TADALAFIL (ROBUST – T) 5mg

1. What Robust – T is and what it is used for? / What is the function/effect?
– Robust – T is a tablet that helps men with erectile dysfunction (ED) by increasing blood flow
to the penis when they are sexually stimulated. It is a Phosphodiesterase Type 5 (PDE5)
Inhibitor which works by blocking an enzyme (PDE5) that normally reduces blood flow. This
allows the blood vessels in the penis to relax, leading to an erection. However, tadalafil will
not cause an erection without sexual arousal.
– Studies show that tadalafil starts working as early as 16 minutes after taking it and can last up
to 36 hours, allowing for more flexibility in timing. It is very selective in how it works, mainly
targeting the enzyme (PDE5) that controls blood flow in the penis, without significantly
affecting other enzymes in the body.
– Tadalafil does not have a major impact on blood pressure, heart rate, or vision, and it does
not significantly interact with blood pressure medications. Clinical trials involving over 3,000
men of different ages and backgrounds found that tadalafil improved erections in about 81%
of users, regardless of the severity of their erectile dysfunction. About 75% of sexual attempts
were successful while using the medication.
2. What you need to know before you use Robust – T?
– To ensure that Robust – T is a safe and effective option for patients with erectile dysfunction,
it is essential to communicate any relevant health information to your doctor or pharmacist.
If there’s anything you’re unsure about, don’t hesitate to ask for clarification.
Do not use Robust – T if any of the following apply:
o You are taking Nitrate Medications.
▪ In clinical studies, tadalafil has been found to enhance the blood pressurelowering (hypotensive) effects of nitrates. This interaction occurs due to the
combined impact of nitrates and tadalafil on the nitric oxide/cGMP pathway,
where both drugs relax blood vessels, potentially lowering blood pressure too
much when used together. As a result, tadalafil should not be taken by
patients using any form of organic nitrate.
o If you are allergic to Tadalafil.
▪ Tadalafil is contraindicated in patients who have a known allergy or
hypersensitivity to tadalafil or any of the other ingredients in the formulation.
Your doctor or pharmacist will be able to provide guidance tailored to your individual needs,
so always be upfront about your medical history.
– WARNINGS AND PRECAUTIONS
o Sexual activity carries a potential cardiac risk for patients with pre-existing
cardiovascular disease. Therefore, treatments for erectile dysfunction, including
tadalafil should not be used in men with cardiac disease for whom sexual activity is
inadvisable. Physicians should consider the potential cardiac risk of sexual activity in
patients with pre-existing cardiovascular disease.o Priapism (prolonged erection) has been reported with PDE5 inhibitors, including
tadalafil. Patients who experience erections lasting 4 hours or more should be
instructed to seek immediate medical assistance. If priapism is not treated
immediately, penile tissue damage and permanent loss of potency may result.
Tadalafil should be used with caution in patients who have conditions that might
predispose them to priapism (such as sickle cell anemia, multiple myeloma, or
leukemia), or in patients with anatomical deformation of the penis (such as
angulation, cavernosal fibrosis or Peyronie’s disease).
The evaluation of erectile dysfunction should include a determination of potential
underlying causes and the identification of appropriate treatment following an
appropriate medical assessment.
The safety and efficacy of combinations of tadalafil and other treatments for erectile
dysfunction have not been studied. Therefore, the use of such combinations is not
recommended.
No data are available in patients with severe hepatic impairment (Child-Pugh Class C)
therefore, caution should be exercised when prescribing tadalafil to this patient
group.
– PREGNANCY AND LACTATION
o Tadalafil is not indicated for use in women, including during pregnancy or lactation.
Studies in rats and mice found no evidence of harm to developing embryos or fetuses,
even at doses up to 1000 mg/kg/day. In a study on pregnant rats, no adverse effects
were observed on pre- or postnatal development at doses up to 30 mg/kg/day. At
this dose, the drug exposure in rats was approximately 18 times higher than the
exposure seen in humans taking a standard 20 mg dose. There are no studies of
tadalafil in pregnant women.
– EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
o Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical
trials was similar, patients should be aware of how they react to tadalafil, before
driving or operating machinery.
– DRUG INTERACTION
o Effects of other medicinal products on tadalafil
▪ Drugs that increase tadalafil levels:
• Certain medications like ketoconazole, ritonavir, and similar drugs
(e.g., erythromycin or itraconazole) can make tadalafil stay in your
system longer and stronger. This might increase side effects.
▪ Drugs that decrease tadalafil levels:• Medications like rifampicin (used for infections) can make tadalafil
less effective by clearing it from your system faster.
▪ Antacids:
• Antacids like magnesium hydroxide or aluminum hydroxide can slow
down how quickly tadalafil is absorbed, but they don’t change how
much gets into your system overall.
▪ Acid-reducing medications:
• Drugs like nizatidine (for reducing stomach acid) don’t affect how
tadalafil works in the body.
o Effects of tadalafil on other medicinal products
▪ Nitrates:
• Combining tadalafil with nitrates (used for chest pain or heart
problems) is dangerous and can cause a severe drop in blood
pressure. This combination is strictly prohibited.
▪ Blood thinners:
• Tadalafil doesn’t interfere with medications like warfarin (a blood
thinner) or aspirin in a significant way, so it’s unlikely to increase
bleeding risk.
▪ Blood pressure medications:
• Tadalafil can amplify the effects of medications that lower blood
pressure. If you take multiple blood pressure drugs, the
combination might cause a bigger drop, but symptoms like dizziness
are rare for most people.
▪ Alpha blockers:
• When used with drugs like doxazosin, there’s a higher chance of
dizziness or fainting due to low blood pressure. The combination
with tamsulosin is generally safer.
▪ Alcohol:
• Drinking alcohol while taking tadalafil is usually safe in moderation.
However, higher amounts of alcohol may cause dizziness or drops in
blood pressure.
▪ Other drugs:
• Tadalafil doesn’t significantly interact with drugs like theophylline
(for breathing problems).
o Some medications can make tadalafil stronger or weaker, so always let your doctor
know what you’re taking. Avoid combining tadalafil with nitrates or large amounts
of alcohol. Be cautious if you’re on blood pressure medications or alpha blockers, as
it could cause dizziness or fainting.
3. How to use/take Robust – T?
– For use as needed:
o Starting dose:▪ 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5
mg based upon efficacy/tolerability. Improves erectile function compared to
placebo up to 36 hours post dose. Not to be taken more than once per day.
▪ The recommended starting dose of Tadalafil film-coated tablet for use as
needed in most patients is 10 mg, taken prior to anticipated sexual activity.
▪ The dose may be increased to 20 mg or decreased to 5 mg, based on
individual efficacy and tolerability.
▪ The maximum recommended dosing frequency is once per day in most
patients.
▪ Tadalafil film-coated tablet for use as needed was shown to improve erectile
function compared to placebo up to 36 hours following dosing. Therefore,
when advising patients on optimal use of Tadalafil film-coated tablet, this
should be taken into consideration.
– For once daily use:
▪ FOR ERECTILE DYSFUNCTION (ED)
• 2.5 mg taken once daily, without regard to timing of sexual activity.
May increase to 5 mg based upon efficacy and tolerability.
• The recommended starting dose of Tadalafil film-coated tablet for
once daily use is 2.5 mg, taken at approximately the same time every
day, without regard to timing of sexual activity.
• The Tadalafil film-coated tablet dose for once daily use may be
increased to 5 mg, based on individual efficacy and tolerability.
▪ FOR BENIGN PROSTATIC HYPERPLASIA (BPH) – A non-cancerous prostate
enlargement that affects urination.
• 5 mg, taken at approximately the same time every day.
• The recommended dose of Tadalafil film-coated tablet for once daily
use is 5 mg, taken at approximately the same time every day.
▪ The recommended dose of Tadalafil film-coated tablet for once daily use is 5
mg, taken at approximately the same time every day, without regard to
timing of sexual activity.
▪ Tadalafil film-coated tablet may be taken without regard to food.
4. Possible side effects.
– Headache and indigestion are the most frequently reported side effects, affecting about 1 in
10 or fewer people.
– Other common side effects include:
o Back pain or myalgia (muscle aches)
o Nasal congestion (Stuffy nose)
o Flushing (redness or warmth, especially on the face)
– Less Common Side Effects (may affect some people):
o Swollen eyelids, mild eye discomfort, or red eyes.o Dyspnea (Shortness of breath) and dizziness.
– Rare Side Effects (very uncommon but possible):
o Allergic reactions: This includes rashes, hives, swelling of the face, or serious skin
conditions like Stevens-Johnson syndrome (a rare, severe rash).
o Heart and circulation problems: Some people have reported heart attacks, strokes,
or chest pain while taking tadalafil. However, these often occurred in people with
existing heart conditions, so it’s not clear if tadalafil, physical activity, or another
factor caused them.
o Low or high blood pressure: Low blood pressure (especially in people taking blood
pressure medications) or high blood pressure.
o Fainting (syncope).
– Other Rare Effects:
o Stomach issues: Pain in the abdomen or acid reflux.
o Sweating more than usual.
o Prolonged erections: This includes priapism (an erection lasting too long), which
needs urgent medical attention.
o Vision issues: Blurred vision, partial loss of vision, or rare eye problems like
nonarteritic anterior ischemic optic neuropathy (NAION).
o Nosebleeds.
o Migraines.
– OVERDOSE
o Single doses of up to 500 mg have been given to healthy subjects, and multiple daily
doses up to 100 mg have been given to patients. Adverse events were similar to those
seen at lower doses. In cases of overdose, standard supportive measures should be
adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.
