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Package leaflet: Information for the patient hameln Injection ergometrine maleate

Read all of this leaflet carefully before you start receiving 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, 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 Ergometrine Injection is given 4. Possible side effects 5. How to store Ergometrine Injection 6. Contents of the pack and other information

1. What Ergometrine Injection is and with the following medicines as they may interact what it is used for with your Ergometrine Injection: Ergometrine Injection is a medicine that causes • anaesthetics which you breathe in to put you contraction of the muscles of the womb and is to sleep during surgery as they could decrease used: the effect of ergometrine (e.g. , cyclopropane, , desflurane, • in the active management of the third stage of ) labour • to control bleeding after the birth. • (used to start labour or to treat stomach ulcers) and similar drugs as the effects 2. What you need to know before you are of both drugs may be increased given Ergometrine Injection • vasoconstrictors (used to narrow the blood vessels and decrease the flow of blood) and You must NOT be given Ergometrine sympathomimetics (used in the treatment Injection: of asthma, nasal congestion and low blood • if you are allergic to ergometrine maleate or any pressure in emergency situations) as the effect of the other ingredients in this injection (listed in of the drug may be increased. This includes section 6) where these types of medicines are part of a • if you have severe or very high blood pressure local anaesthetic or cough or cold remedy • if you have heart disease • antiviral drugs used to treat HIV, AIDS or • if you suffer from severe , kidney, heart or hepatitis (e.g. ritonavir, indinavir, nelfinavir, circulation problems delavirdine, nevirapine) • if you are suffering from eclampsia or pre- • antifungal drugs (e.g. , eclampsia (which causes high blood pressure, , voriconazole) protein in the urine, swelling) • quinolones (antibacterial drugs, e.g. • if your womb is not contracting properly ciprofloxacin, levofloxacin, ofloxacin) • if you are pregnant or if you are in labour but the • certain types of antibiotics (including baby’s shoulder still cannot be seen troleandomycin, erythromycin, clarithromycin, • if you have a serious infection quinupristin, dalfopristin, rifampicin) • if you have Raynaud’s disease or phenomenon • cimetidine used to treat ulcers and heartburn (poor circulation which makes the toes and alkaloids or ergot derivatives, used to treat fingers numb and pale) • and (e.g. ) Warnings and precautions: • used to treat headaches and migraines Talk to your doctor, pharmacist or nurse (e.g. , , , , ) before being given the injection: • beta-blockers used to treat certain heart or eye • if you have raised blood pressure problems, anxiety or prevent migraines • if you have liver or kidney problems • anti-anginal medicines including glyceryl • if you have an infection trinitrate • if you have any heart problems • any medicines that can cause an irregular • if you are going to have an operation under heartbeat general anaesthetic • if your baby is in a breech position (or any other Ergometrine Injection with food and abnormal position) before birth, Ergometrine drink: Injection will not be given until after your baby Tell your doctor or midwife if you have recently has been born. had any grapefruit juice. It is recommended that • if you have a multiple pregnancy (e.g. twins, you do not drink grapefruit juice around the same triplets), Ergometrine Injection will not be given time as your treatment with Ergometrine Injection until after the last baby has been born. as these may interact. If any of the above applies to you, or you are not Pregnancy and breast feeding: sure, speak to your doctor or nurse before you receive Ergometrine Injection. Pregnancy: You must not receive Ergometrine Injection if you Other medicines and Ergometrine are pregnant or if you are in labour but the baby’s Injection: shoulder still cannot be seen. Tell your doctor, pharmacist or nurse if you are If your baby is in a breech position (or any other taking, have recently taken or might take any abnormal position) before birth, Ergometrine other medicines, including medicines obtained Injection will not be given until after your baby has without a prescription. This is especially important been born. If you have a multiple pregnancy (e.g. twins, Reporting of side effects triplets), Ergometrine Injection will not be given If you get any side effects, talk to your doctor, until after the last baby has been born. pharmacist or nurse: This includes any possible Breast-feeding: side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Ergometrine may reduce milk production, Scheme - Website: www.mhra.gov.uk/yellowcard therefore repeated use should be avoided. or search for MHRA Yellow Card in the Google Driving and using machines: Play or Apple App Store. By reporting side effects you can help provide more information on the Ergometrine can start labour. Women with safety of this medicine. contractions should not drive or use machines. Ergometrine can cause the side effects of 5. How to store Ergometrine Injection dizziness and low blood pressure (symptoms of Keep this medicine out of the sight and reach of which are light-headedness and blurred vision) in children. some people. If affected you should not drive or use machinery. Your injection will be stored in a refrigerator between 2 °C to 8 °C and protected from light. 3. How Ergometrine Injection is given Do not use this medicine after the expiry date Your nurse or doctor will give you the injection. which is stated on the label and carton. The expiry Your doctor will decide the correct dosage for you date refers to the last day of that month. and how and when the injection will be given. 6. Contents of the pack and other If you are given more Ergometrine information Injection than you should: What Ergometrine Injection contains: Since the injection will be given to you by a doctor The active ingredient is ergometrine maleate or nurse, it is unlikely that you will be given too 0.05% w.v. Each 1 ml of solution contains 500 much. micrograms of ergometrine maleate. If you think you have been given too much or if The other ingredients are maleic acid and sterile you experience any of the following effects you water for injections. must tell the person giving you the injection immediately. What Ergometrine Injection looks like and contents of the pack: • feeling or being sick • a fall or rise in blood pressure (dizziness, light Ergometrine Injection is supplied in a 1 ml clear headedness, feeling faint) glass ampoule, 10 ampoules are supplied in a • vasospastic reactions (pain or discomfort of carton. your fingers caused by a lack of blood reaching The marketing authorisation number of this the fingertips) medicine is: PL 01502/0008R • difficulty in breathing Marketing Authorisation Holder: • fits • coma hameln pharma ltd Gloucester Ergometrine Injection is not recommended for United Kingdom elderly patients and children. Manufacturer: 4. Possible side effects Siegfried Hameln GmbH Like all medicines, this medicine can cause side Langes Feld 13 effects, although not everybody gets them. 31789 Hameln Tell your doctor or contact your nearest Germany hospital straight away if you notice or suspect any of the following symptoms. You may need hameln rds a.s. urgent medical treatment. Horná 36 • signs of a severe allergic reaction, such as: 900 01 Modra - swelling of the face, tongue or throat Slovak Republic - difficulty breathing - low blood pressure (which can cause fainting For any information about this or dizziness and lightheadedness) medicine, please contact the Marketing - severe irritation, reddening or blistering of your Authorisation Holder skin This leaflet was last revised in April 2020. - collapse - 44173/12/20 • heart attack (which can cause or pain down left arm) Other possible side effects of Ergometrine Injection include: • • • abdominal pains • • dizziness • ringing in the ears • skin rashes • irregular or slowed heart beat • (an awareness of your heart beating) • chest pains • high blood pressure