Proglicem® 25 mg Capsules

PROGLICEM belongs to a group of medicines called thiazides. PROGLICEM Capsules is a medicine used to treat certain types of hypoglycaemia (low blood sugar) in children and adults.

Do not take PROGLICEM Capsules:

• if you are allergic to diazoxide, other thiazides or any of the other ingredients of PROGLICEM Capsules (listed in section 6).
• If you have an unexplainable low sugar level in the blood.

Warnings and precautions

Take special care with PROGLICEM Capsules:

• Only start taking PROGLICEM Capsules if you are under close medical observation in a hospital when you first start treatment.
• The special care to be taken in patients who have difficulties in blood supply to heart and brain.
• Salt and fluid retention is possible with PROGLICEM treatment. This is when there is abnormal build-up of salt and fluid in the body. It is a serious condition that may lead heart failure, especially if you have other heart problems.
• Regular blood or urine tests to monitor levels of blood cells, sugar, electrolyte, and ketone bodies (acidic substances).

Diabetic ketoacidosis, a complication of diabetes that results from increased levels of acid in the blood. Hyperosmolar non-ketotic coma, a coma resulting from very high blood glucose levels leading to dehydration and state of altered consciousness.

Regular assessment for bone and psychological maturation and growth in children.

Dose reduction and serum electrolyte levels should be evaluated in patients with kidney problem.

Regular medical and laboratory monitoring is necessary if you are on long-term treatment with PROGLICEM Capsules.

Other medicines and PROGLICEM Capsules

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines). Some possible interactions are:

• PROGLICEM Capsules may intensify the effect of anti-coagulants (blood thinning medicines).
• PROGLICEM Capsules may weaken the effect of some medicines used for seizure control.
• PROGLICEM Capsules used together with diuretics may intensify the effect on blood sugar levels.
• PROGLICEM Capsules may enhance the effect of some antihypertensives (blood pressure medicines).

Do not share medicine prescribed to you with any other person. The dose of PROGLICEM Capsules is to be gradually adapted by your doctor, based on your individual requirements. Your doctor will tell you how long your treatment with PROGLICEM Capsules will last. Always take PROGLICEM Capsules exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

If you take more PROGLICEM Capsules than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take PROGLICEM Capsules

Do not take a double dose to make up for forgotten individual doses.

PROGLICEM Capsules can have side effects. Not all side effects reported for PROGLICEM Capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PROGLICEM Capsules, please consult your health care provider for advice. If any of the following happens, stop taking PROGLICEM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Abnormal build-up of salt and fluid in the body (Salt and fluid retention).
• A complication of diabetes that results from increased levels of acid in the blood (Diabetic ketoacidosis).
• A coma resulting from very high blood glucose levels leading to dehydration and state of altered consciousness Hyperosmolar non-ketotic coma.

These are all very serious side effects. If you have them, you may have had a serious reaction to PROGLICEM. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following frequent side effects:

• Nausea, vomiting, stomach (abdominal) pain, loss of taste, eating disorder (anorexia)
• Palpitations, rapid heartbeat (Tachycardia)
• Elevated serum uric acid levels
• Low blood pressure (Hypotension)
• High blood or urine sugar levels (Hyperglycaemia or glycosuria)
• Reduced blood platelets (Thrombocytopenia)
• Low levels of neutrophils, a type of white blood cell that fights infections (Neutropenia)
• Headache and weakness, disorder of movement, inflammation of several nerves, perception of tickling, itching or tingling without reason (paresthesia)
• Excessive hair with downy hairs, especially on the forehead, the back and the arms and legs, usually occurring in children and women (Hirsutism)
• Blurry vision

Or less frequent side effects:

• Chest pain
• Diarrhoea
• Obstruction of the intestine (Ileus)
• Inflammation of the pancreas that can lead to permanent pancreatic cell damage (Acute pancreatitis)

Other side effects:

• Presence of fluid in the sac surrounding the heart (Pericardial effusion)
• High blood pressure in blood vessels in the lungs (Pulmonary hypertension)
• Temporary spikes in blood pressure (Transient hypertension)
• High levels of uric acid in the blood which may cause joint pain, redness or swelling (Gout).
• Increased serum glutamic oxalic acid transaminase, elevated alkaline phosphatase, decreased creatinine clearance, reduced production of urine.
• Decreased protein in the blood due to the loss of protein in the urine (nephrotic syndrome), elevated levels of albumin in the urine, blood in the urine, high plasma urine concentration.
• Necrosis of tissue in the pancreas (Pancreatic necrosis)
• Low platelet counts with or without bruising of the skin, reduced numbers of certain white blood cells, decreased levels of hemoglobin, an increased number of certain white blood cells (eosinophilia), reduced concentration of IgG (a particular antibody), swollen lymph nodes (lymphadenopathy).
• Anxiety, trouble falling asleep (Insomnia).
• Itching, skin rash, loss of scalp hair
• Temporary cloudiness in the eye (cataract), presence of blood in the eyes (subconjunctival haemorrhage), blind spot in your field of vision (ring scotoma), double vision (diplopia), excess tear production (lacrimation).
• Advance in bone age
• Fever and discomfort
• Herpes
• Leaking of milk from the breasts unrelated to breastfeeding or enlargement of lump in breast (galactorrhoea).

Side effects may need a dosage adjustment or discontinuation of treatment. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PROGLICEM Capsule.

• Store at or below 25 °C.

• Store all medicines out of reach of children.