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Arnalevocap



PACKAGE LEAFLET


Package leaflet: Information for the user


Arnalevocap50 mg/12.5 mg/200 mg film-coated tablets

Arnalevocap75 mg/18.75 mg/200 mg film-coated tablets

Arnalevocap100 mg/25 mg/200 mg film-coated tablets

Arnalevocap125 mg/31.25 mg/200 mg film-coated tablets

Arnalevocap150 mg/37.5 mg/200 mg film-coated tablets

Arnalevocap175 mg/43.75 mg/200 mg film-coated tablets

Arnalevocap200 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 Arnalevocap is and what it is used for

2. What you need to know before you take Arnalevocap

3. How to take Arnalevocap

4. Possible side effects

How to store Arnalevocap

6. Contents of the pack and other information


1. What Arnalevocap is and what it is used for


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


Do not take Arnalevocap if you



Warnings and precautions

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


Consult your doctor if you are currently taking:


Consult your doctor if during the treatment with Arnalevocap you:


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 Arnalevocap.


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


Arnalevocap 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.


If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Arnalevocap.


Children and adolescents

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


Other medicines and Arnalevocap:

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


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


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


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


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


Arnalevocap with food and drink

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


Driving and using machines

Arnalevocap 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.


Arnalevocap contains lecithin (soya)

If you are allergic to peanut or soya, do not use this medicinal product.


3. How to take Arnalevocap


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:


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


Use in children and adolscents

Arnalevocap should not be used in children and adolescents under 18 years of age.


If you take more Arnalevocap than you should

If you have accidentally taken more Arnalevocap 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 color of your skin, tongue, eyes or urine may change.


If you forget to take Arnalevocap

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 Arnalevocap tablets, to avoid possible side effects.


If you stop taking Arnalevocap

Do not stop taking Arnalevocap 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 Arnalevocap 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.


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 Arnalevocap experience the following symptoms, contact your doctor immediately:


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


Common:(may affect up to 1 in 10 people)


Uncommon:(may affect up to 1 in 100 people)


The following side effects have also been reported:


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 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 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 [To be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Arnalevocap


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 protect the environment.


6. Contents of the pack and other information


What Arnalevocap contains

The active substances are levodopa, carbidopa and entacapone.

- Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa (as monohydrate) and 200 mg of entacapone.

- Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa (as monohydrate) and 200 mg of entacapone.

- Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa (as monohydrate) and 200 mg of entacapone.

- Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa (as monohydrate) and 200 mg of entacapone.

- Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa (as monohydrate) and 200 mg of entacapone.

- Each film-coated tablet contains 175 mg of levodopa, 43.75 mg of carbidopa (as monohydrate) and 200 mg of entacapone.

- Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa (as monohydrate) and 200 mg of entacapone.

- The other ingredients are Tablet core: croscarmellose sodium, hydroxypropylcellulose, trehalose dihydrate, powdered cellulose, anhydrous sodium sulfate, microcrystalline cellulose, magnesium stearate.

- Film coat: polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide (E171), macrogol, iron oxide red (172), lecitin (soya) (E322), iron oxide yellow (E172).


What Arnalevocap looks like and contents of the pack

Arnalevocap 50 mg/12.5 mg/200 mg: Brownish red, oval, biconvex film-coated tablet 6.85 x 14.2 mm with “50” marked on one side and “LEC” on the opposite side.

Arnalevocap 75 mg/18.75 mg/200 mg: Brownish red, oval, biconvex film-coated tablet 7. 04 x 14.7 mm with “75” marked on one side and “LEC” on the opposite side.

Arnalevocap 100 mg/25 mg/200 mg: Brownish red, oval, biconvex film-coated tablet 7.23 x 15.3 mm with “100” marked on one side and “LEC” on the opposite side.

Arnalevocap 125 mg/31.25 mg/200 mg: Brownish red, oval, biconvex film-coated tablet 7.5 x 15.8 mm with “125” marked on one side and “LEC” on the opposite side.

Arnalevocap 150 mg/37.5 mg/200 mg: Brownish red, oval, biconvex film-coated tablet 7.68 x 16.2 mm with “150” marked on one side and “LEC” on the opposite side.

Arnalevocap 175 mg/43.75 mg/200 mg: Brownish red, oval, biconvex film-coated tablet 7.92 x 16.6 mm with “175” marked on one side and “LEC” on the opposite side.

Arnalevocap 200 mg/50 mg/200 mg: Brownish red, oval, biconvex film-coated tablet 8.21 x 17.2 mm with “200” marked on one side and “LEC” on the opposite side.


Pack sizes:

Tablet container with screw cap:

10, 30, 100, 130, and 175 film-coated tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


<[To be completed nationally]>


This medicinal product is authorised in the Member States of the EEA under the following names:


<{Name of the Member State}> <{Name of the medicinal product}>

<[To be completed nationally]>


This leaflet was last revised in 6 August 2014


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