LISPECIP 15 mg. 30 tablets

What Lispecip and what it is used
Lispecip contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus. This is diabetes, which usually develops in adulthood.
Lispecip helps control the level of sugar in your blood when you have type 2 diabetes by helping your body better use the insulin it produces. Your doctor will check whether Pioglitazone acts 3 to 6 months after you start taking it.
Lispetsip may be used alone or in combination with metformin and / or a sulphonylurea, which are also oral anti-diabetic drugs.
Lispetsip may also be administered in combination with insulin.

2. Before take Lispecip
Do not take Lispecip
if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Lispetsip;
if you have or if you have had heart failure;
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 the urine that has not been investigated by your doctor.
Take special care with Lispetsip
Tell your doctor before you start taking this medicine:
if you retain water (fluid retention) or if you have had problems with heart failure, especially if you are over 75 years;
if you have a special type of diabetic eye disease called macular edema (swelling of the back of the eye);
if have ovarian cysts (polycystic ovarian syndrome). There is an increased possibility of becoming pregnant because you may ovulate again when you take Lispetsip. If this applies to you, use appropriate contraception to avoid unplanned pregnancy;
if you have liver problems and heart. Before you start taking Lispetsip will do blood tests to check the function of your liver. This check may be repeated periodically. Some patients with type 2 diabetes with longer duration and heart disease or previous stroke who were treated with insulin and Lispetsip heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling (edema).
If you take Lispetsip with other medicines for diabetes, it is likely your blood sugar falls below normal levels (hypoglycemia).
When you can appear and reduce the number of blood cells (anemia).

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

Children
Use in patients under 18 years is not recommended.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In most cases, it will be able to continue to take other medicines during treatment with Lispetsip. It is likely, however, some drugs can affect your blood sugar:
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 drugs. Your blood sugar will be checked and Lispetsip dose may need to be changed.

Taking Lispecip with food and drink
You can take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and lactation
Tell your doctor if:
you are pregnant or think you may be pregnant, and in the case of a planned pregnancy;
are breastfeeding or plan to breastfeed your baby. Your doctor will advise you to stop treatment with this medicine.
Driving and using machines
Pioglitazone will not affect your ability to drive and use machines but take care if you experience changes in vision.

Important information about some of the ingredients of Lispetsip
This medicinal product contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking Lispetsip.

3. How to take Lispecip
Always take Lispecip just as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor. The initial dose should be one tablet of 15 mg pioglitazone or 30 mg per day. The maximum daily dose is 45 mg pioglitazone daily. If you think the effect of Lispetsip is too weak, consult your doctor.
Lispetsip when taken in combination with other medicines to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Your doctor will ask you to periodically have blood tests during treatment with Lispetsip. This is necessary to check whether your liver is working normally.
If you follow a diet in connection with your diabetes, you should continue with this while taking Lispetsip.
Your weight should be checked regularly. If your weight increases, inform your doctor.

If you take more dose Lispecip
If you accidentally take too many tablets or someone else or a child takes your medicine, tell your doctor or pharmacist. Your blood sugar could fall below the normal level and can be increased by taking sugar. It is advisable to carry your sugar lumps, sweets, biscuits sweetened with sugar or fruit juice.

If you forget to take Lispecip
Take Lispetsip as prescribed. However, if you miss a dose, just carry on with the next dose as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Lispecip
Lispetsip must be taken every day to be effective. If you stop taking Lispetsip your blood sugar may increase. 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, Lispetsip can cause side effects, although not everybody gets them.
Patients are seen in particular the following serious side effects:
For patients who are taking Lispetsip in combination with insulin frequently observed heart failure (1 to 10 users 100). Symptoms are unusual shortness of breath, rapid increase in weight or localized swelling (edema). If you have any of these symptoms, especially if you are over the age of 65, seek medical advice immediately.

Bladder cancer was uncommon (1 to 10 users in 1000) when taking pioglitazone. Signs and symptoms include blood in the urine, urination or a sudden urge to urinate. If you experience any of these symptoms, contact your doctor as soon as possible.

Localized swelling (edema) is also very common adverse effects in patients taking pioglitazone in combination with insulin. If you have this side effect, talk as soon as possible with your doctor.

Broken bones is frequently reported adverse event (1 to 10 users in 100) in women taking pioglitazone. If you have this side effect, talk as soon as possible with your doctor.

Blurred vision due to swelling (or fluid) in the back of the eye (frequency not known) has also been side effects reported in patients taking pioglitazone. If you have these symptoms for the first time, talk to your doctor as soon as possible. Furthermore, if you already have blurred vision and the symptoms get worse, talk to your doctor as soon as possible.

Other side effects that have been observed in some patients taking pioglitazone are:
Common (affects 1 to 10 users in 100):
respiratory tract infection;
impaired vision;
weight gain;
tingling.
Uncommon (affecting 1 to 10 users in 1000):
inflammation of the sinuses (sinusitis);
insomnia (insomnia).
not known (from the available data can not be estimated):
increase in liver enzymes.
Other side effects that have been observed in some patients taking pioglitazone with other drugs for the treatment of diabetes are:
Very common (affecting more than 1 in 10 users):
low blood sugar (hypoglycemia).
Common (affects 1 to 10 users in 100):
headache;
dizziness;
joint pain;
impotence;
back pains;
shortness of breath;
a slight decrease in the number of red blood cells;
flatulence.
Uncommon (affecting 1 to 10 users in 1000):
sugar in urine, proteins in urine;
elevated enzymes;
dizziness (vertigo);
sweating;
fatigue;
increased appetite.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Lispecip
Keep out of reach of children.
Do not use Lispecip after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information
What Lispecip
The active substance is pioglitazone (pioglitazone).
Each tablet contains 15 mg of pioglitazone (as hydrochloride).

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

Lispecip looks like and contents of the pack:
Lispecip 15 mg tablets are white, round, flat tablets marked with "15" on one side and a diameter of approximately 5,5 mm.
The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 90 or 98 tablets in blister PA / Aluminium / PVC / Aluminium. The blisters are placed in a carton. Not all pack sizes may be marketed.