Leaflet: information for the user

GAMALATE B6coated tablets

BGM/GABA/GABOB/Hydrochloride of pyridoxine

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, consult yourdoctor,or pharmacistor nurse.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,evenif they are not listed in this leaflet. See section 4.

GAMALATE B6coated tabletsbelongs to the group of drugs called psychostimulants and nootropics.

GAMALATE B6 coated tablets is indicated for:

Complementary treatment of patients with mild-moderate cognitive disorders, which are accompanied by learning problems due to difficulties with attention and memory, 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 on 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 B6coated tablets

Inform your doctor or pharmacist if you are taking, have taken recently, or may have 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 B6coated tablets with food, drinks, and alcohol

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

GAMALATE B6coated 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 intend to become 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 B6coated tablets contain saccharose.

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

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 2 tablets every 8 hours.

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

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 B6coated tablets 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 B6coated tablets

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, stomach and abdominal 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 storage 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of GAMALATE B 6 Coated tablets per tablet:

• The active principles are: Bromhidrato of ? -amino glutamato de magnesio (BGM) 75 mg; Acido- ? -aminobutírico (GABA) 75 mg; Acido- ? -amino β-hidroxibutírico (GABOB) 37 mg; Hidrocloruro of Piridoxina 37 mg.
• The other components (excipients) are: Sacarosa. 210 mg aprox; sílice coloidal; polivinilpirrolidona (E-1201); carboximetilalmidón; estearato de magnesio; talco (E-553b); almidón de maíz; dióxido de titanio (E-171); carbonato magnésico (E504i); indigotina; Eudragit E; goma arábiga (E-414); propilenglicol (E-1520) and cera de carnauba (E903)

Appearance of the product and content of the packaging

Coated round tablets of blue color, packaged in aluminum/PVC blister.

Box containing 60 tablets.

Other presentations

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

Holder of the marketing authorization and responsible for manufacturing

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Date of the last review of this prospectus: May 2022.

Other sources of information

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

This information is intended solely for healthcare professionals.