Sildenafil Sandoz 100 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
Sildenafil Sandoz 25 mg tablets EFG
Sildenafil Sandoz 50 mg tablets EFG
Sildenafil Sandoz 100 mg tablets EFG
sildenafil
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Sildenafil Sandoz is and what it is used for
- What you need to know before taking Sildenafil Sandoz
- How to take Sildenafil Sandoz
- Possible adverse effects
- How to store Sildenafil Sandoz
- Contents of the pack and other information
1. What Sildenafil Sandoz is and what it is used for
Sildenafil Sandoz 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 to flow in when you are sexually stimulated. Sildenafil will only help you achieve an erection if you are sexually stimulated.
Sildenafil 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 erection suitable for satisfactory sexual activity.
2. What you need to know before taking Sildenafil Sandoz
Do not take Sildenafil Sandoz
- 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 cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used 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 nitrite (“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 sildenafil 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
Talk to your doctor or pharmacist before taking sildenafil:
- if you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (bone marrow cancer),
- if you have a deformity of the penis or Peyronie's disease,
- if you have heart problems. In such cases, your doctor must 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 Sandoz and contact your doctor immediately.
It is not recommended to use sildenafil together with any other oral or local treatment for erectile dysfunction.
You must not take sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.
You must not take sildenafil if you do not have erectile dysfunction.
The use of sildenafil is not indicated in women.
Special considerations in patients with renal impairment or liver 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 is not indicated in individuals under 18 years of age.
Other medicines and Sildenafil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Sildenafil 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 sildenafil and when you took it. Do not take sildenafil with other medicines unless your doctor advises you to do so.
You must not take sildenafil 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 must not take sildenafil 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 sildenafil.
Some patients who are 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 down or standing up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine containing sacubitril/valsartan, used to treat heart failure.
Taking Sildenafil Sandoz with food, drinks, and alcohol
Sildenafil can be taken with or without food. However, you may notice that sildenafil takes slightly longer to work if taken with a heavy meal.
Alcohol intake may temporarily impair the ability to obtain an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking sildenafil.
Pregnancy, breastfeeding, and fertility
The use of sildenafil is not indicated in women.
Driving and using machines
Sildenafil may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.
Sildenafil Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take Sildenafil Sandoz
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again. The recommended starting dose is 50 mg.
Do not take sildenafil more than once a day.
Do not take sildenafil coated tablets together with medicines containing sildenafil in orally disintegrating tablets.
You should take sildenafil approximately one hour before planning to have sexual intercourse. Swallow the tablet whole, without chewing, with a glass of water.
Sildenafil Sandoz 25 mg
The score line is intended solely for dividing the tablet if you find it difficult to swallow the whole tablet.
Tablet splitting
Place the tablet on a hard, flat surface with the score line facing upwards. Press with your thumb at the middle of the tablet, and the tablet will break into two equal doses. You should take both halves to achieve the minimum effective dose.
Sildenafil Sandoz 50 mg
The tablet may be divided into four equal doses. You should take at least two quarters (corresponding to 25 mg) to achieve the minimum effective dose.
Tablet splitting
Place the tablet on a hard, flat surface with the score line facing upwards. Press with your thumb at the middle of the tablet, and the tablet will break into four equal doses.
Sildenafil Sandoz 100 mg
The tablet may be divided into four equal doses.
Tablet splitting
Place the tablet on a hard, flat surface with the score line facing upwards. Press with your thumb at the middle of the tablet, and the tablet will break into four equal doses.
If you notice that the effect of sildenafil is too strong or too weak, inform your doctor or pharmacist.
Sildenafil will only help you achieve an erection if you are sexually stimulated. The time required for sildenafil to take effect varies from person to person, usually between half an hour and one hour. The effect of sildenafil may be delayed if taken with a heavy meal.
If sildenafil 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 Sandoz than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase efficacy.
Do not take more tablets than recommended by your doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone gets them. The adverse effects reported with sildenafil are generally mild to moderate in intensity and short in duration.
If you experience any of the following serious adverse effects, stop taking sildenafil and seek immediate medical attention:
- Allergic reaction, which occurs uncommonly (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, which occurs uncommonly:
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, which occur 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.
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Sudden decrease or loss of vision – this occurs rarely.
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Severe skin reactions, which occur rarely.
Symptoms may include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as fever.
