Dragul 25 mg film-coated tablets EFG: detailed information

Brand name Dragul 25 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

SILDENAFIL CITRATE · 35,12 mg

Prescription type Prescription Only Medicine

ATC code

G04B G04BE G04BE03

Registration number 71721

Manufacturer Biowise Pharmaceuticals, S.L.

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Dragul is and what it is used for
2. What you need to know before taking Dragul
3. How to take Dragul
4. Possible adverse effects
5. Storage of Dragul
6. Package contents and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dragul 25 mg film-coated tablets EFG

Sildenafil (as citrate)

Read the entire 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 or pharmacist.
This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Dragul is and what it is used for
What you need to know before taking Dragul
How to take Dragul
Possible adverse effects
How to store Dragul
Contents of the pack and other information

1. What Dragul is and what it is used for

Dragul 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 in the penis, allowing blood flow into it 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 achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Dragul

Do not take Dragul

If you are allergic (hypersensitive) to sildenafil or to any of the other components of this medicine (listed in section 6).
If you are taking medicines 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 medicines, which are often administered to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
If you are using any medicines known as nitric oxide donors such as amyl nitrate (“poppers”), as the combination may 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 been shown to 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 a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NA-AION).

Warnings and precautions

Consult your doctor or pharmacist before taking Dragul:

If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
If you have a penile deformity or Peyronie’s disease.
If you have heart problems. In such cases, your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity.
If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
If you experience 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 treatments 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 individuals under 18 years of age.

Special considerations in patients with renal impairment or hepatic problems

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

Other medicines and Dragul

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

Dragul tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional that you are taking Dragul and when you took it. You should not take Dragul with other medicines unless advised by your doctor.

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 may 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 pain (or “chest pain”).

You should not take Dragul if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these products may also lead to a potentially dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of Dragul.

Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness 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 after taking Dragul. To reduce the likelihood of these symptoms, you should be on a stable daily dose of the alpha-blocker before starting Dragul. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Dragul.

Use of Dragul with food and drink

Dragul can be taken with or without food. However, you may notice that Dragul takes slightly longer to work if taken with a heavy meal.

Alcohol intake may temporarily impair your ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to consume large amounts of alcohol before taking Dragul.

Pregnancy and breastfeeding

The use of Dragul is not indicated in women.

Driving and use of machines

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

Dragul contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Dragul

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

You must not take Dragul more than once a day.

You should take Dragul approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with some water.

If you find that the effect of this medicine is 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 this medicine takes to work varies from person to person, but generally ranges between half an hour and one hour. The effect of Dragul may be delayed if taken with a heavy meal.

If this medicine 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 the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.

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 Toxicology Information Service at 915 620 420 (indicating the medicine and the amount ingested).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects reported with Dragul are generally mild to moderate in intensity and short-lived.

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

Chest pain – this occurs infrequently. If it occurs during or after sexual intercourse:
- Sit in a semi-upright position and try to relax.
- Do not use nitrates to treat your chest pain.
Allergic reactions – this occurs infrequently (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 rarely (may affect up to 1 in 1,000 people). If you have an erection lasting more than 4 hours, contact your doctor immediately.
Sudden decrease or loss of vision – this occurs rarely.
Severe skin reactions – this occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, as well as fever.
Seizures or fits – this occurs rarely.

Other adverse effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, feeling hot (including sudden sensation of heat in the upper body), indigestion, abnormal colour vision, 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, perception of flashing lights, visual clarity, light sensitivity, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in the urine, pain in arms or legs, nosebleeds, feeling of warmth, and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of throat tightness, numbness of the mouth, bleeding behind the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden decrease or loss of hearing.

Rare adverse effects reported after marketing experience include: unstable angina (heart disease) and sudden death. Most, but not all, of these individuals had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to Dragul.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es. By reporting adverse 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 container to protect it from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Return unused containers and unwanted medicines to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Dragul 25 mg

The active substance in Dragul is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
The other components are:

Tablet core: microcrystalline cellulose, dibasic calcium phosphate, sodium croscarmellose, and magnesium stearate.

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

Appearance of the product and contents of the pack

Dragul 25 mg film-coated tablets are elliptical in shape and blue in colour. They are engraved with “-” on one side.

Dragul is supplied in packs containing 4 tablets in blister packs.

Only certain pack sizes may be marketed.