Sildenafil Tarbis 25 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Sildenafilo Tarbis 25 mg 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 as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Sildenafilo Tarbis is and what it is used for
- What you need to know before taking Sildenafilo Tarbis
- How to take Sildenafilo Tarbis
- Possible side effects
- How to store Sildenafilo Tarbis
- Contents of the pack and other information
1. What Sildenafilo Tarbis is and what it is used for
Sildenafilo Tarbis 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 the penis when sexually stimulated. Sildenafilo Tarbis will only help you achieve an erection if you are sexually stimulated.
Sildenafilo Tarbis is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to achieve or maintain a firm penile erection suitable for satisfactory sexual activity.
2. What you need to know before taking Sildenafil Tarbis
Do not take Sildenafil Tarbis
- 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 may lead to a dangerous drop in your blood pressure. Consult your doctor if you are using any of these medicines, which are often given 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 lead to 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 Tarbis 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NA-AION).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Sildenafil Tarbis:
- If you have sickle cell anemia (a disorder of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of the bone marrow).
- If you have a penile deformity or Peyronie’s disease.
- If you have heart problems. 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 Sildenafil Tarbis and contact your doctor immediately.
It is not recommended to take Sildenafil Tarbis together with any other oral or local treatment for erectile dysfunction.
You must not take Sildenafil Tarbis with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.
You must not take Sildenafil Tarbis if you do not have erectile dysfunction.
The use of Sildenafil Tarbis is not indicated in women.
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.
Children and adolescents
The use of Sildenafil Tarbis is not indicated in individuals under 18 years of age.
Taking Sildenafil Tarbis with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Sildenafil Tarbis tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking Sildenafil Tarbis and when you took it. You should not take Sildenafil Tarbis with other medicines unless your doctor advises you to do so.
You must not take Sildenafil Tarbis if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pain (or “chest pain”).
You must not take Sildenafil Tarbis if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these medicines may also cause a dangerous drop in your blood pressure.
Inform 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 starting treatment with the lowest dose (25 mg) of Sildenafil Tarbis.
Some patients who are taking 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 Sildenafil Tarbis with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Tarbis. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting Sildenafil Tarbis. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Sildenafil Tarbis.
Taking Sildenafil Tarbis with food, drinks, and alcohol
Sildenafil Tarbis can be taken with or without food. However, you may notice that Sildenafil Tarbis takes slightly longer to work if taken with a heavy meal.
Drinking alcohol may temporarily impair your ability to obtain an erection. Therefore, to achieve the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking Sildenafil Tarbis.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before using any medicine.
The use of Sildenafil Tarbis is not indicated in women.
Driving and using machines
Sildenafil Tarbis may cause dizziness and affect vision. You should be aware of how you react to Sildenafil Tarbis before driving or operating machinery.
3. How to take Sildenafil Tarbis
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.
SILDENAFILO TARBIS 25 mg film-coated tablets must not be taken more than once a day.
Take Sildenafil Tarbis approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.
If you notice that the effect of Sildenafil Tarbis is too strong or too weak, inform your doctor or pharmacist.
Sildenafil Tarbis will only help you achieve an erection if you are sexually stimulated. The time Sildenafil Tarbis takes to work varies from person to person, usually ranging between half an hour and one hour. The effect of Sildenafil Tarbis may be delayed if taken with a heavy meal.
If Sildenafil Tarbis 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 Sildenafil Tarbis 2 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.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.
Do not take more tablets than recommended by your doctor.
Contact your doctor if you have taken more tablets than advised.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects reported with the use of Sildenafilo Tarbis are generally mild to moderate in intensity and short in duration.
If you experience any of the following serious adverse effects, stop taking Sildenafilo Tarbis and seek immediate medical attention:
- Allergic reaction – 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.
- Chest pain – this occurs infrequently.
If it occurs during or after sexual activity:
-
Sit in a semi-upright position and try to relax.
-
Do not use nitrates to treat chest pain.
-
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, you must contact your doctor immediately.
-
Sudden decrease or loss of vision – this occurs rarely.
-
Severe skin reactions – this occurs rarely.
Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, 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 of warmth (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, eye irritation, eye discharge/red eyes, eye pain, seeing flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in 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, transient reduction in blood flow to parts of the brain, 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.
During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these effects were directly related to Sildenafilo Tarbis.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sildenafilo Tarbis
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents and additional information
Composition of Sildenafil Tarbis 25 mg film-coated tablets
- The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
- The other components are:
- Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium croscarmellose, colloidal anhydrous silica.
- Film coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 6000 (macrogol 6000), talc, indigo carmine lake (E 132).
Appearance of the medicinal product and contents of the pack
Sildenafil Tarbis 25 mg film-coated tablets are blue, elongated, and printed.
Sildenafil Tarbis 25 mg film-coated tablets are supplied in blisters containing 4 tablets.
Possible marketing of only certain pack sizes.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Tarbis Farma, S.L.
Gran Via Carlos III, 94
08028 - Barcelona
Spain
Manufacturer:
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid
Spain
Laboratorios Liconsa, S.A.
Avenida Miralcampo, 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares - Guadalajara
Spain
Date of the most recent revision of this leaflet: 04/2017.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/