Empagliflozin and Linagliptin Tablets

Read all this information carefully before you start taking this medicine.
Linectra-EF contains two medicines:
It is used:
Do not take this medicine if:
Warnings and precautions
Diabetic Ketoacidosis
• Can occur even with normal blood sugar
• Symptoms:
o Nausea, vomiting
o Stomach pain
o Fast breathing
o Unusual tiredness
→ Stop medicine and seek medical help immediately
Pancreatitis
• Severe abdominal pain (may radiate to back)
→ Stop medicine and consult doctor
Dehydration / Low blood pressure
• Symptoms: dizziness, fainting, thirst
• Maintain adequate fluid intake
Serious infections
• Urinary tract infections
• Genital infections
• Rare: Fournier's gangrene (serious genital infection)
Kidney problems
• Not recommended in severe kidney disease
• Kidney function should be monitored
Other precautions
• Not for Type 1 diabetes
• Maintain good hygiene and foot care
• Monitor blood sugar regularly
Other medicines and Linectra-EF 10/25
Tell your doctor if you are taking:
Pregnancy and breastfeeding
• Do not use during pregnancy
• Avoid during breastfeeding
Driving and using machines
• Be careful if you feel dizzy or have low blood sugar
• Usual dose: One tablet once daily in the morning
• Can be taken with or without food
• Dose may be increased by doctor if needed
If you miss a dose:
• Take it as soon as you remember
• Do NOT take a double dose
Before surgery:
• Stop medicine at least 3 days before surgery
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1 000 people)
These are the signs of diabetic ketoacidosis
• increased levels of "ketone bodies" in your urine or blood
• rapid weight loss
• feeling sick or being sick
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• unusual sleepiness or tiredness
• a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with this medicine.
Contact your doctor immediately if you notice any of the following side effects:
Allergic reactions, seen uncommonly (may affect up to 1 in 100 people)
This medicine may cause allergic reactions, which may be serious, including hives (urticaria) and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema).
Inflammation of the pancreas (pancreatitis), seen uncommonly
This medicine may cause pancreatitis, which usually shows as persistent, severe abdominal (stomach) pain that might reach through to your back, often accompanied by feeling sick or being sick. Your doctor will need to change your treatment.
Low blood sugar (hypoglycaemia), seen commonly (may affect up to 1 in 10 people)
If you take Linectra-EF 10/25 with another medicine that can cause low blood sugar, such as a sulphonylurea or insulin, you are at risk of getting too low blood sugar (hypoglycaemia). The signs of too low blood sugar may include:
• shaking, sweating, feeling very anxious or confused, fast heartbeat
• excessive hunger, headache
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest.
Urinary tract infection, seen commonly
The signs of urinary tract infection are:
• burning sensation when passing urine
• urine that appears cloudy
• pain in the pelvis, or mid-back pain (when kidneys are infected)
An urge to pass urine or more frequent urination may be due to the way this medicine works, but as they can also be signs of urinary tract infection, if you note an increase in such symptoms, you should also contact your doctor.
Loss of body fluid (dehydration), seen uncommonly
The signs of dehydration are not specific, but may include:
• unusual thirst
• lightheadedness or dizziness upon standing
• fainting or loss of consciousness
Other side effects while taking Linectra-EF 10/25:
Seen commonly
• genital yeast infection like thrush
• inflamed nose or throat (nasopharyngitis)
• cough
• passing more urine than usual or needing to pass urine more often
• itching
• skin rash
• increased blood enzyme amylase
• increased pancreas enzyme lipase
• thirst
• constipation
Seen uncommonly
• straining or pain when emptying the bladder
• laboratory blood tests may show changes in blood fat levels, an increase in the amount of red blood cells (increase in haematocrit), and changes related to kidney function (decrease in filtration rate and increase in blood creatinine)
Seen rarely
• sore in the mouth
• necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Seen very rarely
• inflammation of the kidneys (tubulointerstitial nephritis)
Frequency not known (cannot be estimated from the available data)
• 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.
Keep out of reach of children.
Store below 30°C in a dry place. Protect from light.
What Linectra-EF 10/25 tablet contains:
What Linectra-EF 10/25 tablet looks like and contents of the pack
Marketing Authorization Holder
Zorvia Healthcare Limited
Suite 4, 10th Floor, Centaurus, Central Avenue,
Hiranandani Estate, Ghodbunder Road,
Thane West, Maharashtra, India—400607.
This leaflet was last revised on 03/2026