1. What Gleptal is and what it is used for

The active substance of Gleptal, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.

Gleptal is used to treat adult patients with type 2 diabetes. It is used when diabetes cannot be controlled by diet and exercise alone. It helps to control the level of sugar in the blood. Your doctor will prescribe Gleptal either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.

Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the

body produces too much glucagon. Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals. Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances.

How Gleptal works

Gleptal works by making the pancreas produce more insulin and less glucagon.

This helps to control the blood sugar level. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes. Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.

2. What you need to know before

you take Gleptal

Do not take Gleptal:

* if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the other ingredients of Gleptal , do not take this medicine and talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Gleptal.

• if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.

• if you are taking an anti-diabetic

medicine known as a sulphonylurea (your doctor may want to reduce your dose of the sulphonylurea when you take it together with Gleptal in order to avoid low blood glucose [hypoglycaemia]).

• if you have moderate or severe kidney disease (you will need to take a lower dose of Gleptal).

• if you are on dialysis.

• if you have liver disease.

• if you suffer from heart failure.

• if you have or have had a disease of the pancreas.

• If you have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.

• Diabetic skin lesions are a common complication of diabetes. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. You are also advised to pay particular attention to new onset of blisters or ulcers while taking Gleptal. Should these occur, you should promptly consult your doctor.

• A test to determine your liver function will be performed before the start of Gleptal treatment, at three-month intervals for the first year and periodically thereafter.

This is so that signs of increased liver enzymes can be detected as early as possible.

Children and adolescents

The use of Gleptal in children and adolescents up to 18 years of age is not recommended.

Other medicines and Gleptal

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may wish to alter your dose of Gleptal if you are taking other medicines such as:

- Thiazides or other diuretics (also called water tablets)

- Corticosteroids (generally used to treat inflammation)

- Thyroid medicines

- Certain medicines affecting the nervous system.

Pregnancy and breast-feeding

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.

You should not use Gleptal during pregnancy. It is not known if Gleptal passes into breast milk. You should not use Gleptal if you are breast-feeding or plan to breast-feed.

Driving and using machines

If you feel dizzy while taking Gleptal, do not drive or use machines.

Gleptal contains lactose

Gleptal contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Gleptal

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take and when

The amount of Gleptal people have to The maximum daily dose is 100 mg.

The usual dose of Gleptal is either:

• 50 mg daily taken as one dose in the morning if you are taking Gleptal with another medicine called a sulphonylurea.

• 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Gleptal alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.

• 50 mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.

How to take Gleptal

Swallow the tablets whole with some water.

How long to take Gleptal

• Take Gleptal every day for as long as

your doctor tells you. You may have to take this treatment over a long period of time.

• Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you take more Gleptal than you should

If you take too many Gleptal tablets, or if someone else has taken your medicine, talk to your doctor straight away. Medical attention may be needed. If you need to see a doctor or go to the hospital, take the pack with you.

If you forget to take Gleptal
If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the usual time. If it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Gleptal

Do not stop taking Gleptal unless your doctor tells you to. If you have questions about how long to take this medicine, talk to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms need immediate medical

attention:

You should stop taking Gleptal and see your doctor immediately if you experience the following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen

face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.

• Liver disease (hepatitis) (rare):

Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).

• Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.

Other side effects

Some patients have had the following side effects while taking Gleptal and metformin:

Common (may affect up to 1 in 10 people):
Trembling, headache, dizziness, nausea, low blood glucose Uncommon (may affect up to 1 in 100 people): Tiredness.

Some patients have had the following side effects while taking Gleptal and a sulphonylurea:

Common: Trembling, headache, dizziness, weakness, low blood glucose Uncommon: Constipation Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose.

Some patients have had the following side effects while taking

Gleptal and a glitazone:

Common: Weight increase, swollen hands, ankle or feet (oedema) Uncommon: Headache, weakness, low blood glucose.

Some patients have had the following side effects while taking Gleptal alone:

Common: Dizziness Uncommon: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose Very rare: Sore throat, runny nose, fever Some patients have had the following side effects while taking Gleptal, metformin and a sulphonylurea:

Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating

Some patients have had the following side effects while taking Gleptal and insulin (with or without metformin):

Common: Headache, chills, nausea (feeling sick), low blood glucose, heartburn Uncommon: Diarrhoea, flatulence. Since this product has been marketed, the following side effects have also been reported:
Frequency not known (cannot be estimated from the available data): Itchy rash, inflammation of the pancreas, localized peeling of skin or blisters, muscle pain.

Reporting of side effects

The National Pharmacovigilance

and Drug Safety Centre (NPC):

Fax: +966-11-205-7662

Call NPC at +966-11-2038222.

Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

5. How to store Gleptal

- Keep out of the reach and sight of children.

- Do not store above 30ºC.

- Store in the original package in order to protect from moisture.

- Do not use Gleptal after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.

- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.