Cyclogest 400mg Pessaries 3X5’S

Description

Cyclogest 400mg Pessaries is a trusted progesterone pessary formulation designed to support reproductive health and hormonal balance. It is primarily used in fertility treatments, luteal phase support, and to alleviate symptoms associated with low progesterone. This micronized progesterone product offers a convenient and effective method for hormone supplementation, directly addressing the needs of individuals undergoing assisted reproductive technology (ART) or managing conditions like progesterone deficiency.

This vaginal suppository is engineered for efficacy and patient comfort, providing a targeted approach to hormone therapy. Below is a summary of its core attributes:

• Contains 400mg of body-identical micronized progesterone for effective hormonal support.

• Supports the luteal phase in fertility treatments like IVF and IUI, aiding embryo implantation.

• Helps regulate the menstrual cycle and manage conditions such as secondary amenorrhea.

• Provides relief from symptoms of menopause, including night sweats and mood swings.

• Manufactured in the UK under strict Good Manufacturing Practice (GMP) standards.

• Offers flexible administration routes (vaginal or rectal) as directed by a healthcare professional.

Uses and Key Features of Cyclogest 400mg Pessaries

What are the primary uses for Cyclogest 400mg pessaries?

Cyclogest 400mg Pessaries is a versatile hormonal medicine prescribed for several key conditions related to progesterone deficiency. Its main applications support women’s health across different life stages.

Luteal Phase Support in Assisted Reproduction
For women undergoing fertility treatments such as In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI), Cyclogest is crucial. It provides luteal phase support by supplementing the body’s natural progesterone, which is essential for preparing the uterine lining for embryo implantation and maintaining early pregnancy.

Management of Menstrual Disorders
This pessary is effective in treating menstrual irregularities caused by a lack of progesterone. This includes conditions like secondary amenorrhea (the absence of menstrual periods in women who previously had periods) and irregular cycles, helping to restore a regular menstrual rhythm.

Relief from Menopausal Symptoms
Cyclogest can be used as part of Hormone Replacement Therapy (HRT) for menopausal women. It is combined with an estrogen to protect the uterus lining from overgrowth, a condition known as endometrial hyperplasia, which can be a precursor to cancer. It also helps alleviate progesterone-deficient symptoms.

What are the key features and benefits of using Cyclogest 400mg Pessaries?

• Micronized Progesterone: The active ingredient is micronized, meaning it is finely ground for optimal absorption by the body, mimicking the body’s own natural progesterone.

• Dual Administration Route: Offers flexibility with both vaginal and rectal use, allowing for a method that is most comfortable and effective for the patient, as per medical advice.

• Targeted Action: When used vaginally, the progesterone acts locally on the uterus, which is particularly beneficial for fertility support.

• Body-Identical Hormone: Contains progesterone that is chemically identical to the hormone produced by the human corpus luteum, promoting better compatibility and reducing the risk of certain side effects associated with synthetic progestins.

• Convenient Pessary Form: The suppository format is easy to use and avoids the first-pass metabolism of the liver, which can occur with oral medications.

Ingredients and Composition

What is the active ingredient in Cyclogest 400mg Pessaries?

The sole active substance in each pessary is Cyclogest 400mg Pessaries. This progesterone is classified as ‘micronized’, a pharmaceutical process that increases the surface area of the hormone particles to enhance dissolution and absorption in the body.

Are there any inactive ingredients in Cyclogest?

Yes, the pessary base contains inactive ingredients that form the suppository vehicle. The key component is Hard Fat, a semi-synthetic glyceride blend. This base is inert, designed to hold the active ingredient and melt at body temperature to facilitate the release of progesterone. It is free from common allergens like gluten, lactose, and artificial colors, making it suitable for a wide range of patients.

How should I use Cyclogest 400mg pessaries correctly?

What is the proper method for administering a Cyclogest pessary?

Correct administration is vital for the effectiveness and comfort of the treatment. Always follow the specific instructions provided by your doctor or pharmacist.

Step-by-Step Guide for Vaginal Use

1. Wash your hands thoroughly with soap and water.

2. Remove one pessary from its foil wrapper. If the pessary is too soft, you can cool it in the refrigerator for a few minutes or hold it under cold water before unwrapping.

3. Lie on your back with your knees bent, or stand with one foot raised on a chair.

4. Gently insert the pessary, narrow end first, high into the vagina.

5. Remain lying down for a short while after insertion to allow the pessary to melt and be absorbed.

6. Wash your hands again.

Step-by-Step Guide for Rectal Use

1. Wash your hands thoroughly with soap and water.

2. Remove one pessary from its foil wrapper.

3. Gently insert the pessary, narrow end first, into the rectum.

4. Wash your hands again.

It is normal to experience some discharge when using the vaginal route. Using a panty liner can help manage this.

Dosage Information for Cyclogest Treatment

What is the recommended Cyclogest 400mg dosage?

The correct dosage and administration route (vaginal or rectal) must be determined by a qualified healthcare professional based on your individual medical condition and response to treatment. The following are common dosage guidelines.

Dosage for Luteal Phase Support in IVF and Fertility Treatments
The typical dose is one 400mg pessary inserted vaginally, once or twice daily. Treatment usually starts on the day of egg retrieval or embryo transfer and may continue for up to 12 weeks of pregnancy if implantation is successful.

Dosage for Menstrual Irregularities (e.g., Secondary Amenorrhea)
The typical regimen involves inserting one 400mg pessary either vaginally or rectally daily for 10 days. A withdrawal bleed similar to a period is expected after stopping the treatment.

Dosage as Part of HRT for Menopause
For post-menopausal women using estrogen HRT, the typical dose is one 400mg pessary daily for the last 12-14 days of each estrogen therapy cycle.

It is crucial to complete the full course of treatment as prescribed, even if you feel well. Do not alter your dosage or stop using Cyclogest without consulting your doctor.

Important Precautions and Safety Warnings

What are the key precautions before using Cyclogest?

Before you start treatment with Cyclogest, it is essential to discuss your full medical history with your doctor. This medication may not be suitable for everyone.

Who should not use Cyclogest?
Do not use Cyclogest if you:

• Are allergic to progesterone, other progestogens, or any of the other ingredients (like hard fat) in the pessary.

• Have, or have ever had, any form of cancer that is sensitive to progesterone, such as breast or genital cancer.

• Have severe liver disease or a history of liver tumors.

• Have or have had blood clots (thromboembolism), or conditions that predispose you to clotting.

• Have unexplained vaginal bleeding.

• Have a known or suspected pregnancy-related condition called idiopathic jaundice or severe pruritus.

• Have a rare blood disorder called porphyria.

What should I tell my doctor before starting Cyclogest?
Inform your doctor if you have or have had:

• A history of depression.

• Kidney or heart problems.

• Migraine headaches.

• Asthma.

• High blood pressure.

• Diabetes.

• Epilepsy.

Potential Side Effects of Progesterone Treatment

What are the common and serious side effects of Cyclogest?

Like all medicines, Cyclogest can cause side effects, although not everybody gets them. It is important to differentiate between common, usually transient effects and those that require immediate medical attention.

Common Side Effects
These are often mild and may subside as your body adjusts to the treatment. They are more common with the vaginal route of administration.

• Vaginal discharge, itching, or discomfort.

• Drowsiness, dizziness, or tiredness.

• Headaches.

• Abdominal bloating, pain, or nausea.

• Breast tenderness or pain.

• Mood swings, depression, or changes in libido.

• Breakthrough bleeding or spotting.

Serious Side Effects – Contact Your Doctor Immediately
While rare, you should seek urgent medical help if you experience any of the following:

• Signs of a severe allergic reaction (e.g., swelling of the face, lips, tongue, or throat, difficulty breathing, severe skin rash).

• Severe abdominal pain.

• Sudden severe headache, visual disturbances, or migraine (which may be signs of a blood clot).

• Jaundice (yellowing of the skin or eyes), indicating a potential liver issue.

• Signs of a blood clot in the leg (e.g., pain, swelling, and redness in one leg) or lung (e.g., sudden sharp chest pain, difficulty breathing).

• Symptoms of depression.

Storage and Handling Instructions

How should I store Cyclogest pessaries to ensure their stability?

Proper storage is critical for maintaining the integrity and efficacy of the medicine.

• Store in the original foil wrapper in a cool, dry place.

• The ideal storage temperature is below 25°C. Do not freeze.

• Keep the pessaries away from direct sunlight and heat sources.

• Always keep the medicine out of the sight and reach of children and pets.

• Do not use Cyclogest after the expiry date printed on the carton and foil. The expiry date refers to the last day of that month.

• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require.

Manufacturer and Sourcing Credentials

Who manufactures Cyclogest 400mg pessaries?

Cyclogest is manufactured in the United Kingdom by L.D. Collins & Co. Limited. The product is marketed and distributed under the brand name Cyclogest. The manufacturer operates under the strict oversight of the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, ensuring compliance with the highest standards of quality, safety, and efficacy.

Quality and Assurance Standards
The production of Cyclogest adheres to Good Manufacturing Practice (GMP) guidelines. GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. This guarantees that every batch of Cyclogest 400mg pessaries contains the exact specified amount of pure, micronized progesterone in a high-quality, pharmaceutical-grade base, providing you with a reliable and trustworthy product.

Comprehensive Health Benefits of Progesterone Supplementation

How can Cyclogest 400mg benefit my reproductive health?

The benefits of using Cyclogest extend beyond its primary uses, contributing significantly to overall hormonal well-being.

• Enhances Endometrial Receptivity: It directly prepares and maintains the uterine lining (endometrium), creating an optimal environment for a fertilized egg to implant successfully.

• Supports Early Pregnancy: By maintaining progesterone levels, it helps sustain the early stages of pregnancy, reducing the risk of miscarriage due to corpus luteum insufficiency, particularly in IVF cycles.

• Restores Hormonal Balance: It effectively corrects a progesterone deficiency, which can help regulate ovulatory cycles and restore normal menstrual function.

• Provides Uterine Protection in HRT: For menopausal women on estrogen, it counteracts the estrogenic effect on the uterus, significantly lowering the risk of endometrial hyperplasia and cancer.

• Improves Symptom Control: It can effectively reduce the severity of symptoms like premenstrual syndrome (PMS) and perimenopausal mood swings and sleep disturbances linked to low progesterone.

• Offers a Localized Treatment Option: Vaginal administration allows for a high local concentration of progesterone in the uterus with potentially lower systemic side effects compared to oral formulations.

Comparison: Cyclogest vs. Other Progesterone Forms

How does Cyclogest compare to other progesterone supplements?

This table provides a clear comparison to help understand the positioning of Cyclogest among common progesterone delivery methods.

Frequently Asked Questions (FAQs)

Your Cyclogest 400mg Questions Answered

How long does it take for a Cyclogest pessary to dissolve?
A Cyclogest pessary typically melts within 10 to 30 minutes after insertion, depending on your body temperature. It is designed to release the progesterone gradually for absorption.

Can I use Cyclogest during early pregnancy?
Yes, Cyclogest is commonly prescribed to support early pregnancy, especially in women who have undergone fertility treatments like IVF or who have a history of miscarriage due to low progesterone. Its use should always be under strict medical supervision.

What should I do if I miss a dose of Cyclogest?
If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not use a double dose to make up for a forgotten one.

Is it normal to have discharge and spotting while using Cyclogest vaginally?
Yes, a white or cloudy discharge is very common and expected due to the melting of the pessary base. Spotting or breakthrough bleeding can also occur, especially when used for menstrual regulation. If the bleeding becomes heavy or is concerning, contact your doctor.

Can Cyclogest cause weight gain?
Progesterone therapy can sometimes lead to fluid retention and bloating, which may feel like weight gain. Significant weight gain is not a commonly reported side effect but discuss any concerns with your healthcare provider.

How soon after using Cyclogest can I take a pregnancy test?
You should follow the timeline recommended by your fertility clinic or doctor. Generally, a pregnancy test (beta hCG blood test) is scheduled about 10-14 days after embryo transfer in an IVF cycle. Using Cyclogest does not affect the result of a pregnancy test.

Can I have sexual intercourse while using Cyclogest pessaries?
It is generally advised to avoid sexual intercourse during the critical implantation phase of fertility treatment. For other uses, it is best to consult your doctor. If using vaginally, intercourse may be uncomfortable or interfere with the absorption of the medicine.