Mediclarum
Medicine guide

Sildenafil ratiopharm

·

  • Prescription status not stated
  • Urinary and reproductive system, hormones
Active substance
Sildenafil
Made by
Ratiopharm GmbH

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • What Sildenafil ratiopharm is Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This medicine allows an erection to last long enough for you to satisfactorily complete sexual activity. It reduces the action of the natural chemical in your body, which makes erections go away. Sildenafil ratiopharm will only work when you are sexually stimulated.
  • What Sildenafil ratiopharm is used for Sildenafil ratiopharm is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get or keep a hard, erect penis suitable for sexual activity.

From the package leaflet in EMA’s product information, p. 30 · 2022-06-24

How it works

This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (sildenafil citrate). It describes the substance, not this Bulgarian product — its uses and doses can differ.

The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.

NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.

How the body breaks it down

It is eliminated predominantly by hepatic metabolism (mainly CYP3A4) and is converted to an active metabolite with properties similar to the parent, sildenafil.

How it leaves the body

After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).

With food

When sildenafil is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in T max of 60 minutes and a mean reduction in C max of 29%.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-29

Do not take it if

  • if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “poppers”). These medicines are often used to relieve the symptoms of chest pain (angina pectoris). Taking these medicines with Sildenafil ratiopharm could seriously affect your blood pressure. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.
  • if you are taking riociguat. This medicine 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
  • if you have a severe heart problem.
  • if you have recently had a stroke or a heart attack.
  • if you have low blood pressure.
  • if you have a severe liver problem.
  • if you have certain rare inherited eye diseases (such as retinitis pigmentosa).
  • if you have ever suffered from loss of vision due to an eye condition known as “stroke of the eye” (non-arteritic anterior ischaemic optic neuropathy, NAION).

From the package leaflet in EMA’s product information, p. 30–31.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 dose is Take 1 film-coated tablet of Sildenafil ratiopharm about 1 hour before sexual activity. Swallow the film-coated tablet whole with a glass of water.
  • You should not take more film-coated tablets than your doctor tells you to.
  • You should not take Sildenafil ratiopharm more than once a day.
  • This medicine will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil ratiopharm takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that this medicine takes longer to work if you take it with a heavy meal.
  • If this medicine does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse, you should tell your doctor.
  • If you take more Sildenafil ratiopharm than you should Men who take too much Sildenafil ratiopharm may experience more side effects or may get severe muscle pain. If you take more Sildenafil ratiopharm than you should, tell your doctor.
  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 32.

Warnings and precautions

  • Talk to your doctor or pharmacist before taking Sildenafil ratiopharm
  • if you have problems with your heart. Your doctor should in that case carefully check whether your heart can take the additional strain of having sex.
  • if you suffer from any of the following disorders or symptoms, as you may experience more side effects:
  • an abnormality of the red blood cells (sickle cell anaemia);
  • cancer of the blood (leukaemia);
  • a cancer of the bone marrow (multiple myeloma);
  • any disease or deformity of the penis.
  • if you suffer from any of the following disorders, please tell your doctor who will check carefully whether this medicine is suitable for you:
  • if you currently have a stomach ulcer;
  • if you have a blood-clotting disorder (e.g. haemophilia).
  • if you suffer from kidney or liver problems. Please tell your doctor about this. In this case, he/she may decide to give you a lower dose.
  • You should NOT take this medicine
  • if you are already undergoing other treatments for erectile dysfunction.
  • if you are already undergoing treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
  • if you do not have erectile dysfunction.
  • if you are a woman.
  • If you experience sudden decrease or loss of vision, stop taking Sildenafil ratiopharm and contact your doctor IMMEDIATELY.
  • Children and adolescents This medicine should NOT be given to children and adolescents under the age of 18.

From the package leaflet in EMA’s product information, p. 31.

Other medicines

  • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
  • In a medical emergency, you must tell anyone treating you that you have taken Sildenafil ratiopharm.
  • Do NOT take Sildenafil ratiopharm if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “poppers”). These medicines are often used to relieve the symptoms of chest pain (angina pectoris). Simultaneous intake of nitrates or nitric oxide donors with Sildenafil ratiopharm can have severe effects on your blood pressure.
  • Tell your doctor or pharmacist if you are already taking riociguat.
  • Taking Sildenafil ratiopharm together with some medicines may lead to problems. Therefore, tell your doctor if you are taking any of the following medicines:
  • ritonavir or saquinavir (medicines for the treatment of HIV infections);
  • ketoconazole or itraconazole (medicines for the treatment of fungal infections);
  • erythromycin (an antibiotic);
  • cimetidine (medicine for the treatment of heartburn and peptic ulcers);
  • alpha blockers (group of medicines for the treatment of high blood pressure or an enlarged prostate [benign prostatic hyperplasia]).
  • Some patients taking alpha blockers may experience dizziness or light-headedness when getting up. These are symptoms of a fall in blood pressure upon rising quickly from sitting or lying (postural hypotension). These symptoms usually occur within 4 hours of taking Sildenafil ratiopharm. In order to reduce the probability of these symptoms occurring, you should start taking Sildenafil ratiopharm only when you are already well controlled on a regular daily dose of your alpha blocker.
  • medicines containing sacubitril/valsartan, used to treat heart failure.
  • If you are taking one of these medicines, your doctor may start you on the lowest dose (25 mg) of Sildenafil ratiopharm. If you are taking ritonavir, you may not exceed a maximum dose of 25 mg sildenafil within a period of 48 hours.
  • Sildenafil ratiopharm with food, drink and alcohol When this medicine is taken with food, it may take a little longer for Sildenafil ratiopharm to work.
  • Alcoholic drink can make erection difficulties worse. In order to get the maximum benefit from your medicine, it is recommended that you avoid alcohol before intake of this medicine.

From the package leaflet in EMA’s product information, p. 31–32.

Driving and using machines

  • This medicine might make some people feel dizzy or affect their vision or hearing. If you feel dizzy, or if your vision or hearing is affected after taking Sildenafil ratiopharm, do not drive or operate any tools or machines.
  • Sildenafil ratiopharm contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

From the package leaflet in EMA’s product information, p. 32.

Side effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.
  • If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:
  • An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people).
  • Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
  • Chest pains - this occurs uncommonly.
  • If this occurs during or after intercourse:
  • Get in a semi-sitting position and try to relax.
  • Do not use nitrates to treat your chest pain.
  • Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people).
  • If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.
  • A sudden decrease or loss of vision - this occurs rarely.
  • Serious skin reactions - this occurs rarely.
  • Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, 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 flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
  • Uncommon (may affect up to 1 in 100 people): vomiting, skin rash eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
  • Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
  • From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.
  • 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. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 33–34.

How to store it

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
  • The expiry date refers to the last day of that month.
  • This medicine does not require any special storage conditions.
  • Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 34.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

Every strength and form (191)

BulgariaNo exact match for this strength and form

Every strength and form (25)

SpainNo exact match for this strength and form

Every strength and form (174)

CanadaNo exact match for this strength and form

Every strength and form (83)

NetherlandsNo exact match for this strength and form

Every strength and form (88)

SwitzerlandNo exact match for this strength and form

Every strength and form (36)

Details

Made byRatiopharm GmbH
Active substanceSildenafil
Used inUrinary and reproductive system, hormones
ClassificationG04BE03 · Urinary and reproductive system, hormones
GenericYes — a generic medicine, according to the register
Authorised on2009-12-23
Last updated by the regulator2022-06-24
EMA product numberEMEA/H/C/001080

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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