution contains sorbitol, orange yellow S, methyl parahydroxybenzoate, and propyl parahydroxybenzoate, sodium salt:

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

It may produce a mild laxative effect because it contains 3 g of sorbitol per 5 ml dose. Caloric value: 2.6 Kcal/g of sorbitol.

This medication may cause allergic reactions because it contains Orange Yellow S (E 100).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

It may produce allergic reactions (possibly delayed) because it contains Methyl Parahydroxybenzoate (E 218) and Propyl Parahydroxybenzoate (E 216).

3. How to take GAMALATE B6 solution

Follow exactly the administration instructions of this medication 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 10 ml of oral solution every 8 hours.

This dose may be modified at the discretion of your doctor. The daily dose should not exceed 30 ml.

Use in children

The use 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 B6solution 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 B6solution

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

If you have any other doubts 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 experiences them.

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

Respiratory disorders: difficulty breathing.

Gastrointestinal disorders: nausea, vomiting, occasional diarrhea, constipation, gastric 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 leaflet. You can also report them directly through the Spanish Medication Monitoring 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 solution

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 B6solution per ml:

• The active ingredients are: Magnesium glutamate hydrobromide (BGM) 20 mg; Gamma-aminobutyric acid (GABA) 20 mg; Gamma-amino beta-hydroxybutyric acid (GABOB) 10 mg; Pyridoxine hydrochloride 10 mg.
• The other components (excipients) are: Sodium saccharin; citric acid; methyl parahydroxybenzoate (E-218); propyl parahydroxybenzoate (E-216); raspberry flavor; orange yellow S (E-110); sorbitol (E-420); and purified water.

Appearance of the product and package contents

Orange-colored oral solution, packaged in a topaz-colored glass bottle with a screw cap containing 80 ml of oral solution.

Other presentations

GAMALATE B6 coated tablets. Package with 60 tablets.

Marketing authorization holder and manufacturer

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Date of the last revision of this leaflet:June 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.