Gamalate B (6) film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GAMALATE B6 coated tablets

BGM/GABA/GABOB/Pyridoxine hydrochloride

Read all of 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, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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 adverse effects
5. How to store GAMALATE B6 coated tablets
6. Contents of the pack and other information

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

GAMALATE B6 coated tablets belong to a group of drugs known as psycho-stimulants and nootropics.

GAMALATE B6 coated tablets are indicated for:

The adjunctive treatment of patients with mild-to-moderate cognitive disorders, characterized by learning difficulties due to problems with attention and memory, and behavioral issues such as hyperactivity or irritability.

2. What you need to know before starting 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 medicine (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 rash, blisters, and vesicles.

Children and adolescents

The 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 medicines and GAMALATE B6 coated tablets

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

GAMALATE B6 may enhance the effects of central nervous system depressants such as hypnotics (medicines to induce sleep), sedatives, anxiolytics (tranquilizers), and analgesics (pain medicines).

Alcohol consumption may enhance the effect of Gamalate B6 and is therefore not recommended.

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

Taking GAMALATE B6 coated tablets with food, drinks, and alcohol

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

GAMALATE B6 tablets can be taken either before or after meals.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

The sedative properties of the medicine may lead to reduced reflexes; therefore, caution should be exercised by patients who drive vehicles or operate machinery.

GAMALATE B6 coated tablets contain sucrose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take GAMALATE B6 coated tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

This dose may be modified at the discretion of your doctor. The maximum daily dose of 6 tablets must not be exceeded.

Use in children

Use in children under 6 years of age is not recommended.

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

If you take more GAMALATE B6 coated tablets than you should

Doses of pyridoxine exceeding 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 initiated.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take GAMALATE B6 coated tablets

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The frequency of occurrence of adverse effects with this medicine is unknown. The following may occur:

Nervous system disorders: somnolence, restlessness, sedation, insomnia, or disorientation.

Respiratory disorders: difficulty breathing.

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

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of GAMALATE B6 coated tablets

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of GAMALATE B6 coated tablets per tablet:

• Active substances: Magnesium ?-amino glutamate bromhydrate (BGM) 75 mg; ?-aminobutyric acid (GABA) 75 mg; ?-amino β-hydroxybutyric acid (GABOB) 37 mg; Pyridoxine hydrochloride 37 mg.
• Other components (excipients): Sucrose, approx. 210 mg; colloidal silica; polyvinylpyrrolidone (E-1201); carboxymethylstarch; magnesium stearate; talc (E-553b); corn starch; 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 contents of the container

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

Box containing 60 tablets.

Other presentations

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

Marketing Authorization Holder and Manufacturing Responsible

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Date of the most recent review of this package leaflet: May 2022.

Other sources of information

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

This information is intended for healthcare professionals only.