ZOFLAM® 50mg (Diclofenac Potassium INN).
Instruction, Identification, Indications, Contraindications, Dosage and administration, Overdosage, Side effects, Storage and Manufacturers of Zoflam Diclofenac Potassium Tablet Medicine for Pains, Migraine and Swelling.
WHAT YOU SHOULD KNOW ABOUT ZOFLAM 50MG
Please read this carefully before you take your medicine. This leaflet provides some useful Information for you on your medicine. If you have any questions or you are not sure about anything, please ask your doctor or pharmacist.
IDENTIFICATION OF MEDICINE
Brand Name: ZOFLAM®
Pharmaceutical forms and presentations:
ZOFLAM® 50mg Tablets: Pack of 100 tablets.
(As Diclofenac Potassium INN)
Excipients: Sq. for 1 tablet.
Therapeutic Class: Non- steroidal anti-inflammatory drug (NSAID).
WHAT IS YOUR MEDICINE USED FOR?
This medicine relieves pain and inflammation, and is used to treat acute gout, rheumatic diseases and other musculoskeletal disorders such as arthritis, lower back pain, fractures and dislocations. It may also be used to relieve pain and inflammation in orthopedic, dental and other minor surgery. ZOFLAM® can also be used in:
A) Migraine attacks
B) Painful and/or inflammatory conditions in gynaecology e.g. primary dysmenorrhea or adnexitis.
BEFORE TAKING YOUR MEDICINE – TELL YOUR DOCTOR
If you are being treated with any of the following drugs called:
Anticoagulants, Antidiabetics, Antihypertensiva Lithium, Digoxin, Diuretics, Glycosides, Cyclosporine, Mifepristone, Quinolones, Corticosteroids.
Non-steroidal anti-inflammatory drugs (for example Aspirin, Piroxicam, Ibuprofen, indomethacin)
Do you suffer from a stomach ulcer?
Do you have heart, liver, kidney or blood diseases?
Do you suffer from or have you suffered in the past from asthma?
Do you suffer from gastro-intestinal bleeding? You may experience pain in your stomach spreading to your back, very dark stools, and vomit which looks like coffee grounds (partly digested blood)
Have you ever been sensitive to this drug or other Non-steroidal ant-inflammatory drugs before or has it brought on asthma, nasal problems or rashes, or have you reacted to any of the other ingredients before?
Are you recovering from major surgery?
Are you pregnant or trying to become pregnant? (Diclofenac potassium may affect the unborn baby; and it is advised you employ only in compelling situations and only in the lowest effective dose and please don’t use if pregnancy is up to 5 months old).
DOSAGE AND ADMINISTRATION
Adults: The recommended initial daily dosage is 100-150mg in milder cases, as well as for children over 14 years of age, 75-100mg daily is usually sufficient. The daily dose should generally be divided in 2-3 doses.
In primary dysmenorrhea the daily dosage should be individually adjusted and is generally 50-150mg. Initially a dose of 50-100mg should be given and, if necessary, raised in the course of several menstrual cycles up to a maximum of 200mg/day.
Treatment should be started upon appearance of first symptoms and, depending on the symptomatology, continued for a few days.
In migraine an initial dose of 50mg should be taken at first signs of an impending attack, in cases when pain relief within 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200 mg in any 24-hour period.
The tablets should be swallowed whole with liquid.
Children: ZOFLAM® tablets are not recommended for use in children.
WHAT YOU SHOULD DO IN CASE OF AN OVER DOSAGE
Do not exceed the stated dosage and consult a physician if accidental overdose occurs.
WHAT YOU SHOULD DO IF YOU MISS A DOSE
It is important that you do not miss a dose. If you miss a dose take the next one is as normal.
SIDE EFFECTS THAT MIGHT HAPPEN WHILE YOU ARE TAKING YOUR MEDICINE
In common with most drugs, this medicine occasionally causes side effects in a few people.
This drug may cause any of the following side effects:
Stomach pain, indigestion, heartburn, diarrhea, nausea or vomiting;
Constipation (difficulty in passing bowel motions)
Sign of bleeding in the stomach or intestine, e.g. vomiting blood or bowel motions with signs of blood;
Headaches, dizziness, drowsiness or fatigue;
Disturbance of taste, vision, confusion, depression or trembling;
Skin problems or hair loss;
If you think you have blood disorders (your blood may not clot easily or bruises may appear), liver disorders (yellowing of your skin or eyes) or kidney problems (water retention problems urinating i.e. passing water);
Make you become sensitive to light (i.e. burn more easily, or exposure to light causes itching);
You have high blood pressure;
You develop an acute inflammation of the pancreas-(i.e. feel a severe abdominal pain sometimes radiating straight through the back, usually accompanied by nausea and vomiting)
Your tongue becomes swollen;
Your behavior changes or you fuel disturbed;
You experience difficulty in breathing, itching, and swelling.
If you suffer from any other side effect not listed above while taking your medicine, tell your doctor or pharmacist.
Do not exceed the expiry date on the external packaging.
Special precautions for storage:
Do not store above 30oC and safe from the light.
Anhui NHU Pharmaceutical Co.,-Ltd.
Xuancheng Economic and Technical Development Zone, Anhui.
BAKAN GIZO NIG. LTD. (Pharmaceutical Division)
B13 AMAC Office Complex, Kabale Close, Wuse Zone 3, Abuja, FCT Nigeria.