Actos 15 mg tablets

Actos contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus. 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.

Actos may be used on its own or in combination with metformin and / or a sulphonylurea which are also oral anti-diabetic medicines.

Actos may also be used in combination with insulin.

Do not take Actos

• if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Actos.
• 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).

Take special care with Actos
Tell your doctor before you start to take this medicine

• if you retain water (fluid retention) or have heart failures problems in particular if you are over 75 years old.
• 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 women (but not in men) taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children

Use in children 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.

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.

Taking 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 breastfeeding

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

Important information about some of the ingredients of Actos

This medicine contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Actos.

One tablet of 15 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 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 diabetic diet, 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.

Like all medicines, Actos can cause side effects, although not everybody gets them.

The following side effects have been experienced by some patients taking Actos

common (affects 1 to 10 users in 100)

• weight gain
• respiratory infection
• numbness
• abnormal vision
• bone fracture

uncommon (affects 1 to 10 users in 1,000)

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

not known (frequency cannot be estimated from the available data)

• blurred vision due to swelling (or fluid) in the back of the eye. If you experience these symptoms for the first time or if they get worse tell your doctor as soon as possible.
• increase in liver enzymes

The following additional side effects have been experienced by some patients when Actos is taken with other antidiabetic medicines

very common (affects more than 1 user in 10)

• decreased blood sugar (hypoglycaemia)
• localised swelling (oedema)

common (affects 1 to 10 users in 100)

• headache
• dizziness
• flatulence
• joint pain
• impotence
• blood in urine
• small reduction in red blood cell count
• back pain
• shortness of breath
• heart failure (when taken with insulin)

uncommon (affects 1 to 10 users in 1,000)

• spinning sensation (vertigo)
• sweating
• tiredness
• sugar in urine, proteins in urine
• increased appetite
• increase in enzymes

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Actos after the expiry date which is stated on the carton and the blister pack after the word ?EXP?. The expiry date refers to the last day of that month.

This medicine does not require any special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Actos contains

- The active substance is pioglitazone. Each tablet contains 15 mg of pioglitazone (as hydrochloride).
- The other ingredients are lactose monohydrate, hyprolose, carmellose calcium and magnesium stearate.

What Actos looks like and contents of the pack

Actos tablets are white to off white, round, convex tablets marked ?15? 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 Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London, WC2B 4AE, United Kingdom.

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:

BelgiëBelgiqueBelgien Takeda Pharmaceuticals Benelux SPRL BelgiëBelgiqueBelgien TélTel 44 020 3116 8953 LuxembourgLuxemburg Takeda Pharmaceuticals Benelux SPRL BelgiqueBelgien TélTel 44 020 3116 8954

Magyarország Lilly Hungária Kft. Tel 36 1 328 5100 Takeda Global R D Centre Europe, Te. 44 020 3116 8000

eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Malta Takeda Italia Farmaceutici SpA Tel 39 06 5026 01

Nederland Eli Lilly Nederland B.V. Tel 31 0 30 60 25 800 Danmark Takeda Pharmaceuticals Nordics AB Sverige Tlf 44 020 3116 8952

Deutschland Takeda Pharma GmbH Tel. 49 0 241 941-0 Norge Takeda Pharmaceuticals Nordics AB Sverige Tlf 44 020 3116 8950

Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 3726441100 Österreich Takeda Pharma Ges.m.b.H. Tel 43 1 524 40 64

- .... 30 210 629 4600 Polska Takeda Global R D Centre Europe, Wielka Brytania Tel 44 020 3116 8000

España Lilly S.A. Tel 34 91 663 50 00 Portugal Lilly Portugal - Produtos Farmacêuticos, Lda Tel 351 21 412 6600

France Laboratoires Takeda Tél 33 01 46 25 16 16 România Eli Lilly România S.R.L. Tel 40 21 4023000

Ireland Takeda UK Ltd Tel 44 01628 537 900 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10

Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111

Italia Takeda Italia Farmaceutici SpA Tel 39 06 5026 01 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358 09 8545250

Takeda Global R D Centre Europe, 44 020 3116 8000 Sverige Takeda Pharmaceuticals Nordics AB Sverige Tel 44 020 3116 8951

United Kingdom Takeda UK Ltd Tel 44 01628 537 900 Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 7364000

Lietuva
Eli Lilly Holdings Limited atstovyb-
Tel. +370 (5) 2649600

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