SILDENAFIL RATIOPHARM 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafilo ratiopharm 100mg film-coated tablets EFG

sildenafilo

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Sildenafilo ratiopharm and what is it used for
2. What you need to know before taking Sildenafilo ratiopharm
3. How to take Sildenafilo ratiopharm
4. Possible side effects
5. Storage of Sildenafilo ratiopharm
6. Package contents and additional information

1. What is Sildenafilo ratiopharm and what is it used for

What is Sildenafilo ratiopharm

Sildenafilo ratiopharm contains the active substance sildenafilo, which belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. This medication allows an erection to last long enough for you to complete sexual activity satisfactorily. It reduces the effect of natural chemicals in your body that make an erection disappear. Sildenafilo ratiopharm will only work if you are sexually stimulated.

What Sildenafilo ratiopharm is used for

Sildenafilo ratiopharm is a treatment for adult men with erectile dysfunction, sometimes called impotence. This occurs when a man cannot obtain or maintain a rigid and erect penis, suitable for sexual activity.

2. What you need to know before taking Sildenafilo ratiopharm

Do not take Sildenafilo ratiopharm

• if you are allergic to sildenafilo or any of the other components of this medication (listed in section 6).
• if you are taking medications that contain nitrates (e.g., glyceryl trinitrate) or nitric oxide donors (e.g., amyl nitrite, also called "poppers"). These medications are often used to relieve symptoms of chest pain (angina pectoris). If you take these medications with Sildenafilo ratiopharm, your blood pressure may be seriously affected. Inform your doctor if you are taking any of these medications. If you are unsure, consult your doctor or pharmacist.
• if you are taking riociguat. This medication is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as sildenafilo, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.
  • if you have a serious heart problem.
  • if you have recently had a stroke or myocardial infarction.
  • if you have low blood pressure.
  • if you have a serious liver problem.
  • if you have certain rare hereditary eye diseases (such as retinitis pigmentosa)

• if you have ever experienced vision loss due to an eye disease known as "eye stroke" (non-arteritic anterior ischemic optic neuropathy, NAION)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo ratiopharm.

• if you have heart problems. In this case, your doctor must carefully check if

your heart is able to withstand the extra effort of having sexual intercourse.

• if you suffer from any of the following diseases or symptoms, as you may experience more side effects:
  • a red blood cell anomaly (sickle cell anemia);
  • blood cancer (leukemia)
  • bone marrow cancer (multiple myeloma);
  • any disease or deformation of the penis.

• if you suffer from any of the following diseases, inform your doctor, who will carefully check if

this medication is suitable for you:

• if you currently have a stomach ulcer;
• if you have a coagulation disorder (e.g., hemophilia)

• if you have kidney or liver problems. Inform your doctor about them. In this

case, it is possible that the doctor will decide to administer a lower dose.

Do not take this medication

• if you are already using another treatment for erectile dysfunction.
• if you are already using treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other PDE5 inhibitor.
• if you do not have erectile dysfunction
• if you are a woman.

If you experience a sudden decrease or loss of vision, stop taking Sildenafilo ratiopharm and contact your doctor IMMEDIATELY.

Children and adolescents

This medication MUST NOT be administered to children or adolescents under 18 years of age.

Taking Sildenafilo ratiopharm with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

In case of a medical emergency, you must inform any healthcare professional who treats you that you have taken Sildenafilo ratiopharm to anyone who treats you.

Do not take Sildenafilo ratiopharm if you are taking medications that contain nitrates(e.g., glyceryl trinitrate) or nitric oxide donors (e.g., amyl nitrite, also called "poppers"). These medications are often used to relieve symptoms of chest pain (angina pectoris). Taking nitrates or nitric oxide donors with Sildenafilo ratiopharm can have serious effects on your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you take Sildenafilo ratiopharm with certain medications, you may have problems. Therefore, inform your doctor if you are taking any of the following medications:

• ritonavir or saquinavir (medications for treating HIV infections);
• ketoconazole or itraconazole (medications for treating fungal infections)
• erythromycin (an antibiotic)
• cimetidine (medication for treating acidity and peptic ulcers)
• alpha-blockers (a group of medications for treating high blood pressure or enlarged prostate

[benign prostatic hyperplasia]). Some patients who take alpha-blockers may experience dizziness or a feeling of fainting when standing up. These are symptoms of a drop in blood pressure when standing up quickly from a sitting or lying position (postural hypotension). These symptoms usually occur within 4 hours of taking Sildenafilo ratiopharm. To reduce the likelihood of these symptoms, you should start taking Sildenafilo ratiopharm only when you are already well-controlled with a regular daily dose of your alpha-blocker.

