Cervagem 1Mg Pessary Under Observation

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INFORMATION FOR THE USER • If the operation is delayed for more • Chest pain or in some cases with than three hours, you will be kept tightness, crushing or squeezing Cervagem 1mg Pessary under observation. This is because pressure on the chest and may gemeprost termination may occur anyway. radiate to the neck, shoulder or • If you start to bleed, tell the doctor arms (coronary spasm) or nurse. • Heart attack Is this leaet hard to x You have kidney problems. Termination of pregnancy between Reporting of side effects If you get any side effects, talk to your see or read? x You have had an operation on your the fourth and sixth month womb, like a caesarean section. • One pessary inserted every three doctor, pharmacist or nurse. This Phone 0800 035 2525 includes any possible side effects not for help Do not use this medicine if any of the hours. above apply to you. If you are not sure, • Up to 5 pessaries are normally given. listed in this leaflet. You can also report Read all of this leaflet carefully talk to your doctor or nurse before you • Sometimes you may need up to five side effects directly via the Yellow Card before you are given this medicine are given the first pessary. more pessaries. Scheme at: www.mhra.gov.uk/yellowcard or search - Keep this leaflet. You may need to Take special care with • If the termination has not happened for MHRA Yellow Card in the Google read it again. Cervagem Pessary by this time, your doctor or nurse - If you have any further questions, will use another method to finish Play or Apple App Store. ask you doctor or nurse. the termination. By reporting side effects you can help Talk to your doctor or nurse before you provide more information on the safety - If any of the side effects gets serious, Termination of a pregnancy between or if you notice any side effects not are given this medicine if: of this medicine. ▲ You have breathing problems. the fourth and sixth month, if the listed in this leaflet, please tell your unborn baby (foetus) has already died 5. How to store doctor or nurse. ▲ You have glaucoma (raised pressure in the eye which affects your sight). • One pessary will be inserted every Cervagem Pessary In this leaflet: ▲ You have any heart problems. three hours. • Keep this medicine in a safe place 1. What Cervagem Pessary is and what ▲ You have dizziness, lightheadedness • Up to 5 pessaries are normally given where children cannot see or reach it is used for. or fainting. This may be due to low to you. them 2. What you need to know before you blood pressure After the treatment, the doctor or nurse • Store below minus 10°C in a freezer take Cervagem Pessary. ▲ You have a rare genetic disease will check to make sure the termination 3. How you are given Cervagem known as sickle cell anaemia has been completed properly. • Do not use Cervagem Pessary Pessary ▲ You have epilepsy It is important to keep your after the expiry date stated on the 4. Possible side effects ▲ You have unusual vaginal discharge, appointment if you are due a follow-up box and the foil pouches. The 5. How Cervagem Pessary is stored pain when passing water or examination after this treatment. expiry date refers to the last day 6. Contents of the pack and other of that month. increased need to pass water. 4. Possible side effects information. These may be signs of cervicitis • Before use, each pessary should be ▲ You have vaginal pain, itching or allowed to warm up to room 1. What Cervagem Pessary is Like all medicines, Cervagem temperature and what it is used for discharge. These may be signs of vaginitis Pessary can cause side effects, Medicines should not be disposed of although not everybody gets via wastewater or household waste. Cervagem Pessary contains a ▲ You have an illness where the level them. Ask your doctor or nurse how to medicine called gemeprost. of glucose in your blood is not dispose of medicines no longer i This belongs to a group of controlled properly (diabetes mellitus) Very rare allergic reactions that can medicines called ▲ You have a problem with your blood occur with prostaglandins such as required. These measures will help to prostaglandins. It works by making the clotting Cervagem protect the environment. womb contract.Cervagem is normally Taking or using other You could notice the following signs of 6. Contents of the pack and given to women in the following medicines an allergic reaction: other information • Flushing, fainting, fever and chills situations: Please tell your doctor or • Itching and redness all over your • To make the operation to terminate nurse if you are taking or have What Cervagem Pessary contains a pregnancy in the first three recently taken any other medicines, body • The active substance is gemeprost. months easier. including medicines obtained without • Tight chest and difficulty in • The other ingredients are Witepsol S • To terminate a pregnancy between prescription. This includes medicines breathing 52 and dehydrated ethanol. the fourth and sixth month. • Back pain you can buy without prescription, What Cervagem Pessary looks like • To terminate a pregnancy between including herbal medicines. This is If you think that Cervagem is causing the fourth and sixth month, if the an allergic reaction, tell your doctor and contents of the pack because Cervagem can affect the way The pessary is a bullet-shaped waxy unborn baby (foetus) has already some other medicines work. Also some straight away. died. solid, 2-3 centimetres long and it comes medicines can affect the way Very rare side effects in boxes of 5 pessaries. 