20 mg film-coated tablets
1. What ADCIRCA is and what it is used for
ADCIRCA contains the active substance tadalafil.
ADCIRCA belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5), which improve the blood flow to the lungs by affecting the blood vessels around the lungs so that they relax. The result is improved capacity during physical exertion.
ADCIRCA is a treatment for pulmonary arterial hypertension in adults.
2. What you need to know before taking ADCIRCA
Do not take ADCIRCA if you
– is allergic to tadalafil or any of the other ingredients (see section 6).
– Take medicines containing nitrates, such as amyl nitrite, which are used to treat chest pain. ADCIRCA has been shown to increase the efficacy of these drugs. If you are taking any form of nitrate or are unsure, talk to your doctor.
– has ever before lost sight – a condition called “stroke in the eye” (non-arteritic anterior ischemic optic neuropathy – NAION).
– has had a heart attack in the last 3 months.
– has low blood pressure.
– tar riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension(ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as ADCIRCA, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
Warnings and cautions
Talk to your doctor before taking ADCIRCA.
Before taking the tablets, tell your doctor if you have:
– heart problems other than your high blood pressure in the lungs
– problems with your blood pressure
any hereditary eye disease
– abnormal red blood cells (sickle cell anemia)
– bone marrow cancer (multiple myeloma )
– blood cell cancer ( leukemia )
a deformed penis, or unwanted or persistent erection lasting more than 4 hours
– severe liver disease
– severe kidney disease.
If you experience a sudden visual impairment or loss of vision, contact your doctor immediately.
Impaired hearing or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the events are related to tadalafil, you should contact a doctor immediately if you experience hearing loss or sudden hearing loss.
Other medicines and ADCIRCA
Tell your doctor if you are taking, have recently taken, or might take any other medicines. DO NOT take this medicine if you are already taking nitrates.
Some medicines may be affected by ADCIRCA or they may affect the effect of ADCIRCA. Tell your doctor or pharmacist if you are already taking:
– bosentan (new drugs used to treat pulmonary arterial 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).
ADCIRCA with alcohol
Alcohol intake can temporarily lower your blood pressure. Avoid consuming large amounts of alcohol (over 5 units of alcohol) after taking or planning to take ADCIRCA as this may increase the risk of dizziness when standing up.
Children and young people
ADCIRCA should not be given to children or adolescents under 18 years of age.
Pregnancy, breastfeeding, and fertility
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 using this medicine. Do not use ADCIRCA during pregnancy unless clearly 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 during pregnancy or breast-feeding.
Dogs that were treated had reduced sperm development in the testicles. A decrease in sperm concentration has been demonstrated in some men. Its effects are unlikely to impair male fertility.
Driving and using machines
Dizziness has been reported. Know how you react to the medicine before driving or using machines.
ADCIRCA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
3. How to take ADCIRCA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
ADCIRCA is supplied as a 20 mg tablet. The usual dose is two 20 mg tablets once a day. You should take both tablets at the same time, one after the other. Your doctor may have prescribed you only one 20 mg tablet daily if you have mild to moderate liver or kidney problems.
Swallow the tablets with a little water. You can take the tablets regardless of the meal.
If you use more ADCIRCA than you should
If you or anyone else takes more tablets than you should, contact your doctor or go to the hospital immediately and take the medicine pack with you. You may experience some of the side effects described in section 4.
If you forget to take ADCIRCA
Take a dose as soon as you remember it if it is within 8 hours of you taking your dose. DO NOT take a double dose to make up for a forgotten tablet.
If you stop using ADCIRCA
Do not stop taking your tablets unless your doctor has told you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild or moderate in nature.
If you get any of the following side effects, stop using the medicine and see a doctor immediately:
– allergic reactions with a rash (uncommon).
– chest pain – do not use nitrates but consult a doctor immediately (common).
priapism, prolonged, and possibly painful erection after taking ADCIRCA (uncommon). If you get an erection that lasts continuously for more than 4 hours, you should contact a doctor immediately.
– sudden loss of vision (rare).
The following side effects have been reported very commonly in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, redness, nasal congestion, and blocked sinuses, nausea, indigestion (including abdominal pain), muscle aches, back pain, and pain or discomfort in the arms and bones.
Other side effects have been reported:
Common (may affect up to 1 in 10 users)
- blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal abdominal bleeding, facial swelling, acid regurgitation, migraine, irregular heartbeat, and fainting.
Uncommon (may affect up to 1 in 100 people)
- seizures, temporary memory loss, hives, profuse sweating, bleeding from the penis, presence of blood in semen and/or urine, high blood pressure, palpitations, sudden cardiac death, and tinnitus (sound in the ears without external sound source).
PDE5 inhibitors are also used to treat erectile dysfunction in men. Some side effects are reported rarely:
- Partial, temporary, or permanent vision loss or loss of vision in one or both eyes and severe allergic reaction that causes swelling of the face and throat. Sudden deterioration 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 side effects have not been reported in clinical trials of pulmonary arterial hypertension and therefore the frequency is unknown:
- swollen eyelids, pain in the eyes, red eyes, heart attack, and stroke .
Most but not all men who reported palpitations, irregular heartbeats, heart attacks, strokes, and sudden cardiac death had known heart problems before taking the drug. It is not possible to determine whether these reactions were directly related to tadalafil
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store ADCIRCA
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 or blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive. 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.
6. Contents of the packaging and other information
The active substance is tadalafil. One tablet contains 20 mg of tadalafil.
Other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.
What the medicine looks like and the contents of the pack
ADCIRCA 20 mg tablets are orange and film-coated. They are almond-shaped and marked “4467” on one side.
Marketing Authorization Holder and Manufacturer
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
ADCIRCA 20 mg is supplied in blister packs containing 28 or 56 tablets.
Not all pack sizes may be marketed.
Contact the representative of the marketing authorization holder to find out more about this medicine
Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/