15 mg, 30 mg, 45 mg tablets
pioglitazone
What Pioglitazone Accord is and what it is used for
Pioglitazone Accord contains pioglitazone. It is an antidiabetic medicine used to treat type 2 diabetes mellitus in adults when metformin is not appropriate or has sufficient effect. This type of diabetes is also called “non-insulin-dependent” and usually occurs in adulthood.
Pioglitazone Accord helps keep blood sugar levels under control in type 2 diabetes so that the body can make better use of the insulin that is produced. 3 to 6 months after starting treatment, your doctor will check if Pioglitazone Accord is working for you.
Pioglitazone Accord can be used as the only treatment in patients who can not take metformin and when treatment with diet and exercise fails to keep blood sugar levels under control. Pioglitazone Accord can also be added to other treatments (such as metformin, sulphonylureas, or insulin ) that have failed to adequately control blood sugar levels.
What you need to know before you use Pioglitazone Accord
Do not take Pioglitazone Accord
- if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
- if you have or have had heart failure in the past.
- if you have liver disease.
- if you have had diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea, and vomiting).
- if you have or have ever had bladder cancer.
- if you have blood in your urine that your doctor has not examined further.
Warnings and cautions
Talk to your doctor or pharmacist before taking Pioglitazone Accord (see also section 4)
- if you are accumulating water ( fluid retention ) or have problems with heart failure, especially if you are over 75 years old. Tell your doctor if you are taking anti-inflammatory medications that may cause you to accumulate fluid and swell.
- if you have a type of diabetes-related eye disease called macular edema (swelling in the back of the eye).
- if you have ovarian cysts ( polycystic ovary syndrome ). There may be an increased chance of getting pregnant because you may ovulate again when you take Pioglitazone Accord. If this affects you, use appropriate contraception to avoid unplanned pregnancy.
- if you have liver or heart problems. Before you start using Pioglitazone Accord, you will need to have a blood test to check your liver function. This check may be repeated at intervals. Some patients who have had type 2 diabetes mellitus and heart disease for many years or previous strokes developed heart failure during treatment with Pioglitazone Accord and insulin. Tell your doctor as soon as possible if you get signs of heart failure such as unexpected shortness of breath, rapid weight gain, or local swelling ( edema ).
If you use Pioglitazone Accord with other diabetes medicines, your blood sugar may likely drop below normal levels (hypoglycemia).
You may also have a decrease in the number of blood cells ( anemia ).
Fracture
A higher incidence of bone fractures has been observed in patients, especially in women taking pioglitazone. Your doctor will take this into account when treating your diabetes.
Children and young people
Use in children and adolescents under 18 years of age is not recommended.
Other medicines and Pioglitazone Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
You can normally continue to use other medicines while you are being treated with Pioglitazone Accord. However, some drugs are especially likely to affect the amount of sugar in your blood:
- Gemfibrozil (cholesterol lowering)
- Rifampicin (used to treat tuberculosis and other infections )
Tell your doctor or pharmacist if you are taking any of these preparations. Your blood sugar will be monitored and your dose of Pioglitazone Accord may need to be adjusted.
Pioglitazone Accord with food, drink, and alcohol
The tablets can be taken with or without food. The tablets should be swallowed together with a glass of water.
Pregnancy and breastfeeding
Tell your doctor
- you are pregnant or think you are pregnant or planning to become pregnant.
- if you are breastfeeding or planning to breastfeed your baby.
Your doctor will advise you to stop taking this medicine.
Driving and using machines
Pioglitazone does not affect your ability to drive or use machines, but use caution if you experience visual disturbances.
Pioglitazone Accord contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.
How to take Pioglitazone Accord
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual starting dose is a 15 mg or 30 mg pioglitazone tablet once a day. Your doctor may increase your dose to a maximum of 45 mg once a day. Your doctor will tell you which dose to take.
If you have the impression that the effect of Pioglitazone Accord is too weak, talk to your doctor.
When Pioglitazone Accord is taken in combination with other medicines used to treat diabetes (such as insulin, chloropropamide, glibenclamide, gliclazide, and tolbutamide), your doctor will tell you if you need to take a smaller dose of any of your medicines.
