Linagliptin Abdi

Package leaflet: Information for the user

Linagliptin Abdi 5 mg film-coated tablets

linagliptin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Linagliptin Abdi contains the active substance linagliptin, which belongs to a class of medicines known as "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 Abdi 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 Abdi may be used in combination with other antidiabetic medicines, such as metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin or insulin.

It is important that you continue to follow the advice you have received from your doctor or nurse regarding diet and physical exercise.

2. What you need to know before taking Linagliptin Abdi

Do not take Linagliptin Abdi
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 Abdi 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 Abdi 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 Abdi, in order 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 disease of the pancreas.

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 might be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Linagliptin Abdi.
Skin lesions typical of diabetes are a common complication of this disease. It is recommended that you follow the advice given to you by your doctor or nurse regarding skin and foot care.

Children and adolescents
Linagliptin Abdi 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 unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Linagliptin Abdi
Tell 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 (convulsions) 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 breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Linagliptin Abdi is harmful to the unborn baby. Therefore, it is preferable to avoid taking Linagliptin Abdi during pregnancy.
It is not known whether Linagliptin Abdi passes into human breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue treatment with Linagliptin Abdi or to discontinue the therapy.

Driving and using machines
Linagliptin Abdi does not affect or affects negligibly the ability to drive and use machines.
However, taking Linagliptin Abdi 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. You may therefore find it advisable to monitor your blood glucose levels more frequently to minimise the risk of hypoglycaemia, especially when Linagliptin Abdi is used in combination with sulfonylureas and/or insulin.

3. How to take Linagliptin Abdi

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose of Linagliptin Abdi is one 5 mg tablet once daily.
You may take Linagliptin Abdi with or without food.
Your doctor may prescribe Linagliptin Abdi 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 Abdi than you should
If you take more Linagliptin Abdi than you should, contact your doctor immediately.

If you forget to take Linagliptin Abdi

• If you forget to take a dose of Linagliptin Abdi, 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 Abdi
Do not stop taking Linagliptin Abdi without first consulting your doctor. Your blood sugar levels may increase when you stop treatment with Linagliptin Abdi.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms require immediate medical attention
You must stop taking Linagliptin Abdi and contact your doctor immediately if you experience the following symptoms due to low blood sugar levels: tremor, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes or confusion (hypoglycaemia).
Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a known side effect when Linagliptin Abdi 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 Abdi 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 estimated from the 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 in breathing or swallowing (angioedema; frequency: rare). If you experience any of the signs of illness mentioned above, stop taking Linagliptin Abdi 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 Abdi alone or in combination with other medicines for the treatment of diabetes.
STOP taking Linagliptin Abdi 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 could be signs of an inflamed pancreas (pancreatitis).

Some patients experienced the following side effects when taking Linagliptin Abdi 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 nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), increased levels of the enzyme amylase in the blood.
• Rare: skin rash with blisters (bullous pemphigoid).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 Abdi

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 the outer carton after “EXP” or “Scad.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Linagliptin Abdi if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Linagliptin Abdi contains

• The active substance is linagliptin. Each film-coated tablet (tablet) contains 5 mg of linagliptin.
• The other components are: Tablet core: mannitol, pregelatinized starch, copovidone, magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), talc, macrogol, red iron oxide (E172).

Description of the appearance of Linagliptin Abdi and package contents

• Linagliptin Abdi 5 mg tablets are round, biconvex, pink, film-coated tablets with "L" imprinted on one side and smooth on the other side.
• Linagliptin Abdi is available in unit-dose divisible aluminum/aluminum blisters. Pack sizes contain 10 × 1, 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1, 100 × 1 and 120 × 1 tablets.

Not all pack sizes may be marketed in your country.
Marketing Authorization Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany
Manufacturer
lnterpharma Services Ltd.
43A Cherni Vrach Bvld.
Sofia 1407 Bulgaria
Flavine Pharma France
3 Voie d’Allemagne,
Vitrolles, 13127 France
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park, Paola,
PLA 3000, Malta
This medicinal product is authorized in the European Economic Area member states under the following
names:
Czech Republic: Linagliptin Abdi
Germany: Linagliptin Abdi
Spain: Linagliptina Abdi
Netherlands: Linagliptine Abdi
Italy: Linagliptin Abdi