ANDROFARM, TABLETS, 50 MG⚓︎

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What ANDROFARM is and what it is used for⚓︎

The active ingredient in ANDROFARM is cyproterone acetate, which belongs to a group of medicines called anti-androgens. These work by blocking the actions of male sex hormones (androgens) which are released naturally in your body. They also reduce the production of androgens.

It has been shown that the growth of tumours of the prostate gland may be dependent on male hormones. Since ANDROFARM blocks the action of androgens and reduces the amount of androgens produced by the body, it can be used to help relieve the symptoms of a tumour of the prostate gland.

ANDROFARM is also used for reduction of drive in hypersexuality and sexual deviations.

2. What you need to know before you use ANDROFARM⚓︎

Do not use ANDROFARM if you:⚓︎

• are allergic (hypersensitive) to cyproterone acetate, or any of the other ingredients in ANDROFARM (these are listed in section 6)
• have liver disease (including Dubin-Johnson syndrome and Rotor syndrome), malignant tumours (except for carcinoma of the prostate), previous or existing liver tumours (only if these are not due to metastases from carcinoma of the prostate)
• have ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your physician if you are in doubt.
• have or have previously had tumours, other than in your prostate gland
• have or have ever suffered from depression
• suffer from a condition called sickle cell anaemia (abnormalities of the red blood cells)
• have a history of blood clots (heart attack, stroke, thrombosis or embolism)
• suffer from severe diabetes that affects your blood circulation
• are under 18 years of age

Warnings and precautions⚓︎

Talk to your doctor or nurse before using ANDROFARM if you have

• liver disease
• history of blood clots (heart attack, stroke, thrombosis or embolism)
• suffer from diabetes
• suffer from a condition called sickle cell anaemia (abnormalities of the red blood cells)
• have or have ever suffered from depression
• drink alcohol even if it is not regularly
• are planning a family

Use of cyproterone acetate has been linked to the development of a generally benign brain tumour (meningioma). The risk increases especially when you use it for longer duration (several years) or for a shorter duration with high doses (25 mg per day and above). If you are diagnosed with meningioma, your doctor will stop your treatment with cyproterone acetate (see section 'Do not use ANDROFARM'). If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straightaway.

If you are a diabetic and your doctor decides that it is still all right for you to take ANDROFARM, the dose of your medicine used to treat your diabetes (oral diabetic treatments or insulin), may be altered.

It is likely that your doctor will arrange regular blood tests whilst you are taking ANDROFARM.

If you are being treated for an overactive sex drive, your doctor may check your sperm count before and during treatment. Whilst Cyproterone Tablets may reduce the production of sperm, the medicine must not be used instead of contraception.

Other medicines and ANDROFARM⚓︎

Tell your doctor if you are taking or have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

Some medicines may stop ANDROFARM from working properly. Also ANDROFARM may change the way other medicines you are taking are broken down in your body.

Tell your doctor if you take any other medicines regularly, especially: - medicines such as rifampicin for the treatment of tuberculosis - medicines such as phenytoin used to treat epilepsy or other illnesses - products containing the herbal remedy commonly known as St John's wort - medicines such as ketoconazole, itraconazole, clotrimazole for the treatment of fungal conditions - medicines such as ritonavir used to treat HIV infections - cholesterol-lowering drugs such as statins. ANDROFARM may make the side effects of statins worse, for example the breakdown of muscle

If you are diabetic your doctor may need to alter the dose of medicine required to treat your diabetes.

Pregnancy and breast-feeding⚓︎

Do not have ANDROFARM if you are pregnant.

The drug is not indicated for use during pregnancy and lactation.

Driving and using machines⚓︎

Patient whose work (e.g. road users, machine operators) requires great concentration should remember that the use of ANDROFARM may lead to the occurrence of fatigue and reduced energy and that ANDROFARM may reduce the ability to concentrate.

ANDROFARM contains lactose.⚓︎

If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking this medicinal product.

3. How to use ANDROFARM⚓︎

Your doctor will decide what dose you will take depending on your treatment. The duration of treatment should be individually determined. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

A therapeutic effect sometimes occurs after only a few weeks, but it may take a few months before a result is seen. The usual starting dose is 50 mg twice daily. It may be necessary to increase the dose to 100 mg twice daily (200 mg), or even 100 mg three times daily (300 mg) for a short period of time. When a satisfactory result has been achieved, one should try to maintain the therapeutic effect with the lowest possible dose.

