RIVOTRIL 0.5MG TABLETS
Active substance: CLONAZEPAM
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000-0000F
27mm
This product is known as the above name but will be refered to as Rivotril throughout this leaflet. Another strength (2mg) is also available. Please read all of this leaflet carefully before you start taking 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 become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Rivotril is and what it is used for. 2. Before you take Rivotril. 3. How to take Rivotril. 4. Possible side effects. 5. How to store Rivotril. 6. Further information. 1. What Rivotril is and what it is used for: Rivotril contains a medicine called clonazepam. This belongs to a group of medicines called benzodiazepines. Rivotril is used to treat epilepsy in infants, children and adults. It lowers the number of fits (seizures) that you have. Any fits that you do have will be less serious. 2. Before you take Rivotril: Do not take Rivotril if you are allergic (hypersensitive) to: Clonazepam or any of the other ingredients of Rivotril (listed in Section 6: Further Information) Other benzodiazepine medicines. These include diazepam, flurazepam and temazepam. Do not take Rivotril if any of the above apply to you. If you are not sure talk to your doctor of pharmacist before taking Rivotril. Do not take Rivotril if: You have breathing problems or lung disease You have severe liver problems You have a condition called myasthenia gravis (where your muscles become weak and get tired easily) You have a condition called sleep apnoea syndrome (where your breathing stops when you are asleep). Do not take Rivotril if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rivotril. Take special care with Rivotril A small number of people that are being treated with anti-epileptics such as clonazepam have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Check with your doctor or pharmacist before taking Rivotril if: You have liver, kidney or lung problems You have ever had depression You have ever tried to kill yourself A close friend or relative has recently died You regularly drink alcohol or take recreational drugs or you have had problems with alcohol or drug use in the past You have spinal or cerebellar ataxia (where you may become shaky and unsteady, have slurred speech or rapid eye movements) You have a rare inherited blood problem called porphyria. If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Rivotril. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Rivotril can affect the way some other medicines work. Also some other medicines can affect the way Rivotril works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Other medicines to treat epilepsy, such as carbamazepine, hydantoins, phenobarbital, phenytoin, primidone or sodium valproate. Cimetidine (used to treat stomach problems and heartburn). Rifampicin (an antibiotic used to treat infections). Medicines used to make you sleep (hypnotics). Medicines that help with anxiety (tranquillisers). Pain-killers (analgesics) and medicines to relax your muscles (muscle relaxants). Operations If you are going to have an anaesthetic for an operation or for dental treatment, it is important to tell your doctor or dentist that you are taking Rivotril. Taking Rivotril with Alcohol Do not drink alcohol while you are taking Rivotril. This is because it may cause side effects or cause your fits to return. Pregnancy and breast-feeding Do not take Rivotril if you are pregnant, might become pregnant or are breast-feeding, unless your doctor tells you to. This is because Rivotril will affect your baby. Driving and using machines Talk to your doctor about driving and using machines or tools, whilst you are taking Rivotril. This is because it can slow down your reactions, particularly when you start taking it. If you are in any doubt about whether you can do a particular activity, talk to your doctor. Important information about some of the ingredients of Rivotril. This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. 3. How to take Rivotril: Always take Rivotril exactly as your doctor has told you. You should check with your doctor if you are not sure. Your doctor will start you on a low dose of Rivotril and gradually increase it over 2 to 4 weeks until the right dose has been found for you. Your doctor will usually tell you to split your daily dose into three equal amounts which you will take at evenly spaced times throughout the day. If the daily dose cannot be split equally take the largest dose at bedtime. Once your doctor has found the right dose for you, they may tell you to take Rivotril as a single dose in the evening. Adults and children over 12 years The usual starting dose is 1mg a day or less. This will be increased gradually (usually to between 4mg and 8mg a day). The maximum dose is 20mg a day. The elderly The usual starting dose is 0.5mg a day, or less. This will be increased gradually (usually to between 4mg and 8mg a day). The maximum dose is 20mg a day. Infants (aged 0 to 1 years) The usual starting dose is 0.25mg a day or less. This will be increased gradually (usually to between 0.5mg and 1mg a day). Small children (aged 1 to 5 years) The usual starting dose is 0.25mg a day, or less. This will be increased gradually (usually to between 1mg and 3mg a day). Older children (aged 5 to 12 years) The usual starting dose is 0.5mg a day or less. This will be increased gradually (usually to between 3mg and 6mg a day). If you take more Rivotril than you should If you take more Rivotril than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you take too many tablets, you may feel drowsy, sleepy, light-headed, have a lack of co-ordination or be less responsive than normal. If you forget to take Rivotril If you forget to take a dose, skip the missed dose. Then take the next dose when it is due. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
CUSTOMER APPROVED:
DATE:
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
12/03/12
04-1957
DT
DATE:
TO UK PIL FOR 0.5MG & 2MG STRENGTHS GRANTED APRIL 2011
Rivotril 0.5mg tabs
CUSTOMER: Waymade
PRODUCT:
CODE:
6464/2664F
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
RIVOTRIL 0.5mg TABLETS (clonazepam) Patient Information Leaflet
PROOF HISTORY: v.2 - waymade - 12/03/12
Leaflet Flat Size = 180 x 429
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
WARNING!
