Viagra – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Viagra, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor, pharmacist or nurse. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your s. − If you get any side effects, talk to your doctor, p harmacist or nurse. This includes any possible side effects not listed in this leaflet. See sectio n 4.
ℹ️ 1. What VIAGRA is and what it is used for
VIAGRA contains the active substance sildenafil whi ch belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It work s by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help you to get an erection if you are sexually stimulat ed.
VIAGRA is a treatment for adult men with erectile d ysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect pen is suitable for sexual activity.
⚠️ 2. What you need to know before you take VIAGRA
Do not take VIAGRA
− If you are allergic to sildenafil or any of the oth er ingredients of this medicine (listed in section 6). − If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are ta king any of these medicines which are often given for relief of angina pectoris (or “chest pain ”). If you are not certain, ask your doctor or pharmacist. − If you are using any of the medicines known as nitr ic oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure. − If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic throm boembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as VIAGRA 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 or liver problem. − If you have recently had a stroke or a heart attack , or if you have low blood pressure. − If you have certain rare inherited eye diseases (su ch as retinitis pigmentosa ). − If you have ever had loss of vision due to non-arte ritic anterior ischaemic optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before tak ing VIAGRA − If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow). − If you have a deformity of your penis or Peyronie’s disease. − If you have problems with your heart. Your doctor s hould carefully check whether your heart can take the additional strain of having sex. − If you currently have a stomach ulcer, or a bleedin g problems (such as haemophilia). − If you experience sudden decrease or loss of vision , stop taking VIAGRA and contact your doctor immediately.
You should not use VIAGRA with any other oral or lo cal treatments for erectile dysfunction.
You should not use VIAGRA with treatments for pulmo nary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
You should not take VIAGRA if you do not have erect ile dysfunction.
You should not take VIAGRA if you are a woman.
Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or l iver problems. Your doctor may decide on a lower dose for you.
Children and adolescents
VIAGRA should not be given to individuals under the age of 18.
Other medicines and VIAGRA
Tell your doctor or pharmacist if you are taking, h ave recently taken or might take any other medicines.
VIAGRA may interfere with some medicines, especiall y those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, p harmacist or nurse that you have taken VIAGRA and when you did. Do not take VIAGRA with other med icines unless your doctor tells you that you can.
You should not take VIAGRA if you are taking medici nes called nitrates, as the combination of these medicines may lead to a dangerous fall in your bloo d 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 “chest pain”).
You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
Tell your doctor or pharmacist if you are already t aking riociguat.
If you are taking medicines known as protease inhib itors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg film -coated tablets) of VIAGRA.
Some patients who take alpha-blocker therapy for th e treatment of high blood pressure or prostate enlargement may experience dizziness or light-heade dness, which may be caused by low blood pressure upon sitting or standing up quickly. Certa in patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most lik ely to happen within 4 hours after taking VIAGRA. To reduce the chance that these symptoms mi ght happen, you should be on a regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose (25 mg film-coated tablets) of VIAGRA.
Tell your doctor or pharmacist if you are taking me dicines containing sacubitril/valsartan, used to tr eat heart failure.
VIAGRA with alcohol Drinking alcohol can temporarily impair your abilit y to get an erection. To get the maximum benefit from your medicine, you are advised not to drink ex cessive amounts of alcohol before taking VIAGRA.
Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use by women.
Driving and using machines
VIAGRA can cause dizziness and can affect vision. Y ou should be aware of how you react to VIAGRA before you drive or use machinery.
💊 3. How to take VIAGRA
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 starting dose is 50 mg.
You should not take VIAGRA more than once a day.
Do not take VIAGRA orodispersible films in combinat ion with other sildenafil containing products including VIAGRA film-coated tablets or VIAGRA orod ispersible tablets.
You should take VIAGRA about one hour before you pl an to have sex. The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour.
Carefully peel open the aluminium pouch with dry ha nds. Do not cut it open. Take out the orodispersible film with a dry finger and immediate ly place the orodispersible film on the tongue, where it will disintegrate in seconds with or witho ut water. During disintegration saliva may be swallowed, but without swallowing the film.
The orodispersible film should be taken on an empty stomach as you may find that it takes longer to start working if you take it with a heavy meal.
If you require a second 50 mg orodispersible film t o make a 100 mg dose, you should wait until the first one has completely disintegrated and you have swallowed it before taking the second orodispersible film.
If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.
