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Flutamide

Flutamide belongs to the group of antihormones.


Oncology Name

Flutamide


Strength

250mg


Therapeutic Category

Prostate Cancer


Storage

Do not store above 25°C, store in the original container.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


WHAT FLUTAMIDE IS AND WHAT IT IS USED FOR

Flutamide belongs to the group of antihormones. These are medicines that counteract the effects of the male sex hormones that naturally occur in the body (androgens).

Flutamide is used for prostate cancer, when disseminations (metastases) have developed and when surgical removal is not possible. Flutamide is used in combination with a hormonal treatment of LHRH-like substances or operative castration.

BEFORE YOU USE FLUTAMIDE

Do not use Flutamide
•if you are hypersensitive to flutamide, the active substance, or to one of the excipients of the tablet.

Take special care with Flutamide:

Liver:
•If the function of your liver is decreased and long-term use of flutamide is indicated, your liver function should be checked before the start of flutamide treatment. Treatment with flutamide should not be started if your liver is not functioning well. .Furthermore, liver function tests should be performed regularly.
•If your liver is functioning normally, your doctor will perform liver function once monthly for the first 4 month of treatment. After this period, liver function tests will be performed periodically or when first sign/symptoms of liver dysfunction (e.g. itching, dark urine, persistent anorexia, jaundice (a yellowing of the skin and eyes), tenderness or pain in upper right part of the belly, or unexplained flu-like symptoms) occur. Please contact your doctor if you suffer from one of these symptoms.

Kidneys
•If you suffer from kidney deficiency, flutamide should be used with caution

Heart and blood vessels
•If you suffer from cardiac and vascular diseases, there may be a possibility of fluid retention during the treatment with flutamide. Flutamide can exacerbate edema or ankle swelling in if you are prone to these conditions. In severe cases this can lead to chest pain (angina) or heart failure.
•Flutamide can increase the levels of a certain hormone (estradiol). This may cause formation of blood clots (thromboembolic events).

Reproduction and fertility
•With long-term use of flutamide; you should make sure of good contraceptive measures because of a possible effect of flutamide on the sperm. This is only true if no surgical castration has taken place as a part of the treatment of prostate cancer. In case you have to use flutamide for a long time, your doctor will have your sperm counts checked at regular intervals
•Flutamide is only for use in men.

Consult your physician if one of the above mentioned warnings is applicable to you, or has been in the past.

Using other medicines

Attention: The following remarks may also be applicable for the use of medicinal products in the past or in the near future.
The medicinal products mentioned in this section may be known to you under another name, often the brand name. In this section only the name of the active ingredient or the group of active ingredients of the medicinal product is mentioned and not the brand name! Therefore always read on the container or on the insert what the active ingredient is of the medicinal products you are using.

An interaction means that (medicinal) products that are used concomitantly may affect each other’s effect and/or side effect. An interaction may occur with concomitant use of these tablets and:

•blood thinning drugs (such as acenocoumarol or warfarin). Your doctor will closely monitor the coagulation of your blood and adjust the dose of the anticoagulant drug.
•theophylline (drug used in therapy for respiratory diseases such as COPD or asthma), an adjustment of the theophylline dose may be necessary.
•other drugs that may cause toxic affects on the liver. Concurrent treatment of these drugs and flutamide may be started only after careful assessment of benefits and risks by your doctor.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Interactions with food and drink
•alcohol. You should avoid excessive consumption of alcohol, as alcohol can potentiate the adverse effects of flutamide on the liver and kidneys.

Pregnancy and breast-feeding

•Flutamide is only for use in male patients, you should take contraceptive measurements during treatment.
•Flutamide may cause fetal harm when administered to a pregnant woman. Flutamide may be excreted into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

•The use of Flutamide sometimes may cause fatigue, dizziness and blurred vision (see “possible side effects”). If you suffer from these side effects, do not drive and/or use machines that require your attentiveness.

Important information about some of the ingredients of Flutamide

•This medicinal product contains lactose. If your doctor has informed you that you cannot digest certain sugars, please contact your doctor before taking this medicinal product.

HOW TO USE FLUTAMIDE

•Always take Flutamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
•The usual dose is 250 mg three times a day, after meals. The tablet should be taken with some liquid (without chewing).
•If you also have to use a certain other drug for prostate cancer (a LH-RH agonist, such as gosereline), the treatment with flutamide should start three days before the first use of the LH-RH agonist.
•The treatment duration is determined by the physician in accordance with the course of the disease.
•Flutamide is not intended for use in children.

If you use more Flutamide than you should
•In case of an overdose you may notice adverse events such as breast development or tenderness and the amount of a certain enzyme (SGOT) in your body may be elevated

Please tell your doctor immediately if you think you might have taken too much flutamide. Your doctor can start the right treatment, which may consist of carefull monitoring and/or gastric lavage.

If you forget to use Flutamide
•Take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule.
•Do not take a double dose to make up for a forgotten dose.

If you stop using Flutamide
•Do not stop Flutamide unless you are told to do so by your doctor.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Flutamide can cause side effects, although not everybody gets them.

The most frequently reported adverse reactions if you are treated with flutamide alone are:
•enlargement of male breasts (gynecomastia)
•breast tenderness
•excretion of milk from the breast (galactorrhea)

These reactions usually disappear upon discontinuation of treatment or reduction in dosage.

