Prospect: information for the patient

Sildenafilo Sandoz 25 mg tablets EFG

Sildenafilo Sandoz 50 mg tablets EFG

Sildenafilo Sandoz 100 mg tablets EFG

sildenafilo

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Sildenafilo Sandoz

3.How to take Sildenafilo Sandoz

4.Possible adverse effects

5.Storage of Sildenafilo Sandoz

6.Contents of the package and additional information

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

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

Do not take Sildenafilo Sandoz

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6),
• if you are taking certain medicines called nitrates, as the combination may cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist,
• if you are using any of the medicines called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause a potentially dangerous drop 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 clots). Phosphodiesterase type 5 inhibitors, such as sildenafil, have shown to increase the hypotensive effect of this medicine. 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 have a rare inherited eye disease (such asretinitis pigmentosa),
• if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take sildenafil:

• if you have sickle cell anaemia (a blood disorder), leukaemia (blood cancer), multiple myeloma (bone marrow cancer),
• if you have a penile deformity or Peyronie's disease,
• if you have heart problems. In this case, your doctor must carefully check if your heart can cope with the extra effort of having sex,
• if you have a stomach ulcer or bleeding problems (such as haemophilia),
• if you experience a sudden decrease or loss of vision, stop taking Sildenafilo Sandoz and contact your doctor immediately.

Sildenafil should not be used simultaneously 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 phosphodiesterase type 5 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 renal or hepatic impairment

You must 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 people under 18 years of age.

Other medicines and Sildenafilo Sandoz

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medicine.

Sildenafil tablets may interact with some medicines, especially those used to treat chest pain. In case of a medical emergency, you must 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 nitrates, as the combination may cause a potentially dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve chest pain (or "angina").

Do not take sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may cause a potentially dangerous drop in your blood pressure.

Inform 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 taking an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that may be caused by a drop 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 in the 4 hours following sildenafil intake. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may recommend that you start treatment with the lower dose (25 mg) of sildenafil.

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medicinethat contains sacubitril/valsartan, used to treat heart failure.

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

Pregnancy, breastfeeding and fertility

The use of sildenafil is not indicated in women.

Driving and operating machinery

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

Sildenafilo Sandoz contains sodium

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

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

Do not take sildenafil more than once a day.

Do not take sildenafil coated tablets with medications that contain sildenafil in buccal dispersible tablets.

You should take sildenafil approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

Sildenafil Sandoz 25 mg

The groove is only for breaking the tablet if it is difficult to swallow it whole.

Breaking the tablet

Place the tablet on a hard and flat surface with the breaking line facing up. Press with your thumb in the middle of the tablet 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 breaking line facing up. Press with your thumb in the middle of the tablet 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 breaking line facing up. Press with your thumb in the middle of the tablet and the tablet will break into four equal doses.

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

Sildenafil will only help you achieve an erection if you are sexually stimulated. The time it takes for sildenafil to take effect varies from person to person, usually ranging from half an hour to one hour. The effect of sildenafil may be delayed if taken with a large meal.

If sildenafil does not help you achieve an erection or if the erection does not last long enough to complete sexual intercourse, 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 recommended by your doctor.

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported associated with the use of sildenafil are generally mild to moderate in intensity 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 withlow frequency(may affect up to 1 in 100 people).

The symptoms include sudden hissing while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain, this occurs withlow frequency:

If they occur during or after sexual intercourse:

• Position yourself in a semi-sitting position and try to relax.
• Do not use nitratesto treat chest pain.
• Prolonged and sometimes painful erections, this occursrarely(may affect up to 1 in 1,000 people).

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

• Sudden decrease or loss of vision - this occursrarely.

• Severe skin reactions, this occursrarely.

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Convulsions or seizures, this occursrarely.
  

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,
• Warmth (among the symptoms is a sudden feeling of heat in the upper body),
• Indigestion,
• Abnormal color perception, blurred vision, visual deterioration,
• Stuffy nose,
• 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, light sensitivity, or watery eyes,
• Palpitations, rapid heartbeat,
• High blood pressure, low blood pressure,
• Muscle pain,
• Sensation of drowsiness,
• Reduced sensation to touch,
• Dizziness,
• Tinnitus in the ears,
• Dry mouth,
• Blockage or congestion of the nasal sinuses, inflammation of the nasal mucosa (among the symptoms are sneezing, runny nose, and nasal congestion),
• Pain in the upper abdomen, gastroesophageal reflux disease (among the symptoms is heartburn),
• Blood present in urine,
• Pain in the arms or legs,
• Nasal bleeding,
• Sensation of heat,
• Sensation of fatigue.

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

• Loss of consciousness,
• Cerebrovascular accident, heart attack, irregular heartbeat,
• Transient decrease in blood flow to some parts of the brain,
• Sensation of throat constriction, numbness of the mouth,
• Bleeding in the back of the eye, double vision, visual deterioration, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, or change in color of the white part of the eye,
• Bleeding of the penis,
• Blood present in semen,
• Dry nose,
• Swelling of the nasal interior,
• Sensation of irritability,
• Sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that most men who experienced these side effects, although not all of them, had heart problems before taking this medication. It is not possible to determine if these side effects were directly related tosildenafil.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sildenafilo Sandoz

• The active ingredient is sildenafilo.

Sildenafilo Sandoz 25 mg: each tablet contains 25 mg of sildenafilo (as citrato).

Sildenafilo Sandoz 50 mg: each tablet contains 50 mg of sildenafilo (as citrato).

Sildenafilo Sandoz 100 mg: each tablet contains 100 mg of sildenafilo (as citrato).

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

Appearance of the product and packaging size

Sildenafilo Sandoz 25 mg

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

Sildenafilo Sandoz 50 mg

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

Sildenafilo Sandoz 100 mg

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

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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:

Last review date of this leaflet:August 2022

More detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/