Pioglitazone Hydrochloride 15mg Tablets
Package leaflet: Information for the user
Pioglitazone Hydrochloride 15mg tablets Pioglitazone Hydrochloride 30mg tablets Pioglitazone Hydrochloride 45mg tablets
Pioglitazone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. Y ou may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Pioglitazone Hydrochloride 15/30/45mg tablets is and what it is used for
2. What you need to know before you take Pioglitazone Hydrochloride 15/30/45mg tablets
3. How to take Pioglitazone Hydrochloride 15/30/45mg tablets
4. Possible side effects
5. How to store Pioglitazone Hydrochloride 15/30/45mg tablets
6. Contents of the pack and other information
1. What Pioglitazone Hydrochloride 15/30/45mg tablets is and what it is used for
Pioglitazone Hydrochloride 15/30/45mg tablet contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood.
Pioglitazone Hydrochloride 15/30/45mg tablets helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. Your doctor will check whether Pioglitazone Hydrochloride 15/30/45mg tablet is working 3 to 6 months after you start taking it.
Pioglitazone Hydrochloride 15/30/45mg tablets may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulfonylurea or insulin) which have failed to provide sufficient control in blood sugar.
2. What you need to know before you take Pioglitazone Hydrochloride 15/30/45mg tablets Do not take Pioglitazone Hydrochloride 15/30/45mg tablets:
• if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
• if you have heart failure 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 ever had bladder cancer.
• if you have blood in your urine that your doctor has not checked.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pioglitazone Hydrochloride 15/30/45mg tablets
• if you retain water (fluid retention) or have heart failure problems in particular, if you are over 75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.
• if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
• if you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Hydrochloride 15/30/45mg
tablets. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
• if you have a problem with your liver or heart. Before you start taking Pioglitazone Hydrochloride
15/30/45mg tablets you will have a blood sample taken to check your liver function. This check may be repeated at intervals. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Hydrochloride 15/30/45mg tablets and insulin experienced the development of heart failure. Inform 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 localised swelling (oedema).
If you take Pioglitazone Hydrochloride 15/30/45mg tablets with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
You may also experience a reduction in blood count (anaemia).
Broken bones
A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your doctor will take this into account when treating your diabetes.
Children and adolescents
Use in children under 18 years is not recommended.
Other medicines and Pioglitazone Hydrochloride 15/30/45mg tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You can usually continue to take other medicines whilst you are being treated with Pioglitazone Hydrochloride 15/30/45mg tablets
However, certain medicines are especially likely to affect the amount of sugar in your blood:
-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. Your blood sugar will be checked, and your dose of Pioglitazone Hydrochloride 15/30/45mg tablets may need to be changed.
Pioglitazone Hydrochloride 15/30/45mg tablets with food and drink
You may take your tablets with or without food. You should swallow the tablets with a glass of water.
Pregnancy, breast-feeding 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.
Driving and using machines
Pioglitazone will not affect your ability to drive or use machines but take care if you experience abnormal vision. Pioglitazone Hydrochloride 15/30/45mg tablets contains Lactose monohydrate:
This medicinal product contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Hydrochloride 15/30/45mg tablets.
3. How to take Pioglitazone Hydrochloride 15/30/45mg tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of 15/30/45 mg of pioglitazone should be taken once daily. If necessary your doctor may tell you to take a different dose.
If you have the impression that the effect of Pioglitazone Hydrochloride 15/30/45mg tablets is too weak, talk to your doctor.
When Pioglitazone Hydrochloride 15/30/45mg tablets are taken in combination with other medicines used 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 have blood tests periodically during treatment with Pioglitazone Hydrochloride 15/30/45mg tablets. This is to check that your liver is working normally.
If you are following a diabetic diet, you should continue with this while you are taking Pioglitazone Hydrochloride 15/30/45mg tablets.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
If you take more Pioglitazone Hydrochloride 15/30/45mg tablets 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 could fall below the normal level and can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
If you forget to take Pioglitazone Hydrochloride 15/30/45mg tablets
Take Pioglitazone Hydrochloride 15/30/45mg tablets daily as prescribed. However if you miss a dose, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Pioglitazone Hydrochloride 15/30/45mg tablets
Pioglitazone Hydrochloride 15/30/45mg tablets should be used every day to work properly. If you stop using Pioglitazone Hydrochloride 15/30/45mg tablets, your blood sugar may go up. Talk to 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 everybody gets them.
In particular, patients have experienced the following serious side effects:
Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking Pioglitazone Hydrochloride 15/30/45mg tablets in combination with insulin. Symptoms are unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Hydrochloride 15/30/45mg tablets. Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. If you experience any of these, talk to your doctor as soon as possible.
Localised swelling (oedema) has also been experienced very commonly in patients taking Pioglitazone Hydrochloride 15/30/45mg tablets in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.
Broken bones have been reported commonly (may affect up to 1 in 10 people) in women patients taking Pioglitazone Hydrochloride 15/30/45mg tablets. If you experience this side effect, talk to your doctor as soon as possible.
Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking Pioglitazone Hydrochloride 15/30/45mg tablets. If you experience this symptom for the first time, talk to your doctor as soon as possible. Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Hydrochloride. If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor as soon as possible.
The other side effects have been experienced by some patients taking Pioglitazone Hydrochloride 15/30/45mg tablets
common (may affect up to 1 in 10 people)
- respiratory infection
- abnormal vision
- weight gain
- numbness
uncommon (may affect up to 1 in 100 people)
-inflammation of the sinuses (sinusitis)
-difficulty sleeping (insomnia)
not known (frequency cannot be estimated from the available data)
- increase in liver enzymes
- allergic reactions
The other side effects have been experienced by some patients when Pioglitazone Hydrochloride 15/30/45mg tablets is taken with other antidiabetic medicines are:
very common (may affect more than 1 in 10 people)
- decreased blood sugar (hypoglycaemia)
common (may affect up to 1 in 10 people)
- headache
- dizziness
- joint pain
- impotence
- back pain
- shortness of breath.
- small reduction in red blood cell count
- flatulence
uncommon (may affect up to 1 in 100 people)
- sugar in urine, proteins in urine
- increase in enzymes
- spinning sensation (vertigo)
- sweating
- tiredness
- increased appetite
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pioglitazone Hydrochloride 15/30/45mg tablets
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 and the carton after ‘EXP’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Pioglitazone Hydrochloride 15/30/45mg tablets contains
The active substance is pioglitazone.
Each tablet contains 15/30/45 mg of pioglitazone (as hydrochloride).
The other ingredients are:
Lactose monohydrate, Carmellose calcium, Hydroxypropyl cellulose (E 463), Magnesium stearate (E 572).
What Pioglitazone Hydrochloride 15/30/45mg tablets looks like and contents of the pack
15 mg: White to off white, round, biconvex, uncoated tablets debossed with ‘P’ on one side and ‘15’ on other side.
30 mg: White to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘30’ on the other side.
45 mg: White to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side.
Pioglitazone Hydrochloride 15/30/45mg tablets is available in Aluminium/ Aluminium blister packs containing 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Intas Pharmaceuticals Limited,
Sage house, 319, Pinner Road,
North Harrow, Middlesex HA1 4HF,
UK
Manufacturer
Accord Healthcare Limited,
Sage house, 319, Pinner Road,
North Harrow, Middlesex HA1 4HF,
UK
BIOTON S.A.
02-516 Warszawa, ul. Staroscinska 5 Poland