Maxigra

Package Leaflet: Information for the Patient

MAXIGRA, 100 mg, Film-Coated Tablets

Sildenafil

Read All of This Leaflet Carefully Before Taking This Medicine Because It Contains Important Information for You.

• 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 Only. Do Not Pass It On to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Get 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

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

1. What Is Maxigra and What Is It Used For

Maxigra Contains the Active Substance Sildenafil, Which Belongs to a Group of Medicines Called Phosphodiesterase Type 5 (PDE5) Inhibitors. It Works by Helping to Relax the Blood Vessels in Your Penis, Allowing Blood to Flow Into Your Penis When You Get Sexually Excited. Maxigra Will Only Help You to Get an Erection If You Are Sexually Stimulated.

Maxigra Is Used to Treat Adult Men with Erectile Dysfunction, Sometimes Called Impotence. This Means That You Cannot Get, or Keep, a Hard Erection That Is Sufficient for Satisfactory Sexual Activity.

2. Before You Take Maxigra

Do Not Take Maxigra

• If You Are Allergic to Sildenafil or Any of the Other Ingredients of This Medicine (Listed in Section 6).
• If You Are Taking Nitrates (See "Other Medicines and Maxigra").
• If You Are Taking Medicines Called Nitric Oxide Donors Such as Amyl Nitrite (Sometimes Called "Poppers").
• If You Are Taking Riociguat. This Is Another Medicine Used to Treat Pulmonary Hypertension (High Blood Pressure in the Blood Vessels That Carry Blood to the Lungs) and Chronic Thromboembolic Pulmonary Hypertension (High Blood Pressure in the Blood Vessels That Carry Blood to the Lungs Due to Blood Clots).

If You Are Taking Riociguat or Are Uncertain, Tell Your Doctor.

• If You Have Severe Heart or Liver Problems.
• If You Have Recently Had a Stroke or Heart Attack or If You Have Low Blood Pressure.
• If You Have Certain Rare Inherited Eye Diseases (Such as Retinitis Pigmentosa).
• If You Have Ever Had Loss of Vision in One Eye Due to a Condition Called Non-Arteritic Anterior Ischaemic Optic Neuropathy (Naion).

Warnings and Precautions

Before Taking Maxigra, Tell Your Doctor or Pharmacist If:

• You Have Sickle Cell Anaemia (an Abnormality of Red Blood Cells), Leukaemia (Cancer of Blood Cells) or Multiple Myeloma (Cancer of Bone Marrow).
• You Have a Deformity of Your Penis or Peyronie's Disease.
• You Have Heart Problems. Your Doctor Should Carefully Check Whether Your Heart Can Take the Additional Strain of Having Sex.
• You Have Liver or Kidney Problems.

If You Experience Sudden Severe Loss of Vision, Stop Taking Maxigra and Contact Your Doctor Immediately.

Maxigra Should Not Be Taken with Other Oral or Local Treatments for Erectile Dysfunction.

Maxigra Should Not Be Taken with Other Treatments for Pulmonary Arterial Hypertension (PaH) Containing Sildenafil or Any Other Phosphodiesterase Type 5 (PDE5) Inhibitors.

Do Not Take Maxigra If You Are Not Diagnosed with Erectile Dysfunction.

Maxigra Is Not Intended for Use by Women.

Special Considerations for Patients with Kidney or Liver Problems

Patients with Kidney or Liver Problems Should Tell Their Doctor. The Doctor May Decide to Prescribe a Lower Dose.

Children and Adolescents

Maxigra Should Not Be Used in Individuals Below 18 Years of Age.

Maxigra with Other Medicines

Tell Your Doctor or Pharmacist If You Are Taking, Have Recently Taken or Might Take Any Other Medicines, Including Those Obtained Without a Prescription.

Maxigra May Interact with Some Medicines, Especially Those Used to Treat Chest Pain.

In the Event of a Medical Emergency, You Should Tell Your Doctor That You Have Taken Maxigra and When You Took It.

Do Not Take Maxigra with Other Medicines Unless Your Doctor Tells You to.

Do Not Take Maxigra If You Are Taking Nitrates.

Always Tell Your Doctor or Pharmacist If You Are Taking Nitrates, as These Are Often Used to Treat Angina (Chest Pain).

Do Not Take Maxigra If You Are Taking Medicines Called Nitric Oxide Donors, Such as Amyl Nitrite (Sometimes Called "Poppers"), as This Can Lead to a Dangerous Drop in Blood Pressure.

If You Are Taking Riociguat, Tell Your Doctor or Pharmacist.

If You Are Taking Medicines Called Protease Inhibitors, for the Treatment of HIV Infection, Your Doctor May Start You on the Lowest Dose (25 Mg) of This Medication.

Some Patients Who Take Alpha-Blockers for High Blood Pressure or Prostate Problems May Experience Dizziness or Fainting Due to Low Blood Pressure When Taking Maxigra.

Such Symptoms Have Been Reported in Some Patients Taking Maxigra and Alpha-Blockers.

These Symptoms Are Most Likely to Occur Within 4 Hours of Taking Maxigra.

To Reduce the Risk of These Symptoms, Patients Should Be Stabilized on Alpha-Blocker Therapy Prior to Starting Maxigra.

The Doctor May Decide to Prescribe a Lower Starting Dose (25 Mg) of This Medication.

If You Are Taking Medicines Containing Sacubitril/Valsartan, Used to Treat Heart Failure, Tell Your Doctor or Pharmacist.

Maxigra with Food, Drink and Alcohol

Maxigra Can Be Taken with or Without Food.

However, Taking Maxigra with a High-Fat Meal May Delay the Onset of Action.

Alcohol Can Cause Erection Problems and May Make Them Worse.

To Get the Maximum Benefit from Maxigra, You Are Advised Not to Drink Excessive Amounts of Alcohol Before Taking This Medication.

Pregnancy, Breast-Feeding and Fertility

Maxigra Is Not Intended for Use by Women.

Driving and Using Machines

Maxigra May Cause Dizziness and Affect Vision.

Before Driving or Operating Machinery, Patients Should Be Aware of How They React to Maxigra.

Maxigra Contains Sodium

This Medicinal Product Contains Less Than 1 Mmol Sodium (23 Mg) Per Tablet, That Is to Say Essentially "Sodium-Free".

3. How to Take Maxigra

Always Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You.

Check with Your Doctor or Pharmacist If You Are Not Sure.

The Recommended Starting Dose Is 50 Mg.

You Should Not Take Maxigra More Than Once a Day.

Do Not Take Maxigra with Other Medicines Containing Sildenafil.

Take a Maxigra Tablet About 1 Hour Before You Plan to Have Sex.

Swallow the Tablet Whole with a Glass of Water.

If You Feel That the Effect of Maxigra Is Too Strong or Too Weak, Talk to Your Doctor or Pharmacist.

Maxigra Will Only Help You to Get an Erection If You Are Sexually Stimulated.

The Time It Takes for Maxigra to Start Working Varies from Person to Person, but It Normally Takes Between 30 Minutes to 1 Hour.

It May Take Longer to Start Working If You Take It with a Large Meal.

If You Do Not Get an Erection After Taking Maxigra, or If Your Erection Does Not Last Long Enough for Satisfactory Sexual Activity, Tell Your Doctor.

If You Take More Maxigra Than You Should

You May Be More Likely to Experience Side Effects.

Taking More Than 100 Mg Does Not Increase the Efficacy of the Medication.

Do Not Take More Than One Dose of Maxigra Per Day.

Consult a Doctor If You Have Taken More Than the Recommended Dose.

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

4. Possible Side Effects

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

Side Effects Reported in Association with the Use of Maxigra Are Usually Mild to Moderate and of Short Duration.

If You Experience Any of the Following, Stop Taking Maxigra and Seek Medical Help Immediately:

• An Allergic Reaction - This Happens Very Rarely (May Affect Up to 1 in 100 People). Symptoms Include Sudden Wheezing, Difficulty Breathing, Swelling of the Eyelids, Face, Lips, Tongue or Throat.
• Chest Pain - This Happens Very Rarely (May Affect Up to 1 in 100 People). If This Happens During or After Intercourse:
• Sit in a Semi-Upper Position and Try to Relax.
• Do Not Take Nitratesto Treat Chest Pain, as This Can Cause a Dangerous Drop in Blood Pressure.
• Prolonged and Sometimes Painful Erections - This Happens Rarely (May Affect Up to 1 in 1000 People). If You Have an Erection That Lasts More Than 4 Hours, Contact a Doctor Immediately.
• Sudden Loss of Vision - This Happens Rarely (May Affect Up to 1 in 1000 People).
• Severe Skin Reactions - This Happens Rarely (May Affect Up to 1 in 1000 People). Symptoms Can Include Severe Skin Rashes, Blistering, Peeling, Ulcers of the Mouth, Throat, Nose, Genitals and Eyes, Redness and Swelling of the Skin.
• Seizures or Fits - This Happens Rarely (May Affect Up to 1 in 1000 People).

Other Side Effects:

Very Common(May Affect More Than 1 in 10 People):

• Headache.

Common(May Affect Up to 1 in 10 People):

• Flushing, Hot Flushes (Symptoms Include a Feeling of Heat in the Face, Neck and Chest), Nasal Congestion, Dizziness.
• Blurred Vision, Colour Tinge to Vision, Eye Pain, Light Sensitivity, Blurred Vision, Red Eyes.

Uncommon(May Affect Up to 1 in 100 People):

• Vomiting, Skin Rash.
• Eye Irritation, Red Eyes, Eye Pain, Seeing Halos Around Lights, Colour Tinge to Vision, Increased Sensitivity to Light, Watery Eyes.
• Fast or Irregular Heartbeat, High Blood Pressure, Low Blood Pressure.
• Muscle Pain, Sleepiness, Reduced Sense of Touch, Dizziness Due to Inner Ear Problems, Ringing in the Ears.
• Dry Mouth, Stuffy or Runny Nose, Sinusitis (Symptoms Include a Blocked or Runny Nose, Sore Throat and Cough), Upper Abdominal Pain, Gastro-Oesophageal Reflux Disease (Symptoms Include Heartburn).
• Blood in Urine, Pain in the Arms or Legs, Nosebleeds, Feeling Hot or Feeling Tired.

Rare(May Affect Up to 1 in 1000 People):

• Fainting, Stroke, Heart Attack, Abnormal Heartbeat, Temporary Decreased Blood Flow to Part of the Brain.
• Feeling of Throat Tightness, Numbness of the Tongue.
• Bleeding in the Eye, Double Vision.
• Reduced Sharpness of Vision, Abnormal Sensations in the Eye, Swelling of the Eyelids, Redness of the Eyes.
• Small Particles or Floaters in the Eye, Seeing Halos Around Lights.
• Pupil Dilation, Discoloration of the White of the Eye.
• Bleeding from the Penis, Presence of Blood in Semen, Dryness of the Nose, Swelling of the Inside of the Nose.
• Irritability, Sudden Decrease or Loss of Hearing.

After Marketing, Cases of Unstable Angina (a Heart Condition) and Sudden Death Have Been Reported Rarely. In Most, but Not All, of These Men, the Events Were Associated with Pre-Existing Cardiovascular Disease.

It Is Not Possible to Determine Whether These Events Were Directly Related to Sildenafil.

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet.

Side Effects Can Be Reported to the Department of Medicinal Product Monitoring, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktow Biobójczych.

Al. Jerozolimskie 181C, 02-222 Warsaw, Poland.

Tel: +48 22 49 21 301, Fax: +48 22 49 21 309.

Website: Https://Smz.Ezdrowie.Gov.Pl.

Side Effects Can Also Be Reported Directly to the Marketing Authorisation Holder.

By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Maxigra

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

There Are No Special Storage Conditions.

Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton After "Exp". The Expiry Date Refers to the Last Day of That Month.

The "Exp" on the Packaging Indicates the Expiry Date, and "Lot" Indicates the Batch Number.

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 to Protect the Environment.

6. Contents of the Pack and Other Information

What Maxigra Contains

• The Active Substance Is Sildenafil. Each Tablet Contains 100 Mg of Sildenafil (as Citrate).
• The Other Ingredients Are:
• Core: Mannitol (E421), Crospovidone (Type A), Povidone (K30), Colloidal Anhydrous Silica, Maize Starch, Magnesium Stearate, Sodium Lauryl Sulfate.
• Coating: Hypromellose, Macrogol 6000, Titanium Dioxide, Talc, Indigo Carmine (E132).

What Maxigra Looks Like and Contents of the Pack

The Film-Coated Tablets Are Blue, Round, Biconvex.

The Pack Contains 1, 4, 8 or 12 Tablets.

Not All Pack Sizes May Be Marketed.

Marketing Authorisation Holder and Manufacturer

Zaklady Farmaceutyczne Polpharma S.A.

Ul. Pelplińska 19, 83-200 Starogard Gdański, Poland.

Tel: +48 22 364 61 01.

Date of Last Revision of the Leaflet