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Tadalafil 10mg film-coated tablets
Tadalafil 10mg film-coated tablets
1 What Tadalafil is and what it is used for
2 What you need to know before you take Tadalafil
3 How to take Tadalafil
4 Possible side effects
5 How to store Tadalafil
6 Contents of the pack and other information
Tadalafil 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. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Tadalafil contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil 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. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil 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.
Talk to your doctor or pharmacist before taking Tadalafil.
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:
It is not known if Tadalafil is effective in patients who have had:
If you experience sudden decrease or loss of vision, stop taking Tadalafil 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 Tadalafil and contact your doctor immediately.
Tadalafil is not intended for use by women.
Tadalafil 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 Tadalafil if you are already taking nitrates.
Some medicines may be affected by Tadalafil or they may affect how well Tadalafil 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 Tadalafil will work and should be taken with caution. Talk to your doctor for further information.
A reduction in sperm was seen in some men and reduced sperm development was seen during testing, in dogs. These effects are unlikely to lead to a lack of fertility.
Some men taking Tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines. If you experience side effects which may affect your ability to drive or operate machinery safely, then do not do either of these activities until the effects have completely disappeared.
If you have been told by your doctor you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tadalafil 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 10mg tablet before sexual activity. If the effect of this dose is too weak your doctor may increase the dose to 20mg. Tadalafil tablets are for oral use.
You may take a Tadalafil tablet at least 30 minutes before sexual activity.
Tadalafil may still be effective up to 36 hours after taking the tablet.
Tadalafil 10mg and 20mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil 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 Tadalafil, avoid excessive drinking (blood alcohol level of 0.08% or greater, which equates to approximately 4 units of alcohol for a man of average weight), since this may increase the risk of dizziness when standing up.
Contact your doctor. You may experience side effects described in section 4.
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 (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Heart attack and stroke have also been reported rarely in men taking Tadalafil. 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 (may affect up to 1 in 1000 people) have been reported in men taking Tadalafil that were not seen in clinical trials.
The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil.
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 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.
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. This medicine does not require any special temperature storage conditions.
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.
Tablet core: lactose monohydrate (see end of section 2), hydroxypropyl cellulose (E463), croscarmellose sodium (E468), sodium lauryl sulfate, povidone K-25, silica colloidal anhydrous, magnesium stearate (E572).
Film-coat: hypromellose (E464), titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172).
Tadalafil 10mg is a yellow to light yellow round film-coated tablet with ‘338’ imprinted on one side.
Tadalafil 10mg is available in blister packs containing 2, 4, 8, 10, or 12 tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in 01/2023.