Patient leaflet - Stacar 50 mg/12.5 mg/200 mg film-coated tablets

1. What Stacar is and what it is used for

Stacar contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stacar 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.

2. W hat you need to know before you take Stacar

Do not take Stacar if you:

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

Ÿ have narrow-angle glaucoma (an eye disorder)

Ÿ have a tumour of the adrenal gland

Ÿ are taking certain medicines for treating depression (combinations

of selective MAO-A and MAO-B inhibitors, or non-selective MAO-inhibitors)

Ÿ have ever had neuroleptic malignant syndrome (NMS – this is a

rare reaction to medicines used to treat severe mental disorders)

Ÿ have ever had non-traumatic rhabdomyolysis (a rare muscle

disorder)

Ÿ have a severe liver disease.

Warnings and precautions

Ÿ a liver problem, because your dose may need to be adjusted Talk to your doctor or pharmacist before taking Stacar if you have or have ever had:

Ÿ a heart attack or any other diseases of the heart including cardiac

arrhythmias, or of the blood vessels

Ÿ asthma or any other disease of the lungs

Ÿ kidney or hormone-related diseases

Ÿ stomach ulcers or convulsions

Ÿ if you experience prolonged diarrhoea consult your doctor as it

may be a sign of inflammation of the colon

Ÿ any form of severe mental disorder like psychosis

Ÿ 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:

Ÿ antipsychotics (medicines used to treat psychosis)

Ÿ a medicine which may cause low blood pressure when rising from

a chair or bed. Be aware that Stacar may make these reactions worse.

Consult your doctor if during the treatment with Stacar you:

Ÿ 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

Ÿ feel depressed, have suicidal thoughts, or notice unusual changes

in your behaviour

Ÿ find yourself suddenly falling asleep, or if you feel very drowsy. If

this happens, do not drive or use any tools or machines (see also section 'Driving and using machines')

Ÿ notice that uncontrolled movements begin or get worse after you

started to take Stacar. If this happens, your doctor may need to change the dose of your antiparkinson medicine

Ÿ experience diarrhoea: monitoring of your weight is recommended

Ÿ 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

Ÿ feel the need to stop using Stacar, see section 'If you stop taking

Stacar.

Talk to your doctor or pharmacist if you think the effect of Stacar is too strong or too weak, or if you experience possible side effects. Tell your doctor if you or your family/carer notices you are developing:

Ÿ addiction-like symptoms leading to craving for large doses of

Stacar and other medicines used to treat Parkinson's disease

Ÿ alpha-methyldopa, used to treat high blood pressure Ÿ 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 Stacar.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. If you must undergo surgery, please tell your doctor that you are using Stacar.

Stacar 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 Stacar in patients under 18 years is limited. Therefore, the use of Stacar in children or adolescents is not recommended.

Other medicines and Stacar

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

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

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

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

Ÿ rimiterole and isoprenaline, used to treat respiratory diseases

Ÿ adrenaline, used for severe allergic reactions

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

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

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

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

Ÿ phenytoin, used to prevent convulsions

Ÿ papaverine used to relax the muscles.

Stacar may make it harder for you to digest iron.

Therefore, do not take Stacar and iron supplements

at the same time. After taking one of them, wait at

least 2 to 3 hours before taking the other.

Stacar with food and drink

Stacar may be taken with or without food. For some patients, Stacar 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.

Do not breast-feed during treatment with Stacar.

Driving and using machines

Stacar 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.

3. How to take Stacar

For adults and elderly

Ÿ Your doctor will tell you exactly how many tablets of Stacar to take each day.

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

Ÿ Take only one tablet each time.

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

Ÿ If you are taking Stacar 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.

Ÿ If you are taking Stacar 175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of this strength per day.

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

If you take more Stacar than you should

If you have accidentally taken more Stacar 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 Stacar

Do not stop taking Stacar 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 Stacar and other antiparkinsonian medicines it may result in unwanted side effects. Do not take a double dose to make up for a forgotten tablet.

Ÿ 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.

Ÿ 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 Stacar tablets, to avoid possible side effects.

If you stop taking Stacar

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

4. 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 you during the treatment with Stacar experience the following symptoms, contact your doctor immediately:

Ÿ 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).

Ÿ 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)

Ÿ uncontrolled movements (dyskinesias)

Ÿ feeling sick (nausea)

Ÿ harmless reddish-brown discolouration of urine

Ÿ muscle pain

Ÿ diarrhoea

Common (may affect up to 1 in 10 people)

Ÿ light-headedness or fainting due to low blood pressure, high blood

pressure

Ÿ worsening of Parkinson's symptoms, dizziness, drowsiness

Ÿ vomiting, abdominal pain and discomfort, heartburn, dry mouth,

constipation

Ÿ inability to sleep, hallucinations, confusion abnormal dreams

(including nightmares), tiredness

Ÿ mental changes – including problems with memory, anxiety and

depression (possibly with thoughts of suicide)

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

or rhythm

Ÿ more frequent falling

Ÿ shortness of breath

Ÿ increased sweating, rashes

Ÿ muscle cramps, swelling of legs

Ÿ blurred vision

Ÿ anaemia

Ÿ decreased appetite, decreased weight

Ÿ headache, joint pain

Ÿ urinary tract infection

Uncommon (may affect up to 1 in 100 people)

Ÿ heart attack

Ÿ bleeding in the gut

Ÿ changes in the blood cell count which may result in bleeding,

abnormal liver function tests

Ÿ convulsions

Ÿ feeling agitated

Ÿ psychotic symptoms

Ÿ colitis (inflammation of the colon)

Ÿ discolourations other than urine (e.g. skin, nail, hair, sweat)

Ÿ swallowing difficulties

Ÿ inability to urinate

Not known (frequency cannot be estimated from the available data) Ÿ Craving for large doses of Stacar in excess of that required to

control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Stacar.

Ÿ hepatitis (inflammation of the liver)

Ÿ itching

Ÿ Inability to resist the impulse to perform an action that could be

harmful, which may include:

strong impulse to gamble excessively despite serious personal
or 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Stacar

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 after EXP.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment. Do not store above 30°C

6. Contents of the pack and other information

What Stacar contains

Ÿ The active substances are levodopa, carbidopa and entacapone.

Each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

Each tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.

Each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.

Each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.

Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.

Each tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.

Each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.

Ÿ The other ingredients in the tablet core are maltodextrin, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, povidone K 30, isopropyl alcohol, crospovidone type A and magnesium stearate.

The ingredients in the film-coating are

hypromellose 6cPs (E464), polysorbate 80

(E433), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

What Stacar looks like and contents of the pack

Stacar 50 mg/12.5 mg/200 mg: Brown coloured, round shaped, biconvex, film coated tablets,

debossed with "M 71" on one side and plain

surface on the other side.

Stacar 75 mg/18.75 mg/200 mg: Brown coloured, oval shaped, biconvex, film coated tablets, debossed with "M 72" on one side and plain surface on the other side.

Stacar 100 mg/25 mg/200 mg: Brown coloured, oval shaped, biconvex, film coated tablets, debossed with "M 73" on one side and plain surface on the other side.

Stacar 125 mg/31.25 mg/200 mg: Brown coloured, oval shaped, biconvex, film coated tablets, debossed with "M 74" on one side and plain surface on the other side.

Stacar 150 mg/37.5 mg/200 mg: Brown coloured, oval shaped, biconvex, film coated tablets, debossed with "M 75" on one side and plain surface on the other side.

Stacar 175 mg/43.75 mg/200 mg: Brown coloured, oval shaped, biconvex, film coated tablets, debossed with "M 76" on one side and plain surface on the other side.

Stacar 200 mg/50 mg/200 mg: Brown coloured, oval shaped, biconvex, film coated tablets, debossed with "M 70" on one side and plain surface on the other side.

Blister Pack: Blister pack comprises of Plain 25 micron Aluminium foil/ 6 - 8 gsm HSL Aluminium foil and 25 micron OPA/45 micron Aluminium foil/60 micron PVC cold form laminate.

Pack sizes: 10, 30 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Macleods Pharma UK Limited.

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom.

PL 34771/0266-0272

This leaflet was last approved in 07/2022

Stacar 125 mg/31.25 mg/200 mg

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.
Possible side effects
How to store Stacar
What Stacar is and what it is used for
1. 2. W hat you need to know before you take Stacar

Do not take Stacar if you: