Tridestra tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

Disponible des:

Orion Pharma (UK) Ltd

Codi ATC:

G03FB06

formulario farmacéutico:

Not applicable

clase:

No Controlled Drug Status

tipo de receta:

Never Valid To Prescribe As A VMP

Resumen del producto:

BNF: 06040101; GTIN: 6432100003256

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIDESTRA®
Estradiol valerate and Medroxyprogesterone acetate
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.
IN THIS LEAFLET:
1. What Tridestra is and what it is used for
2. What you need to know before you take Tridestra
3. How to take Tridestra
4. Possible side effects
5. How to store Tridestra
6. Contents of the pack and other information
1. WHAT TRIDESTRA IS AND WHAT IT IS USED FOR
Tridestra is a Hormone Replacement Therapy (HRT). It contains two
types of female hormones,
an oestrogen and a progestogen.
Tridestra is used for:
RELIEF OF MENOPAUSAL SYMPTOMS
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 ("hot flushes").
Tridestra alleviates these
symptoms. You will only be prescribed Tridestra if your symptoms
seriously hinder your daily
life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss
all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable
for you, you can use Tridestra to prevent osteoporosis after
menopause.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIDESTRA
MEDICAL HISTORY AND REGULAR CHECK-UPS
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 surger

Fitxa tècnica

OBJECT 1
Tridestra Tablets
Summary of Product Characteristics Updated 02-Feb-2022 | Orion Pharma
(UK) Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Tridestra
2. Qualitative and quantitative composition
Tridestra tablet (white):
Estradiol valerate 2 mg
Excipient with known effect
82 mg lactose (as monohydrate).
Tridestra tablet (light blue, sometimes spotted):
Estradiol valerate 2 mg
Medroxyprogesterone acetate 20 mg
Excipient with known effect
143 mg lactose (as monohydrate).
Tridestra tablet (yellow):
Placebo
Excipient with known effect
82 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablets, oral.
4. Clinical particulars
4.1 Therapeutic indications
Tridestra is indicated in adult women for:
i) Hormone replacement therapy (HRT) for oestrogen deficiency symptoms
in peri- and post-menopausal
women.
ii) Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant of,