Package Insert: Information for the Patient

Vipdomet 12.5 mg/850 mg Film-Coated Tablets

Vipdomet 12.5 mg/1000 mg Film-Coated Tablets

alogliptin/hydrochloride of metformin

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

What is Vipdomet

Vipdomet contains two different medications, called alogliptina and metformin, in a single tablet:

• alogliptina belongs to a group of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptina acts to increase insulin levels in the body after a meal and decrease the amount of sugar in the body.
• metformin belongs to a group of medications called biguanides, which also help decrease blood sugar levels, decreasing the amount of sugar produced by the liver and helping insulin to act more effectively.

Both groups of medications are "oral antidiabetic medications".

What is Vipdomet used for

Vipdomet is used to decrease blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus, or DMNID.

Vipdomet is taken when it is not possible to control blood sugar levels through diet, exercise, and other oral antidiabetic medications such as metformin alone, insulin alone, or metformin and pioglitazona taken together.

If you are already taking alogliptina and metformin in individual tablets, Vipdomet can replace them in a single tablet.

It is important that you do not stop following the diet and exercise advice that your doctor or nurse has given you.

Do not take Vipdomet

• if you are allergic to alogliptin, metformin, or any of the other components of this medication (listed in section 6).
• if you have had a severe allergic reaction to another medication similar to Vipdomet that you take to control blood sugar levels. Symptoms of a severe allergic reaction may include rash, red, raised patches on the skin (urticaria), facial, lip, tongue, and throat inflammation, which may cause difficulty breathing or swallowing. Additionally, other symptoms may include general itching (pruritus) and a sensation of heat, especially affecting the scalp, mouth, throat, palms of the hands, and soles of the feet (Stevens-Johnson syndrome).
• if you have severe kidney function reduction
• if you have uncontrolled diabetes with, 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" accumulate in the blood, which can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath 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 consume excessive alcohol (every day or in large quantities periodically)
• if you have diabetic ketoacidosis (a severe complication of poorly controlled diabetes) Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting, and rapid weight loss

Warnings and precautions

Consult 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 insulin or thiazolidinedione dose if you take Vipdomet with it, to avoid excessively low blood sugar (hypoglycemia).
• if you are taking another diabetes medication that contains a "sulfonilurea", do not start taking Vipdomet.
• if you have or have had pancreatitis.
• if you experience symptoms suggesting liver damage during Vipdomet treatment.

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

Risk of lactic acidosis

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

If any of the above applies to you, consult 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 intense vomiting, diarrhea, fever, exposure to heat, or if you drink less liquid than normal. Consult your doctor for further instructions.

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

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

The symptoms of lactic acidosis include:

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

If you need to undergo major surgery, stop taking Vipdomet while the procedure is being performed and for a time after it. Your doctor will decide when to interrupt Vipdomet treatment and when to restart it.

During Vipdomet treatment, 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 children and adolescents under 18 years of age, due to the lack of data in these patients.

Other medications and Vipdomet

If you need to receive an intravenous injection of a contrast medium containing iodine, for example, in the context of a radiograph or examination, stop taking Vipdomet before the injection or at the time of the injection. Your doctor will decide when to interrupt Vipdomet treatment and when to restart it.

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

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

Vipdomet and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Do not take Vipdomet if you are pregnant.

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

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you exactly how much Vipdomet you need to take. The amount of Vipdomet will vary according to your condition and the doses of metformin alone, metformin in combination with pioglitazona, insulin, and/or individual tablets of alogliptina and metformina you are currently taking.

The recommended dose is one tablet twice a day. If you have reduced renal function, your doctor may prescribe a lower dose that may need to be supplied in separate tablets of alogliptina and metformina.

Swallow the tablets whole with water. You should take this medication with food to reduce the possibility of stomach discomfort.

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 medication, contact or go immediately to the nearest emergency center. Bring 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 missed dose.

If you interrupt treatment with Vipdomet

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

STOP taking Vipdomet and immediately contact a doctor or the nearest hospitalif you notice any symptoms of the followingserious side effects:

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

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

Of unknown frequency(cannot be estimated from available data):

• Allergic reaction. Symptoms may include: skin rash, urticaria, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, and feeling of dizziness.
• Severe allergic reaction:skin lesions or skin patches, which may progress to a ring-shaped ulcer surrounded by pale or erythematous rings, with blisters and/or skin peeling, possibly with symptoms such as itching, fever, general feeling of discomfort, joint pain, vision problems, burning, pain, or itching in the eyes, and mouth ulcers (Stevens-Johnson syndrome and erythema multiforme).
• Intense and persistent abdominal pain(stomach area) that may extend to the back, as well as nausea and vomiting, which could be a sign of pancreatitis.

You should alsoconsult 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):

• Symptoms of low blood sugar(hypoglycemia), which may appear when Vipdomet is taken in combination with insulin or sulfonylureas (e.g., glipizide, tolbutamide, glibenclamide).Symptoms may include: shakiness, sweating, anxiety, blurred vision, tingling in the lips, paleness, change in mood, or feeling of confusion. Your blood sugar level may drop below the normal value, but you can raise it again by consuming sugar. It is recommended that you carry some sugar cubes, candies, biscuits, or fruit juice with sugar.
• Symptoms of a cold, such as sore throat, congested or runny nose, feeling tired, fever, chills, dry cough
• Skin rash
• Itching on the skin, with or without urticaria
• Headache
• Indigestion, heartburn
• Vomiting and/or diarrhea
• Metalllic taste
• Decreased levels of vitamin B12 or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, painful and inflamed 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 may be due to diabetes or other unrelated health problems.

Very rare:

• Liver problems (hepatitis, liver function test abnormalities)
• Erythema (red skin rash).

Of unknown frequency:

• Liver problems such as nausea or vomiting, abdominal pain, unusual or unexplained fatigue, loss of appetite, dark urine, or yellowish discoloration of the skin or eyes.
• Inflammation of the kidney tissue (interstitial nephritis).
• Appearance of blisters on the skin (pemphigoid bullous).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Vipdomet

• Theactive ingredientsare alogliptin and metformin hydrochloride.

Each film-coated tablet of 12.5 mg/850 mg contains benzoate of alogliptin equivalent to 12.5 mg of alogliptin and 850 mg of metformin hydrochloride.

Each film-coated tablet of 12.5 mg/1000 mg contains benzoate of alogliptin equivalent to 12.5 mg of alogliptin and 1000 mg of metformin hydrochloride.

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

Appearance of the product and contents of the pack

• Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are film-coated tablets, oblong (approximately 21.0 mm in length by 10.1 mm in width), biconvex, yellowish in color, with the inscription "12.5/850" engraved on one face and "322M" on the opposite face.
• Vipdomet 12.5 mg/1000 mg film-coated tablets (tablets) are film-coated tablets, oblong (approximately 22.3 mm in length by 10.7 mm in width), biconvex, pale yellow in color, with the inscription "12.5/1000" engraved on one face and "322M" on the opposite face.

Vipdomet is available in blisters with 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

Responsible for manufacturing

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Ireland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.