SILDENAFIL STADA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Stada 25 mg film-coated tablets EFG

Sildenafilo Stada 50 mg film-coated tablets EFG

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 Sildenafilo Stada and what is it used for
2. What you need to know before you take Sildenafilo Stada
3. How to take Sildenafilo Stada
4. Possible side effects

5 Storage of Sildenafilo Stada

1. Contents of the pack and further information

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

Sildenafilo Stada contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by helping to relax 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 indicated for the treatment of erectile dysfunction in adult men, sometimes also called impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity.

2. What you need to know before you take Sildenafilo Stada

Do not take Sildenafilo Stada

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

• If you are taking medicines called nitrates, as the combination can cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). 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 can cause a 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 blood clots). PDE5 inhibitors, such as sildenafil, have shown that they 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, transient ischaemic attack 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 a loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo Stada.

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

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

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

• If you have currently stomach ulcers or bleeding problems (such as haemophilia).

• If you experience a sudden loss of vision, stop taking sildenafil and contact your doctor immediately.

• You must not take sildenafil if you are taking a medicine called ritonavir (for the treatment of HIV).

You must not use sildenafil at the same time as any other treatment for erectile dysfunction.

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

You must 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 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 Sildenafilo Stada

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In case of a medical emergency, you should inform your doctor or pharmacist that you are taking sildenafil and when you took it. Do not take sildenafil with other medicines unless your doctor advises you to.

You must not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines can cause a 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 angina pectoris (or "chest pain").

You must not take sildenafil if you are taking medicines called nitric oxide donorssuch as amyl nitrite ("poppers"), as the combination of these products can also cause a dangerous drop 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. You must not take sildenafil if you are taking the protease inhibitor ritonavir (for the treatment of HIV).

Some patients who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can 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 happen within the first 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should be taking your daily dose of alpha-blockers regularly before starting on sildenafil. Your doctor may advise you to start with the lower dose (25 mg) of sildenafil.

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

Taking Sildenafilo Stada 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.

Drinking alcohol can temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is advised 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 can cause dizziness and affect vision. You should know how you react to sildenafil before driving vehicles or using machinery.

Sildenafilo Stada contains soybean lecithin

Do not use if you are allergic to peanut or soy.

Sildenafilo Stada contains aluminium lake Ponceau 4R

May cause allergic reactions.

Sildenafilo Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, such as lactose, consult your doctor before taking this medicine.

Sildenafilo Stada contains glucose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Sildenafilo Stada contains sodium

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

3. How to take Sildenafilo Stada

Follow exactly the administration instructions of this medicine given by your doctor. Consult your doctor or pharmacist if you have any doubts. The normal starting dose is 50 mg.

Do not take sildenafil more than once a day.

Do not take sildenafil film-coated tablets with 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.

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.

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

If you take more Sildenafilo Stada 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.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 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 rarely(may affect up to 1 in 100 people).

Symptoms include sudden wheezing, coughing, chest pain, shortness of breath, or difficulty breathing, swelling of the eyelids, face, lips or throat.

• Chest pain - this occurs rarely.

If this occurs 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 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 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 flush (including a feeling of warmth), indigestion, abnormal colour vision, blurred vision, visual disturbance, nasal congestion and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, seeing flashes of light, increased light sensitivity, tearing, 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 (including symptoms such as runny nose, sneezing and stuffy nose), pain in the upper abdomen, gastro-oesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds and feeling hot or 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 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 eye, seeing halos around lights, dilation of the pupil, change in colour of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable and sudden loss or decrease in hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been reported rarely. It should be noted that most of the men who experienced these side effects, although not all of them, had 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 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 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 Sildenafilo Stada

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 Content and Additional Information

Sildenafilo Stada Composition

The active ingredient is sildenafil citrate.

Each film-coated tablet contains 25 mg of sildenafil (as citrate)

Each film-coated tablet contains 50 mg of sildenafil (as citrate)

The other components are:

• Tablet core:

Lactose monohydrate

Microcrystalline cellulose E 460

Hydroxypropylcellulose E 464

Croscarmellose sodium

Sodium stearyl fumarate

Anhydrous colloidal silica E 551

• Coating:

Aluminum carmine indigo lacquer E 132

Medium-chain triglycerides

Hypromellose E 463

Maltodextrin

Polydextroses E 1200

Aluminum Ponceau 4R lacquer E 124

Talc E 553b

Titanium dioxide E 171

Dextrose monohydrate

Soy lecithin E 322

Maltodextrin

Potassium aluminum silicate/potassium dioxide pigment E 555

Sodium carboxymethylcellulose E 466

Product Appearance and Container Content

Sildenafilo Stada 25 mg are blue, pearlescent, round, biconvex film-coated tablets with an approximate diameter of 8 mm.

Sildenafilo Stada 50 mg are blue, pearlescent, round, biconvex film-coated tablets with an approximate diameter of 10 mm.

The tablets are presented in blisters containing 1, 2, 3, 4, 8, 12, 24, 36, 48, and 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Vienna

Austria

or

STADA Arzneimittel AG

Stadastr. 2-18,

61118 Bad Vilbel

Germany

or

STADA M&D SRL

Str. Trascaului nr 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Sildeanfil STADA 25 mg/50 mg Filmtabletten

Bulgaria: Sildenafil STADA 25 mg/50 mg ????????? ????????

Germany: Sildenafil AL 25 mg/50 mg Filmtabletten

Spain: Sildenafilo STADA 25 mg/50 mg film-coated tablets EFG

Italy: Sildenafil EG 25 mg/50 mg compresse rivestite con film

Netherlands: Sildenafil STADA 25 mg/50 mg filmomhulde tabletten

Portugal: Sildenafil Ciclum

Romania: Sildenafil Hemofarm 25mg/50 mg comprimate filmate

Date of the Last Revision of this Leaflet:August 2022

Detailed and updated 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/