Active ingredient
- fluphenazine decanoate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL04425/0575.
Modecate Concentrate Injection 100mg/ml
PACKAGE LEAFLET: INFORMATION FOR THE USER
Modecate® Concentrate 100mg/ml Injection
fluphenazine decanoate
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start using this medicine
In this leaflet:
1. What Modecate Concentrate is and what it is used for
2. Before you are given Modecate Concentrate
3. How Modecate Concentrate is given
4. Possible side effects
5. How to store Modecate Concentrate
6. Further information
1. What Modecate Concentrate is and what it is used for
The name of your medicine is Modecate Concentrate 100ml/ml Injection (called Modecate Concentrate throughout this leaflet). Modecate Concentrate contains a medicine called fluphenazine decanoate. This belongs to a group of medicines called ‘phenothiazines’. It works by blocking the effect of a chemical in the brain.
Modecate Concentrate can be used for:
2. Before you are given Modecate Concentrate
Do not have this medicine and tell your doctor if:
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Modecate Concentrate.
You should not be given Modecate Concentrate if you are in a coma.
Take special care with Modecate Concentrate
Check with your doctor or nurse before you have this medicine if:
If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Modecate Concentrate.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Modecate Concentrate can affect the way some other medicines work. Also some medicines can affect the way Modecate Concentrate works.
In particular, do not have this medicine and tell your doctor if you are taking:
The following medicines can increase the chance of you getting side effects, when taken with Modecate Concentrate:
The following medicines can affect the way Modecate Concentrate works or Modecate Concentrate can affect the way some of these medicines work:
Positron Emission Tomography (PET) Studies
Having Modecate Concentrate may affect the results PET studies carried out using labelled glucose. If you are going to have a PET study, it is important to tell your doctor you are having Modecate Concentrate.
Having Modecate Concentrate with food and drink
Do not drink alcohol while you are having Modecate Concentrate. This is because alcohol can increase the effects of Modecate Concentrate and cause serious breathing problems.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Modecate may cause an incorrect false negative result on a pregnancy test.
The following symptoms may occur in newborn babies, of mothers that have used Modecate Concentrate in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
You should not breast-feed if you are taking Modecate Concentrate. This is because small amounts may pass into mothers’ milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel sleepy, tired, have blurred eyesight or your ability to think or respond may be lowered after having this medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Modecate Concentrate
Modecate Concentrate contains:
3. How Modecate Concentrate is given
Modecate Concentrate is normally given by a doctor or nurse. This is because it needs to be given as a deep injection into a muscle.
How much Modecate Concentrate is given
If you are not sure why you are being given Modecate Concentrate or have any questions about how much Modecate Concentrate is being given to you, speak to your doctor or nurse.
The usual dose is:
Adults Modecate Concentrate is usually given every 2 to 5 weeks.
Elderly Your doctor will start you on a lower dose of 6.25mg
Children
Modecate Concentrate should not be given to children.
Tests
Before and during treatment your doctor may want to carry out some tests. These might include blood tests and an ECG to check your heart is working properly.
If you have more Modecate Concentrate than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Ask them if you are not sure why you are getting a dose of medicine.
Having too much Modecate Concentrate may make you feel drowsy and you may become unconscious. You may also feel very cold, have a fast or irregular heartbeat or severe muscle spasms. If you start getting any of these symptoms tell your doctor or nurse straight away. If you are away from the hospital, return straight away and speak to your doctor or nurse or go to the casualty department.
If you miss a dose of Modecate Concentrate
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed.
However, if you do think you have missed a dose, tell your doctor or nurse.
If you stop being given Modecate Concentrate
Keep having Modecate Concentrate until your doctor tells you to stop. If you stop having Modecate Concentrate, your illness may come back and you may have other effects after stopping such as feeling or being sick, sweating and difficulty sleeping. You may also get tics (such as muscle spasms in your face, rolling eyes, jerking muscles) or feel restless.
4. Possible side effects
Like all medicines, Modecate Concentrate can cause side effects, although not everybody gets them.
Tell a nurse or doctor straight away if you have;
Tell a nurse or doctor as soon as possible if you have any of the following side effects:
Talk to your doctor or nurse if any of the following side effects gets serious or lasts longer than a few days:
Tests
As with other phenothiazine medicines, there have been very rare reports of sudden death with Modecate Concentrate. These are possibly caused by heart problems.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Modecate Concentrate
This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it. Store below 25°C, protected from light.
Do not use Modecate Concentrate after the expiry date, which is stated on the ampoule and the carton. The expiry date refers to the last day of the 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. Further Information
What Modecate Concentrate contains
What Modecate Concentrate looks like and contents of the pack
Modecate Concentrate 100 mg/ml Injection is a pale yellow clear liquid supplied in 0.5ml and 1ml colourless glass ampoules with an OPC (one point cut) breaking system.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 02/2015
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