Rotec 50 50mg+200mcg Tablet 10 ‘S

Rotec 50 50mg+200mcg Tablet 10 ‘S is prescribed to treat inflammation (swelling) and pain,especially in the joints 

Rotec 50 50mg+200mcg Tablet 10 ‘S is also be prescribed to treat backache, migraine, menstrual cramps, toothaches, and rheumatoid arthritis

Rotec 50 50mg+200mcg Tablet 10 ‘S contains Diclofenac Sodium and Misoprostol

Rotec 50 50mg+200mcg Tablet 10 ‘S is taken orally (via mouth) 

 

 

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Description

Rotec 50 50mg+200mcg Tablet 10 ‘S belongs to a class of drugs called “anti-inflammatory and anti-rheumatics” (phenylacetic acid/Cox-2 inhibitor) used as a prophylaxis treatment against NSAIDs induced gastric ulcers in rheumatoid arthritis and osteoarthritis. 

Rotec 50 50mg+200mcg Tablet 10 ‘S is a combination of two medicines. Diclofenac sodium is classified as a non steroidal anti-inflammatory drug (NSAID) that prevents pain and inflammation (redness and swelling) by blocking the release of chemical messengers (prostaglandins) responsible for it. However, it may cause gastric (stomach) ulcers. On the other hand, misoprostol is a prostaglandin analogue which plays a role in protecting your stomach and preventing ulcer formation. 

Rotec 50 50mg+200mcg Tablet 10 ‘S is available on prescription, as an oral-delayed release tablet. It is prescribed for treating symptoms of rheumatoid arthritis and osteoarthritis if you’re at risk of stomach ulcers from other pain medications.

Common side effects of this medication are nausea, vomiting, diarrhoea, indigestion, loss of appetite.

Dosage of Rotec 50 50mg+200mcg Tablet 10 ‘S depends on age, severity of condition, patient’s response to medicine and their comorbidities.

Indications

Rotec 50 50mg+200mcg Tablet 10 ‘S is prescribed to adults only and is not recommended for children. 

It is used as a prophylaxis treatment against NSAIDs induced gastric ulcers in rheumatoid arthritis and osteoarthritis.

How does Rotec 50 50mg+200mcg Tablet 10 ‘S work?

Rotec 50 50mg+200mcg Tablet 10 ‘S is a combination of two medicines. Diclofenac sodium is classified as a non steroidal anti-inflammatory drug (NSAID) that prevents pain and inflammation (redness and swelling) by blocking the release of chemical messengers (prostaglandins) responsible for it. However, it may cause gastric (stomach) ulcers. On the other hand, misoprostol is a prostaglandin analogue which plays a role in protecting your stomach and preventing ulcer formation.

How to use Rotec 50 50mg+200mcg Tablet 10 ‘S?

  • Rotec 50 50mg+200mcg Tablet 10 ‘S is available as an oral-delayed release tablet.
  • It should be swallowed whole with a glass of water, juice or milk. Do not break/crush, chew, or dissolve the tablets. Doing so might increase the risk of side effects with the medicine.  
  • Make sure to take them after a meal or snack to avoid getting an upset stomach and chances of diarrhoea.
  • Do not lie down for at least 10 minutes after taking Rotec 50 50mg+200mcg Tablet 10 ‘S
  • Avoid taking antacids containing magnesium when taking Rotec 50 50mg+200mcg Tablet 10 ‘S as it may worsen your diarrhoea. 
  • Use Rotec 50 50mg+200mcg Tablet 10 ‘S regularly as prescribed to get the most benefit out of it.

Dosage

Dosage of Rotec 50 50mg+200mcg Tablet 10 ‘S depends on severity of condition, patient’s response to medicine and other medications you may be taking alongside this medicine.

  • Form: oral delayed-release tablet
  • Strengths: 50 mg diclofenac/200 mcg misoprostol, 75 mg diclofenac/200 mcg misoprostol.

Rheumatoid arthritis:

  • Recommended dose: 1 tablet (diclofenac 50 mg-misoprostol 200 mcg) orally 3 to 4 times a day
  • Maximum doses: diclofenac 225 mg/day; misoprostol 200 mcg/dose and 800 mcg/day

Osteoarthritis: 

  • Recommended dose: 1 tablet (diclofenac 50 mg-misoprostol 200 mcg) orally 3 times a day
  • Maximum doses: diclofenac 150 mg/day; misoprostol 200 mcg/dose and 800 mcg/day

People aged 65 years and older are usually prescribed the lowest dose as they might react more strongly to Rotec 50 50mg+200mcg Tablet 10 ‘S.

Pregnancy use and lactation

If you are pregnant, think you may be pregnant or are planning to have a baby, please consult your doctor before using Rotec 50 50mg+200mcg Tablet 10 ‘S as it is contraindicated.

If you are breastfeeding, please consult your doctor before taking Rotec 50 50mg+200mcg Tablet 10 ‘S as it is contraindicated.

Contraindications

Please inform your doctor if you have a history of any before using Rotec 50 50mg+200mcg Tablet 10 ‘S:

  • Allergic reaction to Rotec 50 50mg+200mcg Tablet 10 ‘S – indicated by skin rash, swelling around face area, wheezing, chest tightness and breathing difficulty
  • Active peptic ulcer (stomach sores)
  • Aspirin/anti-inflammatory drug (such as ibuprofen or naproxen) induced allergy or asthma
  • Proctitis (inflamed rectum or anus)..
  • Severe hepatic or renal impairment (liver or kidney damage)
  • Ischaemic heart disease (recurring chest pain)
  • Cerebrovascular (blood vessels within the brain) disease
  • Peripheral arterial disease (narrowed arteries outside the brain and heart)
  • Congestive heart failure
  • Treatment of pain before CABG surgery. 

Precautions

Please tell your doctor about any of the following conditions while using Rotec 50 50mg+200mcg Tablet 10 ‘S:

  • History of gastro-intestinal (stomach and bowels) disease such as crohn’s disease or ulcerative colitis 
  • Renal (kidney), hepatic (liver) or cardiac (heart) insufficiency and haematological (blood-related) abnormalities
  • Porphyria (group of rare inherited blood disorders)
  • Patient with extracellular volume depletion from any cause (severe dehydration)
  • Old age
  • Cardiovascular (blood vessels in heart) disease
  • Hypertension (high blood pressure) – monitor BP throughout therapy
  • Coagulation defects (blood-clotting defects)
  • Cerebrovascular coronary or peripheral disease. 
  • Pre-menopausal women should use effective contraception. 
  • Haematopoietic disorders, defective coagulation or history of cerebrovascular bleeding
  • Monitor liver function periodically. 
  • Monitor blood counts and renal function during long term treatment. 
  • Use the lowest effective dose for the shortest duration. 

Interaction with other medications

Certain medications could interact with Rotec 50 50mg+200mcg Tablet 10 ‘S, hence, in that case your doctor might alter your dosage and make sure to monitor blood sugar levels more closely.

Please inform your doctor about the use of the following before taking Rotec 50 50mg+200mcg Tablet 10 ‘S:

  • Salicylates
  • Methotrexate
  • Lithium
  • Digoxin
  • Diuretics
  • Cyclosporin
  • Anticoagulants
  • Oral hypoglycemics
  • Quinolones
  • NSAIDs
  • Corticosteroids
  • Methotrexate
  • Tacrolimus
  • Azole antifungals
  • Antiplatelets
  • SSRls
  • Antihypertensives
  • Mifepristone antacids
  • CYP2C9 inhibitors. 

Adverse effects

Like most medicines, Rotec 50 50mg+200mcg Tablet 10 ‘S has some side effects which include:

Common:

  • Nausea 
  • Vomiting 
  • Diarrhoea 
  • Indigestion (stomach ache)
  • Loss of appetite 

Serious:

  • Hypersensitivity/allergic skin reactions; in this case discontinue 
  • Menorrhagia
  • Intermenstrual bleeding
  • Headache
  • Edema
  • Pruritus
  • Fetal malformation
  • Raised LFTs. 
  • difficult or painful swallowing,
  • swelling of the hands or feet,
  • sudden or unexplained weight gain,
  • vision changes,
  • mental/mood changes (e.g., depression),
  • fast or pounding heartbeat,
  • persistent or severe headache,
  • fainting
  • unusual tiredness,
  • easy bruising or bleeding,
  • signs of infection (e.g., fever, persistent sore throat),
  • changes in the amount of urine
  • unexplained stiff neck

How to cope with some of the adverse effects

  • Nausea (feeling sick) Take Rotec 50 50mg+200mcg Tablet 10 ‘S with meals to avoid feeling sick.
  • Vomiting/Diarrhoea – Keep yourself hydrated by having lots of fluids and if the problem persists, consult your doctor before taking any medication for vomiting and diarrhoea
  • Loss of appetite – Continue having your meals at times that you would usually have them. If it helps, decrease the portion of your meals and have them more frequently. Snack on high protein food items like fruits and nuts. 
  • Indigestion – Avoid food items that cause wind. Try having smaller and more frequent meals.
  • Headache – Take a painkiller, rest and keep yourself hydrated at all times. Contact your doctor if your headaches last more than a week and/or become severe.

Inform your doctor immediately if you experience any of the serious side effects.

Key facts about Rotec 50 50mg+200mcg Tablet 10 ‘S

  • Rotec 50 50mg+200mcg Tablet 10 ‘S belongs to a class of drugs called “anti-inflammatory and anti-rheumatics” (phenylacetic acid/Cox-2 inhibitor) used as a prophylaxis treatment against NSAIDs induced gastric ulcers in rheumatoid arthritis and osteoarthritis.
  • Common side effects of this medication are nausea, vomiting, diarrhoea, indigestion, loss of appetite.
  • Rotec 50 50mg+200mcg Tablet 10 ‘S is available as an oral-delayed release tablet
  • Avoid taking antacids containing magnesium when taking Rotec 50 50mg+200mcg Tablet 10 ‘S as it may worsen your diarrhoea.
  • Do not increase your dose or use Rotec 50 50mg+200mcg Tablet 10 ‘S for more than the prescribed time period. 
  • In order to prevent the risk of stomach bleeding and other side effects, start taking Rotec 50 50mg+200mcg Tablet 10 ‘S at the lowest effective dose for the shortest possible time. 
  • It is prescribed to adults only and is not recommended for children. 
  • Rotec 50 50mg+200mcg Tablet 10 ‘S should be taken with food or milk to prevent upset stomach
  • Common side effects of this medication are nausea, vomiting, diarrhoea, indigestion, loss of appetite.
  • Matter of concern arises if you get a rash, itchy skin, swelling on the face and difficulty breathing, in which case you need to inform your doctor immediately. 
  • Long term use may lead to blood, kidney and liver problems hence your doctor will be regularly monitoring your organ functions.

FAQs

1. WHAT EXACTLY DOES Rotec 50 50mg+200mcg Tablet 10 ‘S DO?

Rotec 50 50mg+200mcg Tablet 10 ‘S is a combination of two medicines. Diclofenac sodium is classified as a non steroidal anti-inflammatory drug (NSAID) that prevents pain and inflammation (redness and swelling) by blocking the release of chemical messengers (prostaglandins) responsible for it. However, it may cause gastric (stomach) ulcers. On the other hand, misoprostol is a prostaglandin analogue which plays a role in protecting your stomach and preventing ulcer formation.

2. HOW LONG DOES IT TAKE FOR Rotec 50 50mg+200mcg Tablet 10 ‘S TO START WORKING?

It starts working in a few hours but it may take upto 2 weeks of taking Rotec 50 50mg+200mcg Tablet 10 ‘S regularly before you get the full benefit of it. 

3. HOW LONG WILL I HAVE TO TAKE Rotec 50 50mg+200mcg Tablet 10 ‘S FOR?

The duration for using Rotec 50 50mg+200mcg Tablet 10 ‘S depends on the condition it is prescribed for. Take it regularly for the prescribed time period. Use the lowest effective dose for the shortest duration.

4. CAN I STOP TAKING Rotec 50 50mg+200mcg Tablet 10 ‘S?

Do not just stop taking the medicine, make sure to complete your treatment course even if you feel better.

5. CAN I DRINK ALCOHOL WITH Rotec 50 50mg+200mcg Tablet 10 ‘S?

Avoid consuming alcohol when taking Rotec 50 50mg+200mcg Tablet 10 ‘S to prevent stomach bleeding and ulcers. 

6. WHAT IF I TAKE TOO MUCH OF Rotec 50 50mg+200mcg Tablet 10 ‘S?

If you have taken too much of the prescribed Rotec 50 50mg+200mcg Tablet 10 ‘S you may experience common side effects like nausea, vomiting, diarrhoea, stomach ache, headaches, dizziness, ringing in the ear (tinnitus) and black stool or bloody vomit – a sign of bleeding in the stomach; in which case inform your doctor immediately. 

7. WHAT IF I FORGET TO TAKE Rotec 50 50mg+200mcg Tablet 10 ‘S?

Incase you miss a dose, take your next dose on time and do not try making up for the missed dose by doubling it up. If it helps to remind you, set an alarm so you do not miss any dose. Make sure to complete your course of treatment even if you feel better and think you do not need to take it anymore.

8. CAN I TAKE Rotec 50 50mg+200mcg Tablet 10 ‘S DURING PREGNANCY OR BREASTFEEDING?

Rotec 50 50mg+200mcg Tablet 10 ‘S can cause birth defects, miscarriage, premature labor, or rupture of the uterus if taken while pregnancy. Make sure you consult your doctor if you are breastfeeding as It is not known whether Rotec 50 50mg+200mcg Tablet 10 ‘S passes into breast milk or if it could harm your baby.

9. CAN THE USE OF Rotec 50 50mg+200mcg Tablet 10 ‘S CAUSE DROWSINESS?

It may cause drowsiness, dizziness, fatigue (tiredness) and visual disturbances. However, it is uncommon and is not reported by many people. If you experience any of these symptoms avoid driving or operating heavy machinery.

10. IS IT SAFE TO USE Rotec 50 50mg+200mcg Tablet 10 ‘S FOR A LONG TIME?

Long term use may lead to blood, kidney and liver problems hence your doctor will be regularly monitoring your organ functions. There’s also a small risk of heart failure or kidney failure in people taking very high doses for a long time. Therefore, it’s better to take the lowest dose for the shortest possible time.

11. IS Rotec 50 50mg+200mcg Tablet 10 ‘S SAFE FOR KIDNEYS?

Long-term use and high doses of Rotec 50 50mg+200mcg Tablet 10 ‘S have shown to cause kidney problems  such as protein or blood in urine and painful urination. Patients who are dehydrated, have heart failure, impaired kidney function, hypertension, elderly, who are on medicines which cause excess urination (diuretics), or medicines which have significant impact on kidney function are at maximum risk.. Hence, for such patients regular kidney function monitoring is recommended.

12. WHAT IS THE MOST IMPORTANT INFORMATION I NEED TO KNOW ABOUT Rotec 50 50mg+200mcg Tablet 10 ‘S?

It is important to know that use of Rotec 50 50mg+200mcg Tablet 10 ‘S may increase your chance of having a heart attack or stroke. The risk increases with higher doses taken for a long period of  time. Also, taking Rotec 50 50mg+200mcg Tablet 10 ‘S may cause ulcers, bleeding, or holes in your stomach and intestine. If you experience any such problems, consult your doctor immediately.

13. CAN I DRIVE OR RIDE A BIKE AFTER TAKING Rotec 50 50mg+200mcg Tablet 10 ‘S?

Make sure you know how your body reacts while using Rotec 50 50mg+200mcg Tablet 10 ‘S as it is known to make you feel dizzy. Do not drive or use any machinery until you feel normal again

14. HOW SHOULD Rotec 50 50mg+200mcg Tablet 10 ‘S BE STORED?

Keep the medicine at room temperature in a cool, dry place, away from direct sunlight. Do not keep it in the refrigerator or bathroom. Discard any unused medicine after 14 days. Keep all medications away from children and pets.

Additional information

Type

Tablet

Feature

50mg+200mcg

Unit

'S

Formula

Diclofenac Sodium

Composition

Misoprostol 200 mcg + Diclofenac Sodium 50 mg

Brand

Searle Pharma

Prescription Required

Yes