<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<DIV type=0>

<HEAD weight="bold" >
Progynova 2 mg
</HEAD>


<BLOCK>

<EMPH slant = "italic">
The leaflet for Progynova 2 mg is in the form of a small booklet The information that it contains follows.
</EMPH>

</BLOCK>


<BLOCK>

<EMPH weight="bold">
Please read this carefully before you start your medicine
</EMPH>
.
</BLOCK>


<BLOCK>
This booklet only provides a summary of the information available on your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.
</BLOCK>


<BLOCK>
The reason why you can only get this medicine with a doctor's prescription is that its use needs medical supervision.
</BLOCK>


<BLOCK>
Please tell your doctor if you have any doubts or worries about taking this medicine, either before you start or while you are taking it.
</BLOCK>

<DIV type=1>

<HEAD weight="bold" >
What the "change of life" means
</HEAD>


<BLOCK>
The "change of life" is a long process, normally occurring between the ages of 45 and 55 during which your reproductive organs are undergoing a slow decline. Although the change of life is natural, it often causes distressing symptoms, which are connected with the gradual loss of the hormones produced by the ovaries.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
The name of your medicine is:
</EMPH>
 Progynova 2 mg (oestradiol valerate).
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What does Progynova 2 mg contain?
</HEAD>


<BLOCK>
Each tablet contains 2 mg of oestradiol valerate and the following inactive ingredients: lactose, maize starch, povidone 25 000, povidone 700 000, magnesium stearate (E572), sucrose, polyethylene glycol 6 000, calcium carbonate (E170), talc, glycerin (E422), montan glycol wax, titanium dioxide (E171), indigo carmine (E132)
</BLOCK>


<BLOCK>
Each pack of Progynova 2 mg contains 3 memo packs (strips) of 28 tablets. Packs containing 1 memo strip of 28 tablets are also available to doctors.
</BLOCK>


<BLOCK>
Progynova 2 mg is a hormone replacement therapy.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
The product licence is held by
</EMPH>
 Schering Health Care Ltd, The Brow, Burgess Hill, West Sussex, RH15 9NE.
</BLOCK>


<BLOCK>
Progynova 2 mg is manufactured by Schering AG, Berlin, Germany.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How Progynova 2 mg helps you through the "change of life"
</HEAD>


<BLOCK>
Progynova 2 mg is used for "hormone replacement therapy" because it contains the principal oestrogen hormone that is lost during the "change of life". Therefore, it replaces the oestrogen that your body can no longer make, and this prevents or improves the troublesome symptoms.
</BLOCK>


<BLOCK>
Some women are more likely than others to develop osteoporosis in later life depending on their medical history and lifestyle. If it is appropriate you may be prescribed Progynova 2 mg to prevent osteoporosis. Your doctor will be able to advise you further.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Reasons for not taking Progynova 2 mg
</EMPH>
 Before taking Progynova 2 mg tell your doctor if you have any of these: clots in the blood vessels (thrombotic disorders) or a history of these conditions severe diabetes with changes to the blood vessels abnormal red blood cells (sickle-cell anaemia); high blood fats (disorders of lipid metabolism); existing or treated hormone-dependent tumours of the breast; a history during pregnancy of (1) itching of the whole body (pruritus of pregnancy), (2) the blister-like rash (most commonly on the palms and soles) known as herpes gestationis, (3) deterioration of inherited deafness (otosclerosis) or (4) jaundice not explained by infections, poisons or obstruction of the flow of bile <CB n=2> (idiopathic jaundice of pregnancy);certain other types of idiopathic jaundice (Dubin-Johnson or Rotor syndromes)- severe disturbances of liver function- previous or existing liver tumours; lumpy, painful breasts (mastopathy); the presence of tissue of the lining of the womb in places of the body where it is not normally found (endometriosis). 
</BLOCK>


<BLOCK>

<EMPH weight="bold">
What you should know before taking Progynova 2 mg
</EMPH>
What you should know before taking Progynova 2 
</BLOCK>


<BLOCK>
If you have 
<EMPH slant = "italic">
not
</EMPH>
 had a hysterectomy (i.e. you still have a womb), you will need to take another hormone called a progestogen, with Progynova 2 mg. Your doctor will be able to advise you further.
</BLOCK>


<BLOCK>
Your doctor will carry out gynaecological, blood pressure and other examinations as appropriate, e.g. if you are known to have any liver disease, your doctor will arrange for your liver function to be checked periodically.
</BLOCK>


<BLOCK>
Your doctor will examine your breasts periodically during treatment, particularly if there is a history of breast cancer in your family.
</BLOCK>


<BLOCK>
During or after the use of hormones such as are contained in Progynova 2 mg, benign liver tumours have rarely occurred, and even more rarely malignant liver tumours. In isolated cases, bleeding from such tumours into the abdomen has endangered life. Although such events are extremely improbable with Progynova 2 mg, you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Reasons for stopping Progynova 2 mg immediately
</HEAD>