Stopping Rivotril Do not stop taking your tablets without talking to your doctor. If you do, your fits may return and you may get withdrawal symptoms (see Section 4: Possible side effects). If the dose of Rivotril you take has to be reduced, or stopped, this must be done gradually. Your doctor will let you know how to do this.
27mm
If someone else takes your Rivotril by mistake, they should talk to a doctor or go to a hospital straight away. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines Rivotril can cause side effects, although not everybody will get them. Important side effects to look out for: Allergic reactions If you get an allergic reaction, see a doctor straight away. The signs may include: sudden swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow. sudden swelling of the hands, feet and ankles. skin rash or itching. Effects on the heart If you notice any of the following effects, see a doctor straight away. The signs may include: Breathlessness, swelling of the ankles, cough, tiredness and a racing heart. Chest pain which may spread to your neck and shoulders and down your left arm. Effects on behaviour If you notice any of the following effects, talk to your doctor as they may want you to stop taking Rivotril. The signs may include: Being aggressive, excited, irritable, nervous, agitated, or anxious. Problems sleeping, nightmares and vivid dreams. Mental problems such as seeing or hearing things that are not really there (hallucinations), delusions (believing in things that are not real) and problems with your speech. Types of fits (seizures) that you have not had before. Infants and children If an infant or small child is taking Rivotril, watch them carefully. This is because they could develop breathing problems, coughing or choking. This can be caused by too much saliva being made. Early puberty in children. This is reversible after stopping treatment with Rivotril. Elderly patients Older patients taking benzodiazepine medicines have a higher risk of falling and breaking bones. Other possible side effects When you start taking Rivotril you may notice the following effects: Feeling drowsy and tired. Feeling dizzy and light-headed. Weak or floppy muscles or jerky movements (poor co-ordination). Feeling unsteady when walking. If you notice any of these effects, talk to your doctor. Your doctor may be able to help you by giving you a lower dose of Rivotril and then increasing it slowly. The following may occur at any time during your treatment: Mind and nervous system Poor concentration, confusion and a feeling of being lost (disorientation). Feeling restless. Difficulty remembering new things. Headache. Depression. Slowing or slurring of speech. Poor co-ordination, including feeling unsteady when walking. An increase in how often you have fits. Liver, kidney and blood Changes in how well your liver is working (shown by blood tests). Loss of bladder control. Blood problems. The signs include feeling tired, bruising easily, being short of breath and nose bleeds. Your doctor may want you to have blood tests from time to time.
CUSTOMER APPROVED:
DATE:
Q.A. APPROVED:
DATE:
Stomach and gut Feeling sick (nausea) Stomach upset. Eyes Double vision Jerky movements of the eyes (nystagmus).
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
Skin and hair Skin rashes and itchy skin Changes to the colour of your skin Hair loss (the hair usually grows back). Sexual
TO UK PIL FOR 0.5MG & 2MG STRENGTHS GRANTED APRIL 2011
Loss of sex drive Difficulty getting or keeping an erection (erectile dysfunction).
CUSTOMER: Waymade
Withdrawing symptoms Using benzodiazepines like Rivotril may make you dependant on the medicine. This means that if you stop treatment quickly, or reduce the dose too quickly, you may get withdrawal symptoms. The symptoms can include: Problems sleeping. Muscle pain, shaking (tremor) and feeling restless. Feeling very anxious, tense, confused, irritable or agitated, or changes in your mood. Increased sweating. Headache. Less common withdrawal symptoms include: Feeling sensitive to light, noise and physical contact. Seeing or hearing things that are not really there (hallucinations). Tingling and feeling numb in your arms and legs. A feeling of losing contact with reality. If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Rivotril: Do not use after the expiry date printed on the carton or blister label. Store in the original package and outer carton in order to protect from light. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Don't dispose of them in waste water or household rubbish. Take them back to your pharmacist, who will dispose of them in a way that won't harm the environment. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to. REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours. If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist before taking them.
6. Further information: Each tablet contains 0.5mg (half a milligram) of the active ingredient Clonazepam. The tablets are pinkish-buff, round, marked ROCHE 0,5' on one side and with either a breakline or quadrisected on the reverse. Rivotril 0.5mg tablets are scored so that they can easily be broken into halves. This can allow you to take lower doses at the start of your treatment. Rivotril 0.5mg tablets also contain the following: lactose, magnesium stearate, maize starch, yellow iron oxide (E172), red iron oxide (E172), pregelatinised potato starch and talc. Rivotril 0.5mg tablets are available in blister packs of 60, 90 and 105 tablets. POM PL No: 6464/2664
This product is manufactured by Roche Farma S.A., C/ Severo Ochoa 13, Leganes 28914 Madrid, Spain and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR Leaflet revision and issue date (Ref.) 9.3.2012 RIVOTRIL is a registered trademark of ROCHE PRODUCTS Ltd.
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Rivotril 0.5mg tabs
12/03/12
04-1957
DT
PRODUCT:
CODE:
6464/2664F
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.2 - waymade - 12/03/12
Leaflet Flat Size = 180 x 429
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
WARNING!
27mm
This product is known as the above name but will be refered to as Rivotril throughout this leaflet. Another strength (2mg) is also available. Please read all of this leaflet carefully before you start taking 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 become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Rivotril is and what it is used for. 2. Before you take Rivotril. 3. How to take Rivotril. 4. Possible side effects. 5. How to store Rivotril. 6. Further information. 1. What Rivotril is and what it is used for: Rivotril contains a medicine called clonazepam. This belongs to a group of medicines called benzodiazepines. Rivotril is used to treat epilepsy in infants, children and adults. It lowers the number of fits (seizures) that you have. Any fits that you do have will be less serious. 2. Before you take Rivotril: Do not take Rivotril if you are allergic (hypersensitive) to: Clonazepam or any of the other ingredients of Rivotril (listed in Section 6: Further Information) Other benzodiazepine medicines. These include diazepam, flurazepam and temazepam. Do not take Rivotril if any of the above apply to you. If you are not sure talk to your doctor of pharmacist before taking Rivotril. Do not take Rivotril if: You have breathing problems or lung disease You have severe liver problems You have a condition called myasthenia gravis (where your muscles become weak and get tired easily) You have a condition called sleep apnoea syndrome (where your breathing stops when you are asleep). Do not take Rivotril if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rivotril. Take special care with Rivotril A small number of people that are being treated with anti-epileptics such as clonazepam have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Check with your doctor or pharmacist before taking Rivotril if: You have liver, kidney or lung problems You have ever had depression You have ever tried to kill yourself A close friend or relative has recently died You regularly drink alcohol or take recreational drugs or you have had problems with alcohol or drug use in the past You have spinal or cerebellar ataxia (where you may become shaky and unsteady, have slurred speech or rapid eye movements) You have a rare inherited blood problem called porphyria. If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Rivotril. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Rivotril can affect the way some other medicines work. Also some other medicines can affect the way Rivotril works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Other medicines to treat epilepsy, such as carbamazepine, hydantoins, phenobarbital, phenytoin, primidone or sodium valproate. Cimetidine (used to treat stomach problems and heartburn). Rifampicin (an antibiotic used to treat infections). Medicines used to make you sleep (hypnotics). Medicines that help with anxiety (tranquillisers). Pain-killers (analgesics) and medicines to relax your muscles (muscle relaxants). Operations If you are going to have an anaesthetic for an operation or for dental treatment, it is important to tell your doctor or dentist that you are taking Rivotril. Taking Rivotril with Alcohol Do not drink alcohol while you are taking Rivotril. This is because it may cause side effects or cause your fits to return. Pregnancy and breast-feeding Do not take Rivotril if you are pregnant, might become pregnant or are breast-feeding, unless your doctor tells you to. This is because Rivotril will affect your baby. Driving and using machines Talk to your doctor about driving and using machines or tools, whilst you are taking Rivotril. This is because it can slow down your reactions, particularly when you start taking it. If you are in any doubt about whether you can do a particular activity, talk to your doctor. Important information about some of the ingredients of Rivotril. This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. 3. How to take Rivotril: Always take Rivotril exactly as your doctor has told you. You should check with your doctor if you are not sure. Your doctor will start you on a low dose of Rivotril and gradually increase it over 2 to 4 weeks until the right dose has been found for you. Your doctor will usually tell you to split your daily dose into three equal amounts which you will take at evenly spaced times throughout the day. If the daily dose cannot be split equally take the largest dose at bedtime. Once your doctor has found the right dose for you, they may tell you to take Rivotril as a single dose in the evening. Adults and children over 12 years The usual starting dose is 1mg a day or less. This will be increased gradually (usually to between 4mg and 8mg a day). The maximum dose is 20mg a day. The elderly The usual starting dose is 0.5mg a day, or less. This will be increased gradually (usually to between 4mg and 8mg a day). The maximum dose is 20mg a day. Infants (aged 0 to 1 years) The usual starting dose is 0.25mg a day or less. This will be increased gradually (usually to between 0.5mg and 1mg a day). Small children (aged 1 to 5 years) The usual starting dose is 0.25mg a day, or less. This will be increased gradually (usually to between 1mg and 3mg a day). Older children (aged 5 to 12 years) The usual starting dose is 0.5mg a day or less. This will be increased gradually (usually to between 3mg and 6mg a day). If you take more Rivotril than you should If you take more Rivotril than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you take too many tablets, you may feel drowsy, sleepy, light-headed, have a lack of co-ordination or be less responsive than normal. If you forget to take Rivotril If you forget to take a dose, skip the missed dose. Then take the next dose when it is due. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
CUSTOMER APPROVED:
DATE:
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
12/03/12
04-1957
DT
DATE:
TO UK PIL FOR 0.5MG & 2MG STRENGTHS GRANTED APRIL 2011
Rivotril 0.5mg tabs
CUSTOMER: Waymade
PRODUCT:
CODE:
6464/2664F
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
RIVOTRIL 0.5mg TABLETS (clonazepam) Patient Information Leaflet
PROOF HISTORY: v.2 - waymade - 12/03/12
Leaflet Flat Size = 180 x 429
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
WARNING!
Stopping Rivotril Do not stop taking your tablets without talking to your doctor. If you do, your fits may return and you may get withdrawal symptoms (see Section 4: Possible side effects). If the dose of Rivotril you take has to be reduced, or stopped, this must be done gradually. Your doctor will let you know how to do this.
