The active substance is deflazacort. Each tablet contains 6 mg of deflazacort.
The tablet can be divided into equal parts.
Excipients/Inactive Ingredients: The other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose and magnesium stearate.
Defal is a medicine from a group of medicines known as corticosteroids, which have anti-inflammatory and anti-allergic properties. Its safety profile is different as it interferes less with glucidic metabolism and has less mineralocorticosteroid effect than other corticosteroids.
Defal is indicated for the treatment of: Rheumatic and collagen diseases; Skin diseases; Allergic diseases: bronchial asthma that does not respond to conventional treatment; Respiratory apparatus diseases; Eye diseases; Blood diseases; Digestive system diseases; Kidney diseases; Liver diseases.
Always take this medicine exactly as per the doctor's instructions.
Check with the doctor or pharmacist if the patient is not sure. This medicine is administered by oral route.
The doctor will tell the patient how many tablets he/she needs to take and how often. The dose is individual for each patient and may be changed by the doctor depending on how he/she responds to treatment.
If the patient forgets to take Defal: Do not take a double dose to make up for forgotten doses.
If the patient stops taking Defal: If the patient has any further questions on the use of this medicine, he/she should ask the doctor or pharmacist.
If the patient takes more Defal than he/she should: In the event of overdose or accidental ingestion, call the Toxicology Information Service, stating the medicine and the amount taken and immediately go to a hospital to receive appropriate treatment.
Do not take Defal: If the patient is allergic (hypersensitive) to deflazacort or any of the other ingredients of this medicine (refer to Description); If the patient suffers from stomach ulcer; If the patient suffers from bacterial (active tuberculosis) or viral infections (herpes simplex eye disease, herpes zoster, chicken pox) or generalized infections caused by fungi; If the patient is about to be, or has recently been, vaccinated.
Take special care with Defal.
Tell the doctor if the patient is suffering from: heart disease, congestive heart failure, high blood pressure, thromboembolic diseases (those caused by blood clots), diseases of the oesophagus, stomach or intestine, diabetes mellitus, emotional disorders, psychosis, epilepsy, high intraocular tension (glaucoma), hypothyroidism (failure of the thyroid gland), cirrhosis (severe liver damage).
The dose of corticosteroids must be adjusted in special situations (surgery, infections and others); therefore the doctor must know whether the patient has suffered from any disease.
In children, the prolonged use of this medicine may stop their growth and development.
After long-term treatment with Defal, the dose must be reduced gradually. Do not stop taking this medicine without talking to the doctor first.
Contact the doctor if the patient experiences blurred vision or other visual disturbances. Talk to the doctor before taking this medicine.
Use in athletes: Patients must be warned that this medicine contains deflazacort, which can produce a positive antidoping test result.
Defal 6 mg tablets contains lactose: This medicine contains lactose. If the doctor has indicated that the patient suffers from intolerance to certain sugars, ask them before taking this medicine.
Driving and using machines: Although no information is available, until the response to treatment is satisfactory, the patient is advised not to perform tasks that require special attention, such as driving vehicles, using potentially dangerous machinery, etc.
Defal must not be used during the first three months of pregnancy unless the doctor considers that the benefits outweigh the potential risk.
IMPORTANT INFORMATION FOR WOMEN: If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine. The use of medicines during pregnancy can be dangerous for the embryo or foetus and must be monitored by the doctor.
Defal passes into breast milk, therefore its use during breastfeeding is not recommended.
Like all medicines, Defal can cause side effects, although not everybody gets them.
The side-effects of Defal, which have mainly been observed during long-term treatment, are as follows: Gastrointestinal disorders: gastrointestinal ulcer.
Nervous system disorders: headache, dizziness, restlessness, sleep disorders.
Skin and subcutaneous tissue disorders: healing problems, skin damage.
Cardiac and vascular disorders: increased blood pressure (hypertension), water retention in tissues (oedema).
Endocrine disorders: weight gain, worsening of diabetes mellitus, disappearance of menstruation (amenorrhea).
Musculoskeletal and connective tissue and bone disorders: muscle weakness, osteoporosis.
Eye disorders: eye problems.
With a frequency None known (the frequency can not be estimated with the data available): Blurred vision.
The use of Defal along with other medicines that cause muscle relaxation, especially when high doses are administered for long periods of time, may produce severe muscle disorders. If the patient gets any side effects, he/she should talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines, including medicines obtained without prescription.
In particular, tell the doctor or pharmacist if the patient is taking any of the medicines listed as follows, as Defal might interact with them.
Diabetes medicines: as the dose might need to be changed.
Antibiotics (rifampicin): as they may reduce the effect of Defal.
Oestrogens or oral contraceptives: as the effect of Defal may be increased.
Medicines that cause muscle relaxation: as the relaxant effect may be prolonged.
Anticholinesterase medicines used in myasthenia gravis.
Vaccines and toxoids: as corticosteroids decrease the immune response.
Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital): as they may decrease the effect of Defal.
Some medicines may increase the effects of Defal 6 mg tablets and the doctor may wish to monitor the patient carefully if he/she is taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Place the containers and medicines the patient no longer needs in the recycling point at the pharmacy. If the patient is unsure, ask the pharmacist how to throw away packages and medicines no longer needed. These measures will help protect the environment.
H02AB13 - deflazacort ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Tab 6 mg (round, white, uncoated with a cross on one face and the number 6 on the other) x 20's.
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