Jenetten^® (Tablets) Instructions for Use

Marketing Authorization Holder

Jenapharm, GmbH & Co. KG (Germany)

Manufactured By

Schering, GmbH & Co. Produktions KG (Germany)

ATC Code

G03FA15 (Dienogest and estrogens)

Active Substances

Ethinylestradiol (Rec.INN registered by WHO)

Dienogest (Rec.INN registered by WHO)

Dosage Form

Jenetten®

Tablets, coated 30 mcg+2 mg: 21 or 63 pcs.

Dosage Form, Packaging, and Composition

21 pcs. – blisters (1) – cardboard packs.
21 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Monophasic oral contraceptive with antiandrogenic properties

Pharmacotherapeutic Group

Contraceptive agent (estrogen + progestagen)

Pharmacological Action

Jenetten^® is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

The contraceptive effect of Jenetten^® is achieved through complementary mechanisms, the most important of which are suppression of ovulation and an increase in the viscosity of cervical mucus, making it impenetrable to sperm.

When used correctly, the Pearl index (an indicator reflecting the number of pregnancies per 100 women per year of contraceptive use) is less than 1. If tablets are missed or used incorrectly, the Pearl index may increase.

The progestogenic component of Jenetten^®, Dienogest, has antiandrogenic activity, which has been confirmed by the results of a number of clinical studies. In addition, Dienogest improves the blood lipid profile (increases the amount of high-density lipoproteins).

In women taking combined oral contraceptives (COCs), the pain and intensity of menstrual-like bleeding are reduced, thereby lowering the risk of iron deficiency anemia. Furthermore, there is evidence of a reduced risk of endometrial and ovarian cancer.

Pharmacokinetics

Dienogest

Absorption. When taken orally, Dienogest is rapidly and completely absorbed, with a C_max of 51 ng/mL reached in approximately 2.5 hours. Bioavailability is approximately 96%.

Distribution. Dienogest binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (CBG). About 10% of the total serum concentration is in the free form; about 90% is non-specifically bound to serum albumin.

Induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to plasma proteins.

Metabolism. Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 L/h.

Excretion. The elimination half-life is about 8.5-10.8 hours. A small amount is excreted unchanged by the kidneys as metabolites (elimination half-life – 14.4 hours), which are excreted by the kidneys and through the gastrointestinal tract in a ratio of approximately 3:1.

Steady-state concentration. The pharmacokinetics of dienogest are not influenced by the SHBG serum level. As a result of daily intake, the serum concentration of dienogest increases by approximately 1.5 times.

Ethinylestradiol

Absorption. After oral administration, Ethinylestradiol is rapidly and completely absorbed. The maximum serum concentration, approximately 67 pg/mL, is reached within 1.5-4 hours. During absorption and first-pass metabolism in the liver, Ethinylestradiol is metabolized, resulting in an average oral bioavailability of about 44%.

Distribution. Ethinylestradiol is almost completely (approximately 98%), although non-specifically, bound to albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinylestradiol is 2.8-8.6 L/kg.

Metabolism. Ethinylestradiol undergoes presystemic conjugation, both in the small intestinal mucosa and in the liver. The main metabolic pathway is aromatic hydroxylation. The plasma clearance rate is 2.3-7 mL/min/kg.

Excretion. The decrease in serum ethinylestradiol concentration is biphasic; the first phase is characterized by a half-life of about 1 hour, the second – 10-20 hours. It is not excreted unchanged from the body. Metabolites of ethinylestradiol are excreted by the kidneys and through the gastrointestinal tract in a ratio of 4:6 with a T_1/2 of about 24 hours.

Steady-state concentration. Steady-state concentration is reached during the second half of the treatment cycle.

Indications

• Contraception;
• Treatment of mild to moderate acne and seborrhea in women requiring contraception.

ICD codes

Dosage Regimen

The tablets should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Take one tablet daily continuously for 21 days. The intake of tablets from the next package starts after a 7-day break in tablet intake, during which menstrual-like bleeding usually occurs. Bleeding typically begins on the 2nd-3rd day after taking the last tablet and may not end before starting the tablets from the new package.

Starting treatment with Jenetten^®

If no hormonal contraceptives were taken in the previous month.

Jenetten^® should be started on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is permissible to start on the 2nd-5th day of the menstrual cycle, but in this case, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking tablets from the first package.

When switching from other combined hormonal contraceptives (COC, vaginal ring, transdermal patch).

It is preferable to start taking Jenetten^® on the day after taking the last hormone-containing tablet from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per package). When switching from a vaginal ring or transdermal patch, it is preferable to start taking Jenetten^® on the day the ring is removed or a new patch is applied.

When switching from progestogen-only contraceptives (“mini-pill”, injectable forms, implant) or from a progestogen-releasing intrauterine contraceptive.

A woman can switch from the mini-pill to Jenetten^® on any day (without a break), from an implant or progestogen-containing intrauterine contraceptive – on the day of its removal, from an injectable form – from the day the next injection would have been due. In all cases, it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the tablets.

After a first-trimester abortion.

The woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

After childbirth or a second-trimester abortion.

It is recommended to start taking the drug on the 21st-28th day after childbirth or a second-trimester abortion. If intake is started later, it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the tablets. However, if the woman has already been sexually active, pregnancy must be excluded before starting Jenetten^®, or she must wait for the first menstruation.

Taking missed tablets

If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced. The woman should take the tablet as soon as possible, and the next one is taken at the usual time.

If the delay in taking the tablets is more than 12 hours, contraceptive protection may be reduced. In this case, the following two basic rules can be followed:

• Intake of the drug should never be interrupted for more than 7 days;
• 7 days of continuous tablet intake are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian function.

Accordingly, the following advice can be given if the delay in taking the tablets is more than 12 hours (the interval since the last tablet was taken is more than 36 hours):

First week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if this means taking two tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (e.g., a condom) must be used for the next 7 days. If sexual intercourse occurred during the week before missing the tablets, the possibility of pregnancy must be considered. The more tablets are missed and the closer they are to the break in taking active substances, the higher the probability of pregnancy.

Second week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if this means taking two tablets at the same time). The next tablet is taken at the usual time.

Provided that the woman has taken the tablets correctly for the 7 days preceding the first missed tablet, there is no need to use additional contraceptive measures. Otherwise, and also if two or more tablets are missed, it is necessary to additionally use barrier methods of contraception (e.g., a condom) for 7 days.

Third week of taking the drug

The risk of reduced reliability is inevitable due to the upcoming break in tablet intake. The woman must strictly adhere to one of the following two options. In this case, if all tablets were taken correctly during the 7 days preceding the first missed tablet, there is no need to use additional contraceptive methods.

1. The woman should take the last missed tablet as soon as she remembers (even if this means taking two tablets at the same time). The next tablet is taken at the usual time until the tablets from the current package are finished. The next package should be started immediately. Menstrual-like bleeding is unlikely until the second package is finished, but spotting and breakthrough uterine bleeding may occur while taking the tablets.

2. The woman can also interrupt taking the tablets from the current package. Then she should take a 7-day break, including the day of the missed tablet, and then start a new package.

If a woman missed taking a tablet and then does not have menstrual-like bleeding during the tablet break, pregnancy must be excluded.

Recommendations in case of vomiting and diarrhea

If a woman had vomiting or diarrhea within 4 hours of taking a tablet, absorption may be incomplete, and additional contraceptive measures must be taken. In these cases, the recommendations for missed tablets should be followed (see “Taking missed tablets”).

Changing the day of onset of menstrual-like bleeding

To delay the onset of menstrual-like bleeding, the woman should continue taking tablets from a new package of Jenetten^® immediately after all tablets from the previous one have been taken, without a break in intake. Tablets from this new package can be taken for as long as the woman wishes (until the package is finished). While taking the drug from the second package, the woman may experience spotting or breakthrough uterine bleeding. Resumption of taking Jenetten^® from a new pack should be after the usual 7-day break.

