SILDENAFIL ACTAVIS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafilo Actavis 25 mg, 50 mg and 100 mg film-coated tablets EFG

Sildenafilo Actavis 25 mg film-coated tablets EFG

Sildenafilo Actavis 50 mg film-coated tablets EFG

Sildenafilo Actavis 100 mg film-coated tablets EFG

sildenafil

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Sildenafilo Actavis and what is it used for
2. What you need to know before taking Sildenafilo Actavis
3. How to take Sildenafilo Actavis
4. Possible side effects
5. Storage of Sildenafilo Actavis
6. Contents of the pack and further information

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

Sildenafilo Actavis contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing the blood vessels in the penis, allowing blood flow when you are sexually stimulated. Sildenafilo Actavis will only help you achieve an erection if you are sexually stimulated.

Sildenafilo Actavis is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection sufficient for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Actavis

Do not take Sildenafilo Actavis

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).

• If you are taking medicines called nitrates, as the combination can lead to a dangerous decrease in blood pressure. Inform your doctor if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

• If you are using any of the medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can lead to a dangerous decrease in blood pressure.

• If you are taking riociguat. This medication 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 caused by blood clots). PDE5 inhibitors, such as Sildenafilo Actavis, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

• If you have a serious heart or liver problem.

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

• If you suffer from certain rare hereditary eye diseases (such as retinitis pigmentosa).

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Sildenafilo Actavis:

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).

• If you have a penis deformity or Peyronie's disease.

• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra effort of having sex.

• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).

• If you experience a sudden decrease or loss of vision; stop taking Sildenafilo Actavis and contact your doctor immediately.

It is not recommended to use Sildenafilo Actavis at the same time as any other oral or local treatment for erectile dysfunction.

You should not take Sildenafilo Actavis with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

You should not take Sildenafilo Actavis if you do not have erectile dysfunction.

The use of Sildenafilo Actavis is not indicated in women.

Special considerations in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo Actavis is not indicated in persons under 18 years of age.

Use of Sildenafilo Actavis with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to take any other medication.

Sildenafilo Actavis tablets may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, you should inform your doctor, pharmacist, or nurse that you have taken Sildenafilo Actavis and when you took it. Do not take Sildenafilo Actavis with other medications unless your doctor tells you that you can.

You should not take Sildenafilo Actavis if you are taking medications called nitrates, as the combination of these medications can lead to a dangerous decrease in blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain").

You should not take Sildenafilo Actavis if you are using any of the medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medications can also lead to a dangerous decrease in blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medications known as protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Sildenafilo Actavis.

Some patients who are receiving an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to happen within 4 hours of taking Sildenafilo Actavis. To reduce the likelihood that these symptoms may occur, you should be taking your daily dose of alpha-blocker regularly before starting Sildenafilo Actavis. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo Actavis.

Inform your doctor or pharmacist if you are taking medications that contain sacubitril/valsartan, used to treat heart failure.

Use of Sildenafilo Actavis with food, drinks, and alcohol

Sildenafilo Actavis can be taken with or without food. However, you may notice that Sildenafilo Actavis takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume excessive amounts of alcohol before taking Sildenafilo Actavis.

Pregnancy, breastfeeding, and fertility

The use of Sildenafilo Actavis is not indicated in women.

Driving and using machines

Sildenafilo Actavis can cause dizziness and affect vision. Before driving vehicles or using machinery, you should know how you react to Sildenafilo Actavis.

Sildenafilo Actavis contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Sildenafilo Actavis

Follow the administration instructions of this medication indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

You should not take Sildenafilo Actavis more than once a day.

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

If you notice that the effect of Sildenafilo Actavis is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo Actavis will only help you achieve an erection if you are sexually stimulated. The time it takes for Sildenafilo Actavis to work varies from person to person, but it is usually between half an hour and one hour. You may notice that Sildenafilo Actavis takes a little longer to work if you take it with a large meal.

In the event that Sildenafilo Actavis does not help you achieve an erection, or if the erection is not maintained long enough to complete sexual activity, you should inform your doctor.

If you take more Sildenafilo Actavis than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

You should not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. The side effects reported in association with the use of sildenafil are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking Sildenafilo Actavis and seek medical attention immediately:

• Allergic reaction - this occurs rarely(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 - this occurs with infrequentfrequency

If they occur during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections - this occurs rarely(may affect up to 1 in 1,000 people)

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden decrease or loss of vision - this occurs rarely

• Severe skin reactions - this occurs rarely

Symptoms can include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as 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, flushing, hot flush (including a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, impaired vision, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden decrease or loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been rarely reported. It should be noted that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medication. It is not possible to determine whether these side effects were directly related to sildenafil.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sildenafilo Actavis

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sildenafilo Actavis

• The active ingredient is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate).
• The active ingredient is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
• The active ingredient is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• The active ingredient is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
• The other components are: lactose monohydrate, microcrystalline cellulose, povidone K29-32, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000, aluminum carmine indigo lacquer (E132).

Appearance of the Product and Package Contents

Film-coated tablet.

The film-coated tablets of Sildenafilo Actavis 25 mg are blue, elliptical, biconvex, 10.0 x 5.0 mm in size and marked with “SL25” on one side.

The tablets of Sildenafilo Actavis 50 mg are blue, elliptical, biconvex, 13.0 x 6.5 mm in size and marked with “SL50” on one side.

The tablets of Sildenafilo Actavis 100 mg are blue, elliptical, biconvex, 17.0 x 8.5 mm in size and marked with “SL100” on one side.

The tablets are presented in blisters containing 1, 2, 4, 8, 12 or 24 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers

Marketing Authorization Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

IS-220 Hafnarfjördur

Iceland

Manufacturers

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate

Zetjun ZTN 3000

Malta

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.