Each tablet of Cialis 10mg contains 10 mg of tadalafil.
Each tablet of Cialis 20mg contains 20 mg of tadalafil.
Excipients/Inactive Ingredients: Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see "CIALIS contains lactose" under Precautions.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
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 the patient's penis to relax, allowing the flow of blood into his penis. The result of this is improved erectile function. CIALIS will not help if the patient does not have erectile dysfunction.
It is important to note that CIALIS does not work if there is no sexual stimulation. The patient and his partner will need to engage in foreplay, just as the patient would if he is not taking a medicine for erectile dysfunction.
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.
Always take this medicine exactly as the doctor has told the patient. Check with the doctor or pharmacist if the patient is 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.
The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak the doctor may increase the dose to 20 mg. CIALIS tablets are for oral use.
The patient may take a CIALIS tablet at least 30 minutes before sexual activity.
CIALIS may still be effective up to 36 hours after taking the tablet.
Do not take CIALIS more than once a day. CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that CIALIS does not work if there is no sexual stimulation. The patient and his partner will need to engage in foreplay, just as the patient would if he is not taking a medicine for erectile dysfunction.
Drinking alcohol may affect the ability to get an erection and may temporarily lower the blood pressure. If the patient has taken or is 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.
If the patient takes more CIALIS than he should, contact the doctor. He may experience side effects described in Side Effects.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not take CIALIS if the patient: is allergic to tadalafil or any of the other ingredients of this medicine (listed in Description).
Is 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 the patient is taking any form of nitrate or is unsure, tell the 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".
Is 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 the patient is taking riociguat or is unsure, tell the doctor.
Talk to the 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 the heart. If the patient has a heart problem, they should tell their doctor.
Before taking the tablets, tell the doctor if the patient has: sickle cell anaemia (an abnormality of red blood cells); multiple myeloma (cancer of the bone marrow); leukaemia (cancer of the blood cells); any deformation on the 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 the patient experience sudden decrease or loss of vision, stop taking CIALIS and contact the 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 the patient experience decreased or sudden hearing loss, stop taking CIALIS and contact the doctor immediately.
CIALIS is not intended for use by women.
Fertility: 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.
CIALIS contains lactose: If the patient has been told by his doctor that he has an intolerance to some sugars, contact the doctor before taking this medicinal product.
CIALIS contains sodium: This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.
Driving and using machines: Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how the patient reacts to the tablets before driving or using machines.
Use in Children: CIALIS is not intended for use by children and adolescents under the age of 18.
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
If the patient experiences any of the following side effects stop using the medicine and seek medical help immediately: allergic reactions including rashes (frequency uncommon).
Chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
Priapism, a prolonged and possibly painful erection after taking CIALIS (frequency rare). If the patient has such an erection, which lasts continuously for more than 4 hours he should contact a doctor immediately.
Sudden loss of vision (frequency rare).
Other side effects have been reported: Common (seen in 1 to 10 in every 100 patients): headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Uncommon (seen in 1 to 10 in every 1,000 patients): 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.
Rare (seen in 1 to 10 in every 10,000 patients): 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.
Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials. These include: 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.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Drug Office, Department of Health.
Other medicines and CIALIS: Tell the doctor if the patient is taking, have recently taken or might take any other medicines.
Do not take CIALIS if the patient is already taking nitrates.
Some medicines may be affected by CIALIS or they may affect how well CIALIS will work. Tell the doctor or pharmacist if the patient is 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.
CIALIS with drink and alcohol: Information on the effect of alcohol is in Dosage & Administration. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to the doctor for further information.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer in use. These measures will help protect the environment.
Store in the original package in order to protect from moisture. Do not store above 30°C.
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
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