natgillin/translations-raw huggingface dataset:
Τι είναι το Optruma; Το Optruma είναι φάρμακο που περιέχει τη δραστική ουσία υδροχλωρική ραλοξιφαίνη.
Optruma is a medicine containing the active substance raloxifene hydrochloride.
Σε ποιες περιπτώσεις χρησιμοποιείται το Optruma; Το Optruma χορηγείται για τη θεραπεία και την πρόληψη της οστεοπόρωσης (μιας ασθένειας η οποία καθιστά τα οστά πολύ εύθραυστα) σε γυναίκες μετά την εμμηνόπαυση.
Optruma is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Πώς χρησιμοποιείται το Optruma; Η συνιστώμενη δόση για τους ενήλικες και τους ηλικιωμένους ασθενείς είναι ένα δισκίο την ημέρα με ή χωρίς τροφή.
The recommended dose for adults and the elderly is one tablet taken once a day, with or without food.
Πώς δρα το Optruma; Η οστεοπόρωση παρουσιάζεται όταν δεν αναπτύσσονται επαρκώς νέα οστά για να αντικαταστήσουν όσα έχουν εξασθενήσει.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Ποιες μελέτες εκπονήθηκαν για το Optruma; Εκπονήθηκαν τέσσερις βασικές μελέτες για το Optruma σε ό, τι αφορά τη θεραπεία και την πρόληψη της οστεοπόρωσης Σε τρεις μελέτες για την πρόληψη της οστεοπόρωσης συμμετείχαν 1. 764 γυναίκες, οι οποίες έλαβαν Optruma ή εικονικό φάρμακο (εικονική θεραπεία) για 2 έτη.
What benefit has Optruma shown during the studies?
Στις μελέτες μετρήθηκε η πυκνότητα των οστών.
Optruma was more effective than placebo in preventing and treating osteoporosis.
Κύριος δείκτης μέτρησης της αποτελεσματικότητας ήταν ο αριθμός των γυναικών που υπέστησαν σπονδυλικά κατάγματα κατά τη διάρκεια της μελέτης.
In the prevention of osteoporosis, women receiving Optruma had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Ποιο είναι το όφελος του Optruma σύμφωνα με τις μελέτες; Το Optruma ήταν αποτελεσματικότερο από το εικονικό φάρμακο στην πρόληψη και θεραπεία της οστεοπόρωσης.
When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures.
Στη θεραπεία της οστεοπόρωσης, το Optruma αποδείχθηκε πιο αποτελεσματικό από το εικονικό φάρμακο στη μείωση του αριθμού των σπονδυλικών καταγμάτων.
Over four years, in comparison with placebo, Optruma decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Ποιοι κίνδυνοι συνδέονται με το Optruma; Οι συνηθέστερες ανεπιθύμητες ενέργειες του Optruma (εμφανίζονται σε περισσότερους από 1 στους 10 ασθενείς) είναι η αγγειοδιαστολή (εξάψεις) και συμπτώματα προσομοιάζοντα της γρίπης.
The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
Το Optruma δεν πρέπει να χορηγείται σε γυναίκες: • που μπορεί να μείνουν έγκυες • που παρουσιάζουν ή έχουν παρουσιάσει διαταραχές λόγω θρόμβων στο αίμα, συμπεριλαμβανομένης της βαθειάς φλεβικής θρόμβωσης και της πνευμονικής εμβολής (θρόμβοι αίματος στους πνεύμονες) • σε περίπτωση ηπατικής νόσου, σοβαρής νεφροπάθειας, ανεξήγητης αιμορραγίας από τη μήτρα ή καρκίνου του ενδομητρίου.
Optruma should not be used in women who: • could become pregnant; • have or have had any blood clot disorders, including deep vein thrombosis and pulmonary embolism (a blood clot in the lungs); • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Για ποιους λόγους εγκρίθηκε το Optrum; Η Επιτροπή Φαρμάκων για Ανθρώπινη Χρήση (CHMP) έκρινε ότι έχει αποδειχθεί η αποτελεσματικότητα του Optruma στην πρόληψη και τη θεραπεία της οστεοπόρωσης, και ότι το φάρμακο δεν έχει καμία επίδραση στους μαστούς και τη μήτρα.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Η επιτροπή αποφάσισε ότι τα οφέλη του Optruma υπερτερούν των κινδύνων που συνδέονται με αυτό για τη θεραπεία και την πρόληψη της οστεοπόρωσης σε μετεμμηνοπαυσιακές γυναίκες και εισηγήθηκε τη χορήγηση άδειας κυκλοφορίας για το Optruma.
The Committee recommended that Optruma be given marketing authorisation.
