Numient

Основна информация

  • Търговско наименование:
  • Numient
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Numient
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Anti Parkinson drugs
  • Терапевтична област:
  • Parkinson Disease
  • Терапевтични показания:
  • Symptomatic treatment of adult patients with Parkinson’s disease,
  • Каталог на резюме:
  • Revision: 3

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002611
  • Дата Оторизация:
  • 18-11-2015
  • EMEA код:
  • EMEA/H/C/002611
  • Последна актуализация:
  • 28-03-2019

Доклад обществена оценка

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

EMA/660645/2015

EMEA/H/C/002611

EPAR summary for the public

Numient

levodopa / carbidopa

This is a summary of the European public assessment report (EPAR) for Numient. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Numient.

For practical information about using Numient, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Numient and what is it used for?

Numient is used in adults to treat the symptoms of Parkinson’s disease, a progressive brain disorder

that causes shaking and muscular stiffness and slows down movement.

It contains the active substances levodopa and carbidopa.

How is Numient used?

Numient is available as capsules to be taken by mouth. The starting dose for patients who have not

previously taken levodopa is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa,

three times daily for the first three days. The doctor may then increase the dose depending on how the

condition responds to treatment. For patients already taking levodopa, the doctor will determine the

dose of Numient based on their current treatment.

Numient capsules are taken with a glass of water. They can be taken with or without food, but should

not be taken at the same time as high protein meals, which can reduce absorption.

Patients who have difficulty swallowing can have the content of the capsules sprinkled on soft food

such as apple sauce, yoghurt or pudding. The patient should then swallow the food immediately

without chewing.

Numient

EMA/660645/2015

Page 2/3

Numient can only be obtained with a prescription and it is available in the following strengths:

95 mg/23.75 mg, 145 mg/36.25 mg, 195 mg/48.75 mg and 245 mg/61.25 mg. For further information

on how to use Numient, see the summary of product characteristic (also part of the EPAR).

How does Numient work?

In patients with Parkinson’s disease, the cells in the brain that produce dopamine, a neurotransmitter

important for controlling movement, begin to die and the amount of dopamine in the brain decreases.

Numient contains levodopa which converts into dopamine in the brain and helps to restore dopamine

levels. The carbidopa in Numient stops the levodopa from converting into dopamine while still in the

general circulation, before it has reached the brain.

The combination of levodopa and carbidopa is used in other medicines for Parkinson’s disease. In

Numient, a portion of the active substances is released immediately, while the remaining is released

gradually, leading to more steady levodopa levels. These types of capsules are known as modified-

release capsules.

What benefits of Numient have been shown in studies?

In a study of 381 patients with early stage Parkinson’s disease, Numient at various doses was more

effective at improving symptoms than placebo (a dummy treatment). After 30 weeks, patients taking

Numient had their symptoms improve by an average of between 11.7 and 14.9 points (depending on

dose) on a standard symptom scale (Unified Parkinson’s Disease Rating Scale, UPDRS Part II and Part

III). Patients who took placebo had an average improvement of 0.6 points.

A second study compared Numient with another treatment containing levodopa and carbidopa in 393

patients with advanced Parkinson’s disease. This study looked at how well the treatments reduced the

time when patients have more difficulty moving about, called ‘off periods’. After 13 weeks, patients

taking Numient had off periods of about 24% of their waking hours compared with 30% of waking

hours in patients taking the comparator medicine. Both groups had off periods of about 36-37% at the

start of the study.

What are the risks associated with Numient?

The most frequent side effects with Numient are nausea in (12% of patients), dizziness, headache and

involuntary movements (each occurring in 8% of patients), and insomnia (in 6% of patients). More

serious side effects include bleeding from the gut and allergic reactions, and have been reported

uncommonly.

Numient must not be used in patients with narrow angle glaucoma (an eye disorder) or

pheochromocytoma (a tumour of the adrenal glands). It must also not be used in patients taking

medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of

certain medical conditions. For the full list of all side effects and restrictions, see the package leaflet.

Why is Numient approved?

Studies show that Numient is effective at reducing symptoms in patients with early and late stage

Parkinson’s disease. Another benefit is the way the active substances are formulated in Numient, which

helps maintain more steady levodopa levels.

Numient

EMA/660645/2015

Page 3/3

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Numient’s

benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of

Numient?

A risk management plan has been developed to ensure that Numient is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Numient, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Numient

The European Commission granted a marketing authorisation valid throughout the European Union for

Numient on 19 November 2015.

