Patient Information Leaflet

CACHEXAN, 40 mg/ml, oral suspension
Megestrol acetate
Read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

What Cachexan is and what it is used for
Important information before taking Cachexan
How to take Cachexan
Possible side effects
How to store Cachexan
Contents of the pack and other information

1. What Cachexan is and what it is used for

The active substance in Cachexan, megestrol acetate, is a synthetic progestogen administered orally in suspension form. It promotes weight gain due to increased appetite.
Cachexan is indicated for the treatment of lack of appetite (anorexia) or weight loss resulting from cancer or acquired immunodeficiency syndrome (AIDS).

2. Important information before using Cachexan

When not to use Cachexan:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
if the woman is pregnant or breastfeeding,
if the patient has thromboembolic disease.

Warnings and precautions
Before starting treatment with Cachexan, consult a doctor or pharmacist.
Cachexan should be used with caution in patients who have previously experienced thrombophlebitis.
In patients with diabetes, an increased insulin requirement may occur.
During treatment or after discontinuation of Cachexan, clinical and laboratory signs of mild adrenal suppression have been reported. If the drug is stopped abruptly, patients should be carefully monitored for symptoms such as hypotension, nausea, vomiting, dizziness, or weakness.
Other medicines and Cachexan
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
There are no known confirmed interactions between megestrol acetate and other concomitantly administered medicines.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Cachexan must not be given to pregnant women or women who are breastfeeding.
Driving and operating machinery
The effect of Cachexan on driving and operating machinery is unknown.
Cachexan contains sucrose, sodium benzoate, ethanol, and sodium
This medicine contains 29.34 mg of alcohol (ethanol – a component of the orange flavouring in the liquid) in each 20 ml of suspension. The amount of alcohol in 20 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
This medicine contains 2 mg of benzoic acid salt in 1 ml of suspension.
This medicine contains less than 1 mmol (23 mg) of sodium in 1 ml of suspension, meaning the medicine is considered "sodium-free".

3. How to use Cachexan

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Administration method
The suspension should be thoroughly mixed before administration.
Recommended dose
Adults: 400–800 mg (10 to 20 mL of suspension), orally.
Treatment with Cachexan should be continued for at least two months.
Elderly patients
There is insufficient clinical data on megestrol acetate in patients aged 65 years and older to determine whether its effects differ from those in younger patients. Based on clinical experience, no differences in effects have been observed between elderly and younger patients. Dose selection should be cautious in elderly individuals. Due to the higher prevalence of impaired liver, kidney, or heart function, concomitant diseases, and use of other medications, treatment is generally initiated at the lower end of the dosing range.
Megestrol acetate is primarily excreted by the kidneys. Therefore, the risk of toxic effects may be higher in patients with impaired renal function. Since age-related decline in renal function is more likely in elderly patients, caution should be exercised when determining dosage. Monitoring of renal function may also be beneficial.
Use in children and adolescents
Cachexan is not recommended for use in children and adolescents.
Overdose of Cachexan
Consult a doctor immediately.
If necessary, the doctor will initiate appropriate supportive treatment.
Missed dose of Cachexan
Do not use a double dose to make up for a missed dose.
Stopping Cachexan
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common adverse reactions (occurring in 1 to 10 patients out of 100):

nausea, vomiting, diarrhoea, bloating,
rash,
uterine bleeding,
impotence (reduced sexual function, erectile dysfunction),
fatigue, pain, swelling at the injection site.

Adverse reactions with unknown frequency (which cannot be estimated based on available data):

rapid tumour growth,
adrenal insufficiency (symptoms: increasing weakness, loss of appetite, weight loss, nausea, vomiting, irritability),
Cushing-like symptoms, Cushing's syndrome (symptoms: obesity, so-called moon face, stretch marks, hypertension, rapid fatigue),
diabetes, impaired glucose tolerance, hyperglycaemia (excessively high blood glucose concentration, symptoms: excessive thirst, dry mouth, weight loss, drowsiness), increased appetite,
mood changes,
carpal tunnel syndrome (symptoms: tingling in the wrist and fingers, weakened grip, lack of movement precision), lethargy,
circulatory failure,
thrombotic phlebitis, pulmonary embolism (in some cases resulting in death), hypertension, hot flushes,
dyspnoea,
constipation,
alopecia,
frequent urination,
weight gain.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Cachexan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the stated month.
Period of use after first opening the bottle – 6 months.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Cachexan contains

The active substance is megestrol acetate. 1 ml of suspension contains 40 mg of megestrol acetate.
The other ingredients are: macrogol 1500, polysorbate 80, xanthan gum, sucrose, anhydrous citric acid, sodium citrate, orange flavouring liquid, sodium benzoate, purified water. Contains a small amount of ethanol.

What Cachexan looks like and contents of the pack
A white suspension with an orange odour.
The medicine is packed in a 250 ml HDPE plastic bottle with a PP/HDPE plastic screw cap, a PE sealing liner, a tamper-evident ring made of HDPE, child-resistant closure of the "child resistant" type, and a PP plastic dosing syringe, placed in a cardboard box.
Pack size: 1 bottle containing 240 ml of suspension.
Marketing authorisation holder and manufacturer:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45