Tadaflo 5 Mg (Tadalafil)

What is Tadaflo 5 mg?

• Tadaflo 5 contains 5 mg of tadalafil.
• Tadalafil is a selective, reversible inhibitor of PDE5.
• It is used to treat erectile dysfunction and benign prostatic hyperplasia.
• It is marketed in India by Cipla Ltd. 
• 5 mg is the recommended strength for once-daily use.
• Sexual stimulation is still required for it to be effective.
• Tadalafil has no effect in the absence of sexual stimulation.
• Daily dosing maintains a steady level rather than timing each dose.
• Steady-state plasma concentrations are reached within 5 days.
• It may be taken with or without food.
• It does not increase sexual desire or libido.
• It does not cure the underlying cause of erectile dysfunction.
• It is not approved to delay ejaculation.
• It offers no protection against sexually transmitted infections.
• It is not habit forming.
• Tadalafil is not indicated for use by women.
• It is not indicated for anyone under 18.
• A medical history and physical examination should precede treatment.

How It Works (Mechanism of Action)

The mechanism below is described in the approved product information.

1. Sexual stimulation causes local release of nitric oxide.
2. Nitric oxide raises levels of cyclic guanosine monophosphate (cGMP).
3. cGMP produces smooth muscle relaxation in the corpus cavernosum.
4. Relaxed muscle allows blood to flow into penile tissue.
5. An enzyme called PDE5 breaks cGMP down.
6. Tadalafil selectively and reversibly inhibits PDE5.
7. Inhibiting PDE5 keeps cGMP levels elevated.
8. Blood flow is therefore maintained, producing an erection.

How it helps prostate symptoms: In benign prostatic hyperplasia, tadalafil relaxes the smooth muscle in the bladder and prostate. This reduces urinary symptoms such as frequency, urgency, and difficulty starting urination, and eases pressure on the urethra.

Why daily dosing works differently: The mean half-life of tadalafil is 17.5 hours. With once-daily dosing, steady-state plasma concentrations are attained within 5 days. Rather than timing a dose before each occasion, the aim is a continuous background level.

Give it several days. Because steady state takes around 5 days to establish, the full effect of a daily regimen is not apparent from the first tablet.

Why visual side effects are uncommon with tadalafil: Tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, the retinal enzyme responsible for phototransduction. Using the Farnsworth-Munsell 100-hue test, no impairment of blue-green colour discrimination was detected. Across all clinical studies, reports of changes in colour vision were rare, at under 0.1%.

A note on heart rhythm: A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported with once-a-day tadalafil compared with placebo. Most were not associated with adverse reactions.

Dosage Guide

Patient Group	Approved Guidance	Frequency	Key Notes
Men suited to a daily regimen	5 mg	Once daily	Taken at approximately the same time each day
Men who find 5 mg poorly tolerated	2.5 mg	Once daily	Dose may be decreased on tolerability
Men using treatment less than twice weekly	On-demand dosing may suit better	–	10 mg before activity is the usual on-demand dose
Benign prostatic hyperplasia	5 mg	Once daily	An established use at this strength
Elderly men	No adjustment required	Once daily	Exposure is 25% higher but not clinically significant
Mild to moderate renal impairment	No adjustment required	Once daily
Severe renal impairment	Once-daily dosing not recommended	–	10 mg is the maximum on-demand dose
Hepatic impairment	Once-daily dosing not evaluated	–	Careful individual benefit/risk evaluation needed
Men with diabetes	No adjustment required	Once daily
Taking potent CYP3A4 inhibitors	Caution	Once daily	Ketoconazole raised tadalafil exposure substantially
Taking doxazosin	Not recommended	–	Significant additional blood pressure fall
Under 18	Not indicated	–
Absolute maximum frequency	Once per day	–

Timing: Take it at approximately the same time each day. Food: The rate and extent of absorption are not influenced by food. It may be taken with or without food. Time of day: Morning versus evening dosing had no clinically relevant effect on absorption. Steady state: Reached within 5 days of once-daily dosing. Review: The appropriateness of continued daily use should be reassessed periodically. Missed dose: Take it when you remember, unless the next dose is due soon. Never take two tablets to catch up. Do not exceed the prescribed dose.

How to Take It

1. Take the tablet exactly as your doctor prescribed.
2. Swallow it whole. Do not chew, crush, or break it.
3. Take it once a day, at roughly the same time each day.
4. It may be taken with or without food.
5. Choose a time you will remember consistently.
6. Sexual stimulation is still required for an erection.
7. Allow around 5 days for the full effect to establish.
8. Do not take more than one tablet per day.
9. Do not take an extra tablet before sexual activity.
10. Do not combine it with any other ED treatment without medical advice.
11. Never take two tablets to make up a missed dose.
12. Avoid alcohol, which can reduce your ability to get an erection and worsen dizziness.
13. Do not stop and restart without discussing it with your doctor.
14. Tell every doctor and dentist you take daily tadalafil.
15. Attend your review appointments.
16. Do not share your tablets with anyone else.

Precautions

Absolute Contraindications – Do Not Use If You

The following are formal contraindications in the approved product information.

• Are hypersensitive to tadalafil or any excipient.
• Are using any form of organic nitrate.
• Take riociguat or another guanylate cyclase stimulator.
• Have cardiac disease for which sexual activity is inadvisable.
• Had a myocardial infarction within the last 90 days.
• Have unstable angina, or angina occurring during sexual intercourse.
• Have had NYHA Class 2 or greater heart failure in the last 6 months.
• Have uncontrolled arrhythmias.
• Have hypotension below 90/50 mmHg.
• Have uncontrolled hypertension.
• Have had a stroke within the last 6 months.
• Have lost vision in one eye because of NAION.

The Indian product listing summarises this as: do not use if you have recently taken nitrates, or if you have had a heart attack in the past 3 months, a stroke, or heart failure in the past 6 months.

Critical -nitrates: Administration to patients using any form of organic nitrate is contraindicated. With daily dosing you will not have a 48-hour nitrate-free interval, so this must be discussed with your doctor before starting.

Critical – doxazosin: The combination of tadalafil and doxazosin is not recommended. Co-administration significantly increases the blood-pressure-lowering effect, lasting at least twelve hours, and may cause syncope.

Conditions to Disclose to Your Doctor

Tell your doctor before use if you have or had:

• Any cardiovascular condition, since sexual activity carries cardiac risk.
• Any previous heart attack, stroke, or heart failure.
• Angina, or any prescription for nitrates in the past.
• Any likelihood of needing nitrate treatment in future.
• High or low blood pressure.
• Any arrhythmia, or a slow resting heart rate.
• Liver disease of any type, where daily dosing is unevaluated.
• Kidney disease, where severe impairment rules out daily dosing.
• Any eye disease or sudden vision loss previously.
• Any previous hearing loss.
• An anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie’s disease.
• Sickle cell anaemia, multiple myeloma, or leukaemia, which predispose to priapism.
• Any pelvic surgery or radical non-nerve-sparing prostatectomy.
• Diabetes.
• Whether you take any alpha-blocker.
• Any prostate symptoms, which may affect the choice of regimen.
• Recent or planned surgery, including dental procedures.

Also disclose every medicine, supplement, and herbal product you take.

Food and Drink Precautions

Item	Effect	Recommendation
Food generally	Rate and extent of absorption are not influenced by food	May be taken with or without food
Alcohol	Can reduce your ability to get an erection and worsen dizziness	Use with caution; avoid larger amounts
Larger amounts of alcohol	5 units or more can increase headache, dizziness, raised heart rate, or low blood pressure	Avoid
Grapefruit juice	A CYP3A4 inhibitor; expected to increase tadalafil plasma concentrations	Best avoided
Water	No interaction	Swallow the tablet with water

Before-Use Safety Checklist

Confirm every point below before starting, and review it periodically:

• ☐ A doctor has prescribed the once-daily regimen for me.
• ☐ I take no nitrate medicine of any kind.
• ☐ I am unlikely to need nitrate treatment at short notice.
• ☐ I take no riociguat.
• ☐ I take no doxazosin.
• ☐ I have had no heart attack in the past 3 months.
• ☐ I have had no stroke or heart failure in the past 6 months.
• ☐ I have no severe kidney impairment.
• ☐ I have no liver impairment.
• ☐ I take no other ED medicine.
• ☐ I take no ketoconazole, itraconazole, ritonavir, or clarithromycin.
• ☐ My doctor knows all my current medicines.
• ☐ My heart is fit enough for sexual activity.
• ☐ I have avoided grapefruit juice.
• ☐ I have a review appointment arranged.
• ☐ Everyone treating me knows I take daily tadalafil.
• ☐ The strip is sealed and the expiry date valid.
• ☐ I know the emergency warning signs listed below.

