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LEVOVAR 5 MG/1.25 MG DISPERSIBLE TABLET FOR DOSE DISPENSER

Active substance(s): CARBIDOPA / LEVODOPA

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PACKAGE LEAFLET

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Package leaflet: Information for the user
Levovar 5 mg/1.25 mg dispersible tablets for dose dispenser
levodopa/carbidopa

Read all of this leaflet carefully before you start using 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 Levovar is and what it is used for
2.
What you need to know before you take Levovar
3.
How to take Levovar
4.
Possible side effects
5.
How to store Levovar
6.
Contents of the pack and other information

1.

What Levovar is and what it is used for

Levovar improves the signs of Parkinson’s disease. Parkinson's disease is a long-term illness where:
 you become slow and unsteady
 your muscles feel stiff
 you may develop shaking or trembling (called ‘tremor’).
If not treated, Parkinson's disease can make it hard for you to continue your normal daily activities.
Levovar contains two different medicines called levodopa and carbidopa.
 levodopa turns into a material called ‘dopamine’ in your brain. The dopamine helps to improve the
signs 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.
Levovar are small "micro-tablets" which are taken using a dose dispenser. The dose dispenser which can be
programmed by your doctor or nurse delivers a certain number of tablets for each scheduled dose.

2.

What you need to know before you take Levovar

Do not take Levovar:
 if you are allergic to carbidopa or levodopa or any of the other ingredients of this medicine (listed in
section 6).
 if you have ever had skin cancer or you have any unusual moles which have not been examined by
your doctor
 if you are taking certain medicines called ‘MAOIs’ (Monoamine Oxidase Inhibitors) used for
depression. You need to stop using these medicines at least two weeks before you start
Carbidopa/Levodopa Fair-Med (see also under ‘Taking other medicines’ below).

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if you have a condition called ‘narrow-angle glaucoma’ that may cause a sudden build up of pressure
in the eye
if you suffer from attacks of hypertension induced by tumor of the adrenal medulla
(pheochromocytoma)
hormonal problems (overproduction of cortisol or thyroid hormone)
if you have severe heart disease

Do not take Levovar if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist
before taking Levovar.
Warnings and precautions
Talk to your doctor or pharmacist before taking Levovar:
 if you have a history of fits (convulsions)
 if you have a lung problem (such as bronchial asthma)
 if you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood
 if you have had a heart attack, heart beat problems, circulation problems
 if you are taking a medicine which may cause low blood pressure when rising from a chair or bed
(orthostatic hypotension)
 if you have kidneyor liver problems
 if you have hormonal problems
 if you have had depression or other mental problems
 if you have a condition called ‘chronic wide-angle glaucoma’ that may cause a build-up of pressure
in the eye. You will need to have regular checks on the pressure in your eye.
 if you sometimes have sudden sleep attacks or sometimes feel very sleepy
 if you are due to have surgery.
Tell the 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.
This medication can affect some laboratory tests that your doctor may perform on blood or urine samples.
If you are unsure if any of the above applies to you, talk to your doctor or pharmacist.
Other medicines and Levovar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This
includes herbal medicines. The effect of the treatment may be affected if Levovar and certain other drugs are
taken concomitantly.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:

Parkinson’s disease (such as tolcapone, entacapone, amantadine)

Severe allergic reactions, asthma, chronic bronchitis, heart diseases and low blood pressure (such as
anticholinergics and sympathomimetics)

Fits (convulsions) or epilepsy (such as phenytoin)

High blood pressure (antihypertensives)

Mental problems (antipsychotics such as phenothiazines, butyrophenons and risperidone)

Depression (such as ‘tricyclic antidepressants’ or ‘non-selective monoamine oxidase inhibitors’)

Tuberculosis (such as isoniazide)

Anxiety (such as benzodiazepines)

Anaemia (such as iron tablets)

Sickness (such as metoclopramide)

Spasms in the blood vessels (such as papaverine).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this
medicine.
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Pregnancy, breast-feeding and fertility
Do not take Levovar if you are pregnant as sufficient experience from use in pregnant women is missing.
Do not take Levovar if you are breast-feeding as levodopa passes into human milk.
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.
Driving and using machines



3.

Levovar affects different people in different ways. Levovar 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. (see 'Possible side effects').
Levovar can also make you sleepy or cause 'sudden sleep attacks'. If this happens to you, you must
not drive or use tools or machines. Your doctor will tell you if you can start driving again if these
attacks stop.
How to take Levovar

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The dosage will be decided by your doctor who will adjust the dosage individually for you.
Your doctor will monitor you on a regular basis and adjust your dosage if necessary.
Taking this medicine
The tablets should be dissolved in half a glass of water. When dissolved in water, a whitish solution is
formed that should be consumed immediately.
Levovar should only be used with MyFID dose dispenser. Your doctor will adjust the dosage to you
by using functions of the dose dispenser.
The tablets should be taken at regular time intervals. The dose dispenser has a function that reminds
you and facilitates for you to remember to take your tablets.
The dose dispenser registers doses taken and has a rating system of your symptoms from which data
can be transferred to your doctor.
The dose dispenser is loaded with a cartridge containing 750 dispersible tablets. At normal dosage one
cartridge lasts 1–2 weeks. The foil bag should be removed before the cartridge is placed into the dose
dispenser.
The tablets should be taken as follows;
The dose dispenser MyFID alerts and a message switches between "TAKE DOSE” and a specified
time. Press this message. You can take your dose 15 minutes before to 15 minutes after the specified
time. Before you take a dose, turn the dose dispenser upside down. This to allow any jammed tablets
to detach. After pressing "TAKE DOSE" a window will open. Adjust the dose upwards or downwards
if needed and recommended by your doctor. Please note that your doctor will set how much you are
allowed to adjust. Then press "TAKE DOSE" again. The tablets are counted and collected in a
container inside the dose dispenser (the collector). Keep the dose dispenser MyFID upright during the
tablet count.
The micro tablets are now fed into the container inside the dose dispenser. When the tablet count has
ended, a new window will open. Keep the dose dispenser upright above a glass and press "EJECT",
and the micro tablets will be ejected into the glass/cup. Keep the dose dispenser upright until the
dispensing is finished.
After the tablets have been ejected, add ½- 1 dl of water. The tablets dissolve in 15 seconds and a clear
solution with white sediment is obtained. Stir the glass to suspend the sediment and drink everything,
including the sediment. Rinse preferably with an additional ½ dl of water to be sure that you
swallowed the entire dose. The solution should be taken immediately after dissolution.
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Doses above 100 mg, i.e. above 20 tablets will be counted and ejected in two rounds. You will be
asked to eject the tablets twice. Follow the instructions on the screen. Tablets in the second round will
be dispensed only after you pressed "EJECT".
For further information, see the manual of the dose dispenser.
Levovar with food and drink: Some patients may experience slightly less effect of Levovar if the
tablets are taken with protein rich food. Meat, fish, eggs, beans, milk and cheese contain protein. If
possible, take Levovar 30 minutes before or 1 hour after a meal.

If you have not had levodopa before
100 mg (20 dispersible tablets) three times a day. Your doctor will gradually increase the dose using an
escalation scheme in the dose dispenser.
Patients with unsatisfactory effect at the end of dose interval (wearing off) may be helped by dividing the
dosage into smaller, more frequent dosing without, however, altering the daily dose. Your doctor will help
you to adjust the dose and dosage frequency.
If you have had levodopa before
your doctor will ask you to stop taking your medicine for Parkinson’s disease before you start taking
Levovar.
Use in children and adolescents
The safety of Levovar in patients under 18 years has not been established. There is no relevant use of
Levovar for children and adolescents for the treatment of Parkinson's disease.
If you take more Levovar than you should
If you take too many tablets see your doctor immediately.
If you forget to take Levovar
Do not take a double dose to make up for a forgotten dose.
If you stop taking Levovar
Do not stop taking Levovar without talking to your doctor. When you stop taking Levovar you may
experience muscles stiffness, high temperature (fever) and mental changes.
If you temporarily have to stop your treatment with Levovar, e.g. before surgery, you should continue with
your regular dosage as soon as possible.
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.
Stop taking Levovar and see your doctor straight away if notice any of the following side effects:

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

chest pain

uneven (irregular) heart beat or palpitations

bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastrointestinal bleeding)

blood problems, the signs may include pale skin (pallor), tiredness, fever, sore throat or mild bruising
and prolonged bleeding after injury

muscle stiffness, severe inability to sit still, high fever, sweating, increased salivation and impaired
consciousness (neuroleptic malignant syndrome)

mental changes including delusions, hallucinations and depression (very rarely) suicidal tendencies

fits (convulsions).
Other side effects that may occur:
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Common (may affect up to 1 in 10 people):
loss of appetite (anorexia)
confusion, dizziness, nightmares, drowsiness, tiredness, sleeplessness, feeling of well-being
(euphoria), dementia, feeling of stimulation, dream abnormalities
movement disorders (dyskinesia), a disorder characterised by sudden involuntary movements (chorea),
muscle tone disorder (dystonia), movement disorders caused from outside the nervous system , sudden
changes in Parkinson’s symptoms ("on-off" symptoms), slowdown in movements during "on-off"
periods (bradykinesia)
a drop in blood pressure caused e.g. by getting up too quickly from a sitting or lying position,
sometimes accompanied by dizziness (orthostatic hypotension), tendency to faint
sudden loss of consciousness
nausea, vomiting, dry mouth, bitter taste
Uncommon (may affect up to 1 in 100 people):
weight loss or weight gain
disturbance of muscle coordination (ataxia), increase in hand tremors
increase in blood pressure
hoarseness, chest pain
constipation, diarrhea, wind
increased salivation, difficulties in swallowing
fluid accumulation (oedema)
muscle spasms
dark urine
loss of strength (asthenia), weakness
feeling of being unwell (malaise)
hot flushes
Rare (may affect up to 1 in 1,000 people):
a blood disorder (lack of white blood cells) accompanied by an increased susceptibility to infections
(leukopenia), anaemia , a blood disorder (lack of blood platelets) accompanied by bruising and a
tendency to bleed (thrombocytopenia)
excitement (agitation), anxiety, impaired ability to think, disorientation, headache, increased sexual
desire, numbness, fits/ seizures
episodes of serious mental illness, during which control over one’s own conduct and behaviour is
impaired
a serious condition as a result of using neuroleptics, which may manifest as muscle stiffness, a severe
inability to sit still, high fever, sweating, increased salivation and impaired consciousness (neuroleptic
malignant syndrome),
feelings of prickling, tingling and itchiness without any apparent cause ,
more frequent falling, gait disorders, lockjaw
blurred vision, spasm of the orbicularis oculi muscle surrounding the eye (this may be a sign of
overdosage), activation of a pre-existing Horner's syndrome (an eye disorder), double vision, dilated
pupils, a deterioration in eye movements,
inflammation of the veins
breathlessness, abnormal breathing patterns
impaired digestion with symptoms such as feelings of fullness in the upper abdomen, upper
abdominal pain, belching, nausea, vomiting and heartburn (dyspepsia), stomach and intestinal pain,
dark saliva, grinding of teeth, hiccups, stomach and intestinal bleeding , burning tongue, duodenal
ulcers
sudden build-up of fluid in the skin and mucous membranes (e.g. throat and tongue), breathing
difficulties and/or itching and skin rash, often appearing as an allergic reaction (angioedema)
skin rash with severe itching and the formation of wheals (urticaria), itching, facial redness, hair loss,
skin rash, increased sweating, dark sweat
in children, allergy-related bleeding in the skin and gastrointestinal tract wall (Schönlein- Henoch
purpura)
urine retention, involuntary passing of urine, persistent erection (priapism)
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Very rare (may affect up to 1 in 10,000 people):
a very serious blood disorder (lack of white blood cells) accompanied by sudden high fever, severe
sore throat and mouth ulcers (agranulocytosis)
drowsiness and constant daytime fatigue/ sudden attacks of sleep
Not known (frequency cannot be estimated from the available data):
muscle twitching
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.
If any symptoms persist or you experience any other side effects please tell your doctor or pharmacist. It will
help if you make a note of what you experienced, when it started and how long it lasted.
Reporting of side effects
If you get any side effects, talk to your doctor orpharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website:
www.mhra.go.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Levovar

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Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light and moisture.
After removing the foil bag, the cartridge should be used within 2 months and stored below 30°C.
Do not expose the cartridge to moisture.
Do not use this medicine after the expiry date which is stated on the cartridge 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 medicines you no longer use. These measures will help protect the environment.

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6.

Contents of the pack and other information

What Levovar contains
– The active substances are levodopa and carbidopa.
– The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, maize starch,
sodium, magnesium stearate.
What Levovar looks like and contents of the pack
Cartridge packaged in an aluminium foil/polyethylene/polyester bag containing 750 white, spherical,
dispersible tablets with a diameter of about 3 mm.
Pack size: 10x750 dispersible tablets.
Levovar should be used with a dose dispenser. Only MyFID dose dispenser should be used.
Marketing Authorisation Holder and Manufacturer
Sensidose AB
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Vetenskapsvägen 10
S-191 38 Sollentuna
Sweden
Manufacturer
Recipharm Pharmaceutical Development AB
Gårdsvägen 10
S-169 70 Solna
Sweden

This medicinal product is authorised in the Member States of the EEA under the following names:
SE
DK
NO
FI
IS
DE
AT
BE
NL
LU
PL
LV
EE

Flexilev
Flexilev
Suades
Flexilev
Flexilev
Suades 5 mg/1,25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen für einen
Dosierspender
Flexilev
Suades 5 mg/1,25 mg, dispergeerbare tablet voor dispenser
Flexilev 5 mg/1,25 mg, dispergeerbare tablet voor dispenser
Flexilev
Flexilev
Flexilev 5 mg/1,25 mg disperģējamā tablete tablešu izsniegšanas ierīcei (Sensidose AB)
Flexilev

This leaflet was last revised in July 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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