Vipdomet 12.5 mg/1000 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vipdomet 12.5 mg/850 mg film-coated tablets

Vipdomet 12.5 mg/1000 mg film-coated tablets

alogliptin/hydrochloride metformin

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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 a single tablet:

• alogliptin belongs to a group of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works by increasing insulin levels in the body after a meal and reducing the amount of sugar in the body.
• metformin belongs to a group of medicines known as biguanides, which also help reduce blood sugar by decreasing the amount of sugar produced by the liver and helping insulin work more effectively.

Both groups of medicines are "oral antidiabetic agents".

What Vipdomet is used for

Vipdomet 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.

Vipdomet is taken when blood sugar cannot be 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 alogliptin and metformin as separate tablets, Vipdomet may replace them with a single tablet.

It is important that you continue to follow the dietary and exercise advice given to you by your doctor or nurse.

2. What you need to 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 any other similar medicine used to control blood glucose. Symptoms of a severe allergic reaction may include rash, raised red spots on the skin (urticaria), swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. Additionally, other symptoms may include generalized itching (pruritus) and a sensation of warmth, particularly affecting the scalp, mouth, throat, and palms of the hands and soles of the feet (Stevens-Johnson syndrome).
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, for example, with severe hyperglycemia (high blood glucose), 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, potentially leading to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or fruity-smelling breath.
• if you have a serious infection or are severely dehydrated (your body has lost a large amount of water)
• if you have recently had a heart attack or have severe circulatory problems, including shock
• if you have serious breathing difficulties
• if you have liver disease
• if you consume excessive amounts of alcohol (daily or periodically in large quantities)
• if you have diabetic ketoacidosis (a serious complication of poorly controlled diabetes). 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 insulin or thiazolidinedione dose when taken together with Vipdomet to avoid blood sugar levels becoming too low (hypoglycemia).
• if you are taking another diabetes medicine containing a "sulfonylurea," you should not start taking Vipdomet.
• if you have or have had a pancreatic disease.
• if you experience symptoms suggesting liver injury during treatment with Vipdomet.

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

Risk of lactic acidosis

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

If any of the above apply to you, consult your doctor for further instructions.

Stop taking Vipdomet temporarily if you develop a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

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

Lactic acidosis is a medical emergency and must be treated in a hospital. If you suspect you have lactic acidosis, seek immediate medical attention from your doctor or hospital.

Symptoms of lactic acidosis include:

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

If you need to undergo major surgery, you must stop taking Vipdomet during the procedure and for some time afterward. Your doctor will decide when to interrupt and when to restart treatment with Vipdomet.

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

Children and adolescents

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

Other medicines and Vipdomet

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example during an X-ray or scan, you must stop taking Vipdomet before or at the time of the injection. Your doctor will decide when to interrupt and when to restart treatment with Vipdomet.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. You may require 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 conditions such as asthma and arthritis
• cimetidine, used to treat stomach problems
• bronchodilators (beta-2 agonists), used for the treatment of 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 hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• medicines containing alcohol

Vipdomet and alcohol

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

Pregnancy and breastfeeding

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

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

Driving and using machines

It is unknown whether Vipdomet affects the ability to drive and use machines. Taking Vipdomet in combination with medicines called pioglitazone or insulin may cause excessively low blood sugar levels (hypoglycemia), which could impair your ability to drive and use machines.

3. How to take Vipdomet

Follow exactly the instructions for administration of this medicine given 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 you require will vary depending on your condition and the doses you are currently taking of metformin alone, metformin in combination with pioglitazone, insulin, and/or individual 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 administered using separate tablets of alogliptin and metformin.

Swallow the tablets whole with water. You should take this medicine with food to reduce the possibility 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 your doctor or go immediately to the nearest emergency department. 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 first consulting your doctor. Your blood glucose levels may rise if you stop taking Vipdomet.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

STOP taking Vipdomet and contact a doctor or the nearest hospital immediately if you notice any of the following serious adverse 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 may lead to coma. For symptoms, see section “Warnings and precautions”

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

• Allergic reaction. Symptoms may include: rash, hives, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue, and feeling faint.
• Severe allergic reaction: skin lesions or skin spots, which may progress to ulcers surrounded by pale or erythematous rings, with blisters and/or skin peeling, possibly accompanied by symptoms such as itching, fever, general malaise, joint pain, 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) that may spread to the back, along with nausea and vomiting, as this could be a sign of inflammation of the pancreas (pancreatitis).

You should also consult your doctor if you experience any of the following adverse 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 levels (hypoglycaemia), which may occur when Vipdomet is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling in the lips, paleness, change in mood or feeling confused. Your blood sugar level may drop below normal, but you can raise it again by consuming sugar. It is recommended that you carry sugar lumps, sweets, biscuits, or sugary fruit juice with you.
• Cold-like symptoms, such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, dry cough
• Rash
• Itching of the skin, with or without hives
• Headache
• Indigestion, heartburn
• Vomiting and/or diarrhoea
• Metallic taste
• Decreased levels of vitamin B12 or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), painful and red tongue (glossitis), tingling (paraesthesia), 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, changes in liver function tests)
• Erythema (skin redness)

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 whites of the eyes.
• Inflammation of the connective tissue inside the kidneys (interstitial nephritis).
• Appearance of blisters on the skin (bullous pemphigoid).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vipdomet

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

Do not use this medicine after the expiry date stated on the carton and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vipdomet

• 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/1000 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg of alogliptin and 1000 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).

Nature and contents of the container

• 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 tablets, with the imprint “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 tablets, with the imprint “12.5/1000” engraved on one side and “322M” on the opposite side.

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

Only certain 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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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