Sildenafil Macleods 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil Macleods 25 mg film-coated tablets EFG

Sildenafil

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

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

Leaflet contents:

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

1. What Sildenafil Macleods is and what it is 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 flow into the penile tissue when you are sexually aroused. Sildenafil Macleods will only help you achieve an erection if you are sexually stimulated.

Sildenafil Macleods is a treatment for adult men who suffer from erectile dysfunction, sometimes also known as impotence. This is when a man is unable to achieve or maintain a firm erection sufficient for sexual activity.

2. What you need to know before taking 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 drop in your blood pressure. Speak with your doctor if you are taking any of these medicines, which are commonly prescribed to treat angina (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

• If you are using any medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), since the combination may also cause a potentially dangerous drop in 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 been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

• If you have severe liver or heart problems.

• If you have recently had a heart attack or stroke, or if you have low blood pressure.

• If you have a rare inherited eye disease (such as retinitis pigmentosa).

• If you have ever experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Sildenafil Macleods:

• If you have sickle cell anemia (a red blood cell disorder), leukemia (blood cancer), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor should assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or a bleeding disorder (such as hemophilia).
• If you experience 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 treatments 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 liver or kidney problems

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

Children and adolescents

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

Other medicines and Sildenafil Macleods

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

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

You must not take Sildenafil if you are taking medicines called nitrates, because combining these products may cause a potentially dangerous drop in 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").

You must not take Sildenafil if you are taking any nitric oxide donor medicines, such as amyl nitrite ("poppers"), because their combination may also cause a potentially dangerous drop in blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil.

Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness due to low blood pressure when standing up or sitting down quickly. Some patients have reported 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 an alpha-blocker before starting Sildenafil. Your doctor may advise you to begin 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 notice that Sildenafil takes longer to start working if taken with a heavy meal.

Drinking alcohol may temporarily reduce your ability to get an erection. To get the best results from your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil.

Pregnancy, breastfeeding, and fertility

Sildenafil is not indicated for use in women.

Driving and using machines

Sildenafil may cause dizziness and affect vision. It is important that you understand how you react to Sildenafil Macleods before driving or operating machinery.

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

3. How to take Sildenafil Macleods

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Sildenafil Macleods 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 Macleods approximately one hour before sexual activity. Swallow the tablet whole with a glass of water.

If you notice that the effect of Sildenafil Macleods is too strong or too weak, inform your doctor or pharmacist.

Sildenafil Macleods will only help you achieve an erection if you are sexually stimulated. The time Sildenafil Macleods takes to start working varies from person to person, but is normally between half an hour and one hour. You may find that Sildenafil Macleods takes longer to work if taken with a heavy meal.

If Sildenafil Macleods tablets do not help you achieve an erection, or if your erection does not last long enough for complete sexual intercourse, you should inform your doctor.

If you take more Sildenafil Macleods than you should

You may experience an increase in adverse effects and their severity. Doses higher than 100 mg do not increase efficacy.

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

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Adverse effects reported with Sildenafil are usually 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 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 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, contact your doctor immediately.

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

• Severe skin reactions – this occurs rarely.

Symptoms may include severe skin peeling and swelling, 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,
flushing (symptoms include 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 sensation to touch, dizziness, tinnitus, dry mouth, nasal blockage or congestion, 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 of fatigue.

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 behind 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 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other 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 components are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium croscarmellose, hypromellose, and magnesium stearate.

Coating: hypromellose 6cP, titanium dioxide (E171), triacetin, and indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Film-coated blue diamond-shaped tablets, engraved with "CL 35" on one side and smooth on the other.

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

Only certain 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

Local representative:

UXAfarma, S.A.

Avda. J.V. Foix, 62

08034 Barcelona – Spain

Date of the most recent review of this leaflet: 06/2022

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/