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INTRODUCTION
FLAMESE AP 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.
FLAMESE AP 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 FLAMESE AP 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.
FLAMESE AP 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.
FLAMESE AP 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 FLAMESE AP 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 FLAMESE AP TABLET
Treats acute painful inflammatory conditions (such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis) which can be associated with/without fever in affected individuals
HOW FLAMESE AP TABLET WORKS
FLAMESE AP TABLET provides relief from pain and reduces fever, where aceclofenac and paracetamol work by blocking the action of prostaglandin (chemical messengers responsible for pain, fever and inflammation) thus reducing fever and providing relief from pain in affected individuals.
DIRECTIONS FOR USE
Take FLAMESE AP 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 on your age, body weight and disease condition.
SIDE EFFECTS OF FLAMESE AP TABLET
COMMON
- gastrointestinal disorders such as indigestion,
- abdominal pain, nausea
- rash
- rubber
- red itchy welts
- bedwetting
- headache
- dizziness
- drowsiness
RARE
- constipation
- ulcerative stomatitis (painful ulcers in the mouth), gastrointestinal bleeding, gastrointestinal ulceration, pancreatitis, interstitial nephritis (kidney disorder)
- inflammation of the skin, flushing, purpura (purple-coloured spots)
- signs of allergic reactions such as red itchy welts, itching, rashes, nasal congestion
- anaemia, vasculitis (inflammation of blood vessels), tiredness
- signs of granulocytopenia (low white blood cell count) such as infected ulcers in mucous membranes of mouth, throat
- signs of thrombocytopenia (low platelet count) such as excessive bleeding, tiredness, prolonged bleeding (from cuts)
- signs of neutropenia (low white blood cell count) such as fever, tiredness, sore throat
- oedema (a condition marked by swelling in arms and legs), leg cramps
- racing heartbeat
- burning/pickling sensation
- tremors, depression, abnormal dreaming, excessive sleepiness, sleeplessness
- low blood sugar
HOW TO MANAGE SIDE EFFECTS
Indigestion:
Try to have smaller and more frequent meals and drink slowly. Reduce your 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 FLAMESE AP TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.
Headache:
If FLAMESE AP 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 FLAMESE AP TABLET. If it lasts more than a week or is 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-fibre 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
PREGNANCY
FLAMESE AP TABLET is generally not recommended for use in pregnant women unless it is clearly considered necessary. Consult your doctor before taking this medicine.
BREASTFEEDING
FLAMESE AP TABLET is not recommended for breast feeding women. Consult your doctor before taking this medicine.
KIDNEY
FLAMESE AP TABLET is not recommended for use in patients with kidney problems such as severely impaired renal organ function. It should be used with caution in patients with kidney problems such as mild hepatic impairment. Consult your doctor before taking this medicine.
LIVER
FLAMESE AP TABLET is not recommended for use in patients with liver problems such as severely impaired hepatic function. Consult your doctor before taking this medicine.
ALLERGY
Do not take FLAMESE AP TABLET if you are allergic (hypersensitive) to aceclofenac, paracetamol, and/or other ingredients of this medicine.
LUNGS
FLAMESE AP TABLET is not recommended for use in patients with lung problems such as asthma or bronchospasm. Consult your doctor before taking this medicine.
HEART DISEASE
FLAMESE AP TABLET is not recommended for use in patients with heart problems such as severe heart failure. Consult your doctor before taking this medicine.
OTHERS
Before taking FLAMESE AP TABLET, inform your doctor if you:
- a history of gastrointestinal ulceration (stomach ulcer) with ulcerative colitis /Crohn’s disease (chronic inflammatory bowel disease)
- bleeding diathesis (increased susceptibility to bleeding/bruising)
- haematological abnormalities
Use in Pediatrics:
FLAMESE AP TABLET is not recommended for children (aged below 6 years). Consult your doctor before administering this medicine to the child.
Use in Geriatrics:
FLAMESE AP TABLET should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking this medicine.
INTERACTIONS
A. Drug - Drug interactions:
Before taking FLAMESE AP 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 FLAMESE AP TABLET, consult your doctor immediately.
SYNOPSIS
| Drug | : | Aceclofenac and Paracetamol |
| Pharmacological Category | : | Non-steroidal Anti-inflammatory drugs |
| Therapeutic Indication | : | Acute painful inflammatory conditions (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis) which can be associated with/without fever in affected individuals |
| Dosage Forms | : | Tablet, Oral suspension, Suspension, Syrup |
MORE INFORMATION
- Keep FLAMESE AP TABLET out of reach of children
- Store FLAMESE AP TABLET at room temperature
FAQs ABOUT FLAMESE AP TABLET
What is FLAMESE AP TABLET used for?
FLAMESE AP TABLET 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.
How does FLAMESE AP TABLET work?
FLAMESE AP TABLET provides relief from pain and reduces fever. 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 pain in affected individuals.
What are the most common side effects of receiving FLAMESE AP TABLET?
The most common side effects of taking FLAMESE AP 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.
Does FLAMESE AP TABLET cause nausea?
Yes, FLAMESE AP TABLET causes nausea as it is the commonest side effect to occur after taking medicine. If such a side effect is experienced, then try to take FLAMESE AP TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.
Can FLAMESE AP TABLET be used in pregnant and breastfeeding women?
No, FLAMESE AP TABLET is not recommended for use during pregnancy and in breastfeeding 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)
AUTHOR DETAILS
Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 25 Oct 2022 | 08:01 PM(IST)
PRODUCT DETAILS
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