NOBINERVE Capsule 15?s Allschoolabs -

Description

INTRODUCTION
NOBINERVE CAPSULE is a combination of Pregabalin and Methylcobalamin which belongs to the group of medicines called Anticonvulsants and Vitamin-B complex respectively. NOBINERVE CAPSULE is indicated for the treatment of neuropathic pain in adults. Neuropathic pain is a chronic painful condition caused by damage or disease affecting the somatosensory (sense of touch) nervous system (such as lesion or disease of spinal cord and/or brain).
It can also be caused by prolonged diabetes mellitus, infectious diseases (such as HIV infection or leprosy), chemotherapy, auto-immune disease (Ex. Guillain-Barre syndrome) or by other metabolic dysfunctions. Symptoms include shooting, burning or stabbing pain, tingling and numbness, spontaneous pain (pain without stimulus) or pain caused by normal daily activities that are typically not painful (such as brushing your hair, being in cold temperatures or rubbing against something).
Do not stop taking NOBINERVE CAPSULE without consulting your doctor as it could precipitate withdrawal symptoms such as headache, insomnia (lack of sleep), nausea, pain, diarrhea, flu syndrome, anxiety, nervousness, depression, convulsion, excessive sweating, dizziness and physical dependence.
NOBINERVE CAPSULE has high potential to cause addiction and therefore caution should be exercised among patients who already has a history of substance abuse. NOBINERVE CAPSULE can cause suicidal ideation in some individuals and therefore appropriate treatment should be considered as soon as the signs emerge.
NOBINERVE CAPSULE is not recommended for use in pregnant or breastfeeding women unless advised by the doctor and in male patients who plan to father a child. Consult your doctor before taking NOBINERVE CAPSULE.
The most common side effects of taking NOBINERVE CAPSULE are dizziness, sleepiness, headache, dry mouth, mood changes, fluid retention and weight gain. Consult your doctor if any of the side effects worsen.
USES OF NOBINERVE CAPSULE

Treats neuropathic pain in adults

HOW NOBINERVE CAPSULE WORKS
NOBINERVE CAPSULE effectively alleviates the symptoms of various types of neuropathic pain, where methylcobalamin acts by rejuvenating the damaged neurons by improving the production of myelin (a substance that covers and protects the nerve fibers from damage) and pregabalin acts by interfering with various pain signals travelling through the damaged nerves and the brain, thus leading to a significant pain relief in various neuropathic pain states.
DIRECTIONS FOR USE
Take NOBINERVE CAPSULE as advised by your physician. Swallow NOBINERVE CAPSULE with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of NOBINERVE CAPSULE for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF NOBINERVE CAPSULE

COMMON

Dizziness, sleepiness, headache

Nasopharyngitis (common cold)

Nausea, vomiting, increased appetite, constipation, diarrhea, flatulence, abdominal distension, dry mouth

Euphoric mood (feeling excited or pleasurable)

Confusion, irritability, disorientation

Insomnia (lack of sleep)

Decrease in sex drive, erectile dysfunction

Ataxia (impaired balance or coordination), tremor (shaking)

Dysarthria (disorder of speech)

Memory impairment, attention disturbance

Paresthesia (tingling and numbness in extremities)

Hypoaesthesia (decreased sense of touch)

Tiredness

Blurred vision

Vertigo (spinning sensation)

Muscle cramps

Pain in limbs, joints or back

Cervical spasm (a sudden, involuntary contraction of a muscle in the neck)

Peripheral edema

Fall (accidental injury)

Weight gain

UNCOMMON

Abnormally low count of a type of white blood cell (neutrophils).

Loss of appetite

Low blood sugar levels

Hallucination, panic attack, restlessness, agitation, depression

Elevated mood, aggression, mood swings, depersonalisation, word finding difficulty

Abnormal dreams, libido increased, anorgasmia, apathy

Fainting, unresponsiveness (stupor)

Myoclonus (muscle jerks)

Loss of consciousness, psychomotor hyperactivity

Dizziness postural

Involuntary eye movement

Cognitive disorder

Mental impairment

Hyporeflexia (reduction or absence of normal bodily reflexes)

Hyperaesthesia (excessive physical sensitivity)

Burning sensation

Loss of sensation of taste

General discomfort

Visual disturbance, eye swelling

Eye pain or strain

Photopsia?(presence of flashes of light or floaters in the vision)

Dry eye

Lacrimation increased, eye irritation

Disorder in loudness perception

Fast or slow heart rate, congestive heart failure

Increased or decreased blood pressure

Hot flushes, flushing, peripheral coldness

Shortness of breath, bleeding from nose

Cough, nasal congestion

Stuffy nose, snoring, nasal dryness

Gastrooesophageal reflux disease, salivary hypersecretion

Oral numbness

Rash popular, urticaria, itching

Excess sweating

Joint swelling, muscle or neck pain

Muscle twitching or stiffness

Urinary incontinence, painful urination

Sexual dysfunction, ejaculation delayed

Pain menstruation or breast pain

Generalised oedema, face oedema, chest tightness, pain

Fever, thirst, chills, lack of energy

Decreased weight

RARE

Disinhibition (a pattern of antisocial, impulsive, norm-violating tendency)

