SILDENAFIL SANDOZ 50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafil Sandoz 25 mg film-coated tablets

Sildenafil Sandoz 50 mg film-coated tablets

Sildenafil Sandoz 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 or pharmacist.

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Sildenafil Sandoz contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood to flow into it, which helps to achieve an erection when you are sexually stimulated. Sildenafil will only help you to get an erection if you are sexually stimulated.

Sildenafil is used to treat adult men with erectile dysfunction, sometimes called impotence. This is when a man cannot get, or keep, a hard erection that is sufficient for satisfactory sexual activity.

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

Do not take Sildenafil Sandoz

• 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 cause a potentially dangerous decrease in your blood pressure. Tell your doctor if you are taking any of these medicines, often used to treat angina (or “chest pain”). If you are not sure, 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 cause a potentially dangerous decrease 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 caused by blood clots). PDE5 inhibitors, such as sildenafil, have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult 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 loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Tell your doctor or pharmacist before you start taking sildenafil:

• if you have sickle cell anemia (a disorder of the red blood cells), leukemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow),
• if you have a deformity of your penis or Peyronie's disease,
• if you have heart problems. In this case, your doctor should carefully check if your heart can take the extra strain of having sex,
• if you currently have a stomach ulcer or bleeding problems (such as hemophilia),
• if you experience sudden or decreased vision loss, stop taking Sildenafil Sandoz and contact your doctor immediately.

It is not recommended to take sildenafil in combination with any other oral or local treatment for erectile dysfunction.

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

Do not take sildenafil if you do not have erectile dysfunction.

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

Other medicines and Sildenafil Sandoz

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

Sildenafil tablets may interact with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should inform any healthcare professional that you are taking sildenafil and when you took it. Do not take sildenafil with other medicines unless your doctor advises you to.

Do not take sildenafil if you are taking medicines called nitrates, as the combination of these products can cause a potentially dangerous decrease in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pectoris (or “chest pain”).

Do not take sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these products can also lead to a potentially dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of sildenafil.

Some patients who are taking an alpha-blocker, a medicine used to treat high blood pressure or an enlarged prostate, 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 occur within 4 hours after taking sildenafil. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting sildenafil. Your doctor may advise you to start treatment with the lower dose (25 mg) of sildenafil.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine that contains sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Sandoz with food, drinks, and alcohol

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

Consuming large amounts of alcohol may temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking sildenafil.

Pregnancy, breastfeeding, and fertility

The use of sildenafil is not indicated in women.

Driving and using machines

Sildenafil can cause dizziness and affect vision. You should know how you react to sildenafil before driving vehicles or using machinery.

Sildenafil Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Sildenafil Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. The recommended starting dose is 50 mg.

Do not take sildenafil more than once a day.

Do not take sildenafil film-coated tablets with medicines that contain sildenafil in orodispersible tablets.

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

Sildenafil Sandoz 25 mg

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

Breaking the tablet

Place the tablet on a hard, flat surface with the score line facing up. Press the tablet gently with your thumb, and the tablet will break into two equal doses. You should take both halves to achieve the minimum effective dose.

Sildenafil Sandoz 50 mg

The tablet can be divided into four equal doses. You should take at least two quarters (corresponding to 25 mg) to achieve the minimum effective dose.

Breaking the tablet

Place the tablet on a hard, flat surface with the score line facing up. Press the tablet gently with your thumb, and the tablet will break into four equal doses.

Sildenafil Sandoz 100 mg

The tablet can be divided into four equal doses.

Breaking the tablet

Place the tablet on a hard, flat surface with the score line facing up. Press the tablet gently with your thumb, and the tablet will break into four equal doses.

If you notice that the effect of sildenafil is too strong or too weak, tell your doctor or pharmacist.

Sildenafil will only help you to get an erection if you are sexually stimulated. The time it takes for sildenafil to work varies from person to person, but it normally takes between half an hour and one hour. The effect of sildenafil may be delayed if you take it with a large meal.

If you find that sildenafil does not help you to get an erection, or if the erection does not last long enough for you to complete sexual intercourse, you should consult your doctor.

If you take more Sildenafil Sandoz than you should

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

Do not take more tablets than your doctor has recommended.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

4. 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 short duration.

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

• Allergic reaction, this occurs with rare frequency(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 rare frequency:

If they occur during or after intercourse:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat chest pain.
• Prolonged and sometimes painful erections, this occurs very 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 or decreased vision loss - this occurs very rarely.

• Severe skin reactions, this occurs very rarely.

Symptoms can include severe skin peeling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits, this occurs very 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 flushes (including symptoms such as sudden feeling of heat in the upper part of the body),
• indigestion,
• abnormal color vision, blurred vision, visual disturbance,
• nasal congestion,
• dizziness.

Uncommon(may affect up to 1 in 100 people):

• vomiting,
• skin rash,
• eye irritation, eye discharge/ red eyes, eye pain, flashing lights, increased light sensitivity, eye discomfort,
• palpitations, 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 nose, inflammation of the lining of the nose (including symptoms such as runny nose, sneezing, and nasal congestion),
• upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn),
• blood in urine,
• arm or leg pain,
• nosebleed,
• feeling hot,
• feeling tired.

Rare(may affect up to 1 in 1,000 people):

• fainting,
• stroke, heart attack, irregular heartbeat,
• temporary decrease in blood flow to some parts of the brain,
• feeling of tightness in the throat, numbness in the mouth,
• bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white part of the eye,
• penile bleeding,
• presence of blood in the semen,
• dry nose,
• swelling inside the nose,
• feeling irritable,
• sudden or decreased hearing loss.

During post-marketing experience, unstable angina (heart disease) and sudden death have been reported rarely. It is noteworthy that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Sandoz

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

This medicine does not require any special storage conditions.

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 the month stated.

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

6. Package Contents and Additional Information

Sildenafil Sandoz Composition

• The active ingredient is sildenafil.

Sildenafil Sandoz 25 mg: each tablet contains 25 mg of sildenafil (as citrate).

Sildenafil Sandoz 50 mg: each tablet contains 50 mg of sildenafil (as citrate).

Sildenafil Sandoz 100 mg: each tablet contains 100 mg of sildenafil (as citrate).

• The other ingredients are: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, sodium saccharin, and aluminum lake with carmine (E 132).

Product Appearance and Package Size

Sildenafil Sandoz 25 mg

Light blue, round tablets, slightly speckled, with a notch on one side and engraved "25" on the other.

Sildenafil Sandoz 50 mg

Light blue, round tablets, slightly speckled, with a cross-notch on one side and engraved "50" on the other.

Sildenafil Sandoz 100 mg

Light blue, round tablets, slightly speckled, with a cross-notch on both sides and engraved "100" on one side.

They are available in packages of 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava

Slovenia

or

Lek Pharmaceuticals d.d.

Verovska, 57

SLO-1526 Ljubljana,

Slovenia

or

Lek S.A.

Domaniewska 50 C

02-672 Warsaw

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

S.C. Sandoz S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu Mures

Romania

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Date of the last revision of this leaflet:August 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/