Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tandemact

Document Subject

Generated Narrative: MedicinalProductDefinition mpbef5164082ea0e74f1594414cc1788ab

identifier: http://ema.europa.eu/identifier/EU/1/06/366/006

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Tandemact 30 mg/2 mg tablets

type: Full name

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part: nan

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-bef5164082ea0e74f1594414cc1788ab

identifier: http://ema.europa.eu/identifier/EU/1/06/366/006

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tandemact

Attesters

What is in this leaflet

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

Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level.

It is used in adults when metformin is not suitable to treat type 2 (non-insulin dependent) diabetes mellitus. This type 2 diabetes usually develops in adulthood where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces.

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. Your doctor will check whether Tandemact is working 3 to 6 months after you start taking it.

Do not take Tandemact

• if you are allergic to pioglitazone, glimepiride, other sulphonylureas or sulphonamides, 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 diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or vomiting)
• if you have severe problems with your kidneys
• if you have or have ever had bladder cancer
• if you have blood in your urine that your doctor has not checked
• if you have insulin dependent diabetes (type 1)
• if you are in a diabetic coma
• if you are pregnant
• if you are breast-feeding

Warnings and precautions Talk to your doctor or pharmacist before taking Tandemact (see also section 4)

• if you have a problem with your heart. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together 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 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), talk to your doctor if you notice any change to your vision.
• if you have a problem with your liver. Before you start taking Tandemact you will have a blood sample taken to check your liver function. This check should be repeated at intervals. Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
• 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 Tandemact. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
• if you are already taking other medicines for the treatment of diabetes.
• if you have problems with your enzyme called Glucose-6-phosphodehydrogenase since it can decrease your red cells.

You may also experience a reduction in blood count (anaemia). Your doctor may take blood tests to monitor your blood cell levels and liver function.

Hypoglycaemia When you take Tandemact, your blood sugar could fall below the normal level (hypoglycaemia). If you experience symptoms of hypoglycaemia such as cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea, you should take some sugar to increase your blood sugar level again. Ask your doctor or pharmacist for more information if you are not sure how to recognise this. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.

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 Tandemact Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some medicines can weaken or strengthen the effect of Tandemact on the level of sugar in your blood.

The following medicines can increase the blood sugar lowering effect of Tandemact. This can lead to a risk of hypoglycaemia (low blood sugar):

• gemfibrozil and fibrates (to lower high cholesterol level)
• insulin, metformin or other medicines to treat diabetes mellitus
• phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like medicines (to treat pain and inflammation)
• long acting sulphonamides, tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin (to treat bacterial or fungal infections)
• anabolic steroids (supporting muscle build up) or male sex hormone replacement therapy
• fluoxetine, MAO-inhibitors (to treat depression)
• angiotensin-converting enzyme (ACE) inhibitors, sympatholytics, disopyramide, pentoxifylline, coumarin derivatives such as warfarin (to treat heart or blood problems)
• allopurinol, probenecid, sulfinpyrazone (to treat gout)
• cyclophosphamide, ifosfamide, trofosfamide (to treat cancer)
• fenfluramine (to reduce weight)
• tritoqualine (to treat allergies)

The following medicines may decrease the blood sugar lowering effect of Tandemact. This can lead to a risk of hyperglycaemia (high blood sugar level):

• oestrogens, progestogens (female sex hormones)
• thiazide diuretics and saluretics also called water tablets (to treat high blood pressure)
• levothyroxine (to stimulate the thyroid gland)
• glucocorticoids (to treat allergies and inflammation)
• chlorpromazine and other phenothiazine derivatives (to treat severe mental disorders)
• adrenaline and sympathicomimetics (to increase heart beat, to treat asthma or nasal congestion, coughs and colds or used in life-threatening emergencies)
• nicotinic acid (to treat high cholesterol level)
• long-term use of laxatives (to treat constipation)
• phenytoin (to treat fits)
• barbiturates (to treat nervousness and sleep problems)
• azetazolamide (to treat increased pressure in the eye also called glaucoma)
• diazoxide (to treat high blood pressure or low blood sugar)
• rifampicin (to treat infections, tuberculosis)
• glucagon (to treat severe low blood sugar levels)

The following medicines can increase or decrease the blood sugar lowering effect of Tandemact:

• H2 antagonists (to treat stomach ulcers)
• beta-blockers, clonidine, guanethidine and reserpine (to treat high blood pressure or heart failure). These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines

Tandemact may either increase or weaken the effects of the following medicines:

• coumarin derivatives such as warfarin (to slow down or stop blood clotting)

Tell your doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and your dose of Tandemact may need to be changed.

Tandemact with alcohol Avoid alcohol while taking Tandemact since alcohol may increase or decrease the blood sugar lowering action of Tandemact in an unpredictable way.

Pregnancy and breast-feeding Do not use Tandemact if you are pregnant. You must tell your doctor if you are, you think you may be pregnant or are planning to have a baby. Your doctor will advise you to discontinue this medicine. Do not use Tandemact if you are breastfeeding or are planning to breast-feed (see section Do not take Tandemact ).

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 use machines.
Take care if you experience abnormal vision.

Tandemact contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tandemact.
Tandemact contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

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 recommended dose is one tablet taken once daily shortly before or with the first main meal. Your doctor will tell you the dose to take or if necessary to change to a different dose. You should swallow the tablets with a glass of water.

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.

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. Your blood sugar could fall below the normal level. The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness, nausea, coma or convulsion. Your blood sugar level 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 Tandemact Take Tandemact daily as prescribed. However if you miss a dose, skip the missed dose and 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 Tandemact Tandemact should be used every day to work properly. If you stop using Tandemact, 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:

Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact. 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.

Hypoglycaemia (low blood sugar) has been reported uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact. The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea. 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 and what you should do if you experience the symptoms.

Decrease in blood platelets (which increases risk of bleeding or bruising), red blood cells (which makes the skin pale and cause weakness or breathlessness) and white blood cells(which makes infections more likely) have been reported in patients taking Tandemact rarely (may affect up to 1 in 1,000 people). If you experience this side effect, talk to your doctor as soon as possible. These problems generally get better after you stop taking Tandemact.

Localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in patients taking Tandemact 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 Tandemact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Tandemact. 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 (macular oedema) has also been reported in patients taking Tandemact (frequency cannot be estimated from the available data). 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 with frequency not known (cannot be estimated from the available data) in patients taking Tandemact. 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 immediately.

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

Common (may affect up to 1 in 10 people)

• weight gain
• dizziness
• gas
• respiratory infection
• numbness

Uncommon (may affect up to 1 in 100 people)

• headache
• inflammation of the sinuses (sinusitis)
• vertigo
• abnormal vision
• sweating
• tiredness
• difficulty sleeping (insomnia)
• decreased blood sugar
• sugar in urine
• proteins in urine
• increased appetite
• increase of an enzyme called lactic dehydrogenase (LDH)

Rare (may affect up to 1 in 1,000 people)

• noticeable changes in blood

Very rare (may affect up to 1 in 10,000 people)

• liver disease
• allergic reactions including allergic shock
• feeling sick (nausea), vomiting and diarrhoea
• stomach ache
• abdominal pressure
• feeling of fullness in the stomach
• sensitivity to light
• decrease in salt (sodium) concentrations in the blood

Not known (frequency can not be estimated from the available data)

• increase in liver enzymes
• itchy skin
• raised and itchy rash (hives)

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 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 after EXP . The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via waste water or household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tandemact contains

• The active substances are pioglitazone and glimepiride.
  Each Tandemact 30 mg/2 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg glimepiride. Each Tandemact 30 mg/4 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
• The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate (see section 2 Tandemact contains lactose monohydrate ), magnesium stearate and polysorbate 80. What Tandemact looks like and contents of the pack
• Tandemact 30 mg/2 mg tablets are white to off-white, round, convex and debossed 4833 G on one face and 30/2 on the other.
• Tandemact 30 mg/4 mg tablets are white to off-white, round, convex and debossed 4833 G on one face and 30/4 on the other. The tablets are supplied in aluminium/aluminium blister packs containing 28 tablets.

Marketing authorisation holder CHEPLAPHARM Arzneimittel GmbH Ziegelhof 17489 Greifswald Germany

Manufacturer Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), Italy Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 98, 16515 Oranienburg, Germany

This leaflet was last revised in 08/2023. Other sources of information

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