NOTICE
ANSM - Updated: 26/06/2015
Name of the drug
SILDENAFIL PFIZER 50 mg film-coated tablets
framed
Read all of this leaflet carefully before you start taking this medicine.
· Keep this leaflet, you may need to read it again.
· If you have any other questions, if you are not sure, ask your doctor or pharmacist for more information.
· This medicine has been prescribed for you. Never give it to anyone else even with identical symptoms, it could be harmful.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. What is SILDENAFIL PFIZER 50 mg film-coated tablet and in what cases is it used?
2. What you need to know before taking SILDENAFIL PFIZER 50 mg film-coated tablets .
3. How to take SILDENAFIL PFIZER 50 mg, film-coated tablet ?
4. What are the possible side effects?
5. How to store SILDENAFIL PFIZER 50 mg, film-coated tablet ?
6. Additional information.
1. WHAT IS SILDENAFIL PFIZER 50 mg film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Sildenafil Pfizer contains the active substance sildenafil (as citrate), which belongs to a group of drugs called phosphodiesterase type 5 (PDE5) inhibitors.
Its action is to help the relaxation of the blood vessels of the penis, promoting blood flow into the penis, during sexual arousal. This medication will help you get an erection only if you have sexual stimulation.
Therapeutic indications
This medication is a treatment for adult men with erectile dysfunction, sometimes called impotence; that is, when a man can not achieve or maintain an erection sufficient for sexual activity.
2. BEFORE YOU TAKE SILDENAFIL PFIZER 50 mg film-coated tablets.
List of information needed before taking the medication
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take SILDENAFIL PFIZER 50 mg film-coated tablets in the following circumstances:
· if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6),
· If you take drugs called nitrates, because the combination can cause a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines that are often used for the relief of angina attacks. If in doubt, seek the advice of your doctor or pharmacist,
· If you use any of the drugs known as nitric oxide donors such as amyl nitrite ("poppers"), because the combination can also cause a dangerous fall in your blood pressure,
· If you have serious heart or liver problems,
· If you have recently had a stroke or a heart attack or if your blood pressure is low,
· If you suffer from some rare hereditary eye diseases (such as retinitis pigmentosa),
· If you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Precautions for use; special warnings
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before taking Sildenafil Pfizer :
· if you have sickle cell disease (abnormal red blood cells), leukemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow),
· if you have penile deformity or Peyronie's disease,
· if you have heart problems. Your doctor should carefully assess whether your heart can tolerate the extra effort of sexual activity,
· if you currently have a stomach ulcer or bleeding disorders (such as hemophilia),
· if you experience a sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.
You should not use this medicine at the same time as any other oral or local treatment for erectile dysfunction.
You should not take Sildenafil Pfizer if you do not have an erection disorder.
You should not take Sildenafil Pfizer if you are a woman.
You should not use this medicine together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
Special precautions for patients with kidney or liver problems
You must tell your doctor if you have kidney or liver problems. Your doctor may decide to prescribe a lower dose.
Children and adolescents
This medication should not be administered to people under 18 years of age.
The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Interactions with other drugs
Other medicines and SILDENAFIL PFIZER 50 mg film-coated tablets
If you are taking, have recently taken or are planning to take another medicine, tell your doctor or pharmacist.
SILDENAFIL PFIZER tablets may interact with some medicines, especially those used for angina pectoris. In the event of a medical emergency, you should inform any healthcare professional who is treating you that you have taken SILDENAFIL PFIZER 50 mg film-coated tablets and when. Do not take this medicine at the same time as other medications unless your doctor tells you to.
You should not take this medicine if you are taking medicines called nitrates because the combination of these medicines can cause a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or angina).
You should not take this medicine if you are taking any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers") because this combination can also cause a dangerous fall in your blood pressure.
If you are taking medicines known as protease inhibitors, especially for the treatment of HIV infection, your doctor may start treatment with SILDENAFIL PFIZER 50 mg film-coated tablets with the lowest dose (25 mg ).
Some patients taking alpha-blocking medication for the treatment of high blood pressure or enlarged prostate may experience dizziness or intoxication, which may be due to low blood pressure during rapid switch to sitting or standing. Some patients experienced these symptoms when taking this medication with alpha-blockers. This occurs most often within 4 hours of taking this medication. To reduce the likelihood of these symptoms occurring, you should be treated with a constant daily dose of alpha-blocker before starting treatment with this medication. Your doctor may initiate your treatment with this medicine at a lower dose (25 mg).
Interactions with food and drinks
SILDENAFIL PFIZER 50 mg film-coated tablets with food, drink and alcohol
This medicine can be taken with or without food.
However, you may notice that this medication works more slowly if you take it with a high fat meal.
Drinking alcohol can temporarily affect your ability to have an erection. To get the most benefit from your medicine, you are advised not to drink a lot of alcohol before taking this medicine
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy, lactation and fertility
This medicine is not indicated for women.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
This medication may cause dizziness and may affect vision. Before driving or using machines, you must know how you react to this medicine.
