INTRODUCTION

ACECLOCACH 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.

ACECLOCACH 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 ACECLOCACH 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.

ACECLOCACH 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.

ACECLOCACH 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 ACECLOCACH 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 ACECLOCACH TABLET

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

HOW ACECLOCACH TABLET WORKS

ACECLOCACH 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 ACECLOCACH 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 ACECLOCACH TABLET

COMMON

gastrointestinal disorders such as indigestion, abdominal pain, nausea
rash
ruber
red itchy welts
bedwetting
headache
dizziness
drowsiness

RARE

constipation
ulcerative stomatitis (painful ulcers in mouth), gastrointestinal bleeding, gastrointestinal ulceration, pancreatitis, interstitial nephritis (kidney disorder)
inflammation of skin, flushing, purpura (purple-coloured spots)
signs of allergic reactions such as red itchy welts, itching, rashes, nasal congestion
anaemia, vasculitis (inflammation of blood vessel), 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 (condition marked by swelling in arms, 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 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 ACECLOCACH 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 ACECLOCACH 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 ACECLOCACH 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

PREGNANCY

ACECLOCACH TABLET is generally not recommended for use in pregnant women unless it is clearly considered necessary. Consult your doctor before taking this medicine.

BREASTFEEDING

ACECLOCACH TABLET is not recommended for breast feeding women. Consult your doctor before taking this medicine.

DRIVING AND USING MACHINES

Do not take ACECLOCACH TABLET while driving or operating machines since it may cause blurred vision, dizziness and/or drowsiness.

KIDNEY

ACECLOCACH 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

ACECLOCACH 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 ACECLOCACH TABLET if you are allergic (hypersensitive) to aceclofenac, paracetamol and/or other ingredients of this medicine.

LUNGS

ACECLOCACH TABLET is not recommended for use in patients with lung problems such as asthma, bronchospasm. Consult your doctor before taking this medicine.

HEART DISEASE

ACECLOCACH 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 ACECLOCACH 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 of bleeding/bruising)
haematological abnormalities

Use in Pediatrics:

ACECLOCACH TABLET is not recommended for children (aged below 6 years). Consult your doctor before administering this medicine to the child.

Use in Geriatrics:

ACECLOCACH 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 ACECLOCACH 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 ACECLOCACH 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 ACECLOCACH TABLET out of reach of children
Store ACECLOCACH TABLET at room temperature

FAQs ABOUT ACECLOCACH TABLET

Q: What is ACECLOCACH TABLET used for?

A: ACECLOCACH 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 ACECLOCACH TABLET works?

A: ACECLOCACH 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 ACECLOCACH TABLET?

A: The most common side effects of taking ACECLOCACH 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 ACECLOCACH TABLET cause nausea?

A: Yes, ACECLOCACH 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 ACECLOCACH 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 ACECLOCACH TABLET be used in pregnant and breast-feeding women?

A: No, ACECLOCACH 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)

AUTHOR DETAILS

Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 13 Jan 2023 | 10:34 AM(IST)

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