– If you notice any unusual or severe symptoms, it’s important to stop using the medication and
seek medical attention.
– For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph Seek medical
attention at the first sign of any adverse drug reaction.
5. How to store Robust – T?
– Store at temperatures not exceeding 30°C. Store in the original package.
6. Contents of the pack and other information.
– FORMULATION:
Each tablet contains:
o Tadalafil – 5 mg
– Tadalafil (Robust-T) 5 mg Film-coated Tablet: Yellow to dark yellow, 5 mm, round-shaped,
biconvex, film-coated tablet, plain on both sides.
– Available in Alu/PVC Film Clear with Tropical Foil Blister Pack x 2’s in boxes of 2’s, 4’s, 10’s and
20’s.7. Advantage vs competitor.
– Long-Lasting Effectiveness
o Up to 36 Hours of Effectiveness: Robust-T provides extended relief, allowing for
spontaneity and reducing the need for precise timing compared to shorter-acting
alternatives.
o Quick Onset: Clinical studies show results as early as 16 minutes, making it faster than
many competitors.
– Flexible Dosing Options for Different Needs
o As-Needed Use: Offers a starting dose of 10 mg with adjustable options (5 mg or 20
mg) to suit individual tolerability and effectiveness.
o Daily Use Option: Low-dose daily regimens (2.5 mg or 5 mg) provide consistent
support for men who engage in frequent sexual activity.
– Superior Safety Profile
o Highly Selective PDE5 Inhibition: Focuses primarily on PDE5, significantly reducing
unwanted side effects like vision changes or heart-related risks seen in less selective
medications.
o Minimal Cardiovascular Impact: Safe for most patients without severe heart
conditions, with no significant drop in blood pressure for the majority.
– Convenience
o Convenient Intake: Can be taken with or without food, offering flexibility and ease
of use in everyday life.
o Film-Coated Tablets: Designed for easy swallowing and reduced stomach irritation,
ensuring better user comfort.
– Trustworthy Manufacturing and Accessibility
o Locally Manufactured: Produced by Philippine United Pharma Corp., ensuring
adherence to stringent quality standards.
o Reliable Distribution: Exclusively distributed by ATC Healthcare in the Philippines,
guaranteeing accessibility and customer support.
– Affordability and Value
o Cost-Effective: Robust-T offers the same trusted efficacy as leading brands at a more
competitive price, making it a smart choice for budget-conscious patients.
– Proven Clinical Results
o Backed by Research: Clinical studies demonstrate a 75% success rate in achieving
satisfactory sexual activity and improved erections across all levels of erectile
dysfunction severity (mild, moderate, and severe).
ROBUST – T vs CIALIS 5 MG
➢ Cost-Effectivity
o Affordability: Robust-T provides the same active ingredient (Tadalafil 5 mg) and clinical
efficacy as Cialis but at a more budget-friendly price, making it an ideal choice for costconscious patients.
➢ Local Manufacturing and Accessibility
o Trusted Local Production: Robust-T is manufactured by Philippine United Pharma Corp.,
ensuring high-quality standards and compliance with local regulatory requirements.o Nationwide Availability: Exclusively distributed by ATC Healthcare, Robust-T is widely
accessible across the Philippines, ensuring a consistent supply for pharmacies and
patients.
➢ Flexible Packaging Options
o Robust-T offers multiple packaging sizes (2, 4, 10, or 20 tablets), allowing patients to
purchase quantities that suit their usage and budget. Cialis often offers limited
packaging options, potentially increasing costs for patients needing smaller or specific
quantities.
➢ Comparable Clinical Efficacy
o Same Duration of Action: Robust-T provides up to 36 hours of effectiveness, offering the
same long-lasting performance as Cialis.
o Daily Use Approved: Both products can be used in a daily regimen (5 mg once daily),
ensuring consistent management of erectile dysfunction (ED) or benign prostatic
hyperplasia (BPH).
➢ Broad Patient Suitability
o Like Cialis, Robust-T is safe for:
▪ Elderly individuals
▪ Diabetic patients
o Patients with mild to moderate kidney or liver impairments
This ensures suitability for a wide range of users without the need for complex dose
adjustments.
➢ Identical Safety Profile
o Highly Selective PDE5 Inhibitor: Robust-T shares Cialis’s precise mechanism of action,
minimizing off-target effects such as vision disturbances or cardiac complications.
o Minimal Side Effects: Both products have similar mild side effects, like headaches or
nasal congestion, which decrease with continued use.
➢ Enhanced Value Without Compromising Quality
o Same Trusted Results: Robust-T delivers the same high-quality efficacy and safety as
Cialis, with the added benefit of greater affordability, better packaging flexibility, and
consistent local availability