Dolo-Neurobion

Dolo-Neurobion

Manufacturer:

P&G Phil

Distributor:

Zuellig
Full Prescribing Info
Contents
Paracetamol, vitamin B-complex.
Description
Each film coated tablet of Paracetamol + Vitamin B1 + Vitamin B6 + Vitamin B12 (Dolo-Neurobion) Tablet contains the following active ingredients: see table.

Click on icon to see table/diagram/image
Action
Paracetamol + Vitamin B1 + Vitamin B6 + Vitamin B12 (Dolo-Neurobion) Tablet is a combination of paracetamol and B vitamins that provide a synergistic effect on a number of pain conditions which are mainly of mixed pain origin, wherein both the underlying nociceptive (e.g. cuts, burns of the skin; broken bones) as well as neuropathic components of the pain complex are treated.
In mixed pain conditions nociceptive and neuropathic types of pain are present. Both have to be treated with compounds of different modes of action.
Neuropathies/neuropathic pain component are described as numbness, tiredness, tingling, pins and needles sensations, etc.
Vitamin B1 is an important component that helps provide energy to nerve cells which is essential in maintaining its healthy state and function as well as help in nerve regeneration and healing.
Vitamin B6 acts as a coenzyme in the body that helps process carbohydrates, fats and proteins that are needed in the maintenance of the body's healthy state.
Vitamin B12 is an essential component that helps in the maintenance, metabolism and maturation of nerve cells as well as all other cells of the body. It also has an important role in hematopoiesis or red blood cell formation. It helps in the formation of the myelin sheath, which is the protective covering of the nerves.
In combination, vitamins (B1, B6 and B12) are all involved in important functions of the nervous system and contribute to nerve regeneration or healing. Thus, this contributes in the treatment of the neuropathic component and the underlying nerve damage in "mixed pain".
Paracetamol is an effective non - steroid, non - opiate medicine that has an analgesic (for pain) and antipyretic (for fever) action.
Indications/Uses
Paracetamol + Vitamin B1 + Vitamin B6 + Vitamin B12 (Dolo-Neurobion) Tablet is used for the treatment of mild to moderate pain (mixed pain generated by nociceptive and neuropathic components).
Explanatory note: Mixed pain conditions include back pain (lumbalgia, radiculitis, spondylitis), neck pain, shoulder pain/shoulder-arm-syndrome (brachialgia), sciatica and carpal tunnel syndrome, pain after surgery and other painful conditions.
Dosage/Direction for Use
Paracetamol + Vitamin B1 + Vitamin B6 + Vitamin B12 (Dolo-Neurobion) Tablet should be taken orally.
Adults, the elderly, and children and adolescents over 14 years of age: Take one (1) tablet, one to three times daily. The tablet should be swallowed without chewing with a little liquid after meals to minimize the effects of gastrointestinal irritation.
The tablet should be taken every 4-6 hours. Do not exceed 4,000mg of Paracetamol within 24 hours (1 day).
The duration of treatment should be as short as possible. If symptoms do not disappear, consult the physician.
Missed dose: If the patient has forgotten to take Paracetamol + Vitamin B1 + Vitamin B6 + Vitamin B12 (Dolo-Neurobion) Tablet, the patient should not make up for it by doubling the next dose.
Simply take the next dose at the usual time.
Overdosage
Symptoms: Vitamin B6: Sensorial neuropathy and other sensorial neuropathy syndromes which can be caused by long-term administration of very high doses of pyridoxine improve gradually upon vitamin discontinuation.
This product is not recommended for long term use.
10-15 mg/kg as single dose and 60mg/kg as maximum dose of Paracetamol must not be exceeded.
Paracetamol: An overdose of Paracetamol can cause life-threatening hepatotoxicity. The patients should be treated within the first 10 hours with the specific antidote N-acetylcysteine (intravenously). The administration of activated charcoal cannot be routinely advocated but it can be considered if a toxic dose of paracetamol has been taken and fewer than 2 hours have elapsed since ingestion.
Gastrointestinal decontamination could be particularly important if N-acetylcysteine cannot be administered within 8 hours of ingestion.
What to do when patient has taken more than the recommended dosage: Observe for adverse reactions as a result of over dosage. Consult a Physician immediately when these are noticeable
Contraindications
The patient should not take this medicine if the patient has known allergies or hypersensitivity to any component of this product. This should not be given to children less than 14 years old due to the high content of the active ingredients.
Special Precautions
Vitamin B6: In the literature, rare cases of neuropathies are described under long term intake (6- 12 months) of more than 50 mg mean daily dose of vitamin B6.
Under long-term use of high doses of vitamin B6, regular monitoring is recommended.
This product is not intended to be used long-term.
Paracetamol: Do not exceed the recommended dosage. Exceeding the recommended dose may result in severe liver impairment.
Paracetamol should be given with precaution in following cases: Hepatic insufficiency, chronic alcohol abuse, severe renal insufficiency, patients with impaired glucose-6-phosphate dehydrogenase.
Rarely, Paracetamol can cause serious, potentially fatal skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN).
Before taking the tablet, please ensure that it was stored in a cool dry place, not exceeding 25°C. The packaging should not be damaged or opened as there might be danger of product degradation or exposure to contaminants.
Take Paracetamol + Vitamin B1 + Vitamin B6 + Vitamin B12 (Dolo-Neurobion) Tablet only as recommended in this leaflet. If symptoms persist, consult a Physician.
Adverse Reactions
Vitamin B1, B6 and B12: Immune system disorders: Hypersensitivity reactions, such as sweating, tachycardia, and skin reactions with itching and urticaria.
Gastrointestinal disorders: Gastrointestinal complaints, such as nausea, vomiting, diarrhoea and abdominal pain.
Renal and urinary disorders: Chromaturia ("reddish urine", appeared during the first 8 hours after an administration and typically resolved within 48 hours).
Paracetamol: Immune system disorders: Hypersensitivity reactions.
Skin and subcutaneous tissue disorders: Skin reactions (e.g. rash, urticaria).
Gastrointestinal disorders (e.g. abdominal pain, nausea, vomiting).
Blood and lymphatic system disorders: Hematological reactions (e.g. leucopenia, thrombocytopenia).
Hepatobiliary disorders: Hepatic effects (e.g. increased level of aminotransferase, jaundice)
Drug Interactions
Vitamin B1, B6 and B12: L-dopa: The effect of L-dopa may be reduced when vitamin B6 is administered concomitantly.
Pyridoxine-antagonists, e.g. isoniazid (INH), cycloserine, penicillamine, hydralazine: The efficacy of vitamin B6 (pyridoxine) may be decreased.
Loop diuretics, e.g. furosemide: The blood level of thiamine (vitamin B1) may be reduced.
Long-term use of acid lowering agents may lead to vitamin B12 deficiency.
Paracetamol: A prolonged regular use of Paracetamol may potentiate the effect of oral anticoagulants (e.g. warfarin).
The risk of Paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes (e.g. anti-epileptics).
Paracetamol decreases the effectiveness of lamotrigine.
Taking Paracetamol + Vitamin B1 + Vitamin B6 + Vitamin B12 (Dolo-Neurobion) Tablet with alcohol increases the concentration of hepatotoxic metabolites in plasma and may lead to hepatotoxicity.
Storage
This medicine should be stored at temperatures not exceeding 25°C.
ATC Classification
N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Presentation/Packing
FC tab (biconvex, oblong shaped yellow film, with MERCK engraved on one side and plain on the other side) 100's.
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