INTRODUCTION

BIGNAC MR 8 is a combination of Aceclofenac 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 treat painful inflammatory conditions associated with muscle spasms.

BIGNAC MR 8 can also be used to treat pain associated with musculoskeletal (bone) disorders such as osteoarthritis, rheumatoid arthritis (inflammation of joints) or ankylosing spondylitis (back pain caused due to inflammation of bones in the spine).

Aceclofenac is a non-steroidal anti-inflammatory drug. It acts by blocking the production of certain chemicals that causes pain and inflammation in the body. 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, BIGNAC MR 8 relieves painful muscle spasms associated with inflammatory disease conditions.

Before taking BIGNAC MR 8, 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 or fits.

Do not take BIGNAC MR 8 if you have asthma or varicella infection. Consult your doctor before taking BIGNAC MR 8 if you are pregnant, think you may be pregnant or breastfeeding.

Take BIGNAC MR 8 only as advised by your doctor. Do not take BIGNAC MR 8 longer than recommended by your doctor as it may cause serious side effects. Avoid smoking and consumption of alcohol while undergoing therapy with BIGNAC MR 8 to achieve better results.

The most common side effects of taking BIGNAC MR 8 are dizziness, drowsiness, nausea, and stomach pain. Consult your doctor if any of these side effect worsens.

USES OF BIGNAC MR 8

It is used in adults to treat:

• painful muscle spasms
• pain associated with musculoskeletal disorders (such as osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis)

HOW BIGNAC MR 8 WORKS

BIGNAC MR 8 is a muscle relaxant with anti-inflammatory and analgesic properties. It effectively reduces pain caused due to muscle spasms and inflammatory bone disorders, where aceclofenac acts by blocking the release of certain chemicals (prostaglandins) that causes pain and inflammation in the body and thiocolchicoside acts by blocking the effects of certain chemical messengers (GABA) in the brain that causes painful muscle spasms. Collectively, BIGNAC MR 8 relieves painful muscle spasms associated with inflammatory disease conditions.

DIRECTIONS FOR USE

Take BIGNAC MR 8 as directed by your physician. Swallow the medicine with a glass of water and do not crush or chew the medicine. BIGNAC MR 8 can be taken 1 hour before or 2 hours after meals. Your doctor will decide the correct dose for you depending upon your health condition.

SIDE EFFECTS OF BIGNAC MR 8

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take BIGNAC MR 8 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.

Diarrhoea:

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

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.

Dizziness:

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.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking BIGNAC MR 8, inform your doctor if you are taking any of the following medicines such as:

• medicines used to treat nausea or vomiting (Ex. metoclopramide or domperidone)
• medicines used for blood thinning (Ex. warfarin)
• medicines used to reduce blood pressure (Ex. enalapril, olmesartan, losartan)
• cardiac glycosides used to treat heart failure (Ex. digoxin, digitoxin)
• medicines used to treat bacterial infection (such as ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin)
• medicines used to treat HIV infections (such as zidovudine)
• medicines used to reduce blood sugar levels (such as glibenclamide, glycoside, and tolbutamide)
• medicines used for pain relief (such as aspirin or ibuprofen)
• oral corticosteroids (used to treat pain and inflammation) Ex. dexamethasone
• proton-pump inhibitors (used to reduce stomach acid production) Ex. omeprazole
• SSRI (used to treat depression) Ex. citalopram, fluoxetine, sertraline
• misoprostol (used to treat or prevent stomach ulcers)
• immunosuppressants (used to suppress immune function) Ex. cyclosporin, tacrolimus
• colestyramine (a medicine used to control blood cholesterol levels)
• diuretics (used to increase urine output) Ex. furosemide
• lithium (a medicine used to treat mental illness)
• methotrexate (a medicine used to treat auto-immune diseases or cancer)
• mifepristone (birth control pill)

Overdosage:

If you or anyone else accidentally took more BIGNAC MR 8, 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 BIGNAC MR 8 out of reach of children
• Store BIGNAC MR 8 at room temperature

FAQs ABOUT BIGNAC MR 8

Can higher dose of BIGNAC MR 8 improve my disease condition?

No. Do not take a higher dose of BIGNAC MR 8 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.

Can BIGNAC MR 8 cure arthritis?

No. BIGNAC MR 8 can only be used to relieve pain caused due to arthritis and cannot cure arthritis. Your doctor may prescribe you other medicines along with BIGNAC MR 8 to help to treat your disease condition.

How long should I need to take BIGNAC MR 8?

It is not advisable to take BIGNAC MR 8 for more than 7 days, especially while taking at higher doses. This is because, [GBNKEYWORD may cause chromosomal changes in the body which might lead to unwanted side effects. Strictly follow the instructions given by your doctor regarding the duration of the therapy.

Can I stop taking BIGNAC MR 8 once my pain is relieved?

Yes. BIGNAC MR 8 can be discontinued from use once pain is relieved. However, consult your doctor before doing so, as stopping BIGNAC MR 8 too early may cause the pain to come back.

Who should take BIGNAC MR 8 and who should not?

BIGNAC MR 8 should be used under medical supervision. Do not take BIGNAC MR 8 if you have asthma or varicella infection. Consult your doctor before taking BIGNAC MR 8 if you are pregnant, think you may be pregnant or breastfeeding. Before taking BIGNAC MR 8, 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 or fits.

Can BIGNAC MR 8 be taken with vitamin B12 supplements?

BIGNAC MR 8 can be taken together with vitamin supplements as vitamins tends to improve healing of inflammation and reduces pain. However, consult your doctor before taking.

For what conditions BIGNAC MR 8 is prescribed?

BIGNAC MR 8 is given for reliving musculoskeletal pain associated with muscle spasms.

Is BIGNAC MR 8 safe for pregnant women?

BIGNAC MR 8 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.

Can I take BIGNAC MR 8 with antibiotics?

BIGNAC MR 8 may interact with certain antibiotics (such as ciprofloxacin, ofloxacin, levofloxacin or moxifloxacin) and may produce an altered response. Inform your doctor about the medicines which you use currently.

Is BIGNAC MR 8 a painkiller?

BIGNAC MR 8 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.

Does BIGNAC MR 8 make you feel sleepy?

BIGNAC MR 8 may make you feel sleepy because of its sedative property. Therefore, be caution while you drive or operate any heavy tools or machines. Do not consume alcohol or other medicine that can seduces your brain further such as antidepressants (Ex. citalopram, sertraline). Consult your doctor if you continue to feel sleepy that interferes with your day-to-day activities.

Is BIGNAC MR 8 addictive?

BIGNAC MR 8 is not a habit-forming medicine. However, you might feel better that only if you take BIGNAC MR 8. This is because, BIGNAC MR 8 can only reduce pain caused due to inflammatory conditions. It cannot treat the actual cause of the pain. And so, if you stop taking BIGNAC MR 8, your pain may reappear once again. To avoid this, take BIGNAC MR 8 only as advised by the physician for the stipulated duration.

Is BIGNAC MR 8 a steroid?

No. BIGNAC MR 8 is not a steroid. It contains aceclofenac 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.

Can BIGNAC MR 8 be used in children?

No. BIGNAC MR 8 is strictly not recommended for use in children aged below 16 years. Children above this age group must also consult their doctor before taking BIGNAC MR 8.

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. Manish N. Maladkar, Chitra M. Tekchandani, Ashok S, Yadhav. National Library of Medicine. Targeting the Therapeutic Need in Musculoskeletal Inflammatory Pain with Thiocolchicoside and Aceclofenac Sustained Release with Combination Therapy. Aristo Pharmaceuticals Private Limited. ResearchGate. January 2019. [Accessed on 30th April 2022]                                        https://www.researchgate.net/publication/335020828_Targeting_the_therapeutic_need_in_musculoskeletal_inflammatory_pain_with_thiocolchicoside_and_aceclofenac_sustained-release_combination_therapy

3. TORRENT PHARMACEUTICALS LTD. ZULU AT. Torrent.com. [Revised on April 2021]. [Accessed on 30th April 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/3026.pdf

4. Cipla Ltd. IBUGESIC TH Tablets (Aceclofenac + Thiocolchicoside). Ciplamed.com. [Revised in June 2018]. [Accessed on 30th April 2022] https://ciplamed.com/content/ibugesic-th-tablets

5. Thichoren- AC. La Renon Healthcare Pvt Ltd. [Accessed on 30th April 2022] https://www.larenon.com/wp-content/uploads/2020/01/THICHOREN-2-page1.pdf

6. Novel formulations of thiocolchicoside. Patents.google.com. March 2015. [Accessed on 18th April 2022] https://patents.google.com/patent/EP2848260A1/en