Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - pioglitazone

Document Subject

Generated Narrative: MedicinalProductDefinition mp7829b4b361ffed64965739b1e7cc1436

identifier: http://ema.europa.eu/identifier/EU/1/12/755/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Pioglitazone Actavis 15 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7829b4b361ffed64965739b1e7cc1436

identifier: http://ema.europa.eu/identifier/EU/1/12/755/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - pioglitazone

Attesters

What is in this leaflet:

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

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

Pioglitazone Actavis 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.

Do not take Pioglitazone Actavis

• if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Pioglitazone Actavis (see section 6 for a list of ingredients).
• 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 before you start to take this medicine:

• if you retain water (fluid retention) or have heart failure problems and 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 Actavis. 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 Actavis 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 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 Actavis 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 Actavis 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 Actavis. 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 Actavis may need to be changed.

Pioglitazone Actavis 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 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 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.

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

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 Pioglitazone Actavis is too weak, talk to your doctor.

Pioglitazone Actavis can be taken with or without food.

When Pioglitazone Actavis 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 Pioglitazone Actavis. 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 Actavis.

Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

If you take more Pioglitazone Actavis 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 Actavis Take Pioglitazone Actavis 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. For the 14, 28, 56, 84 and 98 tablets pack sizes, you can check the day on which you last took a tablet of Pioglitazone Actavis by referring to the calendar printed on the blister.

If you stop taking Pioglitazone Actavis
Pioglitazone Actavis should be used every day to work properly. If you stop using Pioglitazone Actavis, 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, 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 (up to 1 in 10 people) in patients taking pioglitazone 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 (up to 1 in 100 people) in patients taking pioglitazone. 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 in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.

Broken bones have been reported commonly (up to 1 in 10 people) in female patients taking pioglitazone and have also been reported in male patients (frequency cannot be estimated from the available data) taking pioglitazone. 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. 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 Actavis. 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 pioglitazone:

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 pioglitazone 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 (wind)

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.

Keep out of the sight and reach of children.

Do not use Pioglitazone Actavis 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.

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 to protect the environment.

What Pioglitazone Actavis contains

• The active substance is pioglitazone.

Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as hydrochloride).

Each tablet contains 15 mg of pioglitazone (as hydrochloride).

Each tablet contains 30 mg of pioglitazone (as hydrochloride).

Each tablet contains 45 mg of pioglitazone (as hydrochloride).

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

What Pioglitazone Actavis looks like and contents of the pack Pioglitazone Actavis 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with TZ15 on one side. Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with TZ30 on one side. Pioglitazone Actavis 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with TZ45 on one side.

The tablets are supplied in aluminium blister packs of 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.
The packs with 14, 28, 56, 84 and 98 tablets contain blisters with abbreviations for days of the week printed on the blister (Mon, Tue, Wed, Thu, Fri, Sat, Sun).

Not all the pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Actavis Group PTC ehf.
Dalshraun 1 220 Hafnarfj r ur Iceland

Manufacturer Actavis Ltd. BLB 015-016 Bulebel Industrial Estate Zejtun ZTN 3Malta

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

Belgi /Belgique/Belgien Actavis Group PTC ehf. IJsland/Islande/Island T l/Tel: +354 5503Lietuva UAB Teva Baltics Tel: +370 52660

: +359 24899Luxembourg/Luxemburg Actavis Group PTC ehf. Islande/Island T l/Tel: +354 5503 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland Actavis Group PTC ehf. Island Tel: +354 5503Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar A.B.E.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Actavis Group PTC ehf. Islandia Tel: +354 5503Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Actavis Group PTC ehf. Islande T l: +354 5503Portugal Actavis Group PTC ehf. Isl ndia Tel: +354 5503Hrvatska Pliva Hrvatska d.o.o.
Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Actavis Group PTC ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Actavis Group PTC ehf. Islanda Tel: +354 5503Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar A.B.E.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: