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RATIOPHARM COLD & FLU LEMON FLAVOUR 500MG/12.2MG POWDER FOR ORAL SOLUTION

Active substance(s): PARACETAMOL / PHENYLEPHRINE

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Package leaflet: Information for the patient
ratiopharm Cold & Flu Lemon Flavour 500mg/12.2mg 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.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, or pharmacist.
This
medicine
has
been
prescribed
for
you
only.
Do not pass it on to others. It may harm them, even if their signs of illness are the same as
yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
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.
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 ratiopharm Cold & Flu Lemon Flavour is and what it is used for
2.
What you need to know before you take ratiopharm Cold & Flu Lemon Flavour
3.
How to take ratiopharm Cold & Flu Lemon Flavour
4.
Possible side effects
5.
How to store ratiopharm Cold & Flu Lemon Flavour
6.
Contents of the pack and other information

1.

What ratiopharm Cold & Flu Lemon Flavour is and what ist is used for

ratiopharm Cold & Flu Lemon Flavour contains paracetamol, an analgesic which relieves aches and
reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose.
ratiopharm Cold & Flu Lemon Flavour is used for the relief of the symptoms of colds and influenza,
including the relief of aches , headache, nasal congestion and lowering of temperature.
Use ratiopharm Cold & Flu Lemon Flavour only if you have colds and flu accompanied by stuffy
nose. If you do not have stuffy nose, monocomponent products containing only paracetamol should be
preferred.

2.

What you need to know before you take ratiopharm Cold & Flu Lemon Flavour

Do not take ratiopharm Cold & Flu Lemon Flavour:

-

-

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 before taking ratiopharm Cold & Flu Lemon Flavour
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), 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.
if you suffer from chronic malnutrition.
if you suffer from glutathione depletion due to metabolic deficiencies.
if your prostate is enlarged
if you suffer from a neuroendocrine tumor of the medulla of the adrenal glands
(pheochromocytoma)
if you have asthma and are hypersensitive to acetylsalicylicacid (for pain relief or for blooddilution). You may also be hypersensitive to Paracetamol/Phenylephrine.
Important:
This product contains Paracetamol. Do not take with any other paracetamol-containing products.
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. Do not take with any other flu, cold or decongestant
products.

Children and adolescents
ratiopharm Cold & Flu Lemon Flavour is indicated for adults and children over 16 years of age.

Other medicines and ratiopharm Cold & Flu Lemon Flavour
Do not use ratiopharm Cold & Flu Lemon Flavour 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.
Do not combine decongestant nose drops, containing phenylephrine and ephedrine or other
sympathomimetics with ratiopharm Cold & Flu Lemon Flavour.

As both of the active substances of ratiopharm Cold & Flu Lemon Flavour, 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
- vasodilators
- beta-blockers and other antihypertensives
- 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 ratiopharm Cold
& Flu Lemon Flavour 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)
- 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
ratiopharm Cold & Flu Lemon Flavour have no significant effect.
- Regular use of paracetamol may increase the toxic effects of zidovudine (AZT) (for treatment for
HIV)
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
ratiopharm Cold & Flu Lemon Flavour with alcohol
Do not drink alcohol (e.g. wine, beer, spirits) whilst taking ratiopharm Cold & Flu Lemon Flavour.

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.
ratiopharm Cold & Flu Lemon Flavour is not recommended during pregnancy and breastfeeding.
Driving and using machines
There have been no reports on negative influence of ratiopharm Cold & Flu Lemon Flavour on the
ability to drive and to use machines up to date.
ratiopharm Cold & Flu Lemon Flavour 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.
Each sachet contains approximately 1.9 g of carbohydrates. This should be taken into account in
patients with diabetes mellitus.
3.

How to take ratiopharm Cold & Flu Lemon Flavour

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

How many
One sachet

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

Method of administration
Oral administration after dissolution in water.
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 fruity and coulorless solution.
This medicine is for short-term use only. Do not take this medicine for more than 3 days without
talking to your doctor.
Use in children and adolescents
ratiopharm Cold & Flu Lemon Flavour is not recommended for use in children and adolescents below
16 years of age.
Elderly
There is no indication that the dosage needs to be modified in the elderly.

If you take more ratiopharm Cold & Flu Lemon Flavour than you should
If you or someone else took too much of ratiopharm Cold & Flu Lemon Flavour, or if you think a
child has swallowed any of content of the sachets, contact your nearest hospital casualty department 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 ratiopharm Cold & Flu Lemon Flavour
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. Within each
frequency grouping, undesirable effects are presented in order of decreasing seriousness
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data
Paracetamol
In therapeutic doses, the undesirable effects of paracetamol occur rarely and with mild clinical course.
Rare:
Blood and lymphatic system disorders: 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.
Hepatobiliary disorders: Abnormal hepatic function (increase in hepatic transaminases), hepatic
failure, hepatic necrosis, jaundice (yellowing of the skin or eyes).
Skin and subcutaneous tissue disorders: Hypersensitivity including skin rash and urticaria, pruritus,
sweating, purpura (small bleedings underneath the skin), angioedema (sudden swelling of the skin an
mucous membrane).
Immune system disorders: Allergic or hypersensitivity reactions including skin rashes, urticaria,
anaphylaxis (serious allergic reaction which causes difficulty in breathing or dizziness).
Very rare:
Respiratory, thoracic and mediastinal disorders: bronchospasm (difficulty in breathing or wheezing)
Renal and urinary disorders: After prolonged use of high doses of paracetamol sterile pyuria (urine
which contains white blood cells, cloudy urine) and renal side effects may develop
Gastrointestinal disorders: Acute pancreatitis (inflammation of the pancreas which causes severe pain
in the abdomen or back)
Phenylephrine
Common:
Gastrointestinal disorders: Loss of appetite, nausea and vomiting
Rare:

Cardiac disorders: Tachycardia (faster heart beat), palpitation (feeling your heartbeat)
Vascular disorders: blood pressure increase
Immune system disorders: 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:
Nervous system disorders: Insomnia (difficulty in sleeping), nervousness, tremor (shaking), anxiety,
restlessness, confusion, irritability, dizziness and headache may occur

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

5.

HOW TO STORE RATIOPHARM COLD & FLU LEMON FLAVOUR

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 carton and sachet. The expiry date
refers to the last day of that month.

Duration of storage after reconstitution:
The reconstituted solution in hot water is stable for 60 min at room temperature.
Store in original container in order to protect from light and moisture.
This medicinal product does not require any special temperature storage conditions.

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 to protect the environment.

6.

Content of the pack and other information

What ratiopharm Cold & Flu Lemon Flavour contains
-

The active substances are: Paracetamol 500 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 (Lemon
flavour contains: Natural lemon oils and natural and nature identical flavouring substances,
Maltodextrin, Mannitol (E421), Gluconolactone, Acacia , Sorbitol (E420) and Silica colloidal
anhydrous and all-rac-alpha-Tocopherol (E 307)), Saccharin sodium, Silica colloidal anhydrous,
Citric acid anhydrous, and Sodium citrate.

What ratiopharm Cold & Flu Lemon Flavour looks like and contents of the pack
ratiopharm Cold & Flu Lemon Flavour is a white coloured powder which is packed in laminated
sachets in a carton box.
Pack-sizes:
6, 8, 10, 12, 14, 16, 20 sachets are contained in a cardboard carton.

Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany
Manufacturer
Hermes Pharma Ges.m.b.H, Allgäu 36, 9400 Wolfsberg, Austria
OR*
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
OR*
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
OR*

TEVA Pharma B.V., Swensweg 5, 2031 Haarlem, The Netherlands
OR*
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary

This leaflet was last revised 06/2012
PL 15773/0912
*Only the actual site of batch release will appear on the printed version of the leaflet

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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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