Glubrava 15 mg/850 mg film-coated tablets

Glubrava tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus. This is the diabetes that usually develops in adulthood.

Glubrava tablets help 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.

Do not take Glubrava:

• If you are allergic (hypersensitive) to pioglitazone, metformin or any of the other ingredients of Glubrava tablets.
• If you have heart failure.
• If you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
• If you have liver disease.
• If you drink alcohol excessively (either every day or only from time to time).
• If you have diabetic ketoacidosis (complication of diabetes with rapid weight loss, nausea or vomiting).
• If you have a problem with your kidneys.
• If you have a severe infection or are dehydrated.
• If you are going to have a certain type of X-ray with an injectable dye. You will need to stop taking Glubrava tablets at the time of and for a few days after the procedure.
• If you are breast-feeding.

Take special care with Glubrava

Tell your doctor before you start to take this medicine:

• If you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
• If you are planning to become pregnant.
• If you are going to have an operation under general anaesthetic, as you may need to stop taking Glubrava for a couple of days before and after the procedure.
• If you have polycystic ovary syndrome. There may be an increased possibility of your becoming pregnant because of how your medicine works.
• If you are under 18 years of age because use in such patients is not recommended.
• If you already take any other tablets to treat diabetes.

Taking other medicines:

Please let your doctor know if you already take cimetidine, glucocorticoids, beta-2-agonists, diuretics or ACE inhibitors. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding:

Tell your doctor if you are, you think you might be or are planning to become pregnant. Your doctor will advise you to discontinue this medicine. You should not use Glubrava if you are breast-feeding or are planning to breast-feed your baby.

Driving and using machines:

This medicine will not affect your ability to drive or operate machinery.

Always take Glubrava tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet taken twice daily. If necessary your doctor may tell you to take a different dose.

You should take the tablets with or just after food to reduce the chance of an upset stomach.

If you are following a diabetic diet, you should continue with this while you are taking Glubrava tablets.

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

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).

In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), 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.

Your doctor will ask you to have blood tests periodically during treatment with Glubrava. This is to check that your liver is working normally. At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working normally.

If you take more Glubrava 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.

If you forget to take Glubrava:

Try to take Glubrava 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 Glubrava:

Do not stop taking Glubrava tablets without first discussing it with your doctor.

If you have any further questions on the use of Glubrava tablets ask your doctor or pharmacist.

Like all medicines, Glubrava can have side effects.

Some patients experience the following side effects whilst taking pioglitazone and/or metformin (the two active substances of Glubrava).

Very rarely patients taking metformin have experienced a condition called lactic acidosis (excess of lactic acid in your blood), particularly those whose kidneys are not working properly. Symptoms include feeling cold and uncomfortable, severe nausea and vomiting, abdominal pain, unexplained weight loss, or rapid breathing. If you experience some of these symptoms stop taking Glubrava and consult a doctor immediately.

Blurred vision due to swelling (or fluid) at the back of the eye has been reported. If you experience these symptoms for the first time or if they get worse talk to your doctor as soon as possible.

Between 1 in 10 and 1 in 100 patients experience

• localised swelling (oedema)
• weight gain
• headache
• respiratory infection
• abnormal vision
• joint pain
• impotence
• blood in urine
• anaemia

Between 1 in 100 and 1 in 1000 patients experience

• sinusitis
• flatulence
• insomnia

Between 1 in 1000 and 1 in 10000 patients experience

• impaired liver function

Less than 1 in 10,000 patients experience

• a condition called lactic acidosis (excess of lactic acid in your blood) due to metformin, particularly those whose kidneys are not working properly
• blurred vision due to swelling (or fluid) in the back of the eye.

Keep out of the reach and sight of children.

Do not use Glubrava after the expiry date which is stated on the carton and blister.

This medicinal product does not require any special storage conditions.

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 Glubrava Tablets contain

The active substances are 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.

The other ingredients are, microcrystalline cellulose, povidone (K 30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide.

What Glubrava Tablets look like and contents of the pack

Glubrava tablets are white to off white, oblong, convex, film-coated tablets embossed ?15 / 850? on one face and ?4833M? on the other. The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.

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. Takeda Italia Farmaceutici SpA, Via Crosa, 86, I-28065 Cerano (NO), Italy.

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

BelgiëBelgiqueBelgien Takeda Global Research and Development Centre Europe Ltd, Royaume-Uni TélTel 44 0203 116 8000 LuxembourgLuxemburg Takeda Global Research and Development Centre Europe Ltd., Royaume-Uni TélTel 44 0203 116 8000

Takeda Global Research and Development Centre Europe Ltd., Te. 44 0203 116 8000 Magyarország Takeda Global Research and Development Centre Europe Ltd., Nagy-Britannia Tel. 44 0203 116 8000

eská republika Takeda Global Research and Development Centre Europe Ltd., Velká Británie Tel 44 0203 116 8000 Malta Takeda Global Research and Development Centre Europe Ltd., Ir-Renju Unit Tel 44 0203 116 8000

Danmark Takeda Global Research and Development Nederland Takeda Global Research and Development

Centre Europe Ltd., Storbritannien Tlf 44 0203 116 8000 Centre Europe Ltd., Verenigd Koninkrijk Tel 44 0203 116 8000

Deutschland Takeda Pharma GmbH Tel 49 0 241 941-0 Norge Takeda Global Research and Development Centre Europe Ltd., Storbritannia Tlf 44 0203 116 8000

Eesti Takeda Global Research and Development Centre Europe Ltd., Ühendkuningriik Tel 44 0203 116 8000 Österreich Takeda Global Research and Development Centre Europe Ltd., Vereinigtes Königreich Tel 44 0203 116 8000

Takeda Global Research and Development Centre Europe Ltd., 44 0203 116 8000 Polska Takeda Global Research and Development Centre Europe Ltd., Wielka Brytania Tel. 44 0203 116 8000

España Takeda Farmacéutica España, S.A. Tel 34 931845730 Portugal Takeda - Farmacêuticos Portugal, Unipessoal LDA Tel 351 21 464 3222

France Laboratoires Takeda Tél 33 01 46 25 16 16 România Takeda Global Research and Development Centre Europe Ltd., Marea Britanie Tel 44 0203 116 8000

Ireland Takeda Global Research and Development Centre Europe Ltd., United Kingdom Tel 44 0203 116 8000 Slovenija Takeda Global Research and Development Centre Europe Ltd., Velika Britanija Tel 44 0203 116 8000

Ísland Takeda Global Research and Development Centre Europe Ltd., Bretland Sími 44 0203 116 8000 Slovenská republika Takeda Global Research and Development Centre Europe Ltd., Veká Británia Tel 44 0203 116 8000

Italia Takeda Italia Farmaceutici SpA Tel 39 06 5026 01 SuomiFinland Takeda Global Research and Development Centre Europe Ltd., Iso-Britannia PuhTel 44 0203 116 8000

Takeda Global Research and Development Centre Europe Ltd., 44 0203 116 8000 Sverige Takeda Global Research and Development Centre Europe Ltd., Storbritannien Tel 44 0203 116 8000

Latvija Takeda Global Research and Development Centre Europe Ltd., Lielbritnija Tel 44 0203 116 8000 United Kingdom Takeda Global Research and Development Centre Europe Ltd. Tel 44 0203 116 8000

Lietuva
Takeda Global Research and Development
Centre (Europe) Ltd., Jungtin- Karalyst-
Tel. + 44 (0)203 116 8000

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