15 mg, 30 mg, 45 mg tablets
pioglitazone (pioglitazone)
What Pioglitazone Actavis is and what it is used for
Pioglitazone Actavis contains pioglitazone. It is an antidiabetic medicine used to treat type 2 diabetes mellitus when metformin is not suitable or has sufficient effect. This type of diabetes is also called “non-insulin-dependent” and usually occurs in adulthood.
Pioglitazone Actavis 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 Actavis is working for you.
Pioglitazone Actavis can be used only in patients who can not take metformin and when treatment with diet and exercise fails to control blood sugar levels or can be added to other treatments (such as metformin, sulphonylureas, or insulin ) that have failed to control blood sugar levels.
What you need to know before you take Pioglitazone Actavis
Do not take Pioglitazone Actavis
- if you are allergic (hypersensitive) to pioglitazone or any of the other ingredients of Pioglitazone Actavis (see section 6 Contents).
- 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, or 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 before taking this medicine:
- 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 Actavis. If this affects you, use appropriate contraception to avoid unplanned pregnancy.
- if you have liver or heart problems. Before you start using Pioglitazone Actavis, 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 Actavis 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 Actavis 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 under 18 years of age is not recommended.
Other medicines and Pioglitazone Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can normally continue to take other medicines while you are being treated with Pioglitazone Actavis. 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 Actavis may need to be adjusted.
Pioglitazone Actavis with food and drink
The tablets can be taken with or without food. The tablets should be swallowed together with a glass of water.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
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 Actavis 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 Actavis.
How to take Pioglitazone Actavis
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 taken once daily. 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 Actavis is too weak, talk to your doctor.
Pioglitazone Actavis can be taken with or without food.
When Pioglitazone Actavis is taken in combination with other medicines used to treat diabetes (such as insulin, chloropropamide, glibenclamide, gliclazide, 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 Actavis. This is done to check that the liver is functioning normally.
If you have been recommended for a diabetic diet, you should continue with this while you are taking Pioglitazone Actavis.
Check your weight regularly and tell your doctor if the weight increases.
If you take more Pioglitazone Actavis 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 Actavis
Try to take Pioglitazone Actavis 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.
For pack sizes of 14, 28, 56, 84, and 98 tablets, you can see which day you last took a Pioglitazone Actavis tablet using the calendar printed on the blister card.
If you stop taking Pioglitazone Actavis
Pioglitazone Actavis should be used daily to achieve the desired effect. If you stop taking Pioglitazone Actavis, 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 (up to 1 in 10 people) in patients taking pioglitazone 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 years old.
Bladder cancer has been detected in some patients (up to 1 in 100 people) taking pioglitazone. 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 for patients taking pioglitazone in combination with insulin to experience local swelling ( edema ). Contact your doctor as soon as possible if you experience this side effect.
It has been common (up to 1 in 10 people) for female patients taking pioglitazone to report bone fractures. Bone fractures have also been reported in male patients taking pioglitazone (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 (unknown frequency) has also been reported in patients taking pioglitazone. 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 (no known frequency) in patients taking Pioglitazone Actavis. 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.
Other side effects that have occurred in patients taking pioglitazone are:
common (can affect up to 1 in 10 people)
- respiratory tract infection
- visual impairment
- weight gain
- numbness
less common (may affect up to 1 in 100 people)
- sinusitis
- insomnia
no known frequency (can not be calculated from the available data)
- elevated levels of liver enzymes
- allergic reactions
Other side effects that have occurred in some patients who have used pioglitazone with any other antidiabetic medicine are:
very common (may affect more than 1 in 10 people)
- decreased blood sugar (hypoglycemia)
common (can 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
less common (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 Actavis
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after the words “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 is pioglitazone. Each tablet contains 15 mg, 30 mg, or 45 mg of pioglitazone (in the form of hydrochloride). Each tablet contains 15 mg of pioglitazone (in the form of hydrochloride). Each tablet contains 30 mg of pioglitazone (in the form of hydrochloride). Each tablet contains 45 mg of pioglitazone (in the form of hydrochloride).
- The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium, and magnesium stearate.
What the medicine looks like and the contents of the pack
Pioglitazone Actavis 15 mg tablets are white, round, flat, beveled, 5.5 mm in diameter, and engraved with “TZ15” on one side.
Pioglitazone Actavis 30 mg tablets are white, round, flat, beveled, 7 mm in diameter, and engraved with “TZ30” on one side.
Pioglitazone Actavis 45 mg tablets are white, round, flat, beveled, 8 mm in diameter, and engraved with “TZ45” on one side.
The tablets are delivered in blister packs of aluminum with 14, 28, 30, 50, 56, 84, 90, 98, or 100 tablets.
The packs of 14, 28, 56, 84, and 98 tablets contain blisters with abbreviations for the days of the week printed on the blister (Mon, Tue, Wed, Thu, Fri, Sat, Sun).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Natives approved for sale :
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer:
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
| Belgium / Belgique / BelgienActavis Group PTC ehf.Iceland / Iceland / IcelandTel: +354 5503300 | LithuaniaUAB Teva BalticsTel: +370 52660203 |
| BulgariaTeva TV LADTel: +359 24899585 | Luxembourg / LuxemburgActavis Group PTC ehf.IcelandTel: +354 5503300 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel: +36 12886400 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals IrelandL-IrelandTel: +44 2075407117 |
| GermanyActavis Group PTC ehf.IcelandTel: +354 5503300 | The NetherlandsActavis Group PTC ehf.IcelandTel: +354 5503300 |
| EestiUAB Teva Baltics Eesti subsidiaryTel: +372 6610801 | NorwayTeva Norway ASTel: +47 66775590 |
| GreeceSpecify ABEE:Ηλ: +30 2118805000 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070 |
| SpainActavis Group PTC ehf.IcelandTel: +354 5503300 | PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300 |
| FranceActavis Group PTC ehf.IcelandTel: +354 5503300 | PortugalActavis Group PTC ehf.IcelandTel: +354 5503300 |
| CroatiaPliva Hrvatska dooTel: +385 13720000 | RomaniaTeva Pharmaceuticals SRLTel: +40 212306524 |
| IrelandTeva Pharmaceuticals IrelandTel: +44 2075407117 | SloveniaPliva Ljubljana dooTel: +386 15890390 |
| IcelandActavis Group PTC ehf.Phone: +354 5503300 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 257267911 |
| ItalyActavis Group PTC ehf.IcelandTel: +354 5503300 | Finland / FinlandTeva Finland OyPuh / Tel: +358 201805900 |
| .ΠροςSpecify ABEEGreece:Ηλ: +30 2118805000 | SwedenTeva Sweden ABTel: +46 42121100 |
| LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67323666 | United KingdomTeva Pharmaceuticals IrelandIrelandTel: +44 2075407117 |