12.5 mg/850, 12.5 mg/1000 film-coated tablets
alogliptin/metformin hydrochloride
What Vipdom is and what it is used for
What Vipdom is
Vipdomet contains two different medicines in one tablet. The two substances are alogliptin and metformin.
– alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works by increasing the levels of insulin in the body after a meal and reducing the amount of sugar in the body.
– metformin belongs to a group of medicines called biguanides which also help to lower blood sugar by reducing the amount of sugar produced in the liver and helping insulin to work better.
Both of these drugs belong to a group called oral antidiabetics (drugs for diabetes taken by mouth).
What Vipdomet is used for
Vipdomet is used to lower the blood sugar level in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes
Vipdomet is used when blood sugar cannot be adequately controlled with diet, exercise, and other diabetes medicines, for example, metformin alone, insulin alone, or metformin and pioglitazone together.
If you already take both alogliptin and metformin as separate tablets, Vipdomet can replace them in one tablet.
You must continue to follow the diet and exercise advice given to you by your nurse or doctor.
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 serious allergic reaction to any similar medicine that you take to control your blood sugar. Symptoms of a severe allergic reaction may include, rash, red raised spots on the skin (hives), and swelling of the face, lips, tongue, and throat which may cause difficulty in breathing and swallowing. Additional symptoms may include general itching and a feeling of warmth, particularly affecting the scalp, mouth, throat, palms of the hands, and soles of the feet (Stevens-Johnson syndrome).
- if you have severely impaired kidney function.
- 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 where substances called ketone bodies to accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach ache, fast and deep breathing, sleepiness, or your breath having a different, fruity smell.
- if you have a severe infection or are severely dehydrated (have lost a lot of water from your body).
- if you have recently had a heart attack or have severe circulatory problems, including shock.
- have severe breathing difficulties.
- if you have any liver disease.
- if you drink large amounts of alcohol (either every day or large amounts from time to time).
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 take Vipdomet with insulin or thiazolidinedione. Your doctor may want to lower the dose of insulin or thiazolidinedione when you take it together with Vipdomet to avoid blood sugar getting too low (hypoglycemia).
- if you use any other diabetes medicine that is a so-called sulphonylurea, you should not start taking Vipdomet.
- if you have or have had the pancreatic disease.
- if you get symptoms that indicate liver damage during treatment with Vipdomet.
Risk of lactic acidosis
Vipdomet can cause the very rare, but very serious, side effect of lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infection, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where a part of the body has reduced oxygen supply (including acute severe heart disease).
If any of the above apply to you, talk to your doctor for more detailed instructions.
Stop taking Vipdomet for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to your doctor for more detailed instructions.
Stop taking Vipdomet and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as the condition can lead to a coma.
Lactic acidosis is an acute medical condition that must be treated in a hospital. If lactic acidosis is suspected, seek medical or hospital care.
The symptoms of lactic acidosis include:
- vomiting
- abdominal pain (stomach)
- muscle cramps
- a general feeling of not feeling well and pronounced fatigue
- hard to breathe
- lowered body temperature and pulse.
If you are going to undergo a major operation, you must stop taking Vipdomet during the operation and for a certain time after it. The doctor decides when you must stop taking Vipdomet and when you should start taking it again.
During treatment with Vipdomet, the doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.
Children and young people
Vipdomet is not recommended for children and adolescents under the age of 18 because there is a lack of data from these patients.
Other medicines and Vipdomet
If you need to receive an injection into the blood with a contrast agent containing iodine, for example in connection with an X-ray or CT scan, you must stop taking Vipdomet before or at the time of the injection. The doctor decides when you must stop taking Vipdomet and when you should 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 to have more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Vipdomet. You must mention the following:
- hydrocortisone and prednisolone ( corticosteroids ), which are used to treat diseases with elements of inflammation, such as asthma and arthritis
- cimetidine used to treat stomach problems
- bronchodilators (beta-2 agonists ) used to treat asthma
- drugs that increase urine production ( diuretics )
- medicines used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
- certain medicines for the treatment of high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists).
- medicines containing alcohol
Vipdom with alcohol
Avoid heavy alcohol intake while taking Vipdomet as alcohol 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Vipdomet if you are pregnant.
Vipdomet is not recommended during breastfeeding, as metformin passes into breast milk.
Driving ability and use of machinery
Vipdomet has no known effect on the ability to drive vehicles and use machines. Taking Vipdomet together with other medicines called pioglitazone or insulin can cause low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines.
How to take Vipdomet
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The doctor will tell you exactly how much Vipdomet you should 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 daily. If you have reduced kidney function, the doctor may prescribe a lower dose, which may need to be given as separate tablets of alogliptin and metformin.
