Prospect: information for the patient

Sildenafilo ratiopharm 100mg film-coated tablets

sildenafilor

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you, and you must not give it to other people even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

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

2.What you need to knowbefore starting totake Sildenafilo ratiopharm

3.How to take Sildenafilo ratiopharm

4.Possible adverse effects

5.Storage of Sildenafilo ratiopharm

6.Contents of the package andadditional information

What is Sildenafilo ratiopharm

Sildenafil ratiopharmcontains the active ingredient sildenafilo, whichbelongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine allows an erection to last long enough for you to complete your sexual activity satisfactorily. It reduces the effect of natural chemicals in your body that make an erection disappear. Sildenafilo ratiopharm will only act if you are sexually stimulated.

What is Sildenafilo ratiopharm 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 penis that is rigid and erect enough for sexual activity.

Do not take Sildenafilo ratiopharm

-if you are allergic to sildenafil or any of the other ingredients of this medication (listed in section6)..

-if you are taking medications that contain nitrates (e.g., glyceryl trinitrate) or nitric oxide donors (e.g., amyl nitrite, also known as “poppers”). These medications are often used to relieve chest pain (angina). Taking these medications with Sildenafilo ratiopharm may severely affect your blood pressure. 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 clots). Phosphodiesterase type 5 inhibitors, such as sildenafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor..

• if you have a serious heart condition.
• 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 inherited eye diseases (such as retinitis pigmentosa)

-if you have ever experienced vision loss due to a known eye disease called “eye apoplexy” (ischemic optic neuropathy, NOIA-NA)

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 verify that your heart is able to withstand the additional strain of sexual activity.

Your doctor must verify that your heart is able to withstand the additional strain of sexual activity.

-if you have any of the following diseases or symptoms, as you may experience more side effects:

•an abnormality of red blood cells (sickle cell anemia);

•blood cancer (leukemia)

•bone marrow cancer (multiple myeloma);

•any disease or deformity of the penis.

• if you have any of the following diseases, inform your doctor, who will carefully verify if this medication is suitable for you:

if you have any of the following diseases, inform your doctor, who will carefully verify if this medication is suitable for you:

•if you currently have a stomach ulcer;

•if you have a bleeding disorder (e.g., hemophilia)

• if you have kidney or liver problems. Inform your doctor about them. In this case, your doctor may decide to administer a lower dose.

Inform your doctor about them. In this case, your doctor may 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 sildenafil or any other phosphodiesterase type 5 inhibitor.
• if you do not have erectile dysfunction
• if you are a woman.

If you experience sudden vision loss, stop taking Sildenafilo ratiopharm and contact your doctor immediately.

Children and adolescents

This medication should not be administered to children or adolescents under 18 years old.

Taking Sildenafilo ratiopharm with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In case of a medical emergency, you must inform any healthcare professional treating you that you have taken Sildenafilo ratiopharm.

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 known as “poppers”). These medications are often used to relieve chest pain (angina). Taking these medications with Sildenafilo ratiopharm may severely affect your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you take Sildenafilo ratiopharm with certain medications, you may experience 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 (a medication for treating acid reflux and stomach ulcers)
• alpha blockers (a group of medications for treating high blood pressure or enlarged prostate [benign prostatic hyperplasia]). Some patients taking alpha blockers may experience dizziness or lightheadedness when standing up. These are symptoms of a drop in blood pressure when standing up quickly (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.

Inform your doctor or pharmacist if you are taking any of the following medications:

• medications that contain sacubitril/valsartan, used for treating heart failure.

If you are taking any of these medications, your doctor may instruct you to start with the lowest dose (25 mg) of Sildenafilo ratiopharm. If you are taking ritonavir, you will not be able to exceed a maximum dose of 25 mg of sildenafil 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 act.

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

Driving and operating machinery

This medication may cause some people to feel dizzy or experience visual or auditory disturbances. Do not operate tools or machinery 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; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.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 prescribed by your doctor approximately 1 hour before initiating sexual activity. Swallow the tablet whole with a glass of water.

Do not take more film-coated tablets than indicated by your doctor.

Do not take Sildenafilo ratiopharm more than once a day.

This medication will only help you achieve an erection if you are sexually stimulated. The time it takes for Sildenafilo ratiopharm to act varies from person to person, but it usually takes between 30 minutes and 1 hour. It is possible that this medication may take longer to act if taken 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, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.The side effects reported associated with the use of sildenafil are generally of mild to moderate intensity and short duration.

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

-Allergic reaction: this occurs withlow frequency(may affect up to 1 in 100 people).

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

-Chest pain: this occurs withlow frequency.

If they occur during or after sexual intercourse:

• Position yourself in a semi-recumbent position and try to relax.
• Do not use nitratesto treat chest pain.

-Prolonged and sometimes painful erections: this occursrarely(may affect up to 1 in 1,000people).

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

-Sudden decrease or loss of vision: this occursrarely.

-Severe skin reactions: this occursrarely.

The symptoms may include severe peeling and swelling of the skin, vesicular buccal, genital, and around the eyes, as well as fever.

-Convulsions or seizures: this occursrarely.

Otherside effects:

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

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

Uncommon(may affect up to 1in 100people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

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

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this leaflet.You can also report them directly through the national notification system included in theAnexo V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the outer packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Sildenafilo ratiopharm

• The active ingredient is sildenafilo.

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

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

Appearance of the product and contents of the package

Sildenafilo ratiopharm is presented as film-coated tablets of color white to off-white, elongated, with a bevel and a notch on one of its faces. The tablet can be divided into equal doses.

Sildenafilo ratiopharm is presented in packages of 1, 2, 4, 8, 12, 24 or 48 film-coated tablets, in blisters. Only some package sizes may be commercially available.

Holder of the marketing authorization

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturers responsible

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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: {MM/AAAA}.

For detailed information about this medicine, please visit the website of the European Medicines Agency http://www.ema.europa.eu.