Rigevidon Pills

What is Rigevidon?

Rigevidon is a combined oral contraceptive pill, commonly referred to as "the pill." It contains two synthetic female hormones: ethinylestradiol (an oestrogen) and levonorgestrel (a progestogen). These hormones work together to prevent pregnancy through multiple mechanisms.

Mechanism of Action

Rigevidon prevents pregnancy through three primary mechanisms:

1. Inhibition of Ovulation: The hormones suppress the release of luteinising hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland, which prevents the ovary from releasing an egg each month.
2. Thickening of Cervical Mucus: Levonorgestrel causes the cervical mucus to become thicker, creating a barrier that makes it difficult for sperm to reach the egg.
3. Alteration of Endometrial Lining: The hormones change the lining of the womb (endometrium), making it less receptive to a fertilised egg should conception occur.

Biological Pathway Explanation

In a normal menstrual cycle, the hypothalamus releases gonadotropin-releasing hormone (GnRH), which stimulates the pituitary gland to produce FSH and LH. These hormones trigger follicle development and ovulation. Rigevidon provides a constant level of synthetic hormones that negative feedback to the hypothalamus and pituitary, suppressing the natural hormonal fluctuations that lead to ovulation.

Think of Rigevidon as a "traffic controller" for your reproductive system - it sends consistent signals that prevent the monthly release of an egg, while simultaneously creating barriers (thickened cervical mucus) and altering the "landing environment" (endometrium) to prevent pregnancy.

What is Rigevidon Used For?

Rigevidon is primarily prescribed for contraception (prevention of pregnancy). When taken correctly, it is over 99% effective at preventing pregnancy. According to the NHS, it may also provide additional benefits for some women, although these are not its licensed indications.

Approved Indications

• Contraception: Prevention of pregnancy in women of reproductive age
• Menstrual Regulation: Can help regulate menstrual cycles and make periods more predictable
• Menstrual Symptom Relief: May reduce menstrual pain (dysmenorrhea) and premenstrual symptoms for some women

Target Patient Populations

Rigevidon is suitable for most women of reproductive age who:

• Are seeking reliable, reversible contraception
• Do not have contraindications to combined hormonal contraception
• Are non-smokers or smokers under 35 years old
• Do not have a personal or strong family history of blood clots
• Are able to take a pill at approximately the same time each day

Before Using Rigevidon

Before starting Rigevidon, your healthcare provider will conduct a thorough medical assessment to ensure it's safe and appropriate for you. This assessment helps identify any factors that might increase your risk of complications.

Medical History Assessment Checklist

Your doctor will ask about:

• Personal history of blood clots, heart attack, stroke, or migraine with aura
• Family history of blood clots or cardiovascular events at a young age (before 50)
• Current or past medical conditions (liver disease, breast cancer, diabetes, etc.)
• Medications you're currently taking
• Smoking status and age
• Blood pressure measurements
• Weight and BMI calculation
• Pregnancy status and plans

Required Baseline Tests

Before prescribing Rigevidon, your doctor will typically:

1. Measure blood pressure: High blood pressure is a relative contraindication
2. Calculate BMI: Obesity (BMI >30) increases blood clot risk
3. Consider blood tests: May be recommended if there's a family history of clotting disorders or lipid abnormalities
4. Perform breast examination: If indicated based on age or family history

Pre-treatment Evaluations

It's important to discuss:

• Your understanding of how to take the pill correctly
• What to do if you miss a pill
• Recognising warning signs of serious side effects
• Backup contraception methods for the first 7 days and if you miss pills

Rigevidon Contraindications

Certain conditions make Rigevidon unsuitable or require careful consideration before use. Contraindications can be absolute (should never take) or relative (may take with caution under medical supervision).

Absolute Contraindications

Do NOT take Rigevidon if you have any of the following:

• Current or history of blood clots (venous or arterial thrombosis)
• Known thrombophilic disorders (Factor V Leiden, protein C/S deficiency, antiphospholipid antibodies)
• Current or history of heart attack, stroke, or angina
• Migraine with aura (currently or in the past)
• Diabetes with vascular complications
• Severe or multiple risk factors for arterial disease
• Current or history of breast cancer or other hormone-dependent cancers
• Liver disease or liver tumors
• Unexplained vaginal bleeding
• Pregnancy or suspected pregnancy
• Allergy to any ingredients in Rigevidon

Relative Contraindications (Require Medical Supervision)

Special Population Considerations

Elderly Patients

Rigevidon is not intended for use in postmenopausal women. For women over 35, careful risk assessment is required, particularly regarding cardiovascular risk factors. Smokers over 35 should not use combined hormonal contraceptives like Rigevidon.

