Kwikaton

Patient Information Leaflet

Kwikaton, 50 mg, tablets
vildagliptin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Kwikaton is and what it is used for
2. What you need to know 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 Kwikaton is and what it is used for

The active substance in Kwikaton, 50 mg tablets, is vildagliptin, which belongs to a group of medicines called oral antidiabetic agents.
Kwikaton, 50 mg tablets, is a medicine used to treat adult patients with type 2 diabetes mellitus whose blood sugar levels are not adequately controlled by diet and exercise alone.
Kwikaton helps control blood glucose levels. Your doctor may prescribe Kwikaton either as the only antidiabetic medicine or in combination with other antidiabetic medicines you may be taking, if they have not been sufficiently effective in controlling blood glucose levels.
Type 2 diabetes is a condition in which the body either does not produce enough insulin or the insulin produced does not work properly. Diabetes may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood glucose levels, especially after meals.
Glucagon is a substance that stimulates glucose production in the liver and increases blood glucose levels. Both of these substances are produced in the pancreas.

How Kwikaton works
Kwikaton works by stimulating the pancreas to produce more insulin and by reducing the production of glucagon. Therefore, Kwikaton helps control blood glucose levels. It has been shown to reduce blood glucose levels, which may help prevent complications associated with diabetes. Even if you are taking antidiabetic medicines, it is important to continue following your recommended diet and (or) exercise regimen.

2. Important information before using Kwikaton

When not to use Kwikaton

• if the patient is allergic to vildagliptin or any of the other ingredients of this medicine

(listed in section 6);
Warnings and precautions
Before starting treatment with Kwikaton, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has type 1 diabetes (i.e. if the patient's body does not produce insulin) or if the patient has a condition called diabetic ketoacidosis,
• if the patient is taking an antidiabetic medicine called a sulfonylurea [the doctor may wish to reduce the dose of the sulfonylurea taken together with this medicine to avoid low blood glucose levels (hypoglycaemia)],
• if the patient has moderate or severe kidney disease (a lower dose of Kwikaton should be used),
• if the patient is on dialysis,
• if the patient has liver disease,
• if the patient has heart failure,
• if the patient has had or currently has pancreatic diseases.

If the patient previously took vildagliptin but had to discontinue it due to liver disease, this medicine should not be used.
Skin complications are common in diabetes. The patient should follow the advice of the treating doctor or nurse regarding skin and foot care. During treatment with Kwikaton, the patient should pay particular attention to the development of new blisters or ulcers. If these occur, the patient should contact the treating doctor immediately.
Before starting treatment with Kwikaton and every three months during the first year of treatment, and thereafter periodically, liver function tests should be performed. This allows symptoms of increased liver enzyme activity to be detected as early as possible.
Children and adolescents
Kwikaton is not recommended for use in children and adolescents under 18 years of age.
Kwikaton and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
The doctor may adjust the dose of Kwikaton if the patient is taking other medicines such as:

• thiazides or other diuretics (also known as water tablets)
• corticosteroids (usually used to treat inflammatory conditions)
• medicines used to treat thyroid disorders
• certain medicines affecting the nervous system.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine must not be used during pregnancy.
It is unknown whether Kwikaton passes into human breast milk. Kwikaton must not be used during breastfeeding or when planning to breastfeed.
Driving and operating machinery
If the patient experiences dizziness while taking Kwikaton, the patient must not drive or operate machinery.
Kwikaton contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Kwikaton contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Kwikaton

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Dosage
The dose of Kwikaton varies depending on the patient's condition. Your doctor will determine exactly how many tablets
of
Kwikaton should be taken. The maximum daily dose is 100 mg.
The usual dose of Kwikaton is:

• 50 mg once daily in the morning when Kwikaton is used together with a medicine called a sulfonylurea.
• 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Kwikaton is used alone, with metformin, with a glitazone, in combination with metformin and a sulfonylurea, or with insulin (with or without metformin).
• 50 mg daily taken in the morning if the patient has moderate or severe kidney disease or is undergoing dialysis.

How to take Kwikaton
Tablets should be swallowed whole with water.
How long to take Kwikaton
Kwikaton should be taken daily for as long as prescribed by the doctor. The doctor may
decide on long-term treatment.
The doctor will regularly monitor the patient's health to assess whether the treatment is achieving
the intended effect.
Taking more Kwikaton than prescribed
If too many Kwikaton tablets have been taken or if someone else has taken this medicine, you must
immediately
consult a doctor. The patient may require medical attention. If it becomes necessary
to visit a doctor's office or hospital, bring the medicine packaging with you.
Missed dose of Kwikaton
If a dose of this medicine is missed, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed tablet.
Stopping Kwikaton
Do not stop taking this medicine without the doctor's approval.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions require immediate medical attention:
If any of the following adverse reactions occur, stop taking the medicine Kwikaton immediately and consult a doctor:

• Angioedema (rare: may occur in no more than 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives.
• Liver disease (hepatitis) (rare): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine.
• Pancreatitis (frequency unknown): Symptoms include severe and persistent abdominal (stomach area) pain which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
The following adverse reactions have been reported in some patients taking vildagliptin and metformin:

Common (may occur in no more than 1 in 10 people):

• Tremor, headache, dizziness, nausea, low blood glucose levels

Uncommon (may occur in no more than 1 in 100 people):

• Fatigue

The following adverse reactions have been reported in some patients taking vildagliptin and a sulfonylurea:

Common:

• Tremor, headache, dizziness, weakness, low blood glucose levels

Uncommon:

• Constipation

Very rare (may occur in no more than 1 in 10,000 people):

• Sore throat, cold symptoms

The following adverse reactions have been reported in some patients taking vildagliptin and a glitazone:

Common:

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

Uncommon:

• Headache, weakness, low blood glucose levels

The following adverse reactions have been reported in some patients taking vildagliptin as monotherapy:

Common:

• Dizziness

Uncommon:

• Headache, constipation, swollen hands, ankles or feet (oedema), joint pain, low blood glucose levels

Very rare:
Sore throat, cold symptoms, fever

The following adverse reactions have been reported in some patients taking vildagliptin, metformin and a sulfonylurea:

Common:

• Dizziness, tremor, weakness, low blood glucose levels, excessive sweating

The following adverse reactions have been reported in some patients taking vildagliptin and insulin (with or without metformin):

Common:

• Headache, chills, nausea, low blood glucose levels, heartburn

Uncommon:

• Diarrhoea, flatulence

After the marketing of medicinal products containing vildagliptin as a single substance, the following adverse reactions have also been reported:

Frequency unknown (cannot be estimated from available data):

• Itchy rash, pancreatitis, localised skin peeling or blistering, muscle pain
• Liver disease (hepatitis) – usually reversible upon discontinuation of treatment. Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine.
• Abnormal liver function test results – usually reversible upon discontinuation of treatment

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Kwikaton

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and cardboard
container after: EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
There are no special requirements regarding storage temperature.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such practices help
protect the environment.

6. Contents of the pack and other information

What Kwikaton contains

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

What Kwikaton looks like and contents of the pack
Kwikaton is a round, flat tablet with bevelled edges, white to slightly yellowish in colour, with a diameter of 8.0 ± 0.2 mm.
Kwikaton is available in standard blisters and in unit dose blisters, containing 14, 28, 30, 56, 60, 90, 105, 112, or 180 tablets in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA M&D SRL
Str. Trascăului, nr 10
401135, Turda
Romania

This medicinal product is authorised in the European Economic Area under the following names:
Sweden: Kwikaton
Hungary: Kwikaton 50 mg tabletta
Poland: Kwikaton