Getting started – How to take Fintepla

Fintepla (fenfluramine) should always be taken exactly as your doctor, pharmacist or nurse has explained. Check with your healthcare professional if you are not sure or have any questions about how to take it. Please also read the Package Leaflet which is included in the packaging.

If the patient who is to take Fintepla:

  • has glaucoma
  • had thoughts about harming or killing themselves
  • is taking a medicine called cyproheptadine, which is used to treat allergies or to improve appetite

it is important to talk to your doctor, pharmacist or nurse before starting treatment with Fintepla.

What’s in the carton

Each carton of Fintepla contains a bottle of clear, colourless, cherry-flavoured oral solution with a child-resistant, tamper evident cap.

The carton also contains:

  • two 3mL oral syringes with 0.1mL graduations
  • two 6mL oral syringes with 0.2mL graduations
  • a bottle adaptor
  • a copy of the Package Leaflet

Before taking Fintepla

Serotonin syndrome

Before taking Fintepla, tell your doctor or pharmacist if the patient who is going to take Fintepla is taking medicines which can increase the levels of serotonin in their brain. This is because taking these medicines along with Fintepla can cause serotonin syndrome, which is a life-threatening condition. Medicines that can increase serotonin levels include:

  • ‘triptans’ (such as sumatriptan) – used for migraine
  • MAOI medicines – used for depression
  • SSRI or SNRI medicines – used for depression and anxiety

Look out for the signs of serotonin syndrome which include:

  • being agitated, seeing things which are not there (hallucinations) or passing out
  • heart and circulation problems such as fast heartbeat, blood pressure going up and down, high body temperature, sweating
  • twitching muscles and being uncoordinated
  • feeling or being sick and diarrhoea

Tell your doctor straight away if you notice any of the serious side effects above.

MAOI, monoamine oxidase inhibitors; SSRI, selective serotonin reuptake inhibitor; SNRI, serotonin-norepinephrine reuptake inhibitor.

Other medicines and Fintepla

Tell your doctor or pharmacist if the patient who is to take Fintepla is taking, has recently taken, or might take, any other medicines. This is because Fintepla can affect the way some other medicines work, and some other medicines can also affect the way Fintepla works.

Fintepla can make the patient who is taking it feel sleepy. They may be even more sleepy if they take other medicines such as anti-depressants or alcohol at the same time as Fintepla.

In particular, tell your doctor or pharmacist if the patient who is to take Fintepla has recently taken, or might take:

  • stiripentol, a medicine for epilepsy, as the patient’s dose of Fintepla may need to be reduced
  • ‘triptans’, MAOI, SNRI or SSRI medicines – see above under ‘Serotonin syndrome’
  • carbamazepine, primidone, rifampicin, phenobarbital and other barbiturates, phenytoin, and efavirenz, as the patient’s dose of Fintepla may need to be increased

Also speak with your doctor or pharmacist if the patient who is to take Fintepla smokes as the dose of Fintepla may need to be increased.

MAOI, monoamine oxidase inhibitors; SSRI, selective serotonin reuptake inhibitor; SNRI, serotonin-norepinephrine reuptake inhibitor.

Information about Fintepla ingredients and allergies

Fintepla should not be taken if the patient is allergic to fenfluramine or any of the other ingredients of this medicine.

Fintepla contains:

  • sodium ethyl p-hydroxybenzoate (E 215) and sodium methyl p-hydroxybenzoate (E 219) which may cause allergic reactions (possibly delayed)
  • sulfur dioxide (E 220) which may rarely cause hypersensitivity reactions and bronchospasm
  • glucose, which, as a sugar, may be harmful to teeth. (If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Fintepla)
  • less than 1 mmol sodium (23mg) per 12 mL, that is to say essentially ‘sodium-free’

About Fintepla

  • Fintepla is taken by mouth and can be taken with food or between meals
  • Fintepla oral solution is compatible with a ketogenic diet
  • Fintepla is a clear, colourless, cherry-flavoured liquid. The solution is available in a white bottle with a child-resistant, tamper-evident cap. Use the oral syringes provided to measure the dose, as explained below
  • Fintepla oral solution is compatible with most enteral feeding tubes

Use the green 3mL syringe for doses up to 3.0mL

Use the purple 6mL syringe for doses between 3.2mL and 6.0mL

How much to take

Your doctor, nurse or pharmacist will tell you how many millilitres (mL) of Fintepla to take for each dose.

