PATIENT INFORMATION LEAFLET

NEUROMADE Hard Capsules

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

The vitamins are essential nutrients that intervene in numerous human metabolism processes.

Neuromade capsules is indicated in adults and patients over 14 years old, in:

Treatment of states of deficiency of vitamins B1, B6 and B12, which could cause neuropathies (peripheral nervous system disorders) and could manifest in cases of back pain, such aslumbalgias. Convalescence. Insufficient diet.

Do not take NEUROMADE capsules

• if you are allergic (hypersensitive) to the active principles, to cobalamins (e.g. hydroxobalamine), to cobalt, or to any of the other components of the medication (see section 6).
• if you are being treated with levodopa (Parkinson's disease medication).
• if you have Leber's disease (hereditary optic nerve atrophy) or tobacco amblyopia (decreased visual acuity that can occur in people who abuse tobacco), as they may worsen.

Due to the vitamin doses contained, do not take this medication:

• if you are pregnant or breastfeeding.
• children under 14 years old.

Be especially careful with NEUROMADE capsules

• Do not take a higher dose than recommended or for a longer period than recommended. When large doses of pyridoxine (vitamin B6) are administered continuously, neurological side effects (headache, tingling sensation, etc.) may occur. Cases of dependence and withdrawal have been reported when taking 200 mg of pyridoxine for a month.
• Since it contains vitamin B12, if you have any blood disease such as anemia, your doctor should check the cause before taking it.
• If you are prone to gout, your doctor should perform a special clinical check because it could worsen.
• If you have kidney or liver disease, do not take this medication, as the doses contained exceed the recommended amounts in these situations.
• If you have conditions such as uremia (accumulation of urea in the blood), infections, iron deficiency, or folic acid deficiency, or are being treated with medications that have a suppressive effect on the bone marrow (e.g. chloramphenicol), the therapeutic response to vitamin B12 may decrease.
• Be cautious with the sun or avoid exposure to it, as pyridoxine can cause photosensitivity with skin eruption.
• If you have previously had an allergy to vitamin B1 contact with your skin (contact dermatitis) for professional reasons, you may experience a relapse when taking this medication.
• Interference with diagnostic tests: Inform your doctor if you are taking this medication, as it may alter the results. In some determinations of urobilinogen, theophylline, and uric acid, false results may occur.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Neuromade capsules may interact with the following medications:

• Levodopa (Parkinson's disease medications).
• Phenobarbital, phenytoin (epilepsy medications).
• Amiodarone (for the heart).
• Altretamine (for cancer treatment).
• Medications that block neuromuscular transmission (used in anesthesia, for surgery).
• The following medications may interfere with pyridoxine (vitamin B6) and reduce its levels, including: antibiotics for tuberculosis (isoniazid, cycloserine, and ethionamide), penicillamine (for rheumatic diseases), hydralazine (for hypertension), immunosuppressants such as corticosteroids or cyclosporine and azathioprine (used in organ transplantation), cyclophosphamide (for cancer).
• Several medications may decrease the absorption of cyanocobalamin (vitamin B12) or reduce its effect, such as: high doses of ascorbic acid (vitamin C), aminoglycoside antibiotics, colchicine (for gout treatment), H2 antagonists (medications against acidity or stomach ulcers, such as ranitidine, cimetidine, etc.), aminosalicylic acid (for intestinal diseases), omeprazole (for stomach ulcers), epilepsy medications, metformin (for diabetes), chloramphenicol (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 beverages

Alcoholic beverages decrease the effect of vitamins.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Due to the vitamin B doses contained in this medication, which are higher than those recommended during pregnancy and lactation, it is contraindicated during these periods.

Vitamin B1, pyridoxine, and cyanocobalamin pass into breast milk.

Driving and operating machines

This medication may cause drowsiness in a few patients, who should not drive and/or operate machines during treatment.

Follow exactly the administration instructions for Neuromade capsules as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

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

Oral administration.

The capsules are taken with the help of a sufficient amount of water.

Generally, treatment should not exceed 2 weeks, although your doctor may recommend administration for more than 15 days.

Use in children

This medication is contraindicated in children under 14 years old.

If you take more NEUROMADE capsules than you should

It is not expected that a large dose of Neuromade capsules will produce 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 sensitivity, tingling, numbness in feet and hands; you may also experience headaches, increased sensitivity to sunlight with skin lesions; drowsiness, difficulty breathing, among other effects, depending on the dose. In rare cases, a severe allergic reaction (anaphylactic shock) may occur.

In children, accidental ingestion of very high doses of vitamin B6may also produce deep sedation, weakness, and difficulty breathing.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take NEUROMADE capsules

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

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

Like all medications, Neuromade capsules can produce adverse effects, although not all people will experience them.

The assessment of adverse effects that may occur is based on the following frequencies:

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

Infrequently, the following may appear: nausea, headache, effects on sensitivity (paresthesias) that manifest as a sensation of tingling in arms and legs or alterations in touch, drowsiness, and skin rash (reactions to vitamins B1, B6, and B12).

Other adverse effects that have been reported, with an unknown frequency, are: digestive discomfort, diarrhea, photosensitivity with skin lesions such as blisters, dizziness, restlessness; disorder with reduced sensitivity and tingling, unsteady gait, numbness of feet or hands, which generally decrease when treatment is interrupted; a pyridoxine withdrawal syndrome more likely as doses increase and in treatments exceeding one month; changes in urine color, swelling, and eye irritation; occasionally anaphylactic reaction with itching, swelling, difficulty breathing, etc.; some cases of a condition with nodules and pus on the face and neck.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is apossibleadverse effect not appearing in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Neuromade capsules after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Composition of NEUROMADE Hard Capsules

• The active principles 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 product and contents of the package

Neuromade capsules are presented in packages of20 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

TEOFARMA Srl

Vía F.lli Cervi, 8

27010 Valle Salimbene (PV) – Italy

This leaflet was approved in September/2011.

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