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PARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE 1000 MG/12.2 MG POWDER FOR ORAL SOLUTION

Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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Sandoz Ltd

Page 1

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

11/08/2014

Package leaflet: Information for the patient
Paracetamol/Phenylephrine Hydrochloride 500 mg/12.2 mg Powder for Oral Solution
Paracetamol/Phenylephrine Hydrochloride 1000 mg/12.2 mg Powder for Oral Solution

paracetamol / phenylephrine hydrochloride

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 after 3 days

What is in this leaflet
1.
What Paracetamol/Phenylephrine is and what it is used for
2.
What you need to know before you take Paracetamol/Phenylephrine
3.
How to take Paracetamol/Phenylephrine
4.
Possible side effects
5.
How to store Paracetamol/Phenylephrine
6.
Contents of the pack and other information

1.

What Paracetamol/Phenylephrine is and what it is used for

Paracetamol/Phenylephrine contains paracetamol, an analgesic which relieves aches and
reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose.
Paracetamol/Phenylephrine is used for the relief of the symptoms of colds and influenza,
including the relief of pain, headache, nasal congestion and lowering of temperature at adults
and adolescents over 16 years of age who weigh more than 50 kg.
Use Paracetamol/Phenylephrine only if you have colds and influenza accompanied by stuffy
nose. If you do not have stuffy nose, monocomponent products containing only paracetamol
should be preferred.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

PIL. 1391-2.001d

Licence Application

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Sandoz Ltd

Page 2

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

2.

11/08/2014

What you need to know before you take Paracetamol/Phenylephrine

Do not take Paracetamol/Phenylephrine:
 if you are allergic to paracetamol and phenylephrine hydrochloride or any of the other
ingredients of this medicine (listed in section 6).
 if you have severe coronary heart disease (a condition associated with impaired
function of the heart)
 if you have high blood pressure
 if you have glaucoma (a disorder of the eyes often associated with increased pressure of
the fluid in the eye)
 if your thyroid gland is overactive (hyperthyroidism)
 if you are taking monoamine oxidase inhibitors or if you are taking tricyclic
antidepressants (for depression) or have taken them within the last 14 days





if you suffer from severe liver disease (severe hepatic insufficiency)

if you suffer from acute inflammation of the liver (acute hepatitis).
if you suffer from alcohol abuse

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol/Phenylephrine
 if you have Raynaud’s Phenomenon, a condition caused by poor blood-circulation in the
fingers and toes.
 if you have Diabetes mellitus, a condition associated with high levels of blood-sugar.
 if you suffer from moderate and severe renal insufficiency.
 if you suffer from liver function disorders:
 mild to moderate hepatocellular insufficiency (including Gilbert’s syndrome), severe
hepatic insufficiency (Child-Pugh >9), acute hepatitis and concomitant treatment with
medicinal products affecting hepatic functions.
 if you suffer from haemolytic anaemia (a reduction in red blood cells which can make the
skin pale yellow and cause weakness or breathlessness).
 if you suffer from dehydration.
 alcohol abuse
 if you suffer from chronic malnutrition.
 if you suffer from glutathione depletion due to metabolic deficiencies.
 if you have asthma and are hypersensitive to acetylsalicylicacid (for pain relief or for
blood-dilution). You may also be hypersensitive to .
 If you have an enlarged prostate
 If you have a tumour on the adrenal gland (called phaechromocytoma)
Important:
This product contains Paracetamol. Do not take with any other paracetamol-containing
products. Never take more Paracetamol/Phenylehrine than recommended. Higher doses than
those recommended do not increase the pain-relieving effect, but may cause very serious liver
damage. The symptoms of liver damage normally do not appear until after a few days. After

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Sandoz Ltd

Page 3

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

11/08/2014

an overdose, it is therefore very important to seek medical advice as soon as possible, even if
you feel well. Do not take with any other flu, cold or decongestant products.

Children and adolescents
Paracetamol/Phenylephrine is indicated for adults and children over 16 years of age who
weigh more than 50 kg.

Other medicines and Paracetamol/Phenylephrine
Do not use Paracetamol/Phenylephrine if you are taking monoamine oxidase inhibitors (MAO
inhibitors, such as moclobemide or tranylcypromin) or tricyclic antidepressants (such as
amitriptyline, amoxapine, clomipramine, desipramine and doxepine), used for treatment of
depression, or have taken them within the last 14 days.