List of excipients with known effect
SILDENAFIL PFIZER 50 mg film-coated tablets contain lactose.
3. HOW TO TAKE SILDENAFIL PFIZER 50 mg film-coated tablets
Instructions for a good use
Always follow the dosage given by your doctor or pharmacist. If you are uncertain, consult your doctor or pharmacist. The usual dose of initiation is 50 mg.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
You should not use SILDENAFIL PFIZER more than once a day.
You should take this medicine about an hour before you intend to have sex. Swallow the tablet whole with a glass of water.
If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
This medication will help you get an erection only if you have sexual stimulation. The time of action of this drug varies from one person to another, it is normally half an hour to an hour. You may observe that this medication works more slowly if you take it during a high-fat meal.
If this medicine does not allow you to have an erection, or if your erection is not long enough to allow you to have full sex, talk to your doctor.
Symptoms and instructions in case of overdose
If you take more SILDENAFIL PFIZER 50 mg film-coated tablets than you should:
You may experience an increase in the number of side effects and their severity. Doses above 100 mg do not increase the efficacy of the product.
Do not take more tablets than your doctor tells you.
Contact your doctor if you take more tablets than you should.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, this medicine has the potential to cause side effects, although not everybody gets them.
The side effects reported with this medication are usually mild to moderate and of short duration.
If you get any of the serious side effects listed below, stop taking SILDENAFIL PFIZER 50 mg film-coated tablets and contact your doctor immediately:
· An allergic reaction (this rarely happens).
Symptoms may include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
· Chest pain (this is uncommon ).
If this happens during or after intercourse:
o Put yourself in a semi-sitting position and try to relax.
o Do not take nitrates to relieve your chest pain.
· Prolonged erections sometimes painful ( frequency indeterminate ).
If you have an erection that persists continuously for more than 4 hours, you should contact a doctor immediately.
· Sudden decrease in vision ( indeterminate frequency ).
· Serious skin reactions ( indeterminate frequency ).
Symptoms may include severe desquamation and swelling of the skin, blisters in the mouth, genital area and around the eyes, and fever.
· Seizures or epileptic seizures ( frequency not known ).
Other adverse effects
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): facial redness, indigestion, vision effects (including color vision disturbances, sensitivity to light, blurred vision or decreased visual acuity), stuffy nose and dizzying sensations.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, bleeding in the back of the eye, eye irritation, bloodshot / red eyes, eye pain, double vision, abnormal sensations in the eye, watery eyes, palpitations, accelerated heartbeat, muscle pain, drowsiness, decreased sensitivity to touch, dizziness, ringing of ears, nausea, dry mouth, bleeding from the penis, presence of blood in the sperm and / or urine, chest pain and feeling tired.
Rare (may affect up to 1 in 1,000 people): high blood pressure, low blood pressure, fainting, stroke, heart attack, irregular heartbeat, nosebleeds, and sudden hearing loss or loss.
Undetermined (can not be estimated from the available data):
Additional side effects reported during the postmarketing experience: unstable angina (heart disease), sudden death or temporary decrease in blood supply to parts of the brain. Most men who experienced these side effects, but not all, had heart problems before taking this medication. It is not possible to determine whether these events were directly related to this drug.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also declare the undesirable effects directly via the national system of declaration National Agency of safety of the drug and health products (Ansm) and network of the Regional centers of Pharmacovigilance - Website: www.ansm.sante.fr. By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE SILDENAFIL PFIZER 50 mg film-coated tablets
Keep out of the reach and sight of children.
Expiration date
Do not use SILDENAFIL PFIZER 50 mg film-coated tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 30 ° C.
Store in the original package, away from moisture.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away at the sewer or with household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does SILDENAFIL PFIZER 50 mg, film-coated tablet contain?
The active substance is :
Sildenafil (as citrate) ........................................... .................................................. .............. 50 mg
For a film-coated tablet
The other components are :
Core : Microcrystalline Cellulose, Calcium Hydrogen Phosphate (Anhydrous), Croscarmellose Sodium, Magnesium Stearate.
Film coating: hypromellose, lactose monohydrate, glycerol triacetate, titanium dioxide (E171).
Pharmaceutical form and content
What is SILDENAFIL PFIZER 50 mg film-coated tablet and contents of the pack?
SILDENAFIL PFIZER 50 mg film-coated tablets are white to off-white, rounded diamond-shaped tablets. It is written "50" on one side.
Boxes of 2, 4, 8, 12 or 24 tablets under pads.
Not all presentations may be marketed.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
PFIZER HOLDING FRANCE
23-25 AVENUE OF DOCTOR LANNELONGUE
75014 PARIS
exploiting
PFIZER PFE FRANCE
23-25 AVENUE OF DOCTOR LANNELONGUE
75014 PARIS
Maker
FAREVA AMBOISE
INDUSTRIAL ZONE
29, INDUSTRIAL ROAD
37530 POCE-SUR-CISSE
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Ansm (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.