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INTRODUCTION
DULOBA M 20 TABLET is a combination of Duloxetine and Methylcobalamin which belongs to the group of medicines called Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) and Vitamins. It is indicated for the treatment of neuropathic pain.
DULOBA M 20 TABLET is not recommended for use in patients with liver or severe kidney disease. Contact your doctor before taking DULOBA M 20 TABLET should be used with caution in patients with kidney disease. [GBNKKEYWORD] is generally not recommended for use in pregnancy unless necessary.
DULOBA M 20 TABLET should not be used by breastfeeding women because it may pass through the breast milk.DULOBA M 20 TABLET is generally not advised for use in children and adolescents under the age of 18 unless necessary.
DULOBA M 20 TABLET should be used with caution in patients over the age of 65. Specific serious side effects include the risk of suicidal ideation or behaviour (suicidality) after taking DULOBA M 20 TABLET. This medicine's most common side effects are headache, feeling sleepy, nausea, dry mouth, etc. Contact your physician if any of the symptoms worsen.
USES OF DULOBA M 20 TABLET
- Treats neuropathic pain
HOW DULOBA M 20 TABLET WORKS
DULOBA M 20 TABLET helps treat neuropathic pain, whereas duloxetine increases serotonin and noradrenaline levels in the brain. These messengers inhibit the pain signals reaching the brain and methylcobalamin, which helps in the production of myelin, a substance that protects nerve fibres and rejuvenates damaged nerve cells, Together, relieves neuropathic pain.
DIRECTIONS FOR USE
Take this medicine as advised by your physician. Swallow this medicine as a whole with a glass of water and do not crush or chew the medicine.
SIDE EFFECTS OF DULOBA M 20 TABLET
COMMON
- headache, feeling sleepy
- nausea, dry mouth
- constipation, diarrhoea, stomach pain, vomiting, heartburn or indigestion, flatulence
- lack of appetite
- trouble sleeping, feeling agitated
- decreased sexual drive
- failure to experience orgasm
- anxiety
- unusual dreams
- dizziness, sluggish, tremor, numbness, pricking or tingling of the skin
- blurring of eyes
- tinnitus
- feeling pressure on the heart
- increased blood pressure, flushing
- increased yawning
- increased sweating, (itchy) rash
- muscle pain or spasm
- painful urination, frequent urination
- problems getting an erection
- changes in ejaculation
- falls
- fatigue
- weight loss
UNCOMMON
- throat inflammation causing a hoarse voice
- suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of motivation
- sudden involuntary jerks or muscle twitches, the sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty in concentration, changes in sense of taste, difficulty in controlling movement ex. lack of coordination or involuntary muscle movements, restless legs syndrome and decreased sleep
- large pupils, problems with eyesight
- dizziness or spinning sensation (vertigo), ear pain
- heart palpitations
- fainting, dizziness, light-headedness or fainting on standing up, cold fingers and toes
- throat tightness, nose bleeds
- vomiting blood or black tarry stools (faeces), gastroenteritis, burping, difficulty in swallowing
- night sweats, hives, cold sweats, sensitivity to sunlight and bruises easily
- muscle tightness or twitching
- difficulty in urination
- abnormal vaginal bleeding
- abnormal periods such as heavy, painful, irregular or prolonged periods or light or missed periods,
- pain in the testicles or scrotum
- pain in the chest
- coldness, thirsty
- shivers, feeling hot
- abnormal gait
- weight gain
- increases in liver enzymes
- increase in potassium
- increase in creatine phosphokinase
- elevated sugar levels
- increased cholesterol in the blood
RARE
- decreased thyroid function causing tiredness or weight gain
- low sodium levels (hyponatremia), dehydration
- syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
- serotonin syndrome (feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
- fits
- increased pressure in the eye (glaucoma)
- coughing, wheezing and shortness of breath, accompanied by a high fever
- mouth inflammation
- passing red-coloured stools
- bad breath, inflammation of the large intestine causing diarrhoea
- contraction of the jaw muscle
- change in urine smell
- symptoms of menopause
- abnormal breast milk production in men or women
- excessive vaginal bleeding after birth (postpartum haemorrhage)
- acne-like and blister rashes
Stop taking DULOBA M 20 TABLET and contact your physician immediately if you experience any of the following side effects:
- allergic reaction such as itchy rash, swelling of the face, lips, tongue or throat causing difficulty in breathing
- symptoms of Stevens-Johnson syndrome such as serious illness with blisters on the skin, mouth, eyes and genitals
- symptoms of liver disease such as yellowish discolouration of the skin or whites of the eyes (jaundice), abdominal pain
- vomiting blood or black tarry stools
- mania (over-activity), hallucinations, aggression and anger
- suicidal behaviour or thoughts about suicide or dying
- new or worsening depression
- new or worsening anxiety
- feeling very agitated or restless
- panic attacks
- insomnia
- new or worse irritability
- aggressiveness, being angry or violent
- acting on dangerous impulses
- other unusual changes in behaviour or mood
HOW TO MANAGE SIDE EFFECTS
Nausea, vomiting:
Take this medicine with meals or just after meals. Stick to simple meals. Avoid eating oily or spicy foods.
Headache:
Rest and relax. Drink plenty of fluids, such as water or electrolytes and apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if the symptom does not improve.
Diarrhoea:
Drink lots of fluids, such as water or fruit juices, to keep you hydrated. Take no medication on your own to treat diarrhoea. Contact your doctor if the symptom does not improve.
Stomach pain:
Try to rest and relax. Consume small meals regularly. Keep a heating pad on your stomach. Contact your doctor if the symptom does not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not consume alcohol, as it can aggravate your dizziness. Contact your doctor if the symptom does not improve.
Flatulence:
Eat smaller and more frequent meals. Eat and exercise regularly. Contact your doctor if the symptom does not improve.
Constipation:
Eat plenty of fibre-rich foods, such as fresh fruits, vegetables and cereals and drink water. Exercise regularly.
Skin rash:
Avoid hot showers because hot water can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturise your skin. Contact your doctor if the symptoms do not resolve.
WARNING & PRECAUTIONS
PREGNANCY
[GBNKKEYWORD] is generally not recommended for use in pregnancy unless considered necessary. Contact your doctor before taking it.
BREASTFEEDING
DULOBA M 20 TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Contact your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy or sleepy after taking DULOBA M 20 TABLET.
ALCOHOL
Avoid consumption of alcohol while taking DULOBA M 20 TABLET as it may lead to unwanted effects.
KIDNEY
DULOBA M 20 TABLET is not recommended for use in patients with severe kidney disease. Contact your doctor before taking it.
LIVER
DULOBA M 20 TABLET is not recommended for use in patients with liver disease. Contact your doctor before taking it.
ALLERGY
Do not take DULOBA M 20 TABLET if you are allergic to Duloxetine, Methylcobalamin or sucrose, lactose, some sugars or other ingredients of this medicine.
HEART DISEASE
DULOBA M 20 TABLET should be used with caution in patients with heart diseases. Contact your doctor before taking it.
OTHERS
DULOBA M 20 TABLET is not recommended for use if you have:
- uncontrolled blood pressure
Before taking DULOBA M 20 TABLET, inform your doctor if you have:
- seizures
- mania
- major depressive disorder
- bipolar disorder
- depression or anxiety
- glaucoma
- Leber’s disease
- history of bleeding disorders
- low sodium levels
- low potassium levels
- urinary incontinence or retention
- orthostatic hypotension and syncope
- concomitant illness
- decreased gastric emptying
- diabetes
- pernicious anaemia
- iron or folic acid deficiency
Use in Paediatrics:
DULOBA M 20 TABLET is generally not recommended for use in children and adolescents under 18 years of age unless necessary. Contact your doctor before taking it.
Use in Geriatrics:
DULOBA M 20 TABLET should be used with caution in elderly patients (aged 65 years or above). Contact your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Inform your physician if you are using:
- medicines used for depression like moclobemide, fluvoxamine, nortriptyline, amitriptyline, imipramine, desipramine, clomipramine, paroxetine, fluoxetine, venlafaxine
- benzodiazepines (medicines used for seizures, insomnia) Ex. diazepam
- tramadol, pethidine (medicines used for severe pain)
- antipsychotics like olanzapine and risperidone (medicines used to treat psychoses)
- phenobarbital (medicines used to treat seizures)
- antihistamines like chlorpheniramine (used for allergies)
- linezolid (medicines used to treat bacterial infections)
- St John's Wort (medicines used for depression)
- sumatriptan (medicines used for migraine)
- tryptophan (nutrient supplement)
- theophylline (medicines used to treat asthma)
- tolterodine (a medicine used for overactive bladder)
- flecainide, propafenone and metoprolol (medicines used to treat heart diseases)
- oral contraceptives (used for preventing pregnancy)
- steroids (medicines used to treat pain and inflammation) Ex. prednisone
- anticoagulants Ex. warfarin (medicines used to treat blood clots)
- antiplatelet agents like dipyridamole (medicines used to prevent blood cell clumping)
- aluminium- and magnesium-containing antacids (medicines used to treat heartburn or indigestion)
- cimetidine, famotidine (medicines used for stomach ulcers)
- ciprofloxacin or enoxacin (medicines used for bacterial infections)
- diuretics (medicines used to treat high blood pressure) Ex. Chlorothiazide
- neomycin, chloramphenicol (medicines used to treat bacterial infections)
- colchicine (medicines used to treat gout)
- metformin (medicines used to treat diabetes mellitus)
- omeprazole, lansoprazole (medicines used to treat stomach ulcers, indigestion)
- cholestyramine (medicines used to decrease high cholesterol levels)
- potassium chloride (medicines used to treat potassium correction)
- methyldopa (medicines used for hypertension)
- antimetabolites like fluorouracil (medicines used to treat cancer)
Overdosage:
If you or anyone else accidentally took too much of this medicine, consult your doctor immediately. Symptoms of overdose are somnolence, coma, serotonin syndrome (feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), seizures, syncope, tachycardia, hypotension, hypertension and vomiting.
