Sildenafil Aurobindo Italia
Italy
Patient Information Leaflet
Sildenafil Aurobindo Italia 20 mg film-coated tablets
Sildenafil
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.
- Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Sildenafil Aurobindo Italia is and what it is used for
- What you need to know before taking Sildenafil Aurobindo Italia
- How to take Sildenafil Aurobindo Italia
- Possible side effects
- How to store Sildenafil Aurobindo Italia
- Contents of the pack and other information
1. What Sildenafil Aurobindo Italia is and what it is used for
Sildenafil Aurobindo Italia contains the active substance sildenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil Aurobindo Italia reduces blood pressure in the lungs by dilating the pulmonary blood vessels.
Sildenafil Aurobindo Italia is used to treat adults, children, and adolescents aged 1 to 17 years with high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension).
2. What you should know before taking Sildenafil Aurobindo Italia
Do not take Sildenafil Aurobindo Italia
- if you are allergic to sildenafil or to any of the other ingredients of this medicine
- (listed in section 6).
- if you are taking medicines containing nitrates or nitric oxide donors, such as amyl nitrate ("poppers"). These medicines are often used to relieve chest pain attacks (or "angina pectoris"). Sildenafil Aurobindo Italia can cause a significant increase in the effects of these medicines. Inform your doctor if you are taking any of these medicines. If you have any doubts, consult your doctor or pharmacist.
- 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 secondary to blood clots). PDE5 inhibitors, such as Sildenafil Aurobindo Italia, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
- if you have recently had a stroke, a heart attack, or if you have severe liver disease or very low blood pressure (< 90/50 mmHg).
- if you are taking a medicine to treat fungal infections, such as ketoconazole or itraconazole, or medicines containing ritonavir (for HIV).
- if you have previously experienced vision loss caused by reduced blood flow to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil Aurobindo Italia if:
- the condition is due to obstruction or narrowing of a pulmonary vein rather than an artery.
- you have a serious heart condition.
- you have problems with the heart ventricles.
- you have high blood pressure in the blood vessels of the lungs.
- you have low blood pressure while at rest.
- you are losing large amounts of body fluids (dehydration), which may occur when you sweat excessively or do not drink enough fluids. This may happen if you are ill with fever, vomiting, or diarrhea.
- you have a rare inherited eye disease (retinitis pigmentosa).
- you have a red blood cell disorder (sickle cell anemia), a blood cell tumor (leukemia), a bone marrow tumor (multiple myeloma), or any disease or deformity of the penis.
- you currently have a stomach ulcer, a bleeding disorder (such as hemophilia), or nosebleeds.
- you are taking medicines for erectile dysfunction.
When PDE5 inhibitors, including sildenafil, have been used to treat erectile
dysfunction (ED), the following vision-related adverse effects have been reported, with unknown frequency:
partial, sudden, temporary or permanent reduction or loss of vision in one or both eyes.
If you experience sudden decrease or loss of vision, stop taking Sildenafil
Aurobindo Italia and contact your doctor immediately (see also section 4).
Prolonged and sometimes painful erections have been reported in men after taking sildenafil. If
you have an erection lasting continuously for more than 4 hours, stop taking Sildenafil
Aurobindo Italia and contact your doctor immediately (see also section 4).
Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you must inform your doctor, as a dose adjustment may be necessary.
Children
Sildenafil Aurobindo Italia must not be administered to children under 1 year of age.
Other medicines and Sildenafil Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
- Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrate ("poppers"). These medicines are often used to relieve angina pectoris or "chest pain" (see section 2. What you should know before taking Sildenafil Aurobindo Italia).
- Inform your doctor or pharmacist if you are already taking riociguat.
- Treatments for pulmonary hypertension (e.g. bosentan, iloprost).
- Medicines containing St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used for epilepsy).
- Medicines that inhibit blood coagulation (e.g. warfarin), although no adverse effect has been observed.
- Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as a dose adjustment may be required.
- Treatment with alpha-blockers (e.g. doxazosin) for high blood pressure or prostate problems, as the combination of these two medicines may cause symptoms leading to low blood pressure (e.g. dizziness, lightheadedness).
Sildenafil Aurobindo Italia with food, drinks and alcohol
You must not drink grapefruit juice while being treated with Sildenafil Aurobindo Italia.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Sildenafil Aurobindo Italia must not be taken during pregnancy unless absolutely necessary.
Sildenafil Aurobindo Italia must not be administered to women of childbearing age unless they are using adequate contraceptive methods.
Stop breastfeeding when starting treatment with Sildenafil Aurobindo Italia. Sildenafil Aurobindo
Italia must not be administered to women during breastfeeding because it is not known whether the
medicine passes into breast milk.
