Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - viagra

Document Subject

Generated Narrative: MedicinalProductDefinition mp8faa7fbd6f78086e379dcef9dff9ad32

identifier: http://ema.europa.eu/identifier/EU/1/98/077/002-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VIAGRA 25 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8faa7fbd6f78086e379dcef9dff9ad32

identifier: http://ema.europa.eu/identifier/EU/1/98/077/002-004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - viagra

Attesters

What is in this leaflet

1. What VIAGRA is and what it is used for
2. What you need to know before you take VIAGRA
3. How to take VIAGRA
4. Possible side effects
5. How to store VIAGRA
6. Contents of the pack and other information

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works 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 stimulated.

VIAGRA 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.

Do not take VIAGRA

If you are allergic to sildenafil or any of the other 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 taking 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 nitric 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 drug 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 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 (such as retinitis pigmentosa).

If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking 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 should carefully check whether your heart can take the additional strain of having sex.

If you currently have a stomach ulcer, or a bleeding 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 local treatments for erectile dysfunction.
You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile 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 liver 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, have recently taken or might take any other medicines.

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may lead to 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 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 taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking VIAGRA. To reduce the chance that these symptoms might 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) of VIAGRA.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with food and drink and alcohol VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive 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. You should be aware of how you react to VIAGRA before you drive or use machinery.

VIAGRA contains lactose If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking VIAGRA.

VIAGRA contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

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 film-coated tablets in combination with other sildenafil containing products including VIAGRA orodispersible tablets or VIAGRA orodispersible films.

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

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. The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.

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 tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of VIAGRA 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 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 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 VIAGRA.

Reporting of side effects If you get any side effects, talk to you doctor or pharmacist or nurse. 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.

Keep this medicine out of the sight and reach of children. Do not store above 30 oC.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What VIAGRA contains

The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as the citrate salt).

The other ingredients are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),

croscarmellose sodium (see section 2 VIAGRA contains sodium ),

magnesium stearate

Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2

VIAGRA contains lactose ), triacetin, indigo carmine aluminium

lake (E132)

What VIAGRA looks like and contents of the pack VIAGRA film-coated tablets (tablets) are blue, with a rounded-diamond shape. They are marked PFIZER on one side and VGR 25 on the other side. The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands.

Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Poc -sur-Cisse, France.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique / Belgien Viatris T l/Tel: +32 (0)2 658 61 Luxembourg/Luxemburg Viatris T l/Tel: +32 (0)2 658 61 (Belgique/Belgien)

.: +359 2 44 55 Magyarorsz g Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2 esk republika Viatris CZ s.r.o.
Tel: +420 222 004 Malta V.J. Salomone Pharma Limited Tel: (+356) 21 220 Danmark Viatris ApS Tlf: +45 28 11 69 Nederland Mylan Healthcare BV Tel: +31 (0) 20 426 3Deutschland Viatris Healthcare GmbH Tel: +49 (0) 800 0700 Norge Viatris AS Tlf: +47 66 75 33 Eesti Viatris O
Tel: +372 6363 sterreich Mylan sterreich GmbH Tel: +43 1 86
Viatris Hellas Ltd .: +30 2100 100 Polska Mylan Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 Espa a Viatris Pharmaceuticals, S.L. Tel: +34 900 102 Portugal Viatris Healthcare, Lda.
Tel: +351 21 412 72 France Viatris Sant
T l: +33 (0)4 37 25 75 Rom nia BGP Products SRL Tel: +40 372 579 Hrvatska Viatris Hrvatska d.o.o. Tel: + 385 1 23 50 Slovenija Viatris d.o.o. Tel: + 386 1 236 31 Ireland Mylan Ireland Limited Tel: + 353 1 8711Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 sland Icepharma hf. S mi: + 354 540 8Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9Italia Viatris Pharma S.r.l. Tel: +39 02 612 46Sverige
Viatris AB Tel: +46 (0)8 630 19
GPA Pharmaceuticals Ltd
: +357 22863United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: + 353 18711Latvija Viatris SIA Tel: +371 676 055 Lietuva Viatris UAB Tel. +370 52051This leaflet was last revised in.

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: