INTRODUCTION

TREMENDUS PLUS TABLET is a combination of Aceclofenac and Paracetamol, which belongs to the group of medicines called Non-steroidal anti-inflammatory drugs. It is used in the treatment of acute painful inflammatory conditions (such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis) which can be associated with/without fever in affected individuals.

TREMENDUS PLUS TABLET is not recommended for use in patients allergic (hypersensitive) to aceclofenac and paracetamol. It is also not recommended for use in patients with lung problems (such as asthma or bronchospasm), kidney problems (such as severely impaired renal organ function), liver problems (such as a severely impaired hepatic function) and/or heart problems (such as severe heart failure).

Before taking TREMENDUS PLUS TABLET, inform your doctor if you have a history of gastrointestinal ulceration (stomach ulcer) with ulcerative colitis /Crohn’s disease (chronic inflammatory bowel disease), bleeding diathesis (increased susceptibility of bleeding/bruising) and/or haematological abnormalities.

TREMENDUS PLUS TABLET is generally not recommended for use in pregnant women unless it is clearly considered necessary. It is also not recommended for use in breast feeding women. Consult your doctor before taking this medicine.

TREMENDUS PLUS TABLET is not recommended for use in children (aged below 6 years) which should be used with caution in elderly patients (aged 65 years and above).

The most common side effects of taking TREMENDUS PLUS TABLET are gastrointestinal disorders (such as indigestion, abdominal pain, nausea), rash, red itchy welts, bedwetting, headache, dizziness and/or drowsiness. Consult your doctor if any of these symptoms worsen.

USES OF TREMENDUS PLUS TABLET

• Treats acute painful inflammatory conditions (such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis) which can be associated with/without fever in affected individuals

HOW TREMENDUS PLUS TABLET WORKS

TREMENDUS PLUS TABLET provides relief from pain and reduces fever where aceclofenac and paracetamol works by blocking the action of prostaglandin (chemical messengers responsible for pain, fever and inflammation) thus reducing fever and providing relief from fever in affected individuals.

DIRECTIONS FOR USE

Take TREMENDUS PLUS TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF TREMENDUS PLUS TABLET

HOW TO MANAGE SIDE EFFECTS

Indigestion:

Try to have smaller and more frequent meals and drink slowly. Reduce consumption of coffee, cola, tea or alcohol and lose weight if you are obese. Try to avoid smoking and don’t have rich, fatty or spicy foods. Consult your doctor and inform if the symptom does not improve.

Nausea:

Try to take TREMENDUS PLUS TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if symptom gets worse.

Headache:

If TREMENDUS PLUS TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking TREMENDUS PLUS TABLET. If it lasts more than a week or severe, inform your doctor.

Dizziness:

Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.

Constipation:

Try to eat high-fiber foods such as vegetables, cereals, fresh fruit and drink plenty of water. Involve in regular exercise (going for a daily walk or run) and if this does not help, consult and inform your doctor for receiving alternate treatments for constipation.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking TREMENDUS PLUS TABLET, inform your doctor if you are taking any of the following medicine:

• other analgesics such as aspirin, cyclooxygenase-2 selective inhibitors (Ex. celecoxib, valdecoxib)
• anti-hypertensives (medicines used to reduce hypertension) Ex. atenolol, proponolol
• diuretics (used to reduce hypertension) Ex. hydrochlorothiazide, furosemide
• cardiac glycosides (to treat heart failure) Ex. digoxin, digitoxin
• lithium (medicine used to treat depression)
• methotrexate (medicine used to treat cancer)
• mifepristone (used for abortion)
• corticosteroids (used to treat inflammation and allergy) Ex. prednisone, dexamethasone
• anti-coagulants (medicine used to prevent blood clots) Ex. warfarin
• quinolone antibiotics (used to treat bacterial infections) Ex. ciprofloxacin, levofloxacin
• antiplatelets (medicine used to prevent blood clotting) Ex.warfarin
• selective serotonin reuptake inhibitors (medicines used to depression) Ex. citalopram, dapoxetine, escitalopram, fluoxetine
• cyclosporin (used to prevent organ rejection after transplantation)
• tacrolimus (used to treat moderate to severe atopic dermatitis)
• zidovudine (used to treat HIV)
• anti-diabetic agents (medicines used to treat high blood sugar) Ex. glipizide, glyburide
• cholestyramine (used to treat high cholesterol level)
• metoclopramide, domperidone (used to treat nausea and vomiting)
• chloramphenicol (used to treat serious bacterial infections)

Overdosage:

If you or anyone else accidentally takes too much of TREMENDUS PLUS TABLET, consult your doctor immediately.

SYNOPSIS

MORE INFORMATION

• Keep TREMENDUS PLUS TABLET out of reach of children
• Store TREMENDUS PLUS TABLET at room temperature

FAQs ABOUT TREMENDUS PLUS TABLET

Q: What is TREMENDUS PLUS TABLET used for?

A: TREMENDUS PLUS TABLET is used in the treatment of acute painful inflammatory conditions (such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis) which can be associated with/without fever in affected individuals.

Q: How TREMENDUS PLUS TABLET works?

A: TREMENDUS PLUS TABLET provides relief from pain and reduces fever where aceclofenac and paracetamol works by blocking the action of prostaglandin (chemical messengers responsible for pain, fever and inflammation) thus providing reducing fever and providing relief from fever in affected individuals.

Q: What are the most common side effects of receiving TREMENDUS PLUS TABLET?

A: The most common side effects of taking TREMENDUS PLUS TABLET are gastrointestinal disorders (such as indigestion, abdominal pain, nausea), rash, red itchy welts, bedwetting, headache, dizziness and/or drowsiness. Consult your doctor if any of these symptoms worsen.

Q: Does TREMENDUS PLUS TABLET cause nausea?

A: Yes, TREMENDUS PLUS TABLET causes nausea as it is the commonest side effect to occur after taking the medicine. If such side effect experienced, then try to take TREMENDUS PLUS TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if symptom gets worse.

Q: Can TREMENDUS PLUS TABLET be used in pregnant and breast-feeding women?

A: No, TREMENDUS PLUS TABLET is not recommended for use during pregnancy and in breast feeding since it may affect the foetus and nursing child. Consult your doctor before receiving the medicine.

REFERENCES

1. KD Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 204, 206.

2. Anil Pareek, Nitin Chandurkar, V D Sharma, Mohan Desai, Seema Kini, Girish Bartakke. A randomized, multicentric, comparative evaluation of aceclofenac-paracetamol combination with aceclofenac alone in Indian patients with osteoarthritis flare-up. NIH National Library of Medicine. National Center for Biotechnology Information. PubMed.gov. April 2009. [Accessed on 26th March 2022] https://pubmed.ncbi.nlm.nih.gov/19351223/

3. Antoni Sicras-Mainar , Salomé de Cambra-Florensa, Ruth Navarro-Artieda. Consumption of oral analgesics and dosage forms in elderly patients: population-based study. NIH National Library of Medicine. National Center for Biotechnology Information. PubMed.gov.  May 2009. [Accessed on 26th March 2022] https://pubmed.ncbi.nlm.nih.gov/19712600/

4. Vibcare Pharma Pvt. Ltd. ACRIMOL. [Accessed on 26th March 2022] https://vibcare.co.in/aceclofenac-paracetamol/

5. Bliss Gvs Pharma Limited. Food and Drugs Authority- Ghana. [Revised in June 2016] [Accessed on 26th March 2022] https://fdaghana.gov.gh/img/pils/Alfenac-P%20Tablet%20(Aceclofenac%20and%20Paracetamol).pdf

USEFUL DIAGNOSTIC TESTS

• Erythrocyte sedimentation rate (ESR)
• C-reactive protein (CRP)