COMPOSITION :
Each f/c tablet contains: Tadalafil 10mg , 20mg. 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 the 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 (10mg ) to be taken before sexual activity (30 min. to 12 hours) with or without food. If the effect of this dose is too weak, it may be increased to 20mg. The efficacy may persist up to 24 hours post - dose. Dosage adjustment 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 have 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 patients with cardiac state 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 galactose heredity 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 INTERACTION :
- 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 effect 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.
STORAGE INSTRUCTIONS :
Store below 30oC, in a dry place. Protect from light.
PRESENTATIONS :
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 Council of Arab Health Ministers Union of Arab Pharmacists 012-06-054 4/15 Mfd. By P.O. Box : 4265 Sana’a /Yemen.