Leaflet: information for the user

Dragul 25 mg film-coated tablets EFG

Sildenafil (as citrate)

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

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

1. What Dragul is and for what it is used

2. What you need to know before starting to take Dragul

3. How to take Dragul

4. Possible side effects

5. Storage of Dragul

6. Contents of the pack and additional information

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

Dragul is indicated for the treatment of male erectile dysfunction, sometimes referred to as impotence. This occurs when a man is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Dragul

• If you are allergic (hypersensitive) to sildenafil 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 cause a potentially hazardous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, which are often administered to alleviate chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medications called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause a potentially hazardous 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 Dragul, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

• If you have a severe heart or liver problem.
• If you have recently experienced 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 vision loss 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 red blood cell abnormality), leukemia (blood cancer), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor must carefully check if your heart can withstand the additional effort of having sex.
• If you 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 simultaneously with any other oral or local treatment for erectile dysfunction.

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

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

Use of Dragul is not indicated in women.

Special considerations in children and adolescents

Use of Dragul is not indicated in individuals under 18 years old.

Special considerations in patients with renal or hepatic problems

You must inform your doctor if you have renal or hepatic problems. Your doctor may decide to reduce your dose.

Other medications and Dragul

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

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

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

Do not take Dragul if you are taking nitrates, as the combination of these products may cause a potentially hazardous decrease in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medications, which are often used to alleviate chest pain (or "chest pain").

Do not take Dragul if you are taking medications known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a potentially hazardous decrease 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 recommend that you start treatment with the lowest dose (25 mg) of Dragul.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate hypertrophy, may experience dizziness or lightheadedness that may be caused by a decrease in blood pressure when sitting or standing quickly. Some patients have experienced these symptoms when taking Dragul with alpha-blockers. This is more likely to occur within 4 hours after taking Dragul. To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting Dragul. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Dragul.

Use of Dragul with food and beverages

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

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to maximize the benefits of the medication, it is recommended not to consume large amounts of alcohol before taking Dragul.

Pregnancy and breastfeeding

Use of Dragul is not indicated in women.

Driving and operating machinery

Dragul may cause dizziness and affect your vision. You should know how you react to Dragul before driving vehicles or operating machinery.

Dragul contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Dragul more than once a day..

Take Dragul approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a little water.

If you estimate that the action of this medicationis too strong or too weak, inform your doctor or pharmacist.

Dragul will only help you achieve an erection if you are sexually stimulated. The time it takes for this medication to take effect varies from person to person, generally ranging from half an hour to one hour. The effect of Dragul may be delayed if taken with a large meal.

If this medication does not help you achieve an erection or if the erection does not last 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.

Do not take more tablets than recommended by your doctor

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The reported side effects associated with the use of Dragul are generally of mild to moderate intensity and short duration.

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

• Chest pain - this occurs withlow frequency.If it occurs during or after sexual intercourse:

• Position yourself in a semi-recumbent position and try to relax.

• Do not use nitratesto treat your chest pain.

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

• Prolonged and sometimes painful erections - this occursrarely(may affect up to 1 in 1,000 people). If you have an erection that lasts more than 4 hours, you must contact your doctor immediately.

• Sudden loss or decrease in vision - this occursrarely.

• Severe skin reactions - this occursrarely. Symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.
  
• Convulsions or attacks - this occursrarely.

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, warmth (including symptoms such as sudden heat sensation in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, 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, light sensitivity, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as sneezing, runny nose, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as stomach burning), blood in the 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 the vision, halos around lights, pupil dilation, change in color of the white part of the eye, penile bleeding, blood in semen, dry nose, nasal interior swelling, feeling of irritability, and sudden hearing loss.

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

Reporting side effects

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

Keep out of sight and reach of children.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Dragul 25 mg

• The active ingredient of Dragul is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).

• The other components are:

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

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

Appearance of the product and contents of the packaging

Dragul 25 mg tablets have a coating, are elliptical in shape, and are blue in color. They are engraved with “-” on one face.

Dragul is presented in blisters of 4 tablets per packaging.

Only some packaging sizes may be commercially marketed.

Other presentations:

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

Dragul 100 mg, packaging with 4 or 8 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Illes Balears

Responsible manufacturer:

ATLANTIC PHARMA -S.A. PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2

Abrunheira, Sintra - Portugal

Last review date of this leaflet:February2024

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