Skip to Content

CLIMAVAL 2MG FILM-COATED TABLETS

Active substance(s): OESTRADIOL VALERATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Read Direction
(DUMMY)

Package leaflet: Information for the user

Climaval®

2. What you need to know before you take Climaval
Medical history and regular check-ups

1 and 2 mg film-coated tablets
(Oestradiol valerate)

Read all of this leaflet carefully, before you start taking this
medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Climaval is and what it is used for
2. What you need to know before you take Climaval
3. How to use Climaval
4. Possible side effects
5. How to store Climaval
6. Content of the pack and other information

Do not take Climaval

1. What Climaval is and what it is used for

Climaval is a Hormone Replacement Therapy (HRT). It contains the female hormone
oestrogen.
Oestradiol valerate is identical to the natural female hormone oestrogen. This
hormone is produced by the ovaries before the menopause.
Climaval is used for:

Relief of symptoms occurring after menopause

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.
Before you start (or restart) Climaval, your doctor will ask about your own and your
family’s medical history. Your doctor may decide to perform a physical examination.
This may include an examination of your breasts and/or an internal examination, if
necessary. He/she should tell you what kind of changes in the breast you should look
out for and may advise you to have a breast X-ray (a mammogram). Once you have
started on Climaval, you should see your doctor for regular check-ups (at least once a
year). At these check-ups, discuss with your doctor the benefits and risks of
continuing with Climaval.
Go for regular breast screening, as recommended by your doctor.

Menopause occurs naturally in all women, usually between the ages of
45 and 55 years. It occurs also in younger women who have their ovaries removed by
surgery. During the menopause, the amount of the oestrogen produced by a woman’s
body drops. This can cause symptoms such as hot face, neck and chest

If any of the following applies to you. If you are not sure about any of the points below,
talk to your doctor before taking Climaval,
• if you have or have ever had breast cancer, or if you are suspected of having it;
• if you have cancer which is sensitive to oestrogens, such as cancer of the womb
lining (endometrium), or if you are suspected of having it;
• if you have any unexplained vaginal bleeding;
• if you have excessive thickening of the womb lining (endometrial hyperplasia)
that is not being treated;
• if you have severe kidney disease;
• if you have or have ever had a blood clot in a vein (thrombosis), such as in the
legs (deep venous thrombosis), or the lungs (pulmonary embolism);
• if you have a blood clotting disorder (such as protein C, protein S or antithrombin
deficiency);

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
Both
WO:
1315358
Comp. Description: Leaflet_Climaval_Clima/Meri_Range_FCT_1MG/2MG_GB
Comp. Number New: 1315358 GB
Comp. Number Old: n/a
Format/Dimension: 600 x 160 mm
Tech. Drawing No.: 600x160_FHC-c_rev1

Production Site:
CTM:
Printing Colours:

Piramal Healthcare
Monk, Danielle
Black

Technical Colours: Cutting
Dimensions

Minimum Font Size: 9.0pt
Font Type: Wingdings 2, News Gothic
12/11/2014

When to take special care with Climaval

Tell your doctor if you have ever had any of the following problems, before you
start the treatment, as these may return or become worse during treatment with
Climaval. If so, you should see your doctor more often for check-ups.
• Fibroids inside your womb
• Growth of womb lining outside your womb (endometriosis) or a history of
excessive growth of the womb lining (endometrial hyperplasia)
• Increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
• Increased risk of getting an oestrogen-sensitive cancer (such as having a
mother, sister or grandmother who has had breast cancer)
• High blood pressure
• A liver disorder, such as a benign liver tumour (liver adenoma)
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many organs of the body (Systemic
lupus erythematosus,SLE), an autoimmune disorder
• Epilepsy
• Asthma
• A disease affecting the eardrum and hearing (otosclerosis)
• A very high level of fat in your blood (triglycerides)
• Fluid retention due to cardiac or kidney problems
• Hypothyroidism (a condition in which your thyroid gland fails to produce enough
thyroid hormone and for which you are treated with thyroid hormone replacement
therapy)
• Hereditary angioedema or episodes of rapid swelling of the hands, feet, face,
lips, eyes, tongue, throat (airway blockage) or digestive tract.

Unexpected bleeding

Stop taking Climaval and see a doctor immediately.
If you notice any of the following when taking HRT:
–– Any of the conditions mentioned in the ‘Do Not take Climaval’ section
–– Yellowing of your skin or the whites of your eyes (jaundice). These may be signs of
a liver disease
–– A large rise in your blood pressure (symptoms may be headache, tiredness,
dizziness)
–– Migraine-like headaches which happen for the first time, with or without disturbed
vision. Headaches like these can be an early sign of a stroke. If you have already
had a stroke, talk with your doctor about whether the benefits of the treatment
outweigh the possibly increased risk.
–– If you get pain in your chest that spreads to your arm or neck. This pain may be a
sign of heart disease.
–– If you notice signs of a blood clot, such as:
¡¡ painful swelling and redness of the legs
¡¡ sudden chest pain
¡¡ difficulty in breathing

You will have a bleed once a month (so-called withdrawal bleed) while taking
Climaval. But, if you have unexpected bleeding or drops of blood (spotting) besides
your monthly bleeding, which:
–– carries on for more than the first 6 months
–– starts after you have been taking Climaval for more than 6 months
–– carries on after you have stopped taking Climaval
–– if you have painful menstrual periods

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

Compare

Leila Parker

! P LEASE TU R N OV E R P R I N T I N G O N !
574279_1

See your doctor as soon as possible.
Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also
oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on
how long you take HRT. The additional risk becomes clear within a few years.
However, it returns to normal within a few years (at most 5) after stopping treatment.
For women who have had their womb removed and who are using oestrogen-only HRT
for 5 years, little or no increase in breast cancer risk is shown.

HRT and cancer
Excessive
of
lining of the womb (endometrial hyperplasia)
and cancer of the lining of the womb (endometrial cancer)

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be
diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are
taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in
1000 users (i.e. an extra 4 to 6 cases).

Taking oestrogen-only HRT will increase the risk of excessive thickening of the
lining of the womb (endometrial hyperplasia) and cancer of the womb lining
(endometrial cancer).

Regularly check your breasts. See your doctor if you notice any
changes such as:

Taking a progestogen in addition to the oestrogen for at least 12 days of each 28 day
cycle protects you from this extra risk. So your doctor will prescribe a progestogen
separately if you still have your womb. If you have had your womb removed
(a hysterectomy), discuss with your doctor whether you can safely take this product
without a progestogen.
In women who still have a womb 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 aged 50 to 65 who still have a womb and who take oestrogen-only HRT,
between 10 and 60 women in 1000 will be diagnosed with endometrial cancer
(i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.

Read Direction
(DUMMY)

1315358_GB_p1_LFT.indd 1

Proof Number: 1
Braille:

• if you have or recently have 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 a liver disease and your liver function tests have not
returned to normal;
• if you have a rare blood problem called “porphyria” which is passed down in
families (inherited);
• if you are allergic (hypersensitive) to oestradiol valerate or any of the other
ingredients of Climaval (listed in section 6);
If any of the above conditions appear for the first time while taking Climaval, stop
taking it at once and consult your doctor immediately.

thickeng

(“hot flushes”), sleep problems, irritability, and depression. Some women also have
problems with urine control or dryness of the vagina, which may cause discomfort
during or after sexual intercourse. Climaval alleviates these symptoms after
menopause. You will only be prescribed Climaval if your symptoms seriously hinder
your daily life.

• dimpling of the skin
• change in the nipple
• any lump you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported
in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will
be diagnosed with ovarian cancer over a 5-year period. For women who have been
taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to
1 extra case).

Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than
in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain,
breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any of the
following applies to you. Inform your doctor if any of these situations applies to you:
• you are unable to walk for a long time because of major surgery, injury or illness
(see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a
medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or an
other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Climaval and see a doctor immediately”.

Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year
period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT for over
5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
For women in their 50s who have had their womb removed and have been taking
oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users
(i.e. 1 extra case).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly
more likely to develop heart disease than those not taking any HRT.
For women who have had their womb removed and are taking oestrogen-only therapy
there is no increased risk of developing a heart disease.
1315358 GB

12/11/2014 11:26

Stroke

The risk of getting stroke is about 1.5 times higher in HRT users than in non-users.
The number of extra cases of stroke due to use of HRT will increase with age.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would
be expected to have a stroke over a 5-year period. For women in their 50s who are
taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).

Other conditions

HRT will not prevent memory loss. There is some evidence of a higher risk of memory
loss in women who start using HRT after the age of 65. Speak to your doctor for
advice.

Other medicines and Climaval

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription, herbal
medicines or other natural products. Some medicines may interfere with the effect of
Climaval. This might lead to irregular bleeding. This applies to the following
medicines:
• medicines for epilepsy (such as phenobarbital, phenytoin, carbamazepine),
• medicines for tuberculosis (such as rifampicin, rifabutin),
• medicines for HIV infection (such as nevirapine, efavirenz, ritonavir, nelfinavir),
• herbal remedies containing St John’s wort (Hypericum perforatum),
• other anti-infective medicines (such as ketoconazole, erythromycin).

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking
Climaval, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Not applicable, because Climaval is only indicated in women without a uterus.

Driving and using machines

Climaval has no known effects on the ability to drive and use machines.

Climaval contains lactose

Lactose is a form of sugar. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking Climaval.

3. How to take Climaval

Always take this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure. 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. During the treatment your doctor may adjust
the dose according to your individual needs.

When to start treatment

• If you are currently not taking any form of HRT (patches or tablets), or if you
have been taking a continuous combined HRT product (where oestrogen and
the progestogen are given every day without interruption), you can start to take
Climaval on any convenient day.
• If you are changing from a cyclic or sequential HRT treatment (where the
progestogen is added for 12-14 days of the cycle), you should start to take
Climaval on the day after you complete your previous cycle.

How to take Climaval
Take one tablet each day by following the sequence of numbers and
arrows on the calendar pack.
Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the tablets correctly.
Write the name of the day you take your first tablet in the box below. For example, if
you start your tablets on a Wednesday, then write “Wednesday” in the box. This day
will also be the day on which you will take tablets 8, 15 and 22. This will help you
check that you have taken each tablet on the right day.
Write your start day here:

When you finish one blister pack, start the new one the next day whether or not you
experience bleeding. This will normally be the same day of the week as you started
the previous blister pack. Do not take a break between blister packs unless your
doctor tells you.
The tablets are best taken at the same time every day; try to get into a routine.
Follow your doctor’s instructions as to how and when you should take Climaval
tablets and never change the dose yourself, however well you feel.

1315358_GB_p1_LFT.indd 2

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
Both
WO:
1315358
Comp. Description: Leaflet_Climaval_Clima/Meri_Range_FCT_1MG/2MG_GB
Comp. Number New: 1315358 GB
Comp. Number Old: n/a
Format/Dimension: 600 x 160 mm
Tech. Drawing No.: 600x160_FHC-c_rev1

Production Site:
CTM:
Printing Colours:

Piramal Healthcare
Monk, Danielle
Black

Technical Colours: Cutting
Dimensions

Minimum Font Size: 9.0pt
Font Type: Wingdings 2, News Gothic
12/11/2014

How long to take Climaval

• heart disease
• stroke
• probable memory loss if HRT is started over the age of 65

From time to time, you will need to discuss with your doctor the possible risks and
benefits associated with Climaval and whether you still need the treatment. It is
important that you take the lowest possible effective dose and only as long as needed.

For more information about these side effects, see Section 2.
Like all medicines, this medicine can cause side effects, although not everybody
gets them.

If you take more Climaval than you should

Some effects could be serious

Contact your doctor or pharmacist immediately if you have taken too much Climaval.

If you forget to take Climaval

If you forget to take a tablet at your usual time, try to take it within 12 hours. If this is
not possible, leave the forgotten tablet and continue to take the remaining tablets at
the usual time.

If you need to have surgery

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

If you stop taking Climaval

Stopping Climaval may increase the risk of breakthrough bleeding or spotting. If this
occurs after you stop treatment, contact your doctor immediately. Your doctor will
need to work out the reasons for this.
After a long treatment break, consult your doctor before starting to take Climaval
again.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

The following diseases are reported more often in women using HRT compared to
women 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)

These symptoms need immediate medical attention.
• Unexpected vaginal bleeding or spotting (breakthrough bleeding) after taking
Climaval for some time, or after you stop treatment
• Painful menstrual periods
• Painful swelling and redness of the legs
• Sudden chest pain
• Difficulty in breathing
• Pain in your chest that spreads to your arm or neck
• Yellowing of the eyes and face (jaundice)
• Rapid increase in your blood pressure
• Unexplained migraine-like headaches
• Breast changes, including dimpling of the breast skin, changes in the nipple,
lumps that you can see or feel.
Stop taking Climaval and tell your doctor immediately if you get any of the effects
mentioned above. Check the risks to be aware of with HRT in general in section 2,
When to take special care with Climaval.

Other side effects

In addition, the following side effects have been reported with Climaval:
• Breast tension and pain, breast cancer.
• Discharge from the vagina.
• Headache, dizziness, vertigo, changes in sexual desire, depression.
• Increased blood pressure, palpitations (sensation of fluttering in the chest), fast
heart beat or other heart symptoms, tender or painful veins (signs of
thrombophlebitis), fluid retention, nose bleeds.
• Indigestion, wind, nausea, vomiting, abdominal pain and bloating, problems with
your gall bladder (biliary stasis).
• General itching, hair loss, hives and skin rash.
• Glucose intolerance which can make you sweat or feel faint after eating.

• Weight gain.
• Hypersensitivity reaction such as rash, itching, hives.
The following side effects have been reported with other HRTs:
• Gall bladder disease
• Various skin disorders:
–– discoloration of the skin especially of the face or neck known as “pregnancy
patches” (chloasma)
–– painful reddish skin nodules (erythema nodosum),
–– rash with target-shaped reddening or sores (erythema multiforme)
• Decline in memory or mental ability
• Diarrhoea
• Migraine,
• Fibroids (benign growths in the uterus)
• Pain in extremity
• Dry eyes and contact lens discomfort
Reporting of side effects
If you get 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 (see details below). By reporting side effects,
you can help provide more information on the safety of this medicine.
United Kingdom

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

5. How to store Climaval

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
• Do not store above 25°C.
• Store in the original package.
• Do not throw away any medicine via wastewater or household waste. Ask your
pharmacist how to throw away of medicines you no longer use. This measure will
help to protect the environment.

6. Contents of the pack and other information
What Climaval contains

• The active substance is either 1 or 2 mg oestradiol valerate (equivalent to
0.764 or 1.528 mg oestradiol).

• The other ingredients are lactose monohydrate, maize starch, FD & C blue
no. 2 lake (E132), povidone (grade 30), purified water, talc (sterilized, white),
magnesium stearate, hypromellose, propylene glycol, Opaspray blue M-1-6516
(1 mg tablets) or Opaspray blue M-1-6517 (2 mg tablets) (E132, E171 and E464).

What Climaval looks like and contents of the pack

• The Climaval 1 mg film-coated tablets are blue tablets with “OC” on one side and
“CG” on the other.
• The Climaval 2 mg film-coated tablets are grey-blue tablets with “OD” on one side
and “CG” on the other.
Climaval tablets are available in cartons of 28 tablets (1 blister pack) or 84 tablets
(3 blisters packs). Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley,
Surrey GU16 7SR.

Manufacturer

Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West Sussex,
RH12 5AB United Kingdom and Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, England, United Kingdom.

This medicinal product is authorised in the Member States of the
EEA under the following name
Germany: Merimono
United Kingdom: Climaval

This leaflet was revised in October 2014.
If you would like any more information, or would like the leaflet in a different format,
please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone
number 01276 698370
Climaval is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

1315358 GB

12/11/2014 11:26

The Maltings

Proof Number: 1
Braille:

If you are unsure about how much medicine to take or when to take it, ask your
doctor or pharmacist.

Leila Parker

! P LEASE TU R N OV E R P R I N T I N G O N !
574279_1

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide