Patient leaflet - Linagliptin 5 mg film-coated tablets
1. What Linagliptin is and what it is used for
Linagliptin 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 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 may be used together with other anti-diabetic medicines e.g. metformin 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
Do not take Linagliptin
- 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 if you:
- have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Linagliptin should not be used to treat these conditions
- are taking an anti-diabetic medicine known as a ‘sulphonylurea’ (e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Linagliptin 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.
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 is not recommended 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
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 substances:
- 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 is harmful to the unborn child. Therefore, it is preferable to avoid using Linagliptin if you are pregnant.
It is not known if Linagliptin passes into human breast milk. A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Linagliptin therapy.
Driving and using machines
Linagliptin has no or negligible influence on the ability to drive and use machines.
Taking Linagliptin 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, especially when Linagliptin is combined with sulphonylurea and/or insulin.
3. How to take Linagliptin
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 is one 5 mg tablet once a day.
You can take Linagliptin with or without food.
Your doctor may prescribe Linagliptin 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 than you should
If you take more Linagliptin than you should, talk to a doctor immediately.
If you forget to take Linagliptin
- If you forget to take a dose of Linagliptin, 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
Do not stop taking Linagliptin without first consulting your doctor. Your blood sugar levels may increase when you stop taking Linagliptin.
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.
STOP taking Linagliptin and contact a doctor immediately if you notice any of the following serious side effects
Very common (may affect more than 1 in 10 people):
- Hypoglycaemia: symptoms of low blood sugar include trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion. Hypoglycaemia is an identified side effect when Linagliptin is taken together with metformin and a sulphonylurea.
Uncommon (may affect up to 1 in 100 people):
Allergic reactions (hypersensitivity) while taking Linagliptin 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) (not known, frequency cannot be estimated from the available data)
- rash (uncommon, may affect up to 1 in 100 people)
- hives (urticaria) (rare, may affect up to 1 in 1,000 people)
- swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema) (rare, may affect up to 1 in 1,000 people)
If you experience any of the signs of allergic reaction mentioned above, stop taking Linagliptin and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Rare (may affect up to 1 in 1,000 people):
Inflammation of the pancreas (pancreatitis) while taking Linagliptin alone or in
combination with other medicinal products for the treatment of diabetes. Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting,
could be a sign of an inflamed pancreas.
Other side effects while taking Linagliptin alone or in combination with other medicinal products for the treatment of diabetes
Common (may affect up to 1 in 10 people):
- level of lipase in the blood increased.
Uncommon (may affect up to 1 in
100 people):
- inflamed nose or throat (nasopharyngitis)
- cough
- constipation (in combination with insulin)
- level of amylase in the blood increased.
Rare (may affect up to 1 in 1,000 people):
- 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 Website 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
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 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 contains
The active substance is linagliptin.
Each film-coated tablet (tablet) contains 5 mg of linagliptin.
The other ingredients are:
Tablet core: Mannitol (E421), maize starch, copovidone, magnesium stearate (E470b). Film coating: Hypromellose 2910, 5 mPa.s (E464), titanium dioxide (E171), talc (E553b), macrogol (6000), iron oxide red (E172).
What Linagliptin looks like and contents of the pack
- Linagliptin 5 mg tablets are 8 mm in diameter, round, light red, biconvex, bevel-edged film-coated tablets debossed with "L5" on one side and plain on the other side
- Linagliptin is available in perforated aluminium/aluminium unit dose blisters. The pack sizes are 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 film-coated tablets.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF
United Kingdom
Manufacturers
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF
United Kingdom
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park,
Paola, PLA 3000, Malta
This leaflet was last revised in September 2026
If you would like a leaflet with larger text, please contact
01271 385257
| - | ||||
| Customer | Accord | |||
| Description | Linagliptin 5 mg Tab | |||
| Market | UK | |||
| Language | English | |||
| 170 x 550 mm | ||||
| 9 | ||||
| Version No. | 4 | |||
| Date | 10~03~2025 (Linagliptin_5 mg (ACC-UK)PIL) |
(6035653) Date : 14,07,25 - 17,07,25, (R) 11.08.2026, 13.08.2026 (1), 17.08.2026, 28.09.2026