Kamastil^® (Tablets) Instructions for Use

Marketing Authorization Holder

Hetero Labs, Limited (India)

Manufactured By

Hetero Labs, Limited (India)

Labeled By

MAKIZ-PHARMA, LLC (Russia)

ATC Code

G04BE03 (Sildenafil)

Active Substance

Sildenafil

Dosage Forms

	Kamastil®	Film-coated tablets, 25 mg: 1, 2, 3, 4, 8 or 12 pcs.
		Film-coated tablets, 50 mg: 1, 2, 3, 4, 8 or 12 pcs.
		Film-coated tablets, 50 mg: 1, 2, 4, 8, 10 or 20 pcs.
		Film-coated tablets, 100 mg: 1, 2, 3, 4, 8 or 12 pcs.
		Film-coated tablets, 100 mg: 1, 2, 4, 8, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue, diamond-shaped, biconvex, with an engraving on one side “I” and on the other “35”; on the cross-section, the tablet core is white or almost white.

Excipients: microcrystalline cellulose – 74 mg, anhydrous calcium hydrogen phosphate – 33.88 mg, croscarmellose sodium – 9 mg, magnesium stearate – 3 mg.

Shell composition Opadry II 31K80956 blue (lactose monohydrate – 40%, hypromellose HPMC 2910 (E464) – 28%, titanium dioxide (E171) – 20.5%, triacetin – 8%, blue/indigo carmine dye (E132) – 3.5%) – 4.65 mg, opadry clear 02K19253 (hypromellose HPMC 2910 (E464) -90%, triacetin – 10%) – 0.8 mg.

1 pc. – PVC/aluminum foil blisters (1) – cardboard packs.
1 pc. – PVC/aluminum foil blisters (2) – cardboard packs.
1 pc. – PVC/aluminum foil blisters (3) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (1) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (2) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (3) – cardboard packs.

Film-coated tablets blue, diamond-shaped, biconvex, with an engraving on one side “I” and on the other “36”; on the cross-section, the tablet core is white or almost white.

Excipients: microcrystalline cellulose – 148 mg, anhydrous calcium hydrogen phosphate – 67.76 mg, croscarmellose sodium – 18 mg, magnesium stearate – 6 mg.

Shell composition Opadry II 31K80956 blue (lactose monohydrate – 40%, hypromellose HPMC 2910 (E464) – 28%, titanium dioxide (E171) – 20.5%, triacetin – 8%, blue/indigo carmine dye (E132) – 3.5%) – 9.3 mg, opadry clear 02K19253 (hypromellose HPMC 2910 (E464) -90%, triacetin – 10%) – 1.6 mg.

1 pc. – PVC/aluminum foil blisters (1) – cardboard packs.
1 pc. – PVC/aluminum foil blisters (2) – cardboard packs.
1 pc. – PVC/aluminum foil blisters (3) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (1) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (2) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (3) – cardboard packs.

Film-coated tablets blue, diamond-shaped, biconvex, with an engraving on one side “I” and on the other “36”; on the cross-section, the tablet core is white or almost white.

Excipients: microcrystalline cellulose – 148 mg, anhydrous calcium hydrogen phosphate – 67.76 mg, croscarmellose sodium – 18 mg, magnesium stearate – 6 mg.

Shell composition Opadry II 31K80956 blue (lactose monohydrate – 40%, hypromellose HPMC 2910 (E464) – 28%, titanium dioxide (E171) – 20.5%, triacetin – 8%, blue/indigo carmine dye (E132) – 3.5%) – 9.3 mg, opadry clear 02K19253 (hypromellose HPMC 2910 (E464) -90%, triacetin – 10%) – 1.6 mg.

1 pc. – contour cell packaging (1) – cardboard packs.
4 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.

Film-coated tablets blue, diamond-shaped, biconvex, with an engraving on one side “I” and on the other “58”; on the cross-section, the tablet core is white or almost white.

Excipients: microcrystalline cellulose – 296 mg, anhydrous calcium hydrogen phosphate – 135.52 mg, croscarmellose sodium – 36 mg, magnesium stearate – 12 mg.

Shell composition Opadry II 31K80956 blue (lactose monohydrate – 40%, hypromellose HPMC 2910 (E464) – 28%, titanium dioxide (E171) – 20.5%, triacetin – 8%, blue/indigo carmine dye (E132) – 3.5%) – 18.6 mg, opadry clear 02K19253 (hypromellose HPMC 2910 (E464) -90%, triacetin – 10%) – 3.19 mg.

