The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 14895/0229.
ADCIRCA® 20 mg film-coated tablets
1. What ADCIRCA is and what it is used for
2. What you need to know before you take ADCIRCA
3. How to take ADCIRCA
4. Possible side effects
5 How to store ADCIRCA
6. Contents of the pack and other information
ADCIRCA contains the active substance tadalafil.
ADCIRCA is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above.
It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.
Talk to your doctor before taking ADCIRCA.
Before taking the tablets, tell your doctor if you have:
If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking ADCIRCA, stop taking ADCIRCA 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, contact your doctor immediately.
ADCIRCA is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age because it has not been studied in this age group.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do NOT take these tablets if you are already taking nitrates.
Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work.
Tell your doctor or pharmacist if you are already taking:
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.
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.
Dizziness has been reported. Check carefully how you react to this medicine before driving or using any machinery.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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.
ADCIRCA is supplied as a 20 mg tablet. Swallow the tablet(s) whole with a drink of water. The tablet(s) can be taken with or without food.
Pulmonary arterial hypertension in adults
The usual dose is two 20 mg tablets taken once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.
Pulmonary arterial hypertension in children (age 2 years and above) weighing at least 40 kg
The recommended dose is two 20 mg tablets taken once a day. Both tablets should be taken at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.
Pulmonary arterial hypertension in children (age 2 years and above) weighing less than 40 kg
The recommended dose is one 20 mg tablet taken once a day. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take 10 mg once per day.
Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. You may experience any of the side effects described in section 4.
Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do NOT take a double dose to make up for the one that you have forgotten.
Do not stop taking your tablets, unless advised otherwise by your doctor.
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.
The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)
Other side effects have been reported:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely reported:
Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These events were not seen in clinical trials for pulmonary arterial hypertension and therefore frequency is unknown:
Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:
Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to 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 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 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 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “ADCIRCA contains lactose” and “ADCIRCA contains sodium”.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.
ADCIRCA 20 mg comes as orange film-coated tablets (tablets). They are in the shape of almonds and have "4467" marked on one side.
ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in September 2023.