Prolixin Deconate Retard 25 MG/ML Bulb

PROLIXIN Decanoate Retard 25 mg/ml IM/SC Ampoule For intramuscular or subcutaneous administration.

Active ingredient
25 mg fluphenazine decanoate per ampoule (1 ml).

Excipients
Benzyl alcohol, sesame oil.

1. What is PROLIXIN DECONATE and what is it used for?

PROLIXIN is a light yellow, sterile, clean, clear, oily liquid.

PROLIXIN contains the active ingredient fluphenazine decanoate and belongs to a group of medicines called antipsychotics.

PROLIXIN is used for the long-term treatment of certain mental disorders (such as chronic schizophrenia).

PROLIXIN should not be used for the treatment of non-mental disorders or for treatments of less than 3 months.

Fluphenazine decanoate, the active ingredient of PROLIXIN, has not been shown to be effective in the treatment of behavioral disorders associated with the disease in patients with mental retardation.

2.How to use PROLIXIN DECONATE?

Instructions for proper use and dose/frequency of administration

Always use PROLIXIN as your doctor has told you. If you are not sure, you should consult your doctor or pharmacist.

The usual starting dose of PROLIXIN is between 2.5 mg-12.5 mg once daily.

Depending on the condition of your disease and your response to treatment, your doctor may decide that lower or higher doses, up to 100 mg per day, are necessary.

Application route and method

It is administered by intramuscular or subcutaneous injection. Care should be taken that the needle or syringe is not wet.

Use in children

Use in the elderly
Use in the elderly (65 years and older):

Use in the elderly

Special use cases

Use in the elderly

If you have the impression that the effect of PROLIXIN is too strong or too weak, talk to your doctor or pharmacist.

If you use more PROLIXIN DECONATE than you should

If you use more PROLIXIN DECONATE than you should

If you have used more than you should use from PROLIXIN, talk to a doctor or pharmacist.

If you forget to use PROLIXIN DECONATE

If you forget to use PROLIXIN DECONATE

Do not take a double dose to make up for forgotten doses. Effects that may occur when treatment with PROLIXIN is terminated:

Your doctor will tell you how long your treatment with PROLIXIN will last. Even if you feel well, do not stop the treatment early without consulting your doctor.

When high-dose therapy is stopped abruptly, gastritis (inflammation of the gastric mucosa), nausea and vomiting, drowsiness and tremors may occur.

If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in PROLIXIN DECONATE.

If any of the following occur, stop using PROLIXIN and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:

- Itching, rash, respiratory arrest, swelling of the tongue and face

- Skin rash, sudden weakness and mental change

- Sensitivity to light, vision problems, convulsions

These are all very serious side effects.

If you have any of these, you have a serious allergy to PROLIXIN. You may need emergency medical attention or hospitalization.

All of these very serious side effects are very rare.

If you notice any of the following, tell your doctor immediately or go to the nearest hospital emergency department:

- upper respiratory tract infections

- Decrease in blood values

- Darkening of urine and yellowing of the skin

- False positive pregnancy test

- A decrease in the level of sodium in the blood below normal

- Increased body temperature, change in consciousness, and muscle stiffness (may be signs of NMS)

- Pneumonia (lung inflammation)

- Problems with cerebral vessels, cerebral edema, seizures

- Chest pain

- Constipation

- mouth watering, fainting

- Involuntary muscle movements, stretching of the body

- Parkinson's disease-like symptoms

- Eye problems, glaucoma (increased intraocular pressure)

- Problems with your heart; e.g. sudden death from cardiac causes

- Irregularities in your blood pressure

- Problems with the lungs

- Unidentified fever and itching

- Problems with your liver; eg jaundice, liver test abnormalities

- acute renal failure

- Sweating of hands and feet

All these are serious side effects. Emergency medical attention may be required. Serious side effects are very rare.

Tell your doctor if you notice any of the following:

- Loss of appetite, weight changes

- Restlessness, abnormal dreams

- Headache

- Dry mouth, constipation, excessive salivation, pain in the mouth and throat, nausea, vomiting

- Male breast enlargement, menstrual irregularity, lactation disorder, erectile dysfunction, sexual desire disorders

- Excessive urination

These are mild side effects of PROLIXIN.