INTRODUCTION THYLONERV XT CAPSULE is a combination of Alpha lipoic acid, Methylcobalamin, Folic acid, Pregabalin and Pyridoxine which belongs to the group of medicines called Antioxidants, Cyclic GABA analogues and Vitamin B complex respectively. It is used in adults to treat painful diabetic neuropathy (nerve damage occurring over time because of high sugar and fat levels in the blood due to diabetes). The symptoms depend on the type of neuropathy, such as pain and numbness in your feet or problems with organ functions like those of your heart and bladder. Avoid consuming alcohol during treatment with GBNKEYWORD. THYLONERV XT CAPSULE is not recommended for use in children and adolescents (younger than 18 years), so consult your doctor before taking it. Before taking THYLONERV XT CAPSULE, inform your doctor if you have any kidney, liver, heart, respiratory or nervous system problems; diabetes; or a history of alcoholism or any drug abuse or dependence. THYLONERV XT CAPSULE should not be used in pregnant or breastfeeding women unless necessary. The most common side effects of taking THYLONERV XT CAPSULE are dizziness, drowsiness, headache, increased appetite, blurred vision, weight gain etc. Contact your doctor if any of the symptoms get worse. USES OF THYLONERV XT CAPSULE Treats painful diabetic neuropathy in adults HOW THYLONERV XT CAPSULE WORKS THYLONERV XT CAPSULE relieves nerve pain where alpha-lipoic acid reduces oxidative stress, which is considered a main pathophysiology of diabetic neuropathy development, folic acid (Vitamin B9) is found to improve the functional recovery of nerves, speed of nerve conduction and cell multiplication and methylcobalamin takes part in the production of myelin (a compound which covers and protects nerve fibres), thus restoring the damaged nerve cell. Pregabalin binds with high affinity to certain sites in the tissues of the central nervous system and acts as a growth factor for nerve cells, helping to regenerate the damaged nerve tissue and pyridoxine acts as a coenzyme in a wide range of metabolic functions affecting protein, carbohydrate and lipid utilization, like the breakdown of glycogen to glucose-1-phosphate and the synthesis of gamma-aminobutyric acid (GABA). DIRECTIONS FOR USE Take THYLONERV XT CAPSULE as advised by your physician. Swallow it with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of THYLONERV XT CAPSULE for you based on your age, body weight and disease condition. Do not stop taking THYLONERV XT CAPSULE unless your doctor advises you to stop. SIDE EFFECTS OF THYLONERV XT CAPSULE COMMON Dizziness, drowsiness, headache Feeling elated, confused or disorientated Decreased sexual interest, irritability Disturbed attention, clumsiness, memory impairment or loss, shaking, trouble speaking, tingling feeling, numbness, sedation, lethargy, lack of sleep, fatigue, feeling weird Double vision Spinning sensation, problems with balance, fall Increased appetite, dry mouth, constipation, vomiting, gas, diarrhoea, nausea, swollen abdomen Difficulties with erection Swollen body including extremities Feeling drunk, abnormal walking style Weight gain Muscle cramp, joint, back or limb pain Sore throat UNCOMMON Loss of appetite and weight Low or high blood sugar Change in self-perception, agitation, mood swings, restlessness, depression, difficulty finding words Seeing things that are not there, unusual dreams, panic attacks, lack of interest, aggression, elevated mood Mental impairment, trouble thinking, increased sexual interest, sexual problems including inability to achieve a sexual climax, delayed ejaculation Changes in eyesight, unusual eye movement, tunnel vision, flashes of light Jerky movements, reduced reflexes, increased activity, dizziness on standing, skin sensitivity Taste loss, burning sensation, shaking on movement, low or loss of consciousness, increased noise sensitivity, feeling unwell Eye swelling, pain, weakness, watering, irritation or dryness Heart rhythm changes, increased heart rate, low or high blood pressure, changes in heartbeat, heart failure Flushing, hot flushes Nasal dryness or congestion Increased salivation, heartburn, numbness around the mouth Sweating, rash, chills, fever Muscle twitching, swollen joints, stiff muscle, muscle or neck pain Breast pain Troubled or painful urination, incontinence Weakness, thirst, chest tightness Changes in blood and liver test results (high blood creatinine phosphokinase, alanine aminotransferase, aspartate aminotransferase, blood creatinine and low platelet count, neutrophils and blood potassium) Hypersensitivity, swollen face, itchiness, hives, cough, snoring, runny nose, nosebleed Painful menstrual periods Cold hands and feet RARE Abnormal sense of smell, swinging vision, changed the perception of depth, visual brightness, vision loss Dilated pupils, cross eyes Cold sweat, throat tightness Pancreatic inflammation Trouble swallowing Slow or decreased body movement Trouble writing properly Increased abdominal fluid Fluid in the lungs Muscle damage Breast discharge, unusual breast growth, breast enlargement in men Interrupted menstrual periods Decreased white blood cell count Inappropriate behaviour Allergic reactions (trouble breathing, eye inflammation, a serious skin reaction characterized by rash, blisters, peeling skin and pain) Jaundice (yellow skin and eyes) Stop taking THYLONERV XT CAPSULE and contact your doctor immediately if you experience any of the following side effects: Swollen face Skin turning red and starting to blister or peel Allergic reaction (swelling of the face, lips, tongue and throat, diffuse skin rash) Blurring or loss of eyesight or other changes in vision Kidney failure, reduced urine volume Thoughts of harming or killing self Constipation Fits Trouble breathing or shallow breaths HOW TO MANAGE SIDE EFFECTS Nausea: Take THYLONERV XT CAPSULE with or just after, meals. Stick to simple meals. Avoid eating oily or spicy foods. If you still feel nauseous, contact your doctor. Vomiting: Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like eating; you don’t have to eat or avoid any specific foods. If vomiting does not improve, contact your doctor. Constipation: Eat plenty of fibre-rich foods like fresh fruits and vegetables and cereals and drink plenty of water. Exercise more regularly. If you still feel constipated, contact your doctor. Diarrhea: Drink lots of fluids, like water or fruit juice, to keep yourself hydrated. Ask your doctor before taking any medicine for diarrhea. If diarrhoea does not improve, contact your doctor. Gas: Eat smaller and more frequent meals. Eat and drink slowly and exercise regularly. If flatulence does not improve, contact your doctor. Headache: Drink plenty of water and get adequate rest. Try to be relaxed and stress-free. Check with your doctor before taking any medicine for a headache. If your headache does not improve, consult your doctor. Dizziness: Lie down until the dizziness is resolved, then get up slowly. Do not hurry and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol and drugs. If dizziness does not improve, consult your doctor. WARNING & PRECAUTIONS PREGNANCY THYLONERV XT CAPSULE is not recommended for use in pregnant women unless considered necessary. Females of child-bearing capability must use effective contraception. Consult your doctor before taking it. BREASTFEEDING THYLONERV XT CAPSULE is not recommended for use in breastfeeding women unless considered necessary. Consult your doctor before taking it. DRIVING AND USING MACHINES Do not drive or operate any machines if you experience dizziness, sleepiness or decreased concentration after taking THYLONERV XT CAPSULE. ALCOHOL Avoid consumption of alcohol while taking THYLONERV XT CAPSULE. Let your doctor know if you have a history of alcoholism. KIDNEY THYLONERV XT CAPSULE should be taken with caution in patients with kidney disease or impairment. Consult your doctor before taking it. LIVER THYLONERV XT CAPSULE should be taken with caution in patients with liver disease. Consult your doctor before taking it. ALLERGY Do not take THYLONERV XT CAPSULE if you are allergic to Alpha lipoic acid, Methylcobalamin, Folic acid, Pregabalin, Pyridoxine or any of the other ingredients of THYLONERV XT CAPSULE. LUNGS THYLONERV XT CAPSULE should be taken with caution in patients with respiratory disorders. Consult your doctor before taking it. HEART DISEASE THYLONERV XT CAPSULE should be taken with caution in patients with a history of heart disease or who received a coronary stent (a tube inserted in the artery that leads to the heart, to prevent blockages). Consult your doctor before taking it. OTHERS Before taking THYLONERV XT CAPSULE, inform your doctor if you: Have diabetes (high blood sugar) Are prone to constipation Have a history of any drug abuse or dependence Have nervous system disorders Have a folate-dependent tumour Use in Pediatrics: THYLONERV XT CAPSULE is not recommended for use in children and adolescents (under 18 years of age). Consult your doctor before taking it. Use in Geriatrics: THYLONERV XT CAPSULE should be used with caution in elderly patients (aged above 75 years) with kidney problems and the elderly in general as it causes dizziness and sleepiness which could increase the occurrence of accidental injury (fall) in them. Consult your doctor before taking it. INTERACTIONS A. Drug-Drug interactions: Before taking THYLONERV XT CAPSULE, inform your doctor if you are taking any of the following medicines: Oxycodone (used to treat severe pain) Lorazepam (used to treat anxiety) Medicines containing alcohol Overdosage: If you or anyone else accidentally took too much of THYLONERV XT CAPSULE, contact your doctor immediately. Symptoms of THYLONERV XT CAPSULE overdose are sleepiness, confusion, agitation, restlessness or fits. SYNOPSIS Drug :   Alpha Lipoic Acid, Methylcobalamin, Folic Acid, Pyridoxine, Pregabalin Pharmacological Category :   Antioxidants, Vitamins, Cyclic GABA analogues Therapeutic Indication :   Painful diabetic neuropathy Dosage Forms :   Tablet, Capsule MORE INFORMATION Keep THYLONERV XT CAPSULE out of reach from children Store THYLONERV XT CAPSULE below 25°C FAQs ABOUT THYLONERV XT CAPSULE Q: Can I take THYLONERV XT CAPSULE if I have diabetes? A: Before taking THYLONERV XT CAPSULE, inform your doctor if you have diabetes and about the medicines you are taking for it, as according to current clinical practice, some diabetic patients who gain weight on THYLONERV XT CAPSULE treatment may need to adjust the doses of their anti-diabetic