Sildenafil Stada 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sildenafil Stada 25 mg film-coated tablets EFG

Sildenafil Stada 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Sildenafil is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Stada

Do not take Sildenafil Stada

• If you are allergic to sildenafil, peanuts, or soy, or to 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 dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often prescribed to relieve angina (or "chest pain"). If you are unsure, speak with your doctor or pharmacist.

• If you are using any medicines known as nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may 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 been 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, cerebral infarction, 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before taking Sildenafil Stada.

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of 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 assess whether your heart can tolerate the additional strain of sexual activity.

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

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

• You should not take sildenafil if you are taking a medicine called ritonavir (used to treat HIV).

You must not use sildenafil simultaneously with any other treatment for erectile dysfunction.

You must not take sildenafil with treatments for pulmonary arterial hypertension (PAH) containing 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

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 individuals under 18 years of age.

Other medicines and Sildenafil Stada

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

Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor or pharmacist that you are taking sildenafil and when you took it. Do not take sildenafil with other medicines unless advised by your doctor.

Do not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines may 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 (or "chest pain").

Do not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a 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 in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil. You should not take sildenafil if you are taking the protease inhibitor ritonavir (used to treat HIV).

Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness 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 within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of alpha-blockers before starting sildenafil. Your doctor may advise you to begin treatment with the lowest dose (25 mg) of sildenafil.

Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Stada with food, drinks, and alcohol

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

Alcohol consumption may temporarily impair your ability to obtain an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable 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 may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.

Sildenafil Stada contains soya lecithin

Do not use if allergic to peanuts or soya.

Sildenafil Stada contains Ponceau 4R aluminium lake

May produce allergic reactions.

Sildenafil Stada contains lactose

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

Sildenafil Stada contains glucose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Sildenafil Stada contains sodium

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

3. How to take Sildenafil Stada

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist. The usual starting dose is 50 mg.

Sildenafil must not be taken more than once a day.

Do not take sildenafil film-coated tablets together with sildenafil orodispersible tablets.

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

If you notice that the effect 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 required for sildenafil to take effect varies from person to person, but generally ranges between half an hour and one hour. The effect of sildenafil may be delayed if you take it with a heavy 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 Stada than you should

You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. The adverse effects reported with sildenafil are generally mild to moderate in intensity and short in duration.

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

• 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 chest pain occurs during or after sexual activity:

• Sit in a semi-upright position and try to relax.

• Do not use nitrates to 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 lasting more than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision – this occurs rarely.

• Severe skin reactions – this occurs rarely.

Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area, and around the eyes, as well as fever.

• Seizures or fits – this occurs rarely.

Other adverse effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, feeling hot (including sudden sensation of warmth in the upper body), 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 flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling tired.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, throat tightness, numbness of the mouth, bleeding at 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, pupil dilation, change in the colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

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

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Stada

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Stada

The active substance 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
Sodium croscarmellose
Sodium stearyl fumarate
Colloidal anhydrous silica E 551

• Coating:

Indigo carmine aluminium lake E 132
Medium-chain triglycerides
Hypromellose E 463
Maltodextrin
Polydextrose E 1200
Ponceau 4R aluminium lake E 124
Talc E 553b
Titanium dioxide E 171
Dextrose monohydrate
Lecithin (soy) E 322
Maltodextrine
Potassium aluminium silicate / potassium dioxide pigment E 555
Sodium carboxymethylcellulose E 466

Appearance of the product and contents of the pack

Sildenafil Stada 25 mg are blue, pearly, film-coated, round, biconvex tablets with a diameter of approximately 8 mm.

Sildenafil Stada 50 mg are blue, pearly, film-coated, round, biconvex tablets with a diameter of approximately 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: Sildenafil 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 most recent review of this leaflet: August 2022

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