• medications that contain sacubitril/valsartan, used to treat heart failure.

If you are taking any of these medications, it is possible that your doctor will indicate that you start with the lowest dose (25 mg) of Sildenafilo ratiopharm. If you are taking ritonavir, you must not exceed a maximum dose of 25 mg of sildenafilo in a 48-hour period.

Taking Sildenafilo ratiopharm with food, drinks, and alcohol

If this medication is taken with food, it may take a little longer to work.

Alcoholic beverages can worsen erectile dysfunction. To get the maximum benefit from your medication, it is recommended that you avoid consuming alcohol before taking this medication.

Driving and using machines

This medication can make some people feel dizzy or have visual or hearing difficulties. Do not operate tools or machines if you feel dizzy or if your vision or hearing is affected after taking Sildenafilo ratiopharm.

Sildenafilo ratiopharm contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is, essentially "sodium-free".

3. How to take Sildenafilo ratiopharm

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

Take half or one film-coated tablet of Sildenafilo ratiopharm as your doctor has prescribed, approximately 1 hour before starting your sexual activity. Swallow the tablet whole, with a glass of water.

Do not take more tablets than your doctor indicates.

Do not take Sildenafilo ratiopharm more than once a day.

This medication will help you achieve an erection only if you are sexually stimulated. The time it takes for Sildenafilo ratiopharm to work varies from person to person, but it usually takes between half an hour and one hour. You may notice that this medication takes longer to work if you take it with a large meal.

If this medication does not help you achieve an erection or if your erection does not last long enough to complete intercourse, you should inform your doctor.

If you take more Sildenafilo ratiopharm than you should

Men who take too much Sildenafilo ratiopharm may experience more side effects or intense muscle pain. If you take more Sildenafilo ratiopharm than you should, inform your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. The side effects reported in association with the use of sildenafilo are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking Sildenafilo ratiopharm and seek medical attention immediately:

• Allergic reaction: this occurs infrequently (may affect up to 1 in 100 people).

The symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain: this occurs infrequently.

If it occurs during or after sexual intercourse:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections: this occurs rarely (may affect up to 1 in 1,000 people).

If you experience an erection that lasts more than 4 hours, you should contact a doctor immediately.

• Sudden decrease or loss of vision: this occurs rarely.

• Severe skin reactions: this occurs rarely.

The symptoms may include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits: this occurs rarely.

Other side effects:

Very common(may affect more than 1 in 10 people): headache.

Common(may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (including symptoms such as a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual impairment, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or congested nasal passages, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white of the eye, penile bleeding, presence of blood in the semen, dry nose, swelling of the inside of the nose, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience, cases of unstable angina (heart disease) and sudden death have been rarely reported. It is noteworthy that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine whether these episodes were directly related to Sildenafilo ratiopharm.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sildenafilo ratiopharm

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer packaging and on the blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Sildenafil ratiopharm Composition

• The active ingredient is sildenafil.

Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.

• The other ingredients are: microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, calcium hydrogen phosphate, talc, macrogol 6000, titanium dioxide, red iron oxide.

Product Appearance and Package Contents

Sildenafil ratiopharm is presented as white to off-white, elongated, film-coated tablets with a bevelled edge and a score line on one side. The tablet can be divided into equal doses.

Sildenafil ratiopharm is presented in packs of 1, 2, 4, 8, 12, 24 or 48 film-coated tablets, in blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturers

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Poland

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovakia

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:{MM/YYYY}.

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.