As both of the active substances of Paracetamol/Phenylephrine, phenylephrine hydrochloride
and paracetamol, may adversely interact with other medicines, please make sure that you tell
your doctor or pharmacist about all other medicines you might be using at the same time,
especially:
 drugs, which may interfere with phenylephrine as medicines used for the treatment of high
blood pressure, heart or circulatory problems as
- sympathomimetics, including nasal or eye decongestant products
- vasodilators
- alpha- and beta-blockers and other antihypertensives (e.g. guanethidine)
 drugs, which may potentiate the effect of phenylephrine on the blood vessels, as
- digoxin (for heart diseases)
- tetracyclics (for depression) such as maprotiline
- antidepressants such as phenelzine, isocarboxylic acid, nialamide
- Parkinson's disease drugs such as selegiline
- furazolidone (for bacterial infections)
 drugs, which may interfere with the liver-metabolism of the active substances of
Paracetamol/Phenylephrine and may increase the toxic effects of paracetamol on the liver,
as
- alcohol
- barbiturates (sedatives),
- anticonvulsants (for epilepsy) such as phenytoin, phenobarbital, methylphenobarbital
and primidone
- rifampicin (for tuberculosis)
- probenecid (for gout)
 drugs, which have an influence of the availability of paracetamol in the body, as
- anticholinergic drugs (e.g. glycopyrronium, propantheline)
- metoclopramide or domperidone (for feeling sick or being sick)

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Sandoz Ltd

Page 4

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution





11/08/2014

- cholestyramine (to reduce blood fat levels)
- isoniazide (for tuberculosis)
- propranolol (for high blood pressure)
warfarin and other coumarins (blood thinners), as their anticoagulant effect may be
enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding;
occasional doses of Paracetamol/Phenylephrine have no significant effect.
regular use of paracetamol may increase the toxic effects of zidovudine (AZT) (for
treatment for HIV)
the duration of action of chloramphenicol may be prolonged by paracetamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Paracetamol/Phenylephrine with food, drink and alcohol
Do not drink alcohol (e.g. wine, beer, spirits) whilst taking .
The effect of alcohol will not be enhanced by the addition of paracetamol, but alcohol may
increase the toxic effects of paracetamol on your liver.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Paracetamol/Phenylephrine is not recommended during pregnancy and breastfeeding.
Driving and using machines
There have been no reports on negative influence of Paracetamol/Phenylephrine on the ability
to drive and to use machines up to date.
Paracetamol/Phenylephrine contains sucrose, aspartame, sorbitol, carbohydrates
This medicine contains aspartame (E951) which is a source of phenylalanine. May be harmful
for people with phenylketonuria (a hereditary metabolic-disorder).
The medicine contains sorbitol (E420) and sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
For 500 mg/12.2 mg:
Each sachet contains 1.8 g of sucrose. This should be taken into account in patients with
diabetes mellitus.
For 1000 mg/12.2 mg:
Each sachet contains 3.9 g of sucrose. This should be taken into account in patients with
diabetes mellitus.

PIL. 1391-2.001d

Licence Application

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Sandoz Ltd

Page 5

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

3.

11/08/2014

How to take Paracetamol/Phenylephrine

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
have told you. Check with your pharmacist if you are not sure.
The recommended dose is:
Age
Adults and children over 16
years of age

How many
One sachet

Adults and children over 16
years of age who weigh more
than 50 kg

How often
The dose may be repeated in
4 to 6 hours.
Do not take more than 4
sachets in 24 hours.

Please observe that higher doses than those recommended may result in a risk of very serious
liver damage.
Method of administration
Oral administration after dissolution in water.
For 500 mg/12.2 mg:
Dissolve the contents of the sachet in a small cup (125 ml) of hot, but not boiling, water. Stir
shortly until dissolved and drink the lemon-flavoured and coulorless solution.
For 1000 mg/12.2 mg:
Dissolve the contents of the sachet in a mug (250 ml) of hot, but not boiling, water. Stir
shortly until dissolved and drink the lemon-flavoured and coulorless solution.
Use in children and adolescents
Paracetamol/Phenylephrine is not recommended for use in children and adolescents below 16
years of age.
Older people
There is no indication that the dosage needs to be modified in the elderly.
If symptoms persist for more than 3 days or worsen, consult your doctor.
If you take more Paracetamol/Phenylephrine than you should
If you or someone else took too much of Paracetamol/Phenylephrine, or if you think a child
has swallowed any of content of the sachets, contact your nearest hospital casualty department

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Licence Application

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Sandoz Ltd

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Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

11/08/2014

or your doctor immediately, even if you/the other person feel/feels well, because of the risk of
delayed, serious liver damage. Please take this leaflet, any remaining sachets and the container
with you to the hospital or doctor so that they know which medicinal product was consumed.
If you forget to take Paracetamol/Phenylephrine
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most people will not have problems, but some may get some.
The following summary includes side effects of paracetamol and phenylephrine.

