Sildenafil sandoz
Poland
Table of Contents
Package leaflet: Information for the user
Sildenafil Sandoz, 100 mg, tablets
Sildenafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- Ask your doctor or pharmacist if you have any further questions.
- This medicine has been prescribed for a specific individual and must not be passed on to others. It may harm other people, even if their symptoms are the same.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Sildenafil Sandoz is and what it is used for
- Before you take Sildenafil Sandoz
- How to take Sildenafil Sandoz
- Possible side 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. The medicine works by helping to relax the blood vessels in the penis, allowing increased blood flow into the penis during sexual stimulation.
Sildenafil Sandoz helps achieve an erection only if there is prior sexual stimulation.
Sildenafil Sandoz is used to treat erectile dysfunction in adult men, i.e. impotence defined as the inability to obtain or maintain an erection sufficient for sexual intercourse.
2. Before you take 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);
- you are taking nitrates, as their concomitant use may cause potentially dangerous lowering of blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve symptoms of angina (chest pain). If in doubt, consult your doctor or pharmacist;
- you are taking any medicines that release nitric oxide, such as amyl nitrite (known as “poppers”), as their concomitant use may also cause dangerous lowering of blood pressure;
- you are taking riociguat – a medicine used to treat pulmonary arterial hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as Sildenafil Sandoz have been shown to enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat (or are unsure), inform your doctor;
- you have severe heart or liver disease;
- you have recently had a stroke or heart attack, or if you have low blood pressure;
- you have inherited degenerative retinal disorders such as retinitis pigmentosa;
- you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and precautions
Before starting Sildenafil Sandoz, discuss with your doctor, pharmacist, or nurse if you have:
- sickle cell anaemia (an abnormality of red blood cells),
- leukaemia (a blood cancer), multiple myeloma (a cancer of the bone marrow);
- penile deformity or Peyronie’s disease;
- heart function disorders. Your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity;
- stomach ulcer or bleeding disorders (such as haemophilia).
If you experience sudden worsening of vision or sudden vision loss, stop taking Sildenafil Sandoz and contact your doctor immediately.
Do not take Sildenafil Sandoz together with other oral or locally administered treatments for erectile dysfunction.
Do not take Sildenafil Sandoz together with medicines used to treat pulmonary arterial hypertension that contain sildenafil or other phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil Sandoz should not be used in the absence of erectile dysfunction.
Sildenafil Sandoz is not intended for use in women.
Special considerations for patients with kidney or liver impairment
Patients with impaired kidney or liver function should inform their doctor, who may decide to prescribe a lower dose of Sildenafil Sandoz.
Children and adolescents
Sildenafil Sandoz must not be used in individuals under 18 years of age.
Sildenafil Sandoz and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Sildenafil Sandoz tablets may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and requires urgent medical attention, inform your doctor, pharmacist, or nurse that you have taken Sildenafil Sandoz and specify when it was taken. Do not take Sildenafil Sandoz with other medicines without your doctor’s approval.
Do not take Sildenafil Sandoz if you are using nitrates, as this combination may cause dangerous lowering of blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking such medicines, which are often used to relieve symptoms of angina (chest pain).
Do not take Sildenafil Sandoz if you are using medicines that release nitric oxide, such as amyl nitrite (known as “poppers”), as this combination may cause dangerous lowering of blood pressure.
If you are already taking riociguat, inform your doctor or pharmacist.
For patients taking protease inhibitors used in the treatment of HIV infection, your doctor may decide to start treatment with the lowest initial dose of Sildenafil Sandoz (25 mg).
In some individuals taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness due to low blood pressure may occur when standing up or sitting down quickly. Such symptoms have been reported in some individuals taking Sildenafil Sandoz together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking Sildenafil Sandoz. To reduce the risk of such symptoms, ensure you are taking a stable dose of your alpha-blocker before starting Sildenafil Sandoz. Your doctor may decide to start treatment with a 25 mg dose of Sildenafil Sandoz.
Inform your doctor or pharmacist if you are currently taking, have recently taken, or plan to take any other medicines containing sacubitril/valsartan, used in the treatment of heart failure.
Taking Sildenafil Sandoz with food, drink and alcohol
Sildenafil Sandoz can be taken with or without food, although taking it with a heavy meal may delay the onset of action.
Alcohol may temporarily impair the ability to achieve an erection. To maximise the therapeutic effect of Sildenafil Sandoz, avoid consuming large amounts of alcohol before taking the medicine.
Pregnancy, breast-feeding and fertility
Sildenafil Sandoz is not intended for use in women.
Driving and using machines
Sildenafil Sandoz may cause dizziness and visual disturbances. Before driving or operating machinery, you should assess how this medicine affects you.
Sildenafil Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered to be “sodium-free”.
3. How to use Sildenafil Sandoz
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Sildenafil Sandoz more than once a day.
Do not take Sildenafil Sandoz tablets together with other sildenafil-containing medicines
that dissolve in the mouth.
Take a Sildenafil Sandoz tablet approximately one hour before planned sexual activity.
Swallow the tablet whole without chewing or crushing, with a glass of water.
The tablet may be divided into four equal parts.
Dividing tablets
Place the tablet on a hard, flat surface with the deeper dividing line facing upwards.
Press your thumbs on the centre of the tablet to break it into four equal parts.
If you feel the effect of Sildenafil Sandoz is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Sandoz enables an erection only in the presence of sexual stimulation.
The time until Sildenafil Sandoz takes effect varies between patients, but usually ranges from
half an hour to one hour. The effect may occur later if the medicine is taken with a heavy meal.
If an erection does not occur after taking Sildenafil Sandoz, or if the duration of erection is not
sufficient for sexual intercourse, inform your doctor.
Taking more than the recommended dose of Sildenafil Sandoz
This may increase both the frequency and severity of adverse effects. Taking a dose higher than
100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than prescribed by your doctor.
If you have taken more tablets than recommended, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor,
pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects associated with the use of Sildenafil Sandoz are usually mild to
moderate and transient.
If any of the serious adverse effects listed below occur,
discontinue use of Sildenafil Sandoz immediately and seek medical help without delay.
Allergic reaction – occurs not frequently (may occur in fewer than 1 in 100 people)
Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain – occurs not frequently
If chest pain occurs during or after sexual intercourse:
- adopt a semi-sitting position and try to relax,
- under no circumstances should nitrates be taken to relieve chest pain.
Prolonged and sometimes painful erection – occurs rarely (may occur in fewer than 1 in 1000 people).
If erection lasts longer than 4 hours, contact a doctor immediately.
Sudden worsening or loss of vision – occurs rarely
Severe skin reactions – occur rarely.
Symptoms may include severe peeling and swelling of the skin, formation of blisters inside the mouth, genital organs and around the eyes, fever.
Seizures or convulsions – occur rarely.
Other adverse effects
Very common (may affect more than 1 in 10 people)
headache.
Common (may affect fewer than 1 in 10 people)
nausea,
sudden flushing of the face,
hot flushes (sudden sensation of heat in the upper body),
dyspepsia,
seeing coloured halos,
blurred vision,
visual disturbances,
nasal congestion,
dizziness.
Not common (may affect fewer than 1 in 100 people)
vomiting,
skin rash,
eye irritation, eye redness/bloodshot eyes, eye pain, perception of flashing lights,
photosensitivity, lacrimation,
palpitations, rapid heartbeat,
high or low blood pressure,
muscle pain,
drowsiness,
reduced sense of touch,
balance disorders,
tinnitus,
dryness of the mouth,
sensation of blocked sinuses, inflammation of the nasal mucosa (with symptoms such as runny nose, sneezing and blocked nose),
upper abdominal pain, gastroesophageal reflux disease (including heartburn),
presence of blood in urine,
pain in arms or legs,
nosebleeds,
sensation of warmth,
feeling of fatigue.
Rare (may affect fewer than 1 in 1000 people)
fainting,
stroke, myocardial infarction, irregular heartbeat,
transient reduction in blood flow to certain parts of the brain,
throat tightness,
oral numbness,
retinal haemorrhage, double vision, reduced visual acuity,
abnormal sensation in the eye, swelling of the eye or eyelid, perception of floaters or spots, seeing halos around light sources, pupil dilation, discolouration of the sclera,
penile bleeding,
presence of blood in semen,
nasal dryness,
swelling of nasal mucosa,
irritability,
sudden hearing loss or hearing impairment.
Since sildenafil has been marketed, rare cases of unstable angina (a symptom of heart disease) and sudden death have been reported. In most patients (although not all), pre-existing cardiac conditions were present prior to administration of Sildenafil Sandoz. It is not possible to determine whether these events were directly related to the use of Sildenafil Sandoz.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301/fax: + 48 22 49 21 309/website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.
5. How to store Sildenafil Sandoz
Keep this medicine out of sight and reach of children.
There are no special requirements for storage conditions.
Do not use Sildenafil Sandoz after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Sildenafil Sandoz contains
The active substance is sildenafil.
Each tablet contains 100 mg of sildenafil (as citrate).
The other ingredients are: calcium hydrogen phosphate anhydrous, microcrystalline cellulose,
copovidone, sodium croscarmellose, magnesium stearate, sodium saccharin, indigotine (E132),
aluminium lake of lac dye.
What Sildenafil Sandoz looks like and contents of the pack
Sildenafil Sandoz 100 mg are blue, round, slightly mottled tablets, with criss-cross score lines on both sides and the imprint "100" on one side.
The medicine is available in blisters containing 1, 2, 4, 8 or 12 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturers:
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
S.C. Sandoz, S.R.L.
7A Livezeni Street
540472 Targu Mures,
Jud. Mures, Romania
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
For further information about this medicine and its names in other European Economic Area countries,
please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel: +48 22 209 70 00