250 mg tablets
Flutamide

1. What Flutamide Stada is and what it is used for

Flutamide Stada contains the active substance Flutamide and belongs to a group of medicines that inhibit certain effects of male sex hormones in the body.

Flutamide Stada is used to treat prostate cancer. The prostate is a gland located at the base of the bladder in men. Flutamide Stada can be used alone or in combination with other drugs that inhibit male sex hormone, so-called LHRH ( luteinizing hormone-release hormone ) agonists.

Flutamide Stada is also used to treat men who have had their testicles removed.

Flutamide contained in Flutamide Stada may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Flutamide Stada

Do not use Flutamide Stada

THIS MEDICINE SHOULD NOT BE USED BY WOMEN

Do not take Flutamide Stada if:

  • you are allergic to flutamide or any of the other ingredients of this medicine (listed in section 6)
  • You currently have severe liver problems.

Talk to your doctor if you are unsure about the above.

Warnings and cautions

Talk to your doctor or pharmacist before taking Flutamide Stada

  • if you have problems with your liver or kidneys
  • if you have cardiovascular disease including cardiac arrhythmias ( arrhythmia ), or if you are taking medication for this. The risk of heart rhythm disorders may be increased when taking Flutamide Stada
  • if you start to get any signs of hepatitis such as:
    • jaundice (yellowing of the skin and whites of the eyes)
    • itching
    • dark-colored urine
    • abdominal pain
    • fatigue
    • loss of appetite
    • nausea or vomiting

During treatment, your doctor may need to check the effect with regular blood tests.

  • If you have problems with your heart and have not received any medication or surgery to inactivate your testicles. (In patients with heart disease and normally functioning testicles, flutamide can make the heart work harder by gradually building up fluid in the circulation)

Other medicines and Flutamide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Flutamide Stada may affect some other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).

Always tell your doctor or pharmacist if you are taking the following medicines as the effect may change; your doctor may need to change the dose:

  • medicines that prevent the blood from clotting, so-called anticoagulants.

Flutamide Stada with food, drink, and alcohol

The tablets should be swallowed whole with a glass of water after a meal. Avoid drinking large amounts of alcohol while you are being treated with Flutamide Stada.

Pregnancy, breastfeeding, and fertility

This medicine should not be used by women. Use a suitable contraceptive (condom) during treatment.

Driving and using machines

At the beginning of treatment with Flutamide Stada, you may feel tired. The effect should decrease with continued treatment. If you feel drowsy, do not drive or use machines until the drowsiness subsides.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Descriptions of these effects and side effects can be found in other sections. Therefore, read all information in this information for guidance. If you are not sure, talk to your doctor or pharmacist.

Flutamide Stada contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Flutamide Stada

Always take this medicine exactly as your doctor has told you. Your doctor will tell you how many tablets to take and when to take them. If you are not sure, talk to your doctor or pharmacist. It is important to take the right dose at the right time.

The usual recommended dose is 1 tablet (250 mg) 3 times daily at eight-hour intervals. However, your doctor will determine the dose to suit your practical needs.

Flutamide Stada tablets should be taken with a glass of water and preferably after a meal

You should continue to take the tablets until the treatment that your doctor has told you to take is over. You mustn’t stop taking the tablets just because you are starting to feel better. After taking almost the entire course, check with your doctor if treatment should continue or if you can stop taking the medicine.

If you use more Flutamide then you should 

If you happen to take too many tablets, contact your doctor immediately or go to the nearest emergency room. Always bring leftover tablets, as well as the package and this leaflet, so that your healthcare professional knows what you have taken.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Flutamide Stada

If you miss a full daily dose, take the normal dose the next day. Do not take a double dose to make up for a forgotten dose. If you are not sure, talk to your doctor or pharmacist.

If you stop using Flutamide Stada

DO NOT discontinue or change the treatment before talking to your doctor.

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

4. Possible side effects

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

IMPORTANT: If you experience itching, jaundice (yellowing of the skin and whites of the eyes), dark urine, loss of appetite, stomach pain, or flu-like symptoms, stop taking the medicine and contact your doctor as soon as possible.

When taking Flutamide Stada tablets only:

Very common (may affect more than 1 user in 10):

  • The most common side effect is tenderness and enlargement of the area around the nipple. The nipple can also produce a milky white fluid. These effects are temporary and disappear when you stop taking Flutamide Stada or when your doctor recommends a lower dose. These effects are less common when you take Flutamide Stada with an LHRH agonist.

Common (may affect up to 1 in 10 people):

  • Other side effects that occur less frequently are nausea, vomiting, diarrhea, increased appetite, difficulty sleeping, fatigue, and liver problems.

Rare (may affect up to 1 in 1,000 people):

  • A few people may feel decreased sexual desire, upset stomach, decreased appetite, stomach ulcer-like pain, heartburn, constipation, swelling in the feet and lower legs, bruising of the skin, shingles, itching, inflammatory disease that attacks the skin and joints (lupus-like syndrome), redness, headache, drowsiness, general discomfort, blurred vision, thirst, chest pain, anxiety, depression, swollen lymph nodes.

Very rare (may affect up to 1 in 10,000 people):

  • very rarely, breast cancer in men and hypersensitivity to sunlight ( photosensitivity ) have been reported.

Has been reported (occurs in an unknown number of users):

  • changes ( QT prolongation) in ECG ( electrocardiogram ).

When you take Flutamide Stada with an LHRH agonist:

Very common (may affect more than 1 user in 10):

  • The most common side effects are hot flushes, decreased sexual desire or ability, diarrhea, nausea, and vomiting.

Uncommon (may affect up to 1 in 100 people):

  • Breast augmentation in men
  • Inflammation of the liver ( hepatitis )

Rare (may affect up to 1 in 1,000 people):

  • Rare side effects include blood clots, liver problems, jaundice (yellowing of the skin and whites of the eyes), decreased appetite, upset stomach, rash, swelling of the feet and lower legs, muscle aches or muscle twitching, high blood pressure, drowsiness, depression, confusion, and anxiety. , discomfort from the genitals.

Very rare (may affect up to 1 in 10,000 people):

  • Contact your doctor immediately if you have severe breathing difficulties. This is very rare.
  • Very rarely, certain types of anemia ( anemia ) have been reported.
  • Very rarely, a few people have also experienced photosensitivity and a change in the color of the urine to dark yellow or yellow-green.
  • Seek medical attention immediately if you get itching, blisters, and redness of the skin.
  • Very rarely can your blood sugar rise. If you already have diabetes mellitus, your doctor may need to change the dose of one of the medicines you are taking for your diabetes.
  • Seek medical attention immediately if you get itchy skin, darkening of the urine, persistent poor appetite, yellowing of the eyes or skin, soreness in the upper right part of the abdomen, or flu-like symptoms. These symptoms may be signs of liver damage that have been reported in a few people taking flutamide.

Has been reported (occurs in an unknown number of users):

  • Also, blood clots can form and clog blood vessels

5. How to store Flutamide Stada

Keep this medicine out of the sight and reach of children.

This medicine has no special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified 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. Contents of the packaging and other information

Content declaration

The active substance is flutamide. 1 tablet Flutamide Stada contains 250 mg flutamide.

The other ingredients are microcrystalline cellulose; corn starch; sodium lauryl sulfate; lactose monohydrate; silica, colloidal, anhydrous, and magnesium stearate.

What the medicine looks like and the contents of the pack

There is only one strength of Flutamide Stada tablets. The tablets are light yellow and round. The tablets are available in packs of 21, 50, 84, 90, 100, 105, or 200 tablets.

Marketing Authorization Holder and Manufacturer

Stada Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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