natgillin/translations-raw huggingface dataset:
Optruma е по- ефективен от плацебо за предотвратяване и лечение на остеопороза.
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%.
Когато се прилага за лечение на остеопороза, Optruma е по- ефективен от плацебо за намаляване на броя на вертебралните фрактури.
When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures.
Най- честите нежелани реакции при Optruma (наблюдавани при повече от 1 на 10 пациентки) са вазодилатация (горещи вълни) и грипоподобни симптоми.
The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
Optruma не трябва да се използва при жени, които: • могат да забременеят; • имат или са имали нарушения в кръвосъсирването, включително дълбока венозна тромбоза и белодробна емболия (кръвен съсирек в белите дробове); • имат чернодробно заболяване, тежко бъбречно заболяване, маточно кървене с неустановена причина или рак на ендометриума (рак на лигавицата на матката).
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).
Комитетът решава, че ползите от Optruma са по- големи от рисковете за лечение и профилактика на остеопороза при жени в постменопауза.
The Committee decided that Optruma’ s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за Optruma на Eli Lilly Nederland B. V. на 5 август 1998 г.
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/ 001
Invented name
Optruma
Strength
EU/ 1/ 98/ 074/ 002
Route of Administration
Optruma
Packaging
EU/ 1/ 98/ 074/ 003
EU/ 1/ 98/ 074/ 001 EU/ 1/ 98/ 074/ 002 EU/ 1/ 98/ 074/ 003 EU/ 1/ 98/ 074/ 004
Optruma
Optruma Optruma Optruma Optruma
блистер (поливинилхлорид (PVC) / полиетилен (PE) / полихлоротрифлуороетиле н (PCTFE))
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
бутилки (HDPE)
blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). bottle (HDPE)
100
14 tablets 28 tablets 84 tablets 100 tablets
OPTRUMA 60 mg
SUMMARY OF PRODUCT CHARACTERISTICS
56 mg
1 1.
60 mg
OPTRUMA 60 mg film coated tablets
.
2.
(raloxifene hydrochloride),
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)
,
For a full list of excipients, see section 6.1.
’ 4 165 ’.
Film coated tablet.
OPTRUMA
4.1 Therapeutic indications
,
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
.
When determining the choice of OPTRUMA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
,
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.
OPTRUMA
Use in renal impairment:
,
OPTRUMA should not be used in patients with hepatic impairment (see section 4.3).
,
4.3 Contraindications
(
Hypersensitivity to the active substance or to any of the excipients.
.
Must not be used in women with child bearing potential.
5. 1).
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
4. 2
2 Hepatic impairment including cholestasis.
OPTRUMA "
Severe renal impairment.
4. 3).
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.
OPTRUMA
4.4 Special warnings and precautions for use
"
OPTRUMA should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
4. 3).
Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.
2 4. 3
This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation.
!
The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.
4. 4
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.
. *
Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
,
Patients with this medical history should have serum triglycerides monitored when taking raloxifene.
2, 2
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.
Optruma ".
Optruma contains lactose.
Lapp
4.5 Interaction with other medicinal products and other forms of interaction
.
Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
"-
Effects on prothrombin time may develop over several weeks if OPTRUMA treatment is started in patients who are already on coumarin anticoagulant therapy.
"
Raloxifene has no effect on the pharmacokinetics of methylprednisolone given as a single dose.
OPTRUMA ".
Raloxifene does not affect the steady-state AUC of digoxin.
Cmax
The Cmax of digoxin increased by less than 5%.
"
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
"
Compared to placebo there was no increased use in OPTRUMA treated patients.
#
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.
",! 1 -
OPTRUMA is only for use in postmenopausal women.
(
If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
4 OPTRUMA
4 It is not known whether raloxifene is excreted in human milk.
in vitro.
Its clinical use, therefore, cannot be recommended in breast-feeding women.
(,% /),. '
OPTRUMA may affect the development of the baby.
"
4.7 Effects on ability to drive and use machines
"
Raloxifene has no known influence on the ability to drive and use machines.
OPTRUMA
4.8 Undesirable effects
4. 7
In osteoporosis treatment and prevention studies involving over 13,000 postmenopausal women all adverse reactionswere recorded.
6
The duration of treatment in these studies ranged from 6 to 60 months.
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.
,
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).
OPTRUMA
Vascular disorders Very common):
"OPTRUMA (
Vasodilation (hot flushes) Uncommon:
, 24, 3% OPTRUMA 18, 2%
Leg cramps General disorders and administration site conditions Very common:
66, 10, 6% OPTRUMA 7, 1%
Flu syndrome Common:
(. +) "
Peripheral oedema
,
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).
OPTRUMA 1, 6
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
($
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.
# -
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.
($*) 0, 95 - 2, 71)
A relative risk of 1.60 (CI 0.95, 2.71) was observed in OPTRUMA treated patients compared to placebo.
-
The hazard ratio for all VTE events in the RUTH study was
RUTH HR = 1, 44, (1, 06 – 1, 95). '
5 HR = 1.44, (1.06 – 1.95).
1%
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.
0, 6%
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.
"-
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
.
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%).
"
The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
#
The adverse reactions reported in post-marketing experience are presented in the table below.
OPTRUMA OPTRUMA
Blood and lymphatic system disorders Very rare: thrombocytopenia Gastrointestinal disorders Very rare:
OPTRUMA
Increased blood pressure Nervous system disorders Very rare:
OPTRUMA 1, 9%
Rash Reproductive system and breast disorders Very rare:
7, 1% OPTRUMA
Vascular disorders Rare: venous thromboembolic reaction Very rare: arterial thromboembolic reaction
6
6 4.9 Overdose
RUTH
No cases of raloxifene overdose were reported during clinical trials.
120 mg
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
180 mg.,
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
,
No fatalities associated with overdose have been reported.
"
There is no specific antidote for raloxifene hydrochloride.
)
5.1 Pharmacodynamic properties
&)
Selective Oestrogen Receptor Modulator.
G03XC01
G03XC01
,
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.
(% (+),
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.
31% (. +0, 69; $* 0, 56,
Replacement therapies generally reverse the excessive resorption of bone.
2
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.
, 86; < 0, 001).
i) Incidence of fractures.
2 45,
In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, OPTRUMA treatment for 3 years reduced the incidence of vertebral fractures by 47% (RR 0.53, CI 0.35, 0.79; p < 0.001) and 31% (RR 0.69, CI 0.56, 0.86; p < 0.001) respectively.
15
Forty five women with osteoporosis or 15 women with
3
7 osteoporosis with an existing fracture would need to be treated with OPTRUMA for 3 years to prevent one or more vertebral fractures.
46% (. +0, 54, $* 0, 38, 0, 75) 32% (. +0, 68,
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.
$* 0, 56, 0, 83).%
In the 4th year alone, OPTRUMA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
39% (. +0, 61, $*
An effect on non-vertebral fractures has not been demonstrated.
35%
Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
OPTRUMA
ii) Bone Mineral Density (BMD):
2
The women were 2 to 8 years postmenopausal.
2% -
This increase was generally a 2% increase in BMD compared to placebo.
7
A similar increase in BMD was seen in the treatment population who received OPTRUMA for up to 7 years.
iii),
iii) Calcium kinetics.
iv) 1
iv) Histomorphometry (bone quality).
(
Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
60 mg OPTRUMA
b) Effects on lipid metabolism and cardiovascular risk
(
HDL cholesterol and triglyceride concentrations did not change significantly.
3
After 3 years therapy OPTRUMA decreased fibrinogen (6.71%).
6%) LDL
Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
(4
The risk of a thromboembolic event was greatest in the first four months of therapy.
1, 60 ($* 0, 95, 2, 71)
c) Effects on the endometrium and on the pelvic floor
",
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
831
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
211
After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9% of the 211 women treated with raloxifene 60 mg/ day compared to 1.8% of the 219 women who received placebo.
,
In addition, in a study with 2.5 x the recommended daily dose of OPTRUMA there was no evidence of endometrial proliferation and no increase in uterine volume.
60 mg /
In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
4
Endometrial thickness measurements in OPTRUMA treated women were not different from baseline after 4 years of therapy.
4
After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
OPTRUMA
d) Effects on breast tissue
"
Across all placebo-controlled trials, OPTRUMA was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
. 2
These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
OPTRUMA, &
e) Effects on cognitive function
"
No adverse effects on cognitive function have been seen.
, 9%,
9 5.2 Pharmacokinetic properties
OPTRUMA,
Absorption
62% (. +0, 38, $* 0, 21, 0, 69),
Raloxifene is absorbed rapidly after oral administration.
OPTRUMA. '& -
Approximately 60% of an oral dose is absorbed.
+) 79% (. +0, 21, $* 0, 07, -,.
Presystemic glucuronidation is extensive.
5. 2
Absolute bioavailability of raloxifene is 2%.
* (* "%
Distribution
+
The volume of distribution is not dose dependent.
"(98- 99%).
Raloxifene is strongly bound to plasma proteins (98-99%).
* #! /)
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).
