VIPDOMET 12.5 mg/1000 mg FILM-COATED TABLETS

2. What you need to know before you take 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 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 soles of the feet (Stevens-Johnson syndrome).
• if you have severe kidney problems
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone bodies" build up in the blood, which can lead to a pre-diabetic coma. The symptoms include stomach pain, rapid and deep breathing, drowsiness, or breath that develops an unusual fruity odor.
• if you have a severe infection or are severely dehydrated (your body has lost a lot of water)
• if you have recently had a heart attack or have severe circulatory problems, including shock
• if you have severe breathing difficulties
• if you have liver disease
• if you drink excessive amounts of alcohol (every day or in large amounts from time to time)
• if you have diabetic ketoacidosis (a serious complication of poorly controlled diabetes). The symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting, and rapid weight loss.

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 need to reduce your dose of insulin or thiazolidinedione if you take it with Vipdomet to avoid low blood sugar levels (hypoglycemia).
• if you are taking another diabetes medicine that contains a "sulfonylurea", you should not start taking Vipdomet.
• if you have or have had pancreatitis.
• if you develop symptoms that suggest liver damage during treatment with Vipdomet.

Contact your doctor if you develop 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.

Risk of lactic acidosis

Vipdomet may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol intake, dehydration (see below), liver problems, and any medical condition in which a part of the body has a reduced supply of oxygen (such as severe and acute heart disease).

If any of the above applies to you, talk to your doctor for further instructions.

Stop taking Vipdomet for a short period if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than usual. Talk to your doctor for further instructions.

Stop taking Vipdomet and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition can lead to a coma.

Lactic acidosis is a medical emergency and must be treated in a hospital. If you suspect you have lactic acidosis, go to your doctor or hospital for medical attention.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense tiredness
• difficulty breathing
• decreased body temperature and heart rate

If you need to undergo major surgery, you should stop taking Vipdomet during the procedure and for some time after. Your doctor will decide when you should stop taking Vipdomet and when you can start taking it again.

During treatment with Vipdomet, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is worsening.

Children and adolescents

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

Other medicines and Vipdomet

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking Vipdomet before the injection or at the time of the injection. Your doctor will decide when you should stop taking Vipdomet and when you can start taking it again.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust your dose of Vipdomet. It is especially important to mention the following:

• hydrocortisone and prednisolone (corticosteroids), used to treat diseases that involve 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 with alcohol

Avoid excessive alcohol intake while taking Vipdomet, as this can increase the risk of lactic acidosis (see "Warnings and precautions").

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. You should not take Vipdomet if you are pregnant.

Vipdomet is not recommended during breastfeeding, as metformin passes into breast milk.

Driving and using machines

It is not known if Vipdomet affects the ability to drive and use machines. Taking Vipdomet in combination with medicines called pioglitazone or insulin may cause low blood sugar levels (hypoglycemia), which could affect your ability to drive and use machines.

3. How to take Vipdomet

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

Your doctor will tell you exactly how much Vipdomet to take. The amount of Vipdomet will vary depending on your condition and the doses you are currently taking of metformin alone, metformin in combination with pioglitazone, insulin, and/or separate tablets of alogliptin and metformin.

The recommended dose is one tablet twice a day. If you have reduced kidney function, your doctor may prescribe a lower dose that may need to be given using separate tablets of alogliptin and metformin.

Swallow the tablets whole with water. You should take this medicine with food to reduce the chance of stomach upset.

If you take more Vipdomet than you should

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

If you stop taking Vipdomet

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

If you have any further questions on the use of this product, 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 a doctor or the nearest hospital immediatelyif you notice any of the following serious side effects:

Very rare(may affect up to 1 in 10,000 people):

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

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

• Allergic reaction. The symptoms can include: skin rash, hives, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, and a feeling of fainting.
• Severe allergic reaction:skin lesions or patches on the skin, 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 abdominal painthat may radiate to the back, as well as nausea and vomiting, as this could be a sign of pancreatitis (inflammation of the pancreas).

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

Very common(may affect more than 1 in 10 people):

• stomach pain
• diarrhea
• loss of appetite
• nausea
• vomiting

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

• Low blood sugar symptoms(hypoglycemia), which can occur when Vipdomet is taken 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 raise it again by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits, or sugary fruit juice with you.
• cold symptoms, such as sore throat, stuffy or runny nose, feeling tired, fever, chills, dry cough
• skin rash
• itching of the skin, with or without hives
• headache
• indigestion, heartburn
• vomiting and/or diarrhea
• metallic taste
• decreased levels of vitamin B12 or low levels of vitamin B12 in the blood (the symptoms can include extreme tiredness (fatigue), sore and reddened tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). Your doctor may arrange some tests to identify the cause of the symptoms, as many of them can be due to diabetes or other health problems not related to the medicine.

Very rare:

• liver problems (hepatitis, changes in liver function tests)
• redness of the skin (erythema)

Frequency not known:

• liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of the skin or the whites of the eyes.
• inflammation of the connective tissue in the kidneys (interstitial nephritis)
• appearance of blisters on the skin (bullous pemphigoid)

Reporting of side effects

If you experience 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. Storing 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. The expiry date refers to the last day of the month stated.

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. Package Contents and Additional Information

Vipdomet Composition

• The active ingredientsare 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/1000 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg of alogliptin and 1000 mg of metformin hydrochloride.

• The other componentsare mannitol, microcrystalline cellulose, povidone K30, crospovidone type A, magnesium stearate, hypromellose, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Product Appearance and Package Contents

• Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are film-coated, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, light yellow in color, with the inscription “12.5/850” engraved on one side and “322M” on the opposite side.
• Vipdomet 12.5 mg/1000 mg film-coated tablets (tablets) are film-coated, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, pale yellow in color, with the inscription “12.5/1000” engraved on one side and “322M” on the opposite side.

Vipdomet is available in blisters of 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, or 200 film-coated tablets and multiple packs with 2 packs each containing 98 film-coated tablets.

Only some 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

You can request more information about this medicine by contacting the local representative of the marketing authorization 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.