PROPAIN PLUS
Active substance: PARACETAMOL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
(Paracetamol, Doxylamine, Caffeine, Codeine)
PROPAIN PLUSTM
SZ94303LT04A
This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it If you take this medicine for headaches for more than three days it can make them worse Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. This medicine can only be used for backache, neuralgia, muscular aches and pains, toothache, rheumatic pain, headache and tension headache, period pain, migraine and pain following operations and dental surgery. You must contact a doctor if your symptoms worsen or do not improve after 3 days. 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.
In this leaflet: 1. What are Propain Plus and what are they used for 2. Before you take Propain Plus 3. How to take Propain Plus 4. Possible side effects 5. How to store Propain Plus 6. Further Information
The name of your medicine is Propain Plus.
1
What are Propain Plus and what are they used for
This medicine contains paracetamol, an analgesic (pain killer). Doxylamine is an antihistamine, caffeine is a mild stimulant which also acts to help the effectiveness of paracetamol. Codeine is an analgesic. For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This medicine can be used to relieve: backache neuralgia muscular aches and pains toothache rheumatic pain headache and tension headache period pain migraine This medicine can also be used to relieve pain following operations and dental surgery.
have or suffer from: high blood pressure, bowel disorder, abdominal conditions, thyroid gland problems, adrenal gland disease, prostate problems, shock or gallstone. have irregular, fast or slower than usual heart beat (cardiac arrhythmias), your doctor will tell you if you have this. suffer from convulsions.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription. In particular you should tell your doctor if you are taking any of the following: anticholinergic agents such as atropine; sedatives or tranquillizers; cimetidine (for stomach ulcers); antidepressants (tricyclic or MAOIs); quinidine, mexiletine (used to correct heart rhythm); opioid and narcotic analgesics (for pain relief); ergot alkaloids (for migraine); enzyme-inducing agents such as alcohol or anti-epileptic medicines; naloxone (used to counter the effects of an opioid overdose); coumarins (to thin the blood); phenylbutazone, indometacin (anti-inflammatory medicines); naltrexone (for drug addiction); aspirin; phenothiazines (antipsychotics); diuretics (used to reduce the amount of water in the body); central nervous system depressants including alcohol; colestyramine (used to lower Cholesterol); antihypertensives (used to reduce blood pressure); barbiturates (to help you sleep or treat epilepsy); metoclopramide, cisapride, domperidone (used to help stop nausea and vomiting); antidiarrhoeals (such as loperamide); hypnotics (to help you sleep); anxiolytics (to help with anxiety).
This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it. If you take a painkiller for headaches for more than three days it can make them worse.
2
Before you take Propain Plus
Do not take Propain Plus If you are allergic to paracetamol, codeine, caffeine, doxylamine succinate, antihistamines or to any of the other ingredients in this medicine. Take special care with Propain Plus Before taking this medicine, you need to know the following: This product contains paracetamol. Do not take with any other paracetamol containing products.
Talk to your doctor or pharmacist before taking this medicine if you: suffer from asthma. have kidney or liver disease. are an elderly person. have had recent gastrointestinal surgery. have a history of drug abuse. have emotional problems.
Taking Propain Plus with food and drink You should not drink alcohol while taking this medicine. Alcohol may increase the sedative effects of this medicine and make you very sleepy. It can increase the risk of some side effects. Pregnancy and breast-feeding You should not use this medicine during pregnancy or breast-feeding as it is not recommended for use at this time.
Continued on the next page >>
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines This medicine may cause drowsiness and impaired concentration. If you are affected, do not drive or operate machinery.
The usual dose is described below.
3
How to take Propain Plus
These tablets are for oral administration. They should be swallowed with a glass of water. Dosage instructions Adults and children over 12 years of age: Take 1-2 caplets every 4-6 hours as needed for relief. Do not take more than 8 caplets in 24 hours. Children under 12 years: Not recommended.
Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.
How do I know if I am addicted? If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor: You need to take the medicine for longer periods of time You need to take more than the recommended dose When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again 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.
tinnitus (ringing in the ears), extreme feelings of happiness or depression, restlessness or excitement, irritability, nightmares, loss of appetite, difficulty passing water, dryness of the mouth, tightness of the chest, tingling, heaviness or weakness of the hands, muscle tremors, high blood pressure (hypertension), fast or irregular heartbeat.
