Neuromade hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

NEUROMADE hard capsules

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Neuromade capsules are and what they are used for
2. Before you take Neuromade capsules
3. How to take Neuromade capsules
4. Possible side effects
5. How to store Neuromade capsules
6. Further information

1. What NEUROMADE CAPSULES is and what it is used for

Neuromade capsules is a combination of the water-soluble B vitamins: thiamine (vitamin B1), pyridoxine (vitamin B6), and cyanocobalamin (vitamin B12), intended for oral administration.

Vitamins are essential nutrients that participate in numerous processes of human metabolism.

Neuromade capsules is indicated in adults and patients over 14 years of age for:

Treatment of deficiencies of vitamins B1, B6, and B12, which may cause neuropathies (disorders of the peripheral nervous system) and may manifest in conditions such as back pain, including lumbago. Convalescence. Inadequate diet.

2. Before taking NEUROMADE CAPSULES

Do not take NEUROMADE capsules

• if you are allergic (hypersensitive) to the active substances, cobalamins (e.g. hydroxocobalamin), cobalt, or any of the other ingredients of the medicine (see section 6).
• if you are being treated with levodopa (a medicine for Parkinson's disease).
• if you have Leber's disease (hereditary optic nerve atrophy) or tobacco amblyopia (reduced visual acuity that may occur in people who abuse tobacco), as these conditions could worsen.

Due to the vitamin doses it contains, do not take this medicine:

• if you are pregnant or breastfeeding.
• in children under 14 years of age.

Take special care with NEUROMADE capsules

• Do not take a higher dose than recommended or for a longer period than advised. When high doses of pyridoxine (vitamin B6) are administered continuously, neurological adverse effects may occur (e.g. headache, tingling sensations, etc.). Cases of dependence and withdrawal symptoms have been reported after taking 200 mg doses of pyridoxine for one month.
• Because it contains vitamin B12, if you have a blood disorder such as anemia, your doctor must determine the cause before you take this medicine.
• If you are predisposed to gout, your doctor should monitor you closely due to the vitamin B12 content, as your condition could worsen.
• Do not take this medicine if you have kidney or liver disease, as the doses contained exceed those recommended in such conditions.
• If you have conditions such as uremia (accumulation of urea in the blood), infections, iron or folic acid deficiency, or are receiving treatment with medications that suppress bone marrow function (e.g. chloramphenicol), the therapeutic response to vitamin B12 may be reduced.
• Be cautious about sun exposure or avoid sunlight, as pyridoxine may cause photosensitivity and skin rashes.
• If you have previously experienced an allergic skin reaction (contact dermatitis) to vitamin B1 due to occupational exposure, you may experience a relapse when taking this medicine.
• Interference with laboratory tests: If you are scheduled to undergo any diagnostic tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results. False results may occur in certain tests for urobilinogen, theophylline, and uric acid.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

NEUROMADE capsules may interact with the following medicines:

• Levodopa (medicines for the treatment of Parkinson's disease).
• Phenobarbital, phenytoin (medicines for epilepsy).
• Amiodarone (for heart conditions).
• Altretamine (for cancer treatment).
• Neuromuscular blocking agents (used in anesthesia for surgery).
• The following medicines may interfere with pyridoxine (vitamin B6) and reduce its levels: antibiotics for tuberculosis (isoniazid, cycloserine, and ethionamide), penicillamine (for rheumatic diseases), hydralazine (for hypertension), immunosuppressants such as corticosteroids, cyclosporine, and azathioprine (used in organ transplantation), and cyclophosphamide (for cancer).
• Several medicines may reduce the absorption of cyanocobalamin (vitamin B12) or diminish its effect, such as: high-dose ascorbic acid (vitamin C), aminoglycoside antibiotics, colchicine (for gout treatment), H2 antagonists (medicines for acidity or stomach ulcers, such as ranitidine, cimetidine, etc.), aminosalicylic acid (for intestinal diseases), omeprazole (for stomach ulcers), antiepileptic medicines, metformin (for diabetes), chloramphenicol (an antibiotic), sustained-release potassium preparations, or cobalt radiation.
• Oral contraceptives may reduce levels of both vitamin B6 and vitamin B12.