Convulsions

Parosmia (a smell disorder)

Dysgraphia (trouble in writing)

Heart problems (such as prolonged QT interval, sinus tachycardia or sinus arrhythmia)

Pulmonary edema (fluid retention in the lungs) and throat tightness

GI tract problems (such as fluid buildup in stomach, pancreatitis, swollen tongue or dysphagia)

Cold sweats

Kidney problems (such as renal failure, oliguria and urinary retention)

Amenorrhea (lack of menstrual periods)

Breast discharge or enlargement

Gynecomastia (breast enlargement in males)
Stop taking NOBINERVE CAPSULE and contact your doctor immediately if you experience any of the following side effects:
Severe allergic reactions (such as skin rash, itching, swelling of the face, lips, throat, neck and difficulty in breathing)

Symptoms of elevated creatine kinase (such as unexplained muscle pain, tenderness or weakness, accompanied by malaise or fever)

Rhabdomyolysis (severe muscle injury)

Suicidal ideation or behavior

HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Try to take NOBINERVE CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.
Diarrhea:
Drink lots of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.
Headache: ?
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.
Flatulence:
Eat smaller and frequent meals. Eat and drink slowly and exercise regularly. Consult your doctor if the symptom did not improve.
Constipation:?
Eat fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Try to exercise more regularly. Consult your doctor if the symptom did not improve on its own.
WARNING & PRECAUTIONS

PREGNANCY
There is no proper information on the use of NOBINERVE CAPSULE during pregnancy and therefore should be used only if the benefit to the mother clearly outweighs the potential risk to the fetus. Consult your doctor before taking NOBINERVE CAPSULE. Women of childbearing potential should use a suitable contraceptive method to avoid pregnancy while taking NOBINERVE CAPSULE.
BREASTFEEDING
NOBINERVE CAPSULE is not recommended for use in breastfeeding women unless it is considered clearly necessary. Consult your doctor whether to discontinue breast-feeding or to discontinue therapy with NOBINERVE CAPSULE.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you experience dizziness or sleepiness after taking this medicine. Consult your doctor before taking NOBINERVE CAPSULE.
ALCOHOL
Avoid consumption of alcohol while taking NOBINERVE CAPSULE, as it may cause impairment of motor skills and sedating effects of alcohol. Consult your doctor before taking NOBINERVE CAPSULE.
KIDNEY
NOBINERVE CAPSULE should be taken with caution in patients with impaired kidney function. Consult your doctor before taking NOBINERVE CAPSULE.
LIVER
NOBINERVE CAPSULE should be taken with caution in patients with liver disease. Consult your doctor before taking NOBINERVE CAPSULE.
ALLERGY
Do not take NOBINERVE CAPSULE if you are allergic to Pregabalin, Methylcobalamin or any other ingredients of NOBINERVE CAPSULE.
HEART DISEASE
NOBINERVE CAPSULE should be taken with caution in patients with heart disease (such as congestive heart failure). Consult your doctor before taking NOBINERVE CAPSULE.
OTHERS
NOBINERVE CAPSULE is not recommended for use if you:
Have Leber?s disease (a hereditary eye disease)

Have problems in glucose metabolism (Ex. galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
Before taking this medicine, inform your physician if you:
Have history of misuse or substance abuse

Have folate deficiency

Have diabetes

Have epilepsy

Have or at risk of encephalopathy (a brain disease)
Use in Pediatrics:
NOBINERVE CAPSULE is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety data. Consult your child?s doctor for advice.
Use in Geriatrics:
NOBINERVE CAPSULE should be used with caution in elderly patients (aged 65 years and above), especially in patients with decreased renal function. Proper dose adjustments and careful monitoring of kidney function are required in such patients. Consult your doctor before taking NOBINERVE CAPSULE.
INTERACTIONS
A. Drug-Drug interactions:
Before taking NOBINERVE CAPSULE, inform your doctor, if you are taking any of the following medicines:
Medicines used to reduce blood glucose level (Ex. metformin, pioglitazone, rosiglitazone)

Anti-spasticity agents (used to reduce muscle stiffness) Ex. dantrolene, baclofen

Opioid analgesics (Ex. morphine, pethidine) (used to treat severe pain)

CNS depressants (Ex. lorazepam) (used to treat anxiety)

Oral contraceptives (birth control pills) Ex. norethisterone and/or ethinyl estradiol

Chloramphenicol (an antibiotic used to treat bacterial infections)

Large doses of folic acid (a vitamin supplement)

Vitamin C supplements

Medicines used to control blood cholesterol levels (Ex. cholestyramine or colestipol)

Colchicine (used to treat gout)

Para-amino salicylic acid?(used to treat tuberculosis)

Potassium chloride (used to treat low potassium levels)

Nitrous oxide (an anesthetic)
Overdosage:
If you or anyone else accidentally take too much of NOBINERVE CAPSULE, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of NOBINERVE CAPSULE might include sleepiness, confusion, agitation, restlessness, seizures and coma.
SYNOPSIS

Drug :?? Pregabalin, Methylcobalamin

Pharmacological Category :?? Anticonvulsants, Vitamin B complex

Therapeutic Indication :?? Neuropathic pain

Dosage Forms :?? Tablet, Capsule, Soft gels

MORE INFORMATION

Keep NOBINERVE CAPSULE out of reach of children

Store NOBINERVE CAPSULE at room temperature

FAQs ABOUT NOBINERVE CAPSULE
Q: Can NOBINERVE CAPSULE affect fertility?
A: Fertility studies in men have shown that there were no effects on sperm motility. However, NOBINERVE CAPSULE can be associated with an increased risk of male-mediated teratogenicity (abnormalities in fetus). Men being treated with NOBINERVE CAPSULE who plan to father a child should be informed about the potential risk of male-mediated teratogenicity. There are not enough clinical data on the effects of this medicine on female fertility.
Q: Can NOBINERVE CAPSULE cause weight gain?
A: Yes, NOBINERVE CAPSULE can cause weight gain in some individuals mainly due to the formation of peripheral edema (fluid retention). Weight gain can be more prominent among diabetic patients who are treated with thiazolidinediones (Ex. pioglitazone, rosiglitazone) and so inform your doctor if you have diabetes prior to treatment with NOBINERVE CAPSULE as a precaution.
Q: Can NOBINERVE CAPSULE decrease libido?
A: Yes, NOBINERVE CAPSULE may cause decrease in sex drive (libido) in some individuals, although not everybody gets them. Consult your doctor if this symptom troubles you.
Q: Is NOBINERVE CAPSULE addictive?
A: Yes, NOBINERVE CAPSULE has high potential to create substance abuse or dependence and therefore caution should be exercised among patients who already has a history of substance abuse. Careful monitoring of symptoms of abuse are required in such patients.
Q: Can I stop taking NOBINERVE CAPSULE once my pain is relieved?
A: No. Do not stop taking NOBINERVE CAPSULE without consulting your doctor as it could precipitate withdrawal symptoms such as headache, lack of sleep, nausea, pain, diarrhea, flu syndrome, anxiety, nervousness, depression, convulsion, hyperhidrosis and dizziness and dependence. If your condition improves, contact your doctor so that he might reduce the dose appropriately before discontinuation of the therapy with NOBINERVE CAPSULE.
REFERENCES
1. KD. Tripathi. Antiepileptic Drugs & Hematinics and Erythropoietin. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 420 & 608.
2. Gerald G. Briggs and Roger K. Freeman. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page ? 3223-3225.
3. Yasmin U Dongre?and?Onkar C Swami. Sustained release pregabalin with methylcobalamin in neuropathic pain: an Indian real-life experience. NCBI; PMC US National Library of Medicine, National Institute of Health. May 2013. [Accessed on 21st October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3674019/
4. Gupta JK and Qureshi Shaiba Sana. Potential Benefits of Methylcobalamin: A Review. Austin Potential benefits of Pharmacology and Therapeutics. 2015. [Accessed on 21st October 2022] https://austinpublishinggroup.com/pharmacology-therapeutics/fulltext/ajpt-v3-id1076.php
5. Ram Prabhoo,?Atul Panghate,?Raj Pavitra Dewda,?Balaji More,?Tanay Prabhoo and?Rajiv Rana. Efficacy and Tolerability of a Fixed Dose Combination of Methylcobalamin and Pregabalin in the Management of Painful Neuropathy. NCBI; PMC US National Library of Medicine, National Institute of Health. November 2012. [Accessed on 21st October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3503385/
6. Torrent Pharmaceuticals Ltd. Predgeb M OD (Pregabalin Sustained Release and Methylcobalamin Tablets). Torrentian.com. May 2017. [Accessed on 21st October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/1836.pdf
7. Torrent Pharmaceuticals Ltd. Pregalin M (Pregabalin & Methylcobalamin Capsules). Torrentian.com. May 2017. [Accessed on 21st October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/1428.pdf
8. Cipla Ltd. Nova M Capsules?(Pregabalin + Methylcobalamin). Ciplamed.com. [Revised in May 2016]. [Accessed on 21st October 2022] https://www.ciplamed.com/content/nova-m-capsules
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