SILDENAFIL MACLEODS 25 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil Macleods 25 mg film-coated tablets EFG

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. 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 Macleods and what is it used for
2. What you need to know before you take Sildenafil Macleods
3. How to take Sildenafil Macleods
4. Possible side effects
5. Storage Sildenafil Macleods
6. Contents of the pack and further information

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

Sildenafil Macleods 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 into the penis when you are sexually stimulated. Sildenafil Macleods will only help you to get an erection if you are sexually stimulated.

Sildenafil Macleods is a treatment for adult men with erectile dysfunction, also 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 Macleods

Do not take Sildenafil Macleods

• 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 lead to a dangerous decrease in your blood pressure. Tell your doctor if you are taking any of these medicines, which are often used to treat angina (or "chest pain"). If you are not sure, consult 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 also lead to 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 Macleods, have shown that they increase the effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.
• If you have severe liver or heart problems.
• 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 ever had a loss of vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Sildenafil Macleods:

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

Do not take Sildenafil with any other local or oral 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 for patients with liver or kidney problems

Tell your doctor if you have liver or kidney problems. Your doctor may decide to prescribe you a lower dose.

Children and adolescents

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

Other medicines and Sildenafil Macleods

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Sildenafil may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should inform your doctor, pharmacist, or nurse 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 may cause a potentially dangerous increase in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to treat angina (or "chest pain").

Do not take Sildenafil if you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also produce a potentially dangerous increase 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 start you on the lowest dose (25 mg) of Sildenafil.

Some patients who are taking alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by low blood pressure upon standing up or sitting up quickly. Some patients have reported these symptoms when taking Sildenafil with alpha-blockers. This is more likely to happen within 4 hours after taking Sildenafil. To reduce the likelihood of these symptoms, you should be taking a regular daily dose of alpha-blockers before starting to take Sildenafil. Your doctor may advise you to start with the lowest dose (25 mg) of Sildenafil Macleods.

Medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil with food, drinks, and alcohol

Sildenafil Macleods 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 reduce your ability to get an erection. To get the most out of your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil.

Pregnancy, breastfeeding, and fertility

Sildenafil is not indicated for women.

Driving and using machines

Sildenafil can cause dizziness and affect vision. It is essential that, before driving or using machines, you are aware of how Sildenafil Macleods affects you.

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

3. How to take Sildenafil Macleods

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

Do not take Sildenafil Macleods more than once a day.

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

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

If you feel that the effect of Sildenafil Macleods is too strong or too weak, talk to your doctor or pharmacist.

Sildenafil Macleods will only help you to get an erection if you are sexually stimulated. The time Sildenafil Macleods takes to work varies from person to person, but it normally takes between 30 minutes to 1 hour. You may find that Sildenafil Macleods takes longer to work if you take it with a large meal.

If Sildenafil Macleods tablets do not help you to get an erection, or if your erection does not last long enough for you to have sex, you should tell your doctor.

If you take more Sildenafil Macleods 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.

Consult your doctor if you take more tablets than you should.

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

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.

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, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs rarely.

If this happens during or after sex:

• 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 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 decrease or loss of vision - 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, feeling hot (including a feeling of warmth or heat in the upper body), indigestion, abnormal color perception, 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 sensitivity to light, watery eyes, 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 nasal congestion), inflammation of the lining of the nose (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot, and 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, change in color 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 decrease or loss of hearing.

During post-marketing experience, there have been rare reports of unstable angina (heart disease) and sudden death. It should be noted that most of the men who experienced these side effects, although not all of them, 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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 Macleods

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 is 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. Contents of the pack and further information

Composition of Sildenafil Macleods

The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.

The other ingredients are:

Core of the tablet: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, croscarmellose sodium, hypromellose, and magnesium stearate.

Coating: Hypromellose 6cP, titanium dioxide (E171), triacetin, and aluminum indigo lake (E132).

Appearance ofproduct and contents of the pack

Blue, diamond-shaped, film-coated tablets with "CL 35" engraved on one face and smooth on the other.

The tablets are available in blister packs of 2, 4, 8, 12, and 24 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB, United Kingdom

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020, Poland

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Local representative:

UXAfarma, S.A.

Avda. J.V. Foix, 62

08034 Barcelona – Spain

Date of last revision of this leaflet:06/2022

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