Patient leaflet - Linagliptin Krka 5 mg film-coated tablets

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 anti

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diabetics”. Oral anti

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diabetics are used to treat high blood sugar levels. They work by helping the body reduce the level of sugar in your blood.

Linagliptin Krka is used for ‘type 2 diabetes’ in adults, if the disease cannot be adequately controlled with one oral anti

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diabetic medicine (metformin or sulphonylureas) or diet and exercise alone. Linagliptin Krka may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.

It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.

2. What you need to know before you take Linagliptin Krka

Do not take Linagliptin Krka

if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions

Talk to your doctor or pharmacist before taking Linagliptin Krka if you:

have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Linagliptin Krka should not be used to treat these conditions.
- are taking an anti
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  diabetic medicine known as a ‘sulphonylurea’(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Linagliptin Krka in order to avoid your blood sugar going too low.
- have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.
- have or have had a disease of the pancreas. If you have symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain), you should consult your doctor.

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Linagliptin Krka.

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.

Children and adolescents

Linagliptin Krka is not recommended for children and adolescents under 18 years. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.

Other medicines and Linagliptin Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you should tell your doctor if you are using medicines containing any of the following active substances:

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

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. It is unknown if linagliptin is harmful to the unborn child. Therefore, it is preferable to avoid using Linagliptin Krka if you are pregnant.

It is not known if linagliptin passes into human breast milk. A decision must be made by your doctor whether to discontinue breast

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feeding or to discontinue/abstain from Linagliptin Krka therapy.

Driving and using machines

Linagliptin Krka has no or negligible influence on the ability to drive and use machines.

Taking Linagliptin Krka in combination with medicines called sulphonylureas and/or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold. However, more frequent blood glucose testing might be recommended to minimise the risk for hypoglycaemia, especially when Linagliptin Krka is combined with sulphonylurea and/or insulin.

3. How to take Linagliptin Krka

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

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The recommended dose of Linagliptin Krka is one 5 mg tablet once a day.

You can take Linagliptin Krka with or without food. Your doctor may prescribe Linagliptin Krka together with another oral anti

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diabetic medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health.

If you take more Linagliptin Krka than you should

If you take more Linagliptin Krka than you should, talk to a 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 it. 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 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 taking Linagliptin Krka.

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

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 Linagliptin Krka and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating,

anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is an identified side effect when linagliptin is taken together with metformin and a sulphonylurea. Some patients have experienced allergic reactions (hypersensitivity; frequency uncommon, may affect up to 1 in 100 people) while taking linagliptin alone or in combination with other medicinal products for the treatment of diabetes, which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, frequency cannot be estimated from the available data). Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1 000 people), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare). If you experience any of the signs of illness mentioned above, stop taking Linagliptin Krka and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your 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 medicinal products 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 and persistent pain in the abdomen (stomach area) which might reach through to your back, as well
as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Some patients have had the following side effects while taking linagliptin alone or in combination with other medicinal products for the treatment of diabetes:
- Common: level of lipase in the blood increased.
- Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.
- Rare: blistering of skin (bullous pemphigoid). Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: yellowcard. mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 box and 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Linagliptin Krka contains

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

What Linagliptin Krka looks like and contents of the pack

Dark pink, round, biconvex, film-coated tablet (tablet). Tablet dimension: diameter approx. 8 mm.

Linagliptin Krka is available in boxes 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 tablet in perforated unit dose blisters.
28 film-coated tablets in blisters, calendar pack. Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This leaflet was last revised in September 2025.