Posaconazole Stada

Package Leaflet: Information for the Patient

Posaconazole STADA, 100 mg, Gastro-Resistant Tablets

Posaconazole

Read All of This Leaflet Carefully Before Taking This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicine Has Been Prescribed for You. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any of the Following Side Effects, or Any Other Unlisted Side Effects, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Table of Contents of the Package Leaflet

• 1. What Is Posaconazole STADA and What Is It Used For
• 2. Important Information Before Taking Posaconazole STADA
• 3. How to Take Posaconazole STADA
• 4. Possible Side Effects
• 5. How to Store Posaconazole STADA
• 6. Contents of the Pack and Other Information

1. What Is Posaconazole STADA and What Is It Used For

Posaconazole STADA Contains the Active Substance Posaconazole. It Belongs to a Group of Antifungal Medicines. This Medicine Is Used to Prevent and Treat Many Types of Fungal Infections.

This Medicine Works by Killing or Inhibiting the Growth of Fungi That Can Cause Infections.

Posaconazole STADA Can Be Used in Adults to Treat Fungal Infections Caused by Fungi of the Genus Aspergillus.

Posaconazole STADA Can Be Used in Adults and Children Aged 2 Years and Older, Weighing Over 40 Kg, to Treat the Following Types of Fungal Infections:

• Infections Caused by Species of the Genus AspergillusThat Do Not Respond to Antifungal Medicines - Amphotericin B or Itraconazole, or When Treatment with These Medicines Must Be Discontinued;
• Infections Caused by Species of the Genus FusariumThat Do Not Respond to Amphotericin B, or When Treatment with Amphotericin B Must Be Discontinued;
• Infections Caused by Fungi Known as Chromoblastomycosis and Mycetoma, Which Do Not Respond to Treatment with Itraconazole or When Treatment with Itraconazole Must Be Discontinued;
• Infections Caused by Fungi of the Genus CoccidioidesThat Do Not Respond to One or More of the Following Medicines - Amphotericin B, Itraconazole, or Fluconazole, or When Treatment with These Medicines Must Be Discontinued;

This Medicine Can Also Be Used to Prevent Fungal Infections in Adults and Children Aged 2 Years and Older, Weighing Over 40 Kg, Who Are at High Risk of Such Infections, Namely:

• Patient with Weakened Immune System Due to Chemotherapy for Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
• Patient Receiving High-Dose Immunosuppressive Therapy After Hematopoietic Stem Cell Transplantation (HSCT).

2. Important Information Before Taking Posaconazole STADA

Do Not Take Posaconazole STADA:

• If You Are Allergic to Posaconazole or Any of the Other Ingredients of This Medicine (Listed in Section 6),
• If You Are Taking: Terfenadine, Astemizole, Cisapride, Pimozide, Halofantrine, Quinidine, Any Medicines Containing Ergot Alkaloids, Such as Ergotamine or Dihydroergotamine, or a Statin, Such as Simvastatin, Atorvastatin, or Lovastatin,
• If You Have Started Treatment with Venetoclax or the Dose of Venetoclax Is Being Gradually Increased as Part of the Treatment of Chronic Lymphocytic Leukemia (CLL).

Do Not Take Posaconazole STADA If Any of the Above Applies to You. If in Doubt, Consult Your Doctor or Pharmacist Before Taking Posaconazole STADA.

Warnings and Precautions

Before Taking Posaconazole STADA, Consult Your Doctor, Pharmacist, or Nurse in the Following Cases:

• If You Have Ever Had an Allergic Reaction to Other Antifungal Medicines, Such as Ketoconazole, Fluconazole, Itraconazole, or Voriconazole.
• If You Have Had or Currently Have Liver Problems. Blood Tests May Be Necessary While Taking This Medicine.
• If You Have Severe Diarrhea or Vomiting, as These Conditions May Reduce the Effectiveness of This Medicine.
• Abnormal Heart Rhythm (ECG) Showing Prolonged QTc Interval
• Heart Muscle Weakness or Heart Failure
• Very Slow Heart Rate
• Heart Rhythm Disorders
• Any Disorders Related to Potassium, Magnesium, or Calcium Levels in the Blood.
• Taking Vinca Alkaloids, Such as Vincristine, Vinblastine, and Other Vinca Alkaloids (Used to Treat Cancer)
• If You Are Taking Venetoclax (a Medicine Used to Treat Cancer).

If Any of the Above Applies to You (or Is Suspected), Tell Your Doctor, Pharmacist, or Nurse Before Taking Posaconazole STADA.

Children and Adolescents

Posaconazole STADA Should Not Be Given to Children Under 2 Years of Age.

Posaconazole STADA and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking, Have Recently Taken, or Might Take.

