Budestine®

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many capsules to take and when to take them.

The amount and route of administration is as follows:

Crohn’s disease: The recommended dose for acute phase of Crohn’s disease is 3 capsules in the morning before breakfast.

Normally, you will take this number of capsules for up to 8 weeks. Your doctor will then gradually reduce the dose. The medicine will usually have its full effect within 2 to 4 weeks.

Ulcerative colitis: For treatment of active disease, take 3 capsules once daily in the morning. When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy. For the maintenance of remission: Take 2 capsules once daily in the morning (or the lowest effective dose).

Contraindications:

Budesonide Capsules should NOT be used under certain conditions. Which include:

• Have history of allergies to Budesonide or any of the ingredients in capsules.
• If you have an infection.

Talk with your doctor about other ways of managing your disease if any of the above applies to you or you are not sure about them.

Interactions:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Steroid medicines, such as prednisolone or dexamethasone
• Colestyramine
• Ketoconazole or itraconazole
• Medicines that contain estrogen, such as hormone replacement therapy (HRT) and some oral contraceptives
• HIV protease inhibitors (such as ritonavir)
• Carbamazepine

Avoid ingestion of grapefruit juice with Budesonide. Intake of grapefruit juice which inhibits CYP3A4 activity with budesonide can increase the systemic exposure for budesonide

Pregnancy and Lactation:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

Budesonide is placed in category C pregnancy. When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time. Avoiding high doses during the first trimester.

Breast-Feeding:

Budesonide is excreted in breast milk. If there is concern about exposure to the infant, some guidelines recommend waiting 4 hours after the maternal dose of an oral systemic corticosteroid before breast-feeding in order to decrease potential exposure to the nursing infant.

Warning and Precaution:

Talk to your doctor or pharmacist before taking Budesonide Capsules if you have:

• History of Tuberculosis (TB).
• High blood pressure.
• Diabetes.
• Osteoporosis
• Stomach ulcers.
• Glaucoma (increased pressure in the eye) or Cataracts.
• Liver disease. Patients with moderate to severe liver disease should be monitored for increased signs or symptoms of hypercriticism. Reducing the dose of budesonide should be considered in these patients. No dosage adjustment is needed in patients with mild hepatic impairment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Budesonide Capsules.

Contact your doctor if you experience blurred vision or other visual disturbances

Adverse Reactions:

Like all medicines, Budesonide can cause side effects, although not everybody gets them. It may cause:

Common (Prevalence 1-10%)

• Heartburn.
• Muscle cramps
• palpitations
• Rash or itchy skin
• Heavy or irregular periods in women.
• Low levels of potassium in the blood which may cause muscle weakness.
• Cushingoid features such as a rounded face, acne, weight gain and bruising more easily.
• Behavioral changes such as feeling nervous, difficulty sleeping, mood swings and depression.

Storage:

Store below 30 and protect from light and moisture.