What PIZONA is and what it is used for
The pill contains pioglitazone. Pison is an antidiabetic medicine used to treat type 2 (non-insulin-dependent) diabetes mellitus. This is diabetes, which usually develops in adult patients.
Pizona helps control the level of sugar in the blood when you have type 2 diabetes, helping your body to better utilize insulin produced by it. Your doctor will check if Pison works 3 to 6 months after you start taking it.
The pison can be used alone or in combination with metformin and / or sulfonylurea derivatives that are also oral antidiabetic medicines.
Pison can be used in combination with insulin.
2. What you need to know before taking PIZONA
Do not take Pison:
If you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Pison (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, causing rapid weight loss, nausea or vomiting);
If you have or have had bladder cancer;
If you have blood in urine that has not been studied by your doctor.
Warnings and precautions
Tell your doctor or pharmacist before taking Pioneer:
If you retain water (fluid retention) or if you have problems with heart failure, especially if you are over 75 years of age;
If you have a special type of diabetic eye disease called macular edema (swelling of the back of the eye);
If you have ovarian cysts (polycystic ovarian syndrome). There is an increased chance of becoming pregnant because you may have ovulation again when you take Pizona. If this applies to you, use appropriate contraception to avoid an unplanned pregnancy;
If you have liver and heart problems. Before you start taking Pison, you should do blood tests to check for the function of your liver. This check may periodically be repeated. Some patients with long-term type 2 diabetes mellitus and heart disease or stroke who are on insulin and pioglitazone receive heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling (swelling).
If you take Pioneer with other diabetes medicines, your blood sugar is likely to fall below normal levels (hypoglycaemia).
You may also experience a decrease in the number of blood cells (anemia).
Broken bones
There is a greater number of bone fractures in women (but not in men) taking pioglitazone. Your doctor will take this into account in the treatment of your diabetes.
Children and adolescents
Use in patients under 18 years of age is not recommended.
Other Drugs and PIZONA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In most cases, you will be able to continue taking other medicines during Pison treatment.
However, it is likely that some of the following medicines will affect the amount of sugar in your blood:
Gemfibrozil (used to lower cholesterol);
Rifampicin (for the treatment of tuberculosis and other infections).
Tell your doctor or pharmacist if you are taking any of these medicines.
Your blood sugar will be checked and your dose of pioglitazone may need to change.
Pizza with food and beverages
You can take your tablets with or without food.
You should swallow the tablets with a glass of water.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will advise you to stop your treatment with this medicine.
Driving and using machines
PIZONA will not affect your ability to drive or use machines, but take action if you experience changes in vision.
PIZONA contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take PIZONA
Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet of pioglitazone 15 mg or 30 mg daily. The maximum daily dose is 45 mg pioglitazone per day. If you think the effect of Pioneer is too weak, talk to your doctor.
When PIZONA is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide), your doctor will tell you if you need a smaller dose of your medicines.
Your doctor will ask you to periodically perform blood tests during Pison treatment. This is necessary to check if your liver is functioning properly.
If you are following a diet related to your diabetes, you should continue to do so during PIZONA . Your weight should be monitored regularly. If you notice a weight gain, please tell your doctor.
If you take more PIZONA than you should
Your blood sugar may drop below normal levels.
If you have taken more than the necessary number of tablets or someone else or a child has taken your medicine, please tell your doctor or pharmacist immediately.
Your blood sugar may increase by taking sugar. It is recommended that you bring with you lumps of sugar, sweet biscuits or sugar-sweetened fruit juice.
PIZONA
If you forget to take
Take the PIZONA as prescribed. If you miss a dose, continue with the next dose as usual. Do not take two doses in one day.
If you stop taking PIZONA
The PIZONA should be taken every day to have an effect. If you stop taking your medicine, your blood sugar may rise. Tell your doctor before stopping this treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following serious side effects have been observed:
Patients taking pioglitazone in combination with insulin often experience heart failure (1 to 10 patients in 100). Symptoms are unusual shortness of breath, rapid weight gain, and localized edema (edema). If you have any of these symptoms, especially if you are over 65 years of age, seek immediate medical attention;
Bladder cancer is uncommon (1 to 10 patients in 1,000) in patients taking pioglitazone. Signs and symptoms include blood in the urine, urinary pain, sudden urge to urinate. If you get any of these symptoms, contact your doctor as soon as possible;
Localized edema (edema) is also a very common side effect in patients taking pioglitazone in combination with insulin. If you have any of these side effects talk to your doctor as soon as possible;
Broken bones are often reported as an adverse reaction (1 to 10 patients in 100) in women taking pioglitazone. If you have this side effect, tell your doctor immediately.
Blurred vision due to swelling (or fluid) in the back of the eye (not known) has also been reported in patients taking pioglitazone. If you experience these symptoms for the first time, tell your doctor as soon as possible. In addition, if you already have blurred vision and symptoms get worse, tell your doctor as soon as possible.
Other side effects that have been seen in some patients taking pioglitazone are:
Common (affects 1 to 10 patients in 100):
Respiratory tract infection;
Impaired vision;
Weight gain;
Tingling.
Uncommon (affects 1 to 10 patients in 1,000):
Inflammation of the sinuses (sinusitis);
Insomnia (Insomnia).
Not known (can not be estimated from the available data):
Enhancement of liver enzymes.
Other side effects that have been seen in some patients taking pioglitazone concomitantly with other medicines to treat diabetes are:
Very common (affects 1 to 10 patients):
Lower blood sugar.
Common (affects 1 to 10 patients in 100):
Headache;
Dizziness;
Impotence;
Blood in the urine;
Back pains;
Shortness of breath;
A slight decrease in red blood cell counts;
Formation of gases.
Uncommon (affects 1 to 10 users in 1,000):
Sugar in the urine, urine proteins;
Enhanced enzymes;
Vertigo (vertigo);
Sweating;
Fatigue;
Increased appetite.
Reporting of side effects
If any of the side effects gets serious, tell your doctor. This includes all possible side effects not listed in this leaflet.
You can also report side effects directly through a national reporting system to the BDA. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5. How to Store the PIZONA
Keep out of the reach and sight of children.
No special storage conditions.
Store in original packaging.
Do not take this medicine after the expiry date which is stated on the pack after "Do not take after" or "Shelf life". The expiry date refers to the last day of the month. Consult your pharmacist for the shelf life if you have any doubts.
Do not dispose of any medicines in the sewer or household waste. Ask your pharmacist how to dispose of medicines you no longer take. These measures will help to protect the environment.
Shelf life: 3 years.
6. Package Contents and Additional Information
What PIZONA contains
The active substance is pioglitazone.
Each tablet contains 45 mg pioglitazone (as hydrochloride).
The other ingredients are: lactose monohydrate, hydroxypropylcellulose, carmellose calcium and magnesium stearate.
What Pizona looks like and what the package contains
Pizona 45 mg tablets are white, round, convex tablets with "+" on one side.
They are packed in PVC PCTFE PVC (ACLAR PA200 S03) / AL blisters. The blisters are placed in a carton containing 30 tablets.