Dibestor 25 mg Film-Coated Tablets

DIBESTOR improved the levels of insulin after a meal. DIBESTOR is a type of medicine that is called a dipeptidyl peptidase-4 inhibitors (DDP-4) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus. DIBESTOR can be used alone or in combination with certain other medicines that lower blood sugar levels, along with a recommended diet and exercise program.

Do not take DIBESTOR:

• If you are hypersensitive (allergic) to sitagliptin hydrochloride monohydrate or any of the other ingredients of DIBESTOR (listed in section 6).
• If you have type 1 diabetes

Warnings and precautions

Special care should be taken with DIBESTOR:

• If you have any allergies

Tell your doctor if you have or have had:

• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
• any past or present kidney problems
• a disease / inflammation of the pancreas (such as pancreatitis)
• gallstones, very high levels of triglycerides (a form of fat) in your blood or alcohol dependence. These medical conditions can increase your risk of getting pancreatitis (see section 4).

Call your doctor if you experience severe and persistent stomach pain, with or without vomiting, because you could have pancreatitis or if you develop a skin condition that has large, fluid-filled blisters (bulbous pemphigoid).

Children and adolescents

DIBESTOR has not been studied in children under 18 years of age. Therefore, children and adolescents below 18 years should not use this medicine.

Other medicines and DIBESTOR

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems). The level of digoxin in your blood may need to be checked.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. You should not take this medicine during pregnancy. You should not take this medicine if you are breast-feeding or plan to breast-feed as it is not known if this medicine passes into breast milk.

Do not share medicines prescribed for you with any other person. Always take DIBESTOR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose when taken with other medicines used to treat diabetes is one 100 mg film coated tablet. DIBESTOR can be taken with or without food. Your doctor may prescribe a different dose depending on your condition. Your doctor will tell you how long your treatment with DIBESTOR will last. Do not stop treatment early. If you have the impression that the effect of DIBESTOR is too strong or too weak, tell your doctor or pharmacist.

If you take more DIBESTOR than you should

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

If you forget to take DIBESTOR

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for forgotten individual doses.

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

• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
• If you have a serious allergic reaction, including hives, rash, blisters on the skin/peeling skin and swelling of the lips, face, tongue and throat that may cause difficulty in breathing or swallowing

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

Frequent

• Low blood sugar
• Flatulence
• Nausea
• Headache
• Arm or leg pain
• Foot swelling
• Painful joints mostly in the hips, knees and spine

Less frequent

• Diarrhoea
• Vomiting
• Constipation
• Abdominal pain
• Dizziness
• Drowsiness

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 or 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 DIBESTOR.

Store all medicines out of reach of children.

• Store at or below 25 °C
• Keep the blister in the outer carton
• There are no special storage instructions for DIBESTOR
• Protect from light / moisture
• Do not store in a bathroom
• Do not use after the expiry date stated on the carton

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).