Defal

Defal 6 mg – 30 mg

  • International name (active ingredient): deflazacort
  • Production company: FAES FARMA
  • Country of manufacture: Spain
  • Release form:
    • 6 mg tablet No. 20;
    • 30 mg tablet No. 10.
  • Dispensing mode: II group (dispensed with form N3 prescription)

დეფალი

Drug form:

6 mg tablet No. 20
30 mg tablet No. 10

Active substance – Deflazacort.

Each tablet contains 6 mg (pack of 20 tablets) and 30 mg (pack of 10 tablets) of deflazacort.

Excipients: lactose monohydrate, corn starch, microcrystalline cellulose and magnesium stearate.

Deflazacort is a corticosteroid medication that treats Duchenne muscular dystrophy. This condition causes skeletal and heart muscle weakness that quickly gets worse with time. You can take this tablet by mouth as directed by either swallowing the tablets whole or crushing them and adding the tablets into soft, wet food.
What is this medication?
Deflazacort (de FLAZ a kort) is a corticosteroid. This medicine is used for the treatment of Duchenne muscular dystrophy. It is not a cure.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Indications:

  • Rheumatic and collagen diseases.
  • Skin diseases
  • Allergic diseases: bronchial asthma that does not respond to traditional treatment.
  • Diseases of the respiratory system.
  • Eye diseases.
  • Blood diseases.
  • Diseases of the digestive system.
  • Kidney diseases.
  • Liver diseases.

Contraindications:

Do not take Defla: if you are allergic (hypersensitive) to deflazacort or any of the other ingredients of the drug; If you suffer from stomach ulcers; if you suffer from bacterial (active tuberculosis) or viral infections (herpes simplex of the eye, herpes zoster, chicken pox) or generalized fungal infections; in pre- and post-vaccination periods.

– The drug is not prescribed in patients with severe blood diseases without proper monitoring.

Warnings and precautions

Tell your doctor if you have: heart disease, congestive heart failure, high blood pressure, thromboembolic diseases (caused by blood clots), diseases of the esophagus, stomach or intestines, diabetes, emotional disorders, psychosis, epilepsy, high pressure in the eye (glaucoma), hypothyroidism ( decreased function of the thyroid gland), cirrhosis (serious liver damage), the dose of corticosteroids should be adjusted in special cases (surgical intervention, infections, etc.); Therefore, the doctor should know if you have any disease or not. Long-term use of this drug in children can cause growth and development to stop. After long-term treatment with Defal, the dose should be reduced gradually. Do not stop taking the drug without a doctor’s advice. Consult a doctor if you experience blurred vision or other visual disturbances. Consult your doctor before taking the drug.

Use of the drug in athletes
Patients should be warned that this medicine contains deflazacort and that an anti-doping test may show a positive result.

Pregnancy and lactation
Defal is not used during the first three months of pregnancy unless the doctor considers that the benefit outweighs the expected risk.

Important information for women:

If you are pregnant or breastfeeding, suspect pregnancy or plan to become pregnant, ask your doctor or pharmacist for advice before taking the medicine. The use of drugs during pregnancy may endanger the embryo or fetus and the doctor should monitor the situation.
Defal passes into breast milk, therefore its use is not recommended during breastfeeding.

Transport management and use of mechanisms

Although information is not available, it is not recommended to perform such activities that require special attention, such as driving a vehicle, using potentially dangerous mechanisms, and others, until a satisfactory response to treatment is achieved.

Defal 6 mg tablets contain lactose

This medicine contains lactose. If you have been informed by your doctor that you cannot tolerate certain types of sugar, consult your doctor before taking the medicine.

Other drugs and Defal
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or plan to take them.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may interact with Defal.

  • Medicines for diabetes: dosage may need to be changed
  • Antibiotics (Rifampicin): May reduce the effect of Defal.
  • Estrogens or oral contraceptives: may increase the effect of Defal.
  • Drugs that cause muscle relaxation: May prolong the relaxing effect.
  • Anticholinesterase drugs used in myasthenia gravis.
  • Vaccines and toxoids: Corticosteroids reduce the immune response.
  • Drugs used to treat epilepsy and psychiatric diseases (Phenytoin, Phenobarbital): May reduce the effect of Defal.
  • Some medicines may increase the effect of Defal 6mg Tablets and your doctor may monitor your condition if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).

Expected side effects

Like all medicines, Defal can cause side effects, although not everybody gets them.

Side effects of Defal, mainly observed during long-term treatment, are:

  • Disorders of the gastrointestinal tract: gastrointestinal ulcer.
  • Nervous system disorders: headache, dizziness, anxiety, sleep problems.
  • Skin and subcutaneous tissue disorders: healing problems, skin damage.
  • Disorders of the heart and blood vessels: increase in blood pressure (hypertension), fluid retention in tissues (edema).
  • Disorders of the endocrine system: weight gain, complications of diabetes, cessation of menstruation (amenorrhea).
  • Disorders of the skeletal-muscular system, connective tissue and bones: muscle weakness, osteoporosis.
  • Visual disorders: Problems with the eyes.
  • Frequency not known (frequency cannot be determined based on available data): blurred vision.

Taking Defal together with other drugs that cause muscle relaxation, especially in high doses for a long time, can cause serious muscle disorders. If you experience any side effects, contact your doctor or pharmacist. This also applies to any possible side effects that are not listed in this leaflet.

The rule of taking Defal

Always take the medicine exactly as prescribed by the doctor. If you are not sure, check with your doctor or pharmacist. This drug is taken orally. Your doctor will tell you how many tablets and how often you should take them. The dose is individual for each patient and may be adjusted by the doctor depending on how you respond to treatment.

If you take an overdose of Defal

In case of overdose or accidental ingestion of the drug, contact the toxicology information center, provide information about the name of the drug and the amount taken, and immediately refer to the hospital for appropriate treatment.

If you forget to take Defal

Do not take a double dose to make up for a missed dose.

If you stop taking Defal

In case of additional questions related to the use of the drug, consult a doctor or pharmacist.

Packaging form:

6 mg tablet No. 20
30 mg tablet No. 10

Dephal storage conditions

Store at a temperature not exceeding 300C.

Do not use after the expiry date (EXP) stated on the package. Expiry date means the last day of the given month. Place the packaging and drugs that you no longer need in the garbage points located in the pharmacy. You can ask your pharmacist for advice on how to dispose of medicines you no longer need. These measures will protect the environment.

Dispensing mode: II group (dispensed with form N3 prescription)

Keep out of the reach of children!