DRAGUL 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dragul 100 mg film-coated tablets EFG

Sildenafil (as citrate)

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

1. What is Dragul and what is it used for

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

Dragul is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm enough erection for satisfactory sexual activity.

2. What you need to know before you take Dragul

Do not take Dragul

• If you are allergic (hypersensitive) 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 potentially 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 unsure, consult your doctor or pharmacist.
• If you are using any of the medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination can cause a potentially 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 Dragul, have shown that they 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 or heart attack, or if you have low blood pressure.
• If you have had a rare inherited eye disease (such as retinitis pigmentosa).
• If you have previously experienced a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dragul:

• If you have sickle cell anemia (a blood abnormality), 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. In this case, your doctor should carefully check if your heart can withstand the extra effort of having sex.
• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Dragul and contact your doctor immediately.

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

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

You should not take Dragul if you do not have erectile dysfunction.

The use of Dragul is not indicated in women.

Special considerations in children and adolescents

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

Special considerations in patients with renal or hepatic impairment

You should inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Other medicines and Dragul

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Dragul tablets may interfere with some medicines, especially those used to treat chest pain. In case of a medical emergency, you should inform any healthcare professional that you are taking Dragul and when you took it. Do not take Dragul with other medicines unless your doctor advises you to.

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

You should not take Dragul if you are taking medicines called nitrates, as the combination of these products can cause a potentially 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 pectoris (or "chest pain").

You should not take Dragul if you are taking medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these products can also cause a potentially 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 in the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Dragul.

Some patients who are receiving 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 Dragul with alpha-blockers. This is more likely to occur within 4 hours of taking Dragul. To reduce the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Dragul. Your doctor may advise you to start treatment with the lower dose (25 mg) of Dragul.

Using Dragul with food and drink

Dragul can be taken with or without food. However, you may notice that Dragul takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking Dragul.

Pregnancy and breastfeeding

The use of Dragul is not indicated in women.

Driving and using machines

Dragul can cause dizziness and affect vision. You should know how you react to Dragul before driving vehicles or using machinery.

Dragul contains sodium

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

3. How to take Dragul

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

You should not take Dragul more than once a day.

You should take Dragul approximately one hour before you plan to have sex. Swallow the tablet whole with a little water.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Dragul will only help you achieve an erection if you are sexually stimulated. The time it takes for this medicine to work varies from person to person, usually between half an hour and one hour. The effect of Dragul can be delayed if you take it with a large meal.

In the event that this medicine 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 Dragul than you should

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

You should not take more tablets than your doctor recommends

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

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

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 Dragul are generally mild to moderate and short-lived.

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

• Chest pain - this occurs with rare frequency. If it occurs during or after having sex:

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

• Do not use nitratesto treat your chest pain.

• Allergic reactions - this occurs with rare frequency(may affect up to 1 in 100 people). Symptoms include: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

• 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, hot flushes (including symptoms such as 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, watery eyes, eye irritation, eye discharge/red eyes, eye pain, flashing lights, visual clarity, sensitivity to light, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal stuffiness or congestion, 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 the urine, pain in the 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, 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, decrease in visual acuity, 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 of the eye, change in color of the white of the eye, bleeding from the penis, blood in the semen, dry nose, swelling of the inside of the nose, feeling of irritability, and sudden decrease or loss of hearing.

The side effects reported rarely from post-marketing experience include: unstable angina (heart disease) and sudden death. Most, but not all, had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Dragul.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use, Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dragul

Keep out of sight and reach of children.

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicines in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the cartons and any remaining medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dragul 100 mg

• The active substance of Dragul is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

• The other ingredients are:

Core tablet: microcrystalline cellulose, calcium phosphate dibasic, sodium croscarmellose, and magnesium stearate.

Film coating: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, and aluminum lake indigo carmine.

Appearance of the product and pack contents

Dragul 100 mg tablets are film-coated, elliptical, and blue. They are engraved with "+" on one side.

Dragul is available in blisters of 4 or 8 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

Dragul 25 mg, packs of 4 tablets.

Dragul 50 mg, packs of 1, 2, 4, or 8 tablets.

Marketing authorization holder and manufacturer

Holder:

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Illes Balears

Manufacturer:

ATLANTIC PHARMA

PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2

Abrunheira, Sintra - Portugal

Date of the last revision of this leaflet:February 2024

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