Cyclo-Progynova 2mg tablets

Main information

  • Trade name:
  • Cyclo-Progynova 2mg tablets
  • Pharmaceutical form:
  • Not applicable
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Never Valid To Prescribe As A VMP
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cyclo-Progynova 2mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 06040101; GTIN: 5060035240029

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15142/0067
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Packaging Technology Berlin sgqwx

page 2

Bayer Pharma AG

client: JS86

material-no.: 85556738

PZ: 2599F-4A

code-no.: 141

name: LF-Cyclo-Progynova 2MG SCT GB

country: GB/-/MEDA

colors: Black

version: 29.09.2016/01

Restricted Document

dimension: 160 x 594 mm

85556738

2.9

Endometrial cancer (cancer of the

lining of the womb)

Taking oestrogen-only HRT for a long time can

increase the risk of cancer of the lining of the

womb (the endometrium). Taking a progestogen

as well as the oestrogen helps to lower the extra

risk.

If you still have your womb, your doctor will

usually prescribe a progestogen as well as

oestrogen. These may be prescribed separately,

or as a combined HRT product.

If you have had your womb removed (a

hysterectomy), your doctor will discuss with you

whether you can safely take oestrogen without a

progestogen.

If you’ve had your womb removed because of

endometriosis, any endometrium left in your

body may be at risk. So your doctor may

prescribe HRT that includes a progestogen as

well as an oestrogen.

Your product, Cyclo-Progynova contains a

progestogen.

Compare

Looking at women who still have a uterus and

who are not taking HRT – on average 5 in

1000 will be diagnosed with endometrial cancer

between the ages of 50 and 65.

For women who take oestrogen-only HRT, the

number will be 2 to 12 times higher,

depending on the dose and how long you take

The addition of a progestogen to oestrogen-

only HRT substantially reduces the risk of

endometrial cancer.

If you get breakthrough bleeding or spotting,

it’s usually nothing to worry about, especially

during the first few months of taking HRT.

If the bleeding or spotting:

carries on for more than the first few

months

starts after you’ve been on HRT for a while

carries on even after you’ve stopped taking

HRT.

You must make an appointment to see your

doctor. It could be a sign that your endometrium

has become thicker.

2.10

Ovarian cancer

Ovarian cancer is rare – much rarer than breast

cancer. It can be difficult to diagnose, because

there are often no obvious signs of the disease.

The use of oestrogen-only or combined

oestrogen-progestagen HRT has been associated

with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For

example, in women aged 50 to 54 who are not

taking HRT, about 2 women in 2000 will be

diagnosed with ovarian cancer over a 5-year

period. For women who have been taking HRT for

5 years, there will be about 3 cases per 2000

users (i.e. about 1 extra case).

2.11

Dementia

HRT will not prevent memory loss. In one study of

women who started using combined HRT after

the age of 65, a small increase in the risk of

dementia was observed.

2.12 Liver tumor

During or after the use of hormones such as those

that are contained in Cyclo-Progynova, benign liver

tumors have rarely occurred, and malignant liver

tumors even more rarely. In isolated cases,

bleeding from such tumors into the abdominal

cavity has endangered life. Although such events

are extremely improbable you should inform your

doctor about any unusual feelings in your upper

abdomen that do not disappear within a short time.

2.13 Tell your doctor if you are taking any of

the following medicines:

Anticonvulsants such as phenobarbital or

phenytoin (to treat epilepsy)

Antibiotics such as rifampicin or rifabutin (to treat

infections)

Herbal medicines containing the herb St. John’s

Wort

Insulin or other medicines to treat diabetes

Protease inhibitors (to treat HIV)

Transcriptase inhibitors such as nevirapine or

efavirenz (to treat HIV)

Any other medicine, including medicines

obtained without a prescription.

2.14 Contraception

This medicine will not act as a contraceptive.

Ask your doctor for advice if you are already using

a contraceptive. This medicine may interfere with it.

2.15 Pregnancy and breast-feeding

Do not take Cyclo-Progynova if you are pregnant or

breast-feeding.

