Vipdomet

Patient Information Leaflet

Vipdomet 12.5 mg/850 mg film-coated tablets, 12.5 mg/1,000 mg film-coated tablets

alogliptin/metformin hydrochloride
Please read all of this leaflet carefully before taking this medicine, as 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 other people, even if they have the same symptoms as yours, because it may be harmful to them.
• 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 Vipdomet is and what it is used for
2. What you need to know before taking Vipdomet
3. How to take Vipdomet
4. Possible side effects
5. How to store Vipdomet
6. Contents of the pack and other information

1. What Vipdomet is and what it is used for

What Vipdomet is
Vipdomet contains two different medicines called alogliptin and metformin in one tablet:

• Alogliptin belongs to a group of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin helps increase insulin levels in the body after a meal and reduces the amount of sugar in the body.
• Metformin belongs to a group of medicines called biguanides, which help lower blood sugar by reducing the amount of sugar produced in the liver and by helping insulin work more effectively.

Both of these groups of medicines are "oral antidiabetics".
What Vipdomet is used for
Vipdomet is used to lower blood sugar levels in adults with type 2 diabetes.
Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus or NIDDM.
Vipdomet is taken when blood sugar cannot be adequately controlled by diet, exercise, and other oral antidiabetic medicines such as metformin alone, insulin alone, or metformin and pioglitazone taken together.
If you are already taking both alogliptin and metformin as separate tablets, Vipdomet can replace them in a single tablet.
It is important that you continue to follow the diet and exercise plan recommended by your nurse or doctor.

2. What you should know before taking Vipdomet

Do not take Vipdomet

• if you are allergic to alogliptin, metformin, or 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 rash 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 feeling of warmth, particularly on the scalp, mouth, throat, palms of the hands, and soles of the feet (Stevens-Johnson syndrome);
• if you have severely reduced kidney function;
• if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusual fruity odour;
• if you have a severe infection or are severely dehydrated (your body has lost a large amount of water);
• if you have recently had a heart attack or have serious circulatory problems including shock;
• if you have serious breathing difficulties;
• if you have liver disease;
• if you drink alcohol excessively (either daily or occasionally in large amounts).

Warnings and precautions
Talk to your doctor or pharmacist before taking Vipdomet:
if you have type 1 diabetes (your body does not produce insulin);
if you are taking Vipdomet with insulin or a thiazolidinedione. Your doctor may decide to reduce your
dose of insulin or thiazolidinedione when taken together with Vipdomet to avoid blood sugar levels becoming too low (hypoglycaemia);
if you are taking another antidiabetic medicine containing a “sulfonylurea”, you should not start taking
Vipdomet;
if you have or have had a disease of the pancreas.
if you experience symptoms indicating liver damage during treatment with Vipdomet.
If blisters appear on your skin, consult your doctor, as this could be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop treatment with alogliptin.

Risk of lactic acidosis
Vipdomet may cause a very rare but very serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as in severe heart disease).
If you have any of the medical conditions listed above, consult your doctor for further instructions.
Temporarily stop taking Vipdomet if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to heat, or if you are drinking less fluid than normal. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Vipdomet and contact your doctor or the nearest hospital immediately, because lactic acidosis can lead to coma. Lactic acidosis is a medical emergency and must be treated in hospital. If you suspect lactic acidosis, go to your doctor or hospital immediately.
Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of discomfort associated with severe fatigue
• difficulty breathing
• lowered body temperature and slower heart rate

If you are undergoing major surgery, you must stop taking Vipdomet during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you should restart treatment with Vipdomet.
During treatment with Vipdomet, your doctor will monitor the function of your kidneys at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Children and adolescents
Vipdomet is not recommended for children and adolescents under 18 years of age due to lack of data in these patients.

Other medicines and Vipdomet
If you are due to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Vipdomet before or during the injection. Your doctor will decide when you should stop and when you should restart treatment with Vipdomet.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. You may need to have your blood glucose and kidney function tested more frequently, or your doctor may decide to adjust your dose of Vipdomet. It is particularly important to mention the following:

• hydrocortisone and prednisolone (corticosteroids) used to treat diseases involving inflammation such as asthma and arthritis;
• cimetidine, used to treat stomach problems;
• bronchodilators (beta-2 agonists) used to treat asthma;
• medicines that increase urine production (diuretics);
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists);
• medicines containing alcohol.

