STESOLID RECTAL TUBE 10MG
Active substance: DIAZEPAM
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Stesolid Rectal Tubes 5mg and 10mg (diazepam)
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
have someone close to you who has recently died are elderly (as there is an increased risk of side effects). have a personality disorder smoke
Warnings about stopping treatment
In this leaflet: 1 What Stesolid rectal tubes are and what they are used for 2 Before you use 3 How to use 4 Possible side effects 5 How to store 6 Further information
1 What Stesolid rectal tubes are and what they are used for
Stesolid rectal tubes contain diazepam which belongs to a group of medicines called benzodiazepines. Diazepam is used to treat: severe anxiety and agitation muscle spasms epilepsy or febrile convulsions symptoms of alcohol withdrawal Stesolid rectal tubes can also be used to cause relaxation and sleepiness before an operation or dental procedure.
Withdrawal symptoms There is a risk of becoming dependent on this medicine, particularly with high doses, continued use or if you have a history of alcoholism or drug abuse. If dependence has developed, withdrawal symptoms will occur if you suddenly stop treatment. Withdrawal symptoms include: headaches, muscle pain, anxiety, tension, restlessness confusion and irritability and in severe cases: feelings of things being unreal or strange or that your mind is separated from your body, numbness and tingling in the hands and feet, hallucinations, fits or sensitivity to light, noise or touch. Rebound sleeplessness and anxiety When you stop taking this type of medicine, some of the symptoms that led to treatment can return more intensely than before, such as sleep disturbances, anxiety, restlessness or mood changes. The risk of this is greater if you stop suddenly. To avoid these things happening, treatment should be stopped gradually under the advice of a doctor.
Taking other medicines
2 Before you use Do not use Stesolid rectal tubes and tell your doctor if you
are allergic (hypersensitive) to diazepam, other benzodiazepine medicines or to any of the other ingredients (see section 6) have severe breathing problems or have difficulty breathing suffer from depression (with or without anxiety) or hyperactivity have a phobia (a fear of a particular object or situation) or other mental illness have myasthenia gravis (a condition which causes muscle weakness) suffer from sleep apnoea (a condition where you stop breathing whilst asleep) have severe liver disorders have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders) planning a pregnancy or are pregnant (see below Pregnancy and breastfeeding).
Check with your doctor or pharmacist before using Stesolid rectal tubes if you
have a history of alcoholism or drug abuse
Continued top of next column AAAF0330
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: antidepressants, antipsychotics (to treat mental problems), antihistamines (to treat allergies), general anaesthetics, lofexidine (to help relieve symptoms when you stop taking opioids), nabilone (to treat nausea and vomiting), hypnotics (to help you sleep), alpha blockers or moxonidine (to lower high blood pressure), muscle relaxants (eg baclofen, tizanidine). Taking these medicines with diazepam could make you very sleepy. some strong pain killers may give you a heightened sense of well being when taken with diazepam, which can increase your desire to continue taking these medicines (dependency) or can make you very sleepy. disulfiram (to treat alcohol addiction). Taking this medicine with diazepam could make you very sleepy and can cause diazepam to be removed from the body more slowly than usual. medicines for epilepsy eg phenobarbital, phenytoin, carbamazepine, or sodium valproate, (diazepam can affect the blood levels of these medicines). cimetidine or omeprazole (for ulcers), oestrogen-containing contraceptives, erythromycin (an antibiotic), antifungals (fluconazole, voriconazole) or isoniazid (to treat tuberculosis) as these can cause diazepam to be removed from the body more slowly than usual. rifampicin (to treat infections) or theophylline (to treat asthma) as this can cause diazepam to be removed from the body more quickly than usual.
Continued over page
Diazepam (Stesolid) 5mg & 10mg Rectal Tubes PIL - UK
item no: AAAF0330 print proof no: 2 origination date: 27.02.13 originated by: DR approved for print/date revision date: 06.03.13 revised by: DR supplier: Actavis Jakarta Technical Approval date sent: 27.02.13 technically app. date: 01.03.13 dimensions: 200 x 210 pharmacode: min pt size: 8pt
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
amrenavir or ritonavir (antivirals) as these can make you feel sleepy for longer or cause difficulty breathing. medicines to lower high blood pressure, diuretics (water tablets), nitrates (for heart conditions) as these could lower your blood pressure too much. levodopa (to treat Parkinsons Disease) as diazepam may cause levodopa to not work so well.
4 Possible side effects
Like all medicines, Stesolid rectal tubes can cause side effects, although not everybody gets them. Stop treatment and contact a doctor at once if you have the following symptoms of an allergic reaction e.g. itchy skin, rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: drowsiness, sedation, tiredness, slurred speech, light-headedness, unsteadiness or clumsiness and loss of co-ordination (you may notice these even after a single dose and this may continue into the following day) confusion, memory loss (which may be experienced several hours after taking diazepam. If possible, to reduce the risk allow 7 to 8 hours of uninterrupted sleep after taking), seeing or sensing things that are not there, inappropriate behaviour, difficulty concentrating, agitation/irritability, restlessness, experiencing rage, excitement, numbed emotions, depression with suicidal tendencies, headache, spinning sensation blood disorders (you may develop sore throats, nose bleeds or infections) changes in sex drive, visual disturbances, low blood pressure, stomach upsets, yellowing of the skin or whites of the eyes (jaundice) muscle spasms/shaking or weakness, breathing difficulties difficulty passing urine, increase in amount of saliva you feel you are abusing or becoming dependant on this product Stesolid rectal tubes contain sodium benzoate and benzoic acid which may cause irritation to the anus (you may feel a stinging sensation). If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
Using Stesolid and food and drink
Grapefruit juice may increase the amount of diazepam in your blood. If you are elderly, suffer from cirrhosis or any of the conditions listed in section 2, this could possibly increase the sedative effects of Stesolid and you should speak to your doctor or pharmacist. Drinks containing caffeine may reduce the effects of diazepam.
Alcohol
Do not drink alcohol while you are using Stesolid rectal tubes. Alcohol may increase the sedative effects of diazepam and make you very sleepy. You should not use Stesolid rectal tubes if you are pregnant, planning to become pregnant or are breast feeding. If you use Stesolid rectal tubes late in your pregnancy or during labour, your baby might have a low body temperature, floppiness, and breathing difficulties. Your baby may also develop withdrawal symptoms.
Pregnancy and breast-feeding
Driving and using machines
Stesolid rectal tubes can make you sleepy, forgetful, have poor co-ordination along with other side effects that can affect everyday activities (see Possible side effects). You should not drive, operate machinery or take part in such activities where, if affected, you could put yourself or others at risk.
3 How to use
Always use Stesolid rectal tubes exactly as your doctor has told you. The tubes are inserted into the anus using the nozzle provided. Instructions for inserting the tubes are on the folded label on each bag. Please read the instructions very carefully before using your medicine. Doses Adults and children above 1 year of age: 0.5mg per kg of body weight Elderly: 0.25mg per kg of body weight If you have breathing problems you may be given a lower dose. After giving into the anus, the medicine is quickly absorbed and will start to take effect within 5 minutes.
5 How to store
Keep out of the reach and sight of children. Do not store above 25C. Do not use Stesolid rectal tubes after the expiry date stated on the label/carton/ bottle. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6 Further Information What Stesolid rectal tubes contain:
If you dont feel better
If your symptoms or the fit are not brought under control with Stesolid rectal tubes, contact a doctor for advice. Further doses should only be given after consulting a doctor. The maximum dose is 30mg.
The active substance (the ingredient that makes the medicine work) is diazepam. Each rectal tube contains either 5mg or 10mg of diazepam. The other ingredients are benzoic acid, ethanol, propylene glycol, sodium benzoate, benzyl alcohol, water.
What Stesolid rectal tubes look like and contents of the pack
If you use more Stesolid rectal tubes than you should
If you (or someone else) use a lot of medicine at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include clumsiness and loss of coordination, feeling sleepy or deep sleep, speech problems, irregular or slow heartbeat, uncontrolled eye movement, muscle weakness or excitement. An extreme overdose may lead to coma (unrousable unconsciousness), reflex problems and breathing difficulties.
Stesolid rectal tubes contains a clear, colourless to yellowish liquid in a yellow polyethylene tube. Pack size of 5 x 2.5ml, singly packed in aluminium foil. Marketing Authorisation Holder: Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland Manufacturers Actavis B.V., Baarnsche Dijk 1, 3741 LN Baarn, The Netherlands Actavis Group PTC ehf, Reykjavikurvegur 76-78, IS-220 Hafnarfjrur, Iceland Distributor Actavis, Barnstaple, EX32 8NS, UK Date of Revision: February 2013
If you forget to use Stesolid rectal tubes
If you forget to use a dose, use it as soon as you remember it and then use the next dose at the right time. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Continued top of next column AAAF0330
Actavis, Barnstaple, EX32 8NS, UK
Diazepam (Stesolid) 5mg & 10mg Rectal Tubes PIL - UK
item no: AAAF0330 print proof no: 2 origination date: 27.02.13 originated by: DR approved for print/date revision date: 06.03.13 revised by: DR supplier: Actavis Jakarta Technical Approval date sent: 27.02.13 technically app. date: 01.03.13 dimensions: 200 x 210 pharmacode: min pt size: 8pt
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
have someone close to you who has recently died are elderly (as there is an increased risk of side effects). have a personality disorder smoke
Warnings about stopping treatment
In this leaflet: 1 What Stesolid rectal tubes are and what they are used for 2 Before you use 3 How to use 4 Possible side effects 5 How to store 6 Further information
1 What Stesolid rectal tubes are and what they are used for
Stesolid rectal tubes contain diazepam which belongs to a group of medicines called benzodiazepines. Diazepam is used to treat: severe anxiety and agitation muscle spasms epilepsy or febrile convulsions symptoms of alcohol withdrawal Stesolid rectal tubes can also be used to cause relaxation and sleepiness before an operation or dental procedure.
Withdrawal symptoms There is a risk of becoming dependent on this medicine, particularly with high doses, continued use or if you have a history of alcoholism or drug abuse. If dependence has developed, withdrawal symptoms will occur if you suddenly stop treatment. Withdrawal symptoms include: headaches, muscle pain, anxiety, tension, restlessness confusion and irritability and in severe cases: feelings of things being unreal or strange or that your mind is separated from your body, numbness and tingling in the hands and feet, hallucinations, fits or sensitivity to light, noise or touch. Rebound sleeplessness and anxiety When you stop taking this type of medicine, some of the symptoms that led to treatment can return more intensely than before, such as sleep disturbances, anxiety, restlessness or mood changes. The risk of this is greater if you stop suddenly. To avoid these things happening, treatment should be stopped gradually under the advice of a doctor.
Taking other medicines
2 Before you use Do not use Stesolid rectal tubes and tell your doctor if you
are allergic (hypersensitive) to diazepam, other benzodiazepine medicines or to any of the other ingredients (see section 6) have severe breathing problems or have difficulty breathing suffer from depression (with or without anxiety) or hyperactivity have a phobia (a fear of a particular object or situation) or other mental illness have myasthenia gravis (a condition which causes muscle weakness) suffer from sleep apnoea (a condition where you stop breathing whilst asleep) have severe liver disorders have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders) planning a pregnancy or are pregnant (see below Pregnancy and breastfeeding).
Check with your doctor or pharmacist before using Stesolid rectal tubes if you
have a history of alcoholism or drug abuse
Continued top of next column AAAF0330
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: antidepressants, antipsychotics (to treat mental problems), antihistamines (to treat allergies), general anaesthetics, lofexidine (to help relieve symptoms when you stop taking opioids), nabilone (to treat nausea and vomiting), hypnotics (to help you sleep), alpha blockers or moxonidine (to lower high blood pressure), muscle relaxants (eg baclofen, tizanidine). Taking these medicines with diazepam could make you very sleepy. some strong pain killers may give you a heightened sense of well being when taken with diazepam, which can increase your desire to continue taking these medicines (dependency) or can make you very sleepy. disulfiram (to treat alcohol addiction). Taking this medicine with diazepam could make you very sleepy and can cause diazepam to be removed from the body more slowly than usual. medicines for epilepsy eg phenobarbital, phenytoin, carbamazepine, or sodium valproate, (diazepam can affect the blood levels of these medicines). cimetidine or omeprazole (for ulcers), oestrogen-containing contraceptives, erythromycin (an antibiotic), antifungals (fluconazole, voriconazole) or isoniazid (to treat tuberculosis) as these can cause diazepam to be removed from the body more slowly than usual. rifampicin (to treat infections) or theophylline (to treat asthma) as this can cause diazepam to be removed from the body more quickly than usual.
Continued over page
Diazepam (Stesolid) 5mg & 10mg Rectal Tubes PIL - UK
item no: AAAF0330 print proof no: 2 origination date: 27.02.13 originated by: DR approved for print/date revision date: 06.03.13 revised by: DR supplier: Actavis Jakarta Technical Approval date sent: 27.02.13 technically app. date: 01.03.13 dimensions: 200 x 210 pharmacode: min pt size: 8pt
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
amrenavir or ritonavir (antivirals) as these can make you feel sleepy for longer or cause difficulty breathing. medicines to lower high blood pressure, diuretics (water tablets), nitrates (for heart conditions) as these could lower your blood pressure too much. levodopa (to treat Parkinsons Disease) as diazepam may cause levodopa to not work so well.
4 Possible side effects
Like all medicines, Stesolid rectal tubes can cause side effects, although not everybody gets them. Stop treatment and contact a doctor at once if you have the following symptoms of an allergic reaction e.g. itchy skin, rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: drowsiness, sedation, tiredness, slurred speech, light-headedness, unsteadiness or clumsiness and loss of co-ordination (you may notice these even after a single dose and this may continue into the following day) confusion, memory loss (which may be experienced several hours after taking diazepam. If possible, to reduce the risk allow 7 to 8 hours of uninterrupted sleep after taking), seeing or sensing things that are not there, inappropriate behaviour, difficulty concentrating, agitation/irritability, restlessness, experiencing rage, excitement, numbed emotions, depression with suicidal tendencies, headache, spinning sensation blood disorders (you may develop sore throats, nose bleeds or infections) changes in sex drive, visual disturbances, low blood pressure, stomach upsets, yellowing of the skin or whites of the eyes (jaundice) muscle spasms/shaking or weakness, breathing difficulties difficulty passing urine, increase in amount of saliva you feel you are abusing or becoming dependant on this product Stesolid rectal tubes contain sodium benzoate and benzoic acid which may cause irritation to the anus (you may feel a stinging sensation). If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
Using Stesolid and food and drink
Grapefruit juice may increase the amount of diazepam in your blood. If you are elderly, suffer from cirrhosis or any of the conditions listed in section 2, this could possibly increase the sedative effects of Stesolid and you should speak to your doctor or pharmacist. Drinks containing caffeine may reduce the effects of diazepam.
Alcohol
Do not drink alcohol while you are using Stesolid rectal tubes. Alcohol may increase the sedative effects of diazepam and make you very sleepy. You should not use Stesolid rectal tubes if you are pregnant, planning to become pregnant or are breast feeding. If you use Stesolid rectal tubes late in your pregnancy or during labour, your baby might have a low body temperature, floppiness, and breathing difficulties. Your baby may also develop withdrawal symptoms.
Pregnancy and breast-feeding
Driving and using machines
Stesolid rectal tubes can make you sleepy, forgetful, have poor co-ordination along with other side effects that can affect everyday activities (see Possible side effects). You should not drive, operate machinery or take part in such activities where, if affected, you could put yourself or others at risk.
3 How to use
Always use Stesolid rectal tubes exactly as your doctor has told you. The tubes are inserted into the anus using the nozzle provided. Instructions for inserting the tubes are on the folded label on each bag. Please read the instructions very carefully before using your medicine. Doses Adults and children above 1 year of age: 0.5mg per kg of body weight Elderly: 0.25mg per kg of body weight If you have breathing problems you may be given a lower dose. After giving into the anus, the medicine is quickly absorbed and will start to take effect within 5 minutes.
5 How to store
Keep out of the reach and sight of children. Do not store above 25C. Do not use Stesolid rectal tubes after the expiry date stated on the label/carton/ bottle. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6 Further Information What Stesolid rectal tubes contain:
If you dont feel better
If your symptoms or the fit are not brought under control with Stesolid rectal tubes, contact a doctor for advice. Further doses should only be given after consulting a doctor. The maximum dose is 30mg.
The active substance (the ingredient that makes the medicine work) is diazepam. Each rectal tube contains either 5mg or 10mg of diazepam. The other ingredients are benzoic acid, ethanol, propylene glycol, sodium benzoate, benzyl alcohol, water.
What Stesolid rectal tubes look like and contents of the pack
If you use more Stesolid rectal tubes than you should
If you (or someone else) use a lot of medicine at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include clumsiness and loss of coordination, feeling sleepy or deep sleep, speech problems, irregular or slow heartbeat, uncontrolled eye movement, muscle weakness or excitement. An extreme overdose may lead to coma (unrousable unconsciousness), reflex problems and breathing difficulties.
Stesolid rectal tubes contains a clear, colourless to yellowish liquid in a yellow polyethylene tube. Pack size of 5 x 2.5ml, singly packed in aluminium foil. Marketing Authorisation Holder: Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland Manufacturers Actavis B.V., Baarnsche Dijk 1, 3741 LN Baarn, The Netherlands Actavis Group PTC ehf, Reykjavikurvegur 76-78, IS-220 Hafnarfjrur, Iceland Distributor Actavis, Barnstaple, EX32 8NS, UK Date of Revision: February 2013
If you forget to use Stesolid rectal tubes
If you forget to use a dose, use it as soon as you remember it and then use the next dose at the right time. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Continued top of next column AAAF0330
Actavis, Barnstaple, EX32 8NS, UK
Diazepam (Stesolid) 5mg & 10mg Rectal Tubes PIL - UK
item no: AAAF0330 print proof no: 2 origination date: 27.02.13 originated by: DR approved for print/date revision date: 06.03.13 revised by: DR supplier: Actavis Jakarta Technical Approval date sent: 27.02.13 technically app. date: 01.03.13 dimensions: 200 x 210 pharmacode: min pt size: 8pt
colours/plates: 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. 2. 3.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