Your doctor will take blood tests regularly during treatment with Pioglitazone Accord. This is done to check that the liver is functioning normally.
If you are recommended a special diet for diabetes, you should continue with this while taking Pioglitazone Accord.
Check your weight regularly and tell your doctor if the weight increases.
If you take more Pioglitazone Accord than you should
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar can drop below normal levels and can be increased by consuming sugar. It is recommended to carry sugar cubes, sweets, biscuits, or sugary fruit drinks.
If you forget to take Pioglitazone Accord
Try to take Pioglitazone Accord daily as prescribed. However, if you miss a dose, just continue with the next dose as usual. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Pioglitazone Accord
Pioglitazone Accord should be used daily to achieve the desired effect. If you stop taking Pioglitazone Accord, your blood sugar level may increase. Talk to your doctor before stopping this treatment.
If you have any further questions on the use of this product, ask 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:
Heart failure has been common (may affect up to 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin. The symptoms are abnormal shortness of breath or rapid weight gain or local swelling ( edema ). Seek medical attention immediately if you experience any of these, especially if you are over 65.
Bladder cancer has been detected in some patients (may affect up to 1 in 100 people) taking Pioglitazone Accord. Signs and symptoms of this can be blood in the urine, pain when urinating, or urination (sudden need to urinate). Contact your doctor as soon as possible if you experience any of these symptoms.
It has also been very common (may occur in more than 1 in 10 users) that patients taking Pioglitazone Accord in combination with insulin have experienced local swelling ( edema ). Contact your doctor as soon as possible if you experience this side effect.
It has been common (may affect up to 1 in 10 people) that female patients taking Pioglitazone Accord have reported broken bones. This has also been reported in male patients (no known frequency [can not be calculated from the available data]) who have taken Pioglitazone Accord. 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 (occurring in an unknown number of users) has also been reported in patients taking Pioglitazone Accord. Contact your doctor as soon as possible if you experience this symptom for the first time. Also, contact your doctor as soon as possible if you already have blurred vision and the symptom worsens.
Allergic reactions have been reported (occurring in an unknown number of users) in patients taking Pioglitazone Accord. If you get a severe allergic reaction such as hives or swelling of your face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately.
The other side effects that have occurred in patients taking Pioglitazone Accord are:
common (may affect up to 1 in 10 people)
- respiratory tract infection
- visual impairment
- weight gain
- numbness
uncommon (may affect up to 1 in 100 people)
- sinusitis
- insomnia
has been reported (occurs in an unknown number of users)
- elevated levels of liver enzymes
- allergic reactions
The other side effects that have occurred in some patients who have used Pioglitazone Accord with any other antidiabetic medicine are:
very common (may affect more than 1 user in 10)
- decreased blood sugar (hypoglycemia)
common (may affect up to 1 in 10 people)
- headache
- dizziness
- joint pain
- impotence
- back pain
- respiratory distress
- a slight decrease in the number of red blood cells
- weather voltage
uncommon (may affect up to 1 in 100 people)
- sugar in the urine, egg whites in the urine
- increase in enzymes
- dizziness
- sweating
- fatigue
- increased appetite
How to store Pioglitazone Accord
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 blister pack and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance in Pioglitazone Accord is pioglitazone.
- Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
- Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
- Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
- The other ingredients are lactose monohydrate, carmellose calcium, hydroxypropylcellulose (E 465), and magnesium stearate (E 572).
What the medicine looks like and the contents of the pack
- Pioglitazone Accord 15 mg tablets are white to off-white, round, cupped, non-film coated tablets with beveled edges, marked with “P” on one side and “15” on the other side.
- Pioglitazone Accord 30 mg tablets are white to off-white, round, flat, non-film-coated tablets with beveled edges, marked with “PIO” on one side and “30” on the other side.
- Pioglitazone Accord 45 mg tablets are white to off-white, flat, round, non-film-coated tablets with beveled edges, marked with “PIO” on one side and “45” on the other side.
Pioglitazone Accord is available in aluminum / aluminum pressure packs containing 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands