Panimun Bioral 100mg Capsule (Ciclosporin 100mg)

INTRODUCTION

PANIMUN BIORAL contains Cyclosporin which belongs to the group of medicines called immunosuppressive agents. Immunosuppressive agents are the drugs that suppress or reduces the strength of body’s immune system. It is used to prevent graft rejection in patients who have had an organ transplant, bone marrow and stem cell transplantation.

It can also be used to treat various autoimmune disease like severe rheumatoid arthritis, nephrotic syndrome (kidney disease), eye problems (endogenous uveitis, including Behçet’s uveitis) and skin diseases (atopic dermatitis, or eczema and psoriasis). Cyclosporin blocks the development of cells which attack the affected transplanted tissue and suppress abnormal immune function thus preventing the rejection of transplanted organs.

Limit your exposure to sunlight and UV light by wearing protective clothing and by applying a sunscreen to prevent skin cancer. Avoid consumption of alcohol or grapefruit juice while taking this medicine. This medicine should not be given to children for any non-transplant disease, except for nephrotic syndrome. Do not take this medicine if you have any uncontrollable infection or any type of cancer. Consult your doctor for advice.

USES OF PANIMUN BIORAL

Prevents the rejection of transplanted organs
Treats severe rheumatoid arthritis
Treats nephrotic syndrome (kidney disease)
Treats eye problems such as endogenous uveitis, including Behçet’s uveitis
Treats skin diseases such as atopic dermatitis, or eczema and psoriasis)

HOW PANIMUN BIORAL WORKS

Cyclosporin works by inhibiting the production of various cytokines involved in the regulation of T-cell activation. These effects of cyclosporine on T cells and on connective tissue cells can produce a range of cytokines. These in turn promote antibody (Ab) secreting plasma cells which finally bind and inactivate the antigen.

DIRECTIONS FOR USE

Take this medicine as directed by your physician. Your doctor will decide the correct dose for you depending upon your condition. Avoid drinking grapefruit juice while taking this medicine.

SIDE EFFECTS OF PANIMUN BIORAL

SERIOUS
Fever or sore throat
Signs of brain infection (e.g. changes in sight, loss of coordination, memory loss, difficulty in speaking, muscle weakness)
Confusion
Feeling disorientated
Feeling agitated, sleeplessness
Coma, paralysis
Stiff neck
Swelling at the back of eye
Yellowing of skin and eyes
Loss of appetite
Dark colored urine
Problems in urination
Pale skin, feeling tired,
Bruising or bleeding
COMMON
High blood pressure
Headache
Tremor of your body
Unwanted growth of body and facial hair
Fits (seizures)
Tiredness, loss of appetite
Nausea, vomiting, abdominal pain, constipation, diarrhea
Acne, hot flushes
Fever
Feeling numb or tingling
Muscle pain
Overgrowth of gum tissue
RARE
Numbness or tingling in fingers and toes
Severe upper stomach pain
Swelling of face, stomach, hands and/or feet
Chest pain
Changes in menstrual cycle
Breast enlargement in men

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meal. Stick to simple meals. Do not eat rich or spicy food.

Constipation:

Eat fibre rich foods like fresh fruit, vegetables and cereals. Drink plenty of water. Exercise more regularly.

Diarrhea:

Drink lots of fluids to avoid dehydration. Avoid taking any medicines for diarrhoea without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

WARNING & PRECAUTIONS

PREGNANCY
PANIMUN BIORAL should be used with caution in pregnant women. Consult your doctor before taking this medicine.

BREASTFEEDING
PANIMUN BIORAL should be used with caution in breast feeding women. Consult your doctor before taking this medicine.

DRIVING AND USING MACHINES
Avoid driving or operating any machines, if your ability is affected by this medicine.

ALCOHOL
Avoid consumption of alcohol while taking this medicine, as it may increase the risk of side effects.

KIDNEY
Do not take PANIMUN BIORAL if you are suffering from severe kidney disease. Consult your doctor for advice.

LIVER
PANIMUN BIORAL should be taken with caution in patients with severe liver disease. Consult your doctor for advice.

ALLERGY
Do not take this medicine if you are allergic to cyclosporin.

HEART DISEASE
Do not take PANIMUN BIORAL if you are suffering from uncontrollable high blood pressure. Consult your doctor for advice.

OTHERS

Do not take this medicine, if you have:

Any uncontrollable infection or any type of cancer
Gout, alcohol-related problems or epilepsy, low blood magnesium levels, high blood potassium levels, or if you need to have a vaccination

INTERACTIONS

Talk to your doctor, if you are taking,

Medicines that affects your potassium levels (e.g. spironolactone, aldosterone)
Medicines used for heart problems or high blood pressure (e.g. diltiazem, nicardipine, verapamil, amiodarone, nifedipine or digoxin)
Medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
Medicines used to treat HIV (e.g. saquinavir, indinavir, ritonavir)
Antibiotics (used to treat infections) e.g. erythromycin, gentamycin, tobramycin, ciprofloxacin
Anti-fungal agents (used to treat fungal infection) e.g. voriconazole, terbinafine, amphotericin B)
Cholic acid and derivatives (used to treat gallstones)
Telaprevir (used to treat hepatitis C).
Barbiturates (used to induce sleep)
Octreotide (used to treat acromegaly)
Orlistat (used to help weight loss)
St. John’s wort (used to treat depression)
Ticlopidine (used after a stroke)
Repaglinide (oral anti-diabetic medicine)
Ambrisentan (used to treat pulmonary arterial hypertension)