To move the day of onset of menstrual-like bleeding to another day of the week, the woman should shorten the nearest break in taking tablets by as many days as she wants. The shorter the interval, the higher the risk that she will not have menstrual-like bleeding, and subsequently, there will be spotting and breakthrough uterine bleeding while taking the second package (just as in the case when she wants to delay the onset of menstrual-like bleeding).

Information for specific patient groups

Children and adolescents

Jenetten^® is indicated only after menarche.

Elderly patients

Not applicable. Jenetten^® is not indicated after menopause.

Patients with impaired liver function

Jenetten^® is contraindicated in women with severe liver disease until liver function tests return to normal. See also the section “Contraindications”.

Patients with impaired renal function

Jenetten^® has not been specifically studied in patients with impaired renal function. Available data do not suggest a change in treatment for such patients.

Adverse Reactions

When taking Jenetten^®, irregular bleeding (spotting or breakthrough uterine bleeding) may occur, especially during the first months of use.

While taking Jenetten^®, women have experienced other adverse effects listed in the table below. Within each frequency group, adverse effects are presented in order of decreasing severity.

By frequency, adverse effects are divided into common (>1/100 and <1/10), uncommon (>1/1000 and <1/100) and rare (>1/10000 and <1/1000). For additional adverse effects identified only during post-marketing surveillance and for which frequency estimation is not possible, "frequency unknown" is indicated.

Contraindications

The drug Jenetten^® should not be used in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time during its use, the drug should be discontinued immediately.

• Thromboses (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), stroke;
• Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) currently or in history;
• Migraine with focal neurological symptoms currently or in history;
• Diabetes mellitus with vascular complications;
• Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the heart valves, atrial fibrillation, cerebrovascular or coronary artery diseases; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35;
• Hepatic insufficiency and severe liver diseases (until liver function tests normalize);
• Liver tumors (benign or malignant) currently or in history;
• Pancreatitis with severe hypertriglyceridemia currently or in history;
• Identified hormone-dependent malignant neoplasms (including of the genital organs or mammary glands) or suspicion thereof;
• Vaginal bleeding of unknown origin;
• Pregnancy or suspected pregnancy;
• Breastfeeding period;
• Hypersensitivity to any component of the drug Jenetten^®;
• The drug Jenetten^® contains lactose, therefore patients with rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take it.

With caution: the potential risk and expected benefit of using the drug Jenetten^® should be carefully weighed in each individual case in the presence of the following diseases/conditions and risk factors

• Risk factors for thrombosis and thromboembolism: smoking (under the age of 35); obesity; dyslipoproteinemia, controlled arterial hypertension; migraine without focal neurological symptoms; uncomplicated heart valve defects; hereditary predisposition to thrombosis (thromboses, MI or cerebrovascular accident at a young age in any first-degree relatives);
• Other diseases in which peripheral circulation disorders may be noted: diabetes mellitus; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn’s disease and ulcerative colitis; sickle cell anemia; superficial phlebitis;
• Hereditary angioedema;
• Hypertriglyceridemia;
• Diseases that first occurred or worsened during pregnancy or during previous use of sex hormones (e.g., jaundice, cholestasis, gallbladder diseases, otosclerosis with hearing impairment, porphyria, herpes gestationis, Sydenham’s chorea);
• Postpartum period.

Use in Pregnancy and Lactation

The drug Jenetten^® is not prescribed during pregnancy and breastfeeding.

If pregnancy is detected while taking Jenetten^®, it should be discontinued immediately. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or a teratogenic effect when sex hormones were taken inadvertently in early pregnancy. The use of COCs may reduce the amount of breast milk and change its composition, therefore their use is contraindicated during lactation. A small amount of sex hormones and/or their metabolites may be excreted in milk, but there is no confirmation of their negative impact on the health of the infant.

Use in Hepatic Impairment

Contraindicated

• Hepatic insufficiency and severe liver diseases (until liver function tests normalize);
• Liver tumors (benign or malignant) currently or in history.

In rare cases, the development of liver tumors has been observed during the use of COCs, which in some cases led to life-threatening intra-abdominal internal bleeding. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be considered during differential diagnosis.

Pediatric Use

The drug Jenetten^® is indicated only after menarche.

Special Precautions

If any of the conditions, diseases and risk factors listed below are currently present, then the potential risk and expected benefit of using the drug Jenetten^® should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. In case of worsening, intensification or first manifestation of any of these conditions, diseases or risk factors, the woman should consult a doctor who may decide on the need to discontinue the drug.

Cardiovascular diseases

Results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as DVT, PE, MI, cerebrovascular disorders). These diseases are rare.

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking such drugs, mainly during the first 3 months. An increased risk is noted after initial use of COCs or resumption of use of the same or different COCs (after a break in taking the drug of 4 weeks or more).

The overall risk of venous thromboembolism (VTE) in patients taking low-dose COCs (< 50 mcg ethinyl estradiol) is two to three times higher than in non-pregnant patients who do not take COCs, nevertheless, this risk remains lower compared to the risk of VTE during pregnancy and childbirth.

VTE can be fatal (in 1-2% of cases).

Venous thromboembolism (VTE), manifesting as DVT or PE, can occur with the use of any COCs.

Very rarely, thrombosis of other blood vessels occurs with the use of COCs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. There is no consensus regarding the connection between the occurrence of these events and the use of COCs.

Arterial thromboembolism can clinically manifest as stroke, vascular occlusion or MI.

Arterial thromboembolism can be fatal.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases

• With age;
• In smokers (with an increase in the number of cigarettes or increasing age, the risk increases, especially in women over 35 years old);

In the presence of

• Obesity (body mass index more than 30 kg/m2);
• Family history (e.g., venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In case of hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug Jenetten^®;
• Prolonged immobilization, major surgery, any leg surgery or extensive trauma. In these situations, it is advisable to discontinue the use of the drug Jenetten^® (in the case of planned surgery, at least 4 weeks before it) and not resume its use for 2 weeks after the end of immobilization;
• Dyslipoproteinemia;
• Arterial hypertension;
• Migraine;
• Heart valve diseases;
• Atrial fibrillation.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.

An increased risk of thromboembolism in the postpartum period should be taken into account.

Peripheral circulation disorders can also be noted in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of the drug Jenetten^® (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of this drug.

Biochemical parameters indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, it should be taken into account that treatment of the corresponding condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (< 0.05 mg ethinyl estradiol).

Tumors

The most significant risk factor for cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with COC use has not been proven. The possibility of a connection between these data with cervical disease screening and with sexual behavior characteristics (less frequent use of barrier contraceptive methods) is discussed.

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used COCs (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Since breast cancer is rare in women under 40 years of age, the increase in the number of diagnosed breast cancers in women currently taking COCs or who have recently taken them is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in risk may also be a consequence of earlier diagnosis of breast cancer in women using COCs. In women who have ever used COCs, earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, the development of liver tumors has been observed during the use of COCs, which in some cases led to life-threatening intra-abdominal internal bleeding. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be considered during differential diagnosis.

Other conditions

In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while taking COCs. Although a slight increase in blood pressure (BP) has been described in many women taking COCs, clinically significant increases have been rare. However, if a persistent, clinically significant increase in BP develops during the use of the drug Jenetten^®, this drug should be discontinued and treatment for arterial hypertension should be started. The drug can be continued if normal BP values are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking COCs, but their connection with COC use has not been proven: jaundice and/or itching associated with cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham’s chorea; herpes gestationis; hearing loss associated with otosclerosis. Cases of Crohn’s disease and ulcerative colitis during the use of COCs have also been described.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema. Acute or chronic liver function disorders may require discontinuation of the drug Jenetten^® until liver function tests return to normal. Recurrent cholestatic jaundice, which first occurred during pregnancy or previous use of sex hormones, requires discontinuation of the drug Jenetten^®.

Although COCs may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in patients with diabetes using the drug Jenetten^®. However, women with diabetes should be carefully monitored while taking this drug. Chloasma may sometimes develop, especially in women with a history of chloasma of pregnancy. Women prone to chloasma while taking the drug Jenetten^® should avoid prolonged exposure to the sun and ultraviolet radiation.

Preclinical safety data

Preclinical data obtained from studies of toxicity after repeated dose administration, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a special risk to humans. Nevertheless, it should be remembered that sex hormones can promote the growth of some hormone-dependent tissues and tumors.

Laboratory tests

Taking Jenetten^® may affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal function, the content of transport proteins in plasma, parameters of carbohydrate metabolism, blood coagulation and fibrinolysis parameters. Changes usually do not go beyond normal limits.

Reduced effectiveness

The effectiveness of the drug Jenetten^® may be reduced in the following cases: when tablets are missed, with vomiting and diarrhea, or as a result of drug interactions. Frequency and severity of withdrawal bleeding. While taking the drug Jenetten^®, irregular bleeding (spotting or breakthrough uterine bleeding) may occur, especially during the first months of use. Therefore, the assessment of any irregular bleeding should be carried out only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.

In some women, withdrawal bleeding may not develop during the break in taking the tablets. If Jenetten^® was taken as directed, it is unlikely that the woman is pregnant. However, if Jenetten^® was taken irregularly before, or if 2 consecutive withdrawal bleedings are absent, pregnancy must be ruled out before continuing to take the drug.

Medical examinations

Before starting to use the drug Jenetten^®, it is necessary to review the woman’s life history, family history, conduct a thorough general medical (including measurement of BP, heart rate, determination of body mass index) and gynecological examination, including examination of the mammary glands and cytological examination of a cervical smear (Pap test), and exclude pregnancy. When resuming the use of the drug Jenetten^®, the scope of additional studies and the frequency of follow-up examinations is determined individually. Usually, follow-up examinations should be carried out at least once every 6 months.

The woman should be warned that the drug Jenetten^® does not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Effect on ability to drive vehicles and machinery

None identified.

Overdose

No serious disorders from overdose have been reported. Symptoms that may occur with overdose: nausea, vomiting, spotting or metrorrhagia.

There is no specific antidote; symptomatic treatment should be carried out.

Drug Interactions

Interaction of the drug Jenetten^® with other drugs may lead to breakthrough uterine bleeding and/or reduced contraceptive effectiveness. Women taking drugs that can reduce the contraceptive effectiveness of the drug Jenetten^® should temporarily additionally use barrier methods of contraception or choose another method of contraception. The following types of interaction have been reported in the literature. Effect on hepatic metabolism: The use of drugs that induce hepatic microsomal enzymes may lead to an increase in the clearance of sex hormones. Such drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; and most likely oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John’s wort; HIV protease inhibitors (e.g., ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine) and their combinations may also potentially affect hepatic metabolism.

Effect on enterohepatic circulation: According to individual studies, some antibiotics (e.g., penicillins and tetracycline) may reduce the enterohepatic circulation of estrogens, thereby reducing the concentration of ethinyl estradiol.

While taking any of the above drugs, the woman should additionally use a barrier method of contraception (e.g., a condom).

Substances affecting the metabolism of combined hormonal contraceptives (enzyme inhibitors)

Dienogest is a substrate of cytochrome P450 (CYP)3A4. Known inhibitors of CYP3A4, such as azole antifungal drugs (e.g., ketoconazole), cimetidine, verapamil, macrolides (e.g., erythromycin), diltiazem, antidepressants and grapefruit juice, may increase the plasma concentration of dienogest.

While taking drugs that affect hepatic microsomal enzymes and for 28 days after their discontinuation, a barrier method of contraception should be additionally used.

While taking antibiotics (except rifampicin and griseofulvin) and for 7 days after their discontinuation, a barrier method of contraception should be additionally used. If the period of using the barrier method of protection ends later than the tablets in the package, you should proceed to the next package of Jenetten^® without the usual break in taking the tablets.

The drug Jenetten^® may affect the metabolism of other drugs, leading to an increase (e.g., cyclosporine) or decrease (e.g., lamotrigine) in their plasma and tissue concentrations.

Storage Conditions

Store at a temperature not exceeding 30°C (86°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

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.