- Seizures or fits, which occur 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,
- Hot flushes (symptoms include sudden feeling of warmth in the upper body),
- Indigestion,
- Abnormal colour vision, blurred vision, visual disturbance,
- Nasal congestion,
- 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 sensation to touch,
- Dizziness,
- Ringing in the ears,
- Dry mouth,
- Nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion),
- Pain in the upper abdomen, gastroesophageal reflux disease (symptoms include heartburn),
- Blood in urine,
- Pain in arms or legs,
- Nosebleeds,
- Feeling of warmth,
- 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 certain parts of the brain,
- Throat tightness, mouth numbness,
- Bleeding at the back of 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 irritable,
- Sudden decrease or loss of hearing.
During post-marketing experience, cases of unstable angina (heart disease) and sudden death have been reported rarely. 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 adverse effects were directly related to sildenafil.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sildenafil Sandoz
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point located at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sildenafil Sandoz
- The active substance is sildenafil.
Sildenafil Sandoz 25 mg: each tablet contains 25 mg of sildenafil (as citrate).
Sildenafil Sandoz 50 mg: each tablet contains 50 mg of sildenafil (as citrate).
Sildenafil Sandoz 100 mg: each tablet contains 100 mg of sildenafil (as citrate).
- The other components are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, sodium saccharin and aluminium lake with indigo carmine (E 132).
Nature of the product and pack sizes
Sildenafil Sandoz 25 mg
Light blue tablets, round in shape, slightly mottled, with a single score line on one side and engraved "25" on the other.
Sildenafil Sandoz 50 mg
Light blue tablets, round in shape, slightly mottled, with a cross-score on one side and engraved "50" on the other.
Sildenafil Sandoz 100 mg
Light blue tablets, round in shape, slightly mottled, with cross-score on both sides and engraved "100" on one side.
Available in packs of 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Lek Pharmaceuticals d.d.
Trimlini 2D, 9220
Lendava
Slovenia
or
Lek Pharmaceuticals d.d.
Verovska, 57
SLO-1526 Ljubljana,
Slovenia
or
Lek S.A.
Domaniewska 50 C
02-672 Warsaw
Poland
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:
Austria | Sildenafil Sandoz 50 mg – Tablets Sildenafil Sandoz 100 mg – Tablets |
Belgium | Sildenafil Sandoz 25 mg tablets Sildenafil Sandoz 50 mg tablets Sildenafil Sandoz 100 mg tablets |
Denmark | Sildenafil "1A Farma" tablets |
Estonia | Sildenafil Sandoz 50 mg Sildenafil Sandoz 100 mg |
Finland | Sildenafil Sandoz 50 mg tablet Sildenafil Sandoz 100 mg tablet |
France | SILDENAFIL SANDOZ 25 mg, tablet SILDENAFIL SANDOZ 50 mg, tablet SILDENAFIL SANDOZ 100 mg, tablet |
Greece | Sildenafil/Sandoz 50 mg tablets Sildenafil/Sandoz 100 mg tablets |
Hungary | Sildenafil Sandoz 50 mg tablet Sildenafil Sandoz 100 mg tablet |
Italy | SILDENAFIL SANDOZ 25 mg tablets SILDENAFIL SANDOZ 50 mg tablets SILDENAFIL SANDOZ 100 mg tablets |
Latvia | Sildenafil Sandoz 100 mg tablets |
Lithuania | Sildenafil Sandoz 50 mg tablets Sildenafil Sandoz 100 mg tablets |
Malta | SILDENAFIL SANDOZ 25 MG TABLETS SILDENAFIL SANDOZ 50 MG TABLETS SILDENAFIL SANDOZ 100 MG TABLETS Sildenafil Sandoz 100 mg Tablets |
Netherlands | Sildenafil Sandoz 25 mg, tablets Sildenafil Sandoz 50 mg, tablets Sildenafil Sandoz 100 mg, tablets |
Poland | SILDENAFIL SANDOZ, 100 MG, TABLETS |
Portugal | Sildenafil Sandoz 25 mg Tablet Sildenafil Sandoz 50 mg Tablet Sildenafil Sandoz 100 mg Tablet |
Slovakia | Sildenafil Sandoz 100 mg tablets |
Sweden | Sildenafil 1A Farma 50 mg tablet Sildenafil 1A Farma 100 mg tablet |
United Kingdom (Northern Ireland) | Sildenafil Sandoz 25 mg tablets Sildenafil Sandoz 50 mg tablets Sildenafil Sandoz 100 mg tablets |
Czech Republic | Sildenafil Sandoz 50 mg tablets Sildenafil Sandoz 100 mg tablets |
Date of the most recent review of this leaflet: August 2022
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/