Sildenafil 25mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR TH E USER
Sildenafil 25 mg film-coated tablets Sildenafil 50 mg film-coated tablets Sildenafil 100 mg film-coated tablets
(Sildenafil citrate)
Read all of this leaflet carefullybefore you start taking this medicine medicine because it contains important information for you.
• Keep l-it leaflet. You may need tr re ad it again.
• If you -ave any -ert-er questions, ask youa ductrr oe p-armacist
• Tlris medicine -as been |0f0!^crili)er for you only Dr not pass it on to others. It may -arm f-fm, omen if their signs of illness are t-k same as yours.
• If you get any side effe cts! ta Ill to you!r h octor oo p-arnnaci st . T'I'i^;. mdud es any possible sih<^ fuffcrs not listed in t-is leaflet. kee kection 4.
What is in this 'eaflet:
1. W-at ki id en afii is anb u-at it I s used fo o 2 W-at you need to know Uefore y^ou tame k^enafil
3. Hou to ^isrke kildenafil
4. Possible side effects
5. Hou tM store kilhenafil
6. Contents onhe |raclf and ot-isr information
1. What Sildenafii is and what itis used for
Sildenafil belongs to a group ofmedicines called p-osp-odi-sterase type 5 !PDE5) inlrib .tor^. ° nofks by -elp in<:) to retem tu e b lood yt,^<i;^!EhE5in you r pen its, ali owing If i ood Uo flow into youri pen is u-en y ou g et sew.. al ly excite d . kilde n afil will oulyi -i)3 lp yo u to get an eeection if yo u are sexually stimulated. You s-ould not take kildenafi! if you do not -aae erectile dysfunction. You s-ould oottake ^^ldena^i^ if7 you are a woman.
kildena0il is atreatment for men wit- erectil-dysUunction, sometimys known as impotenrn. Tipis is w-en a m<i^n cannot get, or keep a -apd, erecU perns
smtable hor sexual antivity.
2. What you need co lfnotu before you take Sildenafil Do not take SUdenafil
• If you ;s me a1 le mg^ to s.kCenafil or any of r-e d tt^uit ing rede nts oh t-l s
melU iciue (listed in sect io n 6).
• If you are taking medicines called nitrates, as t-e com0ination may csuso a potenfially dangerous decrease in kour blood pressure. Tell youm doctor if you are taking any of t-ese medicines, w-ic- are often given for relief of angina |tentohis (os "c-est pam”). If yoa are not nui-tain, ask your doctor or p-anoarist.
• If you are using any of t-e dmgs known as nitric oxine do rfOhs suc- as amyl nitrite ("poppers”), as t-e combination may also lead to a potentially dangerous decrease in your blood prensurel
• If you are allergic (-ypersensitive) to kildenafil or any of t-e ot-er ingredients of kildenafil .
• If you -avaa severe - eaft or liver problem.
• If you o ave recently -ad a stroke or a -eart attarh, or if7 you -ave tow blood pressure.
• If you -sou cei'tam rare in-erited eye diseases (suc- as retinitis pigmentosa).
• If you -avo ever -ad loss of7 v.sion Cke to non-arteritic antedor isc-aemic optic neuropat-y fNCION).
Warnings and precautions
Talk to yo ur do ctor before tea kmg kildenafil
• If you -ave si -We cell anaemia (an abnomiality of red blood cel ls), leukaemia .cancer o^ blood cess), muitlple myeloma (ranner of bone man-ow)
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• If you -ave a deformity of your penis or Peyronie's Disease.
• If you -ave problems wit- your -eart. Your doctor s-ould in t-at case carefully c-eck w-et-er your -eart can take t-e additional strain of -aving sex.
• If you currently -ave a stomac- ulcer, or a bleeding problem (suc- as -aemop-ilia).
• If you experience sudden decrease or loss of vision, stop taking kildenafil and contact your doctor immediately.
You s-ould not use kildenafil wit- any ot-er oral or local treatment for erectile dysfunction.
Children and adolescents
kildenafil s-ould not be given to individuals under t-e age of 18.
Patients with kidney or liver problems
You s-ould tell your doctor if you -ave kidney or liver problems. Your doctor may decide on a lower dose for you.
Other medicines and Sildenafil
Tell your doctor or p-armacist if you are taking, -ave recently taken or mig-t take any ot-er medicines.
kildenafil tablets may interfere wit- some medicines, especially t-ose used to treat c-est pain. In t-e event of a medical emergency, you s-ould tell any -ealt- care professional treating your condition t-at you -ave taken kildenafil and w-en you did. Do not take kildenafil wit- ot-er medicines unless your doctor tells you t-at you can.
You s-ould not take kildenafil if you are taking medicines called nitrates, as t-e combination of t-ese products may cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or p-armacist if you are taking any of t-ese medicines t-at are often used for t-e relief of angina pectoris (or "c-est pain”).
You s-ould not take kildenafil if you are using any of t-e drugs known as nitric oxide donors suc- as amyl nitrite ("poppers”), as t-e combination may lead to a potentially dangerous decrease in your blood pressure.
If you are taking medicines known as protease in-ibitors, suc- as for t-e treatment of HIV, your doctor may start you on t-e lowest dose (25 mg) of kildenafil.
kome patients w-o take alp-a-blocker t-erapy for t-e treatment of -ig- blood pressure or prostate enlargement may experience dizziness or lig-t--eadedness, w-ic- may be caused by low blood pressure upon sitting or standing up quickly. Certain patients -ave experienced t-ese symptoms w-en taking kildenafil wit- alp-a-blockers. T-is is most likely to occur wit-in 4 -ours after taking kildenafil . In order to reduce t-e likeli-ood t-at t-ese symptoms occur, you s-ould be on a regular daily dose of your alp-a-blocker before you start kildenafil . Your doctor may start you on a lower dose (25 mg) of kildenafil .
Sildenafil with food, drink and alcohol
kildenafil can be taken wit- or wit-out food. However, you may find t-at kildenafil takes longer to start working if you take it wit- a -eavy meal.
Drinking alco-ol can temporarily impair your ability to get an erection. To get t-e maximum benefit from your medicine, you are advised not to drink excessive amounts of alco-ol before taking kildenafil.
Pregnancy and breast-feeding
kildenafil is not indicated for use by women.
Driving and using machines
kildenafil can cause dizziness and can affect vision. You s-ould be aware of -ow you react to kildenafil before you drive or use mac-inery.
Sildenafil contains tartrazine
May cause allergic reactions as it contains Tartrazine (E-102). It can worsen ast-ma.
continued overleaf
3. How to take Sildenafil
Always take this medicine exa ctly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual starting dose is £30 mg.
You should not take Sildenafil more than once a day.
You should take Sildenafil about one houryeyore you plan to have sex. Swallowthe tablet whole wiCh a glass of water.
I. you have the impression that the effect of Sildenafil is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil wol only help you tea get an erection .you aoe sexually stimulated. The amount of time Sildenafil takes to work varies from person to person but 10 normally takes between half an hour and one hour. You may find tdah SHden afil takes longer to work if you take itwith a heavy meal.
If SNd enafil does not he lp you to get an erection, or if your ere ction does not last long enough for you to complete sexual mtercourse you should tell your doctor.
If you take p ore Sildenafil than you should:
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.
You should not take more tablets than your doctor teNs you to.
Contact your doctor ifyou take more tablets thanyou should.
If you have any further question. on the use om this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them. The side effecta reported in association wife mhe use of Sildenafil are usually mild to modetate and of short duration.
If you have chest pains during or after intercourse:
• Get in a semi-sitting pomition and try to relax.
• Do not use nitrates to treat: your chest pain
• Contact your doctor immediately.
All medicines including Sildenafil can cause a.lerg.c reactions. You should contact your doctor immediateiy if you experience any o. the following symptoms after taking Sildenafil: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
Prolonged and sometimes paintal ibentons have been reported after taking Sildenafil . If you have an (^i"(^c^ion vfitich lasts for more than 4 hours, you should contact a doctor immediately.
If you experience a sudden decrease or loss od vision, stop taking Sildenafil and contact your doctor immediately.
A very coppon side effect (may affect more than 1 iL 10 people) is headache.
Coppon side effects (may affect up to 1 in "10 p eo ple) include: facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduce d sharpness of vision) stuffy nose and dizziness.
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Uncoppon side effects (may affect up to 1 in 100 people) include: vomiting, skin rash, bleeding at the back oftlm eye, eue imitation, bloodshot eyes /red eyes, eye pain, double vision, ayno1mal sensation in the eye, watery eyes, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, penile bleeding, presence of blood in semen and/or urine, chest pain and feeling tired.
Rare side effects (may affect up to 1 in 1,000 people) include: high blood pressure, low blood pressure, fainting, stroke, heart attack, nosebleed, sudden decrease or loss of hearing and nonnarteritic anterior ischaemic optic neuropathy.
Additional side effects reported from post-marketing experience include: pounding heartbeat, chest pain, sudden death, or temporary decreased blood flow to parts of the brain. Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Sildenafil . Cases of convulsions or seizures and serious skin reactions characterised by rash, blister, peeling skin and pain which require immediate medical attention have also been reported.
Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sildenafil
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other inforpation
What Sildenafil contains
The active substance is sildenafil.
Each film-coated tablet contains 25 mg of sildenafil, as the citrate.
Each film-coated tablet contains 50 mg of sildenafil, as the citrate.
Each film-coated tablet contains 100 mg of sildenafil, as the citrate.
The other ingredients are:
• Tablet core: cellulose powder, colloidal silicon (anhydrous), calcium phosphate dibasic (anhydrous), croscarmellose sodium, magnesium stearate,
• Film coat: hypromellose, titanium dioxide (E171), triacetin, indigotine aluminium lake (E132), brilliant blue aluminium lake (E133), tartrazine aluminium lake (E102)
What Sildenafil looks like and contents of the pack
Sildenafil film-coated tablets are blue, circular and biconvex tablets. The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
aarketing Authorisation Holder:
Strandhaven Ltd t/a Somex Pharma 600 High Road, Seven Kings, Ilford,
Essex, IG3 8BS, United Kingdom
Manufacturer
Lacer S.A.
C/ Boters 5,
R-08290 Cerdanyola del Valles, Spain
This pedicinal product is authorised in the Mepber State of the EEA under the following napes:
Name of the Member State Sildenafil 25 mg film-coated tablets
Sildenafil 50 mg film-coated tablets Sildenafil 100 mg film-coated tablets
This leaflet was last revised in 09/2013
140 mm