Patient leaflet - Linagliptin Advanz Pharma 5 mg film-coated tablets
1. What Linagliptin Advanz Pharma is and what it is used for
Linagliptin Advanz Pharma contains the active substance linagliptin which belongs to a group of medicines called “oral anti-diabetics”. Oral anti-diabetics are used to treat high blood sugar levels. They work by helping the body reduce the level of sugar in your blood.
Linagliptin Advanz Pharma is used for ‘type 2 diabetes’ in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone. Linagliptin Advanz Pharma 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 Advanz Pharma
Do not take Linagliptin Advanz Pharma
- if you are allergic to linagliptin or 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 Advanz Pharma if you:
- have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Linagliptin Advanz Pharma should not be used to treat these conditions.
- are taking an anti-diabetic medicine known as ‘sulphonylurea’ (e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Linagliptin Advanz Pharma 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 Advanz Pharma.
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 Advanz Pharma is not recomended 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 Advanz Pharma
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 substance:
- 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 Advanz Pharma is harmful to the unborn child. Therefore, it is preferable to avoid using Linagliptin Advanz Pharma if you are pregnant.
It is not known if Linagliptin Advanz Pharma passes into human breast milk. A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Linagliptin Advanz Pharma therapy.
Driving and using machines
Linagliptin Advanz Pharma has no or negligible influence on the ability to drive and use machines. Taking Linagliptin Advanz Pharma 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, specially when Linagliptin Advanz Pharma is combined with sulphonylurea and/or insulin.
3. How to take Linagliptin Advanz Pharma
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Linagliptin Advanz Pharma is one 5 mg tablet once a day. You can take Linagliptin Advanz Pharma with or without food.
Your doctor may prescribe Linagliptin Advanz Pharma together with another oral anti-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 Advanz Pharma than you should
If you take more Linagliptin Advanz Pharma than you should, talk to a doctor immediately.
If you forget to take Linagliptin Advanz Pharma
If you forget to take a dose of Linagliptin Advanz Pharma, 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 Advanz Pharma
Do not stop taking Linagliptin Advanz Pharma without first consulting your doctor. Your blood sugar levels may increase when you stop taking Linagliptin Advanz Pharma.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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 Advanz Pharma 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 Advanz Pharma 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 Advanz Pharma 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 1000 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 Advanz Pharma 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 1000 people) while taking Linagliptin Advanz Pharma alone or in combination with other medicinal products for the treatment of diabetes. STOP taking Linagliptin Advanz Pharma 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 Advanz Pharma 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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 Advanz Pharma
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 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 use Linagliptin Advanz Pharma if the package is damaged or shows signs of tampering. 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 Advanz Pharma contains
- The active substance is linagliptin.
- Each film-coated tablet (tablet) contains 5 mg of linagliptin
The other ingredients (excipients) are:
Tablet core: mannitol (E 421), copovidone, maize starch, magnesium stearate Film-coating: hypromellose, titanium dioxide (E171), macrogol 6000, talc, iron oxide red (E172)
Dimension: 170 x 600 mm Commodity No.: N/A
What Linagliptin Advanz Pharma looks like and contents of the pack
Linagliptin Advanz Pharma are light red, round, biconvex, bevel-edged, film-coated tablets debossed with an “I” on one side, with a diameter of 8.0 mm ± 0.5 mm. Linagliptin Advanz Pharma is available in OPA/Aluminium/PVC/Aluminium blisters containing 7, 10, 14, 28, 30, 56, 84, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17 Northwood House
Northwood Crescent
Dublin 9 D09 V504
Ireland
Manufacturer
SAG Manufacturing, S.L.U.
Ctra. N-I, km 36
28750 San Agustín de Guadalix
Madrid – Spain
Galenicum Health S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
This leaflet was last revised in February 2026.
AW-LF-0001603 (v0.5)
Dimension: 170 x 600 mm Commodity No.: N/A