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• Flexilev dispersible tablets for dose dispenser PL
• Flexilev dispersible tablet ENG PL

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PACKAGE LEAFLET

Package leaflet: Information for the user

Flexilev 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.

What is in this leaflet

1. What Fexilev is and what it is used for

2. What you need to know before you take Flexilev

3. How to take Flexilev

4. Possible side effects

6. Contents of the pack and other information

Flexilev 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.

Flexilev 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.

Flexilev 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.

Do not take Flexilev:

• 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).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Flexilev:

• 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 Flexilev

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 Flexilev 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.

Pregnancy, breast-feeding and fertility

Do not take Flexilev if you are pregnant as sufficient experience from use in pregnant women is missing.

Do not take Flexilev 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

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.

- Flexilev 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.

- 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.

- Flexilev with food and drink: Some patients may experience slightly less effect of Flexilev if the tablets are taken with protein rich food. Meat, fish, eggs, beans, milk and cheese contain protein. If possible, take Flexilev 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 Flexilev.

Use in children and adolescents

The safety of Flexilev in patients under 18 years has not been established. There is no relevant use of Flexilev for children and adolescents for the treatment of Parkinson's disease.

If you take more Flexilev than you should

If you take too many tablets see your doctor immediately.

If you forget to take Flexilev

Do not take a double dose to make up for a forgotten dose.

If you stop taking Flexilev

Do not stop taking Flexilev without talking to your doctor. When you stop taking Flexilev you may experience muscles stiffness, high temperature (fever) and mental changes.

If you temporarily have to stop your treatment with Flexilev, 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 Flexilev 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 (gastro-intestinal 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:

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)

Very rare (may affect up to 1 in 10,000people):

• 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):

- 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 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 Flexilev

- 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.

6. Contents of the pack and other information

What Flexilev contains

What Flexilev 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.

Flexilev should be used with a dose dispenser. Only MyFID dose dispenser should be used.

Marketing Authorisation Holder and Manufacturer

Sensidose AB

Vetenskapsvägen 10

S-191 38 Sollentuna

Sweden

Manufacturer

Recipharm Pharmaceutical Development AB

Gårdsvägen 10

S-169 70 Solna

Sweden

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This leaflet was last revised in 30 June 2016.

<Other sources of information>

<Detailed information on this medicine is available on the website of {MS/Agency}>