Linectra-5

1. What is Linectra-5 tablet and what is it used for

Linectra-5 contains linagliptin, a medicine used to treat type 2 diabetes mellitus in adults.

It is used together with diet and exercise to help control blood sugar levels.

How it works
Linagliptin helps your body increase insulin release and reduce the amount of sugar in your blood, especially after meals.

Important limitations
• It should not be used in type 1 diabetes
• It should not be used to treat diabetic ketoacidosis
• It has not been studied with insulin.

2. What you need to know before you take Linectra-5 tablet

Do not take Linectra-5
if you are allergic to linagliptin or any of the other ingredients of this medicine

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Linectra-5 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). Linectra-5 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 Linectra-5 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 stomachache (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 Linectra-5.

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.

Other medicines and Linectra-5
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 Linectra-5 is harmful to the unborn child. Therefore, it is preferable to avoid using Linectra-5 if you are pregnant.

It is not known if Linectra-5 passes into human breast milk. A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Linectra-5 therapy.

Driving and using machines
Linectra-5 has no or negligible influence on the ability to drive and use machines.

Taking Linectra-5 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 Linectra-5 is combined with sulphonylurea and/or insulin.

3. How to take Linectra-5 tablet?

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 Linectra-5 is one 5 mg tablet once a day.

You can take Linectra-5 with or without food.

Your doctor may prescribe Linectra-5 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 Linectra-5 than you should
If you take more Linectra-5 than you should, talk to a doctor immediately.

If you forget to take Linectra-5
• If you forget to take a dose of Linectra-5, 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 Linectra-5
Do not stop taking Linectra-5 without first consulting your doctor. Your blood sugar levels may increase when you stop taking Linectra-5.

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 Linectra-5 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 Linectra-5 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 Linectra-5 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 1 000 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 Linectra-5 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 1 000 people) while taking Linectra-5 alone or in combination with other medicinal products for the treatment of diabetes.

STOP taking Linectra-5 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 Linectra-5 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 or pharmacist. You can also report side effects via email: medico@zorvia.com

Reporting side effects helps provide more information about the safety of this medicine.

5. How to store Linectra-5 tablets?

Keep out of reach of children.

Store below 30°C in a dry place. Protect from light.

6. Contents of the pack and other information

What Linectra-5 tablet contains:

The active ingredient is Linagliptin 5mg

Other ingredients:
Colours: Titanium Dioxide IP

What Linectra-5 tablet looks like and contents of the pack

Film coated tablet
Pack size: As per carton

Marketing Authorization Holder

Zorvia Healthcare Limited
Suite 4, 10th Floor, Centaurus, Central Avenue,
Hiranandani Estate, Ghodbunder Road,
Thane West, Maharashtra, India—400607.