Patient leaflet - Vipdomet 12.5 mg / 850 mg film-coated tablets

1. What Alogliptin/Metformin Hydrochloride is and what it is used for

What Alogliptin/Metformin Hydrochloride is

Alogliptin/Metformin Hydrochloride contains two different medicines called alogliptin and metformin in one tablet:

alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
metformin belongs to a group of medicines called biguanides which also help to lower blood sugar by lowering the amount of sugar made in the liver and helping insulin to work more effectively.

Both of these groups of medicines are “oral anti-diabetics”.

What Alogliptin/Metformin Hydrochloride is used for

Alogliptin/Metformin Hydrochloride 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.

Alogliptin/Metformin Hydrochloride is taken when your blood sugar cannot be adequately controlled by diet, exercise and other anti-diabetic medicines such as metformin alone; insulin alone; or metformin and pioglitazone taken together.

If you are already taking both alogliptin and metformin as single tablets, Alogliptin/Metformin Hydrochloride can replace them in one tablet.

It is important that you continue to follow the advice on diet and exercise that your nurse or doctor has given you.

2. What you need to know before you take Alogliptin/Metformin Hydrochloride

Do not take Alogliptin/Metformin Hydrochloride:

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 serious allergic reaction to any other similar medicines that you take to control your blood sugar. Symptoms of a serious allergic reaction may include; rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difﬁculty in breathing or swallowing. Additional symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome).
if you have severely reduced kidney function.
if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactate acidosis (see “Risk of lactic
acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
- if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).
- if you 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 alcohol excessively (either every day or in large quantities only from time to time).

Warnings and precautions

Talk to your doctor or pharmacist before taking Alogliptin/Metformin Hydrochloride:

if you have type 1 diabetes (your body does not produce insulin). • if you are taking Alogliptin/Metformin Hydrochloride with insulin or a thiazolidinedione. Your doctor may want to reduce your dose of insulin or a thiazolidinedione when you take it together with Alogliptin/Metformin Hydrochloride in order to avoid too low blood sugar (hypoglycaemia).
if you are taking another medicine for diabetes that contains a “sulphonylurea”, you should not start taking Alogliptin/Metformin Hydrochloride.
if you have or have had a disease of the pancreas. • in case of symptoms suggestive of liver injury during Alogliptin/ Metformin Hydrochloride therapy.

Contact your doctor if you encounter blistering of the skin, as it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop alogliptin.

Risk of lactic acidosis

Alogliptin/Metformin Hydrochloride may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Alogliptin/Metformin Hydrochloride for a short time if you have a condition that may be associated with dehydration (signiﬁcant loss of body ﬂuids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less ﬂuid than normal. Talk to your doctor for further instructions.

Stop taking Alogliptin/Metformin Hydrochloride and contact a doctor or the nearest hospital immediately if you experience some of the 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 lactic acidosis is suspected, seek medical attention from a doctor or a hospital.

Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of not being well with severe tiredness • difﬁculty in breathing
reduced body temperature and heartbeat

Talk to your doctor promptly for further instructions if: • you are known to suffer from a genetically inherited disease affecting mitochondria (the energy-producing components within cells) such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or Maternal inherited diabetes and deafness (MIDD).

you have any of these symptoms after starting metformin: seizure, declined cognitive abilities, difﬁculty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.

If you need to have major surgery you must stop taking Alogliptin/ Metformin Hydrochloride during and for some time before and after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Alogliptin/Metformin Hydrochloride.

During treatment with Alogliptin/Metformin Hydrochloride, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if have worsening kidney function

Children and adolescents

Alogliptin/Metformin Hydrochloride is not recommended for children and adolescents under 18 years due to the lack of data in these patients.

Other medicines and Alogliptin/Metformin Hydrochloride

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Alogliptin/Metformin Hydrochloride before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Alogliptin/ Metformin Hydrochloride.

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 the dose of Alogliptin/Metformin Hydrochloride. It is especially important to mention the following:

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

Alogliptin/Metformin Hydrochloride with alcohol

Avoid excessive alcohol intake while taking Alogliptin/Metformin Hydrochloride since this may increase the risk of lactic acidosis - see section “Warnings and precautions”.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 use Alogliptin/ Metformin Hydrochloride if you are pregnant.

Alogliptin/Metformin Hydrochloride is not recommended during breast-feeding since metformin passes into breast milk.

Driving and using machines

Alogliptin/Metformin Hydrochloride is not known to affect your ability to drive and use machines. Taking Alogliptin/Metformin Hydrochloride in combination with medicines called pioglitazone or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.

3. How to take Alogliptin/Metformin Hydrochloride

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you exactly how much Alogliptin/Metformin Hydrochloride you need to take. The amount of Alogliptin/ Metformin Hydrochloride will vary depending on your condition and the doses you currently take of metformin alone, metformin in combination with pioglitazone, insulin and/or individual 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, which may need to be given as separate tablets of alogliptin and metformin.

Swallow your tablet(s) whole with water. You should take this medicine with food to reduce your chance of an upset stomach.

If you take more Alogliptin/Metformin Hydrochloride 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 your nearest emergency centre straight away. Take this leaﬂet or some tablets with you so that your doctor knows exactly what you have taken.

If you forget to take Alogliptin/Metformin Hydrochloride

If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Alogliptin/Metformin Hydrochloride

Do not stop taking Alogliptin/Metformin Hydrochloride without consulting your doctor ﬁrst. Your blood sugar levels may increase when you stop taking Alogliptin/Metformin Hydrochloride.

If you have any further questions on the use of 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 Alogliptin/Metformin Hydrochloride and contact a doctor or the nearest hospital immediately if you notice any of the symptoms 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) 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. The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint.

A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
Severe and persistent pain in the abdomen (stomach area) which might reach through to your back as well as nausea and vomiting, as it could be a sign of an inﬂamed pancreas (pancreatitis).

You should also discuss with your doctor if you experience the following side effects:

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

Diarrhoea
Loss of appetite
Feeling sick
Being sick.

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

Symptoms of low blood sugar (hypoglycaemia) may occur when Alogliptin/Metformin Hydrochloride is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or feeling confused. Your blood sugar could fall below the normal level, but can be increased again by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Cold symptoms such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, dry cough
Rash
Itchy skin with or without hives
Headache
Indigestion, heartburn
Vomiting and/or diarrhoea
Metallic taste
Decreased or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to ﬁnd out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems.

Very rare:

Liver problems (hepatitis or liver function test abnormalities). • Erythema (redness of skin).

Not known:

Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine or yellowing of your skin or the whites of your eyes. Alogliptin/Metformin

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alogliptin/metformin hydrochloride

Inﬂammation of the connective tissue within the kidneys (interstitial nephritis)
Blistering of the skin (bullous pemphigoid).

Reporting of side effects

If you get 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 Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the GooglePlay or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alogliptin/Metformin Hydrochloride

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 that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Alogliptin/Metformin Hydrochloride 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 alogliptin and 850 mg metformin hydrochloride.

Each 12.5 mg/1 000 mg ﬁlm-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1 000 mg metformin hydrochloride.

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

What Alogliptin/Metformin Hydrochloride looks like and contents of the pack

Alogliptin/Metformin Hydrochloride 12.5 mg/850 mg ﬁlm-coated tablets (tablets) are light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, ﬁlm-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side.
Alogliptin/Metformin Hydrochloride 12.5 mg/1 000 mg ﬁlm-coated tablets (tablets) are pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, ﬁlm-coated tablets with “12.5/1 000” debossed on one side and “322M” debossed on the other side.

Alogliptin/Metformin Hydrochloride is available in blister packs containing 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 tablets and in multipacks comprising 2 packs each containing 98 ﬁlm-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Tel: +44(0)3333 000181

medinfoemea@takeda.com

Manufacturer

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Ireland

This leaﬂet was last revised in May 2025.