📌 COMPOSITION

Each F/C tablet contains: Tadalafil 10 mg, 20 mg.

📌 DESCRIPTION

Golden Tab (Tadalafil) is a potent, selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)‑specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by Tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into penile tissues, thereby producing an erection. Tadalafil is readily absorbed after oral administration, and the mean maximum observed plasma concentration is achieved at a median time of 2 hours after dosing. Tadalafil is distributed into tissues. At therapeutic concentrations, 94% of Tadalafil in plasma is bound to proteins. Protein binding is not affected by impaired renal function. Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces, and to a lesser extent in the urine.

📌 INDICATIONS

Golden Tab is indicated for the treatment of erectile dysfunction.

📌 DOSAGE & ADMINISTRATION

The recommended starting dose is one tablet (10 mg) to be taken before sexual activity (30 minutes to 12 hours) with or without food. If the effect of this dose is too weak, it may be increased to 20 mg. The efficacy may persist up to 24 hours post‑dose. Dosage adjustments are not required in patients with mild or moderate renal or hepatic impairment.

Golden Tab should not be taken more than once a day. Tadalafil has no effect in the absence of sexual stimulation.

📌 RESTRICTIONS ON USE

Contraindications

• Tadalafil was shown to augment the hypotensive effects of nitrates, so Tadalafil should not be used in patients who are using any form of organic nitrate.
• Tadalafil should not be used in patients with a known hypersensitivity to Tadalafil or to any of the excipients.
• Patients with unstable angina or angina occurring during sexual intercourse.
• Patients with uncontrolled arrhythmias, hypotension or uncontrolled hypertension.
• Patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
• Patients with severe hepatic insufficiency (Child-Pugh Class C).
• Patients who have had a recent heart attack.
• Recent stroke during the last six months preceding the use of Tadalafil.
• Tadalafil should not be used together with any other treatments for erectile dysfunction.
• Tadalafil is not intended for use by women or by patients under the age of 18.

Precautions

• The doctor must examine the cardiac state of patients before prescribing this medicament, because sexual activity carries a potential cardiac risk for patients with cardiovascular diseases.
• Caution should be exercised when Tadalafil is administered to patients with hereditary galactose intolerance.
• Tadalafil should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia) or in patients with anatomical deformation of the penis.
• If you have chest pain or other heart‑related symptoms during sex, seek immediate medical help.

Effects on ability to drive and use machines

Patients should be aware of how they react to Tadalafil before driving or operating machinery.

📌 DRUG INTERACTIONS

• Ketoconazole increased Tadalafil AUC by 107%, while Rifampicin reduced Tadalafil AUC by 88%.
• Simultaneous administration of an antacid and Tadalafil reduced the apparent rate of absorption of Tadalafil without altering exposure (AUC) to Tadalafil.
• Tadalafil was shown to augment the hypotensive effects of nitrates.
• Tadalafil does not affect CYP450 isomers, including CYP3A4, CYP1A2, CYP2D6, CYP2E1 and CYP2C9.
• Tadalafil had no clinically significant effect on exposure (AUC) to S‑Warfarin or R‑Warfarin.
• Tadalafil did not potentiate the increase in bleeding time caused by Acetylsalicylic acid.
• Tadalafil had no clinically significant effect on the pharmacokinetics or pharmacodynamics of Theophylline.

📌 ADVERSE EFFECTS

The most commonly reported side effects were: headache, pyrosis or heartburn, muscle pain, dyspepsia and back pain. These side effects were transient and generally mild or moderate.

📌 OVERDOSAGE

In case of overdose, symptomatic and supportive treatment should be given. There is no specific information on the management of overdose. Monitoring of vital signs and supportive care is recommended.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place. Protect from light.

📌 PHARMACEUTICAL FORMS

• Golden Tab 10 mg: packs of 4 tablets and packs of 2 tablets.
• Golden Tab 20 mg: packs of 4 tablets and packs of 2 tablets.

📌 INSTRUCTIONS TO THE PATIENT

• Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
• Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament.
• The doctor and the pharmacist are experts in medicine, its benefits and risks.
• Do not by yourself interrupt the period of treatment prescribed for you.
• Do not repeat the same prescription without consulting your doctor.

Keep medicament out of reach of children

012-06-054 4/15 | Mfd. By: Saba Pharma | P.O. Box: 4265 Sana'a / Yemen | Council of Arab Health Ministers | Union of Arab Pharmacists