ADCIRCA is a treatment for pulmonary arterial hypertension.
ADCIRCA 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.
|Table of Contents|
|What do you have to consider before using it?|
|How is it used?|
|What are possible side effects?|
|How should it be stored?|
Do NOT take ADCIRCA if you:
- are allergic (hypersensitive) to tadalafil or any of the other ingredients (see Section 6 and end of Section 2).
- are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain. ADCIRCA 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 ever had loss of vision ? a condition described as ?stroke of the eye? (non-arteritic anterior ischemic optic neuropathy - NAION).
- have had a heart attack in the last 3 months
- have low blood pressure
ADCIRCA is not intended for use by children and adolescents under the age of 18.
Take special care with ADCIRCA
Before taking the tablets, tell your doctor if you have:
- any heart problems other than your pulmonary hypertension
- problems with your blood pressure
- any hereditary eye disease
- an abnormality of red blood cells (sickle cell anaemia)
- cancer of the bone marrow (multiple myeloma)
- cancer of the blood cells (leukaemia)
- any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours
- a serious liver problem
- a severe kidney problem.
If you experience sudden decrease or loss of vision, contact your doctor immediately.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without prescription.
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:
- bosentan (another treatment for pulmonary aterial hypertension)
- nitrates (for chest pain)
- alpha blockers used to treat high blood pressure or prostate problems.
- rifampicin (to treat bacterial infections)
- ketoconazole tablets (to treat fungal infections)
- ritonavir (for HIV treatment)
- tablets for erectile dysfunction (PDE5 inhibitors).
Taking ADCIRCA with food and drink
These 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 ADCIRCA, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
Pregnancy and breastfeeding
If you are pregnant, or think you might be pregnant, tell your doctor as soon as possible. Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor. Do not breastfeed 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 breastfeeding.
Driving and using machines
Dizziness has been reported. Check carefully how you react to the medicines before driving or using any machinery.
Important information about some of the ingredients of ADCIRCA:
Lactose ? if you know you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take ADCIRCA exactly as your doctor has told you. You should check with him/her if you are unsure.
ADCIRCA is supplied as a 20 mg tablet. 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.
Swallow the tablets whole with a drink of water. The tablets can be taken with or without food.
If you take more ADCIRCA than you should
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.
If you forget to take ADCIRCA
Take your dose as soon as you remember but do NOT take a double dose to make up for the one that you have forgotten.
If you stop taking ADCIRCA
Do not stop taking your tablets, unless advised otherwise by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, ADCIRCA can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
The following side effects have been reported:
Very common (seen in more than 1 in every 10 patients)
- 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).
Common (seen in 1 to 10 in every 100 patients)
- blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, allergic reactions (including skin rashes), swelling of the face, acid reflux, migraine, chest pain and irregular heartbeat.
Uncommon (seen in 1 to 10 in every 1000 patients)
- seizures, passing memory loss, hives, excessive sweating, prolonged and possibly painful erection, high blood pressure, fast heart rate and sudden cardiac death.
PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely reported:
- Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. Sudden decrease or loss of hearing has also been 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:
- swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
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.
Effects were seen in one animal species that might indicate impairment of fertility in men. Subsequent studies in man suggest that this effect is unlikely; however a decrease in sperm concentration was seen in some men.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use ADCIRCA after the expiry date stated on the carton and blister.
Store in the original package in order to protect from moisture. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What ADCIRCA contains
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.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.
What ADCIRCA looks like and contents of the pack
ADCIRCA 20 mg comes as orange film-coated 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 and Manufacturer
Marketing Authorisation Holder: Eli Lilly Nederland B.V.,Grootslag 1-5, NL-3991 RA, Houten, The Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
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