PROGYNOVA 2 MG TABLETS - patient leaflet, side effects, dosage

3. how to take progynova

About the pack When to start If you take more Progynova than you should If you forget to take Progynova If you stop taking Progynova If you need to have surgery

• 4. POSSIBLE SIDE EFFECTS

• 5. HOW TO STORE PROGYNOVA

• 6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. what progynova is and what it is used for

What Progynova is

Progynova is a Hormone Replacement Therapy (HRT). It contains the female hormone, oestrogen. Your ovaries gradually make less of this hormone as you get older and will no longer produce it after you have been through the menopause. Progynova can be used in peri-and postmenopausal wo­men.

What Progynova is used for

3. how to take progynova

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet of Progynova 2 mg to be taken daily.

Use in children and adolescents

Progynova is not for use in adolescents or children.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

About the pack

This pack is designed to help you remember to take your medicine. Each tablet is placed in a section marked with the day of the week on which it should be taken. The arrows between tablets show the order in which they must be taken.

Your doctor may tell you when to start (see „when to start“ for further information).

Your tablets are available in a days of the week blister. Below is a translation of the days of the week.

On the day you start, take your first tablet from the top row of tablets marked with the correct day. For instance, if you start on a Tuesday, press out the tablet from the blister marked ‘DIN/MAR/DIE’.

Take one tablet each day, following the directions of the arrows, until you have finished all 28 tablets in the memo strip. When you have finished each memo strip, start the next memo strip on the following day. Do not leave a break between memo strips. It is best to take your tablet at the same time each day. You can take Progynova with or without food. The tablet should be swallowed whole with a glass of water or milk.

Your doctor may prescribe the hormone progestogen in addition to 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 taking other HRT preparations: carry on until you have finished your current pack and have taken all the tablets for that month. Take your first Progynova tablet the next day. Do not leave a break between your old tablets and the Progynova tablets.

If this is your first HRT treatment and you are still having regular periods: start your Progynova tablets on the first day of bleeding

If this is your first HRT treatment and your periods have become very infrequent or have stopped completely: you can start your Progynova tablets at any time if you are sure you are not pregnant.

If you take more Progynova than you should

Overdose may cause nausea and vomiting and irregular bleeding. No specific treatment is necessary but you should consult your doctor or pharmacist if you are concerned.

If you forget to take Progynova

If you forget to take a tablet at your usual time and you are less than 12 hours late, take it as soon as possible. Take the next tablet at the usual time.

If you are more than 12 hours late, leave the forgotten tablet in the pack. Continue to take the rest of the tablets at the usual time every day. You may experience breakthrough bleeding.

If you stop taking Progynova

You may begin to feel the usual symptoms of menopause again, which may include hot flushes, trouble sleeping, nervousness, dizziness or vaginal dryness. Consult your doctor or pharmacist if you want to stop taking Progynova tablets.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Progynova. You may need to stop taking Progynova about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, “Blood clots in a vein (thrombosis)”). Ask your doctor when you can start taking Progynova again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store progynova

Do not use Progynova after the expiry date which is printed on the label after “EXP”. The expiry date refers to the last day of the month stated.

If the tablets show any signs of discolouration or deterioration consult your pharmacist for advice.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not dispose of medicines down the drain or in the household rubbish. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information what progynova contains

Each coated tablet contains 2 mg of estradiol valerate. Also contains: lactose monohydrate, maize starch, povidone 25000, povidone 700000, magnesium stearate, sucrose, macrogol 6000, calcium carbonate, talc, and montan glycol wax.

What Progynova looks like and the contents of the pack

Progynova 2mg Tablets are available in calendar blister packs of 3 × 28.

Progynova 2mg Tablets are manufactured by Bayer AG, Mullerstrasse 178 13353 Berlin, Germany or Bayer Weimar GmbH und Co. KG, Dobereinerstrasse 20, 99427 Weimar, Germany or Delpharm Lille SAS, Rue de Toufflers, 59390 Lys-Lez Lannoy, France. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd. Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.

PL 20774/1587 Progynova 2mg Tablets

Leaflet revision date 17th November 2020

Progynova is a registered trademark.

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Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471269

L-05–1587–01

What you need to know before you take Progynova Medical history and regular check-ups

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it. The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following diseases are reported more often in women using HRT compared to women not using HRT:

Serious side effects

• 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 over the age of 65

For more information about these side effects see section 2.

Other side effects that have been linked to the use of Progynova and other oral hormone replacement therapies:

• During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting). These symptoms normally lessen with continued treatment. If they don’t, 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, a feeling of being bloated, passing wind, feeling or being sick, abdominal pain, gall bladder disease
• skin rashes or discolouration, itching, eczema, acne, unusual

hair loss or hair growth, increased skin pigment especially on the face (chloasma – see section 2 ‘other conditions’ for more information), some 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 parts of the body
• changes in body weight and sex drive, increased appetite
• muscle cramps, leg pains
• nose bleeds, visual disturbances (such as blurred vision),

discomfort with contact lenses, allergic-type reactions, a worsening of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea).

• The following side effects have been reported with other HRTs: various skin disorders:

• painful reddish skin nodules (erythema nodosum)

• rash with target-shaped reddening or sores (erythema multiforme)