TADALAFIL (ROBUST MAX) 20 mg

1. What Robust Max is and what it is used for? / What is the function/effect?
– Robust Max 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 Max?
– To ensure that Robust Max 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 Max if any of the following apply:
o You are taking Nitrate Medications.
▪ In clinical studies, tadalafil has been found to enhance the blood pressure lowering (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 Max?
– For oral use.
– Use in adult meno The recommended dose of tadalafil is 20 mg taken prior to anticipated sexual activity
and without regard to food.
o It can be taken up to 36 hours and as early as 30 minutes prior to sexual activity.
o Patients may initiate sexual activity at varying time points relative to dosing in order
to determine their own optimal window of responsiveness.
o The maximum recommended dosing frequency is once per day.
– Use in elderly men
o Dosage adjustments are not required in elderly patients.
– Use in men with impaired renal function
o Dosage adjustments are not required in patients with renal impairment
– Use in men with impaired hepatic function
o Dosage adjustments are not required in patients with hepatic impairment (See
Warnings and Precautions).
– Use in men with diabetes
o Dosage adjustments are not required in diabetic patients.
– Use in children
o Tadalafil should not be used in individuals below 18 years of age.
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, USP – 20 mg
– Tadalafil (Robust Max) 20 mg Film-coated Tablet: Yellow to dark yellow, 12 mm x 8 mm,
teardrop-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.
– High Potency with Extended Duration
o Maximum Strength in a Single Dose: Robust Max offers 20 mg of Tadalafil, delivering
powerful relief for even severe erectile dysfunction (ED) cases.
o Up to 36 Hours of Effectiveness: Unlike shorter-acting alternatives, Robust Max
ensures long-lasting results, allowing patients to maintain spontaneity in their
intimate lives.
– Rapid Onset of Action
o Starts Working in Just 30 Minutes: Quick action ensures users are ready when
needed, providing confidence and reliability in performance.
– Flexibility for Every Lifestyle
o Food-Friendly Formulation: Can be taken with or without meals, removing dietary
restrictions that could inconvenience users.
o Adjustable Timing: Patients can find their optimal window of responsiveness, from
as early as 30 minutes up to 36 hours post-dosing.
– Broad Suitability Across Patient Groupso No Dose Adjustments Needed: Safe for elderly individuals, diabetic patients, and
those with mild to moderate kidney or liver impairment. This wide applicability
makes it suitable for diverse patient needs.
– Excellent Safety and Selectivity
o Highly Selective PDE5 Inhibition: Minimizes off-target effects like vision changes or
heart-related risks, ensuring patient safety.
o Minimal Cardiovascular Impact: Demonstrated safety profile for most patients, with
no significant blood pressure drops in controlled conditions.
– Trusted Local Manufacturing and Distribution
o Produced Locally, Trusted Globally: Manufactured by Philippine United Pharma
Corp., adhering to stringent quality control standards.
o Reliable Supply Chain: Exclusively distributed by ATC Healthcare, ensuring consistent
availability and excellent customer support across the Philippines.
– Clinically Proven Efficacy
o Backed by Research: Clinical trials show 75% success in sexual activity attempts,
with improved erectile function reported across mild, moderate, and severe ED
categories.
o Positive Patient Outcomes: Supported by over 3,000 patients in studies, ensuring
confidence in its effectiveness and reliability.
– Affordable and Accessible
o Competitive Pricing: Delivers premium results at a fraction of the cost of leading
international brands, offering exceptional value to patients.
o Accessible Packaging Options: Available in flexible pack sizes (2, 4, 10, or 20 tablets)
to suit different needs and budgets.
ROBUST MAX vs CIALIS 20MG
➢ Cost-Effective Alternative
o Affordability: Robust Max offers the same active ingredient (Tadalafil 20 mg) and
comparable efficacy as Cialis at a significantly lower price, making it a more economical
choice for patients.
➢ Local Manufacturing and Accessibility
o Trusted Local Production: Robust Max is manufactured by Philippine United Pharma
Corp., ensuring stringent quality standards and regulatory compliance in the Philippines.
o Reliable Distribution: Exclusively distributed by ATC Healthcare, Robust Max is readily
available nationwide, ensuring consistent supply for both pharmacies and patients.
➢ Flexible Packaging Options
o Robust Max is available in various pack sizes (2, 4, 10, or 20 tablets), allowing patients to
choose based on their needs and budgets. Cialis typically offers fewer packaging
options, limiting affordability for patients needing smaller or specific quantities.
➢ Comparable Clinical Efficacy
o Proven Effectiveness: Robust Max matches Cialis in potency and duration, providing up
to 36 hours of effectiveness with a single dose. It also shares a rapid onset, starting as
early as 30 minutes post-dose.
➢ Broad Patient Suitabilityo Like Cialis, Robust Max requires no dose adjustments for:
▪ Elderly patients
▪ Individuals with mild to moderate kidney or liver impairments
o Diabetic patients
▪ This ensures a wide range of patients can use Robust Max safely.
➢ Identical Mechanism and Safety Profile
o Selective PDE5 Inhibition: Robust Max, like Cialis, minimizes side effects due to its high
selectivity for PDE5, reducing risks of off-target effects on vision or cardiac function.
o Minimal Drug Interactions: Both products have a well-established safety profile with
minimal interactions with food, alcohol, or most medications.
➢ Enhanced Value Without Compromising Quality
o Patients get the same efficacy, safety, and reliability as Cialis while enjoying the
advantage of affordability and accessibility.