Patient Medication Information: uses, side effects, how to take - Apo-Tadalafil Pah
ABOUT THIS MEDICATION
What the medication is used for:
APO-TADALAFIL PAH is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
What it does:
APO-TADALAFIL PAH belongs to a group of medicines called phosphodiesterase type 5 inhibitors. APO-TADALAFIL PAH works by helping the blood vessels in your lungs to relax, allowing the flow of blood into your lungs. This results in lowering the arterial blood pressure in your lungs.
When it should not be used:
Do not take APO-TADALAFIL PAH if you are taking any medicines that contain nitrates in any form (oral, sublingual [under the tongue], skin-patch, or by inhalation). Similarly, nitrates must never be used by patients who take APO-TADALAFIL PAH. Nitrates are found in many prescription medicines used in the treatment of angina pectoris (chest pain due to heart disease), such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate. If nitrates have previously been prescribed to you, even though you may not have used them, or are unsure, tell your doctor.
If you take APO-TADALAFIL PAH with any nitrate-containing medicines or any other nitrates (e.g., amyl nitrite “poppers”), your blood pressure could suddenly drop to a life-threatening level. You could get dizzy, faint, or even have a heart attack or stroke.
Do not take APO-TADALAFIL PAH if you have had an allergic reaction in the past to tadalafil or other medications that contain tadalafil such as APO-TADALAFIL, or any of the other ingredients in APO-TADALAFIL PAH.
- Do not take APO-TADALAFIL PAH if you have had an eye disease called non-arteritic anterior ischaemic optic neuropathy (NAION) which causes a sudden decrease or loss of vision in one or both eyes.
- Do not take APO-TADALAFIL PAH if you are taking guanylate cyclase stimulators, such as riociguat.
What the medicinal ingredient is:
Tadalafil
What the non-medicinal ingredients are:
Croscarmellose sodium, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, sodium lauryl sulphate and titanium dioxide.
What dosage forms it comes in:
APO-TADALAFIL PAH is supplied as 20 mg orange, almond shaped, biconvex, film-coated tablets. Engraved “APO” on one side, “T20” on the other side. Each tablet of APO-TADALAFIL PAH contains 20 mg of tadalafil.
WARNINGS AND PRECAUTIONS
Before taking APO-TADALAFIL PAH talk to your doctor if you have or had any of the following conditions:
- a disease called pulmonary veno-occlusive disease (PVOD)
- lose a large amount of body fluids (dehydration). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot or don't drink enough liquids.
- heart disease or previously had a heart attack. Patients who experience chest pain or shortness of breath after taking APO-TADALAFIL PAH should not use nitrates and should seek immediate medical attention.
- stroke.
- low blood pressure or uncontrolled high blood pressure.
- liver or kidney problem.
- sickle cell anemia (an abnormality of red blood cells), multiple myeloma (cancer of the bone marrow), or leukemia (cancer of the blood cells).
- deformation of the penis.
- ever had severe loss of vision, including a condition called Non-Arteritic Ischemic Optic Neuropathy (NAION). The specific type of vision decrease or loss known as NAION has been reported rarely after the intake of tadalafil or other
- PDE5 inhibitors. Vision decrease or loss may be partial or complete, in one or very occasionally in both eyes. While in some cases the condition may improve over time, it can also be irreversible. If you are taking APO-TADALAFIL PAH and experience temporary or permanent loss or change in vision, immediately call your doctor.
- retinitis pigmentosa, a rare genetic eye disease.
are pregnant or planning to become pregnant. It is not known if APO-TADALAFIL PAH could harm your unborn baby.
- are breastfeeding. It is not known if APO-TADALAFIL PAH passes into your breast milk or if it could harm your baby.
Long-term studies have shown that tadalafil therapy may decrease sperm concentration in some men. The relevance of this effect on fertility in men is unknown.
Sudden decrease or loss of hearing:
Sudden decrease or loss of hearing has been reported in a few postmarketing and clinical trial cases with the use of PDE5 inhibitors, including tadalafil. It has not been established whether these are related directly to the use of these medications or to other factors. If you experience these symptoms, call your doctor.
Use in children:
APO-TADALAFIL PAH is not intended for use in patients under 18 years of age.
Information for patients intolerant of lactose, one of the ingredients of APO-TADALAFIL PAH:
APO-TADALAFIL PAH contains a small amount of lactose (about 158 mg), which is unlikely to affect you.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including medicines you can buy without prescription and natural health products.
Drugs that may interact with APO-TADALAFIL PAH include:
- nitrates (see previous section)
- rifampin (an antibacterial product used against tuberculosis)
- ketoconazole or itraconazole (used against fungal infections)
- erythromycin (an antibacterial product)
- protease inhibitors such as ritonavir and saquinavir (HIV treatments)
- phenobarbital, phenytoin, carbamazepine.
Tell your doctor if you are taking:
medicines to treat high blood pressure
- alpha-blockers (such as doxazosin) for the treatment of prostate problems.
The combination of these medicines with APO-TADALAFIL PAH may add to the blood-pressure-lowering effect of these drugs.
- Grapefruit juice may affect tadalafil blood levels.
You should not use APO-TADALAFIL PAH together with other medicines containing tadalafil or any other treatments for erectile dysfunction (impotence).
PROPER USE OF THIS MEDICATION
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
How To Take APO-TADALAFIL PAH:
Always take APO-TADALAFIL PAH exactly as your doctor has instructed you. Do not take a higher dose than the one which your doctor prescribed for you. Check with your doctor or pharmacist if you are unsure.
APO-TADALAFIL PAH is a tablet you take by mouth. Take 2 APO-TADALAFIL PAH tablets together (to provide a 40 mg dose) at the same time every day. DO NOT divide the dose over the course of the day.
You may take APO-TADALAFIL PAH with or without food.
Alcohol consumption may temporarily decrease blood pressure.
Overdose:
| If you take too much APO-TADALAFIL PAH, call your doctor or poison control center, or go to an emergency room. |
Missed Dose:
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, APO-TADALAFIL PAH can have some side-effects. These effects are usually mild to moderate in nature.
The most common side effects are headache, muscle pain, facial flushing, nausea, pain in the arms or legs, back pain, upset stomach or heartburn, stuffy or congested nose. If you have any of these side-effects and they are troublesome, severe, or do not go away, tell your doctor.
Allergic reactions (including skin rashes) could occur.
In rare instances it is possible that a prolonged and possibly painful erection may occur after taking APO-TADALAFIL PAH.
If you have such an erection which lasts continuously for more than 4 hours, you should contact a doctor immediately. If this is not treated immediately, permanent penile tissue damage and erectile dysfunction may result.
Sudden decrease or loss of vision has occurred rarely after the use of oral erectile dysfunction medications, including tadalafil. People who have previously experienced a type of vision loss called Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) may be at an increased risk of reoccurrence of NAION. If you experience reduction or loss of vision in one or both eyes, immediately call your doctor.
In case of chest pain or shortness of breath you should NOT use nitrates but you should seek immediate medical assistance.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate and emergency medical attention | |
| Only if severe | In all cases | ||
| Common | |||
| Headache | √ | ||
| muscle pain | √ | ||
| facial flushing | √ | ||
| back pain | √ | ||
| indigestion | √ | ||
| nasal congestion | √ | ||
| Uncommon | |||
| Swelling of eyelids | √ | ||
| eye pain | √ | ||
| allergic reaction | √ | ||
| prolonged erection | √ | ||
| chest pain | √ | ||
| vision loss | √ | ||
| hearing loss | √ | ||
| temporary memory loss (transient global amnesia) | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-TADALAFIL PAH, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of the reach and sight of children.
Store your tablets at controlled room temperature 15°C to 30°C.
Store in the original package.
Do not use after the expiry date.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
If you want more information about APO-TADALAFIL PAH:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website ( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.