Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sildenafil

Document Subject

Generated Narrative: MedicinalProductDefinition mpd674db7613c7ef04137ad9c28d3399bb

identifier: http://ema.europa.eu/identifier/EU/1/09/584/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Sildenafil Teva 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

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d674db7613c7ef04137ad9c28d3399bb

identifier: http://ema.europa.eu/identifier/EU/1/09/584/002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - sildenafil

Attesters

What is in this leaflet

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

Sildenafil Teva 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. Sildenafil Teva will only help you to get an erection if you are sexually stimulated.

Sildenafil Teva 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 Sildenafil Teva

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 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 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 Sildenafil Teva

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 problem (such as haemophilia).

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

You should not use Sildenafil Teva with any other oral or local treatments for erectile dysfunction.

You should not use Sildenafil Teva with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take Sildenafil Teva if you do not have erectile dysfunction.

You should not take Sildenafil Teva 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 Sildenafil Teva should not be given to individuals under the age of 18. Other medicines and Sildenafil Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Sildenafil Teva 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 Sildenafil Teva and when you did. Do not take Sildenafil Teva with other medicines unless your doctor tells you that you can.

You should not take Sildenafil Teva 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 Sildenafil Teva 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 Sildenafil Teva. 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 Sildenafil Teva with alpha-blockers. This is most likely to happen within 4 hours after taking Sildenafil Teva. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil Teva. Your doctor may start you on a lower dose (25 mg) of Sildenafil Teva.

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

Sildenafil Teva with food and drink and alcohol Sildenafil Teva can be taken with or without food. However, you may find that Sildenafil Teva 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 Sildenafil Teva.

Pregnancy, breast-feeding and fertility Sildenafil Teva is not indicated for use by women.

Driving and using machines Sildenafil Teva can cause dizziness and can affect vision. You should be aware of how you react to Sildenafil Teva before you drive or use machinery.

Sildenafil Teva contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated 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 Sildenafil Teva more than once a day.

Do not take Sildenafil Teva film-coated tablets in combination with sildenafil-containing orodispersible tablets.

You should take Sildenafil Teva 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 Sildenafil Teva is too strong or too weak, talk to your doctor or pharmacist.

Sildenafil Teva will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil Teva takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Sildenafil Teva takes longer to work if you take it with a heavy meal.

If Sildenafil Teva 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 Teva 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 or pharmacist.

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 Teva are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Sildenafil Teva 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 sildenafil.

Reporting of side effects If you get any side effects, talk to your 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 use this medicine after the expiry date which is stated on the blister and carton 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 Sildenafil Teva 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, croscarmellose sodium, magnesium stearate. Film coat: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.

What Sildenafil Teva looks like and contents of the pack
Sildenafil Teva 25 mg are white, oval-shaped film-coated tablets, engraved with S 25 on one side, and plain on the other side.
Sildenafil Teva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 x 1 tablet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Teva B.V. Swensweg 5 2031GA Haarlem The Netherlands

Manufacturer: TEVA Pharmaceutical Works Private Limited Company
Pallagi t 4042 Debrecen Hungary

Teva Pharma, S.L.U. Pol gono Industrial Malp ca, calle C,no.4 50016 Zaragoza
Spain

Teva Operations Poland Sp.z.o.o. ul Mogilska 80. 31-546, Krakow,
Poland

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

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

: +359 24899Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland T l/Tel: +49 73140 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar . . . . : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
Portugal Teva Pharma - Produtos Farmac uticos, Lda. T l: +33 155917Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar . . . .

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in

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