The full EPAR and risk management plan summary for Numient can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more

information about treatment with Numient, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

This summary was last updated in 11-2015.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Numient 95 mg/23.75 mg modified-release hard capsules

Numient 145 mg/36.25 mg modified-release hard capsules

Numient

195 mg/48.75 mg modified-release hard capsules

Numient

245 mg/61.25 mg modified-release hard capsules

Levodopa/Carbidopa

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

What Numient is and what it is used for

What you need to know before you take Numient

How to take Numient

Possible side effects

How to store Numient

Contents of the pack and other information

1.

What Numient is and what it is used for

Numient contains two different medicines called levodopa and carbidopa in one hard capsule.

levodopa turns into a material called ‘dopamine’ in your brain. The dopamine helps to improve the

symptoms of your Parkinson’s disease.

carbidopa belongs to a group of medicines called ‘aromatic amino acid decarboxylase inhibitors’. It

helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your

body.

Numient is used to improve the symptoms of Parkinson’s disease in adults.

2.

What you need to know before you take Numient

Do not take Numient:

if you are allergic to levodopa or carbidopa, or any of the other ingredients of this medicine (listed in

section 6);

if you have narrow-angle glaucoma (an eye disorder);

if you have phaeochromocytoma (a rare tumour of the adrenal gland);

if you are taking certain medicines for treating depression [non-selective monoamine oxidase (MAO)

inhibitors]. You need to stop using these medicines at least two weeks before you start Numient (see

also under ‘

Other medicines and Numient

’);

if you have ever had neuroleptic malignant syndrome (NMS –a rare severe reaction to medicines used

to treat severe mental disorders);

if you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder).

Warnings and precautions

Talk to your doctor or pharmacist before taking Numient

if you have, have ever had, or develop:

sudden sleep attacks or sometimes feel very sleepy

any form of severe mental disorder like psychosis

feelings of depression, suicidal thoughts, or notice unusual changes in your behaviour

tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure, or notice

that your muscles get very rigid or jerk violently. If any of this happens,

contact your doctor

immediately

an eye condition called chronic wide angle glaucoma, because your dose may need to be adjusted and

the pressure in your eyes may need to be monitored

melanoma or suspicious skin lesion

a heart attack, heart beat problems, circulation or breathing problems

kidney or liver problems

an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’)

an endocrine (hormone) disease

bronchial asthma

obsessive behaviour(s)

convulsions

low blood pressure or feeling dizzy when getting up

new or increased abnormal body movements (dyskinesias)

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

Numient.

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

Impulse control disorders

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 an increase in sexual

thoughts or feelings. Your doctor may need to review your treatments.

Tests

You may need to have testing of your heart, liver, kidney, and blood cell functions during long-term

treatment with medicines containing levodopa/carbidopa. If you need to have tests on your blood or urine,

tell the doctor or nurse that you are taking Numient. This is because the medicine may affect the results of

some tests.

Children and adolescents

The use of Numient is not recommended in patients under 18 years of age. The safety and efficacy of

Numient in patients under 18 years of age have not been studied

Other medicines and Numient

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

is because other medicines can affect the way Numient works.

Do not take Numient if you have taken a medicine called a ‘non-selective monoamine oxidase (MAO)

inhibitor’ for treating depression in the last 14 days. These medicines include isocarboxazid and phenelzine.

If this applies to you, do not take

Numient

and ask your doctor or pharmacist for advice.

In particular, tell your doctor or pharmacist if you are taking the following medicines:

Other medicines for Parkinson’s disease, such as ‘anticholinergics’ (e.g. orphenadrine and

trihexyphenidyl), ‘selective MAO-B inhibitors’ (e.g. selegiline and rasagiline), and a ‘COMT

inhibitor’ (e.g. entacapone)

Ferrous sulphate (used to treat anaemia caused by low levels of iron in the blood).

Levodopa/carbidopa may make it harder for your body to use iron. Therefore, do not take Numient

and iron supplements or multivitamin supplements containing iron at the same time. After taking one

of them, wait at least 2 to 3 hours before taking the other

Phenothiazines - such as chlorpromazine, promazine and prochloroperazine (used to treat mental

illness)

Benzodiazepines such as alprazolam, diazepam, and lorazepam used to treat anxiety

Tricyclic antidepressants (TCAs; used to treat depression)

Papaverine (used to improve blood flow around the body)

Treatment for high blood pressure (hypertension)

Phenytoin which is used to treat fits (convulsions)

Isoniazid which is used to treat tuberculosis

Dopamine antagonists used to treat mental disorders, nausea, and vomiting

Numient with food and drink

A high-fat, high-calorie meal delays the absorption of levodopa by two hours. If your diet contains too much

protein (meat, eggs, milk, cheese), Numient may not work as well as it should. Avoid taking your capsules at

the same time that you consume a high fat or high protein meal.

