CACHEXAN 40 mg /Ml Suspension

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. CACHEXAN, 40 mg/ml, Oral Suspension
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents:
3. What is Cachexan and What is it Used for
4. Important Information Before Using Cachexan
   1. When Not to Use Cachexan:
   2. Warnings and Precautions
   3. Other Medications and Cachexan
   4. Pregnancy and Breastfeeding
   5. Driving and Operating Machines
   6. Cachexan Contains Sucrose, Sodium Benzoate, Ethanol, and Sodium
5. How to Use Cachexan
   1. Method of Administration
   2. Recommended Dose
   3. Elderly Patients
   4. Use in Children and Adolescents
   5. Overdose of Cachexan
   6. Missed Dose of Cachexan
   7. Stopping Cachexan Treatment
6. Possible Side Effects
7. How to Store Cachexan
8. Package Contents and Other Information
   1. What Cachexan Contains
   2. What Cachexan Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer:
   4. Date of Last Revision of the Package Leaflet:

Package Leaflet: Information for the Patient

CACHEXAN, 40 mg/ml, Oral Suspension

Megestrol Acetate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication has been Prescribed for You Only. Do not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as Yours.
• If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Cachexan and What is it Used for
• 2. Important Information Before Using Cachexan
• 3. How to Use Cachexan
• 4. Possible Side Effects
• 5. How to Store Cachexan
• 6. Package Contents and Other Information

1. What is Cachexan and What is it Used for

The Active Substance of the Medication, Megestrol Acetate, is a Synthetic Progestagen for Oral Administration in the Form of a Suspension. It Causes Weight Gain due to Increased Appetite.
Cachexan is Indicated for the Treatment of Loss of Appetite (Anorexia) or Weight Loss due to Cancer or Acquired Immune Deficiency Syndrome (AIDS).

2. Important Information Before Using Cachexan

When Not to Use Cachexan:

• If You are Allergic to the Active Substance or any of the Other Ingredients of this Medication (Listed in Section 6),
• If You are Pregnant or Breastfeeding,
• If You Have a Blood Clotting Disorder.

Warnings and Precautions

Before Starting to Use Cachexan, Consult Your Doctor or Pharmacist.
Cachexan Should be Used with Caution in Patients who have had Thrombophlebitis in the Past.
In Patients with Diabetes, an Increased Insulin Requirement may Occur.
During Treatment with Cachexan or After Stopping it, Clinical and Laboratory Signs of Mild Adrenal Suppression have been Reported. If the Medication is Stopped Suddenly, Patients Should be Closely Monitored for Symptoms such as Hypotension, Nausea, Vomiting, Dizziness, or Weakness.

Other Medications and Cachexan

Tell Your Doctor or Pharmacist about all Medications You are Currently Taking or have Recently Taken, as well as any Medications You Plan to Take.
No Confirmed Interactions between Megestrol Acetate and Other Medications have been Reported.

Pregnancy and Breastfeeding

If You are Pregnant, Breastfeeding, or Think You may be Pregnant, or Plan to Become Pregnant, Consult Your Doctor or Pharmacist Before Using this Medication.
Cachexan Should not be Given to Pregnant or Breastfeeding Women.

Driving and Operating Machines

The Effect of Cachexan on the Ability to Drive and Operate Machines is not Known.

Cachexan Contains Sucrose, Sodium Benzoate, Ethanol, and Sodium

This Medication Contains 29.34 mg of Alcohol (Ethanol - a Component of Orange Flavor) in each 20 ml of Suspension.
The Amount of Alcohol in 20 ml of this Medication is Equivalent to Less than 1 ml of Beer or 1 ml of Wine. The Small Amount of Alcohol in this Medication will not have a Noticeable Effect.
The Medication Contains Sucrose. If You have been Diagnosed with an Intolerance to some Sugars, Consult Your Doctor Before Taking the Medication.
This Medication Contains 2 mg of Sodium Benzoate in 1 ml of Suspension.
This Medication Contains Less than 1 mmol (23 mg) of Sodium in 1 ml of Suspension, which means the Medication is Considered "Sodium-Free".

3. How to Use Cachexan

Always Use this Medication Exactly as Your Doctor has Told You. If You are not Sure, Ask Your Doctor or Pharmacist.

Method of Administration

Before Administration, the Suspension Should be Shaken Well.

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 Limited Data on the Use of Megestrol Acetate in Patients Aged 65 and Over, and it is not Possible to Determine whether it Works Differently in this Age Group Compared to Younger Patients. Based on Clinical Experience, no Differences in its Effects have been Observed in Elderly and Younger Patients. A Lower Dose Should be Chosen with Caution in the Elderly. Due to the Higher Frequency of Impaired Liver, Kidney, or Heart Function, as well as Concomitant Diseases and the Use of Other Medications, Treatment Usually Starts with a Dose from the Lower End of the Dose Range.
Megestrol Acetate is Mainly Excreted by the Kidneys. Therefore, the Risk of its Toxic Effects may be Higher in Patients with Impaired Renal Function. Since Impaired Renal Function is More Likely in the Elderly, Caution Should be Exercised when Determining the Dose. Monitoring of Renal Function may also be Useful.

Use in Children and Adolescents

Cachexan is not Recommended for Use in Children and Adolescents.

Overdose of Cachexan

Consult a Doctor.
If Necessary, the Doctor will Provide Appropriate Supportive Treatment.

Missed Dose of Cachexan

Do not Take a Double Dose to Make up for a Missed Dose.

Stopping Cachexan Treatment

If You have any Further Questions about Stopping this Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Cachexan can Cause Side Effects, although not Everybody gets them.
Common Side Effects(Occurring in 1 to 10 Patients out of 100):

• Nausea, Vomiting, Diarrhea, Bloating,
• Rash,
• Uterine Bleeding,
• Impotence (Decreased Sexual Performance, Erectile Dysfunction),
• Weakness, Pain, Swelling at the Injection Site.

Side Effects with Unknown Frequency(Which cannot be Estimated from the Available Data):

• Rapid Tumor Growth,
• Adrenal Insufficiency (Symptoms: Increasing Weakness, Loss of Appetite, Weight Loss, Nausea, Vomiting, Irritability),
• Cushing's Syndrome, Cushingoid Symptoms (Symptoms: Obesity, Moon Face, Stretch Marks, Hypertension, Fatigue),
• Diabetes, Glucose Tolerance Disorders, Hyperglycemia (High Blood Sugar Levels, Symptoms: Excessive Thirst, Dry Mouth, Weight Loss, Drowsiness), Increased Appetite,
• Mood Changes,
• Carpal Tunnel Syndrome (Symptoms: Tingling in the Wrist and Fingers, Weak Grip, Lack of Precision in Movements), Lethargy,
• Circulatory Failure,
• Thrombophlebitis, Pulmonary Embolism (Sometimes Fatal), Hypertension, Hot Flashes,
• Dyspnea,
• Constipation,
• Hair Loss,
• Frequent Urination,
• Weight Gain.

If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist.
Reporting Side Effects
If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Drug Safety Monitoring 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
Side Effects can also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Cachexan

Keep this Medication out of the Sight and Reach of Children.
Do not Use this Medication after the Expiration Date Stated on the Carton and Bottle after "EXP". The Expiration Date refers to the Last Day of the Month.
Shelf Life after First Opening the Bottle - 6 Months.
Store in a Temperature below 25°C.
Medications should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist how to Dispose of Medications no Longer Required. This will Help Protect the Environment.

6. Package Contents 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 Flavor, Sodium Benzoate, Purified Water. Contains Small Amounts of Ethanol.

What Cachexan Looks Like and Contents of the Package

White Suspension with an Orange Odor.
The Medication is Packaged in a 250 ml HDPE Plastic Bottle with a PP/HDPE Screw Cap, a PE Sealing Plug, an HDPE Guarantee Ring, and a Child-Resistant Closure, and a PP Measuring Cup, in a Cardboard Box.
Package Size: 1 Bottle Containing 240 ml of Suspension.

Marketing Authorization Holder and Manufacturer:

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45

Date of Last Revision of the Package Leaflet: