Package leaflet: Information for the patient

Linagliptin Pensa 5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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

What Linagliptin Pensa is and what it is used for
What you need to know before taking Linagliptin Pensa
How to take Linagliptin Pensa
Possible side effects
How to store Linagliptin Pensa
Contents of the pack and other information

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

Linagliptin Pensa 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 Pensa 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 Pensa may be used together with other antidiabetic medicines, such as 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 exercise.

2. What you need to know before taking Linagliptin Pensa

Do NOT take Linagliptin Pensa

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 Pensa 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 Pensa 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 Pensa, 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 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 Pensa.
Skin lesions typical of diabetes are a common complication of this disease. It is recommended that you follow the skin and foot care advice provided by your doctor or nurse.
Children and adolescents
Linagliptin Pensa is not recommended for use in 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 Pensa
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 medicines may be used to control epileptic seizures or chronic pain.
Rifampicin. It 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, consult your doctor or pharmacist before taking this medicine.
It is not known whether linagliptin is harmful to the unborn baby. Therefore, it is preferable to avoid taking Linagliptin Pensa during pregnancy.
It is not known whether linagliptin passes into human breast milk. Your doctor will decide whether to discontinue breastfeeding or to stop/abstain from treatment with Linagliptin Pensa.
Driving and using machines
Linagliptin Pensa does not affect or affects negligibly the ability to drive and use machines.
However, taking Linagliptin Pensa in combination with medicines called sulphonylureas and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may impair your ability to drive and use machines or work without protective barriers. To minimise the risk of hypoglycaemia, more frequent monitoring of blood glucose may be advisable, especially when Linagliptin Pensa is taken together with a sulphonylurea and/or insulin.
Linagliptin Pensa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Linagliptin Pensa

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose of Linagliptin Pensa is one 5 mg tablet once daily.
You may take Linagliptin Pensa with or without food.
Your doctor may prescribe Linagliptin Pensa in combination with another oral antidiabetic medicine.
Remember to take all your medicines as directed by your doctor to achieve the best results for your health.

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

If you forget to take Linagliptin Pensa

If you forget to take a dose of Linagliptin Pensa, 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 Pensa
Do not stop taking Linagliptin Pensa without first consulting your doctor. Blood sugar levels may increase when treatment with Linagliptin Pensa is stopped.
If you have any doubts about how to use this medicine, ask 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 Pensa and consult your doctor immediately if you experience the following symptoms due to low blood sugar levels: trembling, 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 an adverse effect observed when linagliptin is taken together 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, including 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), 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 swallowing or breathing (angioedema; frequency: rare). If you experience any of the above symptoms, stop taking Linagliptin Pensa and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another 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 alone or in combination with other diabetes medicines.
STOP taking Linagliptin Pensa and contact your doctor immediately if you notice any of the following serious side effects:

Severe and persistent stomach (abdominal) pain which may radiate to the back, as well as nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

Some patients have experienced the following side effects while taking linagliptin alone or in combination with other diabetes medicines:
Common (may affect up to 1 in 10 people)

increased levels of lipase in the blood.

Not common (may affect up to 1 in 100 people)

inflammation of nose or throat (rhinopharyngitis);
cough;
constipation (in combination with insulin);
increased levels of amylase in the blood.

Rare (may affect up to 1 in 1,000 people)

blisters on the skin (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 Pensa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging following the word “Exp.”. The expiry date refers to the last day of that month.
This medicine requires no 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 Pensa contains

The active substance is linagliptin. Each film-coated tablet (tablet) contains 5 mg of linagliptin.
The other components are: Tablet core: Maize starch, mannitol (E421), hypromellose (low viscosity), sodium croscarmellose, magnesium stearate. Film coating: Hypromellose (2910), titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172).

Description of the appearance of Linagliptin Pensa and package contents

Linagliptin Pensa 5 mg tablets are film-coated, light red in colour, round (approximately 8 mm in diameter), biconvex.
Linagliptin Pensa is available in OPA/Alu/PVC//Alu blisters. Pack sizes of 28 and 30 tablets.
Linagliptin Pensa is also available in perforated unit-dose OPA/Alu/PVC//Alu blisters. Pack sizes of 28 x 1 and 30 x 1 tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan – Italy
Manufacturer
PharmaPath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51,
Greece
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Linagliptin Pensa
Denmark: Linagliptin PharmaPath
Spain: Linagliptina PharmaPath 5 mg comprimidos recubiertos con película EFG
Portugal: Linagliptina PharmaPath