Take the tablet after your morning and evening meals and swallow it whole with a drink of water. ANDROFARM is not for use in youths under 18 years old.

If you take more ANDROFARM than you should⚓︎

As soon as you can, talk to your doctor who will tell you what you need to do. There have been no reports of serious illness from taking too much ANDROFARM in a single dose.

If you forget to take ANDROFARM⚓︎

If you forget to take a dose, take it as soon as you remember and take the next dose when it is due.

Do not take a double dose to make up for a forgotten dose.

If you stop taking ANDROFARM⚓︎

Do not reduce the dose or stop taking your tablets unless your doctor tells you to.

If you have any further questions on 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.

The most serious adverse drug reactions in patients receiving ANDROFARM are hepatic toxicity, benign and malignant liver tumours which may lead to intra-abdominal haemorrhage and thromboembolic events.

The most frequently observed adverse drug reactions in patients receiving ANDROFARM are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis.

Neoplasms, benign, malignant and unspecified (including cysts and polyps): benign and malignant liver tumours, meningiomas;

blood hormone tests: slightly elevated levels of prolactin, reduced levels of cortisol;

blood and lymphatic system disorders: anaemia;

respiratory, thoracic and mediastinal disorders: dyspnoea;

skin and subcutaneous tissue disorders: rash, dry skin;

metabolism and nutrition disorders: weight increase, weight decrease; increased blood sugar in diabetics;

musculoskeletal and connective tissue disorders: osteoporosis;

vascular diseases: thromboembolic events;

general disorders and administration site conditions: fatigue, hot flushes;

immune system disorders: hypersensitivity reactions;

hepatobiliary disorders: hepatic toxicity, including jaundice, hepatitis and hepatic failure;

reproductive system and breast disorders: reversible inhibition of spermatogenesis, gynaecomastia, tenderness to touch of the mamillae;

psychiatric disorders: libido decreased, erectile dysfunction, depressed mood, restlessness (temporary), reduced sexual drive;

gastrointestinal disorders: intra-abdominal haemorrhage.

The occurrence of multiple meningiomas has been reported in association with longer term use (years) of cyproterone acetate at doses of 25 mg/day and above.

Single cases of anaemia and decreased production of autogenic cortisol were observed with high doses of cyproterone acetate.

Under treatment with ANDROFARM, sexual drive and potency are reduced and gonadal function is inhibited. These are in general reversible upon treatment discontinuation.

Over the course of several weeks, cyproterone acetate inhibits spermatogenesis as a result of the antiandrogenic and antigonadotropic actions. Spermatogenesis recovers gradually within a few months of discontinuing the therapy. ANDROFARM may lead to gynaecomastia in men. Sometimes this is combined with tenderness to touch of the mammillae which usually regresses after withdrawal of the preparation.

As with other antiandrogenic treatments, long-term androgen deprivation with ANDROFARM may lead to osteoporosis.

A negative nitrogen balance is usual at the start of treatment, but usually does not persist. Due to this catabolic effect, ANDROFARM should not be taken with diagnosed or suspected malignant diseases (exception is carcinoma of the prostate).

An occasional tendency for the prolactin levels to increase slightly has been observed under higher doses of cyproterone acetate.

The skin may become dry as a result of a reduction in sebum secretion.

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.

5. How to store ANDROFARM:⚓︎

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

Store in the original packaging below 25 °C.

Do not use ANDROFARM after the expiry date which is stated on the carton after EXP.

6. Contents of the pack and other information⚓︎

What ANDROFARM contains

The active substance is cyproterone.

Each tablet contains 50 mg of cyproterone acetate as calculated on 100% substance basis.

The other ingredients are corn starch, lactose monohydrate, anhydrous colloidal silicon dioxide, povidone, magnesium stearate.

What ANDROFARM looks like and contents of the pack

ANDROFARM is white or off-white, round, flat-faced, bevelled-edge, scored tablets. Marbled surface of the tablet is allowed.

10 tablets 50 mg in a blister; 2 or 5 blisters per carton.

Manufacturer and Marketing Authorisation Holder

JSC «Farmak», 74, Kyrylivska str., Kyiv, 04080, Ukraine.

Prescription status

Prescription only.