Stanek 125 Mg/31.25 Mg/200 Mg Film-Coated Tablets

STANEK

50 mg/12.5 mg/200 mg,

75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg,

125 mg/31.25 mg/200 mg, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg AND 200 mg/50 mg/200 mg FILM-COATED TABLETS

levodopa/carbidopa/entacapone

PACKAGE LEAFLET INFORMATION FOR THE PATIENT

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

1. What Stanek is and what it is used for

2. What you need to know before you take Stanek

3. How to take Stanek

4. Possible side effects

5. How to store Stanek

6. Contents of the pack and other information

Ol WHAT STANEK IS AND WHAT IT IS USED FOR

Stanek contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stanek is used for the treatment of Parkinson's disease.

Parkinson's disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson's disease. Carbidopa and entacapone improve the antiparkinson effects of levodopa.

01 WHAT YOU NEED TO KNOW BEFORE YOU TAKE STANEK

Do not take Stanek if you:

• are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6)

• have narrow-angle glaucoma (an eye disorder) • have a tumour of the adrenal gland • are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO-inhibitors)

• have ever had neuroleptic malignant syndrome (NMS - this is a rare reaction to medicines used to treat severe mental disorders)

• have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)

• have a severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Stanek if you have or have ever had:

• a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels

• asthma or any other disease of the lungs • a liver problem, because your dose may need to be adjusted

• kidney or hormone-related diseases • stomach ulcers or convulsions • if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon • any form of severe mental disorder like psychosis

• chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.

Consult your doctor if you are currently taking:

• antipsychotics (medicines used to treat psychosis)

• a medicine which may cause low blood pressure when rising from a chair or bed. You should be aware that Stanek may make these reactions worse.

Consult your doctor if during the treatment with Stanek you:

• notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this happens, contact your doctor immediately • feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour • find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not drive or use any tools or machines (see also section 'Driving and using machines')

• notice that uncontrolled movements begin or get worse after you started to take Stanek. If this happens, your doctor may need to change the dose of your antiparkinson medicine • experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive weight loss • experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a relatively short period of time. If this happens, a general medical evaluation including liver function should be considered • feel the need to stop using Stanek, see section 'If you stop taking Stanek'.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stanek.

If you must undergo surgery, please tell your doctor that you are using Stanek.

Stanek is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with levodopa/carbidopa/entacapone in patients under 18 years is limited. Therefore, the use of Stanek in children is not recommended.

Other medicines and Stanek

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Stanek if you are taking certain medicines for treating depression (combinations of selective MAO-A and MaO-B inhibitors, or non-selective MAO inhibitors).

Stanek may increase the effects and side effects of certain medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine

• rimiterole and isoprenaline, used to treat respiratory diseases

• adrenaline, used for severe allergic reactions

• noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure

• alpha-methyldopa, used to treat high blood pressure

• apomorphine, which is used to treat Parkinson's disease.

The effects of Stanek may be weakened by certain medicines. These include:

• dopamine antagonists used to treat mental disorders, nausea and vomiting

• phenytoin, used to prevent convulsions

• papaverine used to relax the muscles.

Stanek may make it harder for you to digest iron. Therefore, do not take Stanek and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.

Stanek with food and drink

Stanek may be taken with or without food. For some patients, Stanek may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts). Consult your doctor if you think this applies to you.

Pregnancy, breast-feeding and fertility

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

You should not breast-feed during treatment with Stanek.

Driving and using machines

Stanek may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you may put yourself and others at risk of serious injury or death.

Stanek contains lactose

Stanek contains anhydrous lactose (80 mg/tablet).

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Stanek 100 mg/25 mg/200 mg also contains allura red (E129)

Allura red (E129) may cause allergic reactions.

Stanek 150 mg/37.5 mg/200 mg also contains carmoisine (E122)

Carmoisine (E122) may cause allergic reactions. s HOW TO TAKE STANEK

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For adults and older people:

• Your doctor will tell you exactly how many tablets of Stanek to take each day

• The tablets are not intended to be split or broken into smaller pieces

• You should take only one tablet each time

• Depending on how you respond to treatment, your doctor may suggest a higher or lower dose

• If you are taking Stanek 50 mg/12.5 mg/200 mg,

75 mg/18.75 mg/200 mg,

100 mg/25 mg/200 mg,

125 mg/31.25 mg/200 mg or

150 mg/37.5 mg/200 mg tablets, do not take

more than 10 tablets per day

• If you are taking Stanek

175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of this strength per day

• If you are taking Stanek 200 mg/50 mg/200 mg tablets, do not take more than 7 tablets of this strength per day.

Talk to your doctor or pharmacist if you think the effect of Stanek is too strong or too weak, or if you experience possible side effects.

If you take more Stanek than you should

If you have accidentally taken more Stanek tablets than you should, talk to your doctor or pharmacist immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stanek

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose:

Take one tablet as soon as you remember, and the next tablet at the normal time.

If it is less than 1 hour until your next dose:

Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as normal.

Always leave at least an hour between Stanek tablets, to avoid possible side effects.

If you stop taking Stanek

Do not stop taking Stanek unless your doctor tells you to. In such a case your doctor may need to adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your symptoms. If you suddenly stop taking Stanek and other antiparkinsonian medicines it may result in unwanted side effects.

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

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects can be relieved by adjusting the dose.

If during the treatment with Stanek you experience the following symptoms, contact your doctor immediately: your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare severe muscle disorder)

allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)

• uncontrolled movements (dyskinesias) feeling sick (nausea)

• harmless reddish-brown discolouration of urine

• muscle pain

• diarrhoea.

Common (may affect up to 1 in 10 people)

light-headedness or fainting due to low blood

pressure, high blood pressure

worsening of Parkinson's symptoms, dizziness

drowsiness

vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation inability to sleep, hallucinations, confusion, abnormal dreams (including nightmares), tiredness

mental changes - including problems with

memory, anxiety and depression (possibly

with thoughts of suicide)

heart or artery disease events (e.g. chest pain),

irregular heart rate or rhythm

more frequent falling

shortness of breath

increased sweating, rashes

muscle cramps, swelling of legs

blurred vision

anaemia

decreased appetite, decreased weight headache, joint pain urinary tract infection.

Uncommon (may affect up to 1 in 100 people)

heart attack bleeding in the gut

changes in the blood cell count which may result in bleeding, abnormal liver function tests convulsions feeling agitated psychotic symptoms colitis (inflammation of the colon) discolourations other than urine (e.g. skin, nail, hair, sweat) swallowing difficulties inability to urinate.

The following side effects have also been reported:

hepatitis (inflammation of the liver) itching.

You may experience the following side effects:

Inability to resist the impulse to perform an action that could be harmful, which may include:

• strong impulse to gamble excessively despite serious or personal family consequences

• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

• uncontrollable excessive shopping or spending

• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE STANEK

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 bottle and the carton after EXP.

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

This medicinal product does not require any special storage conditions.

Use the tablets within 175 days after first opening of the bottle.

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.

^ CONTENTS OF THE PACK AND OTHER INFORMATION

What Stanek contains

The active substances of Stanek are levodopa, carbidopa and entacapone.

Each Stanek 50 mg/12.5 mg/200 mg Film-coated Tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate

The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), yellow iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium stearate.

Each Stanek 75 mg/18.75 mg/200 mg Film-coated Tablet contains 75 mg of levodopa 18.75 mg of carbidopa and 200 mg of entacapone