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Actos (pioglitazone hydrochloride) – Package leaflet - A10BG03

Updated on site: 05-Oct-2017

Package Leaflet: Information for the patient

Actos 15 mg tablets

Actos 30 mg tablets

Actos 45 mg tablets

Pioglitazone

Read all of 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 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 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 Actos is and what it is used for

Actos contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood.

Actos 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 Actos is working 3 to 6 months after you start taking it.

Actos 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, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.

2. What you need to know before you take 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 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 Actos (also see Section 4)

-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 Actos. 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 Actos 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 Actos 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 Actos 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 and adolescents under 18 years 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 medicines obtained without a prescription.

You can usually continue to take other medicines whilst you are being treated with Actos. 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 Actos may need to be changed.

Actos with food and drink

You may take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and breast-feeding

Tell your doctor if

-you are, you think you might be or are planning to become pregnant.

-you are breast-feeding or if you are planning to breast-feed your baby. Your doctor will advise you to discontinue this medicine.

Driving and using machines

This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.

Actos contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Actos.

3.How to take Actos

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 usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily. Your doctor may increase the dose to a maximum of 45 mg once a day. Your doctor will tell you the dose to take.

If you have the impression that the effect of Actos is too weak, talk to your doctor.

When Actos is 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 Actos. This is to check that your liver is working normally.

If you are following a special diet for diabetes, you should continue with this while you are 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 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 Actos

Take Actos 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 Actos

Actos should be used every day to work properly. If you stop using Actos, 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 Actos 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 Actos. 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 (may affect more than 1 in 10 people) in patients taking Actos 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 female patients taking Actos and have also been reported in male patients (frequency cannot be estimated from the available data) taking Actos. 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 cannot be estimated from the available data) has also been reported in patients taking Actos. 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 cannot be estimated from the available data) in patients taking Actos. 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 that have been experienced by some patients taking Actos are:

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 that have been experienced by some patients when Actos 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 carton and the blister pack after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage precautions.

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 Actos contains

The active substance in 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, hyprolose, carmellose calcium and magnesium stearate. See Section 2 “Actos contains lactose monohydrate”.

What Actos looks like and contents of the pack

Actos 15 mg tablets are white to off white, round, convex tablets marked ‘15’ on one face and ‘ACTOS’ on the other face.

Actos 30 mg tablets are white to off white, round, flat tablets marked ‘30’ on one face and ‘ACTOS’ on the other face.

Actos 45 mg tablets are white to off white, round, flat tablets marked ‘45’ on one face and ‘ACTOS’ on the other face.

The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets. Not all the pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Takeda Pharma A/S, Dybendal Alle 10, DK-2630 Taastrup, Denmark.

Manufacturer

Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland. Lilly S.A, Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Takeda Belgium

Eli Lilly Holdings Limited atstovybė

Tél/Tel: +32 2 464 06 11

Tel. +370 (5) 2649600

takeda-belgium@takeda.com

 

България

Luxembourg/Luxemburg

Такеда България

Takeda Belgium

Тел.: + 359 2 958 27 36; + 359 2 958 15 29

Tél/Tel: +32 2 464 06 11

 

takeda-belgium@takeda.com

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: +420 234 664 111

Tel: +36 1 328 5100

Danmark

Malta

Takeda Pharma A/S

Takeda Italia S.p.A.

Tlf: +45 46 77 11 11

Tel: +39 06 502601

Deutschland

Nederland

Takeda GmbH

Eli Lilly Nederland B.V.

Tel: 0800 825 3325

Tel: +31 (0) 30 60 25 800

medinfo@takeda.de

 

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Takeda AS

Tel: +3726817280

Tlf: +47 6676 3030

 

infonorge@takeda.com

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Takeda Pharma Ges.m.b.H

Τηλ: +30 210 629 4600

Tel: +43(0)800 20 80 50

España

Polska

Lilly S.A.

Takeda Polska Sp. z o.o.

Tel: +34 (91) 663 50 00

Tel.: +48 22 608 13 00

France

Portugal

Takeda France S.A.S

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33 1 46 25 16 16

Tel: +351 21 412 6600

Hrvatska

România

Takeda Pharmaceuticals Croatia d.o.o

Eli Lilly România S.R.L.

Tel: +385 1 377 88 96

Tel: +40 21 4023000

Ireland

Slovenija

Takeda Products Ireland Limited

Takeda GmbH, Podružnica Slovenija

Tel: +353 (0) 1 6420021

Tel.+ 386 (0) 59 082 480

Ísland

Slovenská republika

Vistor hf.

Eli Lilly Slovakia, s.r.o.

Sími: +354 535 7000

Tel: + 421 220 663 111

vistor@vistor.is

 

Italia

Suomi/Finland

Takeda Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: +39 06 502601

Puh/Tel: +358 (0)9 8545250

Κύπρος

Sverige

Takeda Pharma A/S

Takeda Pharma AB

Τηλ: +45 46 77 11 11

Tel: +46 8 731 28 00

 

infosweden@takeda.com

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Takeda UK Ltd

Tel: +371 6 7 364 000

Tel: +44 (0)1628 537 900

This leaflet was last approved in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of CHMP are as follows:

The product information (Sections 4.4 and 4.8 of the SmPC) provides already information on clinical trial results in which showed an increased fracture risk in women only. However epidemiological data from the post-marketing experience shows an increased risk of fractures in both men and women and caution is advised in patients with long term treatment. Therefore it is recommended that the product information for pioglitazone-containing products is updated to accurately reflect the post-marketing experience in the relevant sections of the SmPC and the package leaflet.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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