Sildenafil Actavis

B. PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

sildenafil
Please read this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Sildenafil Actavis is and what it is used for
2. What you need to know before taking 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 class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing blood flow into the penis when sexually stimulated. Sildenafil Actavis will help you achieve an erection only if you are sexually stimulated.
Sildenafil Actavis is a treatment for adult men who have erectile dysfunction, sometimes called impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. What you need to know before taking Sildenafil Actavis

Do not take Sildenafil Actavis

• If you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6)

• If you are taking medicines called nitrates, because this combination could cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

• If you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination could also cause a dangerous drop in 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 due to blood clots). PDE5 inhibitors, such as Sildenafil Actavis, have been shown to enhance the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

• If you have a severe heart or liver problem.

• If you have recently had a stroke or heart attack, or if you have low blood pressure.

• If you have a rare inherited eye disease (such as retinitis pigmentosa).

• If you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Actavis

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (blood cell cancer), or multiple myeloma (a cancer of the bone marrow).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual activity.
• If you currently have a stomach ulcer or coagulation disorders (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafil Actavis and contact your doctor immediately.

You must not use Sildenafil Actavis together with other oral or local treatments for erectile dysfunction.
You must not use Sildenafil Actavis together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take Sildenafil Actavis if you do not have erectile dysfunction.
You must not take Sildenafil Actavis if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.

Children and adolescents
Sildenafil Actavis must not be given to individuals under 18 years of age.

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 interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken Sildenafil Actavis and when. Do not take Sildenafil Actavis with other medicines unless authorized by your doctor.
Do not take Sildenafil Actavis if you are taking medicines called nitrates, because combining these medicines can cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain").
Do not take Sildenafil Actavis if you are using medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination could also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, for example medicines used to treat HIV, your doctor may initially prescribe you the lowest dose of Sildenafil Actavis (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or a sensation of emptiness in the head, which may be caused by low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking Sildenafil Actavis together with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil Actavis. To reduce the likelihood of these symptoms, you should already be on a stable dose of the alpha-blocker before starting treatment with Sildenafil Actavis. Your doctor may start you on a lower dose of Sildenafil Actavis (25 mg).
Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Sildenafil Actavis with food, beverages, and alcohol
Sildenafil Actavis can be taken with or without food. However, you may notice that the onset of action of Sildenafil Actavis is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from this medicine, it is advisable to avoid excessive alcohol consumption before using Sildenafil Actavis.

Pregnancy, breastfeeding, and fertility
Sildenafil Actavis is not indicated for use in women.

Driving and using machines
Sildenafil Actavis may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to Sildenafil Actavis.

Sildenafil Actavis contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take SildenafilA

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Sildenafil Actavis must not be taken more than once a day.
Take Sildenafil Actavis approximately one hour before anticipated sexual activity. Swallow the tablet whole with a glass of water.
If you feel the effect of Sildenafil Actavis is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil Actavis will help you achieve an erection only if you are sexually stimulated. The time required for Sildenafil Actavis to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of Sildenafil Actavis may take longer if you have just consumed a heavy meal.
If Sildenafil Actavis does not help you achieve an erection, or if the erection does not last long enough to complete sexual intercourse, inform your doctor.
If you take more Sildenafil Actavis than you should:
You may notice an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. The adverse reactions reported with Sildenafil Actavis are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious adverse reactions, stop taking Sildenafil Actavis and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly: If this occurs during or after sexual intercourse:
  • Adopt a semi-sitting position and try to relax.
  • Do not use nitrates to treat chest pain.
• Prolonged and sometimes painful erections – occur rarely (may affect 1 in 10,000 people). If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.
• Sudden decrease or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genital area or around the eyes, fever.
• Seizures or convulsions – occur rarely.

Other adverse reactions:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper part of the body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, light flashes, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, somnolence, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, epistaxis, sensation of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numb mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floating particles in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, feeling irritable, sudden decrease or loss of hearing.

Rare cases of unstable angina (a heart condition) and sudden death have been reported during post-marketing experience. It should be noted that most, but not all, of the men who experienced these adverse reactions already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of Sildenafil.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system listed in Annex V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. 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 stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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: monohydrate lactose, microcrystalline cellulose, povidone K29-32, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000, aluminium lake containing indigo carmine (E132).

Description of the appearance of Sildenafil Actavis and the contents of the pack
Film-coated tablets.
Sildenafil Actavis 25 mg film-coated tablets are blue, elliptical, biconvex,
10.0 x 5.0 mm in size, with “SL25” engraved on one side.
Sildenafil Actavis 50 mg film-coated tablets are blue, elliptical, biconvex,
13.0 x 6.5 mm in size, with “SL50” engraved on one side.
Sildenafil Actavis 100 mg film-coated tablets are blue, elliptical, biconvex,
17.0 x 8.5 mm in size, with “SL100” engraved on one side.
The tablets are available in blisters containing 1, 2, 4, 8, 12 or 24 tablets.
Some pack sizes may not be marketed in your country.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/