The most frequently reported adverse effect experienced during combination therapy of flutamide with an LHRH agonist were:
hot flushes
•loss of sexual interest ( libido)
•loss of sexual ability ( impotence)
•diarrhea
•nausea
•vomiting

The other side effects of Flutamide are given below, a difference has been made between treatment with Flutamide alone and Flutamide treatment in combination with LHRH-agonists.

The following frequencies are used:
•Very common: occurring in more than 1 in 10 patients.
•Common: occurring in less than 1 in 10 patients.
•Uncommon: occurring in less than 1 in 100 patients
•Rare: occurring in less than 1 in 1000 patients.
•Very rare: occurring in less than 1 in 10,000 patients.

Therapy with flutamide alone
Investigations
Common: transient changes in functioning of the liver.

Blood and lymphatic system

Rare:
Swelling caused by faulty lymphatic drainage (lymphedema), decrease in the number of red blood cells(anemia), decrease in white blood cells, which are important in fighting infection (leukopenia), decrease in the number of platelets (thrombocytopenia), presence in the blood of a certain protein (methemogloulinemia).

Nervous system
Rare:dizziness, headache, confusion

Eyes
Rare: blurred vision

Heart
Rare: heart disorders

Gastro-intestinal
Common: diarrhea, feeling sick (nausea), vomiting, sores in the mouth (stomatitis), constipation, gastric upset, ulcer-like pain, heartburn.
Rare: general abdominal complaints

Skin
Rare: itching, bruises (ecchymoses).
Very rare: hypersensitivity reaction after exposure to sunlight (photosensitivity), hairloss (alopecia).

Metabolism and nutrition disorders Common Increased appetite
Rare: loss of appetite (anorexia)

Infections
Rare: herpes zoster infections

Benign and malignant tumors
Very rare: formation of a tumor in the breast

Bloodvessels
Rare: Hot flushes

General – Common : Tiredness
Rare: Swelling of the hands, feet or legs (edema), weakness, malaise, thirst, chest pain.

Immune system
Rare: a certain immune disorder with formation of skin lesions, which may also affect joints and other organs such as kidneys (lupus-like syndrome).

Liver
Common: inflammation of the liver (hepatitis), jaundice (yellow discoloration of skin and eyes) Rare: severe inflammation of the liver, starvation of liver cells (hepatic necrosis), damage of the brain caused by severe decreased functioning of the liver (hepatic encephalopathy)
Very rare: toxicity of the liver with fatal outcome.

Reproductive organs and breasts
Very common: enlargement of male breasts (gynecomastia), breast tenderness, excretion of milk from the breast (galactorrhea).
Rare: decreased sexual interest (libido), decreased production of sperm

Psychiatric disorders
Common: difficulties initiating and/or maintaining sleep (insomnia), sleepiness (somnolence). Rare: anxiety, depression.

Therapy with flutamide in combination with a LHRH-agonist

Investigations

Rare: increased amount of certain components in the blood (urea and creatinine).

Blood and lymphatic system
Rare: decrease in the number of red blood cells (anemia), decrease in white blood cells, which are important in fighting infection (leukopenia), decrease in the number of platelets.
Very rare: anemia due to abnormal breakdown of red blood cells(hemolytic anemia),anemia in which the average size of circulating red blood cells is greater than normal (megalocyte anemia), presence in the blood of a certain protein (methemoglobinemia), presence of the greenish coloured substance sulfhemoglobine in the blood (sulfhemoglobinemia).

Nervous system
Rare: numbness, confusion, nervousness

Lungs
Very rare: lung complaints (e.g. difficulty in breathing (dyspnea)), disease of the connective tissue in the lung (interstitial disease).

Gastro-intestinal
Very common: diarrhea, feeling sick (nausea), vomiting.
Rare: general abdominal complaints

Kidneys and urinary tract
Rare: general complaints of the urinary tract or genitals.
Very rare: Amber or greenish-yellow discolouration of the urine.

Skin
Rare: rash.
Very rare: hypersensitivity reaction after exposure to sunlight (photosensitivity), redness (erythema), sores (ulcers), blisters on the skin/ exfoliation of the skin (epidermal necrolysis).

Muscles and bones
Rare: symptoms of the muscles, caused by the nerves (neuromuscular symptoms).

Metabolism and nutrition disorders
Rare: loss of appetite (anorexia)
Very rare: a greater than normal amount of glucose in the blood (hyperglycemia), aggravation of diabetes mellitus.

Blood vessels
Very common: hot flushes.
Rare: increased blood pressure (hypertension).
Not known: A clot in the blood that forms and blocks a blood vessel (thromboembolism).

General
Rare: swelling of the hands, feet or legs (edema), pain at the injection site.

Liver
Uncommon: inflammation of the liver (hepatitis).
Rare: decreased functioning of the liver, jaundice (yellow discoloration of skin and eyes)
Very rare: jaundice caused by an interruption to the drainage of bile in the biliary system (cholestatic icterus) , damage of the brain caused by severe decreased functioning of the liver (hepatic encephalopathy), starvation of liver cells (hepatic necrosis), toxicity of the liver with fatal outcome.

Reproductive organs and breasts
Very common: decreased sexual interest (libido), loss of sexual ability (impotence). Uncommon: enlargement of male breasts (gynecomastia).

Psychiatric disorders
Common: difficulties initiating and/or maintaining sleep (insomnia), sleepiness (somnolence).
Rare: anxiety, depression.

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.

HOW TO STORE FLUTAMIDE

•Do not store above 25°C, store in the original container.
•Keep out of the reach and sight of children.
•Do not use Flutamide after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
•Do not use Flutamide if you notice visible signs of deterioration.
•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.

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