Leaflet: information for the user

Dragul 50 mg film-coated tablets EFG

Sildenafil (as citrate)

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, 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 is Dragul and what it is used for

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 called 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 male 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 dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve 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 dangerous drop 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 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 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 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. 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.

Do not use Dragul simultaneously with any other oral or local treatment for erectile dysfunction.

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

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

Dragul is not indicated for use in women.

Special considerations in children and adolescents

Dragul is not indicated for use in individuals under 18 years of age.

Special considerations in patients with renal or hepatic problems

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, 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 dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain").

Do not take Dragul if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a potentially dangerous drop 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 enlargement, may experience dizziness or lightheadedness that may 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 in the 4 hours following Dragul intake. 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 instruct you to 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 taken with a large meal.

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

Pregnancy and breastfeeding

Dragul is not indicated for use 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. In case of doubt, consult your doctor or pharmacist again if you have any questions. 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The reported side effects associated with the use of Dragul are generally mild to moderate in intensity and of 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 heart rate, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus 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 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, bleeding of the penis, blood in the semen, dry nose, nasal mucosa swelling, feeling of irritability, and sudden loss or decrease in hearing.

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 prospectus. 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 in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Dragul 50 mg

• The active ingredient of Dragul is sildenafil. Each tablet contains 50 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 content of the packaging

Dragul 50 mg tablets have a coating, are eliptical in shape, and are blue in color.

Dragul is presented in blisters of 1, 2, 4, or 8 tablets per packaging.

Only some packaging sizes may be commercially available.

Other presentations:

Dragul 25 mg, packaging of 4 tablets.

Dragul 100 mg, packaging with 4 or 8 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Illes Balears

Responsible for manufacturing:

ATLANTIC PHARMAPRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2

Abrunheira, Sintra - Portugal

Date of the last review of this leaflet:February2024

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