Patient leaflet - Carboprost 250 micrograms/ml solution for injection
1. What Carboprost Solution for Injection is and what it is used for
Therapeutic group*
Carboprost belongs to a group of medicines called prostaglandins. Prostaglandins are produced naturally in your body and are very important for a variety of activities, including childbirth. After childbirth they make the womb contract and to help it stay contracted, which stops heavy bleeding from the womb. Carboprost given after childbirth increases the contraction of your womb which helps to control bleeding after delivery.
Therapeutic indications
- Carboprost Solution for Injection is a sterile solution for injection. It is available in ampoules and contains 250 µg of the active ingredient, carboprost, per ml of solution.
- Carboprost Solution for Injection is used to stop excessive bleeding in women who have just given birth, when bleeding is due to the womb failing to return to its normal size.
* A therapeutic group is one in which a drug is classified depending on its actions and the part(s) of the body it affects.
2. What you need to know before you are given Carboprost Solution for Injection
Carboprost Solution for Injection is not suitable for all women. Your doctor may decide to give you a different medicine if any of these apply to you
You should not be given Carboprost Solution for Injection:
- if you are allergic to Carboprost or to any of the other ingredients of the medicine listed in section 6. See Sections 4 of this leaflet for more details.
- if you currently have an infection of your womb, ovaries or fallopian tubes (this may be causing pain in your pelvis or vaginal discharge).
- if you have any problems with your heart, lung, kidney or liver.
- if you are pregnant.
Warnings and precautions
Talk to your doctor or nurse before you are given Carboprost Solution for Injection if you currently have, or have had in the past any of the following, as Carboprost Solution for Injection will have to be used more carefully
- lung disease, including asthma
- high or low blood pressure (including high blood pressure in pregnancy)
- heart disease or anaemia (low blood count)
- kidney or liver disease (including jaundice)
- glaucoma (raised pressure in your eyes)
- diabetes or epilepsy
- a caesarean section or any other operation on your womb
In very rare cases heart and circulation failure have been reported following the use of prostaglandins (the active ingredient of this medicine).
It is possible that this medicine may lower the oxygen levels in your blood. If you have previously suffered from conditions affecting your heart and lungs your doctor will monitor you and may give you additional oxygen as necessary.
Your doctor may give you other medicines to reduce the side effects of being sick or having diarrhoea as these are the common side effects of all prostaglandins (the active ingredient of this medicine)
Raised temperature has been observed with treatment from Carboprost Solution for Injection. This will usually return to normal several hours after the last injection.
Other medicines and Carboprost Solution for Injection
Please tell your doctor or if you are taking, have recently taken or might take any other medicines.
Treatments that strengthen contraction of the womb, including oxytocin and ergometrine, can be affected by Carboprost Solution for Injection. Medical staff will watch over you very carefully if you have had these treatments as well as Carboprost Solution for Injection.
Pregnancy, breast-feeding and fertility
Carboprost Solution for Injection will only be given shortly after you have delivered your baby and not while you are still pregnant as it could put the embryo or foetus at risk.
It is not known if carboprost is excreted in human breast milk. As your own body produces prostaglandins during childbirth, Carboprost Solution for Injection is not expected to cause any harm to your baby.
It is not known what effects Carboprost Solution for Injection has on your fertility.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive, use any tools or operate machinery soon after receiving Carboprost Solution for injection as it may affect your ability to do so safely. Carboprost Solution for Injection may make you lose consciousness, feel dizzy or drowsy.
3. How your Carboprost Solution for Injection is given to you
This product should be used only in hospitals and clinics with specialised units for pregnancy and childbirth. Medical staff should be available in the hospital at all times. Carboprost Solution for Injection may be given by a doctor or a midwife.
The staff will make sure that this medicine is used in the right way and at the right time. You should never be given Carboprost Solution for Injection while you are pregnant, only after the birth. It must never be given by injection into a vein.
- Carboprost Solution for Injection is given by injection deep into a muscle.
- The first dose is usually 1 ml of solution (250 micrograms of carboprost). Your doctor may give you more doses of 1 ml if you need them. You should not have doses more often than once every 15 minutes. Usually you would have them less often, about once in one-and-a-half hours.
- You should not be given more than 8 doses (2 mg of carboprost) altogether.
Carboprost Solution for Injection is not indicated for use in children.
If you are given more Carboprost Solution for Injection than you should be
If you get very bad sickness and diarrhoea, your doctor may delay the next injection of Carboprost Solution for Injection or may not give you any more doses. Your doctor will treat the symptoms that the Carboprost Solution for Injection has caused.
If you continue to bleed
If you continue to bleed heavily after being given Carboprost Solution for Injection you may be given other medicines to help control the bleeding. Your doctor or midwife will be watching you closely to help them decide whether Carboprost Solution for Injection is working for you
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, Carboprost Solution for Injection can cause side effects, although not everybody gets them.
Effects on your respiratory system and immune system: Carboprost Solution for Injection can very occasionally cause serious breathing difficulties as well as asthma and wheezing. If you have any difficulty breathing after receiving Carboprost Solution for Injection tell your doctor or midwife immediately.
The following side effects are listed by frequency.
Very common conditions may affect more than 1 in 10 patients.
These include: diarrhoea, nausea, vomiting, increased body temperature.
Common conditions may affect up to 1 in 10 patients.
These include: headache, flushing, hot flush, chills, coughing, bleeding from the uterus, retained placenta or membranes, and inflammation of the uterus.
Uncommon conditions may affect up to 1 in 100 patients.
These include: septic shock, urinary tract infection, irregular sleep patterns or general feeling of drowsiness, dizziness, muscle contractions affecting your posture and positioning of the head, general muscle pain, pins and needles, abnormal taste, increased levels of sweating, chest discomfort, severe shortness of breath, asthma and general breathing difficulties such as rapid breathing or wheezing, general pain especially in regions such as the upper abdomen, back and pelvis, tenderness of the breasts, blurred vision, eye pain, dry mouth, hiccups, vertigo, ringing in the ears, increased heart rate, high blood pressure, vomiting blood, uterine rupture, uterine cervical laceration, fluid retention, general feeling of being unwell and injection site pain.
Side effects with unknown frequency.
These include: a rare but severe form of hyperthyroidism, anxiety, nervousness, fainting, temporary loss of consciousness caused by a fall in blood pressure, palpitations, muscle spasm in the walls of the bronchioles, swelling of the throat, choking sensation, nose bleeds, dry throat, infection affecting the nose sinuses and throat, retching, rash, muscle spasms, uncontrolled abnormal contraction or twitch of the eyelid, uterine disorder, chest pain, abnormal physical weakness or lack of energy, excessive thirst and hypersensitivity reactions (e.g. anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, angioedema).
Most effects are mild and short-lived and will wear off quickly after treatment.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Carboprost Solution for Injection
Keep this medicine out of the sight and reach of children.
Do not use Carboprost Solution for Injection after the expiry date which is stated on the carton and on the ampoule after EXP. Your doctor, midwife or nurse will check this before the injection is given. The expiry date refers to the last day of the month.
Carboprost Solution for Injection must be stored in the original package in a refrigerator between 2 - 8°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Carboprost Solution for Injection contains:
The active substance in each ampoule is 250 µg of carboprost.
The other ingredients are: sodium chloride, trometamol, sodium hydroxide, hydrochloric acid and water for injections.
What Carboprost Solution for Injection looks like and contents of the pack Carboprost Solution for Injection is a clear colourless solution (liquid) and is supplied in 1 ml glass ampoules, packed in a cardboard box.
Pack of 10 ampoules.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Galvany Pharma Limited
Business & Technology Centre
Bessemer Drive
Stevenage
SG1 2DX
United Kingdom
Manufacturer
KLEVA Pharmaceuticals S.A.
189 Parnithos Avenue
136 75 Acharnai
GREECE