Welfil – 20 (tadalafil)

WELFIL-20

COMPOSITION

Each film coated tablet contains

Tadalafil………………20mg

Excipients……………………………..q.s

 

Mode of action: Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the absence of sexual stimulation.

 

INDICATIONS: treatment of erectile dysfunction. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil is not indicated for use by women.

 

DOSAGE AND ADMINISTRATION: the dosage of Welfil is 10-20mg taken before sexual activity. The effect of the drug lasts up to 36 hours.

 

CONTRAINDICATIONS: Administration of tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated.

 

SIDE EFFECT: visual disturbance, ringing in the ears, hearing disturbances; chest pain or heavy feeling,light-headedness, priapism.

 

DRUG INTERACTIONS:

Serious interactions may occur if taken together with certain alpha-blocker medication (such as alfuzosin, doxazosin, prazosin, terazosin or doses greater than 0.4mg daily of tamsulosin); nitrates (e.g nitroglycerin, isosorbide); nitroprusside (or any nitric oxide “donor”drugs); recreational drugs called “poppers”containing amyl or butyl nitrite.

Non prescription/herbal drugs that affect certain liver enzymes(CYP 3A4 substrates, inhibitors and inducers such as cimetidine, rifampicin, St. John’s wort, or certain anti-seizure drugs), high blood pressure medicines, other medications for impotence.

Ritonavir, erythromycin, ketoconazole, or itraconazole (examples of potent inhibitors of CYP 3A4), do not take more than a 10mg dose of tadalafil in a 72 hour period

 

PRECAUTIONS & WARNINGS:

Heart problems such as Angina, Heart Failure, Irregular Heartbeat, or history of heart attack.

High or low blood pressure

Stroke

Liver or kidney problems

Severe vision loss, including a condition called Naion.

Retinitis pigmentosa.

A deformed penis shape or peyronie’s disease

Blood cell problems such as sickle cell anemia, multiple myeloma or leukemia.

 

OVERDOSAGE: single doses of 500mg have been given to given to                             healthy subjects and multiple daily doses up to 100mg have been given to patients. Adverse events were similar to those seen in lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

 

STORAGE: Store in a cool place and protect from light. keep out of children.

PRESENTATION: Blister of 4 tablets.