Composition:

Each 5 gm contains:

Sildenafil Citrate Eq. to Sildenafil…….100 mg

Excipients…………………………………………….Q.S.

Approved colour used

Pharmaceutical Form: Oral Jelly

Therapeutic indications: Seedios 0raI Jelly is indicated for adult men with erectile dysfunction, i.e. the inability to obtain or maintain a penile erection sufficient for satisfactory sexual performance. For Seedios 0raI Jelly to be effective, sexual stimulation is necessary.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamic properties: Pharmacotherapeutic group: Urologicals products; Drugs used in erectile dysfunction.

ATC code: G048E03.

Mechanism of action: Sildenafil is an oral treatment for erectile dysfunction. In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.

The physiological mechanism responsible for penile erection involves the release of nitric oxide (N0) in the corpora cavernosa during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, which is found in increased levels of cyclic guanosine monophosphate (cGMP), producing relaxation of smooth muscles in the corpora cavernosa and allowing blood flow.

Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDES) in the corpora cavernosa, where PDE5 is responsible for the degradation of cGMP. Sildenafil has a peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human cavernous bodies, but potently enhances the relaxant effect of N0 on this tissue. When the N0/cGMP pathway is activated, as occurs with sexual stimulation, PDE5 inhibition by sildenafil leads to increased cGMP corpus cavernosum levels. Therefore, sexual stimulation is necessary for sildenafil to produce the intended beneficial pharmacological effects.

Pharmacodynamic effects: In vitro studies have shown that sildenafil is selective for PDE5, which is involved in the erection process. Its effect is more potent on PDE5 than on other known phosphodiesterases.

Pharmacokinetic properties:

Absorption: Sildenafil is rapidly absorbed. Maximum plasma concentrations observed are reached after 30 to 120 minutes (median 80 minutes) of oral administration in the fasting state on an empty stomach. The mean absolute oral bioavailability is 41% (range 25-63%).

When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%.

Biotransformation: Sildenafil is mainly eliminated by microsomal isoenzymes h The main circulating metabolite results from the – demethylation of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to that of sildenafil and an in vitro PDE5 activity approximately SOS that of the parent drug. Plasma concentrations of this metabolite are approximately 406 of those observed for sildenafil. The N-desmethyl metabolite is further metabolized, with a terminal half-life of approximately 4 h.

Elimination: The total body clearance of sildenafil is 41 Ph. with a resultant terminal phase half-life of 3 5 h. After oral or intravenous administration, sildenafil is excreted in the form of metabolites mainly in the faeces and to a lesser extent in the urine.

CONTRAINDICATION: Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, sildenafil has been shown to potentiate the hypotensive effects of nitrates and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated. Co-administration of PDE inhibitors, including sildenafil, with guanylate mcyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable. Seedios Oral Jelly is contraindicated in patients who have vision loss in one eye due to non-arthritic anterior ischemic optic neuropathy (NAION), whether or not this episode is related to prior exposure to an inhibitor of PDE5. The safety of sildenafil has not been studied in the following patient subgroups and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa.

DOSAGE AND METHOD OF ADMINISTRATION:

Dosage Use in adults:

The recommended dose is (100mg/5g), taken as needed approximately one hour before sexual activity. If Seedios Oral Jelly is taken with food, the onset of activity may be delayed compared to the fasting state.

Special populations:

Elderly: No dose adjustment is necessary in elderly patients (65 years old)

Renal impairment: The dosage recommendations described in “Use in adults” apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 MI/min). Seedios Oral Jelly is not indicated for people under the age of 18.

Use in Patients Taking Other Medicines

Mode of administration: for oral use CYP3A4 (main route) and CYP2C9 (minor route).

WARNING & PRECAUTIONS: Do not consume more than one sachet of Seedios Oral Jelly per 24 hours. The same conditions and medications interfere with the natural erection process. The penis cannot fill with enough blood. The man cannot have an erection. This is called erectile dysfunction if it becomes a frequent problem. During sex, your heart works harder.

Therefore, sexual activity may not be recommended for people who have heart problems. Before starting treatment for erectile dysfunction, ask your doctor if your heart is healthy enough to handle the added stress of having sex. If you have chest pain, dizziness, or nausea during sex, stop having sex and tell your doctor right away that you’ve had this problem.

Seedios 0raI Jelly may cause a slight temporary drop in your blood pressure. You will need to undergo a thorough medical examination to diagnose your erectile dysfunction and find out if it is safe to take Seedios 0ral Jelly alone or with your other medications.

Be sure to tell your doctor if you:

have ever had heart problems (for example, angina, chest pain, heart failure, irregular heartbeat, heart attack, or narrowing of the aortic valve)

have ever had a stroke

have low or high blood pressure

have ever had severe vision loss

have a rare inherited eye disease called retinitis pigmentosa

have ever had kidney problems

have ever had liver problems

have ever had blood problems, including sickle cell anemia or leukemia are allergic to sildenafil (the active ingredient)

have a deformed penis, Peronei’s disease, or ever had an erection that lasted longer than 4 hour

have stomach ulcers or any kind of bleeding problems you are taking other medicines

Some medicines can affect the way Seedios Oral Jelly works. Tell your doctor about the medications you are taking. Do not start or stop taking medicine before consulting your doctor. Seedios 0raI Jelly should never be used with medicines containing nitrates. If you take medicines called alpha-blockers for the treatment of high blood pressure or prostate problems, your blood pressure may drop suddenly.

You may feel dizzy or pass out.

If you are taking a protease inhibitor or if your dose can be adjusted.

Seedios oral Jelly should not be used with other medical treatments that cause erections. These treatments include pills, drugs injected or inserted into the penis, implants or vacuum pumps.

Seedios 0raI Jelly only for patients with erectile dysfunction. It is not for newborns, children or women. Seedios 0raI Jelly does not protect you or your partner against sexually transmitted diseases, including HIV – the virus that causes AIDS. It is not a hormone or an aphrodisiac.

PREGNANCY, BREASTFEEDING AND FERTILITY:

Seedios oral Jelly is not indicated for women.

There are no adequate and well-controlled studies in pregnant or breastfeeding women. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.

SIDE EFFECTS:

Most Common Effects: In pre-approval clinical trials with sildenafil, as detailed by eMedTV, the most common side effect was headache, experienced by up to 16% of participants in some studies. Other adverse reactions reported in pre-approval clinical trials and anecdotally post-approval include dizziness, facial flushing, indigestion, upset stomach, diarrhea, nasal congestion, and infection of the throats. urinary tract. Cardiovascular problems: Sildenafil can cause problems for people with cardiovascular disease, as noted in the Physicians.

Desktop Reference (PDR). It has been associated with a fast or irregular heartbeat and therefore may not be safe for people with heart disease, angina pectoris, low or high blood pressure, arrhythmia or anyone who has suffered a heart attack or stroke in the past six months.

Vision side effects: Some men have experienced sudden vision loss after taking sildenafil, according to the J.S. National Institutes of Health (NIH). This may involve a decrease in vision, or a partial or total loss of vision. The condition has been permanent in some cases.

Other visual side effects reported by sildenafil users include blurred vision, eyes that are more sensitive to light, and changes in color vision, such as seeing a blue tint on objects or having difficulty distinguishing green from blue.

Priapism: Sildenafil has been linked to priapism, a condition involving a painful erection that lasts longer than six hours, as explained by the NIH. This side effect requires immediate medical attention, as it can cause permanent damage if left untreated.

Allergic reaction: Although unlikely, some people may experience an allergic reaction. Signs include a rash or hives, itching, difficulty breathing, and swelling of the face or mouth. Because it may contain other ingredients besides sildenafil as well as contaminants which may also cause allergic reactions.

PACKAGING: 4 sachets of 2 orange and 2 pineapple flavors of 5 g, each packed in a cardboard box with insert.

STORAGE: Store in a cool, dry place. Protect from light.

Keep all medicines out of reach of children.

Manufactured for:

CASTILLO INTERNATIONAL COMPANY FOR GENERAL TRADING AND CONTRACTING

Registered Office 321777

State of Kuwait, Sharq, Block 5,

Ahmad Al Jaber Street, Hamad Tower, Floor 12