PATIENT INFORMATION LEAFLET

Sildenafilo Macleods 100 mg Film-Coated Tablets

Sildenafilo

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• 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 leaflet:

1. What Sildenafilo Macleods is and what it is used for
2. What you need to know before you start taking Sildenafilo Macleods
3. How to take Sildenafilo Macleods
4. Possible side effects
5. Storage of Sildenafilo Macleods

Contents of the pack and additional information

SildenafiloMacleodscontains the active ingredient sildenafilo, 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 become sexually aroused. SildenafiloMacleodswill only help you get an erection if you feel sexually stimulated.

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

Do not take Sildenafilo Macleods

• If you are allergic to sildenafilo or any of the other components of this medication (listed in section 6).
• If you are taking certain medications called nitrates, as the combination may lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medications that are commonly prescribed to treat angina pectoris (or "chest pain"). If unsure, consult your doctor or pharmacist.

• If you are using any of the medications known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also cause a potentially dangerous decrease in your blood pressure.
• If you are taking riociguat. This medication 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). PDE5 inhibitors, such as Sildenafilo Macleods, have shown to increase the hypotensive effect of this medication. 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 any rare inherited eye disease (such as retinitis pigmentosa).
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

• If you have sickle cell anemia (a blood 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 must check if your heart can withstand the additional strain of sexual activity.
• If you have an active gastric ulcer or bleeding problem (such as hemophilia).
• If you experience sudden vision loss, stop taking Sildenafilo Macleods and immediately contact your doctor.

Do not take Sildenafilo with any other local or oral treatment for erectile dysfunction.

Do not take Sildenafilo with treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other PDE5 inhibitor.

Do not take Sildenafilo if you do not have erectile dysfunction.

Sildenafilo is not indicated for 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 Sildenafilo Macleods is not indicated for individuals under 18 years old.

Other medications and Sildenafilo Macleods

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Sildenafilo may interact with certain medications, particularly those used to treat angina pectoris. In case of a medical emergency, inform your doctor, pharmacist, or nurse that you are taking Sildenafilo and when you took it. Do not take Sildenafilo with other medications unless your doctor advises you to.

Do not take Sildenafilo if you are taking nitrates, as the combination may cause a potentially dangerous increase in your blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medications, which are commonly prescribed to treat angina pectoris (or "chest pain").

Do not take Sildenafilo if you are taking any of the medications known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination may also cause a potentially dangerous increase in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medications known as protease inhibitors, such as those used to treat HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafilo.

Some patients taking alpha-blockers for hypertension or benign prostatic hyperplasia may experience intense or mild dizziness due to hypotension that occurs when standing or sitting quickly. Some patients have reported these symptoms when taking Sildenafilo with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafilo. To reduce the likelihood of these symptoms, you should be receiving a regular daily dose of alpha-blockers before starting Sildenafilo. Your doctor may recommend starting with the lowest dose (25 mg) of Sildenafilo Macleods.

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

Taking Sildenafilo with food, drinks, and alcohol

Sildenafilo Macleods can be taken with or without food. However, you may notice that Sildenafilo takes longer to start working if you take it with a large meal.

Drinking alcohol may temporarily reduce your ability to achieve an erection. To get the most out of your medication, it is recommended that you do not drink excessive amounts of alcohol before taking Sildenafilo.

Pregnancy, breastfeeding, and fertility

Sildenafilo is not indicated for women.

Driving and operating machinery

Sildenafilo may cause dizziness and affect vision. It is essential to be aware of how you react to Sildenafilo Macleods before driving or operating machinery.

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

Follow exactly the administration instructions for 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 Sildenafilo Macleods more than once a day.

Do not take sildenafilo film-coated tablets with sildenafilo buccal dispersible tablets.

Take Sildenafilo Macleods around one hour before sexual activity. Swallow the tablet whole with a glass of water.

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

Sildenafilo Macleods will only help you achieve an erection if you feel sexually stimulated. The time it takes for Sildenafilo Macleods to start working varies from person to person, but it is usually between 30 minutes to one hour. You may notice that Sildenafilo Macleods takes longer to act if you take it with a large meal.

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

If you take more Sildenafilo 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 recommended by your doctor.

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

If you have any doubts about the use of this medication, consult your doctor, pharmacist, or nurse.

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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported in relation to the use of Sildenafilo are usually mild to moderate and of short duration.

If you experience any of the following serious side effects, stop taking Sildenafilo and seek medical attention immediately:

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

If they occur during or after sexual intercourse:

- Sit in a semi-recumbent position and try to relax.

-Do not use nitratesto treat chest pain.

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

• Sudden decrease or loss of vision - this occursinfrequently

• Severe skin reactions - this occursinfrequently

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

• Seizures or attacks - this occursinfrequently

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,

heat sensation (including sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Infrequent(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, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, 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 acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, feeling of irritability, and sudden decrease or loss of hearing.

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

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 the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es..By reporting side effects, you can contribute to providing more information on 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 box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the 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 Macleods

The active ingredient is sildenafil. Each film-coated tablet contains citrate of sildenafil equivalent to 100 mg of sildenafil.

The other components are:

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

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

Appearance of the product and content of the container

Blue-coated tablets in diamond shape, with the engraving "CL 37" on one face and smooth on the other.

The tablets are presented in blister packs of 2, 4, 8, 10, 12, 20, 24, 30, 36, 48, 60, and 90 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Responsible for manufacturing

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

Last review date of this leaflet:06/2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es/