COMPOSITION

Each chewable tablet contains: Tadalafil 5mg, 10mg.

DESCRIPTION

Golden Time (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.

INDICATIONS

Your doctor may have prescribed you Golden Time to treat either, or both of these conditions:

• Erectile dysfunction.
• Urinary symptoms associated with a common condition called benign prostatic hyperplasia.

DOSAGE & ADMINISTRATION

How to take Golden Time:

• Chew the tablet until you can comfortably swallow it.
• Golden Time efficacy may persist up to 36 hours after taking it.

For erectile dysfunction:

• Golden Time can be taken either on-demand or once-a-day.
• On-demand dosing: (10 mg or 20 mg) tablet before sexual activity (note: it is not recommended for continuous daily use).
• The maximum recommended dose for on-demand use is 20 mg, but those with kidney or liver disease should start with 10 mg. The dose may be increased up to 20 mg, but for patients with severe renal impairment, 10 mg is the maximum recommended dose. Patients with severe hepatic impairment should follow their doctor’s advice.
• Once-a-day dosing (5 mg) is for those who anticipate frequent use. Golden Time once-a-day (5mg) may take up to 1 week for a full effect on Erectile Dysfunction.

Notes:

• Don’t take once-a-day dosing and on-demand dosing concurrently.
• There are no special dosing considerations needed for the elderly or people with diabetes.

For urinary symptoms associated with Benign Prostate Hyperplasia (BPH):

• One tablet (5mg) daily (it must be taken daily at the same time to maintain its effect).

Notes:

• It may take up to a week to notice improvement or a month for full effects.
• Dosage adjustments are generally not needed for patients with kidney disease unless there’s severe renal impairment, in which case once-a-day dosing is not recommended. Similarly, once-a-day dosing is not advised for patients with severe hepatic (liver) impairment. Patients with liver disease should consult their doctor.
• Golden Time has no effect in the absence of sexual stimulation.

RESTRICTIONS ON USE

Contraindications

• Golden Time was shown to augment the hypotensive effects of nitrates so Golden Time should not be used in patients who are using any form of organic nitrate.
• Golden Time should not be used in patients with a known hypersensitivity to Tadalafil.
• Patients with unstable angina or angina occurring during sexual intercourse, uncontrolled arrhythmias, hypotension or uncontrolled hypertension, severe renal insufficiency (creatinine clearance < 30 ml / min) or severe hepatic insufficiency (Child - Pugh Class C).
• Patients have serious heart disease or recently had a heart attack with the last three months.
• Recent stroke during the last six months preceding the use of Tadalafil.
• Golden Time is not intended for use by women or by patients under the age of 18.
• Patients have heart or blood vessel problems that make sexual intercourse inadvisable or vision loss in one eye because of non-arteritic interior ischaemic optic neuropathy (NAION).
• Patients use recreational drugs called “poppers” or “amyl” like amyl nitrite and butyl nitrite that are normally taken through inhalation.
• Patients use guanylate cyclase stimulators such as riociguat, used to treat pulmonary arterial hypertension.

Precautions

• Tell your doctor if you have or have had any of the following medical conditions: liver or kidney problems, heart problems or if you have had a heart attack, blood vessel problems, sickle cell anaemia (an abnormality of red blood cells), multiple myeloma (cancer of the bone marrow), leukaemia (cancer of the blood cells), any deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or loss of vision in one or both eyes and decreased or sudden hearing loss.
• 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 Golden Time is administered to patients with galactose heredity intolerance and if you have chest pain, or other heart-related symptoms during sex, seek immediate medical help.

Effects on ability to drive and use machines:

Golden Time might make some people feel dizzy or affect their vision; if you feel dizzy, or if your vision is affected after taking Golden Time, don’t drive or operate any tools or machines.

DRUG INTERACTION

The caution should be taken when coadministering Golden Time with the following drugs:

• Ketoconazole and etraconazole increased Golden Time AUC by 107% while Rifampicin reduced Tadalafil AUC by 88%.
• Tadalafil was shown to augment the hypotensive effects of nitrates such as glyceryl trinitrate, isosorbide mononitrate and sodium nitroprusside.
• Tadalafil does not affect CYP450 isomers, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, and CYP2C9.
• Golden Time had no clinically significant effect on exposure (AUC) to S-Warfarin or R-Warfarin.
• Some medicines may be affected by Golden Time or may affect how it works, these include: erythromycin, clarithromycin, phenytoin, phenobarbitone, carbamazepine, ritonavir, saquinavir, metoprolol, irbesartan, enalapril, prazosin, doxazosin, finasteride, high doses of alcohol, grapefruit juice, riociguat and other PDE5 inhibitors such as sildenafil.
• You should not take Golden Time together with any other treatments for erectile dysfunction.

ADVERSE EFFECTS

• Common: Headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
• Uncommon: Dizziness, stomach ache, feeling sick, vomiting, reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
• Rare: Fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

STORAGE INSTRUCTIONS

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

PRESENTATIONS

• Golden Time 5mg: packs of different sizes.
• Golden Time 10mg: packs of different sizes.