Paracetamol
In therapeutic doses, the undesirable effects of paracetamol occur rarely and with mild clinical
course.
Rare (may affect up to 1 in 1,000 people):
 blood disorders which may be seen as unexplained bruising, paleness or poor resistance to
infections:
- Blood dyscrasias including platelet disorders, reduction of specific blood-cells
(agranulocytosis, leucopenia, thrombocytopenia), haemolytic anaemia, pancytopenia.






abnormal hepatic function (increase in hepatic transaminases)
hepatic failure
hepatic necrosis
jaundice (yellowing of the skin or eyes)
bronchospasm (difficulty in breathing or wheezing)

 hypersensitivity including skin rash and urticaria, pruritus, sweating, purpura (small
bleedings underneath the skin), angioedema (sudden swelling of the skin an mucous
membrane)
 allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis (serious
allergic reaction which causes difficulty in breathing or dizziness).
Very rare (may affect up to 1 in 10,000 people):

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Licence Application

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Sandoz Ltd

Page 7

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

11/08/2014

 after prolonged use of high doses of paracetamol sterile pyuria (urine which contains white
blood cells, cloudy urine) and renal side effects may develop
 acute pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen
or back)
Very rare cases of serious skin reactions have been reported.
Phenylephrine
Common (may affect up to 1 in 10 people):
 loss of appetite
 nausea and vomiting
Rare (may affect up to 1 in 1,000 people):





tachycardia (faster heart beat)
palpitation (feeling your heartbeat)
blood pressure increase
allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis (serious
allergic reaction which causes difficulty in breathing or dizziness) and bronchospasm
(difficulty in breathing or wheezing)

Very rare (may affect up to 1 in 10,000 people):










insomnia (difficulty in sleeping)
nervousness
tremor (shaking)
anxiety
restlessness
confusion
irritability
dizziness
headache

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: 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/Phenylephrine

Keep this medicine out of the sight and reach of children

PIL. 1391-2.001d

Licence Application

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Sandoz Ltd

Page 8

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

11/08/2014

Do not use this medicine after the expiry date which is stated on the carton and sachet. The
expiry date refers to the last day of that month.
Store in the original container in order to protect from light and moisture.

This medicinal product does not require any special temperature storage conditions
Shelf life after reconstitution:
Reconstituted solution in hot water: 1 hour

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.

Content of the pack and other information

What Paracetamol/Phenylephrine contains
-

-

The active substances are: Paracetamol 500 mg and Phenylephrine hydrochloride 12.2
mg (equivalent to phenylephrine base 10.0 mg)
The active substances are Paracetamol 1000 mg and Phenylephrine hydrochloride 12.2
mg (equivalent to phenylephrine base 10.0 mg)
The other ingredients are: ascorbic acid, sucrose, aspartame (E951), lemon flavour
(containing: natural lemon oils and nature identical flavouring substances, maltodextrin,
mannitol (E421), gluconolactone, acacia gum, sorbitol (E420) , silica colloidal
anhydrous, and α – tocopherol (E307)), saccharin sodium, silica colloidal anhydrous,
citric acid, and sodium citrate.

What Paracetamol/Phenylephrine looks like and contents of the pack
Paracetamol/Phenylephrine is a free flowing, white powder with lemon odour which is packed
in laminated aluminium paper foil sachets in a carton box.

500 mg/12.2 mg:
Pack-sizes: 6, 10, 20 sachets.

PIL. 1391-2.001d

Licence Application

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Sandoz Ltd

Page 9

Paracetamol/Phenylephrine Hydrochloride 500
mg/12.2 mg &1000 mg/12.2 mg Powder for Oral
Solution

11/08/2014

1000 mg/12.2 mg:
10 sachets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR
United Kingdom
Manufacturer
Hermes Pharma Ges.m.b.H
Allgäu 36, 9400 Wolfsberg
Austria
Or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben
Germany
This leaflet was last revised in August 2014

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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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