Swallow the tablets whole with water. Take this medicine with a meal to reduce the risk of an upset stomach.
If you have taken too much Vipdomet
If you have ingested too much medicine, or if e.g. a child has ingested the medicine, you must immediately contact or visit the nearest emergency department. Bring this information and some tablets so the doctor knows exactly what you have taken.
If you forget to take Vipdomet
If you have forgotten to take a dose, take it as soon as you notice that you have missed a dose. Do not take a double dose to make up for a missed dose.
If you stopped taking Vipdomet
Do not stop taking Vipdomet without consulting a doctor. Blood sugar levels may rise when you stop taking Vipdomet.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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 immediately if you experience any of the symptoms of the following serious side effects:
Very rare (affects up to 1 in 10,000 users)
- Lactic acidosis (accumulation of lactic acid in the blood) is a very serious side effect that can lead to coma. Read about the symptoms in the “Warnings and precautions” section
Frequency not known (cannot be estimated from available data):
- Allergic reaction: The symptoms may be: rash, hives, swallowing or breathing problems, swelling of the lips, face, throat, or tongue, and feeling weak.
- Severe allergic: skin lesions or spots on the skin that may turn into sores surrounded by pale or red rings, blisters, and/or peeling of the skin, possibly with symptoms such as itching, fever, general malaise, aching joints, vision problems, feeling hot, painful or itchy eyes and mouth ulcers (Stevens-Johnson syndrome and erythema multiforme).
- Severe and persistent pain: in the stomach which may radiate to the back also nausea and vomiting, as may be a sign of inflammation of the pancreas ( pancreatitis ).
You should also discuss with a doctor if you suffer from the following side effects:
Very common (affects more than 1 in 10 users):
- stomach ache
- diarrhea
- loss of appetite
- nausea
- vomiting
Common (may affect up to 1 in 10 users):
- Symptoms of low blood sugar (hypoglycemia) may occur when Vipdomet is taken together with insulin or a sulphonamide (eg glipizide, tolbutamide, glibenclamide).
- Symptoms may include: tremors, sweating, anxiety, blurred vision, tingling lips, paleness, mood changes, or confusion. Blood sugar can drop below normal levels, but can be made to rise again by eating a little sugar. It is recommended that you carry some sugar cubes, candies, crackers, or sugary fruit juice with you.
- cold symptoms, such as sore throat, nasal congestion, feeling tired, fever, chills, dry cough
- rash
- skin itching with or without hives
- headache
- digestive problems, heartburn
- vomiting and/or diarrhea
- metallic taste
Very rare :
- reduced vitamin B12 levels or anemia, symptoms include fatigue, lethargy, feeling faint, shortness of breath
- liver problems ( hepatitis ) or abnormal liver function values
- erythema (redness of the skin)
No known frequency :
- liver problems such as nausea, vomiting, stomach ache, unusual or unexplained tiredness, decreased appetite, dark urine or yellow skin, or whites of the eyes.
How the Vipdom should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- 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/1000 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1000 mg metformin hydrochloride.
- Other ingredients are mannitol, microcrystalline cellulose, povidone K30, crospovidone type A, magnesium stearate, hypromellose, talc, titanium dioxide (E 171), and yellow iron oxide (E 172).
Appearance and package sizes of the medicine
- Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are light yellow, oblong (approximately 21.0 mm long and 10.1 mm wide), biconvex, film-coated tablet debossed with “12.5/850” on one side and with “ 322M” on the other side.
- Vipdomet 12.5 mg/1,000 mg film-coated tablets (tablets) are light yellow, oblong (approximately 22.3 mm long and 10.7 mm wide), biconvex, film-coated tablets marked “12.5/1,000” on one side and with “322M” on the other side.
Vipdomet is available in blister packs of 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, and 200 tablets and multiple packs of 2 packs each containing 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark
Manufacturer
Takeda Ireland Limited
Bray Business Park
Keel Rudder
Co. Wicklow
Ireland
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
België/Belgique/Belgien/Luxembourg/LuxemburgTakeda BelgiumTél/Tel: +32 2 464 06 11takeda-belgium@takeda.com | LithuaniaTakeda UABPhone: +370 521 09 070lt-info@takeda.com |
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DenmarkTakeda Pharma A/SPhone: +45 46 77 11 11 | The NetherlandsTakeda Nederland bvPhone: +31 23 56 68 777nl.medical.info@takeda.com |
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| IrelandTakeda Products Ireland LimitedPhone: +353 (0) 1 6420021 | Slovenian RepublicTakeda Pharmaceuticals Slovakia s.r.oPhone: +421 (2) 20 602 600 |
| IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is | Finland/FinlandTakeda OyPhone/Tel: +358 20 746 5000 |
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