Document: leaflet MAH BRAND_PL 20075-0419 change

• leaflet MAH BRAND_PL 20075-0419
• leaflet MAH GENERIC_PL 20075-0419

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Placement for Pharmacode no.

Package leaflet: Information for the user

Tremapecil 50 mg/12.5 mg/200 mg film-coated tablets Tremapecil

75 mg/18.75 mg/200 mg film-coated tablets Tremapecil 100 mg/25 mg/200 mg film-coated tablets Tremapecil

125 mg/31.25 mg/200 mg film-coated tablets Tremapecil

150 mg/37.5 mg/200 mg film-coated tablets Tremapecil 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone

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 Tremapecil is and what it is used for

2.    What you need to know before you take Tremapecil

3.    How to take Tremapecil

4.    Possible side effects

5.    How to store Tremapecil

6.    Contents of the pack and other information

1. What Tremapecil is and what it is used for

Tremapecil contains three active substances (levodopa, carbidopa and entacapone) in one film coated tablet. Tremapecil 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. What you need to know before you take Tremapecil

Do not take Tremapecil 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 Tremapecil 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 Tremapecil may make these reactions worse.

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

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

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

Other medicines and Tremapecil

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

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

Tremapecil may increase the effects and side effects of certain medicines.

These include:

-    medicines used to treat depression such as moclobemide, amitryptiline, 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 Tremapecil 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.

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

Tremapecil with food and drink

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

Driving and using machines

Tremapecil 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 Tremapecil

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 elderly:

-    Your doctor will tell you exactly how many tablets of Tremapecil 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 Tremapecil 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 film-coated tablets, do not take more than 10 tablets per day.

-    If you are taking Tremapecil 200 mg/50 mg/200 mg film-coated 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 Tremapecil is too strong or too weak, or if you experience possible side effects.

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 T remapecil 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 discoloration 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 behaviors; 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 For UK

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

For Malta ADR Reporting Website:

www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

crospovidone (Type B), povidone K-30, magnesium stearate and sodium citrate.

- The ingredients in the film-coating are hypromellose, macrogol 6000, titanium dioxide (E171), polysorbate 80, iron oxide red (E172) and iron oxide yellow (E172) (for 50 mg/12.5 mg/200 mg,

100 mg/25 mg/200 mg and 150 mg/

37.5 mg/200 mg).

What Tremapecil looks like and contents of the pack

Tremapecil 50 mg/12.5 mg/200 mg film-coated tablets: Light brown to grayish red colored, round, approximately 11.3 mm in diameter, biconvex, film-coated tablets with debossed "50" on one side and plain on other side.

Tremapecil 75 mg/18.75 mg/200 mg film-coated tablets: Light brown to light pink colored, oval shaped, approximately 15.2 mm in length and 7.2 mm in width, film-coated tablets with debossed "75" on one side and plain on other side. Tremapecil 100 mg/25 mg/200 mg film-coated tablets: Light brown to grayish red colored, oval shaped, approximately 16.7 mm in length and 7.7 mm in width, film-coated tablets with debossed "100" on one side and plain on other side. Tremapecil 125 mg/31.25 mg/200 mg film-coated tablets: Light brown to light pink colored, elongated-ellipse shaped, approximately 15.2 mm in length and 9.7 mm in width, film-coated tablets with debossed "125" on one side and plain on other side.

Tremapecil 150 mg/37.5 mg/200 mg film-coated tablets: Light brown to grayish red colored, elongated-ellipse shaped, approximately 16.2 mm in length and 10.2 mm in width, film-coated tablets with debossed "150" on one side and plain on other side.

Tremapecil 200 mg/50 mg/200 mg film-coated tablets: Dark brownish red colored, oval shaped, approximately 19.15 mm in length and 9.05 mm in width, film-coated tablets with debossed "200" on one side and plain on other side.

Tremapecil comes in three different pack sizes (30, 100 or 130 tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare Limited Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF,

United Kingdom

Manufacturer :

Accord Healthcare Limited Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF,

United Kingdom

Wessling Hungary Kft.,

Foti ut 56., Budapest 1047, Hungary

Pharmacare Premium Ltd.

HHF 003 Hal Far Industrial Estate,

Hal Far, Birzebbugia BBG 3000, Malta

This leaflet was last revised in 04/2016.

5. How to store Tremapecil

HDPE bottle pack should be used within 6 months after first opening.

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.

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.

6. Contents of the pack and other information

Size : 150 x 700 mm