Driving and using machines
Sildenafil Aurobindo Italia may cause dizziness and may affect vision. Before driving or operating
machinery, you should be aware of how you react to this medicine.
Sildenafil Aurobindo Italia contains lactose
Sildenafil Aurobindo Italia film-coated tablets contain lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, such as lactose, contact your doctor before taking this medicine.
3. How to take Sildenafil Aurobindo Italia
Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
For adults, the recommended dose is 20 mg three times a day (taken 6–8 hours apart), with or without food.
Use in children and adolescents
For children and adolescents aged 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg, or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food. Higher doses must not be used in children. This medicine should only be used when administering 20 mg three times a day. Other pharmaceutical forms may be more appropriate for administration to patients weighing ≤ 20 kg and to younger patients who are unable to swallow tablets.
If you take more Sildenafil Aurobindo Italia than you should
Do not take more medicine than prescribed by your doctor.
If you take more medicine than prescribed, contact your doctor immediately.
Taking more Sildenafil Aurobindo Italia than recommended may increase the risk of known side effects.
If you forget to take Sildenafil Aurobindo Italia
If you forget to take Sildenafil Aurobindo Italia, take the missed dose as soon as you remember, then continue taking the medicine at your usual times. Do not take a double dose to make up for the forgotten dose.
If you stop taking Sildenafil Aurobindo Italia
Stopping treatment with Sildenafil Aurobindo Italia suddenly may cause your symptoms to worsen. Do not stop treatment with Sildenafil Aurobindo Italia unless your doctor tells you to. Your doctor may advise you to gradually reduce the dose over several days before stopping treatment completely.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience any of the following side effects, you must stop taking Sildenafil Aurobindo Italia and contact your doctor immediately (see also section 2):
- sudden decrease or loss of vision (frequency not known)
- an erection that lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported after taking sildenafil (frequency not known).
Adults
Very commonly reported side effects (may affect more than 1 in 10 people) have been headache, facial flushing, indigestion, diarrhoea, and pain in the arms or legs.
Commonly reported side effects (may affect up to 1 in 10 people) include:
subcutaneous infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, prickling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, visual disturbances, blurred vision, light sensitivity, disturbances in colour perception, eye irritation, red/bloodshot eyes, dizziness, bronchitis, nosebleeds, runny nose, cough, nasal congestion, stomach inflammation, gastroenteritis, heartburn, haemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.
Uncommonly reported side effects (may affect up to 1 in 100 people) include:
reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, blood in the semen and/or urine, and breast enlargement in men.
Rash, sudden decrease or loss of hearing, and decreased blood pressure have also been reported, with frequency not known (frequency cannot be estimated from the available data).
Children and adolescents
The following serious adverse events have been commonly reported (may affect up to 1 in 10 people): pneumonia, heart failure, right-sided heart failure, heart-related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral gastroenteritis, urinary tract infection, and dental caries.
The following serious adverse events considered related to treatment have been reported uncommonly (may affect up to 1 in 100 people): allergic reactions (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to breathing problems.
Very commonly reported side effects (may affect more than 1 in 10 people) were:
headache, vomiting, sore throat, fever, diarrhoea, influenza, and nosebleeds.
Commonly reported side effects (may affect up to 1 in 10 people) were:
nausea, increased number of erections, pneumonia, and runny nose.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store Sildenafil Aurobindo Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister, following Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Sildenafil Aurobindo Italia contains
- The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as sildenafil citrate).
- The other components are:
Tablet core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
Tablet coating: lactose monohydrate, hypromellose (2910) 15 cP, titanium dioxide (E171), triacetin.
Description of the appearance of Sildenafil Aurobindo Italia and pack contents
Film-coated tablet.
White, round (6.6 mm in diameter), biconvex, film-coated tablets, marked with "20" on one side and smooth on the other side.
Sildenafil Aurobindo Italia tablets are available in blisters containing 28, 30, or 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, Ruislip
HA4 6QD
United Kingdom
Arrow Génériques
26 avenue Tony Garnier
69007 Lyon – France
France
This medicinal product is authorised in EEA Member States under the following names
Belgium: Sildenafil AB 20 mg filmomhulde tabletten
Czech Republic: Sildenafil Aurobindo Italia
France: SILDENAFIL ARROW 20 mg, comprimé pelliculé
Germany: Sildenafil PUREN PAH 20 mg Filmtabletten
Italy: Sildenafil Aurobindo Italia
Netherlands: Sildenafil Aurobindo 20 mg, filmomhulde tabletten
Poland: Sildenafil Aurobindo Italia
Portugal: Sildenafil Aurobindo Italia
Spain: Sildenafilo Aurovit 20 mg comprimidos recubiertos con película EFG
This Patient Information Leaflet was last reviewed on