medicines. Q: Can THYLONERV XT CAPSULE make me feel suicidal? A: Thoughts of harming or killing oneself are seen in a small number of patients being treated with THYLONERV XT CAPSULE. If at any time you have such thoughts, immediately contact your doctor or go to the nearest hospital. Q: Can THYLONERV XT CAPSULE be taken during pregnancy? A: THYLONERV XT CAPSULE should not be used in pregnant women unless necessary. Females who are of childbearing age must use effective contraception. If you are pregnant, think you may be pregnant or are planning to get pregnant, consult your doctor before taking THYLONERV XT CAPSULE. Inform your doctor immediately if you become pregnant during treatment with THYLONERV XT CAPSULE. Q: Can THYLONERV XT CAPSULE cause constipation? A: THYLONERV XT CAPSULE may cause constipation and other gastrointestinal problems like blocked or paralysed intestines when taken with other medicines (like some types of pain medicines). In such cases, eat plenty of fibre-rich foods, such as fresh fruits, vegetables and cereals and drink plenty of water. Inform your doctor if you feel constipated, especially if you are prone to this problem. Q: Can I drink alcohol during treatment with THYLONERV XT CAPSULE? A: Avoid drinking alcohol during treatment with THYLONERV XT CAPSULE and inform your doctor if you have a history of alcoholism. Q: Can THYLONERV XT CAPSULE be given to children? A: No. THYLONERV XT CAPSULE is used for adults and not recommended for children and adolescents below 18 years of age, as the safety and efficacy of THYLONERV XT CAPSULE in this age group have not been established. Your doctor will select a suitable alternative treatment for your child. Q: Can I take THYLONERV XT CAPSULE on an empty stomach? A: Take THYLONERV XT CAPSULE as advised by your physician. You take it with or without food. However, if you feel nauseous, take THYLONERV XT CAPSULE with meals or just after meals. Q: What if I forget to take a dose of THYLONERV XT CAPSULE? A: If you forget to take a dose of THYLONERV XT CAPSULE, take it as soon as you remember. However, omit the missed dose if it is almost time for the next one. Do not take THYLONERV XT CAPSULE twice to make up for the missed dose. Q: Can I stop taking THYLONERV XT CAPSULE on my own? A: Continue taking THYLONERV XT CAPSULE until your doctor tells you to stop, unless you experience any unwanted effects, a worsening of your condition or any new symptoms. In such a case, contact your doctor. Your doctor will advise you to stop taking THYLONERV XT CAPSULE gradually over a period of at least one week. Q: Can THYLONERV XT CAPSULE discontinuation cause withdrawal symptoms? A: After stopping THYLONERV XT CAPSULE treatment, you may experience certain side effects like trouble sleeping, headache, nausea, anxiety, diarrhoea, flu-like symptoms, fits, nervousness, depression, pain, sweating and dizziness. There are more chances of getting these symptoms if you have been taking this medicine for a longer period. If you have any further doubts regarding the use of THYLONERV XT CAPSULE, ask your doctor. Q: How should THYLONERV XT CAPSULE be taken? Can it be crushed? A: No. Do not break, crush or chew THYLONERV XT CAPSULE. Take it as advised by your physician. Swallow it with a glass of water. Your doctor will determine the correct dose and duration for you based on your age, body weight and disease condition. REFERENCES 1. KD Tripathi. Antiepileptic Drugs. Drugs Affecting Blood and Blood Formation. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 420, 608. 2. Serhiyenko V, Serhiyenko L, Suslik G et al. Alpha-lipoic acid: mechanisms of action and beneficial effects in the prevention and treatment of diabetic complications. MOJ Public Health. MedCrave. July 2018. [Accessed on 2nd August 2022] https://medcraveonline.com/MOJPH/alpha-lipoic-acid-mechanisms-of-action-and-beneficial-effects-in-the-prevention-and-treatment-of-diabetic-complications.html 3. Kang WB, Chen YJ, Lu DY, Yan JZ. Folic acid contributes to peripheral nerve injury repair by promoting Schwann cell proliferation, migration and secretion of nerve growth factor. NIH National Library of Medicine, National centre for biotechnology information. PubMed Central. January 2019. [Accessed on 2nd August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6263007/ 4. Vasudevan D, Naik MM, Mukaddam QI. Efficacy and safety of methylcobalamin, alpha lipoic acid and pregabalin combination versus pregabalin monotherapy in improving pain and nerve conduction velocity in type 2 diabetes associated impaired peripheral neuropathic condition. [MAINTAIN]: Results of a pilot study. NIH National Library of Medicine, National canter for biotechnology information. PubMed Central. January 2014. [Accessed on 2nd August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3992764/ 5. Innova Captab Ltd. Alpha Lipoic Acid Methylcobalamin Folic Acid Pregabalin Pyridoxine. [Revised in May 2021] [Accessed on 2nd August 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2732.pdf 6. Micro Labs Ltd. Alpha Lipoic Acid Methylcobalamin Folic Acid Pregabalin Pyridoxine. [Accessed on 2nd August 2022] https://www.microlabsltd.com/elibrary/node/1891 USEFUL DIAGNOSTIC TESTS Nerve conduction testing Electromyography Country Of Origin India