CASODEX 50 mg Фильм-Coated Таблетки

Содержание инструкции

1. CASODEX 150 mg film-coated tablets
   1. What is CASODEX and what it is used for
   2. What you need to know before taking CASODEX
   3. How to take CASODEX
   4. Possible side effects
   5. How to store CASODEX
   6. Package contents and other information

CASODEX 150 mg film-coated tablets

bicalutamide

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CASODEX is and what it is used for
• 2. What you need to know before you take CASODEX
• 3. How to take CASODEX
• 4. Possible side effects
• 5. How to store CASODEX
• 6. Contents of the pack and other information

1. What is CASODEX and what it is used for

CASODEX contains bicalutamide, which belongs to the class of antiandrogens.
CASODEX 150 mg is indicated for the treatment of prostate cancer (a gland that
in men produces seminal fluid), and works by reducing the amount of testosterone (a hormone)
produced by your body.
CASODEX will be prescribed to you alone or in combination with other medicines also:

• following removal of the prostate
• following a course of radiotherapy (a medical technique that uses radiation to treat cancer) CASODEX will be prescribed to you alone:
• if the tumor has spread to other organs and cannot be removed or the action of the testicles is inhibited.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking CASODEX

Do not take CASODEX

• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman or a child (see section Pregnancy and breastfeeding).
• if you are taking terfenadine or astemizole, medicines prescribed to treat allergies (see section Other medicines and Casodex).
• if you are taking cisapride, a medicine prescribed to treat acid reflux from the stomach (see section Other medicines and Casodex).

Warnings and precautions
Talk to your doctor before taking CASODEX.
Talk to your doctor if you suffer from any of the following conditions:

• any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these disorders. The risk of heart rhythm problems may increase with the use of CASODEX;
• if you have a liver disease, even severe (moderate to severe hepatic insufficiency). Your doctor may ask you to undergo frequent checks;
• if you are taking blood thinners or medicines to prevent blood clots (e.g. warfarin) (see section Possible side effects and Other medicines andCASODEX);
• if you are taking CASODEX, you and/or your partner must use contraception both during treatment with CASODEX and for 130 days after the end of therapy with CASODEX, as CASODEX may cause morphological changes in sperm. Talk to your doctor if you have any doubts about contraception (see section Pregnancy, breastfeeding and fertility);
• if your condition worsens and your blood tests show an increase in PSA (prostate-specific antigen). Your doctor may in this case discontinue treatment with CASODEX 150 mg. You must take CASODEX 150 mg as prescribed by your doctor and do not interrupt the treatment unless your doctor decides so. In the event of hospitalization, inform the medical staff of the ongoing treatment with CASODEX 150 mg.

Children
The use of CASODEX 150 mg is contraindicated in children as safety and efficacy have not been
established.

Other medicines and CASODEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
CASODEX may interfere with some medicines used to treat heart rhythm problems
(e.g. quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide) or may increase the risk
of heart rhythm problems when used with some other drugs, for example methadone
(used to relieve pain and in drug detoxification programs),
moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses).
In particular, tell your doctor if you are taking:

• anticoagulants, medicines to make the blood more fluid, for example warfarin (see section Warnings and precautions and Possible side effects)
• terfenadine or astemizole, to treat allergies
• cisapride, to treat acid reflux from the stomach
• cyclosporine, to lower the response of the immune system (the body's defense system)
• calcium channel blockers, to treat high blood pressure or some heart diseases
• cimetidine, to treat stomach ulcers
• ketoconazole, to treat fungal infections
• midazolam, a sedative medicine.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. CASODEX 150
mg is contraindicated in women, including pregnant women or during breastfeeding.
If you are taking CASODEX, you and/or your partner must use contraception both during
treatment with CASODEX and for 130 days after the end of therapy with CASODEX. See
your doctor if you have any doubts about contraception (see section Warnings and
Precautions);
CASODEX may have an effect on male fertility that may be reversible.

Driving and using machines
CASODEX 150 mg does not impair the ability to drive vehicles or use machines.
However, if you experience drowsiness, be careful when driving.

CASODEX contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

CASODEX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take CASODEX

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is one CASODEX 150 mg tablet per day.
No dosage adjustment is necessary in patients with mild or moderate renal and/or hepatic
impairment.
In case of moderate or severe hepatic impairment, your doctor may decide to interrupt the
treatment.
Improvement in your health condition should not lead to interruption of the treatment, unless
decided by your doctor.

If you take more CASODEX than you should
In case of accidental ingestion/intake of an excessive dose of CASODEX, immediately inform
your doctor or go to the nearest hospital.

If you forget to take CASODEX
Do not take a double dose to make up for a missed tablet.

If you stop taking CASODEX
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In this section, side effects are defined according to their frequency:

Very common (may affect more than 1 in 10 people)

• skin rash
• increase in breast size (gynecomastia)
• breast pain. This usually resolves with discontinuation of therapy
• weakness

Common (may affect up to 1 in 10 people)

• reduction in haemoglobin, a protein that carries oxygen in the blood (anaemia)
• decreased appetite
• decreased libido
• depression
• dizziness
• drowsiness
• hot flushes
• abdominal pain
• constipation
• nausea
• difficulty digesting (dyspepsia)
• passage of gas from the intestines (flatulence)
• nausea
• decreased liver function (hepatic insufficiency)
• yellowing of the skin and eyes (jaundice)
• increased liver enzyme values. Liver changes are usually transient.
• hair loss
• increased body and facial hair
• dry skin
• itching
• presence of blood in the urine (haematuria)
• erectile dysfunction
• chest pain
• weight gain
• swelling (oedema)

Uncommon (may affect up to 1 in 100 people)

• allergy
• swelling of the face and lips
• urticaria
• serious lung disease that can lead to death (interstitial pneumonia)

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

• liver disease (severe hepatic insufficiency which can be fatal). In this case, your doctor will ask you to stop treatment with CASODEX
• increased sensitivity of the skin to sunlight

Not known (frequency cannot be estimated from available data)

• changes in ECG tracing (QT prolongation)

If you are taking blood thinners or medicines to prevent blood clots (e.g.
warfarin), there may be an increase in the effects of anticoagulant drugs (see section
Warnings and Precautions and Other medicines and CASODEX).
The possible side effects listed above should not cause alarm, as they may also not
occur.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store CASODEX

Do not store at a temperature above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CASODEX contains

• The active ingredient is bicalutamide 150 mg.
• The other ingredients are lactose monohydrate (see section 2 CASODEX contains lactose), sodium carboxymethylamide A, povidone, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

Description of the appearance of CASODEX and package contents
CASODEX 150 mg is a white film-coated tablet.
CASODEX 150 mg is available in packs of 28 film-coated tablets.

Marketing authorisation holder and manufacturer
Laboratoires Juvisé Pharmaceuticals
149 boulevard Bataille de Stalingrad
69100 Villeurbanne
France

Manufacturer
Corden Pharma GmbH, Plankstadt, Germany
Or:
AstraZeneca Reims Production, Parc Industriel de la Pompelle, Chemin de Vrilly, 51100, Reims,
France
Or:
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom