108 mg/ml solution for injection perphenazine
decanoate
What Trilafon decanoate is and what it is used for
Trilafon decanoate belongs to a group of medicines used in the treatment of psychoses.
Trilafon decanoate blocks certain signaling substances in the central nervous system and thereby acts with a pronounced antipsychotic effect (reduces delusions, delusions, disturbance in thought process, confusion, and disturbance of consciousness) and also acts to suppress psychomotor restlessness (psychologically conditioned movement patterns).
Trilafon decanoate is used for delusions, leaps in thought, disturbance of consciousness, lack of understanding of illness, hallucinations (delusions), with several symptoms of mental illness.
Perphenazine decanoate contained in Trilafon decanoate may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you receive Trilafon decanoate
You cannot get Trilafon decanoate
– if you are allergic to the active substance or any of the other ingredients in this medicine (listed in section 6).
– if you have leukopenia or agranulocytosis (blood count changes).
– if you have pheochromocytoma (a rare benign tumor of the adrenal glands).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive Trilafon decanoate
- if you or someone in your family has a history of blood clots, as this type of medicine has been associated with blood clot formation.
- if you have epilepsy and convulsions
- if you have pronounced arteriosclerosis (hardening of the arteries).
- if you have circulatory failure .
- if you have cardiovascular disease or changes in heart rhythm.
- if you are at risk of brain bleeding ( stroke ).
- if you have liver or kidney disease.
If you have any of these diseases, you should tell your doctor before starting treatment with Trilafon decanoate.
Trilafon decanoate can cause dry mouth and can cause damage to the teeth and oral mucosa during long-term treatment. The teeth should be thoroughly cleaned with fluoride toothpaste 2 times a day.
Trilafon decanoate can cause extrapyramidal symptoms (involuntary movements) at higher dosages . These can often be counteracted by simultaneous treatment with an anti-parkinsonian drug.
Other medicines and Trilafon decanoate
The treatment effect can be affected if this medicine is given at the same time as certain other medicines. Doses may need to be adjusted. Treating physicians need to be aware of other concomitant medications.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those without a prescription.
Always consult a doctor before combining Trilafon decanoate with sleeping pills or strong painkillers (opiates).
Trilafon decanoate with alcohol
Never combine alcohol and Trilafon decanoate.
Pregnancy, breastfeeding 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 using this medicine.
The following symptoms may occur in newborn babies of mothers who used Trilafon decanoate during the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, restlessness, breathing problems and difficulty eating. If your child shows any of these symptoms, you may need to see a doctor.
Trilafon decanoate passes into breast milk but is unlikely to affect children who are breastfed.
Driving ability and use of machinery
Trilafon decanoate can impair the ability to react in some people, which should be taken into account at times when increased attention is required, for example when driving a car and working with precision.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Trilafon decanoate contains propyl paraben and sesame oil
Propylparaben (E216) can cause an allergic reaction (possibly delayed) and exceptionally spasms in the trachea.
In rare cases, sesame oil can cause a severe allergic reaction .
How to get Trilafon decanoate
How Trilafon decanoate is given
Trilafon decanoate is given to you by a doctor or other healthcare professional. The doctor decides how much Trilafon decanoate you will receive.
Trilafon decanoate is injected into a muscle.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
If you experience serious side effects , contact your doctor or pharmacist.
Tell your doctor immediately if you:
Common (may affect up to 1 in 100 users):
- at higher dosage experience involuntary movements (especially extrapyramidal symptoms). This may occur at higher dosages , however, with significant individual variations.
Uncommon (may affect up to 1 in 100 users):
- experience a rapid course (within 1-3 days) of fever, muscle stiffness, confusion and disturbed heart rhythm (neuroleptic malignant syndrome). This may require emergency treatment.
Has been reported (occurring in an unknown number of users):
- get blood clots, especially in the legs (symptoms such as swelling, pain and redness of the legs). Blood clots in the lungs (symptoms such as chest pain and difficulty breathing) have been reported. If you experience any of these symptoms, seek medical attention immediately.
- experience allergic reaction with skin reaction, facial swelling and/or fever. Contact a doctor immediately if swelling of e.g. face, tongue and/or throat and/or difficulty swallowing or hives occurring together with difficulty breathing occurs ( angioedema ).
Other side effects that may occur:
Common (may affect up to 1 in 10 users):
- somnolence
- fatigue
- reduced mobility
- tardive dyskinesia (abnormal repetitive movements)
- akathisia (inability to sit still)
- muscle stiffness
- tremors
- slow movements,
- dry mouth
- mammary gland enlargement (in men)
- milk flow from breast
Uncommon (may affect up to 1 in 100 users):
- weight gain/weight loss
- dizziness
- fainting
- impaired ability to concentrate
- constipation
- urination disorder
- accommodation problems (difficulty reading fine print).
Rare (may affect up to 1 in 1,000 users):
- agranulocytosis (lack of white blood cells )
- palpitation
- impact on heart rhythm
- irregular heart rhythm and EKG changes in connection with this
- cardiac arrest
- rhythm disorders of various kinds (including Torsade de Pointes )
- heart fibrillation
- headache
- nausea
- rash and itching .
Has been reported (occurring in an unknown number of users):
- cases of sudden death, which may be caused by serious heart problems, have been reported with this type of medicine.
- Trilafon decanoate can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with a greatly worsened general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or vomiting, you should see a doctor as soon as possible so that a lack of white blood cells ( agranulocytosis ) can be ruled out via a blood test . It is important that you then inform about your medication.
- liver damage may occur. Jaundice, usually reversible , has been reported in rare cases.
With treatment for longer periods, problems with vision have been reported.
In elderly people with dementia treated with antipsychotic drugs, a small increase in the number of deaths has been reported compared to those not receiving such treatment.
How to store Trilafon decanoate
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25°C.
Use before the expiry date stated on the carton and on the ampoule . The first two digits indicate the month, the following four digits indicate the year. The expiration date is the last day of the specified month.
Contents of the packaging and other information
Contents declaration
- The active substance is perphenazine in the form of perphenazine decanoate. 1 ml contains 108 mg perphenazine decanoate corresponding to 78 mg perphenazine.
- Other ingredients are sesame oil and propylparaben ( preservative E 216).
Appearance and package sizes of the medicine
Trilafon decanoate is a solution for injection .
Trilafon decanoate is available in glass ampoules, 10 x 1 ml. The ampoules have two colored rings. The upper ring is brown and the lower dark blue.
Marketing Authorisation Holder
Orion Corporation
Orion Intie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orion Intie 1
FI-02200 Espoo
Finland
For further information about this medicine, contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com