Evorel Conti

What is Evorel Conti?

Evorel Conti is a continuous combined hormone replacement therapy (HRT) presented as transdermal patches. Each patch contains two active ingredients: estradiol hemihydrate (an oestrogen) and norethisterone acetate (a progestogen). These are synthetic versions of the female hormones naturally produced by the ovaries.

Drug Class and Mechanism of Action

Evorel Conti belongs to the class of combined oestrogen-progestogen hormone replacement therapies. The patches work by delivering a steady, continuous supply of hormones through the skin into the bloodstream.

Patient-friendly analogy: Think of Evorel Conti as a "hormone refill" for your body. During menopause, your ovaries gradually produce less oestrogen (like a battery running low). Evorel Conti patches provide a controlled, steady trickle of hormones (like a slow battery charger) to maintain adequate levels and reduce menopause symptoms.

Biological Pathway Explanation

The estradiol in Evorel Conti replaces the oestrogen that declining ovaries no longer produce adequately. It binds to oestrogen receptors throughout the body, including the brain (reducing hot flushes), bones (preventing bone loss), and vaginal tissues (reducing dryness).

The norethisterone component is crucial for women who still have their womb. Unopposed oestrogen can cause the womb lining to thicken excessively, increasing cancer risk. The progestogen counteracts this by promoting regular shedding of the womb lining, providing protection against endometrial hyperplasia and cancer.

What is Evorel Conti Used For?

Evorel Conti is licensed for two main purposes in postmenopausal women according to BNF guidelines:

1. Relief of Menopause Symptoms

Evorel Conti effectively treats vasomotor symptoms associated with oestrogen deficiency, including:

• Hot flushes (sudden feelings of heat in face, neck and chest)
• Night sweats (disruptive sweating during sleep)
• Vaginal dryness, itching or discomfort
• Painful sexual intercourse (dyspareunia)
• Mood swings and sleep disturbances related to hormone fluctuations

Important: Evorel Conti is specifically indicated for women who have not had a period for at least 18 months (postmenopausal).

2. Prevention of Postmenopausal Osteoporosis

Evorel Conti helps prevent bone loss and reduces fracture risk in postmenopausal women at high risk of osteoporosis, but only when:

• Other osteoporosis treatments have been considered or tried first
• Those alternative treatments are contraindicated or not tolerated
• The benefits of fracture prevention outweigh the risks of HRT

Before Using Evorel Conti

Before starting or restarting Evorel Conti, a thorough medical assessment is essential to ensure it's appropriate for you.

Medical History Assessment Checklist

Your doctor will review:

• Personal history of cancer (especially breast, uterine, ovarian)
• History of blood clots (thrombosis, pulmonary embolism)
• Cardiovascular history (heart attack, stroke, angina)
• Liver disease or abnormal liver function tests
• Unexplained vaginal bleeding
• Migraine with aura
• Autoimmune diseases (SLE, rheumatoid arthritis)
• Diabetes, hypertension, or gallstones
• Family history of breast cancer or thrombosis
• Smoking status and alcohol consumption
• Body Mass Index (BMI) calculation

Required Baseline Tests and Evaluations

1. Breast examination: Clinical breast exam and referral for mammography if due/required
2. Blood pressure measurement: Baseline and regular monitoring
3. Liver function tests: If liver disease suspected
4. Lipid profile: Assessment of cardiovascular risk factors
5. Bone density scan: If prescribing for osteoporosis prevention
6. Cervical smear: Ensure up-to-date with national screening programme

Pre-treatment Considerations

Women with a premature menopause (due to ovarian failure or surgery) require special consideration, as the risks and benefits of HRT may differ from natural menopause. Discuss this thoroughly with your doctor.

Evorel Conti Contraindications

Absolute Contraindications (DO NOT USE)

• Known or suspected breast cancer or history of breast cancer
• Known or suspected oestrogen-dependent malignancies (e.g., endometrial cancer)
• Unexplained vaginal bleeding
• Untreated endometrial hyperplasia
• Active or history of venous thromboembolism (DVT, pulmonary embolism)
• Active or recent arterial thromboembolic disease (e.g., stroke, myocardial infarction)
• Acute or severe liver disease, or history of liver disease with abnormal liver function
• Porphyria (rare inherited blood disorder)
• Hypersensitivity to estradiol, norethisterone, or any excipients
• Known or suspected pregnancy or breastfeeding

Relative Contraindications (Use With Extreme Caution)

These conditions require careful benefit-risk assessment and possibly more frequent monitoring:

• Endometriosis or history of endometrial hyperplasia
• Uterine fibroids (leiomyoma)
• History of or increased risk for venous thrombosis
• History of or increased risk for arterial thrombosis
• Severe hypertension uncontrolled by medication
• Active gallbladder disease or history of pregnancy-related jaundice
• Migraine with focal aura
• Systemic lupus erythematosus (SLE)
• Pancreatitis with severe hypertriglyceridaemia
• Severe diabetes with vascular complications

Special Population Considerations

Elderly Patients

• Women over 60 using combined HRT have a slightly increased risk of heart disease compared to non-users
• The risk of stroke increases with age and is approximately 1.5 times higher in HRT users
• Starting HRT over age 65 may increase the risk of dementia
• Evorel Conti should generally be initiated in women under 60 for symptom relief

Renal Impairment

• No dosage adjustment is normally required for renal impairment
• Women with severe renal impairment should be monitored closely due to potential fluid retention

Hepatic Impairment

• Evorel Conti is contraindicated in acute or severe liver disease
• In mild hepatic impairment, use with caution and monitor liver function
• The transdermal route may have advantages over oral HRT in liver impairment as it avoids first-pass metabolism

Premature Menopause

Women with premature ovarian insufficiency (under age 40) have different risk-benefit considerations. HRT is usually recommended until the average age of natural menopause (around 51), but the formulation and dose may differ from standard postmenopausal HRT.

Evorel Conti and Other Medicines

Several medicines can interact with Evorel Conti, potentially reducing its effectiveness or increasing side effects.

High-Risk Medication Combinations

• Enzyme-inducing anticonvulsants: Phenobarbital, phenytoin, carbamazepine - may reduce HRT effectiveness
• Antibiotics: Rifampicin, rifabutin (for tuberculosis) - may reduce HRT effectiveness
• HIV medications: Nevirapine, efavirenz, ritonavir, nelfinavir - may reduce HRT effectiveness
• Hepatitis C treatments: Telaprevir - may reduce HRT effectiveness
• St John's Wort: Herbal remedy - may reduce HRT effectiveness

Medicines Affected by Evorel Conti

• Anticoagulants: HRT may affect blood clotting; monitor INR in warfarin patients
• Antidiabetics: HRT may affect glucose tolerance; monitor blood sugar
• Thyroid hormones: HRT may increase thyroid-binding globulin; monitor thyroid function

Timing Recommendations

If taking enzyme-inducing medications long-term, your doctor may recommend a higher dose of HRT or alternative treatment. Always inform healthcare providers about all medicines, including over-the-counter, herbal, and supplements.

Pregnancy & Breastfeeding

Pregnancy

• Evorel Conti is contraindicated during pregnancy
• If you become pregnant while using Evorel Conti, remove the patch immediately and contact your doctor
• Evorel Conti is intended for postmenopausal women only and has no indication for use during pregnancy

Breastfeeding

• Evorel Conti is contraindicated during breastfeeding
• The hormones can pass into breast milk and may affect the infant
• Evorel Conti is not indicated for women of childbearing potential unless they are postmenopausal

Contraception Requirements

Evorel Conti is not a contraceptive. If you are perimenopausal (having periods or less than 12 months since your last period) and under 50 years, you should use non-hormonal contraception (condom, diaphragm, copper IUD) to prevent pregnancy while using Evorel Conti.

Driving & Machine Operation

• Evorel Conti is not known to affect the ability to drive or operate machinery
• However, some women may experience side effects that could impair these abilities:
  • Dizziness or lightheadedness (especially when starting treatment)
  • Migraine or severe headaches
  • Visual disturbances (rare)
  • Drowsiness or fatigue
• Recommendation: Understand how Evorel Conti affects you before driving or operating machinery. If you experience any impairing side effects, avoid these activities until symptoms resolve and consult your doctor.

Evorel Conti Ingredients

Active Ingredients

• Estradiol hemihydrate: 3.2 mg per patch (delivers 50 micrograms estradiol per day)
• Norethisterone acetate: 11.2 mg per patch (delivers 170 micrograms norethisterone acetate per day)

Excipients (Inactive Ingredients)

Allergen Warnings

• Evorel Conti contains acrylic adhesives
• If you have a known sensitivity to acrylates or other adhesive components, inform your doctor before use
• Patch application may cause local skin reactions including redness, itching, or rash at the application site

How to Use Evorel Conti

Evorel Conti patches must be applied correctly to ensure proper hormone delivery and adhesion, as recommended by NHS guidelines for continuous combined HRT.

When to Start Treatment

• First-time HRT users: Apply first patch at any time
• Switching from sequential HRT: Apply first Evorel Conti patch at the end of your current cycle or after 7 days if using continuous combined HRT
• Switching from other continuous combined HRT: Start immediately after removing previous patch

Patch Change Schedule

Evorel Conti patches are changed twice weekly (every 3-4 days). Maintain a consistent schedule:

Evorel Conti Dosage Guidelines

Evorel Conti comes in one strength only. Treatment should be initiated at this standard dose.

Titration Schedule

Evorel Conti is not typically titrated. The standard dose is used for all indicated patients. If symptoms are not adequately controlled, your doctor may consider switching to a different HRT formulation rather than increasing the dose, as Evorel Conti only comes in one strength.

Treatment Duration

• Use the lowest effective dose for the shortest duration necessary
• Re-evaluate the need for HRT at least annually with your doctor
• For osteoporosis prevention, consider bone density monitoring and periodic reassessment of fracture risk

Administration Instructions

Follow these step-by-step instructions for proper patch application:

Step-by-Step Application

1. Prepare skin: Clean, dry, and cool the application area. Do not use creams, lotions, powders, or oils on the site as they may reduce adhesion.
2. Choose site: Apply to a clean, dry, hairless area of skin below the waist. Preferred sites are buttocks, thighs, or lower abdomen. Avoid breasts, waistline, or areas with cuts, rashes, or irritation.
3. Open pouch: Tear open the protective pouch along the notched edges. Remove the patch.
4. Peel backing: With the protective backing facing you, bend the patch and peel off half of the backing. Avoid touching the sticky surface.
5. Apply half: Apply the exposed sticky half to your skin.
6. Remove remaining backing: Peel off the other half of the backing and press the entire patch firmly onto skin.
7. Secure adhesion: Press firmly with the palm of your hand for at least 10 seconds, applying warmth and pressure to ensure good adhesion.

Application Site Rotation

• Rotate application sites to avoid skin irritation
• Do not apply a new patch to the same area for at least one week
• Allow skin to recover between applications

If a Patch Falls Off

If a patch detaches prematurely, apply a new patch to a different site but maintain your original schedule. If you've just bathed or showered, wait for skin to cool and dry completely before applying a new patch.

Missed Dose Management

General Principles

• Do NOT apply multiple patches to make up for a missed dose
• Maintain twice-weekly schedule

Time-Based Guidance

Note: If you miss a patch change, you may experience withdrawal bleeding or spotting. This is not harmful but indicates inconsistent hormone delivery. Try to maintain your regular schedule.

Overdose Information

Acute overdose with transdermal patches is unlikely due to the controlled release system. However, applying multiple patches simultaneously or using damaged patches could lead to excessive hormone exposure.

Symptoms of Oestrogen Excess

• Breast tenderness or enlargement
• Nausea, vomiting
• Abnormal vaginal bleeding
• Fluid retention, bloating
• Headache, migraine
• Mood changes, depression

Management of Suspected Overdose

1. Remove all patches immediately
2. Wash skin with soap and water to remove residual hormones
3. Contact your doctor or NHS 111 for advice
4. In severe cases or if concerning symptoms develop, go to A&E or call 999
5. Treatment is symptomatic and supportive; no specific antidote exists

Evorel Conti Side Effects

Like all medicines, Evorel Conti can cause side effects, although not everyone experiences them. Side effects are categorized by frequency based on clinical trial data.

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

• Application site reactions: redness, itching, rash
• Breast pain, tenderness, or enlargement
• Headache, migraine
• Abdominal pain, bloating, nausea
• Leg cramps, back pain
• Vaginal discharge or spotting (especially in first 3-6 months)
• Mood changes, depression, anxiety
• Fluid retention, weight gain
• Fatigue

Long-term Risks Associated with HRT

With long-term use (more than 5 years), combined HRT like Evorel Conti increases the risk of:

• Breast cancer: Risk increases with duration of use. Extra risk reduces after stopping but may persist for 10+ years
• Ovarian cancer: Slightly increased risk (about 1 extra case per 2000 users after 5 years)
• Venous thromboembolism: Risk is 1.3-3 times higher than non-users, highest in first year
• Stroke: Risk is about 1.5 times higher than non-users
• Coronary heart disease: Slightly increased risk in women over 60 starting HRT

Reporting Side Effects

If you experience any side effects, report them to your doctor, pharmacist, or via the UK Yellow Card Scheme. Reporting helps improve medicine safety information.

How to Store Evorel Conti

Storage Conditions

• Store at room temperature (below 25°C)
• Keep in original protective pouch until use
• Store in original carton to protect from light
• Keep out of sight and reach of children and pets
• Do not use after expiry date printed on packaging
• Do not use if protective pouch is damaged or already open

Disposal Guidelines

• Fold used patches in half (sticky sides together) before disposal
• Dispose of safely out of reach of children and pets
• Do not flush down toilet or drain
• Return unused or expired medicine to your pharmacy for safe disposal

Evorel Conti Pack Information

Pack Sizes

• 8 patches: 4 weeks supply (twice weekly application)
• 24 patches: 12 weeks supply (3 months)

Pack Design

Evorel Conti comes in a "memory pack" with days of the week markings to help track patch changes. Each patch is individually sealed in a protective pouch within the pack.

Patch Specifications

• Shape: Square with rounded corners
• Size: 16 cm² surface area
• Appearance: Transparent with flesh-toned backing
• Markings: Each patch is marked "CEN1"

Manufacturer Details

Marketing Authorisation Holder: Theramex HQ UK Limited, London, United Kingdom

Manufacturers: Aesica Pharmaceuticals GmbH (Germany), LTS Lohmann Therapie-Systeme AG (Germany), Pharmapac (UK) Limited (UK)

Where Can I Buy Evorel Conti Online in the UK