Pizona 15 mg. 30 tablets

What is Pizona and what is it used for

Pizona contains pioglitazone. Pizona is an antidiabetic medicine used to treat type 2 (non-insulin dependent) diabetes. This is diabetes that usually develops in adult patients.

Pizona helps control blood sugar levels when you have type 2 diabetes by helping the body make better use of the insulin it makes. Your doctor will check if Pizona works 3 to 6 months after you start taking it.

Piso can be used alone or in combination with metformin and / or sulfonylureas which are also oral antidiabetic drugs.

Pizona can be used in combination with insulin.

2. What you need to know before you take Pizona

Do not take Pizona
• If you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Piso (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 or vomiting);
• If you have or have had bladder cancer;
• If you have blood in your urine that has not been tested by your doctor.

Warnings and precautions
Tell your doctor or pharmacist before taking Piso:
• If you have water retention (fluid retention) or if you have had problems with heart failure, especially if you are over 75 years old;
• 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 ovary syndrome). There is an increased chance of getting pregnant because you may ovulate again when you take Piso. If this applies to you, use appropriate contraception to avoid unplanned pregnancy;
• If you have liver or heart problems. Before you start taking Piso, you must have blood tests to check your liver function. This check may be repeated periodically. Some patients with long-standing type 2 diabetes and heart disease or stroke who are being treated with insulin and pioglitazone develop heart failure. Tell your doctor as early as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling (edema).

If you are taking Piso with other medicines for diabetes, your blood sugar is likely to fall below normal levels (hypoglycaemia).

You may also experience a decrease in the number of blood cells (anemia).

Bone fractures.
There is a greater number of bone fractures in women (but not in men) taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents
Use in patients under 18 years of age is not recommended.

Other drugs and Piso
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 treatment with Piso.

However, some of the following medicines may affect your blood sugar:
• Gemfibrozil (used to lower cholesterol);
• Rifampicin (used to treat 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 be changed.

Piso with food, drinks and alcohol
You can take your tablets with or without food.
You should swallow the tablets with a glass of water.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will advise you to stop treatment with this medicine.

Driving and using machines
Piso will not affect your ability to drive or use machines, but take action if you experience changes in vision.

Piso 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 Piso Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to 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 daily. If you have the impression that the effect of Piso 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 lower dose of your medicine.

Your doctor will ask you to have blood tests periodically

The following serious side effects have been reported:
• Heart failure (1 to 10 patients in 100) is common in patients taking pioglitazone in combination with insulin. Symptoms include unusual shortness of breath, rapid weight gain and localized swelling (edema). If you have any of these symptoms, especially if you are over 65, seek medical attention immediately;
• Bladder cancer is uncommon (1 to 10 patients in 1,000) in patients taking pioglitazone. Signs and symptoms include blood in the urine, pain when urinating and a 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 such a side effect, talk to your doctor as soon as possible;
• Bone fracture is a commonly reported side effect (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 (frequency not known) has also been reported in patients taking pioglitazone. If you have such symptoms for the first time, tell your doctor as soon as possible. In addition, if you already have blurred vision and your symptoms worsen, 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 users in 100)
- Respiratory tract infection;
- Impaired vision;
- Weight gain;
- Numbness.

Uncommon (affects 1 to 10 users in 1,000)
- Inflammation of the sinuses (sinusitis);
- Insomnia.

Not known (cannot be estimated from the available data)
- Increase in liver enzymes.

Other side effects that have been seen in some patients taking pioglitazone at the same time as other medicines used to treat diabetes are:

Very common (affecting 1 to 10 patients)
- Lowering blood sugar.

Common (affects 1 to 10 users in 100)
- Headache;
- Dizziness;
- Impotence;
- Blood in the urine;
- Back pains;
- Lack of air;
- Slight decrease in the number of erythrocytes;
- Gas formation.

Uncommon (affecting 1 to 10 patients in 1,000)
- Sugar in the urine, protein in the urine;
- Elevated enzymes;
- Dizziness (vertigo);
- Sweating;
- Fatigue;
- Increased appetite.

5. How to store Piso

Keep out of reach of children.

This medicinal product does not require any special storage conditions.

Store in the original package.

Do not take this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month. Consult your pharmacist for the expiry date if you have any doubts.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment,

6. Contents of the package and additional information

What does Piso contain
- The active substance is: pioglitazone Each tablet contains 15 mg of pioglitazone (as hydrochloride).

- The other ingredients are: lactose monohydrate, hydroxypropylcellulose, carmellose calcium and magnesium stearate.

What Piso looks like and contents of the pack
Piso 15 mg tablets are white, round, convex tablets.

They are packed in PVC-PE / PVDC / AL blisters. The blisters are placed in a carton containing 30 tablets.

 

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