Label: information for the user

GAMALATE B6oral solution

BGM/GABA/GABOB/Hydrochloride of pyridoxine

Read this label carefully before starting to use this medication,because it contains important information for you.

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

If you have any questions, consult yourdoctor,pharmacistor nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this label. See section 4.

GAMALATE B6solutionbelongs to the group of medications known as psychostimulants and nootropics.

GAMALATE B6 solution is indicated for:

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

Do not take GAMALATE B6

• If you are allergic to the active principles 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.

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

Children and adolescents

The safety and efficacy in children under 6 years have not been established. Gamalate should not be administered to children under 6 years.

Other medications and GAMALATE B6solution

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

GAMALATE B6 may potentiate the effects of central nervous system depressants such as hypnotics (sleep-inducing medications), sedatives, anxiolytics (tranquilizers), analgesics (pain medications).

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

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

Taking GAMALATE B6solution with food, drinks, and alcohol

The effects of alcohol may be potentiated by the magnesium glutamate bromhydrate.

GAMALATE B6solution can be taken both before and after meals.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

GAMALATE B6solution contains sorbitol, Yellow S, parahydroxybenzoate of methyl, and parahydroxybenzoate of propyl, sodium salt:

This medication contains sorbitol. If your doctor has indicated 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 containsYellow S (E 100).

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

It may cause allergic reactions (possibly delayed) because it containsParahydroxybenzoate of methyl (E 218); Parahydroxybenzoate of propyl (E 216).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose for adults and children over 6 years old is 10 ml of oral solution every 8 hours.

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

Use in children

Use in children under 6 years old is not recommended.

In children over 6 years old, the recommended dose is the same as for adults.

If you take more GAMALATE B6 solution than you should

Doses of pyridoxine exceeding therapeutic levels 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take GAMALATE B6 solution

Do not take a double dose to compensate for the missed doses.

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 all people may experience them.

The frequency of adverse effects of this medication is unknown. They may include:
Nervous system disorders: drowsiness, restlessness, sedation, insomnia, or disorientation.

Respiratory disorders: difficulty breathing.

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not require special conservation conditions.

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 after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of GAMALATE B 6 solution per ml:

• The active principles are: Magnesium bromide of -amino glutamate (BGM) 20 mg; GABA 20 mg; GABOB 10 mg; Hydrochloride of Pyridoxine 10 mg.
• The other components (excipients) are: Sodium saccharin; citric acid; methyl parahydroxybenzoate (E-218); propyl parahydroxybenzoate (E-216); raspberry essence; Yellow B (E-110); sorbitol (E-420) and purified water.

Appearance of the product and content of the container

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

Other presentations

GAMALATE B 6 coated tablets. Container with 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Last review date of this leaflet: June 2022

Other sources of information

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

This information is intended solely for healthcare professionals.