Vipdomet and alcohol
Avoid excessive alcohol consumption during treatment with Vipdomet, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use Vipdomet during pregnancy.
Vipdomet is not recommended during breastfeeding as metformin passes into breast milk.

Driving and using machines
No effects of Vipdomet on the ability to drive or use machines have been observed.
However, taking Vipdomet in combination with other medicines called pioglitazone or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and use machines.

3. How to take Vipdomet

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you exactly what dose of Vipdomet you should take. The amount of Vipdomet
you need to take varies depending on your individual condition and your current dosage of metformin
alone, metformin in combination with pioglitazone, insulin and/or single tablets of alogliptin and
metformin.
The recommended dose is one tablet twice daily. If you have reduced kidney function, your
doctor may prescribe a lower dose, which may need to be taken as separate tablets of alogliptin and
metformin.
The tablet or tablets must be swallowed whole with water. To reduce the risk of stomach upset, take this medicine with food.
If you take more Vipdomet 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 Vipdomet
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 Vipdomet
Do not stop treatment with Vipdomet without first consulting your doctor. If you stop taking
Vipdomet, your blood sugar levels may increase.
If you have any questions 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 Vipdomet and contact your doctor or go immediately to the nearest hospital
if you notice any of the symptoms of the following serious side effects:
Very rare (affects up to 1 in 10,000 users):

• Lactic acidosis (build-up of lactic acid in the blood) – this is a very serious side effect that may lead to coma. For symptoms, see section “Warnings and precautions”.

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 skin rashes that may progress to a sore surrounded by pale or red rings, blisters and/or skin peeling, possibly with symptoms such as itching, fever, general feeling of malaise, painful joints, vision problems, burning, pain or itching in the eyes, and mouth sores (Stevens-Johnson syndrome and erythema multiforme).
• Severe and persistent pain in the abdomen (stomach area), which may spread to the back, along with nausea and vomiting, as this could be a sign of inflamed pancreas (pancreatitis).

You should also contact your doctor if you experience any of the following side effects:
Very common (affects more than 1 in 10 users):

• stomach ache
• diarrhoea
• loss of appetite
• feeling unwell
• nausea.

Common (affects up to 1 in 10 users):

• Symptoms of low blood sugar levels (hypoglycaemia) may occur when Vipdomet is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide). Symptoms may include: tremor, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes or feeling confused. Blood sugar levels may fall below normal, but can be raised again by taking sugar. It is recommended to carry some sugar lumps, sweets, biscuits or sugared fruit juice with you.
• cold-like symptoms such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, dry cough
• skin rash
• itching of the skin, with or without hives
• headache
• indigestion, heartburn
• vomiting and/or diarrhoea
• metallic taste
• low or reduced levels of vitamin B__ in the blood; symptoms may include: extreme tiredness (fatigue), red and sore tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin. Your doctor may order tests to determine the cause of these symptoms, as some of them may also be due to diabetes or other health problems.

Very rare:

• liver problems (hepatitis or abnormalities in liver function tests)
• erythema (reddening of the skin).

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 get any side effects, including ones 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 Vipdomet

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 does not require any special storage conditions.
Do not dispose of medicines 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 Vipdomet contains
The active substances are alogliptin and metformin hydrochloride.
Each 12.5 mg/850 mg film-coated tablet contains alogliptin benzoate equivalent to
12.5 mg of alogliptin and 850 mg of metformin hydrochloride.
Each 12.5 mg/1,000 mg film-coated tablet contains alogliptin benzoate equivalent to
12.5 mg of alogliptin and 1,000 mg of metformin hydrochloride.
The other components are: mannitol, microcrystalline cellulose, povidone K30,
crospovidone type A, magnesium stearate, hypromellose, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Description of the appearance of Vipdomet and contents of the pack
Vipdomet 12.5 mg/850 mg film-coated tablets are light yellow, oblong (approximately 21.0 mm in length by 10.1 mm in width), biconvex, film-coated tablets, with "12.5/850" printed on one side and "322M" on the other.
Vipdomet 12.5 mg/1,000 mg film-coated tablets are pale yellow, oblong (approximately 22.3 mm in length by 10.7 mm in width), biconvex, film-coated tablets, with "12.5/1,000" printed on one side and "322M" on the other.
Vipdomet is available in blisters containing 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196,
200 tablets and in multiple packs containing 2 packs, each with 98 film-coated 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tel/Tél: +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 Tel/Tél: +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
Tel: +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 medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.