SILDENAFIL SANDOZ 25 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 is Sildenafil Sandoz and what is it 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 is Sildenafil Sandoz and what is it used for

Sildenafil Sandoz contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. It works by widening the blood vessels in the penis, allowing blood to flow into the penis 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 known as 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, ask 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 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

Tell your doctor or pharmacist before you start taking sildenafil:

• 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 heart problems. In this case, your doctor should carefully check whether your heart can take the additional strain of having sex,
• if you currently have a stomach ulcer or bleeding problems (such as haemophilia),
• if you experience sudden decrease or loss of vision, stop taking Sildenafil Sandoz and contact your doctor immediately.

It is not recommended to take sildenafil with any other treatments 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 for patients with kidney or liver problems

You should tell 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 less than 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 your doctor that you have taken sildenafil and when you took it. Do not take sildenafil with other medicines unless your doctor tells you to.

Do not take sildenafil if you are taking medicines called nitrates, as the combination of these products may cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines, often used to treat 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 may 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 with a 25 mg dose of sildenafil.

Some patients who are taking alpha-blockers, used to treat high blood pressure or prostate problems, may experience dizziness or lightheadedness that can be caused by low blood pressure upon 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 after taking sildenafil. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start taking sildenafil. Your doctor may advise you to start with a lower dose (25 mg) of sildenafil.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines that contain 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 find that sildenafil takes longer to start working if you take it with a large meal.

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

Pregnancy, breast-feeding and fertility

The use of sildenafil is not indicated in women.

Driving and using machines

Sildenafil may cause dizziness and affect vision. You should know how you react to sildenafil before you drive or use machinery.

Sildenafil Sandoz contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Sildenafil Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is 50 mg.

Do not take sildenafil more than once a day.

Do not take sildenafil film-coated tablets at the same time as sildenafil 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 to facilitate breaking the tablet into two equal doses, if you have difficulty swallowing the tablet whole.

Breaking the tablet

Place the tablet on a hard and flat surface with the score line facing upwards. Press the upper side of the tablet 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 and flat surface with the score line facing upwards. Press the upper side of the tablet 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 and flat surface with the score line facing upwards. Press the upper side of the tablet 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 sildenafil takes to work varies from person to person, but it normally takes between 30 minutes and 1 hour. The effect of sildenafil may be delayed if you take it with a large meal.

If you take sildenafil and you do not get an erection, or if the erection does not last long enough to complete sexual intercourse, tell 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 tells you to.

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the national poison centre on +34 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 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, this occurs uncommonly:

If this occurs during or after intercourse:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat the 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, blistering of the skin, 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,
• facial flushing,
• hot flushes (symptoms include a sudden feeling of heat in the upper part of the body),
• indigestion,
• abnormal vision, blurred vision, visual disturbance,
• nasal congestion,
• dizziness.

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

• vomiting,
• rash,
• eye irritation, conjunctivitis, eye pain, seeing flashes of light, increased light sensitivity, eye swelling or redness,
• 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 mucous membrane of the nose (symptoms include runny nose, sneezing and stuffy nose),
• upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn),
• blood in urine,
• arm or leg pain,
• epistaxis,
• 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 parts of the brain,
• feeling of tightness in the throat, numbness in the mouth,
• bleeding in the eye, double vision, decreased visual acuity, abnormal sensation in eye, eye swelling or redness, small particles or spots in the eye, seeing halos around lights, dilation of the pupil of the eye, change in colour of the white of the eye,
• penile bleeding,
• presence of blood in semen,
• dry nose,
• nasal swelling,
• feeling irritable,
• sudden decrease or loss of hearing.

During post-marketing experience, the following rare events have been reported: unstable angina (heart disease) and sudden death. It should be noted that most of the men who experienced these side effects had pre-existing heart disease 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 get 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 Medicines Surveillance System for Human Use: 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 that month.

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. Container contents and additional information

Composition of Sildenafilo Sandoz

• The active ingredient is sildenafil.

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

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

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

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

Appearance of the product and container size

Sildenafilo Sandoz 25 mg

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

Sildenafilo Sandoz 50 mg

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

Sildenafilo 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 containers of 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28 tablets.

Only some container 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 Varsovia

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/