Codeine addiction This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms. If you take more Propain Plus than you should If you or someone else swallows a lot of the caplets all together, or if you think a child has swallowed any of the caplets, contact your nearest hospital casualty department or doctor immediately. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Keep out of reach and sight of children.
5
How to store Propain Plus
Do not use this medicine after the expiry date on the container. The expiry date refers to the last day of that month. Store at or below 25C in the original package. If you notice any visible signs of deterioration such as broken or chipped caplets please take this medicine to your pharmacist.
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday Friday) or fill in a paper form available from your local pharmacy. Like all medicines, Propain Plus can cause side effects although not everybody gets them. It is very unlikely that you will experience the following side effects. However, you should stop taking this medicine and talk to your doctor immediately if you notice any of the following symptoms:
4
Possible side effects
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.
What Propain Plus contains The active ingredients in this medicine are paracetamol 450 mg, doxylamine succinate 5 mg, caffeine anhydrous 30 mg and codeine phosphate 10 mg. The other ingredients are maize starch, povidone, magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose. The film coat contains hypromellose, hydroxypropylcellulose, glycerol and carnauba wax.
6
Further information
You bruise more easily, have bleeding gums or bleed for longer after cutting yourself or you feel tired or look pale. You seem to be getting more infections than usual or you develop ulcers in your mouth or throat. You have a severe abdominal pain (in the upper middle or upper left part of the belly) usually accompanied by sickness, diarrhoea or fever. Allergic (hypersensitivity) reactions such as skin rash may occur. Other more common side effects that have been reported are listed below sedation or drowsiness, dizziness, stomach troubles, blurred vision, insomnia, nausea, constipation, vomiting, gastric ulcers, headache,
What Propain Plus looks like and contents of the pack This medicine is a capsule-shaped tablet called a caplet. The caplets are available in packs of 8, 10, 16, 20 or 32. Not all pack sizes are marketed. Marketing Authorisation Holder and Manufacturer Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Date of leaflet approval: 01/2010
SZ94303LT04A
(Paracetamol, Doxylamine, Caffeine, Codeine)
PROPAIN PLUSTM
SZ94303LT04A
This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it If you take this medicine for headaches for more than three days it can make them worse Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. This medicine can only be used for backache, neuralgia, muscular aches and pains, toothache, rheumatic pain, headache and tension headache, period pain, migraine and pain following operations and dental surgery. You must contact a doctor if your symptoms worsen or do not improve after 3 days. 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.
In this leaflet: 1. What are Propain Plus and what are they used for 2. Before you take Propain Plus 3. How to take Propain Plus 4. Possible side effects 5. How to store Propain Plus 6. Further Information
The name of your medicine is Propain Plus.
1
What are Propain Plus and what are they used for
This medicine contains paracetamol, an analgesic (pain killer). Doxylamine is an antihistamine, caffeine is a mild stimulant which also acts to help the effectiveness of paracetamol. Codeine is an analgesic. For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This medicine can be used to relieve: backache neuralgia muscular aches and pains toothache rheumatic pain headache and tension headache period pain migraine This medicine can also be used to relieve pain following operations and dental surgery.
have or suffer from: high blood pressure, bowel disorder, abdominal conditions, thyroid gland problems, adrenal gland disease, prostate problems, shock or gallstone. have irregular, fast or slower than usual heart beat (cardiac arrhythmias), your doctor will tell you if you have this. suffer from convulsions.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription. In particular you should tell your doctor if you are taking any of the following: anticholinergic agents such as atropine; sedatives or tranquillizers; cimetidine (for stomach ulcers); antidepressants (tricyclic or MAOIs); quinidine, mexiletine (used to correct heart rhythm); opioid and narcotic analgesics (for pain relief); ergot alkaloids (for migraine); enzyme-inducing agents such as alcohol or anti-epileptic medicines; naloxone (used to counter the effects of an opioid overdose); coumarins (to thin the blood); phenylbutazone, indometacin (anti-inflammatory medicines); naltrexone (for drug addiction); aspirin; phenothiazines (antipsychotics); diuretics (used to reduce the amount of water in the body); central nervous system depressants including alcohol; colestyramine (used to lower Cholesterol); antihypertensives (used to reduce blood pressure); barbiturates (to help you sleep or treat epilepsy); metoclopramide, cisapride, domperidone (used to help stop nausea and vomiting); antidiarrhoeals (such as loperamide); hypnotics (to help you sleep); anxiolytics (to help with anxiety).
This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it. If you take a painkiller for headaches for more than three days it can make them worse.
2
Before you take Propain Plus
Do not take Propain Plus If you are allergic to paracetamol, codeine, caffeine, doxylamine succinate, antihistamines or to any of the other ingredients in this medicine. Take special care with Propain Plus Before taking this medicine, you need to know the following: This product contains paracetamol. Do not take with any other paracetamol containing products.
Talk to your doctor or pharmacist before taking this medicine if you: suffer from asthma. have kidney or liver disease. are an elderly person. have had recent gastrointestinal surgery. have a history of drug abuse. have emotional problems.
Taking Propain Plus with food and drink You should not drink alcohol while taking this medicine. Alcohol may increase the sedative effects of this medicine and make you very sleepy. It can increase the risk of some side effects. Pregnancy and breast-feeding You should not use this medicine during pregnancy or breast-feeding as it is not recommended for use at this time.
Continued on the next page >>
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines This medicine may cause drowsiness and impaired concentration. If you are affected, do not drive or operate machinery.
The usual dose is described below.
3
How to take Propain Plus
These tablets are for oral administration. They should be swallowed with a glass of water. Dosage instructions Adults and children over 12 years of age: Take 1-2 caplets every 4-6 hours as needed for relief. Do not take more than 8 caplets in 24 hours. Children under 12 years: Not recommended.
Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.
How do I know if I am addicted? If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor: You need to take the medicine for longer periods of time You need to take more than the recommended dose When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again 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.
tinnitus (ringing in the ears), extreme feelings of happiness or depression, restlessness or excitement, irritability, nightmares, loss of appetite, difficulty passing water, dryness of the mouth, tightness of the chest, tingling, heaviness or weakness of the hands, muscle tremors, high blood pressure (hypertension), fast or irregular heartbeat.
Codeine addiction This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms. If you take more Propain Plus than you should If you or someone else swallows a lot of the caplets all together, or if you think a child has swallowed any of the caplets, contact your nearest hospital casualty department or doctor immediately. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Keep out of reach and sight of children.
5
How to store Propain Plus
Do not use this medicine after the expiry date on the container. The expiry date refers to the last day of that month. Store at or below 25C in the original package. If you notice any visible signs of deterioration such as broken or chipped caplets please take this medicine to your pharmacist.
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday Friday) or fill in a paper form available from your local pharmacy. Like all medicines, Propain Plus can cause side effects although not everybody gets them. It is very unlikely that you will experience the following side effects. However, you should stop taking this medicine and talk to your doctor immediately if you notice any of the following symptoms:
4
Possible side effects
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.
What Propain Plus contains The active ingredients in this medicine are paracetamol 450 mg, doxylamine succinate 5 mg, caffeine anhydrous 30 mg and codeine phosphate 10 mg. The other ingredients are maize starch, povidone, magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose. The film coat contains hypromellose, hydroxypropylcellulose, glycerol and carnauba wax.
6
Further information
You bruise more easily, have bleeding gums or bleed for longer after cutting yourself or you feel tired or look pale. You seem to be getting more infections than usual or you develop ulcers in your mouth or throat. You have a severe abdominal pain (in the upper middle or upper left part of the belly) usually accompanied by sickness, diarrhoea or fever. Allergic (hypersensitivity) reactions such as skin rash may occur. Other more common side effects that have been reported are listed below sedation or drowsiness, dizziness, stomach troubles, blurred vision, insomnia, nausea, constipation, vomiting, gastric ulcers, headache,
What Propain Plus looks like and contents of the pack This medicine is a capsule-shaped tablet called a caplet. The caplets are available in packs of 8, 10, 16, 20 or 32. Not all pack sizes are marketed. Marketing Authorisation Holder and Manufacturer Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Date of leaflet approval: 01/2010
SZ94303LT04A
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.