Side Effects

Side Effect	Frequency	What To Do
Headache	Common (1 in 100 to 1 in 10)	Most occur in the first 10 to 30 days
Dyspepsia (indigestion)	Common	Avoid heavy meals
Back pain	Common	Usually transient
Myalgia (muscle pain)	Common	Usually transient
Pain in extremity	Common	Usually mild and self-limiting
Flushing	Common	Usually mild
Nasal congestion	Common	Temporary; no treatment usually needed
Nausea	Common	Report if persistent
Nasopharyngitis	Common	Usually mild
Dizziness	Uncommon (1 in 1,000 to 1 in 100)	Sit or lie down
Blurred vision or eye pain	Uncommon	Report to your doctor
Tinnitus	Uncommon	Report to your doctor
Tachycardia or palpitations	Uncommon	Rest; seek advice if it persists
Hypotension	Uncommon; more common alongside antihypertensives	Stop use; seek medical advice
Hypertension	Uncommon	Have your blood pressure checked
Dyspnoea or nosebleed	Uncommon	Report if persistent
Abdominal pain, vomiting, reflux	Uncommon	Report if persistent
Rash	Uncommon	Stop use and contact your doctor
Haematuria (blood in urine)	Uncommon	Contact your doctor
Prolonged erections	Uncommon	See section 8
Chest pain, peripheral oedema, fatigue	Uncommon	Seek advice; see section 8 for chest pain
Priapism	Rare (1 in 10,000 to 1 in 1,000)	Emergency; see section 8
NAION (sudden vision loss)	Rare	Emergency; stop use permanently
Retinal vascular occlusion	Rare	Emergency; seek immediate care
Visual field defect or eyelid swelling	Rare	Emergency; seek advice
Sudden hearing loss	Rare	Emergency; stop use immediately
Stroke or transient ischaemic attack	Rare	Emergency; call for help
Syncope (fainting)	Rare	Emergency; seek medical care
Seizures or transient amnesia	Rare	Emergency; call for help
Myocardial infarction	Rare	Emergency; call for help
Unstable angina or ventricular arrhythmia	Rare	Emergency; call for help
Sudden cardiac death	Rare	Emergency
Stevens-Johnson syndrome	Rare	Emergency; stop use immediately
Exfoliative dermatitis	Rare	Emergency; stop use immediately
Angioedema or facial oedema	Rare	Emergency; stop use immediately
Urticaria or hyperhidrosis	Rare	Report to your doctor
Penile haemorrhage or blood in semen	Rare	Contact your doctor promptly
Central serous chorioretinopathy	Not known	Stop use; consult a physician

What users report: Among those leaving feedback on the Indian product listing, headache was the most commonly reported effect at 50%, followed by dizziness, muscle pain, and nasal congestion at 10% each. 10% reported no side effect at all. [

Note on older patients: In trials of tadalafil 5 mg once daily for prostate symptoms, dizziness and diarrhoea were reported more frequently in patients over 75.

Note on fertility: Tadalafil does not affect fertility. It works by relaxing the muscles of the penile blood vessels.

Note on sperm: In studies of tadalafil 10 mg and 20 mg daily, decreases were observed in sperm count and concentration of unlikely clinical relevance, without changes in motility, morphology, or FSH.

Drug Interactions – Avoid With

Contraindicated:

• Any form of organic nitrate.
• Riociguat and other guanylate cyclase stimulators.

Classified as life-threatening interactions on the Indian product listing:

• Nitroglycerin, oral route.
• Isosorbide mononitrate, oral route.
• Isosorbide dinitrate, oral and sublingual routes.
• Nitroprusside, injection route.

May reduce effectiveness:

• Rifampicin reduced tadalafil AUC by 88%.
• Phenobarbital, phenytoin, and carbamazepine.

No clinically significant interaction was found with:

• Calcium channel blockers such as amlodipine.
• ACE inhibitors such as enalapril.
• Beta-blockers such as metoprolol.
• Thiazide diuretics and angiotensin II receptor blockers.
• Warfarin, where tadalafil had no clinically significant effect on prothrombin time.
• Aspirin, where tadalafil did not potentiate increased bleeding time.

Emergency Warning Signs

Stop the medicine and seek immediate medical care if you experience:

1. An erection lasting 4 hours or more.
2. A painful erection lasting more than 6 hours.
3. Chest pain, pressure, or tightness during or after sex.
4. Pain spreading to the jaw, neck, or left arm.
5. Sudden vision loss in one or both eyes.
6. Any sudden visual defect or visual distortion.
7. Sudden decrease in hearing or hearing loss.
8. Ringing in the ears with dizziness.
9. Fainting or collapse.
10. Severe shortness of breath.
11. Swelling of the face, lips, tongue, or throat.
12. Widespread rash with blistering or peeling skin.
13. A seizure or convulsion.
14. Signs of stroke: sudden weakness, slurred speech, facial droop.

9. Why Choose Tadaflo 5 mg

Genuine advantages:

• 5 mg is an authorised tadalafil strength.
• It is the recommended dose for the once-daily regimen.
• It treats both erectile dysfunction and prostate symptoms.
• Daily dosing removes the need to time a tablet before each occasion.
• It suits men who anticipate use at least twice weekly.
• Made by Cipla, one of India’s largest pharmaceutical companies.
• Listed on India’s largest regulated pharmacy platform.
• Absorption is unaffected by food.
• Visual colour changes are rare, under 0.1%, due to 700-fold PDE5 selectivity over PDE6.
• No dose adjustment is needed for age or diabetes.
• The dose can be reduced to 2.5 mg if tolerability is an issue.
• No clinically significant interaction with most common blood pressure medicines.
• It is not habit forming.
• Supplied as a strip of 15 tablets.

Honest limitations you should know:

• It must be taken every day, not just before sex.
• It takes around 5 days to reach steady state.
• Most headaches occur in the first 10 to 30 days.
• You will not have a 48-hour nitrate-free window at any point.
• Daily dosing is not recommended in severe renal impairment.
• Daily dosing has not been evaluated in hepatic impairment.
• Continued use requires periodic reassessment.
• It costs more over time than occasional on-demand dosing.

Consider on-demand dosing instead if:

• You have sex less than twice weekly.
• You prefer not to take a daily tablet.
• You may need nitrate treatment at short notice.
• You have severe kidney impairment.
• You have any degree of liver impairment.

Bottom line: For men using treatment at least twice weekly, or managing prostate symptoms alongside erectile dysfunction, the once-daily 5 mg regimen is an approved and well-characterised option from a major manufacturer. The trade-off is continuous exposure, which matters most for the nitrate question.

Storage Instructions

• Store below 30°C.
• Store in the original package to protect from moisture.
• Keep tablets sealed in the strip until use.
• Do not store in the bathroom or near a sink.
• Do not transfer tablets into unlabelled containers.
• A clearly labelled pill organiser is acceptable for daily use.
• Keep the original pack for the drug name and strength.
• Never mix tablets of different strengths in one container.
• Do not freeze or refrigerate this product.
• Keep it out of the sight and reach of children.
• Accidental ingestion by a child is a medical emergency.
• Check the expiry date printed on the pack.
• Never use tablets after the expiry date.
• Discard damaged, cracked, or discoloured tablets.
• Keep a spare supply when travelling.
• Do not allow yourself to run out mid-regimen.
• Dispose of unused medicine in accordance with local requirements.
• Do not flush tablets or throw them in household waste.

Medical Disclaimer

This content is for information only. It is not medical advice. Tadaflo 5 Tablet is a prescription-only medicine. 5 mg is the recommended tadalafil dose for a once-daily regimen, which suits men anticipating use at least twice weekly; continued use should be reassessed periodically. Administration to patients using any form of organic nitrate is contraindicated, and daily dosing means you will not have a nitrate-free interval. Once-daily dosing is not recommended in severe renal impairment and has not been evaluated in hepatic impairment. This product is not a treatment for pulmonary arterial hypertension. Use only under a qualified doctor’s supervision. Always read the manufacturer’s package insert supplied with your product before use.