АКТОС 15 мг Coated tablet

Содержание инструкции

1. Actos 15 mg tablets, 30 mg tablets, 45 mg tablets
   1. What is Actos and what is it used for
   2. What you need to know before taking Actos
   3. How to take Actos
   4. Possible side effects
   5. How to store Actos
   6. Package Contents and Other Information

Actos 15 mg tablets, 30 mg tablets, 45 mg tablets

pioglitazone

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Actos is and what it is used for
• 2. What you need to know before you take Actos
• 3. How to take Actos
• 4. Possible side effects
• 5. How to store Actos
• 6. Contents of the pack and other information

1. What is Actos and what is it used for

Actos contains pioglitazone. It is an antidiabetic medicine used for the treatment of type 2 diabetes mellitus (non-insulin dependent) in adults, when metformin is not suitable or has not worked adequately. This type of diabetes usually occurs in adults.
Actos helps to control blood sugar levels in patients suffering from type 2 diabetes by helping the body to make better use of the insulin produced. The doctor will check if Actos is working 3-6 months after the start of treatment.
Actos can be used alone in patients who are unable to take metformin, and where diet and exercise have failed to control blood sugar, or it can be added to other therapies (such as metformin, a sulfonylurea or insulin), which have not provided sufficient blood sugar control.

2. What you need to know before taking Actos

Do not take Actos

• if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from heart failure or have suffered from heart failure in the past.
• if you suffer from liver disorders.
• if you have suffered from diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting).
• if you have or have ever had bladder cancer (bladder tumor).
• if you have blood in your urine for which your doctor has not yet carried out investigations.

Warnings and precautions
Talk to your doctor or pharmacist before taking Actos (see also section 4)

• if you retain water (fluid retention) or have problems with heart failure, especially if you are over 75 years old. You should also inform your doctor if you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling,
• if you have a particular type of diabetic eye disease, called macular edema (swelling of the back of the eye).
• if you have cysts on the ovaries (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, because ovulation may resume when you take Actos. If this is the case, use adequate contraception to avoid the risk of an unwanted pregnancy.
• if you have problems with your liver or heart. Before starting to take Actos, you will have a blood test to check your liver function. This test may be repeated periodically. Some patients with type 2 diabetes mellitus of long duration and heart disease or previous stroke who have been treated with Actos and insulin have developed 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 (edema).

If you take Actos with other medicines for diabetes, it is more likely that your blood sugar level may fall below normal (hypoglycemia).
You may also experience a reduction in the number of blood cells (anemia).

Bone fractures
A higher number of bone fractures has been found in patients, especially women who
take pioglitazone. Your doctor will take this into account when treating your diabetes.

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

Other medicines and Actos
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
As a rule, you can continue to take other medicines while being treated with Actos.
However, some medicines in particular are likely to affect the amount of sugar in
your blood:

• gemfibrozil (used to reduce cholesterol levels)
• rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these medicines. Your blood sugar level will be checked and the dose of Actos may need to be adjusted.

Actos with food and drink
You can take the tablets with or without food. You should take the tablets with a glass of water.

Pregnancy and breastfeeding
Tell your doctor if

• you are pregnant, suspect you may be pregnant or are planning to become pregnant.
• you are breastfeeding or are planning to breastfeed with breast milk. Your doctor will advise you to stop treatment with this medicine.

Driving and using machines
This medicine has no effects on the ability to drive or operate machinery, but be careful
if you experience vision problems.

Actos contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
Actos.

3. How to take Actos

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The usual starting dose is one 15 mg or 30 mg pioglitazone tablet to be taken once
a day. Your doctor may increase your dose to a maximum of 45 mg to be taken once a
day. Your doctor will tell you which dose to take.
If you feel that the effect of Actos is too weak, talk to your doctor.
When Actos tablets are taken in combination with other medicines used for the treatment
of diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you if
it is necessary to take a lower dose of the other medicines.
Your doctor will ask you to undergo periodic blood tests during treatment with Actos.
This is to check the normal functioning of the liver.
If you are following a special diet for diabetes, you should continue it while taking Actos.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

If you take more Actos than you should
If you accidentally take too many tablets, or if another person or a child takes your
tablets, contact your doctor or pharmacist immediately. Your blood sugar level
may decrease below normal levels and can be increased by taking
sugar. It is advisable to carry sugar cubes, candies, biscuits or sugary fruit juices
with you.

