Package Leaflet: Information for the Patient

Sildenafilo ratiopharm 50 mg Film-Coated Tablets

sildenafilor

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you onlyaloneand should not be given to others even if they have the same symptomsas you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What Sildenafilo ratiopharm is and what it is 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.Contents of the pack and additional information

Do not take Sildenafilo ratiopharm

-if you are allergic to sildenafil or any of the other ingredients 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 known as “poppers”). These medications are often used to relieve chest pain (angina pectoris). 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 severe liver condition.
• 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 whether your heart is able to withstand the additional strain of sexual activity.

Your doctor must verify whether 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:

•a red blood cell anomaly (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 whether this medication is suitable for you:

•if you currently have a gastric 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.

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 of age.

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, 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 pectoris). 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 ulcers)
• alpha blockers (a group of medications for treating high blood pressure or 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, start taking Sildenafilo ratiopharm only when you are well-controlled with a regular daily dose of your alpha blocker.

• medications containing sacubitril/valsartan, used to treat 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 difficulties. 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 difficulties. 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”.

Composition of Sildenafilo ratiopharm

• The active ingredient is sildenafilo.

Each film-coated tablet contains citrate of sildenafilo equivalent to 50 mg of sildenafilo.

• The other components are: microcrystalline cellulose, hypromellose, sodium croscarmellose, 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 blisters of 1, 2, 4, 8, 12 or 24 film-coated tablets. Only some package sizes may be marketed.

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

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

The detailed information about this medication is available on the website of the European Medicines Agency http://www.ema.europa.eu.