Consumer Information for: PMS-TADALAFIL
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
pms-TADALAFIL is used for treatment of
- erectile dysfunction (ED) in men (when a man cannot get, or keep a hard, erect penis suitable for sexual activity).
- the signs and symptoms of benign prostatic hyperplasia (BPH). These symptoms include a frequent need to urinate, a sensation of not emptying the bladder completely, or painful urination. ·
- both ED and the signs and symptoms of BPH.
What it does
pms-TADALAFIL belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Treatment of ED: Following sexual stimulation pms-TADALAFIL
works by helping the blood vessels in your penis to relax, allowing
the flow of blood into your penis. This results in improved erectile
function.
It is important to note that pms-TADALAFIL works only with
sexual stimulation. pms-TADALAFIL alone does not increase
sexual desire.
Treatment of BPH and ED/BPH: pms-TADALAFIL works by
relaxing muscles in the prostate and bladder, which may reduce
BPH symptoms.
When it should not be used
Do not take pms-TADALAFIL:
- 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 men who take pms-TADALAFIL. 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 pms-TADALAFIL with any nitratecontaining 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 pms-TADALAFIL if you have had an allergic reaction in the past to tadalafil or any of the other ingredients in pms-TADALAFIL listed below.
- If you have had a previous episode of an eye condition called NAION which causes a sudden decrease or loss of vision in one or both eyes.
- If you are taking riociguat.
What the medicinal ingredient is
Tadalafil
What the non-medicinal ingredients are
Colloidal silicon dioxide, croscarmellose sodium, FD&C yellow No.6 aluminum lake (for 10 mg), iron oxide black (for 10 mg, 20 mg), iron oxide red (for 2.5 mg), iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer Lutrol, polyethylene glycol, polyvinyl alcohol, PVAPEG graft copolymer, talc, titanium dioxide
What dosage form it comes in
Tablets: 2.5 mg, 5 mg, 10 mg or 20 mg
Warnings and precautions
Before taking pms-TADALAFIL talk to your doctor if you have or had any of the following conditions:
- Heart disease or previously had a heart attack: Sexual activity carries a possible risk to patients with heart disease because it puts extra strain on your heart. Before you start any treatment for erectile dysfunction, ask your doctor if your heart is healthy enough to handle the extra strain of having sex. If you have chest pains, dizziness or nausea during sex, stop exerting yourself and tell your doctor you have had this problem.
- 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).
- Peptic ulcer or other bleeding disorders.
- 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 pms-TADALAFIL and e
- perience temporary or permanent loss or change in vision, stop taking pms-TADALAFIL and immediately call your doctor.
- Hearing problems: Sudden decrease or loss of hearing has been reported with the use of PDE5 inhibitors, including tadalafil, although it is not known if it is due to drug or other factors.
- Lactose or milk sugar intolerance. pms-TADALAFIL contains a small amount of lactose.
pms-TADALAFIL does not protect against sexually transmitted diseases including HIV/ AIDS.
Long-term studies have shown that pms-TADALAFIL therapy may decrease sperm concentration in some men. The effect on fertility in men is unknown.
pms-TADALAFIL is not intended for use by women or by children under 18 years of age.
When pms-TADALAFIL is used for the treatment of erectile dysfunction, diarrhea was reported more frequently in patients 65 years of age and older (2.5% of patients).
Only your doctor can decide if pms-TADALAFIL is right for you. If you have ED, you will need to have a physical examination to diagnose your erectile dysfunction and to find out if you can take pms-TADALAFIL alone or with your other medicines. If you have urinary problems, you will need to have a physical examination to diagnose your BPH and not a more serious condition such as prostate cancer.
Interactions with this medication
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicine, including the medicine you can buy
without prescription and natural health products.
Drugs that may interact with pms-TADALAFIL 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)
Tell your doctor if you are taking:
- medicines to treat high blood pressure
- alpha-blockers (such as doxazosin) for the treatment of prostate problems.
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 pms-TADALAFIL:
Always take pms-TADALAFIL exactly as your doctor has
instructed you. You should check with your doctor or pharmacist
if you are unsure. Do not take a higher dose than the one which
your doctor prescribed for you.
pms-TADALAFIL tablets are for oral use. Swallow the tablet
whole, with some water.
You may take pms-TADALAFIL with or without food.
Alcohol consumption may decrease the ability to attain an
erection and may also temporarily decrease blood pressure.
There are two different ways of taking pms-TADALAFIL tablets
to treat ED: a 20 mg On-Demand dose taken as needed, or a
lower 5 mg daily dose. It may take up to 5 days of pmsTADALAFIL Once-a-Day to reach steady blood levels.
For patients with ED:
- Try sex at different times to find out what works best for you and your partner. x pms-TADALAFIL works only if you are sexually stimulated. x If you don't get the results you expect ― talk to your doctor or pharmacist.
The recommended dose is one tablet (20 mg) before sexual activity, as needed. You should NOT take more than the prescribed dose of one pms-TADALAFIL 10 mg or 20 mg tablet per day. The 10 mg and 20 mg doses are not recommended for continuous daily use.
You can engage in sexual activity within 30 minutes of taking the tablet and up to 36 hours later. The amount of time pmsTADALAFIL takes to work varies from person to person.
pms-TADALAFIL for Once-a-Day Use:
Treatment of ED: Your doctor may recommend that you take one tablet of pms-TADALAFIL (5 mg or 2.5 mg) Once-a-Day every day, at approximately the same time each day, regardless of when you are planning to have sex.
Treatment of BPH and ED/BPH: Your doctor may recommend that you take one tablet of pms-TADALAFIL 5 mg Once-a-Day every day, at approximately the same time each day.
Overdose
Side effects and what to do about them
Like all medicines, pms-TADALAFIL can have some side-effects.
These effects are usually mild to moderate in nature.
The most common side effects are headache, indigestion, back pain,
muscle aches, nasal congestion, facial flushing, dizziness and high
blood pressure.
Uncommon side effects: swelling of the eyelids, eye pain,
conjunctival hyperemia (red eyes) and allergic reactions (including
skin rashes).
Rarely, a prolonged and possibly painful erection may occur after
taking pms-TADALAFIL. 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 pmsTADALAFIL. People who have previously experienced a type of
vision loss called Non-Arteritic Anterior Ischemic Optic
Neuropathy (NAION) are at an increased risk of reoccurrence of
NAION. If you experience reduction or loss of vision in one or both
eyes, stop taking pms-TADALAFIL and immediately call your
doctor.
If you take pms-TADALAFIL and have chest pain during or
after sexual activity, DO NOT use nitrates and seek immediate
medical assistance.
If you notice any side effects not mentioned in this leaflet, please
inform your doctor or pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Common | |||
| Headache | ✔ | ||
| Indigestion | ✔ | ||
| Back pain | ✔ | ||
| Muscle aches | ✔ | ||
| Nasal congestion | ✔ | ||
| Facial flushing | ✔ | ||
| Uncommon | |||
| Swelling of eyelids | ✔ | ||
| Eye pain | ✔ | ||
| Red eyes | ✔ | ||
| Dizziness | ✔ | ||
| Allergic reaction | ✔ | ||
| Rare | |||
| Prolonged reaction | ✔ | ||
| Chest pain | ✔ | ||
| Vision loss | ✔ | ||
| Hearing loss | ✔ | ||
| Transient amnesia | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking pms-TADALAFIL, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Store your tablets between 15°C and 30°C.
Store in the original package.
Do not use after the expiry date stated on the bottle and blister.
Reporting side effects
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and
unexpected side effects to Health Canada. Your report may help to identify new side effects
and change the product safety information.
3 ways to report:
- Online at MedEffect ((www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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
This document plus the full product monograph, prepared for health
professionals, can be obtained by contacting Pharmascience Inc. at
1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal, 4XHEHF
Canada H4P 2T4
www.pharmascience.com
Last revised: November 25, 2019
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