VIPIDIA 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Vipidia 25mg film-coated tablets

Vipidia 12.5mg film-coated tablets

Vipidia 6.25mg film-coated tablets

a logliptin

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Vipidia and what is it 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 sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus (NIDDM).

Vipidia works to increase insulin levels in the body after a meal and decrease the amount of sugar in the body. It should be taken with other anti-diabetic medicines that your doctor has prescribed, such as sulfonylureas (e.g. glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin.

Vipidia is taken when it is not possible to control blood sugar levels adequately with diet, exercise, and one or more of these other anti-diabetic medicines. It is important that you continue to take your other anti-diabetic medicines and follow the advice on diet and exercise given to you by your nurse or doctor.

2. What you need to know before you take Vipidia

Do not take Vipidia

• if you are allergic to alogliptin or any of the other ingredients of this medicine (listed in section 6).
• if you have had a severe allergic reaction to any other medicine used to control blood sugar levels. The symptoms of a severe allergic reaction can include rash, red raised patches on the skin (hives), swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing. Other symptoms can include itching (pruritus) and a feeling of heat, which particularly affects the scalp, mouth, throat, and palms of the hands and 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 because it does not have enough insulin). The symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting, and rapid weight loss.
• if you are taking a anti-diabetic medicine called a sulfonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin. Your doctor may need to reduce your dose of sulfonylurea or insulin if you take any of these medicines with Vipidia, in order to avoid too low a level of sugar in the blood (hypoglycaemia).
• if you have kidney disease; you can take this medicine, but your doctor may need to reduce the dose.
• if you have liver disease.
• if you have heart failure.
• if you are taking insulin or an anti-diabetic medicine, your doctor may need to reduce the dose of the other anti-diabetic or insulin when you take it with Vipidia, in order to avoid low blood sugar levels.
• if you have or have had pancreatitis.

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

Children and adolescents

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

Other medicines and Vipidia

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

It is not known if Vipidia affects the ability to drive and use machines. Taking Vipidia in combination with other anti-diabetic medicines called sulfonylureas, insulin, or combination therapy with thiazolidinedione and metformin may cause too low a level of sugar in the blood (hypoglycaemia), which could affect your ability to drive and use machines.

Vipidia contains sodium

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

3. How to take Vipidia

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will prescribe Vipidia together with one or more other medicines to control your blood sugar levels. Your doctor will tell you if you need to change the amount of your other medicines.

The recommended dose of Vipidia is 25 mg once a day.

Patient with kidney disease

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

Patient with liver disease

If your liver function is mildly or moderately reduced, the recommended dose of Vipidia is 25 mg once a day. This medicine is not recommended for patients with severely reduced liver function, due to lack of data in these patients.

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

If you take more Vipidia than you should

If you take more tablets than you should, or if someone else or a child takes your medicine, contact your doctor or the nearest emergency department immediately. 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 forgotten dose.

If you stop taking Vipidia

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Vipidia and contact a doctor immediatelyif you notice any of the following serious side effects:

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

• Allergic reaction. The symptoms can include: skin rash, hives, problems swallowing or breathing, swelling of the lips, face, throat or tongue, and a feeling of fainting.
• Severe allergic reaction: skin lesions or blisters, which can progress to an ulcer surrounded by pale or reddened rings, with blisters and/or peeling of the skin, possibly with symptoms such as itching, fever, feeling unwell, joint pain, vision problems, burning, pain or itching in the eyes, and mouth ulcers (Stevens-Johnson syndrome and erythema multiforme).
• Severe and persistent painin the abdomen (stomach area) that may radiate to the back, as well as nausea and vomiting, as it could be a sign of pancreatitis (inflammation of the pancreas).

You should also contact your doctorif you experience any of the following side effects:

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

• Low blood sugar symptoms(hypoglycaemia), which can occur when Vipidia is given in combination with insulin or sulfonylureas (e.g. glipizide, tolbutamide, glibenclamide). The symptoms can include: shaking, sweating, anxiety, blurred vision, tingling of the lips, paleness, change in mood or feeling confused. Your blood sugar level may fall below the normal value, but you can bring it back up by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits, or sugary fruit juice with you.
• Symptoms similar to those of the flu or a cold, such as sore throat, stuffy or runny nose
• Skin rash
• Itching
• Headache
• Stomach pain
• Diarrhea
• 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 the whites of the eyes.
• Kidney problems, such as interstitial nephritis.
• Blisters on the skin (bullous pemphigoid).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Vipidia contains

• The active substanceis alogliptin.

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

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

Appearance and packaging

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Ireland

For further information on this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision 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.