Στις 5 Αυγούστου 1998, η Ευρωπαϊκή Επιτροπή χορήγησε άδεια κυκλοφορίας, η οποία ισχύει σε ολόκληρη την Ευρωπαϊκή Ένωση, στην Eli Lilly Nederland B. V. για το Optruma.
The European Commission granted a marketing authorisation valid throughout the European Union for Optruma to Eli Lilly Nederland B. V. on 5 August 1998.
EU/ 1/ 98/ 074/ 002
Packaging
Optruma
Package size
Κυψέλη (PVC/ PE/ PCTFE)
blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). bottle (HDPE)
60 mg.
OPTRUMA 60 mg film coated tablets
,
2.
E
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
(149. 40 mg)
Excipient: each tablet contains lactose (149.40 mg)
"
Film coated tablet.
4165
Elliptically shaped, white tablets imprinted with the code ’ 4165’.
4. 1! "
CLINICAL PARTICULARS
# OPTRUMA
4.1 Therapeutic indications
. $
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
%,
Due to the nature of this disease process, OPTRUMA is intended for long term use.
&
Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
%,
4.3 Contraindications
, 5. 1).
Must not be used in women with child bearing potential.
%
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
($) $*% + '+
Severe renal impairment.
*: # OPTRUMA 4. 3). # OPTRUMA.
Unexplained uterine bleeding.
,
OPTRUMA should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
(
4.4 Special warnings and precautions for use
* To OPTRUMA 4. 3).
Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.
. (
In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
(placebo).!
However, there was an increase in death due to stroke in women assigned to raloxifene.
1000
The incidence of stroke mortality was 1.5 per 1000 women per year for placebo versus 2.2 per 1000 women per year for raloxifene.
,
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
(placebo)
Raloxifene is metabolised primarily in the liver.
2. 2
Patients with this medical history should have serum triglycerides monitored when taking raloxifene.
1000 ",
Therefore, OPTRUMA should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
,
As safety information regarding co-administration of raloxifene with systemic oestrogens is limited such use is not recommended
0, 3%
3 OPTRUMA is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
Child- Pugh)
Optruma contains lactose.
-,
Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
, ALT
Effects on prothrombin time may develop over several weeks if OPTRUMA treatment is started in patients who are already on coumarin anticoagulant therapy.
AST
Raloxifene has no effect on the pharmacokinetics of methylprednisolone given as a single dose.
3,.
The Cmax of digoxin increased by less than 5%.
/ mmol/ l)
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
"
Concomitant use of vaginal oestrogen preparations was allowed in the clinical trial programme, if necessary to treat atrophic vaginal symptoms.
OPTRUMA
Compared to placebo there was no increased use in OPTRUMA treated patients.
, OPTRUMA
In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen.
%
Raloxifene should not be co-administered with cholestyramine (or other anion exchange resins), which significantly reduces the absorption and enterohepatic cycling of raloxifene.
.
However, since the overall extent of absorption and the elimination rate of raloxifene are not affected, raloxifene can be concurrently administered with ampicillin.
.
These changes do not affect concentrations of free hormones.
# OPTRUMA
4.6 Pregnancy and lactation
# OPTRUMA
OPTRUMA is only for use in postmenopausal women.
OPTRUMA
OPTRUMA must not be taken by women of child bearing potential.
(placebo),
4 It is not known whether raloxifene is excreted in human milk.
4% OPTRUMA.
Its clinical use, therefore, cannot be recommended in breast-feeding women.
. # OPTRUMA
OPTRUMA may affect the development of the baby.
-%
Raloxifene has no known influence on the ability to drive and use machines.
%. $0. +)
4.8 Undesirable effects
1
In osteoporosis treatment and prevention studies involving over 13,000 postmenopausal women all adverse reactionswere recorded.
581
In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7% of 581 OPTRUMA treated patients and 11.1% of 584 placebo-treated patients.
OPTRUMA
The following convention has been used for the classification of the adverse reactions: very common (1/ 10), common (1/ 100 to < 1/ 10), uncommon (1/ 1,000 to < 1/ 100), rare (1/ 10,000 to < 1/ 1,000) very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
(< 1/ 10. 000).
Vascular disorders Very common):
(placebo),
Vasodilation (hot flushes) Uncommon:
OPTRUMA ((placebo),
Flu syndrome Common:
"- OPTRUMA
Peripheral oedema
, 2 18, 2%,
Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in OPTRUMA patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3% OPTRUMA and 18.2% placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6% for OPTRUMA and 7.1% placebo).
10, 6%
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
de novo
In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.
- OPTRUMA
Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.
(placebo)).
A relative risk of 1.60 (CI 0.95, 2.71) was observed in OPTRUMA treated patients compared to placebo.
1, 60 (CI 0, 95, 2, 71)%
The risk of a thromboembolic event was greatest in the first four months of therapy.
(placebo).
Superficial vein thrombophlebitis occurred in a frequency of less than 1%.
1000
In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0% or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4% or 2.70 cases per 1000 patient-years in the placebo group.
% ratio)
The hazard ratio for all VTE events in the RUTH study was
(HR HR =
5 HR = 1.44, (1.06 – 1.95).
0. 6%
In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.
.
Flu syndrome was reported by 16.2% of OPTRUMA treated patients and 14.0% of placebo treated patients.
1%
In the RUTH study, peripheral oedema occurred in 14.1% of the raloxifene-treated patients and 11.7% of the placebo-treated patients, which was statistically significant.
4
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
(5, 5%
Rare cases of moderate increases in AST and/ or ALT have been reported where a causal relationship to raloxifene can not be excluded.
(placebo).
A similar frequency of increases was noted among placebo patients.
.
Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).
OPTRUMA
The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
- 1, 9%
The adverse reactions reported in post-marketing experience are presented in the table below.
%
Rash Reproductive system and breast disorders Very rare:
(placebo).
Mild breast symptoms such as pain, enlargement and tenderness.
2. 6%
6 4.9 Overdose
(2. 3%) (2. 0%).
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
# OPTRUMA (n = 317)% (HRT). '
No cases of raloxifene overdose were reported during clinical trials.
180mg.
The highest overdose has been approximately 1.5 grams.
$
There is no specific antidote for raloxifene hydrochloride.
5. 1.
5.
6 -
PHARMACOLOGICAL PROPERTIES
% +
5.1 Pharmacodynamic properties
G03X C01
G03XC01
1
It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
%
Recent data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/ or gene-specific.
(SERM),
a) Skeletal Effects
. (
The decrease in oestrogen availability which occurs at menopause, leads to marked increases in bone resorption, bone loss and risk of fracture.
% 10
Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses.
,
Likewise, OPTRUMA is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/ or with vertebral fractures, irrespective of BMD.
0, 53, CI 0, 35, 0, 79, p < 0, 001) $(45)
i) Incidence of fractures.
(RR 0, 69, CI 0, 56, 0, 86, p < 0, 001) 15
Forty five women with osteoporosis or 15 women with
.
OPTRUMA treatment for 4 years reduced the incidence of vertebral fractures by 46% (RR 0.54, CI 0.38, 0.75) and 32% (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
46% (RR 0, 54, CI 0, 38, 0, 75)
In the 4th year alone, OPTRUMA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
32% (RR 0, 68, CI 0, 56, 0, 83)
An effect on non-vertebral fractures has not been demonstrated.
39% (RR 0, 61, CI 0, 43, 0, 88).,
In the RUTH study overall clinical fractures were collected as a secondary endpoint.
(HR 0. 65, CI 0. 47 0. 89). #
These results may have been confounded by baseline differences in BMD and vertebral fractures.
(BMD). '
ii) Bone Mineral Density (BMD):
60%,
The efficacy of OPTRUMA once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
OPTRUMA. $OPTRUMA
In one of these trials the women had previously undergone hysterectomy.
(placebo).,
OPTRUMA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
2%
This increase was generally a 2% increase in BMD compared to placebo.
iii). # OPTRUMA
iii) Calcium kinetics.
. # OPTRUMA
OPTRUMA and oestrogen affect bone remodelling and calcium metabolism similarly.
60 mg
OPTRUMA was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
(4- 10%). -
iv) Histomorphometry (bone quality).
"
Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
%..
b) Effects on lipid metabolism and cardiovascular risk
. -%
HDL cholesterol and triglyceride concentrations did not change significantly.
HDL -,
Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
9
8 The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or hormonal replacement therapy.
(placebo) (4. 4).
The risk of a thromboembolic event was greatest in the first four months of therapy.
1, 60 (CI 0, 95, 2, 71)
c) Effects on the endometrium and on the pelvic floor
1, 0 (CI 0, 3, 6, 2)
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
OPTRUMA 60
Endometrial biopsies taken after six months therapy with OPTRUMA 60 mg daily demonstrated non- proliferative endometrium in all patients.
mg /
Safety information following 3 years of raloxifene treatment suggests that raloxifene treatment does not increase pelvic floor relaxation and pelvic floor surgery.
.!
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
OPTRUMA,
d) Effects on breast tissue
OPTRUMA
OPTRUMA does not stimulate breast tissue.
4
Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), OPTRUMA treatment compared to placebo reduced the risk of total breast cancer by 62% (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71% (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79% (RR 0.21, CI 0.07, 0.50).
OPTRUMA
OPTRUMA has no effect on the risk of ER negative breast cancers.
(placebo) (
e) Effects on cognitive function
)
No adverse effects on cognitive function have been seen.
0, 9%
9 5.2 Pharmacokinetic properties
0, 3%
Absorption
(placebo).
Raloxifene is absorbed rapidly after oral administration.
(RR 0, 38, CI 0, 21, 0, 69), 0, 29, CI 0, 13, 0, 58)
Approximately 60% of an oral dose is absorbed.
T OPTRUMA
Presystemic glucuronidation is extensive.
. 2
Absolute bioavailability of raloxifene is 2%.
60% 2%. -
Distribution
% (98- 99%).
Raloxifene is distributed extensively in the body.
5%. ($&
Metabolism
'
Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
%
Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
- 6, 4 '-
Excretion
2
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
10 mg/ kg /
10 Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
% (≥1 mg/ kg).
Teratology studies were conducted in rabbits and rats.
(≥0, 1 mg/ kg) 0
In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/ kg) and hydrocephaly (≥ 10 mg/ kg) were seen.
(≥10 mg/ kg). "
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
$
Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
- & $' $
6.1 List of excipients
() 4
Tablet core:
80
Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
).
Tablet coating:
# (E 171), / 80 + / 400
Titanium dioxide (E 171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
.:
Ink:
/ - 8 (E 132)
Shellac Propylene glycol Indigo carmine (E 132)
6. 2 A%. 5 (+
6.2 Incompatibilities
(.
Not applicable.
- +, 0 "$& +
6.3 Shelf-life
PVC/ PE/ PCTFE "
6.4 Special precautions for storage
(blisters)
Store in the original package.
". #"
Do not freeze.
(blisters)
6.5 Nature and content of container
14, 28
Blister boxes contain 14, 28, or 84 tablets.
$, & - "
No special requirements.
7+
7.
''
9.
%
Date of first authorisation:
1998,
5 August 1998 Date of last renewal:
14.
12 ANNEX II
#
B.
#
13 A.
3 3
B.
#
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
8.
Not applicable.
#
LABELLING AND PACKAGE LEAFLET
15
15 A.
Lilly S. A.
LABELLING
16
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
# 3
BOTTLE LABEL, BOTTLE CARTON:
OPTRUMA 60 mg
NAME OF THE MEDICINAL PRODUCT
60 mg
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
3
STATEMENT OF ACTIVE SUBSTANCE(S)
#
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
!.
3.
=
Also includes lactose
%
See leaflet for further information
33;
For oral use
#
6.
:
Keep out of the reach and sight of children.
)
8.
), (
EXP {MM/ YYYY}
8.:
9.
) '>' {.. / ****)
Store in the original package.
19 9.
Do not freeze.
! li Lilly Nederland B. V.
Marketing Authorisation Holder:
}
Batch {number}
3
Medicinal product subject to medical prescription.
3
15.
BLISTER T
BLISTER BOX FILM COATED TABLETS:
21 9.
Do not freeze.
EU/ 1/ 98/ 074/ 001 14 EU/ 1/ 98/ 074/ 002 28 EU/ 1/ 98/ 074/ 003 84
EU/ 1/ 98/ 074/ 001 14 film coated tablets EU/ 1/ 98/ 074/ 002 28 film coated tablets EU/ 1/ 98/ 074/ 003 84 film coated tablets
BLISTER (
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
OPTRUMA 60 mg.
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
3.:
3.
EXP {.. / ****)
EXP {MM/ YYYY}
4. #
4.
Lot {}
Lot {number}
23 8. # 3
OTHER
24
21 B.
# 3
INFORMATION FOR THE USER
OPTRUMA 60 mg
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
&
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.
# 5% -, -. $:
Do not pass it on to others.
• 3 •! • '
In this leaflet:
+ 1
1.
OPTRUMA OPTRUMA
Before you take OPTRUMA 3.
OPTRUMA
How to take OPTRUMA 4.
6.
Possible side effects 5.
OPTRUMA
How to store OPTRUMA 6.
OPTRUMA
WHAT OPTRUMA IS AND WHAT IT IS USED FOR
# OPTRUMA
OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.
-
A reduction in the risk of hip fractures has not been shown.
%
Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
% +
2.
. # OPTRUMA.
BEFORE YOU TAKE OPTRUMA
# OPTRUMA
Do not take OPTRUMA:
"
This must be investigated by your doctor. • If you have active uterine cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have severe kidney problems.
. # OPTRUMA
23 Take special care with OPTRUMA
.
If any of them apply to you, talk to your doctor before you take the medicine.
%
• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness. • If you are receiving oral oestrogen therapy • If you are suffering from breast cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have had a cerebrovascular accident (e. g. stroke), or if your doctor has told you that you are at high risk of having one.
OPTRUMA
It is unlikely that OPTRUMA will cause vaginal bleeding.
$OPTRUMA:
So any vaginal bleeding while you take OPTRUMA is unexpected.
OPTRUMA.
OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.
OPTRUMA
OPTRUMA lowers total cholesterol and LDL ("bad") cholesterol.
25 •
Taking other medicines
!
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.