Tandemact 45 mg/4 mg tablets

Tandemact is used for the treatment of type 2 (non-insulin dependent) diabetes mellitus. This is the diabetes that usually develops in adulthood.

Tandemact helps control the level of sugar in your blood when you have type 2 diabetes by increasing the amount of insulin available and helping your body make better use of it.

Do not take Tandemact:

• If you are allergic (hypersensitive) to pioglitazone, glimepiride, other sulphonylureas or sulphonamides, or any of the other ingredients of Tandemact.
• If you have heart failure.
• If you have liver disease.
• If you have severe problems with your kidneys.
• If you have insulin dependent diabetes (Type 1).
• If you are pregnant.
• If you are breast-feeding.

Take special care with Tandemact:

Tell your doctor before you start to take this medicine:

• If you are planning to become pregnant.
• If you have polycystic ovary syndrome. There may be an increased possibility of your becoming pregnant because of how your medicine works.
• If you have a problem with your liver or heart.
• If you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
• If you are already taking other medicines for the treatment of diabetes.
• If you are under 18 years of age because use in such patients 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. This is because some medicines can weaken or strengthen the effect of Tandemact on the level of sugar in your blood.

Pregnancy and breast-feeding:

Do not take Tandemact if you are pregnant or breast-feeding. Tell your doctor if you are, you think you might be or are planning to become pregnant, or if you are planning to breast-feed your baby.

Driving and using machines:

Alertness and reaction time may be impaired due to low or high blood sugar due to glimepiride, especially when beginning or after altering treatment or when Tandemact is not taken regularly. This may affect your ability to drive or operate machinery.

Important information about some of the ingredients of Tandemact:

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

Always take Tandemact 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 once daily shortly before or with the first main meal. Tablets should be swallowed whole with some liquid. If necessary your doctor may tell you to take a different dose.

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

If you are following a special diet for diabetes, you should continue with this while you are taking Tandemact.

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

In clinical trials in which pioglitazone was compared to other oral anti diabetic medicines 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.

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).

Your doctor will ask you to have blood tests periodically during treatment with Tandemact.

If you take more Tandemact 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 Tandemact:

Try to take Tandemact daily as prescribed. However if you miss a dose, just carry on with the next dose as normal. Do not take an extra tablet to make up for the one you missed.

If you stop taking Tandemact:

Do not stop taking Tandemact without first discussing it with your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

Some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, including glimepiride:

Common: affects 1 to 10 users in 100

• weight gain
• dizziness
• flatulence
• localised swelling (oedema)
• cold or runny nose
• numbness

Uncommon: affects 1 to 10 users in 1000

• headache
• sinusitis
• vertigo
• abnormal vision
• sweating
• tiredness
• sleeplessness
• decreased blood sugar
• sugar in urine
• proteins in urine
• increased appetite

Rare: affects 1 to 10 users in 10,000

• noticeable changes in the blood
• risk of bone fracture
• risk of heart failure

Very rare: affects less than 1 user in 10,000

• liver disease
• allergic reactions including allergic shock
• nausea, vomiting and diarrhoea
• abdominal pain
• abdominal pressure
• feeling of fullness in the stomach
• decrease in the number of blood cells known as platelets
• sensitivity to light
• decrease in sodium concentrations in the blood

Blurred vision due to swelling (or fluid) in 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. It is important to know what symptoms to expect when hypoglycaemia (low blood sugar) occurs. Ask your doctor or pharmacist for more information if you are not sure how to recognise this. The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea. Tell your doctor if you notice such symptoms.

Lowering of the Hb level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme Glucose-6-phosphodehydrogenase.

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 Tandemact 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 waste water or household waste. Ask you pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Tandemact contains:

The active substances are pioglitazone and glimepiride. Each tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg glimepiride. The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate and polysorbate 80.

What Tandemact looks like and contents of the pack:

The tablets are white to off-white, round, flat and embossed ?4833 G? on one face and ?45/4? on the other. The tablets are supplied in blister packs containing either 14, 28, 30, 50, 90, or 98 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 S.p.A., Via Crosa, 86, 28065 Cerano (NO), Italy.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Takeda Global R D Centre Europe Royaume-Uni TélTel 44 020 3116 8953 LuxembourgLuxemburg Takeda Global R D Centre Europe Royaume-Uni TélTel 44 020 3116 8954

Magyarország

Takeda Global R D Centre Europe Te. 44 020 3116 8000 Takeda Global R D Centre Europe Tel. 44 020 3116 8000

eská republika Takeda Global R D Centre Europe Tel 44 020 3116 8000 Malta Takeda Italia Farmaceutici SpA Tel 39 06 5026 01

Nederland Takeda Global R D Centre Europe Tel 44 020 3116 8000 Danmark Takeda Global R D Centre Europe Storbritannien Tlf 44 020 3116 8952

Deutschland Takeda Pharma GmbH Tel 49 0 241 941-0 Norge Takeda Global R D Centre Europe Storbritannia Tlf 44 020 3116 8950

Eesti Takeda Global R D Centre Europe Tel 44 020 3116 8000 Österreich Takeda Pharma Ges.m.b.H. Tel 43 1 524 40 64

Takeda Global R D Centre Europe 44 020 3116 8000 Polska Takeda Global R D Centre Europe Tel. 44 020 3116 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 R D Centre Europe Tel 44 020 3116 8000

Ireland Takeda UK Ltd Tel 44 01628 537 900 Slovenija Takeda Global R D Centre Europe Tel 44 020 3116 8000

Ísland Takeda Global R D Centre Europe Sími 44 020 3116 8000 Slovenská republika Takeda Global R D Centre Europe Tel 44 020 3116 8000

Italia Takeda Italia Farmaceutici SpA Tel 39 06 5026 01 SuomiFinland Takeda Global R D Centre Europe PuhTel 44 020 3116 8000

Takeda Global R D Centre Europe 44 020 3116 8000 Sverige Takeda Global R D Centre Europe Storbritannien Tel 44 020 3116 8951

Latvija Takeda Global R D Centre Europe Tel 44 020 3116 8000 United Kingdom Takeda UK Ltd Tel 44 01628 537 900

Lietuva
Takeda Global R & D Centre (Europe)

Tel. +44 (0)20 3116 8000

This leaflet was last approved in {date}