1 pc. – PVC/aluminum foil blisters (1) – cardboard packs.
1 pc. – PVC/aluminum foil blisters (2) – cardboard packs.
1 pc. – PVC/aluminum foil blisters (3) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (1) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (2) – cardboard packs.
4 pcs. – PVC/aluminum foil blisters (3) – cardboard packs.

Film-coated tablets blue, diamond-shaped, biconvex, with an engraving on one side “I” and on the other “58”; on the cross-section, the tablet core is white or almost white.

Excipients: microcrystalline cellulose – 296 mg, anhydrous calcium hydrogen phosphate – 135.52 mg, croscarmellose sodium – 36 mg, magnesium stearate – 12 mg.

Shell composition Opadry II 31K80956 blue (lactose monohydrate – 40%, hypromellose HPMC 2910 (E464) – 28%, titanium dioxide (E171) – 20.5%, triacetin – 8%, blue/indigo carmine dye (E132) – 3.5%) – 18.6 mg, opadry clear 02K19253 (hypromellose HPMC 2910 (E464) -90%, triacetin – 10%) – 3.19 mg.

1 pc. – contour cell packaging (1) – cardboard packs.
4 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Erectile dysfunction treatment drug. PDE5 inhibitor

Pharmacotherapeutic Group

Erectile dysfunction treatment agent – PDE5 inhibitor

Pharmacological Action

A potent selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific PDE5.

The realization of the physiological mechanism of erection is associated with the release of NO in the corpus cavernosum during sexual stimulation. This, in turn, leads to an increase in cGMP levels, subsequent relaxation of the smooth muscle tissue of the corpus cavernosum, and increased blood flow.

Sildenafil does not have a direct relaxing effect on the isolated human corpus cavernosum but enhances the effect of NO by inhibiting PDE5, which is responsible for the breakdown of cGMP.

Sildenafil is selective for PDE5 in vitro; its activity against PDE5 exceeds its activity against other known phosphodiesterase isoenzymes: PDE6 – by 10 times; PDE1 – by more than 80 times; PDE2, PDE4, PDE7-PDE11 – by more than 700 times. Sildenafil is 4000 times more selective for PDE5 compared to PDE3, which is of utmost importance since PDE3 is one of the key enzymes regulating myocardial contractility.

A prerequisite for the effectiveness of sildenafil is sexual stimulation.

Pharmacokinetics

The pharmacokinetics of sildenafil in the recommended dose range are linear.

After oral administration, Sildenafil is rapidly absorbed. The absolute bioavailability averages about 40% (from 25% to 63%). In vitro, Sildenafil at a concentration of about 1.7 ng/ml (3.5 nM) inhibits human PDE5 activity by 50%. After a single dose of sildenafil 100 mg, the mean C_max of free sildenafil in plasma of men is about 18 ng/ml (38 nM). C_max after oral administration of sildenafil on an empty stomach is reached on average within 60 min (from 30 min to 120 min). When taken with a high-fat meal, the rate of absorption decreases: C_max decreases by an average of 29%, and T_max increases by 60 min, but the extent of absorption does not change significantly (AUC decreases by 11%).

The V_d of sildenafil at steady state averages 105 L. The binding of sildenafil and its main circulating N-desmethyl metabolite to plasma proteins is about 96% and does not depend on the total concentration of the drug. Less than 0.0002% of the sildenafil dose (average 188 ng) was found in semen 90 minutes after drug administration.

Sildenafil is metabolized mainly in the liver by the cytochrome CYP3A4 isoenzyme (main pathway) and the cytochrome CYP2C9 isoenzyme (minor pathway). The main circulating active metabolite, formed as a result of N-desmethylation of sildenafil, undergoes further metabolism. The selectivity of this metabolite for PDE is comparable to that of sildenafil, and its activity against PDE5 in vitro is about 50% of the activity of sildenafil. The plasma concentration of the metabolite in healthy volunteers was about 40% of the sildenafil concentration. The N-desmethyl metabolite undergoes further metabolism; T_1/2 is about 4 h.

The total clearance of sildenafil is 41 L/h, and the terminal T_1/2 is 3-5 h. After oral administration, as well as after IV administration, Sildenafil is excreted as metabolites, mainly in the feces (about 80% of the oral dose) and, to a lesser extent, in the urine (about 13% of the oral dose).

Indications

Treatment of erectile dysfunction characterized by the inability to achieve or maintain a penile erection sufficient for satisfactory sexual intercourse.

Sildenafil is effective only with sexual stimulation.

ICD codes

Dosage Regimen

Take orally approximately one hour before sexual activity.

The recommended starting dose for most adult patients is 50 mg.

Adjust the dose based on efficacy and tolerability.

Increase the dose to a maximum of 100 mg for insufficient response.

Decrease the dose to 25 mg if side effects are not tolerated.

Do not exceed the maximum recommended dose of 100 mg.

Limit administration to a maximum of once per day.

For patients with hepatic impairment (such as cirrhosis) or severe renal impairment (CrCl <30 mL/min), reduce the sildenafil dose.

In patients taking potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir), a starting dose of 25 mg should be considered.

Concomitant use with alpha-adrenergic blockers may increase the risk of symptomatic hypotension; initiate sildenafil treatment only after the patient is hemodynamically stable on alpha-blocker therapy.

Avoid use with any form of organic nitrates or nitric oxide donors; this combination is contraindicated.

The onset of action may be delayed if taken with a high-fat meal.

Sildenafil is effective only in the presence of sexual stimulation.

Adverse Reactions

Immune system disorders uncommon – hypersensitivity reactions (including skin rash), allergic reactions.

Blood and lymphatic system disorders uncommon – anemia, leukopenia.

Metabolism and nutrition disorders uncommon – feeling of thirst, edema, gout, uncontrolled diabetes mellitus, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.

Eye disorders common – blurred vision, visual impairment, cyanopsia; uncommon – eye pain, photophobia, photopsia, chromatopsia, eye redness/scleral injection, change in brightness perception, mydriasis, conjunctivitis, ocular hemorrhage, cataract, lacrimal apparatus disorder; rare – eyelid and periorbital edema, feeling of dryness in the eyes, seeing halos around lights, eye fatigue, yellow vision (xanthopsia), red vision (erythropsia), conjunctival hyperemia, eye irritation, eye discomfort; frequency unknown – non-arteritic anterior ischemic optic neuropathy, retinal vein occlusion, visual field defect, diplopia*, temporary loss of vision or decreased visual acuity, increased intraocular pressure, retinal edema, retinal vascular disease, vitreous detachment/vitreous traction.

Ear and labyrinth disorders uncommon – sudden hearing loss or impairment, tinnitus, ringing in the ears, ear pain.

Nervous system disorders very common – headache; common – dizziness; uncommon – drowsiness, migraine, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depressive symptoms, insomnia, unusual dreams, hyperreflexia, hypoesthesia; rare – seizures, recurrent seizures, syncope, cerebrovascular accident, transient ischemic attack.

Cardiac disorders common – flushing; uncommon – tachycardia, palpitations, decreased or increased blood pressure, increased heart rate, unstable angina, AV block, myocardial infarction, cerebral vascular thrombosis, cardiac arrest, heart failure, abnormal ECG findings, cardiomyopathy; rare – atrial fibrillation, sudden cardiac death, ventricular arrhythmia.

Respiratory, thoracic and mediastinal disorders common – nasal congestion; uncommon – epistaxis, rhinitis, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum volume, increased cough; rare – throat tightness, dryness of the nasal mucosa, swelling of the nasal mucosa.

Gastrointestinal disorders common – nausea, dyspepsia; uncommon – gastroesophageal reflux disease, vomiting, abdominal pain, dry mouth, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, abnormal liver function tests, rectal bleeding; rare – hypoesthesia of the oral mucosa.

Musculoskeletal and connective tissue disorders common – back pain; uncommon – myalgia, limb pain, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.

Renal and urinary disorders uncommon – cystitis, nocturia, urinary incontinence, hematuria.

Reproductive system and breast disorders uncommon – breast enlargement, ejaculation disorder, genital edema, anorgasmia, hematospermia, penile tissue damage; rare – prolonged erection and/or priapism, penile bleeding.

Skin and subcutaneous tissue disorders uncommon – skin rash, urticaria, herpes simplex, pruritus, hyperhidrosis, skin ulceration, contact dermatitis, exfoliative dermatitis; frequency unknown – Stevens-Johnson syndrome, toxic epidermal necrolysis.

General disorders and administration site conditions uncommon – feeling hot, facial edema, photosensitivity reaction, shock, asthenia, increased fatigue, pain of various localization, chills, accidental falls, chest pain, accidental injuries; rare – irritability.

Contraindications

Hypersensitivity to sildenafil; use in patients receiving continuous or intermittent nitric oxide donors, organic nitrates or nitrites in any form, since Sildenafil enhances the hypotensive effect of nitrates; children and adolescents under 18 years of age; for the registered indication, Sildenafil is not intended for use in women; concomitant use of sildenafil with ritonavir, with other agents for the treatment of erectile dysfunction is not recommended.

With caution

Anatomical deformation of the penis (angulation, cavernous fibrosis, or Peyronie’s disease); conditions predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia); diseases accompanied by bleeding; exacerbation of gastric and duodenal ulcer; retinitis pigmentosa; heart failure, unstable angina, myocardial infarction, stroke, or life-threatening arrhythmias within the last 6 months, arterial hypertension (BP >170/100 mmHg) or hypotension (BP <90/50 mmHg); in patients with a history of non-arteritic anterior ischemic optic neuropathy.

Use in Pregnancy and Lactation

For the registered indication, it is not intended for use in women.

Use in Hepatic Impairment

Since the elimination of sildenafil is impaired in patients with liver damage (particularly cirrhosis), the dose of Sildenafil should be reduced.

Use in Renal Impairment

In mild to moderate renal impairment (CrCl 30-80 ml/min), dose adjustment is not required; in severe renal impairment (CrCl <30 ml/min), the sildenafil dose should be reduced.

Pediatric Use

For the registered indication, Sildenafil is not intended for use in children and adolescents under 18 years of age.

Geriatric Use

Dose adjustment of sildenafil in elderly patients is not required.

Special Precautions

To diagnose erectile dysfunction, determine its possible causes, and select adequate treatment, it is necessary to collect a complete medical history and conduct a thorough physical examination. Erectile dysfunction treatment agents should be used with caution in patients with anatomical deformation of the penis (angulation, cavernous fibrosis, Peyronie’s disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia).

Drugs intended for the treatment of erectile dysfunction should not be prescribed to men for whom sexual activity is undesirable.

Sexual activity poses a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the physician should refer the patient for a cardiovascular assessment. Sexual activity is undesirable in patients with heart failure, unstable angina, myocardial infarction or stroke within the last 6 months, life-threatening arrhythmias, arterial hypertension (BP >170/100 mmHg) or hypotension (BP <90/50 mmHg).

During post-marketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as serious cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension, and hypotension) have been reported, which had a temporal relationship with the use of sildenafil. Most, but not all, of these patients had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some were reported after taking sildenafil without subsequent sexual activity. It is not possible to establish a direct causal relationship between the reported adverse events and the mentioned or other factors.

Sildenafil has a systemic vasodilatory effect, leading to a transient decrease in blood pressure, which is not a clinically significant phenomenon and does not lead to any consequences in most patients. However, before starting sildenafil, the physician should carefully assess the risk of possible adverse manifestations of the vasodilatory effect in patients with relevant conditions, especially in the context of sexual activity. Increased susceptibility to vasodilators is observed in patients with left ventricular outflow tract obstruction ( aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as with the rare multiple system atrophy syndrome, which manifests as severe impairment of blood pressure regulation by the autonomic nervous system.

Concomitant use of sildenafil and alpha-adrenergic blockers may lead to symptomatic arterial hypotension in some sensitive patients. Sildenafil should be used with caution in patients receiving alpha-adrenergic blockers. To minimize the risk of developing postural hypotension in patients taking alpha-adrenergic blockers, sildenafil should be initiated only after hemodynamic stabilization has been achieved in these patients. The advisability of reducing the initial dose of sildenafil should also be considered. The physician should inform patients about what actions to take in case symptoms of postural hypotension appear.

Rare cases of non-arteritic anterior ischemic optic neuropathy as a cause of worsening or loss of vision have been noted with the use of all PDE5 inhibitors, including Sildenafil. Most of these patients had risk factors such as optic disc cupping, age over 50 years, diabetes mellitus, arterial hypertension, coronary artery disease, hyperlipidemia, and smoking. No causal relationship has been established between the use of PDE5 inhibitors and the development of non-arteritic anterior ischemic optic neuropathy. The physician should inform the patient about the increased risk of developing non-arteritic anterior ischemic optic neuropathy if this condition has been previously noted. In case of sudden vision loss, patients should seek immediate medical attention. A small number of patients with hereditary retinitis pigmentosa have genetically determined impairments of retinal PDE function. Data on the safety of sildenafil use in patients with retinitis pigmentosa are lacking; therefore, Sildenafil should be used with caution.

In case of sudden hearing deterioration or hearing loss while taking sildenafil, a physician should be consulted immediately.

Sildenafil enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donor, on human platelets in vitro. Data on the safety of sildenafil use in patients with a tendency to bleeding or exacerbation of peptic ulcer disease are lacking; therefore, Sildenafil should be used with caution in these patients. The frequency of epistaxis in patients with pulmonary hypertension associated with diffuse connective tissue diseases was higher than in patients with primary pulmonary hypertension (Sildenafil 3%, placebo 2.4%). In patients receiving Sildenafil in combination with a vitamin K antagonist, the frequency of epistaxis was higher (8.8%) than in patients not taking a vitamin K antagonist (1.7%).

Effect on the Ability to Drive Vehicles and Operate Machinery

Since taking sildenafil may lead to a decrease in blood pressure, development of chromatopsia, blurred vision, and other side effects, careful attention should be paid to the individual’s reaction to the drug in these situations, especially at the start of treatment and when changing the dosage regimen.

Drug Interactions

The metabolism of sildenafil occurs primarily with the participation of the CYP3A4 isoenzyme (main pathway) and CYP2C9; therefore, inhibitors of these isoenzymes may reduce the clearance of sildenafil, and inducers, respectively, may increase the clearance of sildenafil. A decrease in the clearance of sildenafil has been noted with the simultaneous use of inhibitors of the cytochrome CYP3A4 isoenzyme ( ketoconazole, erythromycin, cimetidine). Cimetidine (800 mg), a non-specific inhibitor of the cytochrome CYP3A4 isoenzyme, when taken concomitantly with sildenafil (50 mg), causes a 56% increase in sildenafil plasma concentration. A single dose of sildenafil 100 mg taken with erythromycin (500 mg twice daily for 5 days), a specific inhibitor of the cytochrome CYP3A4 isoenzyme, against the background of achieving a steady-state concentration of erythromycin in the blood, leads to a 182% increase in the AUC of sildenafil.

When sildenafil (single dose 100 mg) and saquinavir (1200 mg three times daily), an HIV protease inhibitor and inhibitor of the cytochrome CYP3A4 isoenzyme, were taken concomitantly against the background of achieving a steady-state concentration of saquinavir in the blood, the C_max of sildenafil increased by 140%, and the AUC increased by 210%. Sildenafil does not affect the pharmacokinetics of saquinavir.

Stronger inhibitors of the cytochrome CYP3A4 isoenzyme, such as ketoconazole and itraconazole, may cause more pronounced changes in the pharmacokinetics of sildenafil.

Simultaneous use of sildenafil (single dose 100 mg) and ritonavir (500 mg twice daily), an HIV protease inhibitor and a strong inhibitor of cytochrome P450, against the background of achieving a steady-state concentration of ritonavir in the blood, leads to an increase in the C_max of sildenafil by 300% (4-fold), and the AUC by 1000% (11-fold). After 24 hours, the plasma concentration of sildenafil is about 200 ng/ml (after a single dose of sildenafil alone – 5 ng/ml), which is consistent with information about the pronounced effect of ritonavir on the pharmacokinetics of various cytochrome P450 substrates. Sildenafil does not affect the pharmacokinetics of ritonavir. Concomitant use of sildenafil with ritonavir is not recommended.

If Sildenafil is taken at recommended doses by patients who are simultaneously receiving strong inhibitors of the cytochrome CYP3A4 isoenzyme, then the C_max of free sildenafil does not exceed 200 nM, and the drug is well tolerated.

A single dose of an antacid ( magnesium hydroxide/aluminum hydroxide) does not affect the bioavailability of sildenafil.

Inhibitors of the cytochrome CYP2C9 isoenzyme ( tolbutamide, warfarin), the cytochrome CYP2D6 isoenzyme ( selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and thiazide-like diuretics, ACE inhibitors, and calcium channel blockers do not affect the pharmacokinetics of sildenafil.

Azithromycin (500 mg/day for 3 days) does not affect the AUC, C_max, T_max, elimination rate constant, and T_1/2 of sildenafil or its main circulating metabolite.

Sildenafil is a weak inhibitor of the cytochrome P450 isoenzymes -1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 (IC₅₀>150 µmol). When sildenafil is taken at recommended doses, its C_max is about 1 µmol; therefore, it is unlikely that Sildenafil can affect the clearance of substrates of these isoenzymes.

Sildenafil enhances the hypotensive effect of nitrates, both during their long-term use and when prescribed for acute indications. In this regard, the use of sildenafil in combination with nitrates or nitric oxide donors is contraindicated.

With the simultaneous administration of the alpha-adrenergic blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, and 100 mg) in patients with benign prostatic hyperplasia with stable hemodynamics, the mean additional reduction in supine systolic/diastolic blood pressure was 7/7 mm Hg, 9/5 mm Hg, and 8/4 mm Hg, respectively, and in the standing position – 6/6 mm Hg, 11/4 mm Hg, and 4/5 mm Hg, respectively. Rare cases of symptomatic postural hypotension, manifested as dizziness (without syncope), have been reported in such patients. In some sensitive patients receiving alpha-adrenergic blockers, simultaneous use of sildenafil may lead to symptomatic hypotension.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.