Tadaxin

Package Leaflet: Information for the User

Tadaxin, 5 mg, Film-Coated Tablets

Tadalafil

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 or Pharmacist.
• 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 Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

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

1. What Tadaxin Is and What It Is Used For

Tadaxin Contains the Active Substance Tadalafil, Which Belongs to a Group of Medicines Called Phosphodiesterase Type 5 Inhibitors.
Tadaxin, 5 mg Is Used to Treat Adult Men with:

• Erectile Dysfunction. This Is a Condition Where a Man Cannot Achieve or Maintain an Erection Sufficient for Satisfactory Sexual Performance. Tadalafil Has Been Shown to Significantly Improve the Ability to Achieve an Erection Sufficient for Satisfactory Sexual Performance. After Sexual Stimulation, Tadaxin Helps to Relax the Blood Vessels in the Penis, Allowing Blood to Flow Into the Penis. As a Result, the Blood Flow into the Penis Increases, Causing an Erection. Tadaxin Does Not Help Patients Who Do Not Have Erectile Dysfunction. It Is Important to Note That Tadaxin Does Not Work Without Sexual Stimulation. The Patient and His Partner Should Engage in Foreplay, Just as They Would If the Patient Were Not Taking Erectile Dysfunction Medication.
• Symptoms of Benign Prostatic Hyperplasia (Enlargement of the Prostate Gland). This Is a Condition Where the Prostate Gland Enlarges with Age. Symptoms Include: Difficulty Starting to Pass Urine, a Feeling of Not Completely Emptying the Bladder, and the Need to Pass Urine More Often, Even at Night. Tadaxin Improves Blood Flow and Relaxes the Muscles in the Prostate and Bladder, Which May Help to Relieve Symptoms of Benign Prostatic Hyperplasia. It Has Been Shown That Tadalafil Relieves These Urinary Symptoms After 1-2 Weeks of Treatment.

2. Before You Take Tadaxin

When Not to Take Tadaxin:

• If You Are Allergic to Tadalafil or Any of the Other Ingredients of This Medicine (Listed in Section 6);
• If You Are Taking Organic Nitrates or Other Nitric Oxide Donors, Such as Amyl Nitrite. This Is a Group of Medicines ("Nitrates") Used to Treat Angina (Chest Pain). Tadalafil Has Been Shown to Increase the Effects of These Medicines. If You Are Taking Nitrates in Any Form or Are Unsure, Tell Your Doctor;
• If You Have Severe Heart Disease or Have Had a Heart Attack in the Last 90 Days;
• If You Have Had a Stroke in the Last 6 Months;
• If You Have Low Blood Pressure or Uncontrolled High Blood Pressure;
• If You Have Ever Had Loss of Vision Due to Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), a Condition Described as "Stroke of the Eye";
• If You Are Taking Riociguat. This Is a Medicine Used to Treat Pulmonary Hypertension (High Blood Pressure in the Lungs) and Chronic Thromboembolic Pulmonary Hypertension (High Blood Pressure in the Lungs Due to Blood Clots). It Has Been Shown That Phosphodiesterase Type 5 Inhibitors, Such as Tadaxin, Increase the Blood Pressure-Lowering Effects of This Medicine. If You Are Taking Riociguat or Are Unsure, Tell Your Doctor.

Warnings and Precautions

Before Taking Tadaxin, Talk to Your Doctor.
Remember That Sexual Activity Is a Strain on the Heart. If You Have a Heart Condition, Tell Your Doctor.
Benign Prostatic Hyperplasia and Prostate Cancer Can Have the Same Symptoms. Your Doctor Will Check for Prostate Cancer Before Prescribing Tadaxin to Treat Benign Prostatic Hyperplasia.
Tadaxin Is Not for the Treatment of Prostate Cancer.
Before Taking Tadaxin, Tell Your Doctor If You Have:

• Sickle Cell Anemia (Abnormal Shape of Red Blood Cells);
• Multiple Myeloma (Bone Marrow Cancer);
• Leukemia (Blood Cell Cancer);
• Any Deformity of the Penis;
• Severe Liver Disease;
• Severe Kidney Disease.

It Is Not Known If Tadaxin Is Effective in Patients Who Have:

• Had Pelvic Surgery;
• Had Their Prostate Removed (Radical Prostatectomy Without Nerve-Sparing).

If You Experience Sudden Vision Loss or Sudden Decrease in Vision, Stop Taking Tadaxin and Contact Your Doctor Immediately.
In Some Patients Taking Tadalafil, a Sudden Decrease or Loss of Hearing Has Been Observed. Although It Is Not Known If This Event Is Related to Tadalafil, If You Experience a Sudden Decrease or Loss of Hearing, Stop Taking Tadaxin and Contact Your Doctor Immediately.
Tadaxin Is Not Intended for Use by Women.

Children and Adolescents

Tadaxin Is Not Intended for Use by Children and Adolescents Under 18 Years of Age.

Tadaxin and Other Medicines

Tell Your Doctor About All Medicines You Are Currently Taking or Plan to Take, Including Those Obtained Without a Prescription.
Do Not Take Tadaxin If You Are Taking Nitrates.
Tadaxin May Affect or Be Affected by Other Medicines. Tell Your Doctor or Pharmacist If You Are Taking Any of the Following Medicines:

• Alpha-Blockers (Used to Treat High Blood Pressure or Symptoms of Benign Prostatic Hyperplasia);
• Other Medicines Used to Treat High Blood Pressure;
• Riociguat;
• 5-Alpha-Reductase Inhibitors (Used to Treat Benign Prostatic Hyperplasia);
• Certain Medicines Such as Ketoconazole (Used to Treat Fungal Infections) and Protease Inhibitors Used to Treat AIDS or HIV Infection;
• Phenobarbital, Phenytoin, and Carbamazepine (Anti-Epileptic Medicines);
• Rifampicin, Erythromycin, Clarithromycin, or Itraconazole;
• Other Treatments for Erectile Dysfunction.

Tadaxin with Food and Alcohol

Information on the Effect of Alcohol Is Given in Section 3. Grapefruit Juice May Affect the Efficacy of Tadaxin, and Therefore, Caution Should Be Exercised When Consuming It. For More Information, Consult Your Doctor.

Fertility

When Tadaxin Was Administered to Dogs, a Decrease in Sperm Production Was Observed. A Decrease in Sperm Count Has Been Observed in Some Men. It Is Unlikely to Cause Infertility.

Driving and Using Machines

Some Men Taking Tadalafil During Clinical Trials Reported Dizziness. Therefore, You Should Be Aware of How You React to the Tablets Before Driving or Operating Machinery.

Tadaxin Contains Lactose

If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product.

Tadaxin Contains Sodium

This Medicinal Product Contains Less Than 1 mmol (23 mg) of Sodium per Tablet, Which Is Essentially "Sodium-Free".

3. How to Take Tadaxin

Always Take This Medicine Exactly as Your Doctor Has Told You. If You Are Not Sure, Check with Your Doctor or Pharmacist.
Tadaxin Tablets Are for Oral Use Only in Men. The Tablets Should Be Swallowed Whole with a Small Amount of Water. The Tablets Can Be Taken with or Without Food.

Treatment of Erectile Dysfunction

Recommended DoseIs One 5 mg Tablet Taken Once a Day, at Approximately the Same Time of Day. Your Doctor May Adjust the Dose to 2.5 mg Based on Your Response to Tadaxin. In This Case, Take One 2.5 mg Tablet.
Do Not Take Tadaxin More Than Once a Day.
Taking Tadaxin Once a Day Allows for Spontaneous Erection in Response to Sexual Stimulation at Any Time of Day. Taking Tadaxin Once a Day May Be Beneficial for Men Who Plan to Have Sexual Activity Twice a Week or More Often.
It Is Important to Note That Tadaxin Does Not Work Without Sexual Stimulation. The Patient and His Partner Should Engage in Foreplay, Just as They Would If the Patient Were Not Taking Erectile Dysfunction Medication.
Consuming Alcohol May Affect the Ability to Achieve an Erection.

Treatment of Symptoms of Benign Prostatic Hyperplasia

DoseIs One 5 mg Tablet Taken Once a Day, at Approximately the Same Time of Day. If You Have Benign Prostatic Hyperplasia and Erectile Dysfunction, the Dose Remains One 5 mg Tablet per Day.

Taking More Than the Recommended Dose of Tadaxin

Tell Your Doctor. You May Experience Side Effects Described in Section 4.

Forgetting a Dose of Tadaxin

Take a Dose as Soon as You Remember, but Do Not Take More Than One Dose per Day. If You Are Unsure About What to Do, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
These Effects Are Usually Mild or Moderate.

If You Experience Any of the Following Side Effects, Stop Taking Tadaxin and Contact Your Doctor Immediately:

• Allergic Reactions, Including Skin Rashes (Uncommon);
• Chest Pain - Do Not Take Nitrates, and Seek Medical Help Immediately (Uncommon);
• Priapism - Prolonged and Possibly Painful Erection After Taking Tadaxin (Rare). If You Experience This Erection and It Lasts for More Than 4 Hours, Seek Medical Help Immediately;
• Sudden Vision Loss (Rare), Distorted Vision, Blurred Vision, or Sudden Decrease in Vision (Frequency Not Known).

Other Reported Side Effects Include:
Common(May Affect Up to 1 in 10 People)

• Headache, Back Pain, Muscle Pain, Pain in Arms and Legs, Flushing, Nasal Congestion, Indigestion:

Uncommon(May Affect Up to 1 in 100 People)

• Dizziness, Stomach Pain, Nausea, Vomiting, Reflux, Blurred Vision, Eye Pain, Difficulty Breathing, Blood in Urine, Prolonged Erection, Palpitations, Rapid Heartbeat, High Blood Pressure, Low Blood Pressure, Nosebleeds, Ringing in the Ears, Swelling of Hands, Feet, or Ankles, and Feeling Tired.

Rare(May Affect Up to 1 in 1,000 People)

• Fainting, Seizures, and Transient Memory Loss, Swelling of the Eyelids, Redness of the Eyes, Sudden Decrease or Loss of Hearing, Hives (Itchy, Red Bumps on the Skin), Penile Bleeding, Blood in Semen, and Increased Sweating.

Heart Attack and Stroke Have Been Rarely Reported in Men Taking Tadalafil. Most of These Men Had Heart Problems Before Taking This Medicine.
There Have Been Reports of Rare Cases of Partial, Temporary, or Permanent Decrease in Vision or Loss of Vision in One or Both Eyes.
Men Taking Tadalafil Have Reported Several Additional Rare Side Effects, Which Were Not Observed in Clinical Trials. These Include:

• Migraine, Facial Swelling, Severe Allergic Reactions Causing Swelling of the Face and Throat, Severe Skin Rashes, Eye Disorders, Irregular Heartbeat, Angina, and Sudden Cardiac Death.
• Distorted Vision, Blurred Vision, or Sudden Decrease in Vision (Frequency Not Known).

Side Effects Such as Dizziness and Diarrhea Were Reported More Frequently in Men Over 75 Years of Age Taking Tadalafil. Diarrhea Was Reported More Frequently in Men Over 65 Years of Age Taking Tadalafil.

Reporting of Side Effects

If You Experience Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. Side Effects Can Also Be Reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) on the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Tadaxin

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Stated on the Carton and Blister After "EXP".
The Expiry Date Refers to the Last Day of That Month.
Store in a Temperature Not Exceeding 30°C.
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Tadaxin Contains

• The Active Substance Is Tadalafil. Each Tablet Contains 5 mg of Tadalafil.
• The Other Ingredients Are: Tablet Core: Lactose Monohydrate, Microcrystalline Cellulose, Povidone K-29-32, Sodium Citrate, Sodium Lauryl Sulfate, Croscarmellose Sodium, Silica Colloidal Anhydrous, Sodium Stearyl Fumarate. Tablet Coating: Hypromellose 6 cPs, Triacetin, Talc, Titanium Dioxide (E 171), Yellow Iron Oxide (E 172).

What Tadaxin Looks Like and Contents of the Pack

Yellow, Biconvex, Film-Coated Tablets in the Shape of an Almond, with the Embossing "L 62" on One Side and Plain on the Other (Dimensions: 8.6 ± 0.3 mm x 5.1 ± 0.3 mm).
Available Pack Sizes: 2, 4, 8, 10, 12, 14, 28, 56, or 84 Tablets.
Not All Pack Sizes May Be Marketed.

Marketing Authorisation Holder

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

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz

Date of Last Revision of the Leaflet: November 2023