ACEFILE PLUS Tablet 10’s

INTRODUCTION ABOUT ACEFILE PLUS TABLET

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

ACEFILE 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 ACEFILE 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.

ACEFILE 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.

ACEFILE 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 ACEFILE 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 ACEFILE PLUS TABLET

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

HOW ACEFILE PLUS TABLET WORKS

ACEFILE 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 ACEFILE 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 ACEFILE 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 ACEFILE 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 ACEFILE 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 ACEFILE 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 managements for constipation.

WARNING & PRECAUTIONS

PREGNANCY

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

BREASTFEEDING

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

DRIVING AND USING MACHINES

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

KIDNEY

ACEFILE PLUS 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

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

LUNGS

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

HEART DISEASE

ACEFILE PLUS TABLET is not recommended for use in patients with heart problems such as severe heart failure. Consult your doctor before taking this medicine.

INTERACTIONS

A. Drug – Drug interactions:

Before taking ACEFILE 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 manage heart failure) Ex. digoxin, digitoxin
• lithium (medicine used to manage depression)
• methotrexate (medicine used to manage cancer)
• mifepristone (used for abortion)
• corticosteroids (used to manage inflammation and allergy) Ex. prednisone, dexamethasone
• anti-coagulants (medicine used to manage blood clots) Ex. warfarin
• quinolone antibiotics (used to manage bacterial infections) Ex. ciprofloxacin, levofloxacin
• antiplatelets (medicine used to manage blood clotting) Ex.warfarin
• selective serotonin reuptake inhibitors (medicines used to depression) Ex. citalopram, dapoxetine, escitalopram, fluoxetine
• cyclosporin (used to manage organ rejection after transplantation)
• tacrolimus (used to manage moderate to severe atopic dermatitis)
• zidovudine (used to manage HIV)
• anti-diabetic agents (medicines used to manage high blood sugar) Ex. glipizide, glyburide
• cholestyramine (used to manage high cholesterol level)
• metoclopramide, domperidone (used to manage nausea and vomiting)
• chloramphenicol (used to manage serious bacterial infections)

Overdosage:

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

SYNOPSIS

MORE INFORMATION

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