Fintepla is taken twice a day.

Your doctor will start the patient who is to take Fintepla on a low dose. This will then be gradually increased depending on how well Fintepla works and how it affects the patient who is taking it.

The maximum amount of Fintepla patients can take is 6mL twice a day.

If the patient who is taking Fintepla is also taking stiripentol, the maximum amount of Fintepla they can take is 4mL twice a day.

The patient must not take more than the prescribed dose as it may cause serious side effects.

If the patient who is taking Fintepla takes more than the prescribed dose then they should:

Talk to a doctor or go to a hospital straight away. Take the medicine bottle with you. The following effects may happen: being agitated, sleepy or confused, being flushed or hot, shivering and sweating.

If the patient taking Fintepla misses or forgets to take a dose:

  • take it as soon as it is remembered. However, if it is nearly time to take the next dose, skip the missed dose
  • do not take a double dose to make up for a forgotten dose

Take Fintepla in 7 simple steps

Write on the carton the date you first opened the bottle.

You must attach the bottle adaptor the first time you open the bottle. The following instructions tell you how to attach the adaptor.

Inserting the bottle adaptor:

  • when the bottle is first opened the bottle adaptor must be pushed into the bottle
  • wash and dry your hands
  • remove the bottle adaptor from its packaging
  • place the bottle on a flat, firm surface
  • open the bottle

Hold the bottle firmly.

Line up the bottle adaptor with the open top of the bottle.

Push the bottle adaptor into the bottle with your palm until the adaptor is flush with the top of the bottle.

Leave the bottle adaptor in the bottle after using the medicine.

Screw the bottle cap onto the bottle with the bottle adaptor left in.

Taking the medicine:

Before you measure out the dose, make sure the plunger is pushed all the way into the oral syringe.

Hold the bottle of medicine firmly on a hard, flat surface.

Push the tip of the oral syringe into the bottle adaptor until it cannot be pushed further.

Hold the oral syringe and bottle together and turn upside down.

Slowly pull the plunger to draw up the right dose.

Hold the oral syringe and bottle together and then turn over.

Holding the bottle firmly, gently pull the oral syringe out of the bottle adaptor.

Place the tip of the oral syringe against the inside of the patient’s cheek.

Gently push the plunger until it is fully pressed. There will be a small volume left in the tip of the syringe. This is normal.

Do not squirt the medicine into the back of the throat as this may cause choking.

Place the cap back on the bottle and turn until it stops.

Always leave the adaptor in place in the bottle.

Cleaning the syringe:

Rinse the oral syringe with clean water and allow it to air dry after each use.

Rinse the inside of the syringe and the plunger.

Clean water can be pulled into the syringe with the plunger and pushed out several times to clean the syringe.

It is okay to separate the plunger from the syringe to rinse each part.

It is safe to clean the syringe and plunger in a dishwasher.

The syringe and plunger must be completely dry before the next use.

If the patient who is taking Fintepla stops taking it:

The patient should not stop taking Fintepla without talking to their doctor. If the doctor decides to stop Fintepla, they will ask the patient or carer to slowly lower the amount taken each day. Slowly lowering the dose will reduce the risk of having a seizure and status epilepticus (a prolonged seizure).

The patient who was taking Fintepla will need to have an echocardiogram six months after the last dose of Fintepla was taken.

This website is intended for patients in Europe who have been prescribed Fintepla and their caregivers

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you or the person you care for may experience. See the What to look out for section for how to report side effects.

Fintepla is a medicine which is prescribed to treat the seizures that patients with Dravet syndrome can experience. Fintepla is used with other drugs to treat seizures in Dravet syndrome patients aged 2 years of age and older.

Dravet syndrome is a rare form of epilepsy which usually starts when a child is less than 1 year old. Patients who suffer from it often have very frequent and severe seizures. You can learn more about Dravet syndrome here.