Dagfotin Film-Coated Tablets

DAGFOTIN contains two active substances, vildagliptin and metformin hydrochloride, and it is used in the treatment of type 2 diabetes. DAGFOTIN together with diet and exercise helps to control the level of sugar in the blood. Your doctor has prescribed DAGFOTIN for you if your blood sugar level has been controlled when you take vildagliptin and metformin hydrochloride as separate tablets and at the same dosages. DAGFOTIN can be used alone or with other medicines for diabetes such as insulin, sulphonylureas.

Do not take DAGFOTIN :

• if you are allergic (hypersensitive) to vildagliptin, metformin hydrochloride or any of the other ingredients of DAGFOTIN (see section 6).
• if you have severely reduced kidney function (this will be decided by your doctor).
• if you have a problem with your liver.
• if you have recently had a heart attack, have a heart failure, or if you have serious problems with your blood circulation, including shock or breathing difficulties.
• if you have or have had serious complications of your diabetes, such as diabetic ketoacidosis (a complication of diabetes involving rapid weight loss, nausea or vomiting) or diabetic coma.

Warnings and precautions

Take special care with DAGFOTIN : DAGFOTIN is not a substitute for insulin in patients requiring insulin. DAGFOTIN should not be used in patients with type 1 diabetes (i.e., your body does not produce insulin at all) nor for the treatment of a condition called diabetic ketoacidosis.

Tell your doctor or health care provider:

Do not share medicines prescribed for you with any other person. Always use DAGFOTIN 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 exactly how many tablets of DAGFOTIN to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. If you have reduced kidney function, your doctor may prescribe a lower dose. If you are taking an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose. Do not take more DAGFOTIN than your doctor has prescribed.

If you take more DAGFOTIN 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 DAGFOTIN

If you forget to take a dose of DAGFOTIN, 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 a forgotten dose.

DAGFOTIN can have side effects. Not all side effects reported for DAGFOTIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DAGFOTIN, please consult your health care provider for advice.

If any of the following happens, stop taking DAGFOTIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives (symptoms of severe allergic reaction). These are all very serious side effects. If you have them, you may have had a serious reaction to DAGFOTIN. You may need urgent medical attention or hospitalisation.
• Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• feeling cold and uncomfortable, muscle pain, drowsiness, severe nausea or vomiting, abdominal pain, unexplained weight loss, dizziness, irregular heartbeat, or rapid breathing (symptoms of lactic acidosis),
• yellow skin and eyes, nausea, loss of appetite, dark urine (symptoms of liver problems),
• severe upper stomach pain (possible sign of inflamed pancreas),
• headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, feeling jittery (possible symptoms of low level of sugar in the blood known as ‘hypoglycaemia’).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• nausea,
• vomiting,
• abdominal pain,
• loss of appetite,
• dizziness,
• headache,
• involuntary trembling,

Less frequent side effects

• diarrhoea,
• constipation,
• swollen hands, ankle or feet (oedema),
• skin reddening, itching, areas of peeling skin or blisters,
• decrease in the level of vitamin B12 in the blood (anaemia),
• abnormal liver function test results.

If you notice any other 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 using the Med Safety App (MedSafety X SAHPRA) or the eReporting platform (who-umc.org) available on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of DAGFOTIN. You may also report side effects directly to the Holder of Certificate of Registration at: [email protected]

Store all medicines out of reach of children. Store at or below 25°C.