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 Numient.

Numient is not recommended during pregnancy and in women of childbearing potential not using

contraception. However, your doctor may decide to give you Numient if the expected benefits of treatment

outweigh possible risks to the unborn child.

Women should not breast-feed during treatment with Numient.

Driving and using machines

Numient can cause somnolence (excessive drowsiness) and sudden sleep onset episodes. Therefore, you

must refrain from driving or engaging in activities where impaired alertness may put yourself or others at

risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have

resolved.

3.

How to take Numient

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure

Your doctor will tell you exactly how many capsules of Numient to take each day

If you have never had levodopa before, the usual starting dose for Numient is one 95 mg capsule three

times a day for three days. Depending on how you respond to treatment your doctor may then

increase your dose on day four

If you have had levodopa before,

your doctor will determine the appropriate starting dose regimen

based on your current levodopa dose

Numient should be taken approximately every 6 hours no more than 5 times a day

Take this medicine by mouth with a glass of water.

You must

swallow your capsules whole.

Do not

break, crush or chew the capsules

Alternatively, if you have difficulty swallowing a capsule, this medicine may be administered by

carefully opening the capsule and sprinkling the entire contents on a small amount (e.g.,

2 tablespoons) of soft food such as apple sauce, yoghurt, or pudding. Do not heat the medicine/food

mixture and do not sprinkle the contents of the capsule on hot food. Swallow the medicine/food

mixture completely and immediately without chewing and do not store for future use

Take the capsules at regular time intervals according to your doctor's instructions

Do not change the times at which you take your capsules or take any other medicines for Parkinson's

disease without first consulting your doctor. You should not take Numient capsules at intervals of less

than 4 hours apart

Numient can be taken with or without food. Avoid taking your capsules with a high fat meal or one

high in protein since this will delay the time it takes for the medicine to work.

Talk to your doctor or pharmacist if you think the effect of Numient is too strong or too weak, or if

you experience possible side effects

Depending on how you respond to treatment your doctor may then either increase or decrease your

dose and adjust your dosing frequency

If you take more Numient than you should

If you take more Numient than you should (or someone has accidentally ingested Numient) talk to your

doctor or pharmacist immediately. In case of an overdose, you may feel confused or agitated, and your heart

rate may be slower or faster than normal.

If you forget to take a dose of Numient

Take it as soon as you remember unless it is nearly time to take the next dose. Do not take a double dose to

make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Numient

Do not stop taking or change your dose of Numient without talking to your doctor first even if you feel

better.

Do not stop taking Numient suddenly

This can cause muscle problems, fever and mental changes.

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.

If you have any of the following symptoms during your treatment with Numient,

contact your doctor

immediately:

Bleeding in your stomach or intestines which may be seen as blood in your faeces or darkened faeces

An allergic reaction, the signs of which may include hives (nettle rash), itching, rash, swelling of your

face, lips, tongue or throat. This may cause difficulties in breathing or swallowing

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 rhabdomyolisis (a rare severe muscle disorder)

Other possible side effects:

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

Feeling sick to your stomach (nausea)

Common (may affect up to 1 in 10 people)

Decrease in weight

Seeing or hearing things that are not real, depression, anxiety, somnolence (excessive drowsiness),

difficulty falling and/or staying asleep, abnormal dreams, confusion, impaired memory and thinking

skills

Twisting and repetitive movements or abnormal posture caused by involuntary muscle contraction

(dystonia), abnormal involuntary movements (dyskinesia), on and off phenomenon (the time when

your medicine is working and then it begins to no longer work to control your symptoms), worsening

of Parkinsons’s disease, abnormal walking, dizziness, excessive drowsiness, prickling or tingling

feeling in your arms and/or legs, tremor, headache

Irregular heart rhythm

High blood pressure, abnormally low blood pressure when you stand up

Shortness of breath

Abdominal pain, constipation, diarrhoea, dry mouth, vomiting

Hot flushes, excessive sweating, rash

Muscle spasms

Falls

Swelling of the arms and/or legs

Chest pain not due to heart disease

Loss of strength, fatigue

Uncommon (may affect up to 1 in 100 people)

