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The product code(s) for this leaflet is: PLGB 14895/0236.
Cialis 5mg film-coated tablets
CIALIS®5 mg film-coated tablets
tadalafil
1. What CIALIS is and what it is used for
2. What you need to know before you take CIALIS
3. How to take CIALIS
4. Possible side effects
5 How to store CIALIS
6. Contents of the pack and other information
CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
CIALIS 5 mg is used to treat adult men with:
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.
Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with CIALIS for benign prostatic hyperplasia. CIALIS does not treat prostate cancer.
Before taking the tablets, tell your doctor if you have:
It is not known if CIALIS is effective in patients who have had:
If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking CIALIS, 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:
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.
Drinking alcohol 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.
The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS. This will be given as a 2.5mg tablet.
Do not take CIALIS more than once a day.
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. Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.
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.
The dose is one 5 mg tablet taken once a day at approximately the same time of the day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.
Do not take CIALIS more than once a day.
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.
Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
Uncommon (seen in 1 to 10 in every 1,000 patients)
Rare (seen in 1 to 10 in every 10,000 patients)
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:
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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 25°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.
CIALIS 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side.
CIALIS 5 mg is available in blister packs containing 14, 28 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in August 2023.
CI047