If you forget to take Actos
Try to take Actos every day as prescribed. However, if you forget to take a dose,
continue normally with the next dose. Do not take a double dose to make up for the
missed tablet.

If you stop taking Actos
Actos must be used every day to work properly. If you stop using Actos, it is
possible that your blood sugar level will increase. Talk to your doctor before stopping the
treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In particular, the following serious side effects have occurred in some patients:
Common cases (may affect up to 1 in 10 people) of heart failure have occurred in patients who were taking Actos in combination with insulin. Symptoms are unusual shortness of breath or rapid weight gain or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years old, seek medical advice immediately.
Uncommon cases of bladder cancer (bladder tumor) (may affect up to 1 in 100 people) have occurred in patients treated with Actos. Signs and symptoms include blood in the urine, pain during urination, or a sudden need to urinate. If you experience any of these symptoms, talk to your doctor as soon as possible.
Very common cases of localized swelling (edema) (may affect more than 1 in 10 people) have occurred in patients who were taking Actos in combination with insulin. If you experience this side effect, inform your doctor as soon as possible.
Common cases of bone fractures have been reported in female patients and also in male patients taking Actos (available data do not allow an estimate of the frequency). If you experience this side effect, inform your doctor as soon as possible.
Blurred vision due to swelling (edema) of the back of the eye has also been reported in patients taking Actos (frequency cannot be defined based on available data).
Inform your doctor as soon as possible if you notice the onset of these symptoms for the first time. Also inform your doctor as soon as possible if you already have blurred vision and the symptom worsens.
Allergic reactions with unknown frequency (frequency cannot be defined based on available data) have been reported in patients taking Actos. If you have a severe allergic reaction, including hives and swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing, stop taking this medicine and talk to your doctor as soon as possible.
Other side effects that have occurred in some patients taking Actos are:
common (may affect up to 1 in 10 people)

• respiratory infections
• abnormal vision
• weight gain
• numbness

uncommon (may affect up to 1 in 100 people)

• inflammation of the sinuses (sinusitis)
• difficulty sleeping (insomnia)

unknown frequency (frequency cannot be defined based on available data)

• increased liver enzymes
• allergic reactions

Other side effects that have occurred in some patients when taking Actos together with other antidiabetic medicines are:
very common (may affect more than 1 in 10 people)

• low blood sugar (hypoglycemia)

common (may affect up to 1 in 10 people)

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• a slight decrease in the number of red blood cells in the blood
• flatulence

uncommon (may affect up to 1 in 100 people)

• sugar in the urine, protein in the urine
• increased enzymes
• feeling of spinning (vertigo)
• sweating
• fatigue
• increased appetite

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Actos

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 cardboard packaging after
“Exp.” and on the blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage precautions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Actos contains

• The active ingredient of Actos is pioglitazone. Each Actos 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride). Each Actos 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride). Each Actos 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
• The other ingredients are lactose monohydrate, hypromellose, calcium carmellose and magnesium stearate. See section 2 “Actos contains lactose monohydrate”.

Description of the appearance of Actos and package contents

• Actos 15 mg tablets are white to off-white, round, convex, with ‘15’ imprinted on one side and 'ACTOS' on the other.
• Actos 30 mg tablets are white to off-white, round, flat, with ‘30’ imprinted on one side and 'ACTOS' on the other.
• Actos 45 mg tablets are white to off-white, round, flat, with ‘45’ imprinted on one side and 'ACTOS' on the other.

The tablets are provided in blisters, in packs of 28, 56, 98 or 112 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland.
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany.

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .