Linagliptin Macleods

Package leaflet: Information for the patient

Linagliptin Macleods 5 mg film-coated tablets

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

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

Linagliptin Macleods 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 Macleods 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. This medicine 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 given by your doctor or nurse regarding diet and exercise.

2. What you need to know before taking Linagliptin Macleods

Do not take Linagliptin Macleods

• 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 Macleods 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 Macleods must not be used to treat these conditions.

• you are taking an antidiabetic medicine known as a "sulphonylurea" (e.g. glimepiride, glipizide), your doctor may decide to reduce the dose of the sulphonylurea when taken together with Linagliptin Macleods, 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 had a disease of the pancreas.

If you develop 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 Macleods.
Diabetic skin lesions are a common complication of diabetes. 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 Macleods 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 when used in children under 10 years of age.

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

Driving and using machines
Linagliptin Macleods has no effect or has negligible effect on the ability to drive and use machines.
However, taking this medicine in combination with medicines called sulphonylureas 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 be advised to monitor your blood glucose levels more frequently to minimise the risk of hypoglycaemia, especially when used in combination with sulphonylureas and/or insulin.

3. How to take Linagliptin Macleods

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

If you forget to take Linagliptin Macleods

• If you forget to take a dose of Linagliptin Macleods, 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 a forgotten dose. Never take two doses on the same day.

If you stop taking Linagliptin Macleods
Do not stop treatment with this medicine without first consulting your doctor. Your blood sugar levels may increase when you stop treatment with this medicine.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Linagliptin Macleods can cause side effects, although not everyone experiences them.

Some symptoms require immediate medical attention
You must stop taking this medicine and contact your doctor immediately if you experience the following symptoms due to low blood sugar levels: trembling, sweating, anxiety, blurred vision, lip tingling, paleness, mood changes or confusion (hypoglycaemia).
Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a known side effect when this medicine 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 this medicine alone or in combination with other diabetes treatments, which may be severe and may include wheezing and shortness of breath (bronchial hyperreactivity; frequency: not known, frequency cannot be estimated from available data). Some patients have developed 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 that may cause difficulty breathing or swallowing (angioedema; frequency: rare). If you experience any of the above signs of illness, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a treatment for 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 this medicine alone or in combination with other diabetes medicines.

STOP taking this medicine 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 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 this medicine alone or in combination with other diabetes medicines:

• 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, 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 Macleods

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack and carton after
Exp. The expiry date refers to the last day of that month.
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 Macleods contains

• The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
• The other components are: mannitol (E421), pregelatinized starch, copovidone (E1208), magnesium stearate (E470b); coating components: hypromellose (E464), macrogol 400, talc, titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of Linagliptin Macleods and pack contents
Linagliptin Macleods are light red, round, biconvex, film-coated tablets,
with "I 42" engraved on one side and smooth on the other side.
Linagliptin Macleods is available in blister packs (cold-form laminated film blisters in
OPA/Aluminium/PVC with aluminium foil lid). The available pack size is 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Macleods Pharma España S.L.U.
World Trade Center Barcelona
Moll de Barcelona, s/n,
08039 Barcelona, Spain

Manufacturer
Synoptis Industrial Sp. z o.o
ul. Rabowicka 15, Swarzędz,
62-020, Poland.