27, 7
Excretion
1%
The majority of a dose of raloxifene and glucuronide metabolites are excreted within 5 days and are found primarily in the faeces, with less than 6% excreted in urine.
(AUC).
Special populations
6%
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
"
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Child- Pugh)
5.3 Preclinical safety data
(279 mg/ kg /
In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/ theca cell origin was observed in high-dose females (279 mg/ kg/ day).
400
Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
210
In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/ kg, and prostatic leiomyoblastoma in males given 210 mg/ kg.
10 mg/ kg
10 Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
(≥ 0, 1 mg/ kg),
Teratology studies were conducted in rabbits and rats.
(≥ 10 mg/ kg).
In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/ kg) and hydrocephaly (≥ 10 mg/ kg) were seen.
(≥ 1 mg/ kg).
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
12 +
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
:
Tablet core:
80),), (
Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
.: '(E 171) 80 1 (400,
Titanium dioxide (E 171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
4
Ink:
* (132)
Shellac Propylene glycol Indigo carmine (E 132)
6. 3, & (
6.3 Shelf-life
3
3 years.
% #
Store in the original package.
. $
Do not freeze.
OPTRUMA
6.5 Nature and content of container
(PVC)
Blister boxes contain 14, 28, or 84 tablets.
100
Bottles contain 100 tablets.
(PCTFE).,.
11 Not all pack sizes may be marketed in all countries.
14
6.6 Special precautions for disposal
13 7.
No special requirements.
Eli Lilly Nederland B. V Grootslag 1- 5 NL- 3991 RA Houten 1
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
EU/ 1/ 98/ 074/ 001 EU/ 1/ 98/ 074/ 002 EU/ 1/ 98/ 074/ 003 EU/ 1/ 98/ 074/ 004
EU/ 1/ 98/ 074/ 001 EU/ 1/ 98/ 074/ 002 EU/ 1/ 98/ 074/ 003 EU/ 1/ 98/ 074/ 004
.
Date of first authorisation:
1998
5 August 1998 Date of last renewal:
2003
5 August 2003
14 II
12 ANNEX II
7 6
A.
..
B.
.
Name and address of the manufacturers responsible for batch release
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid *
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Spain
"
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
.
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
.
The Marketing Authorisation Holder will provide the PSUR at 3-yearly intervals.
6
14 ANNEX III
• 3
15 A.
3 - &
LABELLING
16 III
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
6
BOTTLE LABEL, BOTTLE CARTON:
18
1.
OPTRUMA 60 mg raloxifene hydrochloride
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
/
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
/
3.
60 mg
LIST OF EXCIPIENTS
,
Also includes lactose
56 mg
See leaflet for further information
100
100 film coated tablets
(8
For oral use
()
8.
(),
EXPIRY DATE
{((/////}
EXP {MM/ YYYY}
$. $.
Store in the original package.
10.
Do not freeze.
6 6 6
17 10.
Marketing Authorisation Holder:
Marketing Authorisation Holder:
EU/ 1/ 98/ 074/ 004
EU/ 1/ 98/ 074/ 004
14.
BATCH NUMBER
15.
Batch {number}
6 6
14.
.
Medicinal product subject to medical prescription.
16
15.
5.
16.
Optruma
Optruma
20
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
,
BLISTER BOX FILM COATED TABLETS:
14 28 84
14 film coated tablets 28 film coated tablets 84 film coated tablets
6.
For oral use
3 3
6.
".
7.
. $
9.
.
Store in the original package.
6 6 6
19 10.
()
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
6
13.
7 6
Batch {number}
.
14.
EU/ 1/ 98/ 074/ 001 14 EU/ 1/ 98/ 074/ 002 28 EU/ 1/ 98/ 074/ 003 84
Medicinal product subject to medical prescription.
13.
15.
5
16.
14.
Optruma
).
1.
15.
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
6 6
2.
.
Lilly
16
3.
.
EXP {MM/ YYYY}
4
Lot {number}
Optruma
21 B.
22
22 PACKAGE LEAFLET:
2.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
7 6
1.
.
OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.
Lilly
A reduction in the risk of hip fractures has not been shown.
3.
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.
6
2.
{MM /////}
Do not take OPTRUMA:
4.
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.
23..
23 Take special care with OPTRUMA
24
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.
5
You should have this investigated by your doctor.
6
OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.
OPTRUMA 60 mg - #)
OPTRUMA lowers total cholesterol and LDL ("bad") cholesterol.
(raloxifene hydrochloride)
In general, it does not change triglycerides or HDL ("good") cholesterol.
• •
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.