Linagliptin Sandoz

Package leaflet: Information for the patient

Linagliptin Sandoz 5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• 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 adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Linagliptin Sandoz contains the active substance linagliptin, which belongs to a class 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 Sandoz 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 Sandoz may be used together with other antidiabetic medicines, such as metformin, sulphonylureas (e.g. glimepiride, glipizide) or insulin.
It is important that you continue to follow your doctor’s or nurse’s advice regarding diet and exercise.

2. What you need to know before taking Linagliptin Sandoz

Do not take Linagliptin Sandoz:

• 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 Sandoz 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 Sandoz 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 sulfonylurea when taken together with Linagliptin Sandoz 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 Sandoz.
Diabetes-related skin lesions 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 Sandoz 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 Sandoz
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, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Linagliptin Sandoz is harmful to the unborn baby. Therefore, it is preferable to avoid taking Linagliptin Sandoz during pregnancy.
It is not known whether Linagliptin Sandoz passes into human breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue/abandon treatment with Linagliptin Sandoz.

Driving and using machines
Linagliptin Sandoz does not affect or has negligible influence on the ability to drive vehicles and use machines.
However, taking Linagliptin Sandoz in combination with medicines called sulfonylureas and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect your ability to drive or operate machinery or work without protective barriers. You may therefore be advised to monitor your blood glucose levels more frequently to minimize the risk of hypoglycaemia, especially when used in combination with sulfonylureas and/or insulin.

3. How to take Linagliptin Sandoz

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

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

If you forget to take Linagliptin Sandoz

• If you forget to take a dose of Linagliptin Sandoz, 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 Sandoz
Do not stop taking Linagliptin Sandoz without first consulting your doctor. Your blood sugar levels may increase when you stop treatment with Linagliptin Sandoz.
If you have any questions about how to use 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 require immediate medical attention.
You must stop taking Linagliptin Sandoz 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 Sandoz 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 Sandoz 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 a skin rash (frequency: not common), hives (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 signs of illness listed above, stop taking Linagliptin Sandoz 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 developed inflammation of the pancreas (pancreatitis; frequency: rare, may affect up to 1 in 1,000 people) while taking Linagliptin Sandoz alone or in combination with other medicines for the treatment of diabetes.

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

• Severe and persistent pain in the stomach area, which may extend 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 while taking Linagliptin Sandoz 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: skin rash with blisters (bullous pemphigoid).

Reporting of side effects
If you experience any side effects, 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton 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 medicines 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 Sandoz contains

• The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
• The other components are:
  Tablet core: mannitol (E421), crospovidone (E1202), hypromellose (E464), anhydrous colloidal silica (E551) and magnesium stearate (E470b).

Coating film: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521) and red iron oxide (E172).

Description of the appearance of Linagliptin Sandoz and contents of the pack

Linagliptin Sandoz are light pink, round, biconvex, film-coated tablets with approximate dimensions of 8 mm in diameter, marked with "5" on one side.

Linagliptin Sandoz is available in aluminum blisters. The pack contains 28 tablets.

Linagliptin Sandoz is also available in unit-dose divisible aluminum blisters. The pack contains 28 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz S.p.A.,
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova ulica 57,
1526 Ljubljana
Slovenia

PharOS MT Ltd.
HF62X, Qasam Industrijali Hal Far,
Hal Far, Birzebbuga BBG3000,
Malta

PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone
Metamorfossi, 14452
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:

Italy: Linagliptin Sandoz
Hungary: Linagliptin 1A Pharma 5 mg filmtabletta