5 mg / 1.25 mg dispersible tablets for dose dispensing
levodopa / carbidopa

1. What Flexilev is and what it is used for

Flexilev improves symptoms of Parkinson’s disease. Parkinson’s disease is a lifelong disease in which:

  • you become slow and unstable
  • your muscles feel stiff
  • you can develop tremors and twitching (so-called tremor )

Without treatment, Parkinson’s disease can make it difficult for you to continue with normal daily activities.

Flexilev contains two different drug substances called levodopa and carbidopa.

  • Levodopa is converted to a substance called dopamine in the brain. Dopamine helps reduce the symptoms of Parkinson’s disease.
  • Carbidopa belongs to a group of medicines called ‘aromatic amino acid decarboxylase inhibitors. Carbidopa helps levodopa to work more efficiently because carbidopa causes levodopa to be broken down more slowly in your body.

Flexilev is a small “micro-tablets” that are taken with the help of a dose dispenser. The dosing dispenser, which can be programmed by your doctor or nurse, delivers a certain number of tablets at each dosing occasion.

Levodopa/carbidopa contained in Flexilev may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Flexilev

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 had skin cancer or have any abnormal skin change that has not been examined by your doctor
  • if you are taking special medicines called MAOIs (monoamine oxidase inhibitors) for depression. You must stop taking these medicines at least two weeks before you start using Flexilev (see also ´Other medicines and Flexilev ‘, below)
  • if you have so-called narrow-angle glaucoma that can cause sudden increased pressure in the eye
  • if you suffer from attacks of high blood pressure induced by a tumor of the adrenal medulla ( pheochromocytoma )
  • if you have hormonal disorders (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 cautions

Talk to your doctor or pharmacist before taking Flexilev:

  • if you have had seizures (convulsions)
  • if you have lung problems (such as bronchial asthma)
  • if you have had stomach ulcers (so-called “duodenal” or “peptic” stomach ulcers ) or bloody vomiting
  • if you have had a heart attack, arrhythmias, circulatory problems
  • if you are taking medicines that can cause low blood pressure when you get up from the chair or bed ( orthostatic hypotension )
  • if you have kidney or liver problems
  • if you have hormonal disorders
  • if you have had depression or other mental difficulties
  • if you have glaucoma ( glaucoma ) with an open chamber angle that can cause excessive pressure in the eye. You should regularly check the pressure in your eye.
  • if you have had sudden sleep attacks or sometimes feel very sleepy
  • if you are going to have surgery

Tell your doctor if you or your family/caregiver notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, dr, I’ve or temptation to perform certain activities that can harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to re-evaluate your treatment.

Tell your doctor if you or your family/caregiver notice that you are developing addictive symptoms that lead to a craving for larger doses of Flexilev and other medicines used to treat Parkinson’s disease.

This medicine may affect some laboratory tests that your doctor may need to perform on blood or urine tests. If you are not sure 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 also applies to herbal medicines. The effect of the treatment can be affected if Flexilev and certain other medicines are taken at the same time.

It is especially important to 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 disease, and low blood pressure (such as anticholinergics and sympathomimetics )
  • Convulsions or epilepsy (such as phenytoin )
  • High blood pressure (antihypertensive)
  • Mental problems (antipsychotics such as phenothiazines, butyrophenones, and risperidone )
  • Depression (such as tricyclic antidepressants or non-selective monoamine oxidase inhibitors )
  • Tuberculosis (such as isoniazid )
  • Anxiety (such as benzodiazepines )
  • Anemia (such as iron tablets)
  • Nausea (such as metoclopramide)
  • Spasm in the blood vessels (such as papaverine)

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

Pregnancy, breastfeeding, and fertility

Flexilev should not be used during pregnancy, as sufficient experience is lacking.

Do not use Flexilev while breast-feeding as levodopa is excreted in 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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

  • Flexilev affects different people in different ways. Flexilev can cause low blood pressure which can make you dizzy. Therefore, caution should be exercised when driving or using tools or machines (see section ‘Possible side effects).
  • Flexilev can also make you sleepy or cause sudden ‘sleep attacks’. If this happens, do not drive or use any tools or machines. If these attacks stop, your doctor will tell you when you can drive again.

3. How to take Flexilev

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one will be determined by your doctor and adjusted individually for you.

Your doctor will monitor you regularly and adjust your dose if necessary.

Use of Flexilev

  • The tablets should be dissolved in half a glass of water. Upon dissolution in water, a whitish solution is formed which should be drunk immediately.
  • Flexilev should only be used with the MiFID dose dispenser. Your doctor will adjust the dosage one for you using the dose dispenser features.
  • Take the tablets at regular times. The dosing dispenser has a reminder function that can make it easier for you to remember to take your tablets.
  • The dosing dispenser registers dose withdrawals and has a system for evaluating your symptoms from which data can be transferred to your doctor.
  • The dosing dispenser is loaded with a cartridge that holds 750 dispersible tablets. At normal dosing, one cartridge lasts 1-2 weeks. Before placing the cassette in the dose dispenser, remove the foil pouch.

The tablets are taken as follows;

  • The dosing dispenser MyFID alarms and the image switches between “TA DOS” and a time. Tap this image. You can take your dose 15 minutes before to 15 minutes after the specified time. Before taking a dose, turn the device upside down. This causes any locked tablets to come loose. After pressing “TA DOS” a window will open. Adjust the dose one up or down if you need to and your doctor will recommend it. Note that your doctor will set how much you can adjust. Then press “TA DOS” again. The tablets are counted and collected in a container inside the dose dispenser (collector). Hold the dose dispenser MiFID upright during the tablet count. The micro-tablets are now fed to the container inside the dose dispenser. When the calculation is complete, a new window will open. Hold the dose dispenser upright over a glass and press “EUT OUT” and the micro tablets are dispensed into the glass/cup. Hold the dose dispenser upright until dispensing is complete.
  • After dispensing the tablets, add ½ – 1 dl of water. The tablets dissolve within 15 seconds and a clear solution with white sediment is obtained. Stir around the glass so the solution slurries up and drink everything, including the sediment. Feel free to rinse with an additional ½ dl to be sure that you have ingested the entire dose. The solution should be taken as soon as possible after dissolution.
  • Dose over 100 mg, ie over 20 tablets will be counted and dispensed in two batches. You will be asked to dispense the tablets twice. Follow the instructions on the screen. The tablets in the second round only come out when you press “Eject”.
  • For further information, see the dose dispenser’s instructions for use.
  • Flexilev with food and drink: Some patients may experience a slightly worse effect of Flexilev if the dispersible tablets are taken with protein-rich foods. 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 taken levodopa before

100 mg (20 dispersible tablets) three times daily. Your doctor will step up the dosing slowly using an escalation schedule in the dose dispenser.

Patients with insufficient effect at the end of the dosing interval (dose gap) can be helped by dividing dose one into smaller doses that are taken more often, without changing the daily dose. Your doctor will help you adjust dose one and how often does one should be taken.

If you have taken levodopa before

Your doctor will ask you to stop taking your medicines for Parkinson’s disease before you start taking Flexilev.

Use for children

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

If you take more Flexilev than you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

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 first. When you stop taking Flexilev, you may experience muscle stiffness, elevated body temperature (fever) and mental changes.

If you have to temporarily stop treatment with Flexilev, for example before an operation, you should continue with your usual dosage as soon as possible.

If you have any further questions on the use of this product, 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 contact a doctor immediately if  you notice any of the following side effects:

  • allergic reaction , signs may include urticaria ( rash ), burning, rash, swelling of the face, lips, tongue or throat. This may cause difficulty breathing or swallowing
  • chest pain
  • irregular (irregular) heartbeat or palpitations
  • bleeding from the stomach that can be seen as blood in the stool or dark stools ( gastrointestinal bleeding)
  • blood problems, signs may be pale skin, fatigue, fever, sore throat or light bruising as well as prolonged bleeding after injury
  • muscle stiffness, difficulty sitting still, high fever, sweating, increased salivation and decreased consciousness (neuroleptic malignant syndrome)
  • mental changes such as imagination, hallucinations and depression (very rare) suicidal tendencies
  • convulsions (convulsions).

Other side effects that may occur:

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

  • loss of appetite (anorexia)
  • confusion, dizziness, nightmares, drowsiness, fatigue, insomnia, feeling of well-being ( euphoria ), dementia, feeling of stimulation, altered dream pattern
  • movement disorders ( dyskinesia ), a disorder that appears as sudden involuntary movements (korea), muscle tone disorder ( dystonia ), movement disorders caused from outside the nervous system, sudden changes in symptoms of Parkinson’s (“ON-OFF effect”), slowing of movements during ON -OFF periods ( bradykinesia )
  • drop in blood pressure caused by, for example, getting up too quickly from a sitting or lying position, sometimes together with dizziness (orthostatic hypotension ), risk of fainting
  • suddenly lost consciousness
  • nausea, vomiting, dry mouth , bitter taste

