Linectra-M 500 / 1000

Linagliptin and Metformin Hydrochloride Tablets (Sustained Release)

Patient Information Leaflet: Information For the User
Prescribing Information

linecta

Linectra-M 500 tablets Linectra-M 1000 tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, healthcare provider or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same.
  • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

  • What Linectra-M 500/1000 tablet is and what it is used for
  • What you need to know before you take Linectra-M 500/1000
  • How to take Linectra-M 500/1000
  • Possible side effects
  • How to store Linectra-M 500/1000
  • Contents of pack and other information

1. What is Linectra-M 500/1000 and what is it used for

Linectra-M 500/1000 contains two medicines:

  • Linagliptin – helps your body increase insulin release and reduce the amount of sugar in your blood
  • Metformin – lowers blood sugar by reducing glucose production and improving insulin use

It is used in adults with type 2 diabetes mellitus to help control blood sugar levels along with diet and exercise.

2. What you need to know before you take Linectra-M 500/1000 tablet

Do NOT take this medicine if you:

  • Have severe kidney problems
  • Have diabetic ketoacidosis or metabolic acidosis
  • Are allergic to linagliptin, metformin, or any ingredient in the tablet

Warnings and precautions

Talk to your doctor before taking this medicine if you:

  • Have kidney, liver, or heart problems
  • Drink alcohol frequently
  • Are dehydrated (vomiting, diarrhoea, fever)
  • Are scheduled for surgery or imaging tests with contrast dye

Important risks

Lactic acidosis (rare but serious)

Stop the medicine and seek medical help immediately if you have:

  • Fast or difficult breathing
  • Severe weakness or tiredness
  • Muscle pain
  • Stomach pain
  • Feeling cold

Low blood sugar (Hypoglycaemia)

More likely if taken with insulin or other diabetes medicines. Symptoms include:

  • Sweating
  • Dizziness
  • Hunger
  • Fast heartbeat

Pancreatitis (inflammation of pancreas)

Stop the medicine and contact a doctor if you have:

  • Severe stomach pain (may spread to the back)
  • Vomiting

Allergic reactions

Seek immediate help if you have:

  • Rash or itching
  • Swelling of face, lips, or throat
  • Difficulty breathing

Other medicines and Linectra-M

Tell your doctor if you are taking:

  • Insulin or sulfonylureas (risk of low sugar)
  • Diuretics, steroids, or thyroid medicines
  • Certain antibiotics or heart medicines
  • Alcohol (avoid excessive intake)

Pregnancy and breastfeeding

  • Do not use during pregnancy
  • Inform your doctor if you are pregnant or planning pregnancy
  • Consult your doctor before breastfeeding

Driving and using machines

This medicine usually does not affect your ability to drive.
However, be careful if you experience low blood sugar.

3. How to take Linectra-M 500/1000 tablets?

  • Take once daily with a meal
  • Swallow the tablet whole
    • Do NOT crush, chew, or break
  • Follow your doctor’s instructions carefully

Missed dose

  • Take it as soon as you remember

Do NOT take a double dose

4. Possible Side Effects

Common side effects

  • Diarrhoea
  • Nausea
  • Stomach pain
  • Taste changes
  • Vitamin B12 deficiency

Less common side effects

  • Cough
  • Loss of appetite
  • Skin rash or itching

Rare but serious

  • Lactic acidosis
  • Pancreatitis
  • Severe allergic reactions
  • Skin blistering (bullous pemphigoid)

Contact your doctor if you notice any unusual symptoms.

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-M 500/1000 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-M 500/1000 tablet contains:

The active ingredients are Linagliptin and Metformin Hydrochloride

Other ingredients:

Colours: Ferric Oxide USP-NF (Red) & Titanium Dioxide IP

What Linectra-M 500/1000 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.

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