Zomarist 50 mg/850 mg film-coated tablets

 

What is it and how is it used?

The active substances of Zomarist belong to a group of medicines called “oral antidiabetics”.

Zomarist is used to treat patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus.

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.

Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level to rise.

Zomarist contains two active substances called vildagliptin and metformin. Both of these substances help to control the level of sugar in the blood. The substance vildagliptin works by making the pancreas produce more insulin and less glucagon. The substance metformin works by helping the body to make better use of insulin.

What do you have to consider before using it?

Do not take Zomarist

  • if you are allergic (hypersensitive) to vildagliptin, metformin or any of the other ingredients of Zomarist (listed in section 6). If you think you may be allergic to any of these, talk to your doctor before taking Zomarist.
  • if you have or have had serious complications of your diabetes, such as diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea and/or vomiting) or diabetic coma.
  • if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems.
  • if you have kidney problems.
  • if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).
  • if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye). Please also see information about this in section “Take special care with Zomarist”.
  • if you have liver problems.
  • if you drink alcohol excessively (whether every day or only from time to time).
  • if you are breast-feeding (see also “Pregnancy and breast-feeding”).

Take special care with Zomarist
Stop taking this medicine and talk to your doctor if you experience one or more of the following symptoms
which may be related to a condition called “lactic acidosis”:

  • feeling cold or uncomfortable
  • muscle pain
  • severe nausea or vomiting
  • pain in or around your stomach (abdominal pain)
  • drowsiness or dizziness
  • rapid breathing

If you have previously taken vildagliptin but had to stop taking it because of side effects (liver disease), you should not take this product.

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 Zomarist. Should these occur, you should promptly consult your doctor.

If you have stopped using Zomarist due to surgery (you should stop at least 48 hours before planned surgery with general anesthesia and should not start again until at least 48 hours afterwards) or due to an x-ray involving an injectable dye, talk to your doctor before taking Zomarist again.

A test to determine your liver function will be performed before the start of Zomarist 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.

Elderly patients (65-74 years) taking Zomarist should have their kidney function monitored regularly. This will happen more often in patients with kidney problems. Zomarist is not recommended for patients aged 75 years or older.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important if you are already taking any medicine to treat a heart condition or problems with your blood sugar, kidneys or blood pressure such as medicines containing

  • glucocorticoids generally used to treat inflammation
  • beta-2 agonists generally used to treat respiratory disorders
  • other medicines used to treat diabetes
  • diuretics (also called water tablets)
  • ACE inhibitors generally used to treat high blood pressure
  • certain medicines affecting the thyroid, or
  • certain medicines affecting the nervous system.

Taking Zomarist with food and drink
Take the tablets either with or just after food. This will lower the risk of an upset stomach.

Avoid alcohol while taking Zomarist since alcohol may increase the risk of lactic acidosis (please see section “Possible side effects”).

Pregnancy and breast-feeding

  • Tell your doctor if you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant. Your doctor will discuss with you the potential risk of taking Zomarist during pregnancy.
  • Do not use Zomarist if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you feel dizzy while taking Zomarist, do not drive or use any tools or machines.

How is it used?

Always take Zomarist exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take
The amount of Zomarist that people have to take varies depending on their condition. Your doctor will tell you exactly the dose of Zomarist to take.

When and how to take Zomarist

  • Swallow the tablets whole with a glass of water,
  • Take one tablet in the morning and the other in the evening with or just after food. Taking the tablet just after food will lower the risk of an upset stomach.

Continue to follow any advice about diet that your doctor has given you. In particular, if you are following a diabetic weight control diet, continue with this while you are taking Zomarist.

At least once a year, your doctor will check that your kidneys are working normally. Your doctor will test your blood and urine for sugar regularly.

If you take more Zomarist than you should
If you take too many Zomarist tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately. Medical attention may be necessary. If you have to go to a doctor or hospital, take the pack and this leaflet with you.

If you forget to take Zomarist
If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway. Do not take a double dose (two tablets at once) to make up for a forgotten tablet.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

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

These side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 patient in 10 common affects 1 to 10 patients in 100 uncommon affects 1 to 10 patients in 1,000 rare affects 1 to 10 patients in 10,000 very rare affects less than 1 patient in 10,000 not known frequency cannot be estimated from the available data.

Some symptoms need immediate medical attention
You should stop taking Zomarist and see your doctor immediately if you experience the following side effects:

  • Angioedema (rare): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of 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).

Other side effects
Some patients have experienced the following side effects while taking Zomarist:
Very common:

  • nausea
  • vomiting
  • diarrhoea
  • pain in and around the stomach (abdominal pain)
  • loss of appetite. Common:
  • dizziness
  • headache
  • trembling that cannot be controlled
  • metallic taste
  • low blood glucose. Uncommon:
  • joint pain
  • tiredness
  • constipation
  • swollen hands, ankle or feet (oedema). Rare:
  • signs of liver disease (hepatitis) Very rare:
  • sore throat, runny nose, fever
  • signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing.
  • redness of the skin, itching
  • decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances).

Since this product has been marketed, the following side effects have also been reported (frequency not known):

  • itchy rash
  • inflammation of the pancreas.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

  • Keep out of the reach and sight of children.
  • Do not use Zomarist after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
  • Store in the original package (blister) in order to protect from moisture.

What is it?

Zomarist is a medicine that contains the active substances vildagliptin and metformin hydrochloride. It is available as oval tablets (light yellow: 50 mg vildagliptin and 850 mg metformin hydrochloride; dark yellow: 50 mg vildagliptin and 1,000 mg metformin hydrochloride).

This medicine is the same as Eucreas, which is already authorised in the European Union (EU). The company that makes Eucreas has agreed that its scientific data can be used for Zomarist.

What is it used for?

Zomarist is used to treat type 2 diabetes. It is used in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Zomarist is one tablet twice a day, with one tablet taken in the morning and one in the evening. The choice of tablet strength to start with depends on the dose of metformin the patient is currently taking, but the recommended dose is 50 mg vildagliptin and 1,000 mg metformin twice a day. Patients already taking vildagliptin and metformin should switch to Zomarist containing the same amounts of each active substance. Doses of vildagliptin above 100 mg are not recommended.

Taking Zomarist with or just after food may reduce any stomach problems caused by metformin. Zomarist should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver. Elderly patients taking Zomarist should have their kidney function monitored regularly.

How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. Zomarist contains two active substances, which each have a different mode of action. Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘incretin’ hormones in the body.

These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut. As a result of the action of both substances, the blood glucose is reduced and this helps to control type 2 diabetes.

How has it been studied?

Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. The studies of Galvus as an add-on to metformin were used to support the use of Zomarist in the same indication. The studies measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

The applicant also presented the results of two studies showing that the active substances in the two strengths of Zomarist were absorbed in the body in the same way as when they were taken as separate tablets.

What benefits has it shown during the studies?

Vildagliptin was more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin. Patients adding vildagliptin had a fall in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%. In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of 8.30%.

What is the risk associated?

The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite. For the full list of all side effects reported with Zomarist, see the package leaflet.

Zomarist should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients. It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack. It must also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast-feeding. For the full list of restrictions, see the package leaflet.

Why has it been approved?

The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment. Therefore, the Committee decided that the benefits of Zomarist are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Zomarist to Novartis Europharm Limited on 1 December 2008. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Zomarist, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2011.