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.
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.