Patient leaflet - PARACETAMOL 120 MG / 5ML ORAL SUSPENSION
1. what paracetamol oral suspension is and what it is used for
Paracetamol belongs to a group of medicines called pain-killers or analgesics.
- It is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains and general aches and pains.
- It is also used to relieve the symptoms of cold and flu.
- It is also used to help reduce a fever (high temperature).
3
2. what you need to know before you take paracetamol oral suspension
Do not take Paracetamol:
- If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath
- If you have a liver disorder.
Speak to your doctor or pharmacist if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol if you have:
- kidney problems
- liver problems, including those due to drinking too much alcohol.
You may be more at risk of the side effects of paracetamol.
Speak to your doctor or pharmacist if any of these apply to you.
4
Other medicines and Paracetamol:
You must not take any other medicines that contain paracetamol while you are taking this medicine.
Tell your doctor if you are taking any of these medicines:
- barbiturates (sleeping tablets)
- tricyclic antidepressants (such as amitriptyline)
- colestyramine (used to treat high cholesterol)
- warfarin (used to thin the blood and prevent clotting)
- zidovudine (used in HIV infections and AIDS)
- domperidone and metoclopramide (used to treat nausea and vomiting)
- anticonvulsants (medicines used to treat epilepsy or fits)
- oral contraceptives “the pill”.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
5
Pregnancy and Breast-feeding:
If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or pharmacist before taking this medicine.
If necessary Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.
Driving and using machines:
This medicine should not affect your ability to drive or use machines.
Paracetamol Suspension contains methyl and propyl parahydroxybenzoate, sucrose, propylene glycol and sorbitol.
- Methyl and propyl parahydroxybenzoates – may cause allergic reactions (possibly delayed).
- Sucrose. Contains 3g of sucrose per 5ml spoonful. This should be taken into account if you have diabetes mellitus. If you have been told by your doctor 6 that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- Propylene glycol. This medicine contains 144.8mg propylene glycol per 5ml spoonful. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you are pregnant, breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
- Sorbitol. This medicine contains 680.5mg sorbitol per 5ml spoonful. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 7
3. How to take Paracetamol Oral Suspension
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.
Taking this medicine
Check the tables below to see how much medicine to use
- This medicine contains 120mg of paracetamol in one 5ml spoonful.
- Take this medicine by mouth only.
- Never give more medicine than shown in table.
- It is important to shake the bottle for at least 10 seconds before use.
- Always use the spoon supplied with the pack. Do not overfill the spoon.
- Do not give this medicine with any other paracetamol-containing product.
- Do not give to babies less than 2 months of age
- Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.
Child’s Age
How Much-Up to 4 times in 24 hours
3 – 6 months
One 2.5mL spoonful (small end)
6 – 24 months
One 5mL spoonful (large end)
2 – 4 years
One 5.0mL spoonful (large end) and one 2.5mL spoonful (small end)
| 4 – 8 years | Two 5mL spoonfuls (large end) |
| 8 – 10 years | Three 5mL spoonfuls (large end) |
| 10 – 12 years | Four 5mL spoonfuls (large end) |
| |
If your child is currently taking any medicine consult your doctor or pharmacist before taking this product. Do not exceed the stated dose. If symptoms persist see your doctor. Read the package leaflet before use.
Do not give this medicine with any other Paracetamol – containing product. Immediate medical advice should be sought in the event of an overdose, even if your child seems well.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK
How much to take
For the relief of fever after vaccination at 2, 3 and 4 months
One 2.5 mL spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
Age: 2 – 3 months Dose
Pain and other causes of fever - if your baby One 2.5mL spoonful (small end). If necessary,
weighs over 4 kg and was born after 37 weeks after 4–6 hours, give a second 2.5mL dose
- Do not give to babies less than 2 months of age Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. i--------------------------------------------------------
Child’s Age How Much
How often (in 24 hours)
| 3 – 6 months | One 2.5 mL spoonful (small end) | 4 times |
| 6 – 24 months | One 5 mL spoonful (large end) | 4 times |
| 2 – 4 years | One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end) | 4 times |
| 4 – 8 years | Two 5 mL spoonfuls (large end) | 4 times |
| 8 – 10 years | Three 5 mL spoonfuls (large end) | 4 times |
| 10 – 12 years | Four 5 mL spoonfuls (large end) | 4 times |
| ||
10
If you take more paracetamol than you should (overdose):
- Immediate medical advice should be sought in the event of an overdose, even if your child seems well, because of the risk of delayed, serious liver damage. Phone your doctor or go to your nearest accident and emergency department straight away.
- There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.
If you forget to take this medicine:
Take the next dose when needed. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
PAGE 1 52mm x 100mm
PAGE 9 52mm x 97mm
PAGE 10 52mm x 96mm
Like all medicines, paracetamol can cause side effects, although not everybody gets them. The side effects below may sometimes happen.
If you have an allergic reaction to this medicine see a doctor straight away. 11
An allergic reaction may include:
- skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever.
- sudden wheezing, fluttering or tightness of the chest or collapse.
If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible:
- bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder)
- severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation)
- very rare cases of serious skin reactions have been reported.
Tell your doctor if you get any of these side effects:
- Skin rash
If paracetamol is taken for a long time, it may lead to liver and kidney problems but if the right amount is taken over a short period of time there should be no problems.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paracetamol Oral Suspension
- Keep out of the sight and reach of children.
- Do not store above 25°C. Protect from light. Store in the original package.
- Do not use after the expiry date (month, year) on the label and carton.
The expiry date refers to the last day of that month.
- If it is out of date or you no longer want it, take it back to the pharmacy.
- Do not use Paracetamol Suspension if you notice anything wrong with the medicine. Talk to your pharmacist.
13
6. Contents of the pack and other information
What Paracetamol Suspension contains
The active substance is paracetamol.
The other ingredients are methyl and propyl parahydroxybenzoate (E218 and
E216), propylene glycol (E1520), xanthan gum (E415), liquid sorbitol (E420), sucrose, mango flavour and purified water.
What Paracetamol Suspension looks like and contents of the pack
1. what paracetamol oral suspension is and what it is used for
Paracetamol belongs to a group of medicines called pain-killers or analgesics.
- It is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains and general aches and pains.
- It is also used to relieve the symptoms of cold and flu.
- It is also used to help reduce a fever (high temperature).
3
2. what you need to know before you take paracetamol oral suspension
Do not take Paracetamol:
- If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath
- If you have a liver disorder.
Speak to your doctor or pharmacist if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol if you have:
- kidney problems
- liver problems, including those due to drinking too much alcohol.
You may be more at risk of the side effects of paracetamol.
Speak to your doctor or pharmacist if any of these apply to you.
4
Other medicines and Paracetamol:
You must not take any other medicines that contain paracetamol while you are taking this medicine.
Tell your doctor if you are taking any of these medicines:
- barbiturates (sleeping tablets)
- tricyclic antidepressants (such as amitriptyline)
- colestyramine (used to treat high cholesterol)
- warfarin (used to thin the blood and prevent clotting)
- zidovudine (used in HIV infections and AIDS)
- domperidone and metoclopramide (used to treat nausea and vomiting)
- anticonvulsants (medicines used to treat epilepsy or fits)
- oral contraceptives “the pill”.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
5
Pregnancy and Breast-feeding:
If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or pharmacist before taking this medicine.
If necessary Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.
Driving and using machines:
This medicine should not affect your ability to drive or use machines.
Paracetamol Suspension contains methyl and propyl parahydroxybenzoate, sucrose, propylene glycol and sorbitol.
- Methyl and propyl parahydroxybenzoates – may cause allergic reactions (possibly delayed).
- Sucrose. Contains 3g of sucrose per 5ml spoonful. This should be taken into account if you have diabetes mellitus. If you have been told by your doctor 6 that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- Propylene glycol. This medicine contains 144.8mg propylene glycol per 5ml spoonful. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you are pregnant, breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
- Sorbitol. This medicine contains 680.5mg sorbitol per 5ml spoonful. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 7
3. How to take Paracetamol Oral Suspension
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.
Taking this medicine
Check the tables below to see how much medicine to use
- This medicine contains 120mg of paracetamol in one 5ml spoonful.
- Take this medicine by mouth only.
- Never give more medicine than shown in table.
- It is important to shake the bottle for at least 10 seconds before use.
- Always use the spoon supplied with the pack. Do not overfill the spoon.
- Do not give this medicine with any other paracetamol-containing product.
- weighs over 4 kg and after 4–6 hours,.. ve
- Do not give to babies less than 2 months of age
- Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.
Child’s Age ]H~wMuch Up to 4 time' in 24 hours
Do not store above25"C. Protect from light. Store in the original package. Keep out of the sight and reach of children.
- PL 00427/0077.?
3 – t^onths One 2.5mL spoonful (small end)
6 – 24 months One 5mL spoonful (large end)
2 – 4 years One 5.0mL spoonful (large end) and one 2.5mL spoonful (small end)
PAGE 1 52mm x 100mm
| 4 – 8 years | Two 5mL spoonfuls (large end) |
| 8 – 10 years | Three 5mL spoonfuls (large end) |
| 10 – 12 years | Four 5mL spoonfuls (large end) |
| |
If your child is 'urrently taking any m'dicine consult your doctor or pharmacist before taking this product. Do not exceed the stated dose. If symptoms persist see your doctor. Read the package leaflet before use.
Do not give this medicine with any other Paracetamol – containing product. Immediate medical advice should be sought in the event of an overdose, even if your child seems well.
M.iu.ctured by the MA Holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK
How much to take
For the relief of fever after vaccination at 2, 3 and 4 months
One 2.5 mL spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
Age: 2 – 3 months Dose
Pain and other causes of fever - if your baby One 2.5mL spoonful (small end). If necessary,
weighs over 4 kg and was born after 37 weeks after 4–6 hours, give a second 2.5mL dose
- Do not give to babies less than 2 months of age Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. i--------------------------------------------------------
Child’s Age How Much
How often (in 24 hours)
| 3 – 6 months | One 2.5 mL spoonful (small end) | 4 times |
| 6 – 24 months | One 5 mL spoonful (large end) | 4 times |
| 2 – 4 years | One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end) | 4 times |
| 4 – 8 years | Two 5 mL spoonfuls (large end) | 4 times |
| 8 – 10 years | Three 5 mL spoonfuls (large end) | 4 times |
| 10 – 12 years | Four 5 mL spoonfuls (large end) | 4 times |
| ||
10
If you take more paracetamol than you should (overdose):
- Immediate medical advice should be sought in the event of an overdose, even if your child seems well, because of the risk of delayed, serious liver damage. Phone your doctor or go to your nearest accident and emergency department straight away.
- There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.
If you forget to take this medicine:
Take the next dose when needed. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
PAGE 9 52mm x 97mm
PAGE 10 52mm x 96mm
Like all medicines, paracetamol can cause side effects, although not everybody gets them. The side effects below may sometimes happen.
If you have an allergic reaction to this medicine see a doctor straight away. 11
An allergic reaction may include:
- skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever.
- sudden wheezing, fluttering or tightness of the chest or collapse.
If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible:
- bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder)
- severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation)
- very rare cases of serious skin reactions have been reported.
Tell your doctor if you get any of these side effects:
- Skin rash
If paracetamol is taken for a long time, it may lead to liver and kidney problems but if the right amount is taken over a short period of time there should be no problems.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paracetamol Oral Suspension
- Keep out of the sight and reach of children.
- Do not store above 25°C. Protect from light. Store in the original package.
- Do not use after the expiry date (month, year) on the label and carton.
The expiry date refers to the last day of that month.
- If it is out of date or you no longer want it, take it back to the pharmacy.
- Do not use Paracetamol Suspension if you notice anything wrong with the medicine. Talk to your pharmacist.
13
6. Contents of the pack and other information
What Paracetamol Suspension contains
The active substance is paracetamol.
The other ingredients are methyl and propyl parahydroxybenzoate (E218 and
E216), propylene glycol (E1520), xanthan gum (E415), liquid sorbitol (E420), sucrose, mango flavour and purified water.
What Paracetamol Suspension looks like and contents of the pack
Paracetamol Suspension is a white to off-white liquid which smells of mango.
It comes in a brown glass bottle holding 100ml or 500ml of suspension.
A 2.5ml/5ml double ended spoon is provided to measure the dose.
The Marketing Authorisation Holder and Manufacturer is:
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street,
Leeds, LS11 9XE, UK. Tel: + 44 (0) 113 244 1400
This leaflet was last revised in 09/2019. 14
PAGE 11 52mm x 95mm
PAGE 12 52mm x 95mm
PAGE 13 52mm x 96mm
PAGE 14 52mm x 95mm
500ml
Paracetamol 120mg/5ml Oral Suspension
| PARACETAMOL |
Each 5ml contains 120mg Paracetamol. E218, E216, E1520, E420 and sucrose.
Manufactured by the
MA Holder: Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK
PL 00427/0077
For pain relief and fever
Do not store above 25"C. Protect from light. Store in the original package.
Keep out of the sight and reach of children.
Administration: For oral use only.
Shake the bottle for at least 10 seconds before use. Always use the spoon supplied with the pack. Do not overfill the spoon. Never give more medicine than shown in the tables.
Child’s Age How Much-Up to 4 times in 24 hours
3 – 6 months
6 – 24 months
2 – 4 years
For the relief of fever after vaccination at 2, 3 and 4 months. See the leaflet in the box.
Age: 2 – 3 months Dose
Pain and other causes of fever – if your baby weighs over 4 kg and was born after 37 weeks
One 2.5mL spoonful (small end). If necessary, after 4–6 hours, give a second 2.5mL dose
- Do not give to babies less than 2 months of age
- Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.
4 – 8 years
8 – 10 years
10 – 12 years
One 2.5mL spoonful (small end) One 5mL spoonful (large end)
One 5.0mL spoonful (large end) and one 2.5mL spoonful (small end) Two 5mL spoonfuls (large end) Three 5mL spoonfuls (large end) Four 5mL spoonfuls (large end)
- Do not give more than 4 doses in any 24 hour period
- Leave at least 4 hours between doses
- Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist
If your child is currently taking any medicine consult your doctor or pharmacist before taking this product. Do not exceed the stated dose. If symptoms persist see your doctor. Read the package leaflet before use.
Do not give this medicine with any other Paracetamol – containing product Immediate medical advice should be sought in the event of an overdose, even if your child seems well.
C7U77RBF2
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PAGE 8
52mm x 95mm
52mm x 96mm
52mm x 95mm
52mm x 95mm
52mm x 96mm
52mm x 97mm
52mm x 100mm
| ..............
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| PAGE 1 | PAGE 9 | PAGE 10 | PAGE 11 | PAGE 12 | PAGE 13 | PAGE 14 |
| 52mm x 100mm | 52mm x 97mm | 52mm x 96mm | 52mm x 95mm | 52mm x 95mm | 52mm x 96mm | 52mm x 95mm |
<1> "co c E 03
BRAILLE TRANSLATION
paracetamol #120 mg/#5 ml oral suspension
Rosemant^^ Patient Information Leaflet
Paracetamol 120mg/5ml Oral Suspension
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse.
2
What is in this leaflet
-
1. What Paracetamol Oral Suspension is and what it is used for
-
2. What you need to know before you take Paracetamol Oral Suspension
-
3. How to take Paracetamol Oral Suspension
-
4. Possible side effects
-
5. How to store Paracetamol Oral Suspension
-
6. Contents of the pack and other information
1. what paracetamol oral suspension is and what it is used for
Paracetamol belongs to a group of medicines called pain-killers or analgesics.
- It is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains and general aches and pains.
- It is also used to relieve the symptoms of cold and flu.
- It is also used to help reduce a fever (high temperature).
3
2. what you need to know before you take paracetamol oral suspension
Do not take Paracetamol:
- If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath
- If you have a liver disorder.
Speak to your doctor or pharmacist if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol if you have:
- kidney problems
- liver problems, including those due to drinking too much alcohol.
You may be more at risk of the side effects of paracetamol.
Speak to your doctor or pharmacist if any of these apply to you.
4
Other medicines and Paracetamol:
You must not take any other medicines that contain paracetamol while you are taking this medicine.
Tell your doctor if you are taking any of these medicines:
- barbiturates (sleeping tablets)
- tricyclic antidepressants (such as amitriptyline)
- colestyramine (used to treat high cholesterol)
- warfarin (used to thin the blood and prevent clotting)
- zidovudine (used in HIV infections and AIDS)
- domperidone and metoclopramide (used to treat nausea and vomiting)
- anticonvulsants (medicines used to treat epilepsy or fits)
- oral contraceptives “the pill”.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
5
Pregnancy and Breast-feeding:
If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or pharmacist before taking this medicine.
If necessary Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.
Driving and using machines:
This medicine should not affect your ability to drive or use machines.
Paracetamol Suspension contains methyl and propyl parahydroxybenzoate, sucrose, propylene glycol and sorbitol.
- Methyl and propyl parahydroxybenzoates – may cause allergic reactions (possibly delayed).
- Sucrose. Contains 3g of sucrose per 5ml spoonful. This should be taken into account if you have diabetes mellitus. If you have been told by your doctor 6 that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- Propylene glycol. This medicine contains 144.8mg propylene glycol per 5ml spoonful. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you are pregnant, breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
- Sorbitol. This medicine contains 680.5mg sorbitol per 5ml spoonful. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 7
3. How to take Paracetamol Oral Suspension
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.
Taking this medicine
Check the tables below to see how much medicine to use
- This medicine contains 120mg of paracetamol in one 5ml spoonful.
- Take this medicine by mouth only.
- Never give more medicine than shown in table.
- It is important to shake the bottle for at least 10 seconds before use.
- Always use the spoon supplied with the pack. Do not overfill the spoon.
- Do not give this medicine with any other paracetamol-containing product.
- weighs over 4 kg and after 4–6 hours,.. ve
- Do not give to babies less than 2 months of age
- Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.
Child’s Age ]H~wMuch Up to 4 time' in 24 hours
Do not store above25"C. Protect from light. Store in the original package. Keep out of the sight and reach of children.
- PL 00427/0077.?
3 – t^onths One 2.5mL spoonful (small end)
6 – 24 months One 5mL spoonful (large end)
2 – 4 years One 5.0mL spoonful (large end) and one 2.5mL spoonful (small end)
PAGE 1 52mm x 100mm
| 4 – 8 years | Two 5mL spoonfuls (large end) |
| 8 – 10 years | Three 5mL spoonfuls (large end) |
| 10 – 12 years | Four 5mL spoonfuls (large end) |
| |
If your child is 'urrently taking any m'dicine consult your doctor or pharmacist before taking this product. Do not exceed the stated dose. If symptoms persist see your doctor. Read the package leaflet before use.
Do not give this medicine with any other Paracetamol – containing product. Immediate medical advice should be sought in the event of an overdose, even if your child seems well.
M.iu.ctured by the MA Holder:
Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK
How much to take
For the relief of fever after vaccination at 2, 3 and 4 months
One 2.5 mL spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
Age: 2 – 3 months Dose
Pain and other causes of fever - if your baby One 2.5mL spoonful (small end). If necessary,
weighs over 4 kg and was born after 37 weeks after 4–6 hours, give a second 2.5mL dose
- Do not give to babies less than 2 months of age Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist. i--------------------------------------------------------
Child’s Age How Much
How often (in 24 hours)
| 3 – 6 months | One 2.5 mL spoonful (small end) | 4 times |
| 6 – 24 months | One 5 mL spoonful (large end) | 4 times |
| 2 – 4 years | One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end) | 4 times |
| 4 – 8 years | Two 5 mL spoonfuls (large end) | 4 times |
| 8 – 10 years | Three 5 mL spoonfuls (large end) | 4 times |
| 10 – 12 years | Four 5 mL spoonfuls (large end) | 4 times |
| ||
10
If you take more paracetamol than you should (overdose):
- Immediate medical advice should be sought in the event of an overdose, even if your child seems well, because of the risk of delayed, serious liver damage. Phone your doctor or go to your nearest accident and emergency department straight away.
- There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.
If you forget to take this medicine:
Take the next dose when needed. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
PAGE 9 52mm x 97mm
PAGE 10 52mm x 96mm
Like all medicines, paracetamol can cause side effects, although not everybody gets them. The side effects below may sometimes happen.
If you have an allergic reaction to this medicine see a doctor straight away. 11
An allergic reaction may include:
- skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever.
- sudden wheezing, fluttering or tightness of the chest or collapse.
If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible:
- bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder)
- severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation)
- very rare cases of serious skin reactions have been reported.
Tell your doctor if you get any of these side effects:
- Skin rash
If paracetamol is taken for a long time, it may lead to liver and kidney problems but if the right amount is taken over a short period of time there should be no problems.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paracetamol Oral Suspension
- Keep out of the sight and reach of children.
- Do not store above 25°C. Protect from light. Store in the original package.
- Do not use after the expiry date (month, year) on the label and carton.
The expiry date refers to the last day of that month.
- If it is out of date or you no longer want it, take it back to the pharmacy.
- Do not use Paracetamol Suspension if you notice anything wrong with the medicine. Talk to your pharmacist.
13
6. Contents of the pack and other information
What Paracetamol Suspension contains
The active substance is paracetamol.
The other ingredients are methyl and propyl parahydroxybenzoate (E218 and
E216), propylene glycol (E1520), xanthan gum (E415), liquid sorbitol (E420), sucrose, mango flavour and purified water.
What Paracetamol Suspension looks like and contents of the pack
Paracetamol Suspension is a white to off-white liquid which smells of mango.
It comes in a brown glass bottle holding 100ml or 500ml of suspension.
A 2.5ml/5ml double ended spoon is provided to measure the dose.
The Marketing Authorisation Holder and Manufacturer is:
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street,
Leeds, LS11 9XE, UK. Tel: + 44 (0) 113 244 1400
This leaflet was last revised in 09/2019. 14
PAGE 11 52mm x 95mm
PAGE 12 52mm x 95mm
PAGE 13 52mm x 96mm
PAGE 14 52mm x 95mm
500ml
Paracetamol 120mg/5ml Oral Suspension
| PARACETAMOL |
Each 5ml contains 120mg Paracetamol. E218, E216, E1520, E420 and sucrose.
Manufactured by the MA Holder: Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK
PL 00427/0077
For pain relief and fever
Do not store above 25"C. Protect from light. Store in the original package.
Keep out of the sight and reach of children.
Administration: For oral use only.
Shake the bottle for at least 10 seconds before use. Always use the spoon supplied with the pack. Do not overfill the spoon. Never give more medicine than shown in the tables.
Child’s Age How Much-Up to 4 times in 24 hours
3 – 6 months
6 – 24 months
2 – 4 years
For the relief of fever after vaccination at 2, 3 and 4 months. See the leaflet in the box.
Age: 2 – 3 months Dose
Pain and other causes of fever – if your baby weighs over 4 kg and was born after 37 weeks
One 2.5mL spoonful (small end). If necessary, after 4–6 hours, give a second 2.5mL dose
- Do not give to babies less than 2 months of age
- Leave at least 4 hours between doses
- Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.
4 – 8 years
8 – 10 years
10 – 12 years
One 2.5mL spoonful (small end) One 5mL spoonful (large end)
One 5.0mL spoonful (large end) and one 2.5mL spoonful (small end) Two 5mL spoonfuls (large end) Three 5mL spoonfuls (large end) Four 5mL spoonfuls (large end)
- Do not give more than 4 doses in any 24 hour period
- Leave at least 4 hours between doses
- Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist
If your child is currently taking any medicine consult your doctor or pharmacist before taking this product. Do not exceed the stated dose. If symptoms persist see your doctor. Read the package leaflet before use.
Do not give this medicine with any other Paracetamol – containing product Immediate medical advice should be sought in the event of an overdose, even if your child seems well.
C7U77RBF2
BRAILLE TRANSLATION
paracetamol #120 mg/#5 ml oral suspension
BASE PAGE
52mm x 144mm