2. What you need to know Cervagem works. • Splitting or tearing of the womb. In particular, tell your doctor you are This usually happens in women who Marketing Authorisation Holder and before you use Manufacturer Cervagem Pessary taking any of the following. have had several children or a Medicines used to speed up labour previous operation on the womb Marketing Authorisation Holder Sanofi Do not use such as oxytocin. This can increase the (such as a caesarian section). effect of Cervagem. • Heart and circulation problems. 410 Thames Valley Park Drive, Reading, Cervagem Pessary if: Berkshire, RG6 1PT, UK. 3. How you will be given Other side effects Tel: 0800 035 2525 x You are allergic (hypersensitive) to Cervagem Pessary If you have any of the following side email:[email protected] effects, do not worry. However if they gemeprost or any of the other Manufacturer ingredients of this medicine (See • Cervagem pessaries will be given to are troublesome, talk to your doctor or you by a doctor or nurse. nurse. These side effects usually last for Sanofi S.r.l. section 6: Further information). Via Valcanello 4 Signs of an allergic reaction include: • The pessaries are inserted into your a short time. vagina. • Bleeding from your vagina and mild 03012 Anagni (FR) a rash, swallowing or breathing ITALY problems, swelling of your lips, face, • The number of pessaries given to pain in your womb (like period pain) throat or tongue. you will depend on the reason for • Feeling sick (nausea) and being sick This leaflet does not contain all the x You are allergic or sensitive to its use. (vomiting) information about your medicine. prostaglandin medicines such as The doctor or nurse will keep an eye on • Diarrhoea If you have any questions or are not you while you are being treated with alprostadil, bimatoprost, • Headache and flushing sure about anything, ask your doctor or Cervagem pessaries. latanoprost, travoprost or • Muscle weakness and backache pharmacist. Cervagem pessaries can be given in one misoprostol. • Feeling dizzy, light headed and faint of the following ways in these situations: This leaflet was last revised in x You have or have had placenta • High temperature and chills October 2020 previa (light or heavy vaginal Termination of pregnancy (shivering) bleeding which may be sudden, in the first three months to • Difficulty in breathing ©Sanofi, 2000 - 2020 painless and recurring). Your doctor make the operation easier • Very fast and uneven heartbeat (palpitations) should check on this and may • One pessary inserted three Turn perform an ultrasound scan. hours before the operation. Over • Fall in blood pressure ✂ The following information is posterior vaginal fornix 3 hours 3. Intrauterine foetal death in valuable signs of impending toxicity intended for healthcare before surgery. the second trimester of are likely to be sedation, tremor, professionals only: gestation. convulsion, dyspnoea, abdominal 2. Therapeutic termination of Practical information on preparation One pessary to be inserted into the pain and diarrhoea, which may be pregnancy in the second and administration of Cervagem posterior vaginal fornix at 3-hourly bloody, palpitations or bradycardia. trimester of gestation. 1mg Pessary (see also Section 3). intervals up to a maximum of Treatment should be symptomatic. One pessary to be inserted into the 5 administrations. A vaginal douche may be of value Store below minus 10°C (-10°C) posterior vaginal fornix at 3-hourly depending on the elapsed time in the original pack Elderly: Not applicable. intervals to a maximum of since insertion of the pessary. 5 administrations. If abortion is not Children: Not applicable. ADMINISTRATION AND DOSAGE PHARMACEUTICAL PRECAUTIONS established after 5 pessaries, a OVERDOSAGE Before administration, the pessary Store below minus 10°C (-10°C) in second course of treatment may be The toxic dose of CERVAGEM in should be allowed to warm to the original pack. Temperature instituted starting 24 hours after women has not been established. room temperature for 30 minutes, cycling should be avoided. Once the initial commencement of Cumulative dosage of 10mg in away from direct heat and sunlight, the foil sachet has been opened, treatment. 24 hours has been well tolerated. in the unopened foil sachet. any pessary not used within If abortion is not well established In animals the acute toxic e ects Adults: 12 hours should be destroyed. after 10 pessaries, a further course are similar to those of 1. Softening and dilatation of the of CERVAGEM treatment is not prostaglandin E1 and include cervix in the rst trimester of recommended and alternative depression of the CNS and gestation. means should be employed to relaxation of the smooth muscle, One pessary to be inserted into the e ect uterine emptying leading to hypotension. Clinically

Via G. Tartini, 2 - 20158 - MILANO CROMinFOTO s.n.c. Tel. 02.375787 • e-mail: [email protected] 795011 GRAFICA - FOTOCOMPOSIZIONE AZIENDA CERTIFICATA UNI EN ISO 9001:2015 (int. version 1) 05 NOV 2020 TYPE OF MATERIAL: DESCRIPTION: COUNTRY: LOGO VERSION: MIN. FONT SIZE:/LINE SPACING: LEAFLET FOLDED CERVAGEM 1 MG U.K. // 10 pt. CODE: VERSION: OLD CODE: DIE CUT: DIMENSIONS mm: COLOURS N°: COLOUR 1: 795011 781210 1 REFLEX BLUE 89036049 1 a 89035530 I021 125 x 420 (125 x 26,25) • If the operation is delayed for more • Chest pain or in some cases with than three hours, you will be kept tightness, crushing or squeezing under observation. This is because pressure on the chest and may termination may occur anyway. radiate to the neck, shoulder or • If you start to bleed, tell the doctor arms (coronary spasm) or nurse. • Heart attack x You have kidney problems. Termination of pregnancy between Reporting of side effects x You have had an operation on your the fourth and sixth month If you get any side effects, talk to your womb, like a caesarean section. • One pessary inserted every three doctor, pharmacist or nurse. This Do not use this medicine if any of the hours. includes any possible side effects not above apply to you. If you are not sure, • Up to 5 pessaries are normally given. listed in this leaflet. You can also report Read all of this leaflet carefully talk to your doctor or nurse before you • Sometimes you may need up to five side effects directly via the Yellow Card before you are given this medicine are given the first pessary. more pessaries. Scheme at: www.mhra.gov.uk/yellowcard or search - Keep this leaflet. You may need to Take special care with • If the termination has not happened for MHRA Yellow Card in the Google read it again. Cervagem Pessary by this time, your doctor or nurse - If you have any further questions, will use another method to finish Play or Apple App Store. ask you doctor or nurse. the termination. By reporting side effects you can help Talk to your doctor or nurse before you provide more information on the safety - If any of the side effects gets serious, Termination of a pregnancy between or if you notice any side effects not are given this medicine if: of this medicine. ▲ You have breathing problems. the fourth and sixth month, if the listed in this leaflet, please tell your unborn baby (foetus) has already died 5. How to store doctor or nurse. ▲ You have glaucoma (raised pressure in the eye which affects your sight). • One pessary will be inserted every Cervagem Pessary In this leaflet: ▲ You have any heart problems. three hours. • Keep this medicine in a safe place 1. What Cervagem Pessary is and what ▲ You have dizziness, lightheadedness • Up to 5 pessaries are normally given where children cannot see or reach it is used for. or fainting. This may be due to low to you. them 2. What you need to know before you blood pressure After the treatment, the doctor or nurse • Store below minus 10°C in a freezer take Cervagem Pessary. ▲ You have a rare genetic disease will check to make sure the termination 3. How you are given Cervagem known as sickle cell anaemia has been completed properly. • Do not use Cervagem Pessary Pessary ▲ You have epilepsy It is important to keep your after the expiry date stated on the 4. Possible side effects ▲ You have unusual vaginal discharge, appointment if you are due a follow-up box and the foil pouches. The 5. How Cervagem Pessary is stored pain when passing water or examination after this treatment. expiry date refers to the last day 6. Contents of the pack and other of that month. increased need to pass water. 4. Possible side effects information. These may be signs of cervicitis • Before use, each pessary should be ▲ You have vaginal pain, itching or allowed to warm up to room 1. What Cervagem Pessary is Like all medicines, Cervagem temperature and what it is used for discharge. These may be signs of vaginitis Pessary can cause side effects, Medicines should not be disposed of although not everybody gets via wastewater or household waste. Cervagem Pessary contains a ▲ You have an illness where the level them. Ask your doctor or nurse how to medicine called gemeprost. of glucose in your blood is not dispose of medicines no longer This belongs to a group of controlled properly (diabetes mellitus) Very rare allergic reactions that can medicines called ▲ You have a problem with your blood occur with prostaglandins such as required. These measures will help to prostaglandins. It works by making the clotting Cervagem protect the environment. womb contract.Cervagem is normally Taking or using other You could notice the following signs of 6. Contents of the pack and given to women in the following medicines an allergic reaction: other information • Flushing, fainting, fever and chills situations: Please tell your doctor or • Itching and redness all over your • To make the operation to terminate nurse if you are taking or have What Cervagem Pessary contains a pregnancy in the first three recently taken any other medicines, body • The active substance is gemeprost. months easier. including medicines obtained without • Tight chest and difficulty in • The other ingredients are Witepsol S • To terminate a pregnancy between prescription. This includes medicines breathing 52 and dehydrated ethanol. the fourth and sixth month. • Back pain you can buy without prescription, What Cervagem Pessary looks like • To terminate a pregnancy between including herbal medicines. This is If you think that Cervagem is causing the fourth and sixth month, if the an allergic reaction, tell your doctor and contents of the pack because Cervagem can affect the way The pessary is a bullet-shaped waxy unborn baby (foetus) has already some other medicines work. Also some straight away. died. solid, 2-3 centimetres long and it comes medicines can affect the way Very rare side effects in boxes of 5 pessaries. 2. What you need to know Cervagem works. • Splitting or tearing of the womb. In particular, tell your doctor you are This usually happens in women who Marketing Authorisation Holder and before you use Manufacturer Cervagem Pessary taking any of the following. have had several children or a Medicines used to speed up labour previous operation on the womb Marketing Authorisation Holder Sanofi Do not use such as oxytocin. This can increase the (such as a caesarian section). effect of Cervagem. • Heart and circulation problems. 410 Thames Valley Park Drive, Reading, Cervagem Pessary if: Berkshire, RG6 1PT, UK. 3. How you will be given Other side effects Tel: 0800 035 2525 x You are allergic (hypersensitive) to Cervagem Pessary If you have any of the following side email:[email protected] effects, do not worry. However if they gemeprost or any of the other Manufacturer ingredients of this medicine (See • Cervagem pessaries will be given to are troublesome, talk to your doctor or you by a doctor or nurse. nurse. These side effects usually last for Sanofi S.r.l. section 6: Further information). Via Valcanello 4 Signs of an allergic reaction include: • The pessaries are inserted into your a short time. vagina. • Bleeding from your vagina and mild 03012 Anagni (FR) a rash, swallowing or breathing ITALY problems, swelling of your lips, face, • The number of pessaries given to pain in your womb (like period pain) throat or tongue. you will depend on the reason for • Feeling sick (nausea) and being sick This leaflet does not contain all the x You are allergic or sensitive to its use. (vomiting) information about your medicine. prostaglandin medicines such as The doctor or nurse will keep an eye on • Diarrhoea If you have any questions or are not you while you are being treated with alprostadil, bimatoprost, • Headache and flushing sure about anything, ask your doctor or Cervagem pessaries. latanoprost, travoprost or • Muscle weakness and backache pharmacist. Cervagem pessaries can be given in one misoprostol. • Feeling dizzy, light headed and faint of the following ways in these situations: This leaflet was last revised in x You have or have had placenta • High temperature and chills October 2020 previa (light or heavy vaginal Termination of pregnancy (shivering) bleeding which may be sudden, in the first three months to • Difficulty in breathing ©Sanofi, 2000 - 2020 painless and recurring). Your doctor make the operation easier • Very fast and uneven heartbeat should check on this and may • One pessary inserted three (palpitations) perform an ultrasound scan. hours before the operation. • Fall in blood pressure 795011 ✂

The following information is posterior vaginal fornix 3 hours 3. Intrauterine foetal death in valuable signs of impending toxicity intended for healthcare before surgery. the second trimester of are likely to be sedation, tremor, professionals only: gestation. convulsion, dyspnoea, abdominal 2. Therapeutic termination of Practical information on preparation One pessary to be inserted into the pain and diarrhoea, which may be pregnancy in the second and administration of Cervagem posterior vaginal fornix at 3-hourly bloody, palpitations or bradycardia. trimester of gestation. 1mg Pessary (see also Section 3). intervals up to a maximum of Treatment should be symptomatic. One pessary to be inserted into the 5 administrations. A vaginal douche may be of value Store below minus 10°C (-10°C) posterior vaginal fornix at 3-hourly depending on the elapsed time in the original pack Elderly: Not applicable. intervals to a maximum of since insertion of the pessary. 5 administrations. If abortion is not Children: Not applicable. ADMINISTRATION AND DOSAGE PHARMACEUTICAL PRECAUTIONS established after 5 pessaries, a OVERDOSAGE Before administration, the pessary Store below minus 10°C (-10°C) in second course of treatment may be The toxic dose of CERVAGEM in should be allowed to warm to the original pack. Temperature instituted starting 24 hours after women has not been established. room temperature for 30 minutes, cycling should be avoided. Once the initial commencement of Cumulative dosage of 10mg in away from direct heat and sunlight, the foil sachet has been opened, treatment. 24 hours has been well tolerated. in the unopened foil sachet. any pessary not used within If abortion is not well established In animals the acute toxic e ects Adults: 12 hours should be destroyed. after 10 pessaries, a further course are similar to those of 1. Softening and dilatation of the of CERVAGEM treatment is not prostaglandin E1 and include cervix in the rst trimester of recommended and alternative depression of the CNS and gestation. means should be employed to relaxation of the smooth muscle, One pessary to be inserted into the e ect uterine emptying leading to hypotension. Clinically 795011