<BLOCK>
There is not known to be any increased risk of blood clotting (thrombosis) during the use of Progynova 2 mg. However, it should not be used if thrombosis is present, and as a precaution you are therefore advised to stop taking Progynova 2 mg at once and consult your doctor if you experience any of the following: the very first attack of migraine (typically a throbbing headache and nausea, preceded by visual disturbances) that you have ever experienced- worsening of pre-existing migraine- any unusually frequent or unusually severe headaches; sudden disturbances of vision or hearing; inflamed veins (phlebitis); pains in the chest or abdomen; swelling in the limbs; pain, tingling or numbness in any part of the body; unexplained cough; breathlessness; pain on breathing.
</BLOCK>


<BLOCK>
Progynova 2 mg must also be stopped at once if you develop jaundice, or if your doctor finds your blood pressure to be significantly raised or if you notice an increase in epileptic seizures.
</BLOCK>


<BLOCK>
If you have any of the symptoms listed above you should stop taking the tablets and contact your doctor at once.
</BLOCK>


<BLOCK>
Ask your doctor for advice on whether you should stop taking the tablets if you are confined to bed, or have an accident or illness, or you need an operation.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
What to do if . . .
</EMPH>

</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
You are taking other medicines at the same time as Progynova 2 mg
</HEAD>


<BLOCK>
Some drugs e.g. antibiotics and antiepileptics may reduce the effectiveness of Progynova 2 mg.
</BLOCK>


<BLOCK>
If you have to take any other medicines regularly, you should inform your doctor.
</BLOCK>


<BLOCK>
If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.
</BLOCK>


<BLOCK>
If in doubt about any medicines you are taking, ask your doctor.
</BLOCK>

<PB n=2>
<CB n=1>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
How to take Progynova 2 mg
</HEAD>


<BLOCK>

<EMPH slant = "italic">
About the pack:
</EMPH>
 The pack is designed to help you remember to take your medicine. Each pill is placed in a section marked with the day of the week on which it should be taken. The arrows between pills show the order in which they must be taken. To use the pack you must first know the day of the week on which you will take the first tablet. Your doctor may advise you to start immediately.
</BLOCK>


<BLOCK>
On the day that you start, take your first tablet from the blue section of the pack (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 'TUE' in the blue section. (
<EMPH slant = "italic">
In the booklet a small diagram of the pack appears at this point
</EMPH>
.)
</BLOCK>


<BLOCK>
Take one tablet each day, following the directions of the arrows, until you have finished all 28 tablets in the pack. It is best to take you r tablet at the same time each day, preferably after a meal. The tablet should be swallowed whole, with a glass of water or milk.
</BLOCK>


<BLOCK>
When you have finished each pack, start the next pack on the following day. Never leave a break between packs. Tablet-taking should be continuous.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
What to do if . . .
</EMPH>

</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
You forget to take a tablet
</HEAD>


<BLOCK>
Take it as soon as possible, and take the next one at your normal time.
</BLOCK>


<BLOCK>
But if you are more than twelve hours late, leave the forgotten tablet in the pack. Continue to take the remaining tablets at the usual time on the right days.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
What to do if . . .
</EMPH>

</BLOCK>


<BLOCK>

<EMPH weight="bold">
You take too many tablets at once There have been no reports of serious ill-effects from overdosage. You should consult your doctor who will be able to advise you what action, if any, is necessary.Side-effects
</EMPH>

</BLOCK>


<BLOCK>
During the first few months of treatment you may experience some breast tenderness or enlargement. These symptoms are usually temporary and normally disappear with continued treatment.
</BLOCK>


<BLOCK>
The other symptoms that have been reported are: indigestion, flatulence, nausea, vomiting, bloated stomach and abdominal pain, greatly increased appetite, increased or reduced weight, leg pains, fluid retention, palpitations, heart symptoms, altered sexual interest, headaches, dizziness, anxiety, depressive moods, nosebleeds, high blood pressure, rashes, inflamed veins with clotting {thrombophlebitis), vaginal discharge, general itching.
</BLOCK>


<BLOCK>
Substances such as are contained in Progynova 1 mg may cause jaundice in people who have an inherited abnormality of bile excretion.
</BLOCK>


<BLOCK>
Tell your doctor if you have any of these symptoms, or, indeed, any other symptoms while you are taking Progynova 1 mg.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Expiry date
</HEAD>


<BLOCK>
The expiry date for this pack of medicine is printed on the label. Do not use the medicine after this date.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Storage
</HEAD>


<BLOCK>
Keep out of the reach of children.
</BLOCK>

<DIV type=2>

<HEAD>
Date of last revision of this leaflet: 16 April 1996
</HEAD>


<BLOCK>

<EMPH weight="bold">
Product licence number
</EMPH>
 0053/0058  Progynova is a registered trademark of Schering AG .
</BLOCK>

</DIV>

</DIV>

</DIV>

</DOCUMENT>
