Sildenafil 100 mg Blue Tablets - Summary of Product Characteristics (SmPC)
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Prescription only medicine
1. Name of the medicinal product
Sildenafil 100 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 100 mg of sildenafil (as citrate).
3. Pharmaceutical form
Film-coated tablet
Sildenafil 100 mg tablet:
Blue colored round, biconvex, approx. 12.00 mm in diameter scored film-coated tablets debossed with 126 on one side and J on the other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4.1 Therapeutic indications
Sildenafil 100 mg is indicated for adult men with erectile dysfunction, a condition characterized by the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Effective sexual stimulation is required for Sildenafil to work.
4.2 Posology and method of administration
Posology
Use in adults
The recommended starting dose is 50 mg, which should be taken as needed approximately one hour before sexual activity. Depending on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg, with a maximum dosing frequency of once per day.
Method of administration
For oral use.
4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients. Co-administration with nitrates in any form, as this may lead to significant hypotension. Not suitable for men for whom sexual activity is inadvisable.
4.4 Special warnings and precautions for use
A thorough medical history and physical examination are recommended prior to prescribing Sildenafil to assess potential cardiovascular risks associated with sexual activity.
Patients should be informed of the potential for priapism, which may occur in those with anatomical deformities of the penis.
4.5 Interaction with other medicinal products
Sildenafil is primarily metabolized by CYP3A4; thus, co-administration with strong CYP3A4 inhibitors, such as ritonavir, should be avoided or used with caution. Other medications can influence Sildenafil's effectiveness and safety, requiring careful management and consultation.
4.6 Fertility, pregnancy and lactation
Sildenafil is not indicated for use by women. Reproduction studies in animals showed no adverse effects, although there are no adequate studies in humans.
4.7 Effects on ability to drive and use machines
Sildenafil may cause dizziness or visual disturbances, which could affect the ability to drive or operate machinery. Patients should know how they respond to the medication before engaging in these activities.
4.8 Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions are headache, flushing, dyspepsia, nasal congestion, dizziness, and visual disturbances. Further monitoring for unusual reactions is advised.
4.9 Overdose
In the event of overdose, standard supportive measures should be adopted. High doses may lead to increased incidence of adverse reactions. Renal dialysis is not expected to significantly enhance clearance.
5. Pharmacological properties
Sildenafil is a selective inhibitor of phosphodiesterase type 5 (PDE5), which enhances the effects of nitric oxide and leads to increased blood flow to the penis during sexual stimulation.
5.1 Pharmacodynamic properties
Sildenafil provides significant improvement in erectile function by enhancing cGMP levels in response to sexual stimulation. Its pharmacokinetic profile shows rapid absorption, efficacy within 30 to 120 minutes, and an active duration of several hours.
5.2 Pharmacokinetic properties
Sildenafil is rapidly absorbed and reaches peak plasma concentrations within one hour. Its bioavailability is approximately 41%, with food potentially affecting its absorption rate.
5.3 Preclinical safety data
No special hazards were identified in preclinical studies related to safety pharmacology and repeated dose toxicity.
6. Pharmaceutical particulars
Tablet core:
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Film coat:
Polyvinyl alcohol, titanium dioxide (E171), talc, indigo carmine aluminium lake (E132), hypromellose.
6.3 Shelf life
The shelf life of Sildenafil 100 mg is three years.
6.5 Nature and contents of container
PVC/Aluminium foil blisters in cartons of 1, 2, 4, 8, 12, or 24 tablets.
7. Marketing authorisation holder
Amarox Limited, Congress House, 14 Lyon Road, Harrow, Middlesex HA1 2EN, United Kingdom.
8. Marketing authorisation number(s)
PL 49445/0032
9. Date of first authorisation/renewal of the authorisation
12/10/2018
10. Date of revision of the text
20/06/2023