Taking NEUROMADE capsules with food and drinks

Alcoholic beverages reduce the effectiveness of the vitamins.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Due to the doses of vitamin B contained in this medicine, which exceed those recommended during pregnancy and breastfeeding, it is contraindicated during these periods.

Thiamine, pyridoxine, and cyanocobalamin are excreted in breast milk.

Driving and using machines

This medicine may cause drowsiness in some patients. These patients should not drive or operate machinery during treatment.

3. How to take NEUROMADE CAPSULES

Follow exactly the instructions for administration of Neuromade capsules provided by your doctor.

If you have any doubts, consult your doctor or pharmacist.

Normal dosage:

It is recommended to take 1 capsule per day. In certain cases, your doctor may indicate taking 2 capsules per day.

Oral use.

The capsules should be taken with a sufficient amount of water.

In general, treatment should not exceed 2 weeks, although your doctor may recommend administration for longer than 15 days.

Use in children

This medicine is contraindicated in children under 14 years of age.

If you take more NEUROMADE capsules than you should

Large doses of Neuromade capsules are not expected to cause toxic effects.

If you have taken more Neuromade capsules than you should, you may experience symptoms such as gastrointestinal discomfort (diarrhea, nausea, and vomiting), nervous system disorders such as reduced sensation, tingling, numbness in feet and hands; headache, increased sensitivity to sunlight with skin lesions, drowsiness, breathing difficulties, and other effects depending on the dose. Rarely, a severe allergic reaction (anaphylactic shock) may occur.

In children, accidental ingestion of very high doses of vitamin B6 may additionally cause deep sedation, weakness, and breathing difficulties.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, 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 NEUROMADE capsules

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

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

4. Possible adverse effects

Like all medicines, Neuromade capsules may cause adverse effects, although not everyone will experience them.

The assessment of possible adverse effects is based on the following frequency categories:

Uncommon (may affect between 1 and 10 out of every 1,000 people).

Uncommonly observed effects include: nausea, headache, sensory disturbances (paraesthesias) manifesting as tingling sensations in arms and legs or alterations in touch perception, somnolence, and skin rash (hypersensitivity reactions to vitamins B1, B6, and B12).

Other adverse effects reported, with frequency not exactly known, include: gastrointestinal discomfort, diarrhea, photosensitivity with skin lesions such as blisters, dizziness, restlessness; neurological disorder with reduced sensitivity and tingling, unsteady gait, numbness in feet or hands, which generally decrease upon discontinuation of treatment; pyridoxine withdrawal syndrome, more likely with higher doses and treatments lasting longer than one month; changes in urine color, eye swelling and irritation; occasionally, anaphylactic reaction with itching, swelling, breathing difficulties, etc.; isolated cases of facial and neck lesions with nodules and pus.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NEUROMADE CAPSULES

Keep out of the reach and sight of children.

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

No special storage conditions are required. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of NEUROMADE hard capsules

• The active substances are: Thiamine hydrochloride (vitamin B1), Pyridoxine hydrochloride (vitamin B6) and Cyanocobalamin (Vitamin B12). Each capsule contains 50 mg of thiamine hydrochloride, 50 mg of pyridoxine hydrochloride and 1,000 micrograms of cyanocobalamin.
• The other components (excipients) are: Microcrystalline cellulose, silicon dioxide and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Neuromade capsules are available in packs of 20 hard capsules.

Marketing Authorization Holder and Manufacturer

TEOFARMA Srl
Via F.lli Cervi, 8
27010 Valle Salimbene (PV) – Italy

This leaflet was approved in September/2011.

Detailed and up-to-date 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/