Get Relief from Menopause Symptoms with Progynova Tablets 1mg

Quantity	1 x 84 tablets

What is Progynova 1mg?

Progynova is a hormone replacement therapy (HRT) medication that contains estradiol valerate, a synthetic form of the female hormone oestrogen. It is primarily used to manage symptoms associated with menopause, such as hot flushes, night sweats, vaginal dryness, and mood swings. Progynova helps restore oestrogen levels in women who are going through menopause or who have had their ovaries removed, thereby alleviating these symptoms. Additionally, Progynova may be prescribed to prevent osteoporosis in postmenopausal women who are at risk of developing bone fractures due to low oestrogen levels.

What is the active ingredient in Progynova 1mg?

Each Progynova tablet contains the active ingredient: estradiol valerate.

What is Progynova 1mg used for?

Progynova is used for hormone replacement therapy (HRT) to manage symptoms associated with menopause, such as hot flushes, night sweats, vaginal dryness, mood swings, and other discomforts that occur due to decreased oestrogen levels. It is also used to prevent osteoporosis in postmenopausal women who are at risk of fractures due to low bone density. Additionally, Progynova may be prescribed for women who have had their ovaries removed or who experience early menopause to maintain balanced hormone levels.

How does Progynova 1mg work?

Progynova is a hormone replacement therapy (HRT) used to alleviate menopause symptoms like hot flushes, night sweats, vaginal dryness, mood swings, and other discomforts caused by decreased oestrogen levels. It also helps prevent osteoporosis in postmenopausal women at risk of fractures due to low bone density. Additionally, Progynova may be prescribed for women who have undergone ovary removal or who experience early menopause to help maintain balanced hormone levels.

How do you use Progynova 1mg?

Always take this medicine exactly as your doctor or pharmacist has instructed. If you are unsure, consult with your doctor or pharmacist.

The typical dosage is one Progynova 2 mg tablet taken daily.

Use in Children and Adolescents: Progynova is not intended for use in adolescents or children.

Your doctor will prescribe the lowest effective dose to manage your symptoms for the shortest time necessary. If you feel the dose is too strong or too weak, speak to your doctor.

Patients with Liver Impairment: Do not take Progynova if you currently have or have had liver tumors, or if you have severe liver disease (see "Do not take Progynova").

About the Pack: The pack is designed to help you remember to take your medicine. Each tablet is marked with the day of the week it should be taken. Follow the arrows between tablets to ensure they are taken in the correct order. Your doctor will advise you on when to start taking the medication.

Start by taking your first tablet from the section marked with the correct day of the week. For example, if you begin on a Tuesday, take the tablet marked 'TUE'. Continue taking one tablet daily, following the arrows, until all 28 tablets are used. Begin the next pack immediately after finishing the previous one, with no break in between. Try to take your tablet at the same time each day, with or without food. Swallow the tablet whole with water or milk.

Your doctor may prescribe a progestogen hormone alongside Progynova for at least 12-14 days each month:

if you still have your womb
if you have a history of endometriosis

When to Start:

If you have been using another HRT preparation: finish your current pack and start Progynova the next day without a break.
If this is your first HRT treatment and you still have regular periods: start Progynova on the first day of your period.
If this is your first HRT treatment and your periods are very infrequent or have stopped completely: you can start Progynova at any time, as long as you are certain you are not pregnant.

If You Take More Progynova Than You Should: Taking too much may cause nausea, vomiting, and irregular bleeding. No specific treatment is required, but consult your doctor or pharmacist if concerned.

If You Forget to Take Progynova:

If you are less than 12 hours late, take the missed tablet as soon as possible and continue with the next tablet at your usual time.
If you are more than 12 hours late, skip the missed tablet and continue with the next tablet at your usual time. You may experience breakthrough bleeding.

If You Stop Taking Progynova: Stopping Progynova may cause menopausal symptoms to return, such as hot flushes, trouble sleeping, nervousness, dizziness, or vaginal dryness. Consult your doctor or pharmacist if you wish to stop taking Progynova.

If You Need to Have Surgery: Inform your surgeon that you are taking Progynova. You may need to stop taking it 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, “Blood clots in a vein (thrombosis)”). Your doctor will advise you when to restart the medication.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

Who should not use Progynova 1mg?

Medical History and Regular Check-Ups

The use of HRT carries risks that need to be carefully considered when deciding whether to start or continue treatment.

If you have experienced premature menopause (due to ovarian failure or surgery), the risks associated with HRT may differ. Discuss these with your doctor.

Before starting or restarting HRT, your doctor will ask about your medical history and that of your family. A physical examination, including a breast exam or internal examination, may be required.

Once you begin taking Progynova, you should schedule regular check-ups with your doctor, at least once a year. During these check-ups, discuss the benefits and risks of continuing the treatment.

Remember to:

Attend regular breast screenings and cervical smear tests as recommended by your doctor.
Regularly check your breasts for any changes, such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.

Do Not Take Progynova:

Avoid taking Progynova if any of the following apply to you. If you're unsure about any of these points, consult your doctor before taking Progynova:

If you have or have ever had breast cancer, or if it is suspected.
If you have cancer sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if it is suspected.
If you have unexplained vaginal bleeding.
If you have untreated excessive thickening of the womb lining (endometrial hyperplasia).
If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep vein thrombosis) or the lungs (pulmonary embolism).
If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
If you have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina.
If you have or have ever had liver disease, and your liver function tests have not returned to normal.
If you have a rare inherited blood disorder called "porphyria."
If you are allergic to estradiol valerate or any other ingredients in this medicine (see section 6).
If you have been advised to avoid lactose or have a rare hereditary condition called Lapp lactase deficiency or glucose-galactose malabsorption.
If you believe you might be pregnant or are breastfeeding.

If any of these conditions appear for the first time while taking Progynova, stop taking it immediately and consult your doctor.

Warnings and Precautions

Before starting Progynova, tell your doctor if you have ever had any of the following conditions, as they may return or worsen during treatment:

Fibroids in your womb
Endometriosis or a history of excessive growth of the womb lining (endometrial hyperplasia)
Increased risk of blood clots (see "Blood clots in a vein (thrombosis)")
Increased risk of oestrogen-sensitive cancer (such as having a mother, sister, or grandmother who had breast cancer)
High blood pressure
Liver disorders, such as a benign liver tumor
Diabetes
Gallstones
Migraines or severe headaches
Systemic lupus erythematosus (SLE), a disease of the immune system
Epilepsy
Asthma
Otosclerosis, a disease affecting the eardrum and hearing
Very high levels of fat in your blood (triglycerides)
Fluid retention due to heart or kidney problems
Hereditary or acquired angioedema

Stop Taking Progynova and Seek Immediate Medical Attention If You Notice:

Any of the conditions mentioned in the ‘Do Not Take Progynova’ section.
Yellowing of your skin or the whites of your eyes (jaundice), which may indicate liver disease.
Swelling of the face, tongue, and/or throat, difficulty swallowing, or hives along with difficulty breathing, which may indicate angioedema.
A significant increase in blood pressure (symptoms may include headache, tiredness, dizziness).
Migraine-like headaches occurring for the first time.
If you become pregnant.
Signs of a blood clot, such as:
- Painful swelling and redness of the legs.
- Sudden chest pain.
- Difficulty breathing.

For more information, see 'Blood clots in a vein (thrombosis).'

Note: Progynova is not a contraceptive. If it has been less than 12 months since your last menstrual period or if you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT and Cancer: FAQs

What is the risk of endometrial cancer with HRT?

Using estrogen-only HRT increases the risk of excessive thickening of the womb lining (endometrial hyperplasia) and endometrial cancer. To mitigate this risk, a progestogen is usually prescribed alongside estrogen for at least 12 days of each 28-day cycle, particularly if you still have your womb. If you have had a hysterectomy, consult your doctor to determine if you can safely use estrogen-only HRT.

For women aged 50 to 65 who do not use HRT, about 5 in 1000 are diagnosed with endometrial cancer. In contrast, those who use estrogen-only HRT face a higher risk, with 10 to 60 in 1000 women being diagnosed, depending on the dosage and duration of use.

What should I do if I experience unexpected bleeding while on HRT?

If you experience unexpected bleeding or spotting outside of your monthly withdrawal bleed while using Oestrogel, especially if it:

Persists beyond the first 6 months,
Starts after more than 6 months of use,
Continues after you’ve stopped using Oestrogel,

You should consult your doctor as soon as possible.

Does HRT increase the risk of breast cancer?

Yes, evidence shows that using combined estrogen-progestogen or estrogen-only HRT increases the risk of breast cancer. This extra risk becomes noticeable within 3 years of use and may persist for 10 years or more after stopping HRT, especially if used for more than 5 years.