Renal Impairment

No specific studies have been conducted in renal impairment. However, Rigevidon is not known to be nephrotoxic. The hormones are metabolised in the liver and excreted in bile and urine. Dose adjustment is not typically required for renal impairment, but caution is advised in severe renal dysfunction.

Hepatic Impairment

Rigevidon is contraindicated in active liver disease or severe hepatic impairment. The hormones are metabolised in the liver, and impaired liver function can lead to increased hormone levels and reduced contraceptive effectiveness. Mild hepatic impairment may require close monitoring.

Pediatric/Adolescent Patients

Rigevidon can be used by adolescents after menarche (first period). No differences in safety or efficacy have been observed between adolescents and adults. However, counselling about adherence and missed pills is particularly important for younger users.

Rigevidon and Other Medicines

Some medications can reduce the effectiveness of Rigevidon or increase the risk of side effects. Always inform your doctor about all medicines you're taking, including prescription, over-the-counter, and herbal supplements.

High-Risk Medication Combinations

Medications That Reduce Effectiveness

• Antibiotics: Rifampicin, rifabutin (others like penicillins may have minor effects)
• Anticonvulsants: Carbamazepine, phenytoin, phenobarbital, primidone, topiramate
• Antiretrovirals: Ritonavir, nevirapine
• Herbal Supplements: St. John's Wort (Hypericum perforatum)
• Other: Modafinil, bosentan

Medications That Increase Hormone Levels

• Atorvastatin
• Paracetamol (may increase ethinylestradiol levels)
• Ascorbic acid (vitamin C)
• Some antifungal medications

Timing Recommendations

If you need to take any medication that may reduce Rigevidon's effectiveness:

1. Use additional barrier contraception (condoms) while taking the interacting medication
2. Continue barrier contraception for 7 days after stopping the interacting medication
3. If these 7 days run into your pill-free week, skip the break and start your next pack immediately
4. Consider using an alternative contraceptive method during long-term treatment with enzyme-inducing drugs

Pregnancy & Breastfeeding

Pregnancy

Rigevidon is contraindicated during pregnancy. If you suspect you might be pregnant, take a pregnancy test before starting or continuing Rigevidon. If pregnancy occurs while taking Rigevidon, discontinue use immediately.

Breastfeeding

Combined oral contraceptives like Rigevidon are generally not recommended during breastfeeding, especially during the first 6 weeks postpartum. Small amounts of hormones pass into breast milk and may reduce milk production. Progestogen-only pills are usually preferred for breastfeeding mothers.

Contraception Requirements

No additional contraception is required while taking Rigevidon correctly. However, if you miss pills, vomit, have severe diarrhoea, or take interacting medications, additional barrier contraception (condoms) should be used for 7 days.

Driving & Machine Operation

Rigevidon has no known effect on the ability to drive or operate machinery. However, some women may experience dizziness, especially when first starting the pill or if they have migraine episodes. If you experience dizziness, blurred vision, or other symptoms that could impair your abilities, avoid driving or operating machinery until the symptoms resolve.

Warning Signs to Watch For

• Sudden severe headache
• Dizziness or lightheadedness
• Visual disturbances (migraine with aura)
• Nausea that affects concentration

If you experience any of these symptoms, do not drive or operate machinery and consult your doctor.

Rigevidon Ingredients

Active Ingredients

• Levonorgestrel: 150 micrograms (synthetic progestogen)
• Ethinylestradiol: 30 micrograms (synthetic oestrogen)

Excipients (Inactive Ingredients)

• Lactose monohydrate
• Maize starch
• Povidone
• Magnesium stearate
• Sucrose
• Calcium carbonate
• Talc
• Macrogol 6000
• Glycolate
• Montanglycol wax
• Titanium dioxide (E171)
• Iron oxide yellow (E172)
• Iron oxide red (E172)

Allergen Warnings

Rigevidon contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. It also contains soya lecithin - if you are allergic to peanuts or soya, do not use this medicine.

How to Use Rigevidon

Rigevidon comes in a blister pack containing 21 active tablets. Each tablet contains the same dose of hormones. You take one tablet daily for 21 days, followed by a 7-day break when you take no tablets (or take placebo tablets if provided).

Step-by-Step Administration

1. Choose a start day: You can start on the first day of your period or on the first Sunday after your period begins.
2. Take one tablet daily: Take at approximately the same time each day.
3. Follow the arrows: Take tablets in the order indicated by the arrows on the blister pack.
4. Complete 21 days: Take one tablet daily for 21 consecutive days.
5. 7-day break: Take no tablets for 7 days. Your period will usually start during this break.
6. Start new pack: After the 7-day break, start a new pack even if your period hasn't finished.

Rigevidon Dosage Guidelines

Titration Schedule

No titration is needed with Rigevidon - you take the same dose throughout the cycle. The standard regimen is 21 days of active pills followed by a 7-day break.

Administration Instructions

Starting Your First Pack

Option 1 (Quick Start): Take your first Rigevidon tablet on the first day of your menstrual period. You will be protected from pregnancy immediately.

Option 2 (Sunday Start): Take your first Rigevidon tablet on the first Sunday after your period begins. Use additional contraception (condoms) for the first 7 days.

Switching from Another Contraceptive

• From another combined pill: Start Rigevidon the day after finishing your previous pack
• From progestogen-only pill: Start Rigevidon the day after taking your last progestogen-only pill
• From implant, injection, or IUS: Start Rigevidon on the day of removal/implant expiry

Taking with Food

Rigevidon can be taken with or without food. Taking it with food may help reduce nausea if you experience this side effect.

What to Do if You Vomit

If you vomit within 3-4 hours of taking a tablet, take another tablet as soon as possible. If you don't take another tablet within 12 hours of your usual time, follow the instructions for missed pills.

Missed Dose Management

Overdose Information

Serious ill effects from overdose of oral contraceptives have not been reported. Overdose may cause nausea, vomiting, and, in young girls, breast enlargement and vaginal bleeding. There is no specific antidote. Treatment should be symptomatic.

Symptom Management Protocols

• Nausea/vomiting: Supportive care, antiemetics if severe
• Vaginal bleeding: Monitor; usually self-limiting
• Breast tenderness: Supportive measures

When to Seek Medical Attention

Contact your doctor or go to the nearest emergency department if:

• A child has taken multiple pills
• You experience severe vomiting that prevents keeping fluids down
• You have symptoms of a blood clot (see section 15)

Rigevidon Side Effects

Like all medicines, Rigevidon can cause side effects, although not everybody gets them. Serious side effects are rare but important to recognise.

Very Common Side Effects (>1 in 10 users)

• Headache
• Nausea
• Breast pain/tenderness
• Mood changes

Common Side Effects (1 in 10 to 1 in 100 users)

• Vomiting
• Diarrhoea
• Acne
• Weight gain
• Changes in libido
• Breakthrough bleeding or spotting
• Depressed mood

Uncommon Side Effects (1 in 100 to 1 in 1,000 users)

• Fluid retention
• Contact lens intolerance
• Chloasma (brown patches on skin)
• Vaginal candidiasis (thrush)

Rare Side Effects (1 in 1,000 to 1 in 10,000 users)

• Blood clots (venous thromboembolism)
• High blood pressure
• Gallbladder disease
• Liver tumors
• Crohn's disease exacerbation
• Ulcerative colitis exacerbation

Blood Clot Risk Statistics

How to Store Rigevidon

Temperature Requirements

• Store below 25°C
• Keep in the original blister pack to protect from light and moisture
• Do not freeze

Disposal Protocols

• Do not dispose of medications via wastewater or household waste
• Return unused or expired medicines to your pharmacy for proper disposal
• This helps protect the environment and prevents accidental ingestion

Expiry Date

Do not use Rigevidon after the expiry date printed on the pack. The expiry date refers to the last day of that month.

Rigevidon Pack Information

Pack Size Variations

• 1 x 21 tablets (1 month supply)
• 3 x 21 tablets (3 month supply)
• 6 x 21 tablets (6 month supply)
• 13 x 21 tablets (12 month supply)

Pack Contents

• Blister strips of 21 tablets
• Patient information leaflet
• Outer carton

Marketing Authorisation Holder

Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

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