Eluryng

Manufacturer AMNEAL PHARMACEUTICALS Active Ingredient Ethinyl Estradiol and Etonogestrel(ETH in il es tra DYE ole & et oh noe JES trel) Pronunciation EL-yoo-ring (Ethinyl Estradiol: ETH-in-il es-tra-DYE-ol; Etonogestrel: et-oh-noe-JES-trel)
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy. If you have been given this drug for some other reason, talk with your doctor for more information.
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Drug Class
Contraceptive
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Pharmacologic Class
Estrogen/Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Dec 2019
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Eluryng is a flexible vaginal ring that you insert yourself once a month to prevent pregnancy. It releases two hormones, ethinyl estradiol (an estrogen) and etonogestrel (a progestin), which work together to stop your body from releasing an egg (ovulation) and make it harder for sperm to reach an egg.
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How to Use This Medicine

Using Your Vaginal Ring: A Step-by-Step Guide

To use this medication correctly, follow your doctor's instructions and read all the information provided. Here's how to use your vaginal ring:

1. Insertion: Wash your hands and remove the ring from its pouch. Keep the pouch to dispose of the ring later. Make sure your hands are dry before handling the ring. Fold the ring in half and press the sides together between your thumb and index finger. Gently insert the folded ring into your vagina. Perfect placement is not necessary for the ring to work, and it will not cause discomfort.
2. Wearing the Ring: Leave the ring in place for 3 weeks. After 3 weeks, remove the ring at the start of the 4th week.
3. Removing the Ring: To remove the ring, hook your index finger around the rim or hold the rim between your index finger and middle finger, and gently pull it out.
4. Disposing of the Ring: Do not flush the ring down the toilet.
5. Starting a New Cycle: After removing the ring, wait 7 days before inserting a new one. Insert the new ring at the same time of day that you removed the previous one.

Important Reminders:

After starting this medication, you may need to use a non-hormonal birth control method, such as condoms, to prevent pregnancy for a short period. Follow your doctor's instructions.
If you miss two periods in a row, take a pregnancy test before starting a new cycle.
If you have not used the ring correctly and miss one monthly period, take a pregnancy test.

What to Do If You Forget to Remove or Insert the Ring:

If the ring has been in place for up to 1 extra week, it will still be effective. Remove the ring and insert a new one 7 days later.
If the ring has been in place for more than 4 weeks, it may not be effective. Consult your doctor to ensure you are not pregnant. Use a non-hormonal birth control method, such as condoms, until you know you are not pregnant. If you are not pregnant, insert a new ring and continue using the non-hormonal birth control method for 7 days.

Storing and Disposing of Your Vaginal Ring:

Store unused rings at room temperature.
Check with your pharmacist to determine how long unused rings can be stored.
Do not use expired medication. Protect the rings from heat and light.

What to Do If the Ring is Accidentally Removed:

If the ring is out of the vagina for less than 3 hours, rinse it with cool to lukewarm water and reinsert it as soon as possible.
If the ring is out of the vagina for more than 3 hours during weeks 1 and 2, rinse it with cool to lukewarm water and reinsert it as soon as possible. Use a non-hormonal birth control method, such as condoms, for 7 days after reinserting the ring.
If the ring is out of the vagina for more than 3 hours during week 3, discard the ring and consult the package insert or your doctor to determine when to insert a new ring. Use a non-hormonal birth control method, such as condoms, for 7 days after inserting the new ring.
If the ring is out of the vagina for more than 1 week or you are unsure how long it has been out, take a pregnancy test before inserting a new ring. Use a non-hormonal birth control method, such as condoms, for 7 days after inserting the new ring.
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Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as smoking significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
  • Eluryng does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Always use condoms to protect against STIs.
  • Maintain regular physical activity and a healthy diet to support overall cardiovascular health.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Insert one vaginal ring vaginally and leave in place for 3 consecutive weeks. Remove the ring for a 1-week ring-free interval. A new ring is inserted after the 1-week ring-free interval.

Condition-Specific Dosing:

initiation: Insert on the first day of menstrual bleeding or on the first Sunday following the start of menstruation, whichever comes first. Use a backup method for the first 7 days if not starting on Day 1.
missed_dose: If ring-free interval is extended beyond 7 days, insert a new ring and use a backup method for 7 days. If ring is out for more than 3 hours during the 3-week use, reinsert as soon as possible and use backup for 7 days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Dosing is the same as for adults once menarche has occurred.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific recommendations; use with caution due to potential fluid retention.

Hepatic Impairment:

Mild: Use with caution
Moderate: Use with caution
Severe: Contraindicated

Pharmacology

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Mechanism of Action

Eluryng works primarily by suppressing ovulation through the inhibition of gonadotropin secretion (FSH and LH). It also causes changes in the cervical mucus, making it more viscous and less permeable to sperm, and alters the endometrium, making it less receptive to implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: Approximately 56% (vaginal); Etonogestrel: Approximately 100% (vaginal)
Tmax: Ethinyl Estradiol: Approximately 1 hour; Etonogestrel: Approximately 1 hour
FoodEffect: Not applicable for vaginal administration

Distribution:

Vd: Ethinyl Estradiol: Approximately 15 L; Etonogestrel: Approximately 2.3 L
ProteinBinding: Ethinyl Estradiol: Approximately 98% (to albumin and sex hormone-binding globulin [SHBG]); Etonogestrel: Approximately 95-98% (to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: Approximately 29 hours; Etonogestrel: Approximately 25 hours
Clearance: Ethinyl Estradiol: Approximately 35 L/hour; Etonogestrel: Approximately 7.5 L/hour
ExcretionRoute: Both Ethinyl Estradiol and Etonogestrel are excreted renally and fecally as metabolites.
Unchanged: Less than 1% (Ethinyl Estradiol); Less than 1% (Etonogestrel)
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of use.
PeakEffect: Steady-state concentrations are reached within approximately 1 week of insertion.
DurationOfAction: 3 weeks of continuous contraceptive efficacy per ring.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combined hormonal contraceptives, including Eluryng, are contraindicated in women who are over 35 years of age and smoke.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Depression or other mood changes
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Toxic shock syndrome (TSS), a rare but potentially life-threatening condition, which may cause:
+ Diarrhea
+ Dizziness or lightheadedness
+ Passing out
+ Fever
+ Muscle pain
+ Upset stomach
+ Vomiting
+ A sunburn-like rash

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, some people may experience:

Vaginal irritation
Weight gain
Headache
Upset stomach or vomiting
Tender breasts
Stomach pain
Pimples (acne)
Lowered interest in sex
Period (menstrual) changes, including spotting or bleeding between cycles

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Sudden severe headache, especially if it's different from your usual headaches.
  • Sudden vision changes (e.g., partial or complete loss of vision, double vision).
  • Sudden numbness or weakness on one side of your body.
  • Sudden trouble speaking or understanding.
  • Severe chest pain, pressure, or heaviness.
  • Pain, swelling, or warmth in your leg, especially in the calf or thigh.
  • Sudden shortness of breath or coughing up blood.
  • Yellowing of your skin or eyes (jaundice), dark urine, or severe abdominal pain (signs of liver problems).
  • Severe depression or mood changes.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, including atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
Unexplained vaginal bleeding
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir)
Any health conditions or use of medications, including herbal products, that may interfere with the effectiveness of hormone-based birth control. Consult your doctor or pharmacist if you are unsure. You may need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
A history of jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control
* Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.

This list is not exhaustive. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

When using this vaginal ring, do not use a diaphragm, cervical cap, or female condom as a form of birth control. If you have diabetes, discuss this with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor, and have regular blood work checked as advised.

Be aware that this medication may increase your blood pressure, so have it checked regularly as recommended by your doctor. Additionally, this drug may raise the risk of blood clots, stroke, or heart attack; discuss this with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this may increase your risk of blood clots.

Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as directed by your doctor. If you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor, as it may interact with this medication.

This drug may affect certain laboratory tests, so inform all your healthcare providers and lab workers that you are taking this medication. Prolonged use may cause dark patches of skin on your face, so avoid sun exposure, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.

Your doctor should monitor your cholesterol and triglyceride levels, as this medication may cause an increase. Note that this drug does not protect against sexually transmitted diseases like HIV or hepatitis; use a latex or polyurethane condom during sexual activity. If you have questions or concerns, discuss them with your doctor.

To ensure the ring is in place, follow the instructions provided by your doctor or the package insert. If you are unable to find the ring after insertion or remove it, contact your doctor immediately. If the ring breaks, discard it and use a new one, and seek medical attention if you experience unusual vaginal pain or bleeding.

Using hormone-based birth control, such as this medication, may increase the risk of cervical cancer, although this may be attributed to other factors. Additionally, some studies suggest a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association; discuss any concerns with your doctor.

This medication is not intended for use in children who have not yet had their first menstrual period. If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Breast tenderness
  • Dizziness
  • Abdominal pain
  • Drowsiness/fatigue
  • Vaginal bleeding (especially in young girls)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Remove the ring. In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (due to risk of ALT elevations)
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, Oxcarbazepine, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Lamotrigine - may decrease lamotrigine plasma concentrations, leading to loss of seizure control.
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Moderate Interactions

  • Moderate CYP3A4 inducers (e.g., Bosentan, Felbamate)
  • CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin) - may increase plasma concentrations of ethinyl estradiol and etonogestrel, potentially increasing adverse effects.
  • Certain antibiotics (e.g., Tetracyclines, Penicillins) - historical concern, but current evidence suggests no significant interaction for most, though backup method often recommended by clinicians.
  • Thyroid hormones (e.g., Levothyroxine) - may increase thyroid-binding globulin, requiring increased thyroid hormone dose.
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Minor Interactions

  • Acetaminophen - may increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To identify pre-existing hypertension and monitor for potential increases, as combined hormonal contraceptives can elevate blood pressure.

Timing: Prior to initiation

Complete Medical History and Physical Examination

Rationale: To identify contraindications and risk factors for adverse events (e.g., VTE, cardiovascular disease, liver disease, certain cancers).

Timing: Prior to initiation

Breast Examination

Rationale: To screen for breast abnormalities, especially in women with risk factors for breast cancer.

Timing: Prior to initiation (as clinically indicated)

Cervical Cancer Screening (Pap test)

Rationale: To screen for cervical abnormalities, as per standard guidelines.

Timing: Prior to initiation (as per screening guidelines)

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Routine Monitoring

Blood Pressure

Frequency: Annually or more frequently if clinically indicated

Target: <140/90 mmHg

Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraceptive method.

Annual Physical Examination

Frequency: Annually

Target: Not applicable

Action Threshold: Identification of new risk factors or contraindications.

Breast Examination

Frequency: Annually (as clinically indicated)

Target: Not applicable

Action Threshold: New or suspicious findings require further investigation.

Cervical Cancer Screening (Pap test)

Frequency: As per national screening guidelines (e.g., every 3-5 years)

Target: Not applicable

Action Threshold: Abnormal results require follow-up.

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Symptom Monitoring

  • Symptoms of deep vein thrombosis (DVT): leg pain, swelling, warmth, redness.
  • Symptoms of pulmonary embolism (PE): sudden shortness of breath, chest pain, coughing up blood.
  • Symptoms of stroke: sudden severe headache, weakness or numbness on one side of the body, vision changes, speech difficulties.
  • Symptoms of myocardial infarction (MI): chest pain, discomfort, pressure, pain radiating to arm/shoulder, shortness of breath, sweating, nausea.
  • Symptoms of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe abdominal pain.
  • Symptoms of severe depression or mood changes.
  • Symptoms of severe allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.

Special Patient Groups

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Pregnancy

Eluryng is contraindicated during pregnancy. If pregnancy occurs while using Eluryng, the ring should be removed immediately.

Trimester-Specific Risks:

First Trimester: Contraindicated. No evidence of increased risk of birth defects with inadvertent exposure.
Second Trimester: Contraindicated. No evidence of increased risk of birth defects with inadvertent exposure.
Third Trimester: Contraindicated. No evidence of increased risk of birth defects with inadvertent exposure.
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Lactation

Use is generally not recommended during lactation, especially in the first 6 weeks postpartum, as combined hormonal contraceptives may decrease the quantity and quality of breast milk and small amounts of steroids may be excreted in breast milk.

Infant Risk: Low risk of adverse effects on the breastfed infant, but potential for decreased milk supply. Monitor infant for jaundice or breast enlargement.
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Pediatric Use

Eluryng is indicated for use in females of reproductive age. Safety and efficacy have been established in adolescent females (post-menarche) and are expected to be similar to adult females. Not indicated for use in pre-menarcheal females.

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Geriatric Use

Eluryng is not indicated for use in post-menopausal women. Safety and efficacy have not been established in geriatric populations.

Clinical Information

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Clinical Pearls

  • Always advise patients to read the full Patient Information leaflet provided with Eluryng.
  • Emphasize the importance of consistent use and proper insertion/removal technique for optimal efficacy.
  • Counsel patients on the black box warning regarding smoking and cardiovascular risk, especially for women over 35.
  • Remind patients that Eluryng does not protect against STIs and that condoms should be used for STI prevention.
  • Educate patients on the signs and symptoms of serious adverse events (e.g., blood clots, stroke, heart attack) and when to seek immediate medical attention.
  • Inform patients about potential changes in bleeding patterns, which are common with hormonal contraceptives.
  • Advise patients on what to do if the ring accidentally comes out or if the ring-free interval is extended.
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Alternative Therapies

  • Progestin-only pills (POPs)
  • Progestin injection (e.g., Depo-Provera)
  • Progestin implant (e.g., Nexplanon)
  • Intrauterine devices (IUDs) - hormonal (e.g., Mirena, Kyleena) or non-hormonal (e.g., Paragard)
  • Barrier methods (e.g., condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $100 - $200 per ring (1-month supply)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered without co-pay under ACA for contraception)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.