For example, in women aged 50 to 54 not using HRT, 13 to 17 in 1000 may be diagnosed with breast cancer over a 5-year period. For those on estrogen-only HRT, the risk increases to 16-17 in 1000, and for those on combined HRT, the risk rises to 21 in 1000.

How can I monitor for breast cancer while on HRT?

Regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel. It’s also important to participate in mammography screening programs as advised by your doctor. When having a mammogram, inform the healthcare provider that you are using HRT, as it can increase breast density and affect the mammogram results.

Does HRT increase the risk of ovarian cancer?

There is a slightly increased risk of ovarian cancer with the use of both estrogen-only and combined estrogen-progestogen HRT. For women aged 50 to 54 who are not using HRT, about 2 in 2000 will be diagnosed with ovarian cancer over 5 years. This increases to about 3 in 2000 for women using HRT.

HRT and Circulation: FAQs

How does HRT affect the risk of blood clots?

The risk of blood clots in the veins (thrombosis) is 1.3 to 3 times higher in HRT users compared to non-users, particularly during the first year of use. Blood clots can be serious, especially if they travel to the lungs, potentially causing chest pain, breathlessness, fainting, or even death.

In women in their 50s not using HRT, about 4 to 7 in 1000 might develop a blood clot over 5 years. This increases to 9 to 12 in 1000 for women using combined HRT, and to 5 to 8 in 1000 for those using estrogen-only HRT after a hysterectomy.

Does HRT affect heart disease risk?

HRT does not prevent heart attacks. Women over 60 using combined estrogen-progestogen HRT are slightly more likely to develop heart disease compared to non-users. However, for women who have had a hysterectomy and are using estrogen-only therapy, there is no increased risk of heart disease.

Does HRT increase the risk of stroke?

Yes, the risk of stroke is about 1.5 times higher in HRT users compared to non-users. For women in their 50s not using HRT, 8 in 1000 are expected to have a stroke over 5 years. This number increases to 11 in 1000 for those using HRT.

Other FAQs

Can Oestrogel be transferred to others?

Yes, Oestrogel can be accidentally transferred from your skin to others, especially children. To prevent this, avoid letting others touch the treated area until it is dry and cover it with clothing if necessary. If a child comes into contact with the treated area, wash their skin with soap and water immediately. If you notice signs of early puberty (e.g., breast development) in a child who may have been exposed to Oestrogel, contact your healthcare provider.

Does HRT affect memory?

HRT does not prevent memory loss, and there is some evidence that starting HRT after age 65 may increase the risk of memory loss. Consult your doctor for advice.

Can Oestrogel interact with other medications?

Yes, Oestrogel can interact with other medications, leading to irregular bleeding or other effects. Medicines for epilepsy, tuberculosis, HIV infection, and certain herbal products like St John’s wort may interfere with Oestrogel. It’s important to inform your doctor about all the medications you are taking.

What should I know about Oestrogel and pregnancy?

Oestrogel is intended for use in postmenopausal women only. If you become pregnant, stop using Oestrogel and contact your doctor.

What are the side effects with Progynova 1mg?

Like all medicines, Progynova can cause side effects, although not everyone will experience them.

Serious Side Effects: The following conditions have been reported more frequently in women using HRT compared to those not using HRT:

Breast cancer
Abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
Ovarian cancer
Blood clots in the veins of the legs or lungs (venous thromboembolism)
Heart disease
Stroke
Probable memory loss if HRT is started after the age of 65

For more details on these side effects, please refer to section 2 of the leaflet.

Other Possible Side Effects Linked to Progynova and Other Oral HRTs:

During the first few months of treatment, you may experience vaginal bleeding at unexpected times (breakthrough bleeding and spotting). These symptoms usually lessen with continued treatment. If they persist, contact your doctor (see section 2 ‘HRT and cancer/Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)’ for more information).
Breast pain, tenderness, or enlargement, breast discharge.
Painful periods, changes in vaginal secretions, pre-menstrual symptoms, increased size of fibroids in the womb, thrush, changes to the neck of the womb.
Indigestion, bloating, gas, nausea or vomiting, abdominal pain, gallbladder disease.
Skin rashes or discoloration, itching, eczema, acne, unusual hair loss or hair growth, increased skin pigmentation, especially on the face (chloasma—see section 2 ‘Other conditions’ for more information), and rare skin problems.
Headache, migraine, dizziness, anxiety or depressive symptoms, fatigue.
Fast or irregular heartbeat (palpitations), high blood pressure, inflammation of veins, usually in the legs.
Fluid retention leading to swelling of body parts.
Changes in body weight and sex drive, increased appetite.
Muscle cramps, leg pain.
Nosebleeds, visual disturbances (such as blurred vision), discomfort with contact lenses, allergic-type reactions, worsening of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea).

Other Side Effects Reported with HRT:

Various skin disorders:
- Painful reddish skin nodules (erythema nodosum)
- Rash with target-shaped reddening or sores (erythema multiforme)

Reporting of Side Effects: If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:

United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

Malta: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

Does Progynova 1mg interact with other medicines?

Some medicines can interfere with the effectiveness of Progynova, potentially leading to irregular bleeding. This includes:

Medications for epilepsy (such as barbiturates, phenytoin, primidone, carbamazepine, and possibly oxcarbazepine, topiramate, and felbamate)
Medications for tuberculosis (such as rifampicin and rifabutin)
Medications for HIV and Hepatitis C Virus infections (such as protease inhibitors and non-nucleoside reverse transcriptase inhibitors like nevirapine, efavirenz, ritonavir, and nelfinavir)
Herbal remedies containing St. John’s wort (Hypericum perforatum)
Medications for fungal infections (such as griseofulvin, fluconazole, itraconazole, ketoconazole, and voriconazole)
Medications for bacterial infections (such as clarithromycin and erythromycin)
Medications for certain heart diseases and high blood pressure (such as verapamil and diltiazem)
Grapefruit juice

Additionally, HRT can affect the action of some other medications, such as:

A medication for epilepsy (lamotrigine), which could lead to an increased frequency of seizures.
Medications for Hepatitis C virus (HCV) (such as the combination regimens ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as the regimen glecaprevir/pibrentasvir) may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using combined hormonal contraceptives (CHCs) containing ethinylestradiol. Progynova contains estradiol instead of ethinylestradiol, and it is unclear whether a similar increase in ALT liver enzyme can occur when using Progynova with these HCV regimens.

Always inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will provide the necessary guidance.

Progynova 1mg FAQs

What is Progynova?

Progynova is an oestrogen-only hormone replacement therapy (HRT) that contains either 1mg or 2mg of estradiol, a form of the female hormone oestrogen. It is used by postmenopausal women to increase oestrogen levels, helping to alleviate symptoms associated with menopause, such as hot flushes, vaginal dryness, and night sweats. Progynova is taken daily without a break, and each pack includes 3 blisters containing 28 tablets. The medication is manufactured by Bayer, a global pharmaceutical company.

What symptoms does Progynova help with?

Progynova is prescribed to postmenopausal women experiencing menopause symptoms that affect their quality of life. It can help relieve the following symptoms:

Hot flushes
Night sweats
Difficulty sleeping
Vaginal dryness and irritation
Reduced sex drive
Headaches
Low mood

What is the difference between Progynova 1 mg and Progynova 2 mg?

Progynova is available in two strengths: 1 mg and 2 mg. Your doctor will prescribe the appropriate dosage based on your individual needs. Both strengths are taken once daily at the same time each day with water.

How does Progynova work?

Progynova works by replacing oestrogen in the body. The tablets contain estradiol, a substance that mimics the female sex hormone oestrogen. During menopause, the ovaries produce less oestrogen, leading to symptoms like hot flushes and vaginal dryness. Progynova helps to reduce these symptoms by increasing oestrogen levels in the body. The estradiol is absorbed through the digestive tract and acts similarly to natural oestrogen by interacting with hormone receptors in the body.

Can I drink alcohol while taking Progynova?

Drinking alcohol while taking Progynova may increase the risk of experiencing side effects such as headaches or nausea. If you choose to drink alcohol while using HRT, it is recommended to do so in moderation. If you have concerns about alcohol consumption while on Progynova, consult your doctor or pharmacist.

What are the alternatives to Progynova?

There are various types of hormone replacement therapies available, including other oestrogen-only HRTs and combined HRTs containing both synthetic oestrogen and progesterone. Progynova is an oestrogen-only HRT tablet that contains estradiol valerate. Equivalent treatments include Elleste Solo tablets and Zumenon tablets.

HRT is available in different forms, such as tablets, patches, creams, and vaginal inserts. Depending on personal preference and medical needs, some women may find certain methods more suitable than others. If you are considering starting HRT or switching treatments, discuss your options with your doctor or specialist.

Download patient leaflet

https://www.medicines.org.uk/emc/files/pil.1417.pdf