Sildenafil ratiopharm 100 mg film-coated tablets

 

What is it and how is it used?

What Sildenafil ratiopharm is
Sildenafil ratiopharm belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Sildenafil ratiopharm 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 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.

What do you have to consider before using it?

Do NOT take Sildenafil ratiopharm

  • if you are allergic (hypersensitive) to sildenafil or any of the other ingredients of 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). 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 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).

Take special care with 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 Sildenafil ratiopharm

  • if you are already undergoing other treatments for erectile dysfunction.
  • if you do not have erectile dysfunction.
  • if you are a woman.

Sildenafil ratiopharm should NOT be given to children and adolescents under the age of 18.

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

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

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. 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.

Using Sildenafil ratiopharm with food and drink
When Sildenafil ratiopharm 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 Sildenafil ratiopharm.

Driving and using machines
Sildenafil ratiopharm 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.

How is it used?

Always take Sildenafil ratiopharm exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual 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.

Sildenafil ratiopharm 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 Sildenafil ratiopharm takes longer to work if you take it with a heavy meal.

If Sildenafil ratiopharm 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 product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Sildenafil ratiopharm can cause side effects although not everybody gets them.

The following frequency conventions are used in the evaluation of side effects very common common uncommon rare very rare not known affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.

Important side effects:

  • Chest pain: If you experience chest pain (uncommon) during or after sexual activity, you should NOT take any medicines that contain nitrates (e.g. glycerol trinitrate). Please contact a doctor IMMEDIATELY.
  • Allergic reactions: Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the eyelids, face, lips or throat have been reported rarely. If you think you are having this type of reaction, you must stop taking Sildenafil ratiopharm and get medical help IMMEDIATELY.
  • Visual disturbances: If you experience a sudden impairment or loss of vision (frequency not known), stop taking Sildenafil ratiopharm and contact your doctor IMMEDIATELY.
  • Prolonged erections: Prolonged and sometimes painful erections have been reported after taking Sildenafil ratiopharm (frequency not known). If you have such an erection, which lasts continuously for more than 4 hours, you should contact a doctor IMMEDIATELY.

You may experience the following additional side effects:

  • very common: headache;
  • common: dizziness, altered vision (increased brightness of light or blurred vision), colour tinge to vision, flushing, stuffy nose, indigestion;
  • uncommon: feeling sleepy, reduced sense of touch, bloodshot eyes, eye pain, watery eyes, abnormal sensation in the eye, vertigo, ringing in the ears, pounding heartbeat, faster heartbeat, vomiting, nausea, dry mouth, skin rash, muscle pain, feeling tired, measurement of faster heartbeat;
  • rare: stroke, fainting, sudden impairment or loss of hearing, high blood pressure, low blood pressure, heart attack, irregular heartbeat, nosebleed;
  • not known: temporary decreased blood flow to parts of the brain, seizure, recurrence of seizures, occlusion of blood vessels inside the eye, partial, sudden, temporary, or permanent impairment or loss of vision in one or both eyes, abnormal heartbeat, unstable angina (chest pain), sudden death, serious skin reactions characterised by rash, blisters, peeling skin and pain, which require immediate medical attention.

Most, but not all, of the men who experienced cardiovascular side effects already had cardiovascular problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Sildenafil ratiopharm 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.

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.

What is it?

Sildenafil ratiopharm is a medicine that contains the active substance sildenafil. It is available as blue, oval tablets (25, 50 and 100 mg).
Sildenafil ratiopharm is a ‘generic medicine’. This means that Sildenafil ratiopharm is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Viagra. For more information on generic medicines, see the question-and-answer document here.

What is it used for?

Sildenafil ratiopharm is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Sildenafil ratiopharm to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Sildenafil ratiopharm is 50 mg taken as needed about one hour before sexual activity. If Sildenafil ratiopharm is taken with food, the onset of activity may be delayed compared with taking Sildenafil ratiopharm without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with liver problems or severe kidney problems should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.

How does it work?

The active ingredient in Sildenafil ratiopharm, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Sildenafil ratiopharm restores erectile function. Sexual stimulation is still needed to produce an erection.

How has it been studied?

Because Sildenafil ratiopharm is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefits has it shown during the studies?

Because Sildenafil ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Sildenafil ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Sildenafil ratiopharm has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP’s view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Sildenafil ratiopharm be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil ratiopharm to ratiopharm GmbH on 23 December 2009. The marketing authorisation is valid for five years, after which it can be renewed.

This summary was last updated in 11-2009.