VIAGRA will only help you to get an erection if you are sexually stimulated.
If VIAGRA 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 VIAGRA than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.
You should not take more films than your doctor tel ls you to.
Contact your doctor if you take more films than you should.
If you have any further questions on the use of thi s medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side ef fects although not everybody gets them. The side effects reported in association with the use of VIA GRA are usually mild to moderate and of a short duration.
If you experience any of the following serious side effects stop taking VIAGRA 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 b reathing 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 o ccurs 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 f lushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indiges tion, colour tinge to vision, blurred vision, visua l 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 bri ghtness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, lo w blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ear s, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny n ose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms i nclude heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and fee ling tired.
Rare (may affect up to 1 in 1 000 people): fainting, str oke, 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 sharpne ss of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or s pots 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 an gina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, o f the men who experienced these side effects had heart problems before taking this medicine. It is n ot possible to determine whether these events were directly related to VIAGRA.
Reporting of side effects
If you get any side effects, talk to you doctor, ph armacist or nurse. This includes any possible side effects not listed in this leaflet. You can also re port side effects directly via the national reporti ng system listed in Appendix V . By reporting side effects you can help provide mo re information on the safety of this medicine.
🌡️ 5. How to store VIAGRA
Keep this medicine out of the sight and reach of ch ildren.
Do not use this medicine after the expiry date whic h is stated on the carton and pouch 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 or h ousehold waste. Ask your pharmacist how to throw away medicines you no longer use. These measu res will help protect the environment.
📦 6. Contents of the pack and other information
What VIAGRA contains
− The active substance is sildenafil. Each orodispers ible film contains 50 mg of sildenafil (as the citrate salt). − The other ingredients are hydroxypropylcellulose (E 463), macrogol, crospovidone (E1202), povidone (E1201), sucralose (E955), macrogol poly(v inyl alcohol) grafted copolymer, levomenthol, hypromellose (E464), titanium dioxide (E171), ferric oxide red (E172).
What VIAGRA looks like and contents of the pack
Each orodispersible film is packed in an individual foil pouch.
They are supplied in cartons containing 2, 4, 8 or 12 pouches.
Some pack sizes may not be marketed in your country .
Marketing Authorisation Holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle a an den IJssel, Netherlands.
Manufacturer
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, Andernach, Rhineland-Palatinate, 56626, Germany.
For any information about this medicine, please con tact the local representative of the Marketing Authorisation Holder.
België /Belgique / Belgien Viatris Tél/Tel: +32 (0)2 658 61 00 Lietuva Viatris UAB Tel. +370 52051288 България Майлан ЕООД Тел .: +359 2 44 55 400 Luxembourg/Luxemburg Viatris Tél/Tel: +32 (0)2 658 61 00 (Belgique/Belgien) Česká republika Viatris CZ s.r.o.
Tel: +420 222 004 400 Magyarország Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100 Danmark Viatris ApS Tlf: +45 28 11 69 32 Malta V.J. Salomone Pharma Limited Tel: (+356) 21 220 174 Deutschland Viatris Healthcare GmbH Tel: +49 (0) 800 0700 800 Nederland Mylan Healthcare BV Tel: +31 (0) 20 426 3300 Eesti Viatris OÜ Tel: +372 6363 052 Norge Viatris AS Tlf: +47 66 75 33 00 Ελλάδα Viatris Hellas Ltd Τηλ .: +30 2100 100 002 Österreich Viatris Austria GmbH Tel: +43 1 86390 España Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712 Polska Viatris Healthcare Sp. z o.o., Tel.: +48 22 546 64 00 France Viatris Santé Tél: +33 (0)4 37 25 75 00 Portugal Viatris Healthcare, Lda.
Tel: +351 21 412 72 00 Hrvatska Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599 România BGP Products SRL Tel: +40 372 579 000 Ireland Viatris Limited Tel: + 353 1 8711600 Slovenija Viatris d.o.o.
Tel: + 386 1 236 31 80 Ísland Icepharma hf.
Sími: +354 540 8000 Slovenská republika Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100 Italia Viatris Pharma S.r.l.
Tel: +39 02 612 46921 Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9555 Κύπρος CPO Pharmaceuticals Limited Τηλ : +357 22863100 Sverige Viatris AB Tel: +46 (0)8 630 19 00 Latvija Viatris SIA Tel: +371 676 055 80 This leaflet was last revised in.
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Viagra (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/98/077).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.