Solpadeine Plus Tablets
Note:
Main body font size 7pt/7.1 Legal Requirement: 9pt/9pt
• This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.
• You should only take this medicine for a maximum of 3 days at a time. If you need to take it for longer than 3 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 3 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 3 days it can make them worse.
Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use Solpadeine Plus Tablets carefully to get the best results from them.
• Keep this leaflet you may need to read it again.
• If you have any questions, or if there is anything you do not understand, ask your pharmacist.
In this leaflet:
1. What Solpadeine Plus Tablets do
2. Check before you take Solpadeine Plus Tablets
3. How to take Solpadeine Plus Tablets
4. Possible side effects
5. How to store Solpadeine Plus Tablets
6. Further information
1. What Solpadeine Plus Tablets do
Solpadeine Plus Tablets can be used in patients over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, rheumatic pain and sciatica. The tablets contain three active ingredients; paracetamol, codeine and caffeine. Codeine and paracetamol are both painkillers.
Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other painkillers. Caffeine acts to further help the effectiveness of paracetamol.
2. Check before you take Solpadeine Plus Tablets
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 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 3 days it can make them worse.
Do not take Solpadeine Plus Tablets:
• If you have ever had an allergic reaction to
paracetamol, caffeine, codeine, other opioid painkillers or to any of the other ingredients (listed in Section 6)
• If you are taking other medicines containing paracetamol or codeine
• If you are under 12 years:
• For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
• If you know that you metabolise very rapidly codeine into morphine
• If you are breastfeeding.
Ask your doctor before you take this medicine:
• If you have liver or kidney disease, including alcoholic liver disease
• If you have bowel problems including blockage of your bowel
• If you have had an operation to remove your gall bladder
If you are taking other medicines
Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] and vomiting [being sick]); cholestyramine (to lower blood cholesterol); monoamine oxidase inhibitors (MAOIs) prescribed for depression in the last 2 weeks, or substances that make you drowsy (e.g. sedatives, antidepressants or alcohol). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Solpadeine Plus Tablets at the same time as anticoagulants.
Warnings and precautions
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice:
Slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Children and adolescents
Use in children and adolescents after surgery: Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems:
u
Pregnancy and breast feeding £
Talk to your doctor before taking Solpadeine £ Plus Tablets if you are pregnant. Do not take £
Solpadeine Plus Tablets while you are breast-feeding. Codeine and morphine passes into breast milk.
Driving and using machines
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine until you know how it affects you. It is an offence to drive if this medicine affects your ability to drive. However, you would not be committing an offence if:
The medicine has been taken to treat a medical or dental problem and
You have taken it according to the information provided with the medicine and It was not affecting your ability to drive safely. Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Details regarding a new driving offence concerning driving after drugs have been taken n the UK may be found here: www.gov.uk/drug-driving-law
3. How to take Solpadeine Plus Tablets
Adults and children aged 12 years and over: Swallow 2 tablets every 4 hours as needed.
Do not take more frequently than every 4 hours.
Do not take more than 8 tablets in 24 hours.
Do not take more than the recommended dose.
Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.
Solpadeine Plus Tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems This medicine should not be taken for more than 3 days. If the pain does not not improve after 3 days, talk to your doctor for advice.
Possible withdrawal effect This medicine contains codeine and can cause addiction if you take it continuously for more than 3 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.
Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is aecause too much paracetamol can cause delayed, serious liver damage. If your symptoms continue or your headache becomes persistent, see your doctor.
4. Possible side effects
Some people may have side effects when using this medicine. If you have any unwanted side effects you should seek advice from your doctor, Dharmacist or other healthcare professional. When using this product you may experience: Constipation
Stop taking this medicine and tell your doctor mmediately if you experience:
* Severe abdominal pain, dry mouth, nausea and vomiting if you have recently had your gall bladder removed_
• Nervousness, dizziness, irritability, drowsiness or restlessness
• Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath
• Skin rash or peeling or mouth ulcers, itching or sweating
• Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
• Unexplained bruising or bleeding
• Nausea, upset stomach, sudden weight loss, loss of appetite and yellowing of the eyes and skin
• Difficulty in urinating.
Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
How do I know if I am addicted?
If you take this medicine according to the instructions on the pack, it is unlikely 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.
5. How to store Solpadeine Plus Tablets
Keep out of the reach and sight of children.
Do not use this medicine after the 'EXP' date shown on the pack.
6. Further information
Active ingredients Each tablet contains Paracetamol 500 mg, Codeine Phosphate Hemihydrate 8 mg and Caffeine 30 mg.
Other ingredients Maize starch, Starch pregelatinised, potassium sorbate (E 202), povidone, purified talc, magnesium stearate, microcrystalline cellulose, stearic acid, hypromellose, carmoisine (E 122).
Carmoisine may cause allergic reactions.
Packs of Solpadeine Plus Tablets contain 16 or 32 tablets printed with Solpadeine in red on one side or plain both sides.
The marketing authorisation holder is Omega Pharma Ltd., 32 Vauxhall Bridge Road, London, SW1V 2SA, United Kingdom and all enquiries should be sent to this address.
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The manufacturer is GlaxoSmithKline r£
Dungarvan Ltd., Co. Waterford, Ireland or c
Swiss Caps GmbH Grassingerstrape 9, 83043 Bad ^ Aibling, Germany (Aenova Group). u
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File title: 9738 LF03523C_11017639 Solpadeine Plus Tabs 32 PIL UK v2
item No.: 11017639
OPi No.: LF03523C
Last edit: 14th October 2015
Brand: Solpadeine
Variant: Plus Tabs 32
Component: Leaflet Market/s: UK
Dimensions: 140 x 21 Omm with 12mm borders
Cutter guide: CG225_Solpadeine_32tabs_LF_140x21 Omm_AEN
TSS file: TSS SOLP 32TABPLUS_UK_AEN-v2
Printer: N/A
Substrate: Uncoated paper, white, 60g/m2
EAN Code: N/A
PharmaCode: 10932
Replacement number: 11016708
Manufacturing Site: Aenova
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81 Rivington Street Shoreditch London EC2A 3AY United Kingdom awk contact Phil Hinckley phi!@oneagency.co +44 (0)7710 521027 +44 (0)203 008 6041
Marketing Approval:
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FRONT
* This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.
* You should only take this medicine for a maximum of 3 days at a time. If you need to take it for longer than 3 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 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it.
* If you take this mediane for headaches for more than 3 days it can make them worse.
5lease read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use Solpadeine Plus Tablets carefully to get the best results from them.
* Keep this leaflet you may need to read it
* If you have any questions, or if there is anything you do not understand, ask your pharmacist.
n this leaflet:
1. What Solpadeine Plus Tablets do
2. Check before you take Solpadeine Plus Tablets
3. How to take Solpadeine Plus Tablets
4. Possible side effects
s. How to store Solpadeine Plus Tablets 6. Further information
1. What Solpadeine Plus Tablets do
Solpadeine Plus Tablets can be used in patients over 12 years of age for the short-term relief of noderate pain that is not relieved by other oainkillers such as paracetamol or ibuprofen alone.
They can be used for migraine, headache, dental aain, period pain, strains & sprains, backache, 'heumatic pain and sciatica. The tablets contain three active ingredients; paracetamol, codeine and caffeine. Codeine and paracetamol are both oainkillers.
Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can oe used on its own or in combination with other oainkillers. Caffeine acts to further help the effectiveness of paracetamol.
2. Check before you take Solpadeine Plus Tablets
* This medicine contains codeine which can cause addiction if you take it continuously for more than 3 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 3 days it can make them worse._
Do not take Solpadeine Plus Tablets:
* If you have ever had an allergic reaction to paracetamol, caffeine, codeine, other opioid painkillers or to any of the other ingredients (listed in Section 6)
* If you are taking other medicines containing paracetamol or codeine
* If you are under 12 years:
* For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
* If you know that you metabolise very rapidly codeine into morphine
* If you are breastfeeding.
Ask your doctor before you take this medicine:
* If you have liver or kidney disease, including alcoholic liver disease
* If you have bowel problems including blockage of your bowel
* If you have had an operation to remove your gall bladder
If you are taking other medicines Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feelingsick] and vomiting [being sick]); cholestyramine (to lower blood cholesterol); monoamine oxidase inhibitors (MAOIs) prescribed for depression in the last 2 weeks, or substances that make you drowsy (e.g. sedatives, antidepressants or alcohol). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Solpadeine Plus Tablets at the same time as anticoagulants.
Warnings and precautions Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice:
Slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Children and adolescents Use in children and adolescents after surgery: Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems:
Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxiaty may be worse in these children.
Pregnancy and breast feeding 8
Talk to your doctor before taking Solpadeine 8 Plus Tablets if you are pregnant. Do not take 8
Note:
Main body font size 7pt/7.'
Solpadeine Plus Tablets while you are oreast-feeding. Codeine and morphine passes nto breast milk.
Driving and using machines
This medicine can affect your ability to drive as it
may make you sleepy or dizzy.
Do not drive while taking this medicine until you know how it affects you. It is an offence to drive if this medicine affects your ability to drive. However, you would not be committing an offence if:
The medicine has been taken to treat a medical or dental problem and
You have taken it according to the information orovided with the mediane and It was not affecting your ability to drive safely. Talk to your doctor or pharmacist if you are not ;ure whether it is safe for you to drive while taking this medicine.
Details regarding a new driving offence concerning driving after drugs have been taken n the UK may be found here: a/ww.gov.uk/drug-driving-law
3. How to take Solpadeine Plus Tablets
Adults and children aged 12 years and over: Swallow 2 tablets every 4 hours as needed.
* Do not take more frequently than every 4 hours.
* Do not take more than 8 tablets in 24 hours.
* Do not take more than the recommended dose.
* Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.
* Solpadeine Plus Tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems
* This medicine should not be taken for more than 3 days. If the pain does not not improve after 3 days, talk to your doctor for advice.
Possible withdrawal effect This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are offering from withdrawal symptoms.
Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is aecause too much paracetamol can cause delayed, serious liver damage, if your symptoms continue or your headache becomes persistent, see your doctor.
4. Possible side effects
Some people may have side effects when using this medicine. If you have any unwanted side effects you should seek advice from your doctor, aharmadst or other healthcare professional. When using this product you may experience:
* Constipation
Stop taking this medicine and teii your doctor mmediately if you experience:
* Severe abdominal pain, dry mouth, nausea
and vomiting if you have recently had your qaii bladder removed_
* Nervousness, dizziness, irritability, drowsiness or restlessness
* Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath
* Skin rash or peeling or mouth ulcers, itching or sweating
* Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
* Unexplained bruising or bleeding
* Nausea, upset stomach, sudden weight loss, loss of appetite and yellowing of the eyes and skin
* Difficulty in urinating.
Reporting of side effects: if you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
How do i know if I am addicted? if you take this medicine according to the instructions on the pack, it is unlikely 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.
5. How to store Solpadeine Plus Tablets
Keep out of the reach and sight of children.
Do not use this medicine after the 'EXP' date shown on the pack.
6. Further information
Active ingredients Each tablet contains Paracetamol 500 mg, Codeine Phosphate Hemihydrate 8 mg and Caffeine 30 mg.
Other ingredients Maize starch. Starch pregeiatinised, potassium sorbate (E 202), povidone, purified talc, magnesium stearate, microcrystaliine cellulose, stearic acid, hypromeilose, carmoisine (E 122).
Carmoisine may cause allergic reactions.
Packs of Solpadeine Pius Tablets contain 16 or 32 tablets.
The marketing authorisation holder is Omega Pharma Ltd., 32 Vauxhall Bridge Road, London, SW1V 2SA, United Kingdom and all enquiries should be sent to this address.
The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or Omega Pharma Manufacturing GmbH & Co. KG, 5
BenzstraGe 25, 71083, Herrenberg, Germany. S
This leaflet was last revised in February 2015. c
“E Last edit: 20th February 2015
Brand: Solpadeine
E Variant: PlusTabs32
E Component: Leaflet -E Market/s: UK
_= Dimensions: 140x210mm with 12t E Printer: TEA
“E Substrate: TEA _E EAN Code: N/A E PharmaCode: 486 “E Replacement number: TEA — Manufacturing Site: Herrenberg
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ph1i@one3gency.co +44(0)7710 521027 +44 (0)203 0086041
Marketing Approval:
Sign:............................................................................... Date:..
Name (please print):......................................................................
Contact email:..................................................................................
Regulatory Approval:
.
Contact email:..................................................................................