KWIKATON 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Kwikaton, 50 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
3. What is Kwikaton and what is it used for
   1. How Kwikaton works
4. Important information before taking Kwikaton
   1. When not to take Kwikaton
   2. Warnings and precautions
   3. Children and adolescents
   4. Kwikaton with other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Kwikaton contains lactose
   8. Kwikaton contains sodium
5. How to take Kwikaton
   1. Dosage
   2. How to take Kwikaton
   3. How long to take Kwikaton
   4. Taking too much Kwikaton
   5. Missing a dose of Kwikaton
   6. Stopping treatment with Kwikaton
6. Possible side effects
   1. Some side effects need immediate medical attention:
   2. Other side effects
   3. Reporting side effects
7. How to store Kwikaton
8. Contents of the pack and other information
   1. What Kwikaton contains
   2. What Kwikaton looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer
   4. This medicine is authorised in the Member States of the European Economic Area under the following names:
   5. Kwikaton
   6. Kwikaton 50 mg tablet
   7. Kwikaton
   8. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Kwikaton, 50 mg, Tablets

Wildagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Kwikaton and what is it used for
• 2. Important information before taking Kwikaton
• 3. How to take Kwikaton
• 4. Possible side effects
• 5. How to store Kwikaton
• 6. Contents of the pack and other information

1. What is Kwikaton and what is it used for

The active substance of Kwikaton, 50 mg, tablets is wildagliptin, which belongs to a group of medicines called "oral anti-diabetic medicines".
Kwikaton, 50 mg, tablets is a medicine used to treat adult patients with type 2 diabetes mellitus, who cannot control their blood sugar levels by diet and exercise alone.
Kwikaton helps to control blood sugar levels. Your doctor may prescribe Kwikaton as the only anti-diabetic medicine or in combination with other anti-diabetic medicines that you are already taking, if they are not sufficient to control your blood sugar levels.
Type 2 diabetes is a condition where the body does not produce enough insulin or the insulin produced by the body does not work properly. Diabetes can also develop if the body produces too much glucagon.
Insulin is a substance that helps to lower blood sugar levels, especially after a meal.
Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels. Both of these substances are produced in the pancreas.

How Kwikaton works

Kwikaton works by stimulating the pancreas to produce insulin and reducing the production of glucagon. This helps to control blood sugar levels. It has been shown that the medicine lowers blood sugar levels, which can help to prevent complications of diabetes. Even if you are taking diabetes medicines, it is important to continue to follow the diet and/or exercise programme recommended by your doctor.

2. Important information before taking Kwikaton

When not to take Kwikaton

• if you are allergic to wildagliptin or any of the other ingredients of this medicine

(listed in section 6);

Warnings and precautions

Before taking Kwikaton, talk to your doctor, pharmacist, or nurse:

• if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have diabetic ketoacidosis,
• if you are taking a sulphonylurea medicine (your doctor may want to reduce the dose of the sulphonylurea medicine to avoid low blood sugar levels [hypoglycaemia]),
• if you have moderate or severe kidney disease (you may need to take a lower dose of Kwikaton),
• if you are on dialysis,
• if you have liver disease,
• if you have heart failure,
• if you have or have had pancreatitis.

If you have taken wildagliptin before and had to stop due to liver disease, you should not take this medicine.
Changes in skin conditions are a common complication of diabetes. You should follow your doctor's advice on skin and foot care. While taking Kwikaton, you should pay particular attention to the appearance of new blisters or ulcers. If they appear, you should contact your doctor immediately.
Before starting treatment with Kwikaton and at 3-month intervals during the first year of treatment, and periodically thereafter, you should perform liver function tests. This will help to find out as soon as possible if you have any signs of increased liver enzyme activity.

Children and adolescents

Kwikaton should not be used in children and adolescents under 18 years of age.

Kwikaton with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Your doctor may need to adjust the dose of Kwikaton if you are taking other medicines such as:

• thiazides or other diuretics (also known as water tablets),
• corticosteroids (usually used to treat inflammation),
• medicines used to treat thyroid disease,
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant.
It is not known if Kwikaton passes into breast milk. Do not take Kwikaton if you are breastfeeding or planning to breastfeed.

Driving and using machines

If you experience dizziness while taking Kwikaton, do not drive or operate machinery.

Kwikaton contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

Kwikaton contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially 'sodium-free'.

3. How to take Kwikaton

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The dose of Kwikaton varies depending on your condition. Your doctor will decide exactly how many tablets of Kwikaton to take. The maximum daily dose is 100 mg.
The usual dose of Kwikaton is:

• 50 mg once daily, taken in the morning, when Kwikaton is taken with a sulphonylurea medicine.
• 100 mg once daily, taken as two doses of 50 mg, one in the morning and one in the evening, when Kwikaton is taken alone or with metformin or a glitazone, or in combination with metformin and a sulphonylurea or insulin (with or without metformin).
• 50 mg once daily, taken in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take Kwikaton

Swallow the tablets whole with water.

How long to take Kwikaton

Take Kwikaton every day, for as long as your doctor recommends. Your doctor may decide on long-term treatment.
Your doctor will regularly check your condition to ensure that the treatment is working.

Taking too much Kwikaton

If you have taken too many tablets, contact your doctor immediately. You may need medical attention. If you have to go to a doctor or hospital, take the pack with you.

Missing a dose of Kwikaton

If you miss a dose, take it as soon as you remember. Then take the next dose at the usual time. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Kwikaton

Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects need immediate medical attention:

If you get any of the following side effects, stop taking Kwikaton and contact your doctor immediately:

• angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives.
• liver disease (hepatitis) (rare). Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite or dark urine.
• pancreatitis (frequency not known): Symptoms include severe and persistent stomach pain (in the abdomen), which may radiate to the back, as well as nausea and vomiting.

Other side effects

In some patients taking wildagliptin and metformin, the following side effects have been reported:
Common (may affect up to 1 in 10 people):

• tremor, headache, dizziness, nausea, low blood sugar

Uncommon (may affect up to 1 in 100 people):

• fatigue

In some patients taking wildagliptin and a sulphonylurea, the following side effects have been reported:
Common:

• tremor, headache, dizziness, weakness, low blood sugar

Uncommon:

• constipation

Very rare (may affect up to 1 in 10,000 people):

• sore throat, cold

In some patients taking wildagliptin and a glitazone, the following side effects have been reported:
Common:

• weight gain, swollen hands, ankles or feet (oedema)

Uncommon:

• headache, weakness, low blood sugar

In some patients taking wildagliptin alone, the following side effects have been reported:
Common:

• dizziness

Uncommon:

• headache, constipation, swollen hands, ankles or feet (oedema), joint pain, low blood sugar

Very rare:
sore throat, cold, fever
In some patients taking wildagliptin, metformin, and a sulphonylurea, the following side effects have been reported:
Common:

• dizziness, tremor, weakness, low blood sugar, excessive sweating

In some patients taking wildagliptin and insulin (with or without metformin), the following side effects have been reported:
Common:

• headache, chills, nausea (vomiting), low blood sugar, heartburn

Uncommon:

• diarrhoea, bloating

After Kwikaton has been marketed, the following side effects have also been reported:
Frequency not known (cannot be estimated from the available data):

• itching rash, pancreatitis, local skin exfoliation or blistering, muscle pain
• liver disease (hepatitis) - usually reversible after stopping treatment. Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite or dark urine.
• abnormal liver test results - usually reversible after stopping treatment

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kwikaton

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kwikaton contains

• The active substance is wildagliptin. Each tablet contains 50 mg of wildagliptin
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate

What Kwikaton looks like and contents of the pack

Kwikaton is a round, flat tablet with bevelled edges, white to light yellow in colour, with a diameter of 8.0 ± 0.2 mm.
Kwikaton is available in standard blisters and blister packs containing 14, 28, 30, 56, 60, 90, 105, 112, 180 tablets, in a carton box.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Kwikaton

Sweden

Kwikaton 50 mg tablet

Hungary
Poland

Kwikaton

Date of last revision of the leaflet: