Prostin E2 3mg Vaginal Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Dinoprostone

Dostupné z:

Pfizer Healthcare Ireland

ATC kód:

G02AD; G02AD02

INN (Medzinárodný Name):

Dinoprostone

Dávkovanie:

3 milligram(s)

Forma lieku:

Vaginal tablet

Typ predpisu:

Product subject to Restricted Prescription (C)

Terapeutické oblasti:

Prostaglandins; dinoprostone

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1985-05-28

Príbalový leták

Page 1 of 5
2021-0073541
PATIENT LEAFLET: INFORMATION FOR THE USER
PROSTIN
® E2 3 MG VAGINAL TABLETS
dinoprostone
[Pfizer Logo]
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, midwife or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.

If you get any side effects, talk to you doctor, midwife or
pharmacist. This includes any possible
side not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Prostin E2 Vaginal Tablets are and what they are used for
2. What you need to know before you are given Prostin E2 Vaginal
Tablets
3. How Prostin E2 Vaginal Tablets are given to you
4. Possible side effects
5. How to store Prostin E2 Vaginal Tablets
6. Contents of the pack and other information
1.
WHAT PROSTIN E2 VAGINAL TABLETS
ARE AND WHAT THEY ARE USED FOR
Prostin E2 Vaginal Tablets contain the prostaglandin dinoprostone and
are used to “induce” labour.
This means that the medicine will help your uterus (womb) to start
contracting and you will go into
labour. Dinoprostone is similar to the natural ‘E2’, type of
prostaglandins which are made in your body
when labour starts. It will only be given to you in a hospital or
clinic which has an obstetric and
maternity unit.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PROSTIN E2 VAGINAL TABLETS
Most women can be treated with Prostin E2 Vaginal Tablets. Some women
may need extra checks
during treatment and for some women a different treatment may be
better. Your doctor or midwife will
ask you questions before giving you Prostin E2 Vaginal Tablets to make
sure they are safe for you. If
you do not understand any of the questions, ask your doctor or midwife
to explain.
DO NOT USE PROSTIN E2 VAGINAL TABLETS:

If you are allergic to dinoprostone or any other prosta

Súhrn charakteristických

Health Products Regulatory Authority
22 July 2021
CRN00CGG5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prostin E2 3mg Vaginal Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg dinoprostone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal Tablet
White, biconvex, special shaped tablet, embossed with ‘Upjohn 715’
one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The induction of labour when there are no gynaecological, obstetrical
or medical conditions, either maternal or foetal, that
preclude vaginal delivery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Usage is restricted to qualified health care professionals and to
hospitals and clinics with specialised obstetric units with
facilities for continuous monitoring.
The recommended dose should not be exceeded, and the dosing interval
should not be shortened as this increases the risk of
uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal
and neonatal death.
_ _
_Adults:_ One tablet to be inserted high into the posterior fornix.
After insertion of the tablet, the patient should be under
observation using external cardiotocography to monitor foetal heart
rate and uterine activity.
If no contractions have occurred by 6 hours, a further tablet is
inserted and monitoring continued as above.
Maximum dose 6 mg.
Once labour has started, the membranes may be ruptured and the foetal
heart monitored using a scalp electrode. Uterine
contractions should be monitored using external tocography.
If evidence of hypertonus develops, any remains of the tablet should
be removed and an intravenous injection of a tocolytic
agent given. Delivery by the appropriate route should be considered.
_Elderly:_ Not applicable
_Paediatric population:_ Not applicable
4.3 CONTRAINDICATIONS
Hypersensitivity to dinoprostone or other prostaglandins or to any of
the excipients listed in section 6.1.
Prostin E2 Vaginal Tablets are not recommended in the follo