Do Not Take Posaconazole STADA If You Are Taking Any of the Following Medicines:

• Terfenadine (Used to Treat Allergies)
• Astemizole (Used to Treat Allergies)
• Cisapride (Used to Treat Stomach Problems)
• Pimozide (Used to Treat Symptoms of Tourette's Syndrome and Mental Illness)
• Halofantrine (Used to Treat Malaria)
• Quinidine (Used to Treat Heart Rhythm Disorders).

Posaconazole STADA May Increase the Amount of These Medicines in Your Blood, Which May Lead to Serious Heart Rhythm Changes:

• Any Medicines Containing Ergot Alkaloids, Such as Ergotamine or Dihydroergotamine, Used to Treat Migraines. Posaconazole STADA May Increase the Amount of These Medicines in Your Blood, Which May Lead to Serious Reduction of Blood Flow to the Fingers and Toes and Damage to Them
• Statins, Such as Simvastatin, Atorvastatin, or Lovastatin, Used to Treat High Cholesterol
• Venetoclax Used at the Start of Treatment for a Certain Type of Cancer Called Chronic Lymphocytic Leukemia (CLL).

Do Not Take Posaconazole STADA If Any of the Above Applies to You. If in Doubt, Consult Your Doctor or Pharmacist Before Taking Posaconazole STADA.

Pregnancy and Breastfeeding

If You Are Pregnant, Breastfeeding, Think You May Be Pregnant, or Are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine.

Do Not Take Posaconazole STADA During Pregnancy, Unless Your Doctor Advises You to Do So.

Women of Childbearing Age Should Use Effective Contraception While Taking Posaconazole STADA. If You Become Pregnant While Taking Posaconazole STADA, Tell Your Doctor Immediately.

Do Not Breastfeed While Taking Posaconazole STADA, as Small Amounts of the Medicine May Pass into Breast Milk.

Driving and Using Machines

While Taking Posaconazole STADA, You May Experience Dizziness, Drowsiness, or Blurred Vision, Which May Affect Your Ability to Drive or Operate Machinery. If This Happens, Do Not Drive or Operate Machinery, and Consult Your Doctor.

Posaconazole STADA Contains Sodium

The Sodium Content of This Medicine Is Less Than 1 Mmol (23 Mg) per Tablet, Which Is Essentially Sodium-Free.

3. How to Take Posaconazole STADA

Always Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You. If You Are Not Sure, Ask Your Doctor or Pharmacist.

Do Not Switch from Posaconazole STADA Tablets to Posaconazole Oral Suspension Without Consulting Your Doctor or Pharmacist, as This May Lead to Ineffective Treatment or Increased Risk of Side Effects.

What Dose to Take

The Typical Dose of Posaconazole Is 300 Mg (Three 100 Mg Gastro-Resistant Tablets) Twice a Day on the First Day, Then 300 Mg (Three 100 Mg Gastro-Resistant Tablets) Once a Day. The Duration of Treatment May Depend on the Type of Infection You Have and May Be Adjusted by Your Doctor. Do Not Adjust the Dose or Change the Prescribed Treatment Schedule Without Consulting Your Doctor.

How to Take Posaconazole STADA

• Swallow the Tablets Whole with a Small Amount of Water.
• Do Not Crush, Chew, Break, or Dissolve the Tablets.
• The Tablets Can Be Taken with or Without Food.

If You Take More Posaconazole STADA Than You Should

If You Think You May Have Taken Too Much of This Medicine, Consult Your Doctor or Go to the Hospital Immediately.

If You Forget to Take Posaconazole STADA

• If You Miss a Dose, Take It as Soon as Possible.
• If It Is Almost Time for Your Next Dose, Do Not Take the Missed Dose. Take the Next Dose at the Scheduled Time.
• Do Not Take a Double Dose to Make Up for a Missed Dose.

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Serious Side Effects

If You Experience Any of the Following Serious Side Effects, Tell Your Doctor, Pharmacist, or Nurse Immediately, as You May Need Urgent Medical Attention:

• Nausea or Vomiting (Feeling Sick or Vomiting), Diarrhea
• Signs of Liver Problems - These Include Yellowing of the Skin or Eyes, Dark Urine or Pale Stool, Feeling Sick Without Reason, Stomach Problems, Loss of Appetite, or Unusual Feeling of Tiredness or Weakness, Increased Liver Enzyme Activity Shown in Blood Tests
• Allergic Reaction

Other Side Effects

If You Experience Any of the Following Side Effects, Tell Your Doctor, Pharmacist, or Nurse.

Common: May Affect Up to 1 in 10 People

• Changes in Electrolyte Levels in the Blood Shown in Blood Tests (Which May Cause Symptoms Such as Confusion or Weakness)
• Abnormal Skin Sensations, Such as Numbness, Tingling, Itching, Burning, Prickling, or Stinging
• Headache
• Low Potassium Levels - Shown in Blood Tests
• Low Magnesium Levels - Shown in Blood Tests
• High Blood Pressure
• Loss of Appetite, Stomach Pain or Upset, Gas, Dry Mouth, Taste Disturbances
• Heartburn (Burning Feeling in the Chest Rising to the Throat)
• Low Neutrophil Count - a Type of White Blood Cell (Neutropenia) Shown in Blood Tests, Which May Increase the Risk of Infections
• Fever
• Feeling Weak, Dizzy, Tired, or Sleepy
• Rash
• Itching
• Constipation
• Discomfort in the Rectum

Uncommon: May Affect Up to 1 in 100 People

• Anemia - Symptoms Include Headaches, Feeling Tired or Dizzy, Shortness of Breath or Paleness, and Low Hemoglobin Levels Shown in Blood Tests
• Low Platelet Count (Thrombocytopenia) Shown in Blood Tests, Which May Lead to Bleeding
• Low White Blood Cell Count (Leukopenia) Shown in Blood Tests - May Increase the Risk of Infections
• High Eosinophil Count (Eosinophilia) - May Occur in Inflammatory Conditions
• Vasculitis
• Heart Rhythm Disorders
• Seizures (Epileptic Fits)
• Nerve Damage (Neuropathy)
• Abnormal Heart Rhythm Shown in ECG, Palpitations, Slow or Fast Heart Rate, High or Low Blood Pressure
• Low Blood Pressure
• Pancreatitis - May Cause Severe Stomach Pain
• Splenic Infarction (Blockage of Blood Supply to the Spleen) - May Cause Severe Stomach Pain
• Severe Kidney Problems - Symptoms Include Passing More or Less Urine Than Usual, or Urine of an Unusual Color
• High Creatinine Levels in the Blood - Shown in Blood Tests
• Cough, Hiccup
• Nosebleeds
• Sharp Chest Pain When Breathing In (Pleuritic Pain)
• Lymph Node Swelling (Lymphadenopathy)
• Numbness or Tingling, Mainly Affecting the Skin
• Tremors
• High or Low Blood Sugar Levels
• Blurred Vision, Sensitivity to Light
• Hair Loss (Alopecia)
• Mouth Ulcers
• Chills, General Feeling of Illness
• Pains, Back Pain or Neck Pain, Arm or Leg Pain
• Fluid Retention (Edema)
• Menstrual Disorders (Abnormal Vaginal Bleeding)
• Difficulty Sleeping (Insomnia)
• Complete or Partial Loss of Speech
• Mouth Swelling
• Unusual Dreams or Sleep Problems
• Problems with Coordination or Balance
• Mucosal Inflammation
• Stuffy Nose
• Breathing Difficulties
• Chest Tightness
• Feeling Bloated
• Nausea of Mild to Severe Intensity, Vomiting, Muscle Cramps, Diarrhea, Usually of Viral Origin, Stomach Pain
• Belching
• Feeling Shaky

Rare: May Affect Up to 1 in 1,000 People

• Pneumonia - Symptoms Include Shortness of Breath and Coughing Up Discolored Sputum
• High Blood Pressure in the Pulmonary Arteries (Pulmonary Hypertension), Which May Lead to Serious Lung and Heart Damage
• Blood Disorders, Such as Abnormal Blood Clotting, Prolonged Bleeding
• Severe Allergic Reactions, Including Widespread Blistering and Skin Peeling
• Mental Problems, Such as Hearing Voices or Seeing Things That Are Not There
• Fainting
• Thinking or Speech Problems, Abnormal Tremors, Mainly Affecting the Hands, Which Cannot Be Controlled
• Stroke - Symptoms Include Pain, Weakness, Numbness, or Tingling in the Arms or Legs
• Blind Spots or Loss of Vision
• Heart Failure or Heart Attack, Which May Lead to Cardiac Arrest and Death, and Heart Rhythm Disorders with Sudden Death
• Blood Clots in the Legs (Deep Vein Thrombosis) - Symptoms Include Severe Pain or Swelling in the Legs
• Blood Clots in the Lungs (Pulmonary Embolism) - Symptoms Include Shortness of Breath or Chest Pain
• Bleeding into the Stomach or Intestines - Symptoms Include Vomiting Blood or Passing Blood in the Stool
• Intestinal Blockage (Intestinal Obstruction); This Mainly Affects the Small Intestine. The Blockage Prevents the Passage of Intestinal Contents into the Lower Parts of the Digestive Tract; Symptoms Include Feeling Bloated, Vomiting, Severe Constipation, Loss of Appetite, and Cramps.
• Hemolytic-Uremic Syndrome - a Condition Characterized by the Breakdown of Red Blood Cells (Hemolysis), Which May Occur with or Without Kidney Failure
• Pancytopenia - Low Levels of All Types of Blood Cells (Red Blood Cells, White Blood Cells, and Platelets) Shown in Blood Tests
• Large Purple Spots on the Skin (Thrombocytopenic Purpura)
• Face and Tongue Swelling
• Depression
• Double Vision
• Chest Pain
• Adrenal Gland Problems - May Cause Weakness, Fatigue, Loss of Appetite, Skin Discoloration
• Pituitary Gland Problems - May Cause Low Levels of Certain Hormones in the Blood That Affect Male and Female Sex Organs
• Hearing Problems
• Pseudoaldosteronism, Which Leads to High Blood Pressure with Low Potassium Levels (Shown in Blood Tests)

Frequency Not Known: Frequency Cannot Be Estimated from the Available Data

• Some Patients Have Also Reported Feeling Confused After Taking Posaconazole
• Redness of the Skin.

If You Experience Any of the Above Side Effects, or Any Other Unlisted Side Effects, Tell Your Doctor, Pharmacist, or Nurse.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Department of Medicinal Product Monitoring, 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, Website: https://smz.ezdrowie.gov.pl. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Posaconazole STADA

Keep This Medicine Out of the Sight and Reach of Children.

Do Not Use This Medicine After the Expiry Date Stated on the Blister or Bottle and on the Carton After the Words "Expiry Date" (EXP). The Expiry Date Refers to the Last Day of the Month Stated.

No Special Precautions for Storage Are Necessary for This Medicine.

Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Posaconazole STADA Contains

The Active Substance Is Posaconazole. Each Gastro-Resistant Tablet Contains 100 Mg of Posaconazole.

The Other Ingredients Are: Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) (Type B), Triethyl Citrate, Xylitol, Hydroxypropyl Cellulose, Propyl Gallate, Microcrystalline Cellulose, Silica, Colloidal, Anhydrous, Sodium Stearyl Fumarate (See Section 2 "Posaconazole STADA Contains Sodium"), Polyvinyl Alcohol, Partially Hydrolyzed, Titanium Dioxide (E 171), Macrogol 3350, Talc, Iron Oxide Yellow (E 172).

What Posaconazole STADA Looks Like and Contents of the Pack

Posaconazole STADA Gastro-Resistant Tablets Are Yellow and Have a Capsule Shape, with the Imprint "100P" on One Side and a Smooth Surface on the Other. The Tablets Are Packaged in Cartons of 24 or 96 Tablets in Non-Perforated Blister Packs, 24 X 1 Tablet or 96 X 1 Tablet in Perforated Blister Packs Divided into Single Doses or 60 Tablets in HDPE Bottles.

Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer/Importer

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

Delorbis Pharmaceuticals Ltd

17 Athinon Street, Ergates Industrial Area

2643 Ergates, P.O. Box 28629

2081 Lefkosia

Cyprus

Clonmel Healthcare Limited

Waterford Road

Clonmel, E91 D768

Ireland

This Medicinal Product Is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria

Posaconazol STADA 100 mg magensaftresistente Tabletten

Croatia

Posakonazol STADA 100 mg želučanootporne tablete

Denmark

Posaconazol STADA

Estonia

Posaconazole STADA

Finland

Posaconazole STADA 100 mg enterotabletti

France

POSACONAZOLE EG 100 mg, comprimé gastrorésistant

Greece

Posaconazole STADA

Spain

Posaconazol STADA 100 mg comprimidos gastrorresistentes EFG

Netherlands

Posaconazol CF 100 mg, maagsapresistente tabletten

Ireland

Posaconazole Clonmel 100 mg gastro-resistant tablets

Iceland

Posaconazole STADA

Lithuania

Posaconazole STADA 100 mg skrandyje neirios tabletės

Latvia

Posaconazole STADA 100 mg zarnās šķīstošās tabletes

Malta

Posaconazole Clonmel 100 mg Gastroresistant Tablets

Germany

Posaconazol AL 100 mg magensaftresistente Tabletten

Poland

Posaconazole STADA

Romania

Posaconazol STADA 100 mg comprimate gastrorezistente

Slovakia

Posaconazol STADA 100 mg gastrorezistentne tablete

Slovakia

Posakonazol STADA 100 mg gastrorezistentne tablete

Sweden

Posaconazole STADA 100 mg enterotablett

United Kingdom

Posaconazole STADA 100 mg Gastro-resistant tablets

Italy

Posaconazolo EG STADA

Date of Last Revision of the Leaflet: 08/2024