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ERGOMETRINE INJECTION BP 0.05%W/V

Active substance: ERGOMETRINE MALEATE

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Package leaflet: Information for the patient

hameln

Ergometrine Injection
ergometrine maleate

Important information about your medicine
Your doctor or nurse will give you the injection
► f this injection causes you any problems talk to your doctor, nurse or pharmacist
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► lease tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
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any of the ingredients of this medicine
► lease tell your doctor or pharmacist, if you are taking any other medicines
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Read all of this leaflet carefully before you start receiving this medicine because it
contains important information for you. In some circumstances this may not be possible
and this leaflet will be kept in a safe place should you wish to read it.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Ergometrine Injection is and what it is used for
2. What you need to know before you are given Ergometrine Injection
3. How to use Ergometrine Injection
4. Possible side effects
5. How to store Ergometrine Injection
6. Contents of the pack and other information

1. What Ergometrine Injection is and
what it is used for
Ergometrine Injection is a medicine that causes
contraction of the muscles of the womb and is
used:
• in the active management of the third stage of

labour

• to control bleeding after the birth.

2. What you need to know before you are
given Ergometrine Injection
You must NOT be given Ergometrine
Injection:
• if you are sensitive or allergic to ergometrine
maleate or any of the other ingredients in this
injection (listed in section 6)
• if you have severe or very high blood

pressure

• if you have heart disease
• if you suffer from severe liver, kidney, heart
or circulation problems
• if you are suffering from eclampsia or preeclampsia (which causes high blood pressure,
protein in the urine, swelling)
• if your womb is not contracting properly
• if you are pregnant or if you are in labour but
the baby’s shoulder still cannot be seen
• if you have a serious infection

Warnings and precautions:
Talk to your doctor, pharmacist or nurse
before being given the injection:
• if you have raised blood pressure
• if you have liver or kidney problems
• if you have an infection
• if you have any heart problems
• if you are going to have an operation under

general anaesthetic

• if your baby is in a breech position (or
any other abnormal position) before birth,
Ergometrine Injection will not be given until after
your baby has been born.
• if you have a multiple pregnancy (e.g. twins,
triplets), Ergometrine Injection will not be given
until after the last baby has been born.
If any of the above applies to you, or you are not
sure, speak to your doctor or nurse before you
receive Ergometrine Injection.

Other medicines
Injection:

and

Ergometrine

Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take any
other medicines, including medicines obtained
without a prescription. This is especially important
with the following medicines as they may interact
with your Ergometrine Injection:
• anaesthetics which you breathe in to put you
to sleep during surgery as they could decrease
the effect of ergometrine (e.g. halothane,
cyclopropane,
sevoflurane,
desflurane,
isoflurane)
• prostaglandins (used to start labour or to
treat stomach ulcers) and similar drugs as the
effects of both drugs may be increased
• vasoconstrictors (used to narrow the blood
vessels and decrease the flow of blood) and
sympathomimetics (used in the treatment
of asthma, nasal congestion and low blood
pressure in emergency situations) as the effect
of the drug may be increased. This includes
where these types of medicines are part of a
local anaesthetic or cough or cold remedy
• antiviral drugs used to treat HIV, AIDS or
hepatitis (e.g. ritonavir, indinavir, nelfinavir,
delavirdine, nevirapine)
• antifungal
drugs
(e.g.
ketoconazole,
itraconazole, voriconazole)

• quinolones
(antibacterial
drugs,
e.g.
ciprofloxacin, levofloxacin, ofloxacin)
• certain types of antibiotics (including
troleandomycin, erythromycin, clarithromycin,
quinupristin, dalfopristin, rifampicin)
• cimetidine used to treat ulcers and heartburn
• ergot alkaloids or ergot derivatives, used
to treat headaches and migraines (e.g.
methysergide)
• triptans used to treat headaches and
migraines (e.g. sumatriptan, zolmitriptan,
rizatriptan, almotriptan, eletriptan)
• beta-blockers used to treat certain heart or
eye problems, anxiety or prevent migraines
• anti-anginal medicines including glyceryl
trinitrate
• any medicines that can cause an irregular
heartbeat

Ergometrine Injection with food and
drink:
Tell your doctor or midwife if you have recently
had any grapefruit juice. It is recommended that
you do not drink grapefruit juice around the same
time as your treatment with Ergometrine Injection
as these may interact.

Pregnancy and breast feeding:
Pregnancy:
You must not receive Ergometrine Injection if you
are pregnant or if you are in labour but the baby’s
shoulder still cannot be seen.
If your baby is in a breech position (or any other
abnormal position) before birth, Ergometrine
Injection will not be given until after your baby has
been born.
If you have a multiple pregnancy (e.g. twins,
triplets), Ergometrine Injection will not be given
until after the last baby has been born.

Breast-feeding:
Ergometrine may reduce milk production,
therefore repeated use should be avoided.

Driving and using machines:
Ergometrine can start labour. Women with
contractions should not drive or use machines.
Ergometrine can cause the side effects of
dizziness and low blood pressure (symptoms of
which are light-headedness and blurred vision) in
some people. If affected you should not drive or
use machinery.

3. How to use Ergometrine Injection
Your nurse or doctor will give you the
injection.
Your doctor will decide the correct dosage for
you and how and when the injection will be
given.

If you are given more Ergometrine Injection
than you should:
Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much.
If you think you have been given too much or if
you experience any of the following effects you
must tell the person giving you the injection
immediately.
• feeling or being sick
• a fall or rise in blood pressure (dizziness, light
headedness, feeling faint)
• vasospastic reactions (pain or discomfort of
your fingers caused by a lack of blood reaching
the fingertips)
• difficulty in breathing
• fits
• coma
Ergometrine Injection is not recommended for
elderly patients and children.

4. Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Tell your doctor or contact your nearest
hospital straight away if you notice or
suspect any of the following symptoms.
You may need urgent medical treatment.
• signs of a severe allergic reaction, such as:

- swelling of the face, tongue or throat
- difficulty breathing
- low blood pressure (which can cause fainting
or dizziness and lightheadedness)
- severe irritation, reddening or blistering of the
skin
- collapse
- shock
• heart attack (which can cause chest pain or
pain down left arm)

Other
possible
side
effects
Ergometrine Injection include:

of

• nausea
• vomiting
• abdominal pains
• headache
• dizziness
• ringing in the ears
• skin rashes
• irregular or slowed heart beat
• palpitations (an awareness of your heart
beating)
• chest pains
• high blood pressure
If you think this injection is causing you any
problems, or you are at all worried, talk to
your doctor, nurse or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse: This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme - website: www.mhra.gov.uk/
yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2
p.m. Mondays to Fridays) or fill in a paper form
available from your local pharmacy. By reporting
side effects you can help provide more information
on the safety of this medicine.

5. How to store Ergometrine Injection
Keep this medicine out of the sight and reach of
children.
Your injection will be stored in a refrigerator
between 2 °C to 8 °C and protected from light.
Do not use this medicine after the expiry date
which is stated on the label and carton after “Exp.
date:” The expiry date refers to the last day of that
month.

6. Contents of the pack and other
information
What Ergometrine Injection contains:
The active ingredient is ergometrine maleate
0.05% w.v. Each 1 ml of solution contains 500
micrograms of ergometrine maleate.
The other ingredients are maleic acid and
sterile water for injections.

What Ergometrine Injection looks like
and contents of the pack:
Ergometrine Injection is supplied in a 1 ml clear
glass ampoule, 10 ampoules are supplied in a
carton.
The marketing authorisation number of this
medicine is: PL 01502/0008R

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Gloucester
United Kingdom

Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder
This leaflet was last revised in January 2015.
44173/05/15

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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.

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