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Oral formulations of tadalafil.

Drugs List

  • ADCIRCA 20mg tablets
  • CIALIS 10mg film coated tablets
  • CIALIS 2.5mg film coated tablets
  • CIALIS 20mg film coated tablets
  • CIALIS 5mg film coated tablets
  • tadalafil 10mg tablets
  • tadalafil 2.5mg tablets
  • tadalafil 20mg tablets
  • tadalafil 5mg tablets
  • TALMANCO 20mg film coated tablets
  • Therapeutic Indications


    Benign prostatic hyperplasia
    Pulmonary arterial hypertension: functional grades II and III
    Treatment of erectile dysfunction


    Not all brands or strengths are licensed for all indications.

    In order for tadalafil to be effective in the treatment of erectile dysfunction, sexual stimulation is required.


    Treatment of erectile dysfunction
    10mg to be taken at least 30 minutes prior to sexual activity. If 10mg does not produce an adequate effect, a 20mg dose may be appropriate.

    The effect of intermittent dosing may persist for longer than 24 hours.

    The maximum recommended dosing frequency for tadalafil 10mg and 20mg is one dose per 24 hours.

    Tadalafil 10mg and 20mg is intended for use before anticipated sexual activity and is not recommended for continuous daily use.

    Once daily dosing
    Tadalafil 2.5mg or 5mg once a day, may be used in patients who anticipate a frequent use of tadalafil (i.e. at least twice weekly).

    Recommended dose is 5mg once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day depending on individual tolerability.

    Physicians should monitor and re-assess the use of the daily regimen periodically.

    Treatment of benign prostatic hyperplasia (BPH)
    5mg taken once daily (at approximately the same time each day).

    Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III
    40mg taken once daily.

    Patients with Renal Impairment

    Treatment of erectile dysfunction or BPH
    Severe renal impairment: Maximum dose 10mg for intermittent use.

    Once daily dosing:
    Severe renal impairment: Not recommended.

    Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III
    Mild to moderate renal impairment: Starting dose of 20mg once a day increasing to 40mg once a day based on efficacy and tolerance.
    Severe renal impairment: Not recommended.

    Patients with Hepatic Impairment

    Once daily dosing in the treatment of erectile dysfunction or BPH has not been evaluated in patients with hepatic impairment.

    Treatment of erectile dysfunction
    10mg to be taken at least 30 minutes prior to sexual activity.

    There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C). Potential risks and benefits should be evaluated before tadalafil is prescribed to these patients.

    Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III
    Child Pugh Class A and B: 10mg starting dose and 20mg once a day.

    Child-Pugh Class C: Not recommended by the manufacturer.


    Children under 18 years
    Systolic blood pressure < 90mmHg
    Angina during sexual intercourse
    Cardiac arrhythmias
    Hereditary degenerative retinal disorder
    History of non-arteritic anterior ischaemic optic neuropathy (NAION)
    Patients in whom sexual activity is inadvisable - if treating BPH or ED
    Retinitis pigmentosa
    Severe hepatic impairment - if treating pulmonary arterial hypertension
    Uncontrolled hypertension
    Unstable angina
    Within 3 months of a myocardial infarction
    Within 6 months of a cerebrovascular accident - if treating BPH or ED
    Within 6 months of NYHA class II failure - if treating BPH or ED

    Precautions and Warnings

    Predisposition to priapism
    Anatomical deformation of penis
    Cardiomyopathy - if treating pulmonary arterial hypertension
    Cardiovascular disorder
    Constrictive pericarditis - if treating pulmonary arterial hypertension
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Lactose intolerance
    Left ventricular dysfunction
    Multiple myeloma
    Renal impairment
    Sickle cell disease
    Valvular heart disease

    Advise ability to drive/operate machinery may be affected by side effects
    Benign prostatic hyperplasia: Exclude prostate carcinoma before treatment
    BPH or ED: Pre-treatment medical history and examination required
    Concurrent alpha blockers: only initiate therapy when blood pressure stable
    Not all available brands are licensed for all indications
    Not all available strengths are licensed for all indications
    Pulmonary hypertension: Treatment to be initiated by a specialist
    Contains lactose
    Assess baseline cardiac function prior to treatment
    Monitor patients for signs of adverse cardiovascular effects
    Advise patient to report any erection lasting more than 4 hours
    Advise patient to report hearing loss or tinnitus
    Advise patient to report new visual problems and symptoms
    BPH or ED: Discontinue and see doctor if sudden visual defect
    Consider veno-occlusive disease if pulmonary oedema occurs
    PAH:Advise patient to seek immediate medical advice if sudden visual defect
    Concurrent anti-hypertensive medication may require adjustment
    Advise patient not to take St John's wort concurrently
    Advise patients not to take nitrates or amyl nitrite concurrently
    Advise patient grapefruit products may increase plasma level
    Advise patients to discontinue if any kind of visual disturbances occur

    Tadalafil has systemic vasodilatory properties which may result in decreases in blood pressure. Patients with severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or resting hypotension could be adversely affected.

    Pulmonary vasodilators may worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and use in such patients is not recommended. If signs of pulmonary oedema occur, consider the possibility of PVOD.

    Pregnancy and Lactation


    Tadalafil is contraindicated in pregnancy.

    Not all brands are indicated for use in women. There is limited data on the use of tadalafil in pregnant women.

    Animal studies have not shown any teratogenicity, embryotoxicity or foetotoxicity.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Tadalafil is contraindicated in breastfeeding.

    Animal data shows excretion in milk and as a risk to a breastfeeding infant cannot be excluded, tadalafil should not be used during breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Amnesia (transient)
    Angina pectoris
    Back pain
    Blurred vision
    Cardiovascular effects
    Chest pain
    Conjunctival hyperaemia
    Exfoliative dermatitis
    Eye pain
    Eyelid swelling
    Facial oedema
    Gastroesophageal reflux
    Hearing disturbances
    Hypersensitivity reactions
    Irregular uterine bleeding
    Myocardial infarction
    Nasal congestion
    Non-arteritic anterior ischaemic optic neuropathy (NAION)
    Painful extremities
    Penile haemorrhage
    Prolonged erection
    Retinal vein occlusion
    Sinus bradycardia
    Stevens-Johnson syndrome
    Sudden cardiac death
    Sudden deafness
    Transient ischaemic attack
    Ventricular arrhythmias
    Visual disturbances
    Visual field defects


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2014

    Reference Sources

    Summary of Product Characteristics: Adcirca 20 mg film-coated tablets. Eli Lilly and Company Ltd. Revised February 2017.

    Summary of Product Characteristics: Cialis 2.5 mg, 5 mg, 10 mg and 20 mg film-coated tablets. Eli Lilly and Company Ltd. Revised March 2017.

    Summary of Product Characteristics: Talmanco 20 mg film-coated tablets. Mylan S.A.S. Revised January 2017.

    NICE Evidence Services Available at: Last accessed: 16 July 2018

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.