27mm
If someone else takes your Rivotril by mistake, they should talk to a doctor or go to a hospital straight away. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines Rivotril can cause side effects, although not everybody will get them. Important side effects to look out for: Allergic reactions If you get an allergic reaction, see a doctor straight away. The signs may include: sudden swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow. sudden swelling of the hands, feet and ankles. skin rash or itching. Effects on the heart If you notice any of the following effects, see a doctor straight away. The signs may include: Breathlessness, swelling of the ankles, cough, tiredness and a racing heart. Chest pain which may spread to your neck and shoulders and down your left arm. Effects on behaviour If you notice any of the following effects, talk to your doctor as they may want you to stop taking Rivotril. The signs may include: Being aggressive, excited, irritable, nervous, agitated, or anxious. Problems sleeping, nightmares and vivid dreams. Mental problems such as seeing or hearing things that are not really there (hallucinations), delusions (believing in things that are not real) and problems with your speech. Types of fits (seizures) that you have not had before. Infants and children If an infant or small child is taking Rivotril, watch them carefully. This is because they could develop breathing problems, coughing or choking. This can be caused by too much saliva being made. Early puberty in children. This is reversible after stopping treatment with Rivotril. Elderly patients Older patients taking benzodiazepine medicines have a higher risk of falling and breaking bones. Other possible side effects When you start taking Rivotril you may notice the following effects: Feeling drowsy and tired. Feeling dizzy and light-headed. Weak or floppy muscles or jerky movements (poor co-ordination). Feeling unsteady when walking. If you notice any of these effects, talk to your doctor. Your doctor may be able to help you by giving you a lower dose of Rivotril and then increasing it slowly. The following may occur at any time during your treatment: Mind and nervous system Poor concentration, confusion and a feeling of being lost (disorientation). Feeling restless. Difficulty remembering new things. Headache. Depression. Slowing or slurring of speech. Poor co-ordination, including feeling unsteady when walking. An increase in how often you have fits. Liver, kidney and blood Changes in how well your liver is working (shown by blood tests). Loss of bladder control. Blood problems. The signs include feeling tired, bruising easily, being short of breath and nose bleeds. Your doctor may want you to have blood tests from time to time.
CUSTOMER APPROVED:
DATE:
Q.A. APPROVED:
DATE:
Stomach and gut Feeling sick (nausea) Stomach upset. Eyes Double vision Jerky movements of the eyes (nystagmus).
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
Skin and hair Skin rashes and itchy skin Changes to the colour of your skin Hair loss (the hair usually grows back). Sexual
TO UK PIL FOR 0.5MG & 2MG STRENGTHS GRANTED APRIL 2011
Loss of sex drive Difficulty getting or keeping an erection (erectile dysfunction).
CUSTOMER: Waymade
Withdrawing symptoms Using benzodiazepines like Rivotril may make you dependant on the medicine. This means that if you stop treatment quickly, or reduce the dose too quickly, you may get withdrawal symptoms. The symptoms can include: Problems sleeping. Muscle pain, shaking (tremor) and feeling restless. Feeling very anxious, tense, confused, irritable or agitated, or changes in your mood. Increased sweating. Headache. Less common withdrawal symptoms include: Feeling sensitive to light, noise and physical contact. Seeing or hearing things that are not really there (hallucinations). Tingling and feeling numb in your arms and legs. A feeling of losing contact with reality. If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Rivotril: Do not use after the expiry date printed on the carton or blister label. Store in the original package and outer carton in order to protect from light. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Don't dispose of them in waste water or household rubbish. Take them back to your pharmacist, who will dispose of them in a way that won't harm the environment. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to. REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours. If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist before taking them.
6. Further information: Each tablet contains 0.5mg (half a milligram) of the active ingredient Clonazepam. The tablets are pinkish-buff, round, marked ROCHE 0,5' on one side and with either a breakline or quadrisected on the reverse. Rivotril 0.5mg tablets are scored so that they can easily be broken into halves. This can allow you to take lower doses at the start of your treatment. Rivotril 0.5mg tablets also contain the following: lactose, magnesium stearate, maize starch, yellow iron oxide (E172), red iron oxide (E172), pregelatinised potato starch and talc. Rivotril 0.5mg tablets are available in blister packs of 60, 90 and 105 tablets. POM PL No: 6464/2664
This product is manufactured by Roche Farma S.A., C/ Severo Ochoa 13, Leganes 28914 Madrid, Spain and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR Leaflet revision and issue date (Ref.) 9.3.2012 RIVOTRIL is a registered trademark of ROCHE PRODUCTS Ltd.
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Rivotril 0.5mg tabs
12/03/12
04-1957
DT
PRODUCT:
CODE:
6464/2664F
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.2 - waymade - 12/03/12
Leaflet Flat Size = 180 x 429
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
WARNING!
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.