If you become pregnant whilst taking this

medicine, you must immediately stop taking this

medicine and ask your doctor for advice.

2.16 Driving and using machines

Whilst taking Cyclo-Progynova you may feel dizzy.

If this happens, do not drive or operate machinery.

2.17 Warning about sugar intolerance

This medicine contains sugar. If you have been told

by your doctor that you have an intolerance to

some sugars, contact your doctor before taking

this medicine.

3.

How to take Cyclo-Progynova

Always take Cyclo-Progynova exactly as your

doctor has told you.

Important:

Your doctor will choose the dose that is right for

you. Your dose will be shown clearly on the label

that your pharmacist puts on your medicine. If it

does not, or you are not sure, ask your doctor or

pharmacist.

3.1

When to start taking your medicine for

the first time

Depending on your situation you should start to

take this medicine at the following times of the

month:

If you are having regular periods, start taking the

medicine on the fifth day of your period.

If you are not having regular periods, you can

start at any time.

If you are changing from another HRT medicine

that gives you a period complete the treatment

course of the other medicine. Then on the next

day start to take this medicine.

If you are changing from another HRT medicine

that does not give you a period, you can start at

any time.

3.2

How to use the medicine

Your pack contains 1 foil memo-strip and 7 blue

stickers showing days of the week. Each blue

sticker starts with a different day of the week.

Peel off a strip that starts with your starting day.

Stick this sticker along the top of the foil

memostrip where it states ‘fix the blue sticker

here’ so that the first day is above the pill

marked ‘start’.

You can now see on which days you have to

take each tablet. Take one tablet each day,

following the direction of the arrows, until you

have finished all 21 tablets.

Swallow the tablets whole with water. Do not

chew the tablets.

Take the tablets at the same time every day.

After day 21 you will have a 7 day tablet free

break. During this week, bleeding similar to a

period may occur. This is normal.

Start the next strip immediately after the 7 day

break. You will start your new strip of tablets on

the same day of each month. Take the tablets

even if your bleeding has not finished.

If you are not sure how to use the sticker and the

memo-pack then please ask your pharmacist for

advice.

3.3

Medical check-ups

Once you are taking this medicine:

Regularly check your breasts for any changes. If

you notice dimpling of the skin, changes in

the nipple, or any lumps you must see your

doctor as soon as possible.

Go for regular breast screening

Go for regular cervical smear tests

See your doctor for regular check-ups (at least

once a year). At these check-ups, your doctor

will discuss with you the benefits and risks of

continuing to take HRT.

3.4

What bleeding pattern to expect with

Cyclo-Progynova

As with normal periods, the amount of blood loss

will vary from woman to woman.

Your bleeding pattern may change when you are

taking this medicine. You may have:

Bleeding in the first three weeks of starting the

tablets. If so, ask your doctor for advice.

Heavier bleeding. You may notice this more if

your periods have become short or lighter before

you started treatment. This is normal.

Bleeding in the break where you take no tablets.

This is normal.

If after several months you are still getting

spotting or breakthrough bleeding, or you are

worried about your bleeding you must see your

doctor.

3.5

If you take more Cyclo-Progynova than

you should

There have been no reports of ill-effects from

overdose. Overdose may cause nausea and

vomiting and irregular bleeding.

No specific treatment is necessary but you should

consult your doctor if you are concerned.

3.6

If you forget to take Cyclo-Progynova

If your tablet is less than 12 hours late, take the

tablet as soon as possible, then take your next

tablet at the normal time.

If your tablet is more than 12 hours late, leave the

forgotten tablet in the pack, and take your next

tablet at the normal time.

You may get some vaginal bleeding

(breakthrough bleeding) if you have missed a

tablet. This is normal.

If you have any further questions about the use of

this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines Cyclo-Progynova can cause side

effects, although not everybody gets them.

If you have any of the following symptoms:

Chest pain that spreads to your arm or

neck

Sudden numbness or confusion

Difficulty breathing

Severe rash that might blister

Sudden pain and swelling in your leg

You notice yellowing of your skin or eyes

Severe or prolonged headache, possibly

with disturbed vision for the first time.

Seek immediate medical help and stop taking

Cyclo-Progynova.

If you get any of the following symptoms:

If you notice any changes in your breast

such as a lump, dimpling in the skin or the

nipple changing

If bleeding or spotting carries on for more

than the first few months, or starts after you

have been taking the tablets for a while

If bleeding or spotting carries on even after

you’ve stopped taking HRT.

See your doctor as soon as possible.

Important: All the symptoms in the boxes above

are signs that you may be developing a serious

problem. If you ignore these symptoms they may

become worse.

Other possible side effects

The following symptoms, which may or may not

have been caused by hormone replacement

therapy, and which in some cases were probably

symptoms of the climacteric, have been reported in

users of different oral hormone replacement

therapy preparations:

Common undesirable effects (between 1 and 10

in every 100 users may be affected)

weight loss or gain

Headache

stomach pain, nausea

rash, itching

vaginal bleeding including Spotting (bleeding

irregularities usually subside during continued

treatment)

Uncommon undesirable effects (between 1 and

10 persons in every 1,000 users may be affected)

allergies (hypersensitivity reaction)

depressed mood

dizziness

visual disturbances

palpitations(irregular, rapid beating or pulsation

of the heart)

dyspepsia (indigestion)

erythema nodosum (reddish painful nodules),

urticaria (hives)

breast pain, breast tenderness

edema(swelling due to excessive fluid retention)

Rare undesirable effects (between 1 and 10 in

every 10,000 users may be affected)

anxiety, libido decreased or libido increased (an

increase or a decreased interest in sex)

migraine

contact lens intolerance

bloating, vomiting

hirsutism (excessive hair growth), acne

muscle cramps

dysmenorrhea (painful period), vaginal discharge,

Pre-menstrual-like syndrome, swollen breast

fatigue

In women with episodes of swelling in body parts

such as hands, feet, face, airway passages that are

caused by a defect in the gene that controls a

blood protein called C1-inhibitor (hereditary

angioedema) the hormone estradiol valerate in

Cyclo-Progynova may induce or exacerbate

symptoms of hereditary angioedema.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more

information on the safety of this medicine.

5.

How to store Cyclo-Progynova

Keep out of the reach and sight of children. Do not

use Cyclo-Progynova after the expiry date on the

carton. The expiry date refers to the last day of that

month.

Medicines should not be disposed of via

wastewater or household waste. Return any

medicine you no longer need to your pharmacist.

6.

Further information

6.1

What Cyclo-Progynova contains

There are two active substances in this medicine.

The white tablets contain 2mg of estradiol

valerate. The pale-brown tablets contain 2 mg of

estradiol valerate and 0.5 mg of norgestrel.

The other ingredients are lactose, maize starch,

povidone, talc, magnesium stearate (E572),

sucrose, calcium carbonate (E170), polyethylene

glycol 6000.

The white tablets also contain titanium dioxide

(E171), yellow ferric oxide (E172) and red brown

ferric oxide (E172)

The pale-brown tablets also contain glycerin and

montan glycol wax.

6.2

What Cyclo-Progynova looks like

Cyclo-Progynova is made up of white and pale

brown tablets.

Each carton contains 1 or 3 memo-packs. Each

memo-pack contains 21 tablets, which include

11 white tablets and 10 pale brown tablets.

Not all pack sizes may be marketed.

6.3

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd, Skyway House,

Parsonage Road, Takeley, Bishop’s Stortford,

CM22 6PU.

6.4

Manufacturer

Bayer Weimar GmbH und Co KG, Weimar,

Dobereinerstrasse 20D-99427, Germany and

Bayer Pharma AG, Berlin, Germany

This leaflet was last updated on September 2016.

If this leaflet is difficult to see or read or you

would like it in a different format, please contact

Meda Pharmaceuticals Ltd, Skyway House,

Parsonage Road, Takeley, Bishop’s Stortford,

CM22 6PU.

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29.09.2016 08:40:23