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

  • weight loss or weight gain
  • disturbance in muscle coordination ( ataxia ), increased tremors in the hands
  • high blood pressure
  • hoarseness, chest pain
  • constipation, diarrhea, flatulence
  • increased salivation, difficulty swallowing
  • fluid retention ( edema )
  • muscle spasms
  • dark-colored urine
  • weakness ( asthenia ), weakness
  • malaise
  • hot flashes

Rare (may affect up to 1 in 1,000 people):

  • a blood disorder (lack of white blood cells ) accompanied by an increased susceptibility to infection (leuopenia), anemia , a blood disorder (lack of red platelets ) accompanied by bruising and a tendency to bleed ( thrombocytopenia )
  • tension ( agitation ), anxiety, impaired thinking ability, disorientation, headache, increased sex drive, numbness, seizures / seizures
  • episodes of severe mental illness where control over their behavior and behavior is impaired
  • a severe condition as a result of the use of neuroleptics which may start as muscle stiffness, difficulty sitting still, high fever, sweating, increased salivation and impaired consciousness (neuroleptic malignant syndrome),
  • tingling, tingling and itching for no apparent reason,
  • increased risk of falling, gait disorders, tetanus
  • blurred vision, spasm of the orbicularis oculi muscle surrounding the eye (this may indicate overdose), activation of the present-day Horner syndrome (an eye disease), double vision, dilated pupils , deterioration in eye movements,
  • venous inflammation
  • shortness of breath, abnormal breathing pattern
  • indigestion with symptoms of satiety in the upper abdomen, upper abdominal pain, belching, nausea, vomiting, and heartburn ( dyspepsia ), gastric and intestinal pain, dark colored saliva, tooth grinding, hiccups, gastrointestinal bleeding, burning tongue, ulcers in the duodenum an
  • sudden accumulation of fluid in the skin and mucous membranes (eg throat and tongue), difficulty breathing and / or itching and rash, often seen as an allergic reaction ( angioedema )
  • skin rash with severe itching and formation of hives ( urticaria ), itching , redness , hair loss, skin rash, increased sweating, dark-colored sweat
  • in children, allergy-related bleeding in the skin and gastrointestinal wall (Henoch-Schönlein Purpura)
  • difficulty urinating, involuntary urination, prolonged erection (priapism)

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

  • a very severe blood disorder (lack of white blood cells ) followed by sudden high fever, severe sore throat and cold sores ( agranulocytosis )
  • drowsiness and constant fatigue during the day / sudden sleep attacks

Has been reported (occurs in an unknown number of users):

  • muscle twitching
  • inability to resist an impulse to perform an action that may be harmful such as:
    • a strong impulse to excessive gambling despite serious consequences for you personally or for your family
    • altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
    • controllable and excessive need to buy things and spend money
    • binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
    • Request a higher dose of Flexilev that is greater than that required to control motor systems, known as dopaminergic dysregulation syndrome. Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings or other side effects after taking larger doses of Flexilev.

Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Flexilev

  • Keep this medicine out of the sight and reach of children.
  • Store in the original package. Sensitive to light. Moisture sensitive.
  • After removal of the foil bag, the cassette should be used within 2 months and stored at a maximum of 30 ° C. Do not expose the cartridge to moisture.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are levodopa and carbidopa.
  • The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, corn starch, sodium starch glycolate, magnesium stearate.

What the medicine looks like and contents of the pack

Cassette for dose dispenser, packed in an aluminum foil / polyethylene / polyester bag, containing 750 white, spherical dispersible tablets with a diameter of about 3 mm.

Pack size: 10×750 dispersible tablets for dose dispenser.

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

Marketing Authorization Holder and Manufacturer

info@sensidose.se

Manufacturer

Desitin Arzneimittel GmbH

Weg beim Jeager 214

22335 Hamburg

Germany

This medicinal product is authorized under the European Economic Area under the names

Belgium Zuades 5 mg / 1.25 mg dispersible tablets for dose dispenser
Denmark Flexilev
Estonia Flexilev
Finland Flexilev
Iceland Flexilev
Latvia Flexilev 5 mg / 1.25 mg dispersed tablet tablets in a similar form (Sensidose AB)
Luxembourg Zuades
Netherlands Zuades 5 mg / 1.25 mg, dispersible tablets for dose dispenser
Norway Zuades
Poland Flexilev
UK Levovar 5 mg / 1.25 mg dispersible tablets for dose dispenser
Germany Suades, 5 mg / 1.25 mg, tablets for the preparation of a suspension for taking a dosing dispenser
Austria Zuades

Muhammad Nadeem

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