30 mg/2 mg, 30 mg/4 mg, 45 mg/4 mg tablets
pioglitazone/glimepiride
What Tandemact is and what it is used for
Tandemact contains pioglitazone and glimepiride which are medicines for diabetes and are used to control blood sugar levels.
The medicine is used in adults when metformin is not suitable for the treatment of diabetes mellitus type 2 (non-insulin-dependent diabetes ). This type 2 diabetes usually occurs in adulthood when the body either does not produce enough insulin (a hormone that controls blood sugar levels) or cannot effectively use the insulin it does produce.
Tandemact helps to keep the blood sugar level under control in type 2 diabetes by increasing the amount of available insulin and helping the body to make better use of it. 3 to 6 months after you start treatment, your doctor will check whether Tandemact is working for you.
What you need to know before you take Tandemact
Do not take Tandemact:
- if you are allergic to pioglitazone, glimepiride, other sulphonylurea compounds or sulphonamide compounds, or any of the other ingredients of this medicine (listed in section 6)
- if you have heart failure or have had heart failure in the past
- if you have any liver disease
- if you have diabetic ketoacidosis (a diabetes complication with rapid weight loss, nausea, or vomiting)
- if you have severe kidney problems
- if you have or have previously had bladder cancer
- if you have blood in your urine that your doctor has not investigated further
- if you have insulin-dependent diabetes (type 1)
- if you have a diabetic coma
- if you are pregnant
- if you are breastfeeding
Warnings and precautions
Talk to your doctor or pharmacist before taking Tandemact (see also section 4)
- if you have heart problems. Some patients with long-standing type 2 diabetes and heart disease or previous stroke treated concurrently with pioglitazone and insulin developed heart failure. Tell the doctor as soon as possible if you experience signs of heart failure such as increased shortness of breath or rapid weight gain or local swelling (edema).
- if you accumulate water ( fluid retention ) or have heart failure problems, especially if you are over 75 years of age. Tell your doctor if you are taking anti-inflammatory medications that can cause fluid retention and swelling.
- if you have a special type of eye disease due to diabetes called macular edema (swelling of the back of the eye), talk to your doctor if you notice any vision changes.
- if you have liver problems. Before you start taking Tandemact, a blood test is taken to check your liver function. This check must be repeated at regular intervals. Tell your doctor as soon as possible if you develop symptoms that indicate liver problems (such as unexplained nausea, vomiting, stomach pain, tiredness, loss of appetite, and/or dark urine) as your liver function should be checked.
- if you have cysts on the ovaries ( polycystic ovary syndrome ). Then there may be an increased risk of becoming pregnant because you may ovulate again while taking Tandemact. If this applies to you, you must use appropriate contraception to avoid the risk of an unplanned pregnancy.
- if you are already taking other medicines to treat diabetes.
- if you have problems with an enzyme called glucose -6-phosphodehydrogenase as it can reduce the number of red blood cells.
You can also get a lack of blood ( anemia ). The doctor may take a blood sample to check your blood values and your liver function.
Hypoglycemia
When taking Tandemact, your blood sugar may fall below the normal level (hypoglycemia). If you experience symptoms of hypoglycemia such as cold sweats, fatigue, headache, fast heartbeat, hunger pangs, irritability, nervousness, or nausea, eat something sweet to bring your blood sugar back up. Ask your doctor or pharmacist for more information if you are not sure how to recognize this. It is recommended that you bring sugar cubes, sweets, biscuits, or fruit drinks that contain sugar.
Fracture
A greater number of bone fractures were seen in patients, especially in women taking pioglitazone. The doctor takes this into account when treating your diabetes.
Children and young people
Use for children and adolescents under 18 years of age is not recommended.
Other medicines and Tandemact
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You need to do this because some medicines can increase or decrease the effect of Tandemact on your blood sugar.
The following medicines may increase the blood sugar-lowering effect of Tandemact. This can lead to a risk of hypoglycemia (low blood sugar):
- gemfibrozil and fibrates (to lower high cholesterol )
- insulin, metformin, or other medicines for the treatment of diabetes mellitus
- phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like drugs (for the treatment of pain and inflammation )
- long-acting sulfonamides, tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin (for the treatment of bacterial or fungal infections)
- anabolic steroids (supports muscle building) or male sex hormone replacement therapy
- fluoxetine, MAOI (for treating depression)
- angiotensin converting inhibitors (ACE inhibitors), sympatholytics, disopyramide, pentoxifylline, coumarin derivatives such as warfarin (to treat heart or blood problems)
- allopurinol, probenecid, sulfinpyrazone (for the treatment of gout )
- cyclophosphamide, ifosfamide, trophosphamide (for the treatment of cancer)
- fenfluramine (for weight loss)
- tritoqualine (for the treatment of allergies )
The following medicines can reduce the blood sugar-lowering effect of Tandemact. This can lead to a risk of hyperglycemia (high blood sugar):
- estrogens , progestogens (female sex hormones)
- thiazide diuretics and saluretics also called diuretic tablets (for the treatment of high blood pressure )
- levothyroxine (for thyroid stimulation)
- glucocorticoids (for the treatment of allergies and inflammation )
- chlorpromazine and other phenothiazine derivatives (for the treatment of severe mental disorders)
- adrenaline and sympathomimetics (for increasing the heartbeat, for the treatment of asthma or nasal congestion, cough and cold, or used in life-threatening acute conditions)
- nicotinic acid (for treating high cholesterol )
- long-term use of laxatives (to treat constipation)
- phenytoin (to treat seizures)
- barbiturates (for treating anxiety and sleep problems)
- acetazolamide (for the treatment of increased pressure in the eye, also called glaucoma )
- diazoxide (to treat high blood pressure or low blood sugar)
- rifampicin (for treatment of infection, tuberculosis )
- glucagon (to treat very low blood sugar)
The following medicines can increase or decrease the blood sugar-lowering effect of Tandemact:
- H 2 – antagonists (for the treatment of peptic ulcers )
- beta-blockers, clonidine, guanethidine, and reserpine (for treating high blood pressure or heart failure ). These can also hide signs of hypoglycemia, which is why special care is needed when taking these medicines
Tandemact can either increase or weaken the effects of the following medicines:
- coumarin derivatives such as warfarin (to reduce or stop blood clotting)
Tell your doctor or pharmacist if you are taking any of these. Your blood sugar will be checked and your Tandemact dose may need to be changed.
Tandemact with alcohol
Avoid alcohol when taking Tandemact as alcohol can increase or decrease the blood sugar-lowering effect of Tandemact unpredictably.
Pregnancy and breastfeeding
Do not take Tandemact if you are pregnant. You must tell your doctor if you are, think you may be or are planning to become pregnant. The doctor will advise you to stop taking this medicine.
Do not use Tandemact if you are breastfeeding or plan to breastfeed (see section “Do not take Tandemact”.
Driving ability and use of machinery
Glimepiride can impair attention and reaction time due to too low or too high blood sugar, especially at the beginning of treatment, after a change in treatment, or if Tandemact is not taken regularly. This may affect your ability to drive and use machines.
Pay attention if your vision is impaired due to the medicine.
Tandemact contains lactose monohydrate and sodium
Tandemact contains lactose monohydrate
If you have an intolerance to certain sugars, you should consult your doctor before taking Tandemact.
Tandemact contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Tandemact
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet taken once daily shortly before or with the first main meal. The doctor will tell you what dose to take or if you need to change to a different dose. You should swallow the tablets with a glass of water.
If you think Tandemact seems to have too weak an effect, talk to your doctor.
If you follow a special diabetes diet, you should continue with it while taking Tandemact.
Check your weight regularly and inform your doctor if the weight increases.
Your doctor will ask you to have regular blood tests during treatment with Tandemact.
If you have taken too much Tandemact
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to your doctor or pharmacist immediately. Your blood sugar may drop below the normal level. Symptoms can be e.g. cold sweats, fatigue, headache, fast heartbeat, hunger pangs, irritability, nervousness, nausea, coma, or convulsions. Blood sugar levels can be raised by consuming sugar. You should always carry some sugar cubes, sweets, biscuits, or fruit juice with sugar.
If you forget to take Tandemact
Take the Tandemact tablets daily as prescribed. If you still miss a dose, skip the missed dose and just continue with the next dose as usual. Do not take a double dose to make up for a missed tablet.
If you stop taking Tandemact
Tandemact must be used every day to work properly. If you stop taking Tandemact, your blood sugar may increase. Talk to your doctor before stopping this treatment.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In particular, patients have experienced the following serious side effects:
Bladder cancer has occurred uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact. Signs and symptoms include blood in the urine, pain when urinating or a sudden need to urinate. If you experience any of these, talk to your doctor as soon as possible.
Hypoglycemia (low blood sugar) has been reported uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact. Symptoms can include cold sweats, fatigue, headache, rapid heartbeat, hunger pangs, irritability, anxiety, or nausea. It is important to know what symptoms to expect when hypoglycemia (low blood sugar) occurs. Ask your doctor or pharmacist for more information if you are not sure how to recognize this and what to do if you experience the symptoms.
Decreases in platelets (which increase the risk of bleeding or bruising), red blood cells (which make your skin pale and make you feel weak or short of breath), and white blood cells (which make you more likely to get an infection ) have been reported in rare cases in patients who taken Tandemact (may affect up to 1 in 1,000 people). If you experience these side effects, talk to your doctor as soon as possible. These problems generally get better when you stop taking Tandemact.
Local swelling (edema) has also occurred commonly (may affect up to 1 in 10 people) in patients taking Tandemact in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.
It has been common (may affect up to 1 in 10 users) for female patients taking Actos to report broken bones. Bone fractures have also been reported in male patients taking Actos (occurring in an unknown number of users). Contact your doctor as soon as possible if you experience this side effect.
Blurred vision due to swelling (or fluid) in the back of the eye (macular edema) has also been reported in patients taking Tandemact (frequency not known, cannot be estimated from available data). If you experience this symptom for the first time, talk to your doctor as soon as possible. If you already have blurred vision and the symptoms get worse, you should also talk to your doctor as soon as possible.
Allergic reactions have been reported with an unknown frequency (cannot be estimated from available data) in patients taking Tandemact. If you get a serious allergic reaction such as hives or swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately.
Some patients experience the following side effects while taking pioglitazone and sulfonylureas, including glimepiride:
Common (may affect up to 1 in 10 people)
- weight gain
- dizziness
- weather tension
- respiratory tract infection
- numbness
Uncommon (may affect up to 1 in 100 people)
- headache
- sinus infection ( sinusitis )
- dizziness
- abnormal vision
- sweating
- fatigue
- difficulty sleeping (insomnia)
- lowered blood sugar
- sugar in the urine
- protein in the urine
- increased appetite
- an elevated enzyme called lactate dehydrogenase (LDH)
Rare (may affect up to 1 in 1,000 people)
- noticeable blood changes
Very rare (may affect up to 1 in 10,000 people)
- liver disease
- allergic reactions including allergic shock
- nausea, vomiting, and diarrhea
- stomach ache
- increased abdominal pressure
- the feeling of fullness in the abdomen
- light sensitivity
- reduced salt levels ( sodium ) in the blood
Frequency not known (cannot be estimated from available data)
- elevation of liver enzymes
- skin itching
- raised and itchy rash ( hives )
Reporting
How to store Tandemact
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and the 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 pioglitazone and glimepiride.
Each Tandemact 30 mg/2 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg glimepiride.
Each Tandemact 30 mg/4 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Each Tandemact 45 mg/4 mg tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg glimepiride. - Other ingredients are microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate (see section 2 “Tandemact contains lactose”), magnesium stearate, and polysorbate 80.
Appearance and package sizes of the medicine
- Tandemact 30 mg/2 mg tablets are white to off-white, round, convex, and debossed with “4833 G” on one side and “30/2” on the other.
- Tandemact 30 mg/4 mg tablets are white to off-white, round, convex, and debossed with “4833 G” on one side and “30/4” on the other.
- Tandemact 45 mg/4 mg tablets are white to off-white, round, flat, and debossed with “4833 G” on one side and “45/4” on the other.
The tablets are packed in aluminum/aluminum pressure packs with either 14, 28, 30, 50, 90, or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland
Delpharm Novara Srl, Via Crosa, 86, 28065 Cerano (NO), Italy
Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 – 98, 16515 Oranienburg, Germany