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GABATOP 75mg Capsule 10's
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INTRODUCTION
GABATOP 75MG CAPSULE is a combination of Pregabalin and Methylcobalamin which belongs to the group of medicines called Anticonvulsants and Vitamin-B complex respectively. GABATOP 75MG 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 GABATOP 75MG 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.
GABATOP 75MG CAPSULE has high potential to cause addiction and therefore caution should be exercised among patients who already has a history of substance abuse. GABATOP 75MG CAPSULE can cause suicidal ideation in some individuals and therefore appropriate treatment should be considered as soon as the signs emerge.
GABATOP 75MG 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 GABATOP 75MG CAPSULE.
The most common side effects of taking GABATOP 75MG 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 GABATOP 75MG CAPSULE
- Treats neuropathic pain in adults
HOW GABATOP 75MG CAPSULE WORKS
GABATOP 75MG 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 GABATOP 75MG CAPSULE as advised by your physician. Swallow GABATOP 75MG CAPSULE with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of GABATOP 75MG CAPSULE for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF GABATOP 75MG 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 GABATOP 75MG 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 GABATOP 75MG 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 GABATOP 75MG 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 GABATOP 75MG CAPSULE. Women of childbearing potential should use a suitable contraceptive method to avoid pregnancy while taking GABATOP 75MG CAPSULE.
BREASTFEEDING
GABATOP 75MG 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 GABATOP 75MG 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 GABATOP 75MG CAPSULE.
ALCOHOL
Avoid consumption of alcohol while taking GABATOP 75MG CAPSULE, as it may cause impairment of motor skills and sedating effects of alcohol. Consult your doctor before taking GABATOP 75MG CAPSULE.
KIDNEY
GABATOP 75MG CAPSULE should be taken with caution in patients with impaired kidney function. Consult your doctor before taking GABATOP 75MG CAPSULE.
LIVER
GABATOP 75MG CAPSULE should be taken with caution in patients with liver disease. Consult your doctor before taking GABATOP 75MG CAPSULE.
ALLERGY
Do not take GABATOP 75MG CAPSULE if you are allergic to Pregabalin, Methylcobalamin or any other ingredients of GABATOP 75MG CAPSULE.
HEART DISEASE
GABATOP 75MG CAPSULE should be taken with caution in patients with heart disease (such as congestive heart failure). Consult your doctor before taking GABATOP 75MG CAPSULE.
OTHERS
GABATOP 75MG 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:
GABATOP 75MG 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:
GABATOP 75MG 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 GABATOP 75MG CAPSULE.
INTERACTIONS
A. Drug-Drug interactions:
Before taking GABATOP 75MG 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 GABATOP 75MG CAPSULE, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of GABATOP 75MG 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 GABATOP 75MG CAPSULE out of reach of children
- Store GABATOP 75MG CAPSULE at room temperature
FAQs ABOUT GABATOP 75MG CAPSULE
Q: Can GABATOP 75MG CAPSULE affect fertility?
A: Fertility studies in men have shown that there were no effects on sperm motility. However, GABATOP 75MG CAPSULE can be associated with an increased risk of male-mediated teratogenicity (abnormalities in fetus). Men being treated with GABATOP 75MG 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 GABATOP 75MG CAPSULE cause weight gain?
A: Yes, GABATOP 75MG 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 GABATOP 75MG CAPSULE as a precaution.
Q: Can GABATOP 75MG CAPSULE decrease libido?
A: Yes, GABATOP 75MG 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 GABATOP 75MG CAPSULE addictive?
A: Yes, GABATOP 75MG 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 GABATOP 75MG CAPSULE once my pain is relieved?
A: No. Do not stop taking GABATOP 75MG 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 GABATOP 75MG 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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