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PARACETAMOL KAPPLER HOT DRINK 600 MG POWDER FOR ORAL SOLUTION

Active substance(s): PARACETAMOL

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Package leaflet: Information for the user
Paracetamol Hot drink 600 mg powder for oral solution
Paracetamol

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, pharmacist or nurse. 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 after 3 days.
What is in this leaflet
1. What Paracetamol Hot drink 600 mg powder for oral solution is and what it is used for
2. What you need to know before you take Paracetamol Hot drink 600 mg powder for oral
solution
3. How to take Paracetamol Hot drink 600 mg powder for oral solution
4. Possible side effects
5. How to store Paracetamol Hot drink 600 mg powder for oral solution
6. Contents of the pack and other information

1. What Paracetamol Hot drink 600 mg powder for oral solution is and what it is used
for
Paracetamol Hot drink 600 mg powder for oral solution is a medicine used for relief of
symptoms of influenza and feverish colds (incl. headache, aches and pains) menstrual pain
and toothache.
For children aged 12 years or older, adolescents and adults.

2. What you need to know before you take Paracetamol Hot drink 600 mg powder for
oral solution
DO NOT take Paracetamol Hot drink 600 mg powder for oral solution
 if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in
section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Hot drink 600 mg powder for
oral solution if you:
 suffer from chronic alcoholism
 suffer from impaired liver function (liver inflammation, Gilbert’s syndrome)
 have existing kidney damage
 are using other medicines that are known to affect the liver
 have a deficiency of a certain enzyme called glucose-6-phosphatedehydrogenase
 have haemolytic anaemia (abnormal breakdown of red blood cells)
 suffer from reduced glutathione levels

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 are dehydrated or have impaired nutritional state e.g. caused by alcohol abuse, anorexia
or wrong nutrition
You must contact a doctor if your symptoms worsen or do not improve after 3 days, or
if you develop a high fever.
To avoid the risk of overdosing, it should be ensured that medicines taken at the same time
as Paracetamol Hot drink 600 mg powder for oral solution do not contain paracetamol.
Prolonged use
You should not use Paracetamol Hot drink 600 mg powder for oral solution over prolonged
periods or at high doses without the advice of a doctor or dentist.
During prolonged, improper use of high-dose painkillers, headache can occur, which must
not be treated by increased doses of the medicine.
In general, habitual use of painkillers may lead to permanent kidney damage with the risk of
kidney failure (analgesic nephropathy), particularly if several painkilling drugs are combined.
Other medicines and Paracetamol Hot drink 600 mg powder for oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Interactions are possible with:
 probenecid, a drug used in gout: If taken at the same time, the dose of Paracetamol Hot
drink 600 mg powder for oral solution should be lowered, as there may be a delay in the
breakdown of paracetamol, the active substance in Paracetamol Hot drink 600 mg powder
for oral solution
 phenobarbital (sleeping medication), phenytoin and carbamazepine (used in epilepsy),
rifampicin (used in tuberculosis), as well as other drugs that can damage the liver. There
is a greater risk of liver damage if Paracetamol Hot drink 600 mg powder for oral solution
is taken at the same time
 metoclopramide and domperidone (used to treat nausea) can speed up the absorption
and onset of action of paracetamol
 colestyramine (used to lower high blood fat levels) can reduce absorption of paracetamol,
thereby making it less effective
 medicines that slow down gastric emptying, e.g. propantheline, can delay the absorption
and onset of action of paracetamol
 zidovudine (used to treat HIV infections) - susceptibility to neutropenia (reduced number
of white blood cells) is increased. Medical advice is therefore needed before taking
Paracetamol Hot drink 600 mg powder for oral solution at the same time as zidovudine
 medicines used to thin the blood such as warfarin and other coumarins. The effect of
blood thinning drugs may be increased by regular use of Paracetamol Hot drink 600 mg
powder for oral solution over a longer period.
Effects of taking Paracetamol Hot drink 600 mg powder for oral solution on laboratory tests
Tests to determine uric acid and blood sugar levels may be affected.
Please remember that this information may also apply to recently used medications (which
may still be in your body).
Paracetamol Hot drink 600 mg powder for oral solution with alcohol
Paracetamol Hot drink 600 mg powder for oral solution must not be taken at the same time
as alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
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baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Paracetamol Hot drink 600 mg powder for oral solution 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.
Breast-feeding
Paracetamol passes into breast milk. It is not known to affect the baby adversely, so
discontinuation of breast-feeding is generally not required during short-term use.
Driving and using machines
Paracetamol Hot drink 600 mg powder for oral solution has no effect on the ability to drive
and use machines. However, caution is always advised after taking any painkillers.
Paracetamol Hot drink 600 mg powder for oral solution contains sucrose and
aspartame
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
Contains 3.8 g sucrose (sugar) per sachet. This should be taken into account in patients with
diabetes mellitus.
Contains aspartame as a source of phenylalanine and may be harmful if you have
phenylketonuria.

3. How to take Paracetamol Hot drink 600 mg powder for oral solution
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
Unless otherwise prescribed by the doctor, the recommended dose is 1 sachet (600 mg
paracetamol) taken as a single dose; maximum of 4 doses in 24 hours with at least 6 hours
between doses.
Do not exceed the stated dose - a single dose of 1 sachet at a time may not be
exceeded.
If other medicines containing paracetamol are taken at the same time, make sure that this
won't exceed the maximum recommended daily dose of paracetamol. Please ask your doctor
or pharmacist if the medicines you are taking contain the active ingredient paracetamol.
He/she will inform you about the dosing and the best time to take such medicines while you
are taking Paracetamol Hot drink 600 mg powder for oral solution.
Patients with liver impairment and mild kidney impairment
Dose must be reduced by prolongation of dosing interval in patients with impaired liver or
kidney function and Gilbert's syndrome.
Patients with severe kidney dysfunction
In cases of severe kidney dysfunction (creatinine clearance < 10 ml/min), there must be an
interval of at least 8 hours between each dose.
Older people
No specific dose adjustment is required.

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Use in adults with a low body weight
Paracetamol Hot drink 600 mg powder for oral solution must not be used in patients weighing
less than 40 kg as the dosage strength is not suitable for these patients. More appropriate
dosage strengths and/or formulations of paracetamol (e.g. syrup or suppositories) are
available for this patient group.
Use in children and adolescents
Paracetamol Hot drink 600 mg powder for oral solution must not be used in children under 12
years of age. More appropriate dosage strengths and/or formulations of paracetamol (e.g.
syrup or suppositories) are available for this patient group.
Method of administration
First, bring water to boil and let cool for about 10 minutes.
Empty the content of one sachet into a cup, top with the hot water and stir well. A slightly
cloudy, colourless to light yellowish solution will be obtained.
Drink after sufficient cooling down to a drinkable temperature.
Dosing after meals may lead to a delayed onset of action.
Duration of treatment
Do not take Paracetamol Hot drink 600 mg powder for oral solution for more than 3 days
without the advice of a doctor or dentist. A doctor should be consulted if symptoms persist for
more than 3 days.
If you take more Paracetamol Hot drink 600 mg powder for oral solution than you
should
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. In treating an overdose, the
doctor will be guided by the symptoms and will take all appropriate courses of action.
In the event of overdose with Paracetamol Hot drink 600 mg powder for oral solution, the
following symptoms can occur:
 nausea
 vomiting
 loss of appetite
 paleness
 stomach ache
 sweating
 drowsiness
 malaise (general feeling of being unwell)
Liver damage and even hepatic coma, heart muscle damage and pancreatitis can occur in
the event of severe overdose.
If you forget to take Paracetamol Hot drink 600 mg powder for oral solution
Do not take a double dose to make up for a forgotten dose.
If you stop taking Paracetamol Hot drink 600 mg powder for oral solution
If Paracetamol Hot drink 600 mg powder for oral solution has been used correctly, there are
no special considerations.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):
 slight increase in liver enzymes (serum transaminases)
Very rare (may affect up to 1 in 10,000 people):
 changes in the blood count such as reduction in blood platelets (thrombocytopenia) or a
pronounced reduction in certain white blood cells (agranulocytosis)
 allergic reactions, from simple skin rash or nettle rash (urticaria) to a shock reaction
 airway constriction (analgesic-induced asthma) can be triggered in sensitive patients
 very rare cases of serious skin reactions have been reported
In the event of an allergic shock reaction, seek immediate help from the nearest available
doctor.
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.

5. How to store Paracetamol Hot drink 600 mg powder for oral solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and sachet
after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Paracetamol Hot drink 600 mg powder for oral solution contains
The active substance is paracetamol.
Each sachet contains 600 mg paracetamol.
The other ingredients are:
ascorbic acid, aspartame (E951), anhydrous citric acid (Ph. Eur.), ethylcellulose, colloidal
anhydrous silica, sucrose, lemon flavouring (consisting of citral, citronella oil, coriander seed
oil, gum arabic and lime oil distilled).

What Paracetamol Hot drink 600 mg powder for oral solution looks like and contents
of the pack
Powder for oral solution in sachet, and is white to slightly yellow with the smell of lemon.
Paracetamol Hot drink 600 mg powder for oral solution is available in packs of 5 and 10
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sachets.

Marketing Authorisation Holder and Manufacturer
Kappler Pharma Consult GmbH
Fonyoder Str. 18
Leipheim
89340
Germany
This medicinal product is authorised in the Member States of the EEA under the
following names:
UK: Paracetamol Hot drink 600 mg powder for oral solution
CZ: Paracetamol Kappler
IE: Paracetamol Kappler 600 mg powder for oral solution in sachet
SK: Paracetamol Kappler Horúci nápoj 600 mg prášok na perorálny roztok

This leaflet was last revised in August 2017.

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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