Progynova Tablets

Progynova Tablets for Hormone Replacement Therapy (HRT)

What is Progynova used for?

Progynova is used to relieve symptoms that occur during and after the menopause. As oestrogen levels fall, many women experience:

• Hot flushes
• Night sweats
• Mood changes
• Trouble sleeping
• Vaginal dryness

Progynova helps ease these symptoms when they are significantly affecting daily life.

It is also used to prevent osteoporosis in postmenopausal women who are at increased risk of fractures.

How Does Progynova Work?

Progynova contains estradiol valerate, which is converted in the body to estradiol – the female hormone your ovaries naturally produce.

During the menopause, oestrogen production gradually declines. This fall in hormone levels is what triggers menopausal symptoms. Progynova works as an oestrogen replacement, restoring levels enough to reduce symptoms and protect against bone loss.

Because Progynova is an oestrogen-only HRT, women who still have their womb will also need to take a progestogen alongside it for at least 12 to 14 days each month. This protects the lining of the uterus from the effects of oestrogen taken alone. Women who have had a hysterectomy can usually take Progynova without a progestogen – your doctor will advise you.

Who can use Progynova?

Progynova is suitable for peri- and postmenopausal women whose symptoms are significantly affecting daily life, or who are at risk of osteoporosis after menopause. Your doctor will review your medical history before starting treatment with Progynova.

Do not take Progynova if you:

• Have or have ever had breast cancer, or are suspected of having it
• Have cancer sensitive to oestrogens, such as cancer of the womb lining, or are suspected of having it
• Have any unexplained vaginal bleeding
• Have untreated endometrial hyperplasia (excessive thickening of the womb lining)
• Have or have ever had a blood clot in a vein (such as deep vein thrombosis or pulmonary embolism)
• Have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• Have or recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina
• Have or have ever had liver disease where liver function has not returned to normal
• Have a rare inherited blood disorder called porphyria
• Are allergic to estradiol valerate or any other ingredient in Progynova
• Have been told to avoid lactose or have Lapp lactase deficiency or glucose-galactose malabsorption
• Are pregnant or breastfeeding, or think you may be pregnant

Speak to your doctor before taking Progynova if you have or have ever had:

• Fibroids or endometriosis
• A history of blood clots or increased clotting risk
• High blood pressure
• A liver disorder
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic lupus erythematosus (SLE)
• Epilepsy, asthma, or otosclerosis
• Very high triglyceride levels
• Fluid retention due to heart or kidney problems
• Hereditary angioedema

How to Take Progynova

Take one tablet daily, swallowed whole with a glass of water or milk. It can be taken with or without food. Try to take it at the same time each day to help keep a routine.

Each pack contains 28 tablets in a memo strip blister, with the days of the week printed on the foil. Start on the correct day and follow the arrows until all 28 tablets are taken. Start the next strip the following day with no break between strips.

Starting Progynova for the first time:

• If you are still having regular periods, start on the first day of bleeding.
• If your periods have become very infrequent or have stopped, you can start at any time, provided you are sure you aren’t pregnant.
• If you are switching from another HRT, finish your current pack and start Progynova the following day with no break.

Your doctor will aim to prescribe the lowest effective dose for the shortest time necessary. Speak to your doctor if you feel the dose is too strong or not strong enough.

Side Effects of Progynova

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

• Bleeding and spotting, particularly in the first few months of treatment
• Breast pain, tenderness, enlargement, or discharge
• Painful periods, changes in vaginal secretions, thrush, increased fibroid size
• Indigestion, bloating, wind, nausea, abdominal pain, gallbladder disease
• Skin rashes, itching, eczema, acne, hair changes, increased facial pigmentation (chloasma)
• Headache, migraine, dizziness, anxiety, low mood, fatigue
• Palpitations, high blood pressure, inflammation of leg veins
• Fluid retention and swelling
• Changes in weight, appetite, or sex drive
• Muscle cramps, leg pains
• Nosebleeds, blurred vision, contact lens discomfort, bladder inflammation

Serious Side Effects

The following conditions may increase the risk of developing in women using HRT compared to those who are not. Speak to your doctor straight away if you experience any of these:

• Increased risk of breast cancer
• Abnormal growth or cancer of the womb lining (endometrial hyperplasia or cancer)
• Ovarian cancer
• Blood clots in the legs or lungs (venous thromboembolism)
• Heart disease
• Stroke
• Memory loss (if HRT is started after the age of 65)

For more detail on these risks, see the patient information leaflet.

If you experience any severe side effects or signs of an allergic reaction, stop taking Progynova and seek immediate medical attention.

Reporting Progynova Side Effects

You can report any side effects directly via the Yellow Card Scheme. This helps improve the safety of medicines for everyone.

Progynova Ingredients

Active ingredient: Estradiol valerate 1 mg / 2 mg

Other ingredients: Lactose monohydrate, maize starch, povidone 25,000, talc, magnesium stearate (E572), sucrose, povidone 700,000, macrogol 6,000, calcium carbonate (E170), titanium dioxide (E171), glycerol 85% (E422), montan glycol wax, ferric oxide pigment (E172), purified water

Progynova contains lactose and sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Progynova Warnings and Precautions

• Progynova isn’t a contraceptive. If it is less than 12 months since your last period, or you are under 50, you may still need contraception. Speak to your doctor for advice.
• Women who still have their womb must take a progestogen alongside Progynova for at least 12 to 14 days each month to protect the womb lining.
• Some medicines can affect how Progynova works, including certain epilepsy medications, tuberculosis treatments, HIV and hepatitis C medicines, antifungals, some antibiotics, St John’s Wort, and grapefruit juice. Always tell your doctor or pharmacist about any other medicines you are taking.
• Progynova can affect the results of some blood tests. Tell your doctor or laboratory staff that you are taking it before any blood tests.
• If you are going to have surgery, tell your surgeon you are taking Progynova. You may need to stop taking it 4 to 6 weeks before the operation to reduce the risk of blood clots.
• Stop taking Progynova and contact your doctor immediately if you develop jaundice, a sudden rise in blood pressure, a new migraine-type headache, signs of a blood clot (such as painful swelling in the leg, sudden chest pain, or difficulty breathing), or if you become pregnant.
• Keep out of the sight and reach of children.
• Do not use after the expiry date shown on the packaging.