Cialis
tadalafil
tadalafil
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What CIALIS is and what it is used for
What you need to know before you take CIALIS
How to take CIALIS
Possible side effects
5 How to store CIALIS
6. Contents of the pack and other information
CIALIS is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction.
It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). CIALIS has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
have serious heart disease or recently had a heart attack within the last 90 days.
recently had a stroke within the last 6 months.
have low blood pressure or uncontrolled high blood pressure.
ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
are taking riociguat. This drug 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 CIALIS, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Talk to your doctor before taking CIALIS.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
sickle cell anaemia (an abnormality of red blood cells).
multiple myeloma (cancer of the bone marrow).
leukaemia (cancer of the blood cells).
any deformation of your penis.
a serious liver problem.
a severe kidney problem.
It is not known if CIALIS is effective in patients who have had:
pelvic surgery.
removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non- nerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking CIALIS and contact your doctor immediately.
Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking CIALIS and contact your doctor immediately.
CIALIS is not intended for use by women.
CIALIS is not intended for use by children and adolescents under the age of 18.
Tell your doctor if you are taking, have recently taken or might take any other medicines
Do not take CIALIS if you are already taking nitrates.
Some medicines may be affected by CIALIS or they may affect how well CIALIS will work. Tell your doctor or pharmacist if you are already taking:
an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
other medicines to treat high blood pressure.
riociguat.
a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin , clarithromycin or itraconazole.
other treatments for erectile dysfunction.
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to your doctor for further information.
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.
Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
CIALIS tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
Do not take CIALIS more than once a day.
Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.
When taken once a day CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner
will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.
Contact your doctor. You may experience side effects described in section 4.
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take CIALIS more than once a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
allergic reactions including rashes (frequency uncommon).
chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
priapsim, a prolonged and possibly painful erection after taking CIALIS (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
sudden loss of vision (frequency rare). Other side effects have been reported:
headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Heart attack and stroke have also been reported rarely in men taking CIALIS. Most of these men had known heart problems before taking this medicine.
Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
migraine, swelling of the face, serious allergic reaction which causes swelling of the face or
throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture. Do not store above 30°C.
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 protect the environment.
The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
The other ingredients are:
CIALIS 2.5 mg is a light orange-yellow film-coated tablet in the shape of an almond and has "C 2 ½" marked on one side.
CIALIS 2.5 mg is available in blister packs containing 28 tablets.
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
ELI LILLY ČR, s.r.o. Tel: + 420 234 664 111
Eli Lilly Danmark A/S Tlf: +45 45 26 60 00
Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222
Eli Lilly Lietuva
Tel. +370 (5) 2649600
Lilly Hungária Kft. Tel: + 36 1 328 5100
Charles de Giorgio Ltd. Tel: + 356 25600 500
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Eli Lilly Nederland B.V. Tel: +372 6 817 280
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600
Lilly S.A.
Tel: + 34-91 663 50 00
Lilly France
Tél: +33-(0) 1 55 49 34 34
Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999
Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377
Icepharma hf.
Sími: + 354 540 8000
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Phadisco Ltd
Τηλ: +357 22 715000
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Tel: +371 67364000
Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780
Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00
Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600
Eli Lilly România S.R.L. Tel: + 40 21 4023000
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800