Linagliptin Krka

Patient Information Leaflet

Linagliptin Krka 5 mg film-coated tablets

linagliptin
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Linagliptin Krka is and what it is used for
2. What you need to know before taking Linagliptin Krka
3. How to take Linagliptin Krka
4. Possible side effects
5. How to store Linagliptin Krka
6. Contents of the pack and other information

1. What Linagliptin Krka is and what it is used for

Linagliptin Krka contains the active substance linagliptin, which belongs to a group of medicines called "oral antidiabetics". Oral antidiabetics are used to treat high blood sugar levels. These medicines work by helping the body to reduce blood sugar levels.
Linagliptin Krka is used in "type 2 diabetes" in adults when the disease cannot be adequately controlled with a single oral antidiabetic medicine (metformin or sulphonylureas) or with diet and exercise alone.
Linagliptin Krka may be used together with other antidiabetic medicines, for example metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin or insulin.
It is important that you continue to follow your doctor’s or nurse’s advice regarding diet and physical exercise.

2. What you should know before taking Linagliptin Krka

Do not take Linagliptin Krka

• if you are allergic to linagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Linagliptin Krka if:

• you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting). Linagliptin Krka must not be used to treat these conditions.
• you are taking an antidiabetic medicine known as a “sulfonylurea” (e.g. glimepiride, glipizide). Your doctor may decide to reduce the dose of the sulfonylurea when taken together with Linagliptin Krka, to avoid blood sugar levels becoming too low.
• you have had allergic reactions to any other medicine you take to control your blood sugar levels.
• you have or have previously had a pancreatic disease. If you experience symptoms of acute pancreatitis, such as persistent and severe stomach pain (abdominal pain), you must consult a doctor.

If blisters appear on the skin, they may be a sign of a condition called
bullous pemphigoid. Your doctor may ask you to stop treatment with Linagliptin Krka.
Skin lesions typical of diabetes are a common complication of this disease. It is
recommended that you follow the advice provided by your doctor or nurse regarding skin and foot care.
Children and adolescents
Linagliptin Krka is not recommended for children and adolescents under 18 years of age. It is not
effective in children and adolescents aged between 10 and 17 years. It is not known whether this
medicine is safe and effective in children under 10 years of age.
Other medicines and Linagliptin Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
In particular, you must inform your doctor if you are taking medicines containing any of the following
active substances:

• Carbamazepine, phenobarbital, or phenytoin. These may be used to control epileptic seizures or chronic pain.
• Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
It is not known whether linagliptin is harmful to the unborn child. Therefore, it is preferable to avoid
taking Linagliptin Krka during pregnancy.
It is not known whether linagliptin passes into human breast milk. Your doctor will decide whether to
discontinue breastfeeding or to discontinue/forego treatment with Linagliptin Krka.
Driving and using machines
Linagliptin Krka has no or negligible influence on the ability to drive and use machines.
However, taking Linagliptin Krka in combination with medicines called sulfonylureas and/or insulin
may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive
and use machines or to work without protective barriers. Therefore, more frequent monitoring of blood
glucose may be advisable to minimize the risk of hypoglycaemia, especially when used in combination
with sulfonylureas and/or insulin.

3. How to take Linagliptin Krka

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Linagliptin Krka is one 5 mg tablet once daily.
You may take Linagliptin Krka with or without food.
Your doctor may prescribe Linagliptin Krka in combination with another oral antidiabetic medicine.
Remember to take all your medicines as prescribed by your doctor to achieve the best possible health outcomes.

If you take more Linagliptin Krka than you should
If you take more Linagliptin Krka than prescribed, contact your doctor immediately.

If you forget to take Linagliptin Krka

• If you forget to take a dose of Linagliptin Krka, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for the forgotten dose. Never take two doses on the same day.

If you stop taking Linagliptin Krka
Do not stop taking Linagliptin Krka without first consulting your doctor. Your blood sugar levels may increase when you stop treatment with Linagliptin Krka.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Some symptoms require immediate medical attention.
You must stop taking Linagliptin Krka and contact your doctor immediately if you experience the following symptoms due to low blood sugar levels: tremor, sweating, anxiety, blurred vision, lip tingling, pallor, mood changes or confusion (hypoglycaemia).
Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a known side effect when linagliptin is taken with metformin and a sulphonylurea.

Some patients have experienced allergic reactions (hypersensitivity; frequency: not common, may affect up to 1 in 100 people) while taking linagliptin alone or in combination with other diabetes medicines, which may be severe and may include wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, frequency cannot be determined from available data). Some patients have developed skin rash (frequency: not common), urticaria (frequency: rare, may affect up to 1 in 1,000 people), and swelling of the face, lips, tongue, and throat which may cause difficulty breathing or swallowing (angioedema; frequency: rare). If you experience any of the above-mentioned signs of illness, stop taking Linagliptin Krka and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes.

Some patients have experienced inflammation of the pancreas (pancreatitis; frequency: rare, may affect up to 1 in 1,000 people) while taking linagliptin alone or in combination with other medicines for the treatment of diabetes.

STOP taking Linagliptin Krka and contact a doctor immediately if you notice any of the following serious side effects:

• Severe, persistent pain in the stomach area (abdomen), which may spread to the back, as well as nausea and vomiting, as these may be signs of an inflamed pancreas (pancreatitis).

Some patients experienced the following side effects when taking linagliptin alone or in combination with other medicines for the treatment of diabetes:

• Common: increased levels of the enzyme lipase in the blood.
• Not common: inflammation of the nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), increased levels of the enzyme amylase in the blood.
• Rare: blistering skin rash (bullous pemphigoid).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Linagliptin Krka

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 carton after Exp. and on the
blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Linagliptin Krka contains

• The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
• The other components (excipients) are mannitol (E421), pregelatinized maize starch, and magnesium stearate in the tablet core; and hypromellose, titanium dioxide (E171), talc, propylene glycol, and red iron oxide (E172) in the film coating.

Description of the appearance of Linagliptin Krka and contents of the pack
Film-coated tablet (tablet), round, biconvex, dark pink in colour. Tablet size: diameter approximately 8 mm.
Linagliptin Krka is available in packs containing:

• 10, 15, 28, 30, 60, 90 or 100 film-coated tablets in blisters.
• 10 x 1, 15 x 1, 30 x 1 or 100 x 1 film-coated tablets in perforated divisible blisters for unit dose.
• 28 film-coated tablets in blister calendar pack.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative for Italy
Krka Farmaceutici Milano S.r.l. – Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names: