Systaflam MR Capsule 10'S

Introduction About SYSTAFLAM MR CAPSULE

SYSTAFLAM MR CAPSULE is a combination of Diclofenac and Thiocolchicoside, which belongs to the group of medicines called Non-Steroidal Anti-inflammatory Drugs and Muscle relaxants respectively. It is used in adults to manage painful muscle spasms.

SYSTAFLAM MR CAPSULE can also be used to manage back pain (Ex. ankylosing spondylitis), joint pain and swelling (Ex. osteoarthritis, rheumatoid arthritis), neck pain, sports injuries and sprains.

Take SYSTAFLAM MR CAPSULE with or just after meals. Avoid smoking and consumption of alcohol while undergoing therapy with SYSTAFLAM MR CAPSULE to achieve better results. Before taking SYSTAFLAM MR CAPSULE, inform your doctor if you have any problems in your liver, liver, kidney, heart or stomach.

You much also inform your doctor if you have diabetes, high blood cholesterol, bleeding or blood related problems, fits or allergic conditions (such as skin rash, itching or watery eyes, repeated sneezing, nasal congestion and nasal itching) as a precaution.

Do not take this medicine without consulting your doctor if you have severe bleeding, perforation or ulcers in the stomach or intestines. SYSTAFLAM MR CAPSULE is also not recommended for use in pregnant or breastfeeding women.

The most common side effects of taking SYSTAFLAM MR CAPSULE dizziness, headache, spinning sensation, nausea, vomiting, indigestion, stomach pain, flatulence, loss of appetite, increased liver enzymes and skin rashes. Consult your doctor if any of these side effect worsens.

Uses Of SYSTAFLAM MR CAPSULE

It is used in adults to manage:

• painful muscle spasms
• joint pain, back pain, neck pain
• sprains, sports injury

How SYSTAFLAM MR CAPSULE Works

SYSTAFLAM MR CAPSULE contains two medicines namely diclofenac and thiocolchicoside. Diclofenac is a pain-relieving medication. It acts by blocking the production of certain chemicals (prostaglandins) in the body that causes pain and inflammation.

Thiocolchicoside is a muscle relaxant. It relaxes the muscles by blocking the action of certain chemical messengers (GABA) in the brain that causes muscle spasm. As a result, SYSTAFLAM MR CAPSULE relieves painful muscle spasms associated with inflammatory disease conditions.

How to use SYSTAFLAM MR CAPSULE

Always take SYSTAFLAM MR CAPSULE as directed by your physician. Swallow the medicine with a glass of water and do not crush or chew the medicine. SYSTAFLAM MR CAPSULE should be taken with or after food.

Your doctor will decide the correct dose for you depending upon your age, body weight and health condition.

Side Effects Of SYSTAFLAM MR CAPSULE

How To Manage Side Effects

Diarrhea

Hydrate yourself by drinking plenty of fluids, such as water or fruit juices. Consuming ORS can also be beneficial. Do not self-manage diarrhea on your own. Consult your doctor if your diarrhea becomes uncontrollable.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Indigestion

Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Always try to have a nutritious snack that is high in calories and protein, such as dried fruit and nuts.

Nausea And Vomiting

Take SYSTAFLAM MR CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.

Warning & Precautions

Pregnancy

Contraindicated

SYSTAFLAM MR CAPSULE is not recommended for use in pregnant women, as it may cause harm to unborn baby. Therefore, consult your doctor before taking it. Women of childbearing age must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with SYSTAFLAM MR CAPSULE.

Breastfeeding

Contraindicated

SYSTAFLAM MR CAPSULE is not recommended for use in breastfeeding women. Therefore, consult your doctor before taking it.

Driving and Using Machines

Use with Caution

Do not drive or handle heavy tools or machines if you feel dizzy or drowsy after taking SYSTAFLAM MR CAPSULE.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking SYSTAFLAM MR CAPSULE to avoid the risk of side effects.

Kidney

Consult your doctor

SYSTAFLAM MR CAPSULE is not recommended for use in patients with kidney failure. It should be used with caution in patients with other kidney diseases. Therefore, consult your doctor before taking it.

Liver

Consult your doctor

SYSTAFLAM MR CAPSULE is not recommended for use in patients with liver failure. It should be used with caution in patients with other liver diseases. Therefore, consult your doctor before taking it.

Allergy

Contraindicated

Do not take SYSTAFLAM MR CAPSULE if you are allergic to Diclofenac or Thiocolchicoside.

Lungs

Contraindicated

SYSTAFLAM MR CAPSULE is not recommended for use in patients with asthma attacks. Therefore, consult your doctor before taking it.

Heart Disease

Consult your doctor

SYSTAFLAM MR CAPSULE is not recommended for use in patients with congestive heart failure, or heart attack. It should be used with caution in patients with high blood pressure. Therefore, consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking SYSTAFLAM MR CAPSULE, inform your doctor if you are taking any of the following medicines such as:

• other medicines used for pain relief (Ex. aspirin, celecoxib, ibuprofen)
• medicines used for blood thinning (Ex. warfarin, clopidogrel, prasugrel)
• medicines used to reduce blood pressure (Ex. enalapril, olmesartan, losartan)
• cardiac glycosides used to manage heart failure (Ex. digoxin, digitoxin)
• potassium sparging diuretics (used to manage potassium loss) such as spironolactone, aldosterone
• medicines used to manage bacterial infection (such as trimethoprim, ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin)
• medicines used to manage fungal infections (such as voriconazole)
• medicines used to reduce blood sugar levels (such as glibenclamide, glycoside, and tolbutamide)
• oral corticosteroids (used to manage pain and inflammation) Ex. dexamethasone
• SSRI (used to manage depression) Ex. citalopram, fluoxetine, sertraline
• immunosuppressants (used to suppress immune function) Ex. cyclosporin, tacrolimus
• colestipol, colestyramine (medicines used to control blood cholesterol levels)
• diuretics (used to increase urine output) Ex. furosemide
• lithium (a medicine used to manage mental illness)
• methotrexate (a medicine used to manage auto-immune diseases or cancer)
• mifepristone (birth control pill)
• phenytoin (a medicine used to manage fits)

Overdosage:

If you or anyone else accidentally took more SYSTAFLAM MR CAPSULE, contact your doctor immediately. Symptoms of overdosage might include nausea, vomiting, upper stomach pain, headache, gastrointestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, and convulsions.

Synopsis

More Information

• Keep SYSTAFLAM MR CAPSULE out of reach of children
• Store SYSTAFLAM MR CAPSULE at room temperature

FAQs About SYSTAFLAM MR CAPSULE

Q: Can a higher dose of SYSTAFLAM MR CAPSULE improve my disease condition?

A: No. Do not take a higher dose of SYSTAFLAM MR CAPSULE without consulting your doctor as it may lead to increased risk of unwanted side effects. Only use the dose prescribed to you by your doctor. Your doctor will decide the correct dose for you depending upon your age, body weight and disease condition. If the prescribed dose does not result in effective pain relief, consult your doctor for advice.

Q: Can SYSTAFLAM MR CAPSULE manage arthritis?

A: No. SYSTAFLAM MR CAPSULE can only be used to relieve pain caused due to arthritis and cannot manage arthritis. Your doctor may prescribe you other medicines along with SYSTAFLAM MR CAPSULE to help to manage your disease condition.

Q: How long should I need to take SYSTAFLAM MR CAPSULE?

A: It is not advisable to take SYSTAFLAM MR CAPSULE for more than 7 days, especially while taking at higher doses. Strictly follow the instructions given by your doctor regarding the duration of the therapy.

Q: Can I stop taking SYSTAFLAM MR CAPSULE once my pain is relieved?

A: Yes. SYSTAFLAM MR CAPSULE can be discontinued from use once pain is relieved. However, consult your doctor before doing so, as stopping SYSTAFLAM MR CAPSULE too early may cause the pain to come back.

Q: Who should take SYSTAFLAM MR CAPSULE and who should not?

A: SYSTAFLAM MR CAPSULE should be used under medical supervision. Do not take SYSTAFLAM MR CAPSULE if you have asthma or bleeding or perforations in the gut. Consult your doctor before taking SYSTAFLAM MR CAPSULE if you are pregnant, think you may be pregnant or breastfeeding. Before taking SYSTAFLAM MR CAPSULE, inform your doctor if you have any problems in your liver, liver, kidney, heart, or stomach. You much also inform your doctor if you have diabetes, high blood cholesterol, allergic conditions, fits or bleeding problems as a precaution.

Q: Can SYSTAFLAM MR CAPSULE be taken with vitamin B12 supplements?

A: SYSTAFLAM MR CAPSULE can be taken together with vitamin supplements as vitamins tends to improve healing of inflammation and reduces pain. However, consult your doctor before taking.

Q: For what conditions SYSTAFLAM MR CAPSULE is prescribed?

A: SYSTAFLAM MR CAPSULE is given for relieving musculoskeletal pain associated with muscle spasms.

Q: Is SYSTAFLAM MR CAPSULE safe for pregnant women?

A: SYSTAFLAM MR CAPSULE is not recommended for use in pregnant women as it may cause harm to the unborn baby. Therefore, consult your doctor for advice before taking.

Q: Can I take SYSTAFLAM MR CAPSULE with antibiotics?

A: SYSTAFLAM MR CAPSULE may interact with certain antibiotics (such as trimethoprim, ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin) and may produce an altered response. Inform your doctor about the medicines which you use currently.

Q: Is SYSTAFLAM MR CAPSULE a painkiller?

A: SYSTAFLAM MR CAPSULE is an anti-inflammatory medicine with pain relieving properties. It helps in reducing pain and swelling while relaxing the muscles. It can be used for reducing pain caused due to muscle contraction or inflammatory bone conditions.

Q: Does SYSTAFLAM MR CAPSULE make you feel sleepy?

A: SYSTAFLAM MR CAPSULE may rarely make you feel sleepy. If you feel drowsy/sleepy, do not drive or operate any heavy tools or machines. Avoid consuming alcohol or taking other medicines that can sedate your brain easily such as antidepressants (Ex. citalopram, sertraline). Consult your doctor if you continue to feel sleepy that interferes with your day-to-day activities.

Q: Is SYSTAFLAM MR CAPSULE addictive?

A: SYSTAFLAM MR CAPSULE is not a habit-forming medicine. However, you might feel better that only if you take SYSTAFLAM MR CAPSULE. This is because, SYSTAFLAM MR CAPSULE can only reduce pain caused due to inflammatory conditions. It cannot manage the actual cause of the pain. And so, if you stop taking SYSTAFLAM MR CAPSULE, your pain may reappear once again. To avoid this, take SYSTAFLAM MR CAPSULE only as advised by the physician for the stipulated duration.

Q: Is SYSTAFLAM MR CAPSULE a steroid?

A: No. SYSTAFLAM MR CAPSULE is not a steroid. It contains Diclofenac which is a non-steroidal anti-inflammatory drug and thiocolchicoside which is a muscle relaxant. They act by blocking the production of certain chemicals in the body that causes pain, inflammation, and muscle spasms. As a result, it relaxes skeletal muscles and reduces pain associated with musculoskeletal disorders such as muscle spasm, arthritis etc.

Q: Can SYSTAFLAM MR CAPSULE be used in children?

A: No. SYSTAFLAM MR CAPSULE is strictly not recommended for use in children aged below 18 years. Children above this age group must also consult their doctor before taking SYSTAFLAM MR CAPSULE.

References

1. K.D. Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Skeletal muscle relaxants. Essentials of Medical Pharmacology. Seventh edition. Page 204 & 368.

2. Justyna Kolodziejska and Michal Kolodziejczyk. Diclofenac in the treatment of pain in patients with rheumatic diseases. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. June 2018. [Accessed on 6th February 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6052370/

3. Darius F Soonawalla, Niteen Joshi. Efficacy of thiocolchicoside in Indian patients suffering from low back pain associated with muscle spasm. Journal of Indian Medical Association. June 2008. [Accessed on 6th February 2023] https://www.researchgate.net/publication/23304092_Efficacy_of_thiocolchicoside_in_Indian_patients_suffering_from_low_back_pain_associated_with_muscle_spasm#:~:text=shown%20that%20thiocolchicoside%20is%20an,Soonawalla%20and%20Joshi%2C%202008%20).

4. Dexcel Pharma. Diclofenac sodium 50mg. Electronic Medicines Compendium. [Revised in April 2021]. [Accessed on 6th February 2023] https://www.medicines.org.uk/emc/files/pil.2660.pdf

5. Pinewood Laboratories Ltd. DICLO 75 mg prolonged release tablets Diclofenac sodium. Electronic Medicines Compendium. [Revised in April 2021]. [Accessed on 6th February 2023] https://www.hpra.ie/img/uploaded/swedocuments/3dd59799-3d2e-4ca3-93cf-ade68e6de330.pdf

6. Salutas Pharma GmbH. Diclac 25mg & 50mg Gastro-resistant Tablets Diclofenac Sodium. Electronic Medicines Compendium. [Revised in August 2016]. [Accessed on 6th February 2023] https://www.hpra.ie/img/uploaded/swedocuments/2182591.PA0711_009_007.63ec5a97-112b-46cc-a493-f4564ff3c8ef.000001Diclac%20Gastro%20Tabs%20PIL.161011.pdf

7. European Medicines Agency. Thiocolchicoside 4 mg and 8mg. [Accessed on 6th February 2023] https://www.ema.europa.eu/en/documents/referral/thiocolchicoside-article-31-referral-annex-iii_en.pdf

8. Torrent Pharmaceuticals Ltd. Diclogesic-TH. Diclofenac Sodium and Thiocolchicoside Tablets. [Revised in August 2017]. [Accessed on 6th February 2023] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2580.pdf

9. Central Drugs Standard Control Organization. Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form). November 2011. Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules. October 2008. Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules. December 2008. [Accessed on 6th February 2023] https://cdscoonline.gov.in/CDSCO/Drugs

Author Details

Written By Srilekha. R - B.Pharm

Reviewed For Accuracy By Dr. Srikar Modepu - MBBS, MD (Diabetology)

Last updated on 08 Feb 2023 | 12:41 PM(IST)