Vipidia 12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Vipidia 25mg film-coated tablets

Vipidia 12.5mg film-coated tablets

Vipidia 6.25mg film-coated tablets

alogliptin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Vipidia is and what it is used for
2. What you need to know before taking Vipidia
3. How to take Vipidia
4. Possible side effects
5. How to store Vipidia
6. Contents of the pack and other information

1. What Vipidia is and what it is used for

Vipidia contains the active substance alogliptin, which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which are "oral antidiabetics". It is used to lower blood glucose levels in adults with type 2 diabetes. Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus (NIDDM).

Vipidia works by increasing insulin levels in the body after a meal and reducing the amount of glucose in the body. It should be taken together with other antidiabetic medicines that your doctor has prescribed, such as sulphonylureas (for example, glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (for example, pioglitazone) and/or insulin.

Vipidia is taken when blood glucose levels cannot be adequately controlled by diet, exercise, and one or more of these other antidiabetic medicines. It is important that you continue taking your other antidiabetic medicines and continue to follow the dietary and exercise advice given to you by your doctor or nurse.

2. What you need to know before taking Vipidia

Do not take Vipidia

• if you are allergic to alogliptin or to any of the other ingredients of this medicine (listed in section 6).
• if you have had a severe allergic reaction to another similar medicine used to control blood sugar. Symptoms of a severe allergic reaction may include rash, raised red patches on the skin (urticaria), swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. Other symptoms may include generalized itching and a sensation of warmth, particularly affecting the scalp, mouth, throat, and palms of the hands and soles of the feet (Stevens-Johnson syndrome).

Warnings and precautions

Talk to your doctor or pharmacist before taking Vipidia:

• if you have type 1 diabetes (your body does not produce insulin).
• if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot metabolize glucose due to insufficient insulin). Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting, and rapid weight loss.
• if you are taking an antidiabetic medicine called a sulfonylurea (for example, glipizide, tolbutamide, glyburide) or insulin. Your doctor may need to reduce your dose of sulfonylurea or insulin when taken together with Vipidia to avoid excessively low blood sugar levels (hypoglycemia).
• if you have kidney disease; you may take this medicine, but your doctor may reduce the dose.
• if you have liver disease.
• if you have heart failure.
• if you are taking insulin or another antidiabetic medicine, your doctor may reduce the dose of the other antidiabetic or insulin when taken with Vipidia to prevent low blood sugar levels.
• if you have or have had a pancreatic disease.

Contact your doctor if blisters appear on the skin, as this could be one of the signs of a condition called bullous pemphigoid. Your doctor will instruct you to stop treatment with alogliptin.

Children and adolescents

The use of Vipidia is not recommended in children and adolescents under 18 years of age due to lack of efficacy in these patients.

Other medicines and Vipidia

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There is no experience with the use of Vipidia in pregnant women or during breastfeeding. Vipidia should not be used during pregnancy or breastfeeding. Your doctor will help you decide whether to continue breastfeeding or to continue using Vipidia.

Driving and use of machines

It is not known whether Vipidia affects the ability to drive and operate machinery. Taking Vipidia in combination with other antidiabetic medicines called sulfonylureas, insulin, or combination therapy with thiazolidinedione plus metformin may cause excessively low blood sugar levels (hypoglycemia), which could affect your ability to drive and use machines.

Vipidia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Vipidia

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will prescribe Vipidia together with one or more additional medicines to control your blood sugar levels. Your doctor will advise you whether you need to adjust the doses of your other medicines.

The recommended dose of Vipidia is 25 mg once daily.

Patients with kidney disease

If you have kidney disease, your doctor may prescribe a reduced dose. This may be 12.5 mg or 6.25 mg once daily, depending on the severity of your kidney disease.

Patients with liver disease

If you have mild or moderate liver impairment, the recommended dose of Vipidia is 25 mg once daily. This medicine is not recommended for patients with severe liver impairment due to lack of data in these patients.

Swallow the tablets whole with water. You may take this medicine with or without food.

If you take more Vipidia than you should

If you take more tablets than prescribed, or if someone else or a child takes your medicine, contact your doctor or go immediately to the nearest emergency department. Take this leaflet or some tablets with you so your doctor knows exactly what you have taken.

If you forget to take Vipidia

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose.

If you stop taking Vipidia

Do not stop taking Vipidia without first consulting your doctor. Your blood sugar levels may increase if you stop taking Vipidia.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

STOP taking Vipidia and contact a doctor immediately if you experience any of the following serious adverse effects:

Frequency not known (cannot be estimated from available data):

• Allergic reaction. Symptoms may include: skin rash, hives, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue, and feeling faint.
• Severe allergic reaction: skin lesions or skin rashes, which may progress to ulcers surrounded by pale or erythematous rings, with blistering and/or skin peeling, possibly accompanied by symptoms such as itching, fever, general malaise, joint pain, vision problems, burning, pain or itching in the eyes, and mouth ulcers (Stevens-Johnson Syndrome and Erythema multiforme).
• Severe and persistent pain in the abdomen (stomach area) that may radiate to the back, along with nausea and vomiting, as this could be a sign of inflammation of the pancreas (pancreatitis).

You should also consult your doctor if you experience any of the following adverse effects:

Common (may affect up to 1 in 10 people):

• Symptoms of low blood sugar levels (hypoglycaemia), which may occur when Vipidia is taken in combination with insulin or sulphonylureas (e.g., glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling of the lips, paleness, changes in mood or feeling confused. Your blood sugar level may fall below normal, but you can raise it again by consuming sugar. It is recommended that you carry sugar lumps, sweets, biscuits, or sugared fruit juice with you.
• Flu- or cold-like symptoms such as sore throat, stuffy or blocked nose
• Skin rash
• Skin irritation
• Headache
• Stomach pain
• Diarrhoea
• Indigestion, heartburn

Frequency not known:

• Liver problems such as nausea and vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of the skin or whites of the eyes.
• Inflammation of the connective tissue within the kidneys (interstitial nephritis).
• Development of blisters on the skin (bullous pemphigoid).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vipidia

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vipidia

• The active substance is alogliptin.

Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg of alogliptin.

• The other components are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).

Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg of alogliptin.

• The other components are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).

Each 6.25 mg tablet contains alogliptin benzoate equivalent to 6.25 mg of alogliptin.

• The other components are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).

Nature of the product and contents of the pack

• Vipidia 25 mg film-coated tablets (tablets) are film-coated, oval-shaped (approximately 9.1 mm long by 5.1 mm wide), biconvex, light red tablets, with the imprint “TAK” and “ALG-25” printed in grey ink on one side.
• Vipidia 12.5 mg film-coated tablets (tablets) are film-coated, oval-shaped (approximately 9.1 mm long by 5.1 mm wide), biconvex, yellow tablets, with the imprint “TAK” and “ALG-12.5” printed in grey ink on one side.
• Vipidia 6.25 mg film-coated tablets (tablets) are film-coated, oval-shaped (approximately 9.1 mm long by 5.1 mm wide), biconvex, light pink tablets, with the imprint “TAK” and “ALG-6.25” printed in grey ink on one side.

Vipidia is available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark

Manufacturer

Takeda Ireland Limited
Bray Business Park
Kilruddery
Co. Wicklow
Ireland

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.