Vipdomet
alogliptin, metformin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Vipdomet is and what it is used for
What you need to know before you take Vipdomet
How to take Vipdomet
Possible side effects
How to store Vipdomet
Contents of the pack and other information
Vipdomet 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”.
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 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, Vipdomet 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.
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)
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 want to reduce your dose of insulin or a thiazolidinedione when you take it together with Vipdomet 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 Vipdomet.
if you have or have had a disease of the pancreas.
in case of symptoms suggestive of liver injury during Vipdomet 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
Vipdomet 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.
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.
If you need to have major surgery you must stop taking Vipdomet 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 Vipdomet.
During treatment with Vipdomet, 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
Vipdomet is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
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 Vipdomet before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Vipdomet.
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 dosage of Vipdomet. 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.
Avoid excessive alcohol intake while taking Vipdomet since this may increase the risk of lactic acidosis - see section “Warnings and precautions”.
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 Vipdomet if you are pregnant.
Vipdomet is not recommended during breast-feeding since metformin passes into breast milk.
Vipdomet is not known to affect your ability to drive and use machines. Taking Vipdomet 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.
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 Vipdomet you need to take. The amount of Vipdomet 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 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 a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Vipdomet without consulting 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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should also discuss with your doctor if you experience the following side effects:
Stomach ache
Diarrhoea
Loss of appetite
Feeling sick
Being sick.
Symptoms of low blood sugar (hypoglycaemia) 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 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 vitamin B12 levels or anaemia; symptoms include tiredness, lethargy, feeling faint, becoming breathless
Liver problems (hepatitis or liver function test abnormalities)
Erythema (redness of skin).
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.
Inflammation of the connective tissue within the kidneys (interstitial nephritis)
Blistering of the skin (bullous pemphigoid).
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 nationalreportingsystem listedin AppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
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.
- 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).
Vipdomet 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.
Vipdomet 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 “12.5/1000” debossed on one side and “322M” debossed on the other side.
Vipdomet 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.
Takeda Pharma A/S Delta Park 45
2665 Vallensbaek Strand Denmark
Takeda Ireland Limited Bray Business Park Kilruddery
Co. Wicklow Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Takeda Belgium
Tél/Tel: +32 2 464 06 11
Takeda UAB
Tel: +370 521 09 070
Такеда България
Тел.: +359 2 958 27 36; +359 2 958 15 29
Takeda Belgium
Tél/Tel: +32 2 464 06 11
Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 722
Takeda Pharma A/S Tlf/Tel: +45 46 77 11 11
TAKEDA HELLAS S.A. Tel: +30 210 6387800
Takeda GmbH
Tel: +49 (0) 800 825 3325
Takeda Nederland B.V.
Tel: +31 20 203 5492
Takeda Pharma AS Tel: +372 6177 669
Takeda AS
Tlf: +47 6676 3030
TAKEDA ΕΛΛΑΣ Α.Ε. Τηλ: +30 210 6387800
Takeda Pharma Ges. m.b.H. Tel: +43 (0) 800-20 80 50
Laboratorios Menarini, S.A. Tel: +34 934 628 800
Takeda Pharma sp. z o.o. Tel. +48 22 608 13 00
Takeda France SAS Tél: +33 1 40 67 33 00
Takeda Farmacêuticos Portugal, Lda. Tel: +351 21 120 1457
Takeda Pharmaceuticals Croatia d.o.o Tel: +385 1 377 88 96
Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91
Takeda Products Ireland Limited Tel: 1800 937 970
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Vistor hf.
Sími: +354 535 7000
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Takeda Oy
Tel. +358 20 746 5000
TAKEDA ΕΛΛΑΣ Α.Ε. Τηλ: +30 210 6387800
Takeda Pharma AB Tel: +46 8 731 28 00
Takeda Latvia SIA Tel: +371 67840082
Takeda UK Ltd
Tel: +44 (0) 2830 640 902