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XELEVIA 25 MG FILM-COATED TABLETS - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - XELEVIA 25 MG FILM-COATED TABLETS

1. what xelevia is and what it is used for

Xelevia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.

Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar.

When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

2. what you need to know before you take xelevia

Do not take Xelevia

  • – if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Xelevia (see section 4).

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 Xelevia.

Tell your doctor if you have or have had:

  • – a disease of the pancreas (such as pancreatitis)

  • – gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.

These medical conditions can increase your chance of getting pancreatitis (see section 4).

  • – type 1 diabetes

  • – diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)

  • – any past or present kidney problems.

  • – an allergic reaction to Xelevia (see section 4).

This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.

Children and adolescents

Children and adolescents below 18 years should not use this medicine. 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 Xelevia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems). The level of digoxin in your blood may need to be checked if taking with Xelevia.

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.

You should not take this medicine during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.

Xelevia contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take xelevia

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose is:

  • – one 100 mg film-coated tablet

  • – once a day

  • – by mouth

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A10 DRUGS USED IN DIABETES

A10B BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors for blood glucose lowering

A10BH01 sitagliptin

Frequently Asked Questions

What is XELEVIA 25 MG and what does it treat?

XELEVIA 25 MG is a prescription medication that contains the active ingredient sitagliptin. It is primarily used to help manage blood sugar levels in adults with type 2 diabetes.

How does XELEVIA work in the body?

XELEVIA works by increasing the levels of incretin hormones which help lower blood sugar levels after eating. It also reduces the amount of sugar produced by the liver.

Can I take XELEVIA if I have kidney problems?

If you have kidney problems, it is important to consult your doctor before taking XELEVIA, as dosage adjustments may be necessary.

What should I do if I miss a dose of XELEVIA?

If you miss a dose of XELEVIA, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at once.

Are there any common side effects associated with XELEVIA?

Common side effects may include headache, upper respiratory infection, or stomach pain. If you experience severe side effects, contact your healthcare provider immediately.

Can XELEVIA be taken with other diabetes medications?

Yes, XELEVIA can be taken alongside other diabetes medications. However, it's essential to follow your doctor's advice regarding combinations and dosages.

Is XELEVIA safe for long-term use?

XELEVIA has been studied for long-term use and is generally considered safe for patients with type 2 diabetes when used as prescribed by a healthcare professional.

What lifestyle changes should I make while taking XELEVIA?

While taking XELEVIA, it's crucial to maintain a balanced diet and exercise regularly. These lifestyle changes can help enhance the medication's effectiveness in managing blood sugar levels.

Can I drink alcohol while taking XELEVIA?

It is advisable to limit alcohol consumption while taking XELEVIA as it can affect blood sugar levels and may interfere with diabetes management.

How should I store XELEVIA tablets?

Store XELEVIA tablets at room temperature away from moisture and heat. Keep them out of reach of children.

What should I tell my doctor before starting XELEVIA?

Before starting XELEVIA, inform your doctor about any other medications you are taking, your medical history, especially kidney issues, pancreatitis, or allergies.

Can pregnant or breastfeeding women take XELEVIA?

If you are pregnant or breastfeeding, consult your doctor before taking XELEVIA to weigh the potential benefits against any risks.

What happens if I overdose on XELEVIA?

In case of an overdose of XELEVIA, seek immediate medical attention. Symptoms may include low blood sugar (hypoglycemia), which can be serious.

Is there a specific diet I need to follow while on XELEVIA?

While there isn't a specific diet mandated by XELEVIA itself, following a diet low in sugars and carbohydrates can help manage your blood glucose levels effectively.

Does XELEVIA cause weight gain?

XELEVIA is generally weight neutral; it doesn’t typically cause weight gain like some other diabetes medications might. However, individual results can vary.

Can children take XELEVIA?

XELEVIA is not approved for use in children under 18 years old; it is intended for adults managing type 2 diabetes.

How long does it take for XELEVIA to start working?

XELEVIA begins to work within a few hours after ingestion; however, it may take weeks to see significant improvements in blood sugar levels.

What should I do if my blood sugar levels remain high while on XELEVIA?

If your blood sugar levels remain high despite taking XELEVIA as prescribed, contact your healthcare provider for further evaluation and potential adjustments in treatment.

Does taking XELEVIA require regular medical check-ups?

Yes, regular check-ups with your healthcare provider are essential while using XELEVIA to monitor your blood sugar levels and overall health.