Gamalate B (6) oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GAMALATE B6 oral solution

BGM/GABA/GABOB/Pyridoxine hydrochloride

Read this entire leaflet carefully before you start using 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 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 could 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 oral solution is and what it is used for
2. What you need to know before taking GAMALATE B6 oral solution
3. How to take GAMALATE B6 oral solution
4. Possible side effects
5. How to store GAMALATE B6 oral solution
6. Contents of the pack and other information

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

GAMALATE B6 solution belongs to a group of medicines known as psychoanaleptics and nootropics.

GAMALATE B6 solution is indicated for:

Adjunctive treatment of patients with mild-to-moderate cognitive disorders, presenting with learning difficulties due to impaired attention and memory, and behavioural 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 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 must not be administered to children under 6 years of age.

Other medicines and GAMALATE B6 solution

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

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

Alcohol consumption could enhance the effect of Gamalate B6; therefore, it is not recommended.

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

Taking GAMALATE B6 solution with food, drinks, and alcohol

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

GAMALATE B6 solution 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 using machines

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 solution contains sorbitol, orange yellow S, methylparaben, and propylparaben, sodium salt:

This medicine contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

It may produce a mild laxative effect as it contains 3 g of sorbitol per 5 ml dose. Calorific value: 2.6 kcal/g of sorbitol.

This medicine may cause allergic reactions as it contains Orange yellow S (E 100).

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

It may cause allergic reactions (possibly delayed) as it contains Methylparaben (E 218); Propylparaben (E 216).

3. How to take GAMALATE B6 solution

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 in adults and children over 6 years of age is 10 ml of oral solution every 8 hours.

This dose may be modified at your doctor's discretion. The daily dose of 30 ml 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, the recommended dose is the same as in adults.

If you take more GAMALATE B6 solution 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take GAMALATE B6 solution

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 not known. The following may occur:

Nervous system disorders: drowsiness, 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of GAMALATE B6 solution

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of GAMALATE B6 solution per ml:

• The active substances are: Magnesium ?-amino glutamate bromide (BGM) 20 mg; ?-aminobutyric acid (GABA) 20 mg; ?-amino β-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 flavour; Orange Yellow S (E-110); sorbitol (E-420); purified water.

Appearance of the product and contents of the pack

Orange-coloured oral solution, packed in an amber glass bottle with screw cap containing 80 ml of oral solution.

Other presentations

GAMALATE B6 coated tablets. Pack containing 60 tablets.

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 leaflet: June 2022

Other sources of information

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

This information is intended for healthcare professionals only.