Vipidia

Patient Information Leaflet

Vipidia 25 mg film-coated tablets, 12.5 mg film-coated tablets, 6.25 mg film-coated tablets

alogliptin
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that 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 or NIDDM.
Vipidia works by increasing insulin levels in the body after a meal and by reducing the amount of sugar produced in the body. It should be taken together with other antidiabetic medicines prescribed by your doctor, such as a sulphonylurea (for example, glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (for example, pioglitazone) and/or insulin.
Vipidia is used when blood sugar cannot be adequately controlled by diet, exercise, and one or more of these other oral antidiabetic medicines. It is important that you continue taking the other antidiabetic medicines prescribed for you and that you continue to follow the diet and exercise programme recommended 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 other similar medicines used to control blood sugar. Symptoms of a severe allergic reaction may include: skin rash, raised red spots on the skin (urticaria), swelling of the face, lips, tongue, and throat which may cause difficulty breathing or swallowing. Additional symptoms may include generalized itching and a sensation of warmth, particularly on the scalp, mouth, throat, 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 diabetes complication occurring when the body cannot use glucose due to insufficient insulin). Symptoms include excessive thirst, frequent need to urinate, loss of appetite, nausea or vomiting, and rapid weight loss;
• if you are taking an antidiabetic medicine known as a sulfonylurea (for example, glipizide, tolbutamide, glibenclamide) or insulin. Your doctor may decide to reduce the dose of sulfonylurea or insulin when taken together with Vipidia in order to avoid blood sugar levels becoming too low (hypoglycemia);
• if you have kidney disease; you may still 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 consider reducing the dose of the other antidiabetic medicine or insulin when taken together with Vipidia to avoid low blood sugar levels;
• if you have or have had a disease of the pancreas.

If blisters appear on your skin, consult your doctor, as this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop treatment with alogliptin.

Children and adolescents
Vipidia is not recommended for 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 take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is no experience with the use of Vipidia during pregnancy or 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 using machines
No effects of Vipidia on the ability to drive or use machines have been observed.
However, taking Vipidia in combination with other antidiabetic medicines called sulfonylureas, insulin, or in combination therapy with thiazolidinedione plus metformin, may cause blood sugar levels to become too low (hypoglycemia), which may affect your ability to drive and use machines.

Vipidia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Vipidia

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will prescribe Vipidia together with one or more medicines to control your blood sugar levels. Your doctor will inform you if 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 you a reduced dose. This could 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 impairment of liver function, the recommended dose of Vipidia is 25 mg once daily. This medicine is not recommended in patients with severe impairment of liver function due to lack of data in these patients.

The tablet or tablets should be swallowed whole with water. This medicine can be taken 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 or go immediately to the nearest emergency department. Take this leaflet or some tablets with you so that the doctor knows exactly what has been 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 the forgotten dose.

If you stop taking Vipidia
Do not stop treatment with Vipidia without first consulting your doctor. If you stop taking Vipidia, your blood sugar levels may increase.

If you have any doubts about how to use 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 your doctor immediately if you notice any of the following
serious side effects:
Not known (frequency cannot be estimated from the available data):

• An allergic reaction. Symptoms may include: rash, hives, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue, and feeling faint.
• A severe allergic reaction: skin lesions or spots on the skin which may progress to sores surrounded by pale or red rings, blisters and/or skin peeling, possibly with symptoms such as itching, fever, general feeling of illness, painful joints, 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) which may spread to the back, as well as nausea and vomiting, as this could be a sign of an inflamed pancreas (pancreatitis).

You should also contact your doctor if you experience any of the following side effects:
Common (affects up to 1 in 10 users):

• Symptoms of low blood sugar (hypoglycaemia) may occur when Vipidia is taken together with insulin or sulphonylureas (for example, glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes or feeling confused. Blood sugar levels may drop below normal, but can be raised again by taking sugar. It is recommended to carry some sugar lumps, sweets, biscuits or sugary fruit juice with you.
• cold- or flu-like symptoms such as sore throat, blocked or stuffy nose,
• rash,
• itching of the skin,
• headache,
• stomach ache,
• diarrhoea,
• indigestion, heartburn.

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),
• blisters on the skin (bullous pemphigoid).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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./EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vipidia contains

• The active substance is alogliptin. Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg of alogliptin.
• The other ingredients 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 ingredients 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 ingredients 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).

Description of the appearance of Vipidia and contents of the pack

• The film-coated tablets (tablets) of Vipidia 25 mg are light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated, with "TAK" and "ALG-25" printed in grey ink on one side.
• The film-coated tablets (tablets) of Vipidia 12.5 mg are yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated, with "TAK" and "ALG-12.5" printed in grey ink on one side.
• The film-coated tablets (tablets) of Vipidia 6.25 mg are light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated, with "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.
Not all pack sizes may be marketed.

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

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: + 32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: + 359 2 958 27 36 Tél/Tel: + 32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel.: + 36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Takeda HELLAS S.A.
Tlf: + 45 46 77 10 10 Tel: + 30 210 6387800
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: + 49 (0)800 825 3325 Tel: + 31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma AS Takeda AS
Tel: + 372 6177 669 Tlf: + 47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Τηλ: + 30 210 6387800 Tel: + 43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Laboratorios Menarini, S.A. Takeda Pharma Sp. Z o.o.
Tel: + 34 934 628 800 Tel.: + 48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Tecnimede – Sociedade Técnico-Medicinal, S.A
Tél: + 33 1 40 67 33 00 Tel: + 351 21 041 41 00
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o Takeda Pharmaceuticals SRL
Tel: + 385 1 377 88 96 Tel: + 40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: + 386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: + 354 535 7000 Tel: + 421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: + 39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma AB
Τηλ: + 30 210 6387800 Tel: + 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: + 371 67840082 Tel: + 44 (0) 2830 640 902
[email protected] [email protected]

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu