Anidulafungin Sinoptis

Package Leaflet: Information for the Patient

Anidulafungin Synoptis, 100 mg, Powder for Concentrate for Solution for Infusion

Anidulafungin

Read the Package Leaflet Carefully Before Using the Medicinal Product, 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, Pharmacist, or Nurse.
• If You Experience any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Table of Contents of the Package Leaflet

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

1. What is Anidulafungin Synoptis and What is it Used for

Anidulafungin Synoptis Contains the Active Substance Anidulafungin and is Prescribed to Adults for the Treatment of Fungal Infections of the Blood or Internal Organs, Known as Invasive Candidiasis. This Infection is Caused by Fungal Cells (Yeast) Called Candida. Anidulafungin Synoptis Belongs to a Group of Medicines Called Echinocandins. Medicines in this Group are Used to Treat Severe Fungal Infections. Anidulafungin Synoptis Inhibits the Production of a Component of the Fungal Cell Wall. Fungal Cells Exposed to Anidulafungin Synoptis Have Incomplete or Damaged Cell Walls, Making them Susceptible to Damage or Preventing them from Growing.

2. Important Information Before Using Anidulafungin Synoptis

When Not to Use Anidulafungin Synoptis

• If the Patient is Allergic to Anidulafungin, Other Medicines in the Echinocandin Group (e.g., Caspofungin Acetate), or Any of the Other Ingredients of this Medicinal Product (Listed in Section 6).

Warnings and Precautions

Before Starting Treatment with Anidulafungin Synoptis, Discuss it with Your Doctor, Pharmacist, or Nurse. The Doctor May Decide to Monitor:

• Liver Function, More Closely if the Patient Develops Liver Function Disorders During Treatment;
• If the Patient is Receiving Anesthetics During Treatment with Anidulafungin Synoptis;
• Symptoms of Allergic Reactions, Such as Itching, Wheezing, Skin Rashes;
• Symptoms Related to Infusion, Which May Include Rash, Urticaria, Itching, Redness;
• Symptoms of Shortness of Breath/Difficulty Breathing, Dizziness, or Feeling of Impending Collapse.

Children and Adolescents

Anidulafungin Synoptis Must Not be Used in Patients Below 18 Years of Age.

Anidulafungin Synoptis and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You are Currently Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.

Pregnancy and Breast-Feeding

The Effect of Anidulafungin Synoptis in Pregnant Women is Not Known. Therefore, Anidulafungin Synoptis Must Not be Used During Pregnancy. Women of Childbearing Age Should Use Effective Contraception. If You Become Pregnant While Using Anidulafungin Synoptis, Tell Your Doctor Immediately. You Should Not Take Anidulafungin Synoptis While Breast-Feeding. Before Taking Anidulafungin Synoptis While Breast-Feeding, Consult Your Doctor or Pharmacist. Before Taking Any Medicine, Consult Your Doctor or Pharmacist.

3. How to Use Anidulafungin Synoptis

Anidulafungin Synoptis Will Always be Prepared and Administered by a Doctor or Other Healthcare Professional (More Information on the Preparation of the Medicinal Product can be Found at the End of the Package Leaflet, in the Section Intended for Healthcare Professionals Only). Treatment Starts with a Dose of 200 mg on the First Day (Loading Dose). Then, a Daily Dose of 100 mg (Maintenance Dose) is Administered. Anidulafungin Synoptis Should be Administered Once a Day, by Slow Intravenous Infusion (Drip). The Infusion Should Last at Least 1.5 Hours for the Maintenance Dose and 3 Hours for the Loading Dose. The Doctor Will Determine the Duration of Treatment and the Dose of Anidulafungin Synoptis to be Administered Each Day and Will Monitor the Patient's Response to Treatment and Condition. In General, Treatment Lasts at Least 14 Days After the Last Day on Which CandidaYeast was Detected in the Patient's Blood.

Overdose of Anidulafungin Synoptis

If You Suspect that the Dose of Anidulafungin Synoptis was Too High, Tell Your Doctor or Healthcare Professional Immediately.

Missed Dose of Anidulafungin Synoptis

Since the Medicinal Product Will be Administered Under Close Medical Supervision, it is Unlikely that a Dose Will be Missed. However, if You Suspect that a Dose has Been Missed, Tell Your Doctor or Pharmacist. The Doctor Should Not Administer a Double Dose of the Medicinal Product.

Stopping Treatment with Anidulafungin Synoptis

If Treatment with Anidulafungin Synoptis is Stopped by the Doctor, No Symptoms Should Occur. After Treatment with Anidulafungin Synoptis, the Doctor May Prescribe Another Medicinal Product to Continue Treatment of the Fungal Infection or to Prevent the Return of Fungal Infections. If the Original Symptoms Return, Tell Your Doctor or Healthcare Professional Immediately. If You Have any Further Questions About the Use of this Medicinal Product, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like all Medicines, Anidulafungin Synoptis can Cause Side Effects, Although Not Everybody Gets them. Some of these Side Effects will be Observed by the Doctor During Monitoring of the Patient's Response to Treatment and Condition. During Administration of Anidulafungin Synoptis, Rare Cases of Life-Threatening Allergic Reactions, Such as Difficulty Breathing with Wheezing or Worsening of Existing Rash, have been Reported.

Serious Side Effects - if You Experience any of the Following Side Effects, Tell Your Doctor or Healthcare Professional Immediately:

• Seizures (Epileptic Fits)
• Sudden Redness of the Face
• Rash, Itching (Pruritus)
• Flushing
• Urticaria
• Sudden Constriction of the Airways, Causing Wheezing and Coughing
• Difficulty Breathing

Other Side Effects

Very Common Side Effects (May Affect More than 1 in 10 People):

• Low Potassium Levels in the Blood (Hypokalemia)
• Diarrhea
• Nausea

Common Side Effects (May Affect up to 1 in 10 People)

• Seizures (Epileptic Fits)
• Headache
• Vomiting
• Abnormal Liver Function Test Results
• Rash, Itching (Pruritus)
• Abnormal Kidney Function Test Results
• Abnormal Bile Flow from the Gallbladder to the Intestine (Cholestasis)
• High Blood Sugar Levels
• High Blood Pressure
• Low Blood Pressure
• Sudden Constriction of the Airways, Causing Wheezing and Coughing
• Difficulty Breathing

Uncommon Side Effects (May Affect up to 1 in 100 People)

• Blood Coagulation Disorders
• Sudden Redness of the Face
• Flushing
• Abdominal Pain
• Urticaria
• Pain at the Injection Site

Frequency Not Known (Cannot be Estimated from the Available Data):

• Life-Threatening Allergic Reactions

Reporting Side Effects

If You Experience any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.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 Medicinal Product.

5. How to Store Anidulafungin Synoptis

Keep this Medicinal Product Out of the Sight and Reach of Children. Do Not Use this Medicinal Product After the Expiry Date Stated on the Label. The Expiry Date Refers to the Last Day of the Month Stated. Store in a Refrigerator (2°C - 8°C). The Reconstituted Solution can be Stored at a Temperature Not Above 25°C for 24 Hours. The Infusion Solution (Diluted) can be Stored at a Temperature Not Above 25°C (Room Temperature) for 48 Hours. Do Not Freeze. Medicines Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Anidulafungin Synoptis Contains

• The Active Substance is Anidulafungin. Each Vial Contains 100 mg of Anidulafungin.
• The Other Ingredients are: Sucrose, Polysorbate 80, Acetic Acid, Sodium Hydroxide (for pH Adjustment), Hydrochloric Acid (for pH Adjustment).

What Anidulafungin Synoptis Looks Like and Contents of the Package

Anidulafungin Synoptis is Available in a Package Containing 1 Vial of 100 mg Powder for Concentrate for Solution for Infusion. The Powder is White or Almost White, Without Visible Impurities.

Marketing Authorization Holder

Synoptis Pharma Sp. z o.o., ul. Krakowiaków 65, 02-255 Warsaw

Manufacturer

Actavis Italy S.p.A, Viale Pasteur 10, 20014 Nerviano, Italy; S.C. SINDAN-PHARMA S.R.L., 11th Ion Mihalache Boulevard, 011171 Bucharest, Romania

Date of Last Revision of the Package Leaflet:

-------------------------------------------------------------------------------------------------------------------------
The Following Information is Intended for Healthcare Professionals Only and Refers to a Single Vial of Anidulafungin Synoptis 100 mg Powder for Concentrate for Solution for Infusion:
The Contents of the Vial Should be Dissolved in Water for Injections, and Then Diluted EXCLUSIVELY with Sodium Chloride 9 mg/ml (0.9%) Solution for Infusion or Glucose 50 mg/ml (5%) Solution for Infusion.
No Incompatibilities of the Reconstituted Anidulafungin Synoptis with Intravenously Administered Substances, Excipients, or Other Medicines have been Established, Except for Sodium Chloride 9 mg/ml (0.9%) Solution for Infusion or Glucose 50 mg/ml (5%) Solution for Infusion.
Reconstitution
With Aseptic Precautions, Dissolve the Contents of Each Vial in 30 ml of Water for Injections to Obtain a Concentrate with a Concentration of 3.33 mg/ml. The Dissolution Time may be up to 5 Minutes.
The Reconstituted Solution Should be Clear and Free of Visible Particles. If Particles or a Color Change are Observed, the Solution Should be Discarded.
After Reconstitution, the Solution can be Stored at a Temperature Not Above 25°C for 24 Hours Before Dilution of the Solution.
Dilution and Infusion
Transfer the Contents of the Reconstituted Vial to an Intravenous Infusion Bag (or Bottle) Containing Sodium Chloride 9 mg/ml (0.9%) Solution for Infusion or Glucose 50 mg/ml (5%) Solution for Infusion, to Obtain an Anidulafungin Solution with a Concentration of 0.77 mg/ml.
The Following Table Shows the Volumes of the Solutions for the Respective Doses.

Requirements for Dilution of Anidulafungin Synoptis Before Administration

The Infusion Rate Should Not Exceed 1.1 mg/min (Which Corresponds to 1.4 ml/min if the Product is Reconstituted and Diluted According to the Instructions).
Medicines for Parenteral Use Should be Inspected Visually for Particulate Matter and Discoloration Prior to Administration, Whenever the Solution and Container Permit.
If Particulate Matter or Discoloration is Observed, the Solution Should be Discarded.
For Single Use Only. Dispose of Waste in Accordance with Local Requirements.