20 mg film-coated tablets
tadalafil
What Tadalafil AOP is and what it is used for
Tadalafil AOP contains the active substance tadalafil.
Tadalafil AOP is a treatment for pulmonary arterial hypertension in adults.
Tadalafil AOP belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which improve blood flow to the lungs by causing the blood vessels around the lungs to relax. The result is improved capacity during physical exertion.
Tadalafil contained in Tadalafil AOP may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Tadalafil AOP
Do not take Tadalafil AOP if you
- are allergic to tadalafil or any of the other ingredients (see section 6).
- taking medicines containing nitrates such as amyl nitrite, which are used to treat chest pain. Tadalafil has been shown to increase the effect of these drugs. If you take any form of nitrate or are unsure, talk to your doctor.
- have ever lost their sight – a condition called ‘stroke in the eye (non-arteritic anterior ischemic optic neuropathy – NAION).
- have had a heart attack in the last 3 months.
- have low blood pressure.
- taking 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 tadalafil, have been shown to increase the blood pressure-lowering effect of this drug. If you are taking riociguat or if you are not sure, talk to your doctor.
Warnings and precautions
Talk to your doctor before taking Tadalafil AOP.
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 decrease 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 whether the events are related to tadalafil, you should contact your doctor immediately if you develop hearing impairment or sudden hearing loss.
Children and young people
Tadalafil AOP should not be given to children or adolescents under 18 years of age
Other medicines and Tadalafil AOP
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 can be affected by Tadalafil AOP or they can affect the effect of Tadalafil AOP. Tell your doctor or pharmacist if you are already taking:
- bosentan (another drug used to treat pulmonary arterial hypertension )
- nitrates (for chest pain)
- alpha-blockers are used to treat high blood pressure or prostate problems.
- riociguat
- rifampicin (to treat bacterial infections)
- ketoconazole tablets (to treat fungal infections)
- ritonavir (for HIV treatment)
- tablets for erectile dysfunction (PDE5 inhibitors)
Tadalafil AOP with alcohol
Alcohol intake can temporarily lower your blood pressure. Avoid consuming large amounts of alcohol (over 5 alcohol units) when you have taken or plan to take Tadalafil AOP as this may increase the risk of dizziness when standing up.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Do not use Tadalafil AOP during pregnancy, unless it is necessary and you have discussed it with your doctor.
Do not breastfeed while taking these tablets, as it is not known whether the drug passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Treated dogs had reduced sperm development in the testes. A reduced sperm concentration has been demonstrated in some men. Its effects are unlikely to impair male fertility.
Driving ability and use of machinery
Dizziness has been reported. Feel how you react to the medicine before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure
Tadalafil AOP contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Tadalafil AOP
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Tadalafil AOP is supplied as a 20 mg tablet. The usual dose is two 20 mg tablets once daily. You should take both tablets at the same time, one after the other. Your doctor may have prescribed just 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 a meal.
If you have taken too much Tadalafil AOP
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. You may experience some of the side effects described in section 4.
If you forget to take Tadalafil AOP
Take dose one 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 a missed tablet.
If you stop taking Tadalafil AOP
Do not stop taking your tablets unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor or pharmacist
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop using the medicine and see a doctor immediately:
- allergic reactions with rash (less common).
- chest pain – do not use nitrates but see a doctor immediately (common).
- priapism, prolonged and possibly painful erection after taking Tadalafil AOP (rare). If you get an erection that lasts continuously for more than 4 hours, consult a doctor immediately.
- sudden loss of vision (rare).
The following side effects have been reported as very common in patients taking Tadalafil AOP (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion, nausea, indigestion (including stomach pain), muscle pain, back pain and pain or discomfort in arms and legs.
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 reflux, migraine, irregular heartbeat, and fainting.
Uncommon (may affect up to 1 in 100 users)
- 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 (ringing in the ears without an external sound source).
PDE5 inhibitors are also used to treat erectile dysfunction in men. Some side effects that are rarely reported:
- Partial, temporary, or permanent visual impairment or loss of vision in one or both eyes and severe allergic reaction causing swelling of the face and throat. Sudden deterioration or loss of hearing has also been reported.
Some side effects have been reported by men taking tadalafil for the treatment of erectile dysfunction. These side effects have not occurred 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, of the men who reported palpitations, irregular heartbeats, heart attack, stroke, 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.
How to store Tadalafil AOP
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton or blister card after EXP. The expiry date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tadalafil. One tablet contains 20 mg of tadalafil.
Other ingredients are:
Tablet core: lactose, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, magnesium stearate
Film coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), iron oxide yellow (E172).
Appearance and package sizes of the medicine
Yellow, oval, biconvex, film-coated tablets, debossed with “T 20” on one side and plain on the other with nominal sizes 13.5 mm x 6.6 mm.
Supplied in blister packs containing 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
Manufacturer:
Genepharm SA
18 km Marathon Avenue
15351 Pallini Atticus
Greece
This medicine is approved in the European Economic Area under the names:
| Denmark: | Tadalafil AOP |
| Estonia: | Tadalafil AOP |
| Finland: | Tadalafil AOP 20 mg tabletti, kalvovärvementinen |
| Croatia: | Tadalafil AOP 20 mg filmom obložene tablete |
| Latvia: | Tadalafil AOP 20 mg otālkotās tabletes |
| Lithuania: | Tadalafil AOP 20 mg plėvele dengtos tabletės |
| Netherlands: | Tadalafil AOP 20 mg film-coated tablet |
| Norway: | Tadalafil AOP |
| Austria: | Tadalafil AOP 20 mg Film-coated tablet |
| Poland: | Tadalafil AOP |
| Romania: | Tadalafil AOP 20 mg comprimate filmate |
| Slovakia: | Tadalafil AOP 20 mg filmom obalene tablety |
| Slovenia: | Tadalafil AOP Orphan 20 mg filmsko obložene tablete |
| Sweden: | Tadalafil AOP 20 mg film-coated tablets |
| Czech Republic: | Tadalafil AOP |
| Germany: | Tadalafil AOP 20 mg Film-coated tablet |
| Hungary: | Tadalafil AOP 20 mg film-coated tablet |