Melanoma (a type of skin cancer)

Anaemia (low red blood cell counts)

Decreased appetite, increased weight

Psychotic episode, agitation

Impulse control disorder (see below)

Sudden sleep onset episodes, restless legs syndrome (unpleasant sensations in the legs with an urge to

move them), difficulty opening the mouth, convulsions

Double vision, dilated pupils, blurred vision

Pounding heartbeat

Fainting, blood clot or inflammation in a blood vessel

Bleeding in the stomach or intestines, peptic ulcer disease, difficulty swallowing, indigestion, unusual

taste in the mouth, burning feeling of the tongue, excessive wind or gas (flatulence)

An allergic reaction, which may include hives (nettle rash), itching, rash, swelling of your face, lips,

tongue or throat, difficulty breathing or swallowing, itching

Inability to urinate

General feeling of illness (malaise)

Increased levels of sugar, uric acid and/or liver enzymes in the blood

Abnormal kidney function tests and/or blood in the urine

You may also 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 behaviours; they will discuss ways of managing or

reducing the symptoms.

The following side effects have also been reported but the chance that they will occur is unknown:

Low blood cell counts (white blood cells, platelets)

Drug abuse of certain medicines used to treat Parkinson’s Disease

Suicide attempt, feeling disoriented, increased sexual feelings

Severe prolonged abnormal eye movements, Horner’s Syndrome (drooping eyelid, small pupil and

decreased sweating on one side of the face), eyelid twitching

Abnormal breathing pattern

Excessive or dark-coloured saliva, grinding of the teeth, hiccups

Hair loss, rash (including a severe rash called Henoch-Schönlein purpura), dark-coloured sweat

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.

5.

How to store Numient

Keep this medicine out of the sight and reach of children.

Store below 30 °C. Store the medicine in the original package, in order to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The

expiry date refers to the last day of that month. After opening the bottle, use within 90 days.

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 Numient contains

The active substances of Numient are levodopa and carbidopa

Each 95 mg/23.75 mg modified-release hard capsule contains 95 mg levodopa and 23.75 mg

carbidopa (as monohydrate)

Each 145 mg/36.25 mg modified-release hard capsule contains 145 mg levodopa and

36.25 mg carbidopa (as monohydrate)

Each 195 mg/48.75 mg modified-release hard capsule contains 195 mg levodopa and

48.75 mg carbidopa (as monohydrate)

Each 245 mg/61.25 mg modified-release hard capsule contains 245 mg levodopa and

61.25 mg carbidopa (as monohydrate)

The other ingredients are cellulose, microcrystalline, mannitol, tartaric acid, ethylcellulose,

hypromellose, sodium starch glycolate, sodium laurilsulfate, povidone, talc, methacrylic acid –

methyl methacrylate copolymers (1:1), methacrylic acid – methyl methacrylate copolymers (1:2),

triethyl citrate, croscarmellose sodium and magnesium stearate

The ingredients in the hard capsule shell are indigo carmine (E132) lake, yellow iron oxide (E172),

titanium dioxide (E171) and gelatine

The ingredients in the ink are SB-6018 blue ink, shellac (E904), propylene glycol, and indigo carmine

(E132) lake

What Numient looks like and contents of the pack

Numient is a modified-release hard capsule.

95 mg/23.75 mg modified-release hard capsule

White body and a blue cap of 18 x 6 mm imprinted with “IPX066” and “95” in blue ink.

145 mg/36.25 mg modified-release hard capsule

Light blue body and a blue cap of 19 x 7 mm imprinted with “IPX066” and “145” in blue ink.

195 mg/48.75 mg modified-release hard capsule

Yellow body and a blue cap of 24 x 8 mm imprinted with “IPX066” and “195” in blue ink.

245 mg/61.25 mg modified-release hard capsule

Blue body and a blue cap of 23 x 9 mm imprinted with “IPX066” and “245” in blue ink.

Numient capsules are supplied in plastic bottles with a dessicant and a plastic cap, available in bottles of 25,

100 or 240 hard capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amneal Pharma Europe Ltd

70 Sir John Rogerson’s Quay

Dublin 2

Ireland

Manufacturer

Central Pharma Contract Packing Limited

Caxton Road, Bedford, Bedfordshire

MK41 0XZ

United Kingdom

44(0) 1234 227816

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu