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ROTARO A Tablet 10's
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INTRODUCTION
ROTARO A TABLET is a combination of Aceclofenac and Drotaverine which belongs to the group of medicines called Antispasmodics. It is used to treat dysmenorrhea (menstrual pain), abdominal pain and cramps.
Do not use ROTARO A TABLET if you are allergic to other NSAIDs like ibuprofen or aspirin. Before taking ROTARO A TABLET, inform your doctor if you have a history of stomach ulcer, have vomited blood, passed blood in faeces, have any kidney, heart, liver, bowel or blood clotting problems, porphyria, diabetes, chicken pox or if you have undergone any bypass surgery.
ROTARO A TABLET is not recommended for use in pregnant and breastfeeding women unless considered necessary by your doctor. ROTARO A TABLET is not recommended for use in children and adolescents (under 18 years of age) so, consult your child’s doctor for advice.
Avoid smoking while taking ROTARO A TABLET. The most common side effects of taking ROTARO A TABLET are dizziness, dry mouth, nausea, sleepiness, blurred vision and weakness. Contact your doctor if any of the symptoms worsen over time.
USES OF ROTARO A TABLET
Treats,
- dysmenorrhea
- abdominal pain
- cramps
HOW ROTARO A TABLET WORKS
ROTARO A TABLET relieves abdominal pain and cramps where Drotaverine relieves contractions in the abdomen by inhibiting phosphodiesterase-IV (a substance specific for smooth muscles) and Aceclofenac blocks the release of prostaglandins (certain chemicals) responsible for causing pain and inflammation.
DIRECTIONS FOR USE
Always take ROTARO A TABLET as directed by your physician. Swallow the medicine with a glass of water and do not crush or chew the medicine. Your doctor will decide the correct dose and duration of ROTARO A TABLET treatment depending upon your age, body weight and disease condition. Do not stop taking ROTARO A TABLET unless your doctor advises you to stop.
SIDE EFFECTS OF ROTARO A TABLET
COMMON
- dizziness, weakness
- dry mouth, nausea
- sleepiness
- blurred vision
UNCOMMON
- mouth ulcers
- inflammation or irritation of stomach lining
- itching, rash, hives, skin inflammation
- increase in blood urea and creatinine levels
- constipation, gas
RARE
- allergic reaction
- problems with eyesight
- heart failure, high blood pressure, breathlessness
- stomach or bowel bleeding or ulceration
Stop taking this medicine and contact your doctor immediately if you experience any of the following side effects:
- severe allergic reaction like anaphylactic shock (fever, difficulty breathing, wheezing, abdominal pain, vomiting, swollen face and throat)
- frequent infections, such as a sore throat, fever or mouth ulcers
- bruising or bleeding
- severe skin rashes such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (large blisters and the skin peeling away, rash appearing in the mouth, throat or eyes, fever, headache and joint pain)
- meningitis (high fever, headache, vomiting, red rashes, neck stiffness, sensitivity to light)
- blood in faeces or black tarry stools, vomit with blood or dark particles
- kidney failure
- indigestion, heartburn, stomach pain
- blood disorders (extreme tiredness, breathlessness, aching of the joints and becoming prone to repeated infections and bruising)
HOW TO MANAGE SIDE EFFECTS
Nausea:
Take ROTARO A TABLET with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If symptom persists, contact your doctor.
Headache:
Take some rest, in a quiet place. Avoid using mobile phones and other electronic devices for a while. Drink water as inadequate hydration may lead you to develop a headache. If the symptom persists, contact your doctor.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. If the symptom persists, contact your doctor.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use alcoholic mouthwashes because they can make your mouth dry, use the one that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. If dryness persists, consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
ROTARO A TABLET is not recommended for use in pregnant women unless considered clearly necessary (especially in last 3 months). Consult your doctor before taking it.
BREASTFEEDING
ROTARO A TABLET is not recommended for use in breastfeeding women unless considered clearly necessary. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness, spinning sensation, drowsiness, tiredness or any difficulty with your eyesight after taking ROTARO A TABLET.
KIDNEY
ROTARO A TABLET is not recommended for use in patients with severe kidney disease.
ROTARO A TABLET should be used with caution in patients having other kidney diseases. Consult your doctor before taking it.
LIVER
ROTARO A TABLET is not recommended for use in patients who have or suspect they have severe liver failure.
ROTARO A TABLET should be used with caution in patients with other liver diseases. Consult your doctor before taking it.
ALLERGY
Do not take ROTARO A TABLET if you are allergic to Aceclofenac, Drotaverine, aspirin, any other NSAIDs (Ex. ibuprofen, naproxen or diclofenac) or any of the other ingredients of this medicine.
LUNGS
ROTARO A TABLET should be used with caution in patients having asthma or any other breathing problems. Consult your doctor before taking it.
HEART DISEASE
ROTARO A TABLET is not recommended for use in patients having heart diseases like heart attack and cerebrovascular diseases like stroke or mini stroke or those who have undergone a surgery to clear or bypass blockages.
ROTARO A TABLET should be used with caution in patients with angina, blood clots, high blood pressure, cholesterol or other body fats such as triglycerides. Consult your doctor before taking it.
OTHERS
ROTARO A TABLET is not recommended for use if you:
- had, have or suspect that you have a stomach ulcer
- have vomited blood or passed black tarry stools
- have blood circulation problems
- have bleeding or blood clotting disorders
- glaucoma (increased eye pressure)
Before taking ROTARO A TABLET inform your doctor if you:
- have stomach or bowel disorders (Ex. ulcerative colitis, Crohn’s disease, ulceration, bleeding or holes in the stomach or bowel)
- have or had blood circulation problems to your brain
- have porphyria (rare genetic disorder)
- smoke
- have diabetes
- have systemic lupus erythematosus (an autoimmune condition)
- have connective tissue disorders
- have chicken pox
- are recovering from any major surgery
Use in paediatrics:
ROTARO A TABLET is not recommended for use in children and adolescents (below 18 years of age). Consult your child’s doctor for advice.
Use in geriatrics:
ROTARO A TABLET should be used with caution in elderly people. Consult your doctor before taking it.
INTERACTIONS
A. Drug - Drug interactions:
Before taking ROTARO A TABLET, inform your doctor if you are taking any of the following medicines:
- medicines used for mental health problems (Ex. fluoxetine, fluvoxamine, citalopram, escitalopram, paroxetine, sertraline, lithium)
- medicines used to treat heart failure, irregular heartbeats, high blood pressure and other heart problems (Ex. digoxin, enalapril, lisinopril, losartan, candesartan, hydralazine, methyldopa, clonidine, moxonidine, propranolol, quinidine, procainamide)
- medicines used to treat infection (ciprofloxacin, ofloxacin, levofloxacin, moxifloxacin)
- medicines used to treat fluid retention (Ex. hydrochlorothiazide, furosemide, amiloride)
- medicines that stop blood clotting (Ex. warfarin, heparin)
- methotrexate (used to treat cancer and autoimmune disorders like arthritis and skin conditions)
- mifepristone (used to terminate pregnancy)
- medicines used to treat swelling and inflammation (Ex. hydrocortisone, prednisolone)
- medicines used to suppress the immune system after transplant (Ex. ciclosporin, tacrolimus)
- zidovudine (used to treat HIV)
- medicines used to reduce blood sugar levels in diabetes (Ex. glibenclamide, gliclazide, tolbutamide)
- other medicines used to reduce pain (Ex. aspirin, ibuprofen, naproxen, celecoxib, etoricoxib)
- clopidogrel (used to dissolve blood clots)
- phenobarbital (used to control fits)
- levodopa (used in Parkinsons’ treatment)
- morphine (used to treat severe pain)
Overdosage:
If you or anyone else accidentally took too much of ROTARO A TABLET, consult your doctor immediately. Symptoms of ROTARO A TABLET overdose include heart problems or paralysis of breathing center.
SYNOPSIS
| Drug | : | Aceclofenac, Drotaverine |
| Pharmacological Category | : | Non-steroidal anti-inflammatory drugs (NSAIDs), Antispasmodics |
| Therapeutic Indication | : | Dysmenorrhea, Abdominal pain, Cramps |
| Dosage Forms | : | Tablet, Injection |
MORE INFORMATION
- Keep ROTARO A TABLET out of reach of children
- Store ROTARO A TABLET at room temperature
FAQs ABOUT ROTARO A TABLET
Can I take paracetamol along with ROTARO A TABLET?
No, if you take paracetamol along with ROTARO A TABLET, it will result in overdosing of NSAIDs, affecting the liver. Avoid taking any other painkillers along with ROTARO A TABLET without your doctor’s advice.
Can ROTARO A TABLET cause dizziness?
Yes, dizziness is a common side effect caused by ROTARO A TABLET. Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines if you feel dizzy. Contact your doctor if dizziness persists.
Can I take additional doses of ROTARO A TABLET if my pain does not reduce?
No, you are not advised to take additional doses of ROTARO A TABLET without doctor’s advice as it may cause seriously harmful effects. If you or anyone else accidentally took too much of ROTARO A TABLET, consult your doctor immediately.
What if I miss a dose of ROTARO A TABLET?
If you miss a dose of ROTARO A TABLET, take it as soon as you remember. However, skip that dose if it's almost time to take the next dose. Do not take ROTARO A TABLET two times to make up for the missed dose.
Can I stop taking ROTARO A TABLET if I feel better?
Keep taking ROTARO A TABLET until your doctor tells you to stop, unless you experience any unusual effects, worsening of your condition or any new symptoms. Contact your doctor in such situation.
Can ROTARO A TABLET be taken in pregnancy?
ROTARO A TABLET is not recommended for use in pregnancy unless your doctor finds it necessary (especially in last 3 months). If you are pregnant, think you may be pregnant or are planning to have a baby, consult your doctor before taking ROTARO A TABLET.
REFERENCES
1. KD. Tripathi. Anticholinergic Drugs and Drugs Acting on Autonomic Ganglia. NSAIDs and Antipyretic-Analgesics. Essentials of medical pharmacology. Eighth edition. 2019. Page- 129, 221.
2. Pareek A, Chandurkar NB, Patil RT, Agrawal SN, Uday RB, Tambe SG. Efficacy and safety of aceclofenac and drotaverine fixed-dose combination in the treatment of primary dysmenorrhoea: a double-blind, double-dummy, randomized comparative study with aceclofenac. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. June 2015. [Accessed on 26th April 2022] https://pubmed.ncbi.nlm.nih.gov/20554370/
3. Janczura, Magdalena, Malgorzata Kobus-Moryson, Szymon Sip, Marcin Zarowski, Agnieszka Warenczak and Judyta Cielecka-Piontek. 2021. "Fixed-Dose Combination of NSAIDs and Spasmolytic Agents in the Treatment of Different Types of Pain—A Practical Review. Journal of Clinical Medicine. July 2021. [Accessed on 26th April 2022] https://www.mdpi.com/20770383/10/14/3118/htm#:~:text=The%20combination%20of%20analgesic%20(metamizole,%2C%20menstruation%2C%20migraine%2C%20etc.
4. Accord Healthcare Limited. Electronic Medicines Compendium (EMC) [Revised in January 2021] [Accessed on 26th April 2022] https://www.medicines.org.uk/emc/files/pil.4240.pdf
5. Belmedpreparaty. Drotaverine Hydrochloride. [Accessed on 26th April 2022] https://www.belmedpreparaty.com/product/anot.php?anat_id=396&lang_id=2
6. Leeford Healthcare. Spastone RM (Aceclofenac + Drotaverine). [Accessed on 26th April 2022] https://www.leeford.in/product/805/spastone-rm
AUTHOR DETAILS
Written By Dr. Jeenal Rajani, Pharm.D.
Last updated on 23 Nov 2022 | 02:01 PM(IST)
The contents of this website are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Do not disregard professional medical advice or delay in seeking it because of something you have read on this website.