SYNOPSIS
| Drug | : | Duloxetine, Methylcobalamin |
| Pharmacological Category | : | Serotonin and Norepinephrine Reuptake Inhibitor and Vitamins |
| Therapeutic Indication | : | Neuropathic pain |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep out of reach from children
- Store DULOBA M 20 TABLET below 30°C
FAQs ABOUT DULOBA M 20 TABLET
Q: How does DULOBA M 20 TABLET function?
A: DULOBA M 20 TABLET helps treat neuropathic pain, where duloxetine works by increasing the levels of serotonin and noradrenaline in the brain. These messengers inhibit the pain signals reaching the brain and methylcobalamin, which helps in the production of myelin, a substance that protects nerve fibres and rejuvenates damaged nerve cells, Together, they relieve neuropathic pain.
Q: Does DULOBA M 20 TABLET cause suicidal thoughts?
A: Yes. DULOBA M 20 TABLET causes suicidal thoughts. Stop taking DULOBA M 20 TABLET and contact your doctor if you experience any unusual symptoms, like suicidal ideation or behaviour.
Q: Does DULOBA M 20 TABLET cause weight gain?
A: Yes. DULOBA M 20 TABLET may cause weight gain with long-term use. Contact your doctor before taking it.
Q: Does DULOBA M 20 TABLET cause sleepiness?
A: Yes. DULOBA M 20 TABLET may cause sleepiness. Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling sleepy. Do not consume alcohol, as it can aggravate your sleepiness. Contact your doctor if the symptom does not improve.
Q: What are the side effects of taking DULOBA M 20 TABLET?
A: The most common side effects of this medicine are headache, feeling sleepy, nausea, dry mouth, etc. Contact your physician if any of the symptoms worsen.
REFERENCES
1. KD Tripathi. Antidepressant and Antianxiety drugs & Haematinics and Erythropoietin. Essentials of medical pharmacology. Seventh edition. 2013. Page- 462, 608.
2. Chetna Sharma, Inderpal Kaur, Harpreet Singh, Inderpal Singh Grover and Jatinder Singh. Uses of methylcobalamin plus duloxetine. Indian Journal of Pharmacology. September 2021. [Accessed on 14th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641739/
3. Jaberpreet S. Dhaliwal, Benjamin C. Spurling, Mohammed Molla. Mechanism of duloxetine. National Institute of Health. NLM. National Centre for Biotechnology Information. Pubmed.gov. May 2022. [Accessed on 14th June 2022] https://www.ncbi.nlm.nih.gov/books/NBK549806/
4. Gupta JK, Qureshi Shaiba Sana. Uses of methylcobalamin. Austin Journal of Pharmacology and therapeutics. October 2015. [Accessed on 14th June 2022] https://austinpublishinggroup.com/pharmacology-therapeutics/fulltext/ajpt-v3-id1076.php#:~:text=Methylcobalamin%20helps%20in%20the%20synthesis,approved%20treatment%20for%20peripheral%20neuropathy
5. Eli Lilly and Company. U.S. Food & Drug Administration. [Revised in October 2010] [Accessed on 14th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516lbl.pdf
6. Pharmathen International S.A. Health Products Regulatory Authority (HPRA). [Revised in February 2021] [Accessed on 14th June 2022] https://www.hpra.ie/img/uploaded/swedocuments/7e72e981-379d-4e2b-989b-7e3ff3db9b91.pdf
7. Eli Lilly and Company Limited. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed on 14th June 2022] https://www.medicines.org.uk/emc/files/pil.3880.pdf
8. Recipharm Limited. Electronic Medicines Compendium (EMC). [Revised in April 2019] [Accessed on 14th June 2022] https://www.medicines.org.uk/emc/files/pil.5716.pdf
9. Duloxetine. Torrent Pharmaceuticals Ltd. [Revised in July 2019] [Accessed on 14th June 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2895.pdf
AUTHOR DETAILS
Written By Dr. Dhivakaran R, BDS
Last updated on 24 Dec 2022 | 03:16 PM(IST)
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