SILDENAFIL HEC PHARM 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafil HEC Pharm 100mg 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, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Sildenafil HEC Pharm is and what it is used for

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

This medication is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot get or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before you take Sildenafil HEC Pharm

Do not take Sildenafil HEC Pharm

• 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 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 not sure, 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 not sure, consult your doctor.

• If you have a serious heart or liver problem.

• 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 previously experienced a loss of vision due to a non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

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

• If you have sickle cell anemia (a blood disorder), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer)

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

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

• If you have stomach ulcers or bleeding problems (such as hemophilia) at the moment.

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

• If you are taking a medicine called ritonavir (for HIV treatment), you should not use sildenafil

It is not recommended to use sildenafil at the same time as any other oral or local treatment for erectile dysfunction.

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

You should not take sildenafil if you do not have erectile dysfunction. The use of sildenafil is not indicated in women.

Special considerations in 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.

Using Sildenafil HEC Pharm with other medicines

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 tell 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.

You should not take sildenafil if you are taking medicines called nitrates, as the combination can cause a dangerous drop in your blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").

You should not take sildenafil if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination 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 (25mg) of sildenafil.

You should not use sildenafil if you are taking the protease inhibitor ritonavir (for HIV treatment).

Some patients who are taking 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 4 hours of taking sildenafil. To minimize the chance of these symptoms, you should be taking your alpha-blocker dose regularly before starting sildenafil. Your doctor may advise you to start with a lower dose (25mg) of sildenafil.

Using Sildenafil HEC Pharm with food, drinks, and alcohol

This medicine can be taken with or without food. However, you may notice that Sildenafil HEC Pharm 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 this medicine.

Pregnancy, breastfeeding, 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 or using machines.

Sildenafil HEC Pharm contains lactose and sodium

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

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

3. How to take Sildenafil HEC Pharm

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50mg.

Do not take Sildenafil HEC Pharm 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 achieve an erection if you are sexually stimulated. The time it takes for sildenafil to work varies from person to person, usually between half an hour and one hour. The effect of sildenafil can be delayed if you take it with a large meal.

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

If you take more Sildenafil HEC Pharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

You may experience an increase in side effects and their severity. Doses above 100mg do not increase efficacy.

Do not take more tablets than your doctor recommends.

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

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

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 sildenafil are usually mild to moderate and of short duration.

If you experience any of the following serious side effects, stop taking Sildenafil HEC Pharm and see a doctor immediately:

• Allergic reaction: this occurs with rare frequency(may affect up to 1 in 100 people).

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

• Chest pain: this occurs with rare frequency.

If they occur during or after sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto 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.

The symptoms can include severe skin peeling and swelling, 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, hot flush (including a sudden feeling of 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, flashing lights, visual clarity, 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, inflammation of the nasal mucosa (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 reduction of blood flow to parts of the brain, feeling of compression 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 or eyelid swelling, small particles or spots in 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 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 of the men who suffered these side effects, although not all of them, had pre-existing 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 experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil HEC Pharm

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. Return any unused medicine to a pharmacy for safe disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

C Sildenafil HEC P

• The active substance of Sildenafil HEC Pharm is sildenafil.

Each tablet contains 100mg of sildenafil (as sildenafil citrate).

• The other ingredients are:
• • Core of the tablet: Calcium hydrogen phosphate, microcrystalline cellulose PH102, sodium croscarmellose, magnesium stearate
  • Coating: Hypromellose 2910 (15 MPA.S), hypromellose 2910 (5 MPA.S), lactose monohydrate, titanium dioxide (E171), triacetin, polyethylene glycol 6000

Appearance and packaging of the product

Sildenafil HEC Pharm 100mg film-coated tablets: Film-coated tablets with a capsule shape, white or almost white in color, with the inscription "L4" on one side and smooth on the other side. The tablet is 16×8mm in size.

PVC/PVDC/aluminum blisters

Package sizes: 4, 8, 10, 12, and 24 film-coated tablets per carton.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17,

10963 Berlin,

Germany

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

Date of last revision of this leaflet:June 2020

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