Package leaflet: Information for the patient

Sildenafil Actvis 25 mg, 50 mg and 100 mg film-coated tablets Sildenafil Actavis 25 mg film-coated tablets Sildenafil Actavis 50 mg film-coated tablets Sildenafil Actavis 100 mg film-coated tablets

sildenafil

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 yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

  
  

  What is in this leaflet

  1. What Sildenafil Actavis is and what it is used for

  2. What you need to know before you take Sildenafil Actavis

  3. How to take Sildenafil Actavis

  4. Possible side effects

  5. How to store Sildenafil Actavis

  6. Contents of the pack and other information

  
  

  1. What Sildenafil Actavis is and what it is used for

     
     

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

     Sildenafil Actavis 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.

     
     

  2. What you need to know before you take Sildenafil Actavis Do not take Sildenafil Actavis

• 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 Sildenafil Actavis 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 Actavis

  
  

• 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 Sildenafil Actavis and contact your doctor immediately.

  You should not use Sildenafil Actavis with any other oral or local treatments for erectile dysfunction. You should not use Sildenafil Actavis with treatments for pulmonary arterial hypertension (PAH)

  containing sildenafil or any other PDE5 inhibitors.

  
  

  You should not take Sildenafil Actavis if you do not have erectile dysfunction. You should not take Sildenafil Actavis 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 Actavis should not be given to individuals under the age of 18.

  
  

  Other medicines and Sildenafil Actavis

  
  

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

  
  

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

  
  

  You should not take Sildenafil Actavis 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 Actavis 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 Actavis.

  
  

  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 with alpha-blockers. This is most likely to happen within 4 hours after taking Sildenafil Actavis. 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 Actavis. Your doctor may start you on a lower dose (25 mg) of Sildenafil Actavis.

  
  

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

  
  

  Sildenafil Actavis with food and drink and alcohol

  Sildenafil Actavis can be taken with or without food. However, you may find that Sildenafil Actavis 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 Actavis.

  
  

  Pregnancy, breast-feeding and fertility

  Sildenafil Actavis is not indicated for use by women.

  
  

  Driving and using machines

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

  
  

  Sildenafil Actavis contains lactose and sodium

  If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

  
  

  1. How to take Sildenafil Actavis

     
     

     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 Actavis more than once a day.

     
     

     You should take Sildenafil Actavis about one hour before sexual activity. Swallow the tablet whole with a glass of water.

     
     

     If you feel that the effect of Sildenafil Actavis is too strong or too weak, talk to your doctor or pharmacist.

     
     

     Sildenafil Actavis will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil Actavis takes to work varies from person to person, but it normally takes between half

     an hour and one hour. You may find that Sildenafil Actavis takes longer to work if you take it with a heavy meal.

     
     

     If Sildenafil Actavis 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 Actavis 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.

     
     

  2. Possible side effects

     
     

     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 are usually mild to moderate and of a short duration.

     
     

     If you experience any of the following serious side effects stop taking Sildenafil Actavis 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 1,000 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 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 you doctor, 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.

  
  

  1. How to store Sildenafil Actavis

     
     

     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 carton after EXP. The expiry date refers to the last day of that month.

     
     

     Store below 30°C.

     
     

     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.

     
     

  2. Contents of the pack and other information What Sildenafil Actavis contains

  

• The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate).

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

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K29-32, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000, indigo carmine aluminium lake (E132).

What Sildenafil Actavis looks like and contents of the pack

Film-coated tablet

Sildenafil Actavis 25 mg film-coated tablets are blue elliptical, biconvex, 10.0 x 5.0 mm and marked “SL25” on one side.

Sildenafil Actavis 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked “SL50” on one side.

Sildenafil Actavis 100 mg film-coated tablets are blue elliptical, biconvex, 17.0 x 8.5 mm and marked “SL100” on one side.

The tablets are provided in blister packs containing 1, 2, 4, 8, 12 or 24 tablets. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Actavis Group PTC ehf. Reykjavíkurvegi 76-78

IS-220 Hafnarfjörður Iceland

Manufacturer

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate Zejtun ZTN 3000

Malta

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

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373

Lietuva

UAB Teva Baltics Tel: +370 52660203

България

Тева Фарма ЕАД Teл: +359 24899585

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien

Tél/Tel: +32 38207373

Česká republika

Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111

Magyarország

Teva Gyógyszergyár Zrt. Tel: +36 12886400

Danmark

Teva Denmark A/S Tlf: +45 44985511

Malta

Teva Pharmaceuticals Ireland L-Irlanda

Tel: +44 2075407117

Deutschland ratiopharm GmbH Tel: +49 73140202

Nederland

Teva Nederland B.V. Tel: +31 8000228400

Eesti

UAB Teva Baltics Eesti filiaal Tel: +372 6610801

Norge

Teva Norway AS Tlf: +47 66775590

Ελλάδα

Specifar A.B.E.E.

Τηλ: +30 2118805000

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070

España

Teva Pharma, S.L.U. Tel: +34 913873280

Polska

Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300

France

Teva Santé

Tél: +33 155917800

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550

Hrvatska

Pliva Hrvatska d.o.o. Tel: +385 13720000

România

Teva Pharmaceuticals S.R.L. Tel: +40 212306524

Ireland

Teva Pharmaceuticals Ireland Tel: +44 2075407117

Slovenija

Pliva Ljubljana d.o.o. Tel: +386 15890390

Ísland

Teva Pharma Iceland ehf. Sími: +354 5503300

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911

Italia

Teva Italia S.r.l. Tel: +39 028917981

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Κύπρος

Specifar A.B.E.E.

Ελλάδα

Τηλ: +30 2118805000

Sverige

Teva Sweden AB Tel: +46 42121100

Latvija

UAB Teva Baltics filiāle Latvijā

Tel: +371 67323666

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland Ireland

Tel: +44 2075407117

This leaflet was last revised in {MM/YYYY}.

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