Romactil 60 Mg (acemetacin) View larger

Emflex (acemetacin) 60 Mg Tablets


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ROMACTIL FORTE 60 mg capsule
It is taken orally.
• Active substance: Each capsule contains 60 mg acemetacine.
Excipients: Lactose monohydrate (produced from cow's milk), sodium dodecyl sulfate,
colloidal anhydrous silica, talc, magnesium stearate, titanium dioxide, yellow iron oxide, red
iron oxide, gelatin (bovine bone gelatin).
In this Instructions for Use:
1. What is ROMACTIL FORTE and what is it used for?
2. Things to watch out for before using ROMACTIL FORTE
3. How to use ROMACTIL FORTE?
4. What are the possible side effects?
5. How to store ROMACTIL FORTE
Headings are included.
1. What is ROMACTIL FORTE and what is it used for?
ROMACTIL FORTE is a product containing 20 capsules in a blister pack.
ROMACTIL FORTE contains acemetacine as an active ingredient.
Acemetacine has anti-inflammatory, pain relieving and antipyretic effects.
It belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs).
It is used in the treatment of the following conditions:
Degenerative joint disease, joint calcification (osteoarthritis)
Rheumatic disease (rheumatoid arthritis) seen with joint inflammation
• A rheumatic
illness (ankylosing spondylitis)
• Occasionally suddenly occurring due to a problem in the breakdown of protein.
protruding, often manifested by inflammation of the big toe, forward over the joints 2/9
Joint inflammation (acute
gouty arthritis)
Acute musculoskeletal pain
Post-operative inflammation, swelling and soft tissue damage
(postoperative pain)
• Pain related to menstrual pain in women (dysmenorrhea)
2. Things to watch out for before using ROMACTIL FORTE
Consult your doctor or pharmacist before using any medication.
DO NOT USE ROMACTIL FORTE in the following situations
• Acemetacine, indomethacin (another anti-inflammatory drug) or ROMACTIL
If you have hypersensitivity to any of the excipients contained in FORTE.
Previous use of aspirin or other non-steroidal anti-inflammatory drugs
post-asthma, wheezing, runny nose, urticaria or allergic-type reactions
if you have lived.
• If you are going to have surgery on your heart-nourishing vessels (coronary artery).
• You have been told you have a malfunction in the production of your blood cells.
• If you have or have ever had ulcers or bleeding in your stomach or intestines.
• If you have ever had gastrointestinal bleeding or perforation associated with NSAIDs or pain medications.
• If you have severe heart, kidney or liver failure.
• If you are in the late stage of pregnancy (after the sixth month).
• You are under 18 years old.
USE ROMACTIL FORTE CAREFULLY in the following situations
• Avoid using it with other pain, fever and anti-inflammatory drugs.
• Disease or risk factor related to your cardiovascular system (high blood fats,
diabetes, smoking)
If you have high blood pressure (hypertension)
If you have been told you have heart failure, fluid retention or edema in various parts of your body
If you have had a previous stroke
• If you have had bleeding, wound formation (ulceration) or perforation in the gastro-intestinal tract
• If you have experienced gastrointestinal side effects before and if you are an elderly patient, if you feel unusual symptoms in the abdominal area (in this case, consult your doctor)
Especially after the use of such pain, fever and anti-inflammatory drugs in elderly patients.
Bleeding and perforation, which can be life-threatening under certain conditions, are more common in the stomach and intestines, so medical monitoring should be given special attention in the treatment of elderly patients.
If you have an increased risk of bleeding, ulcers or perforation in your gastrointestinal tract, or low
If you need to use a dose of aspirin or another drug that increases these risks, your doctor
He or she may prescribe some preventive medications (such as misoprostol or proton pump inhibitors).
If you have or have had inflammatory bowel disease (ulcerative colitis or Crohn's disease)
If you have liver or kidney disease
If you have epilepsy, Parkinson's disease or a psychiatric disorder
If you are taking blood thinners (anti-coagulants) or have problems with blood clotting
If you are over the age of 65 or have a debilitating condition
Immediately after major surgeries and before any surgery
• Since there may be a high risk of developing asthma attacks, especially subcutaneous tissue edema (Quincke's edema) in the lips, eyelids and genital area, allergic reactions that can be seen as urticaria, hay fever, nasal polyps (benign and
often multiple tissue growths) or chronic obstructive breathing