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

Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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Package leaflet: Information for the patient
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
(Paracetamol 500 mg, Phenylephrine Hydrochloride 12.2 mg)
Powder for Oral Solution

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 Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg is and what it is used for
2.
What you need to know before you take Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
3.
How to take Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
4.
Possible side effects
5.
How to store Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
6.
Contents of the pack and other information

1.

What Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg is and what ist is used for

Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg contains paracetamol, an analgesic which relieves
aches and reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose.
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg is used for the relief of the symptoms of colds and
influenza, including the relief of aches , headache, nasal congestion and lowering of temperature at
adults and adolescents over 16 years of age.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2.

What you need to know before you take Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg

Do not take Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg:
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)
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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 Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
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 you have asthma and are hypersensitive to acetylsalicylicacid (for pain relief or for blooddilution). You may also be hypersensitive to Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg.
Important:
This product contains Paracetamol. Do not take with any other paracetamol-containing products.
Never take more Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg 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 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.
Please contact your doctor, if your symptoms are not relieved or even deteriorated within 3 days of
therapy with Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg

Children and adolescents
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg is indicated for adults and children over 16 years of
age.

Other medicines and Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
Do not use Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg 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 Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg, 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
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- 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 Ajuta Cold &
Flu Lemon Flavour 500 mg/12.2 mg 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
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg 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.
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg with food and drink and alcohol
Do not drink alcohol (e.g. wine, beer, spirits) whilst taking Ajuta Cold & Flu Lemon Flavour 500
mg/12.2 mg.
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.
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg is not recommended during pregnancy and
breastfeeding.
Driving and using machines
There have been no reports on negative influence of Ajuta Cold & Flu Lemon Flavour 500 mg/12.2
mg on the ability to drive and to use machines up to date.
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg 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.
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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 Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has 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

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.
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.

Use in children and adolescents
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg 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 Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg than you should
If you or someone else took too much of Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg, 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 Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of thismedicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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Most people will not have problems, but some may get some.

The following summary includes side effects of paracetamol and phenylephrine.
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

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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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5.

HOW TO STORE Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg

Keep this medicine out of the sight and reach of children and adolescents.
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 the original container in order to protect from light and 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 to protect the environment.

6.

Content of the pack and other information

What Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg contains
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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 flavouring substances, maltodextrin, mannitol (E421),
gluconolactone, acacia gum, sorbitol (Ph.Eur.) (E420) , silica colloidal anhydrous, and all-rac-αtocopherol (E 307)), saccharin sodium, silica colloidal anhydrous, citric acid, and sodium
citrate.

What Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg looks like and contents of the pack
Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg is a white coloured powder which is packed in
laminated sachets in a carton box.
Pack-sizes:
10, 20 sachets are contained in a cardboard carton.
Marketing Authorisation Holder
Hermes Arzneimittel GmbH,
Georg-Kalb-Str. 5-8, 82049 Grosshesselohe/München
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Germany

Manufacturer
Hermes Pharma Ges.m.b.H,
Allgäu 36, 9400 Wolfsburg
Austria
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany / Paracetamol/Phenylephrinhydrochlorid Hermes 500 mg/12,2 mg Pulver zum Herstellen
einer Lösung zum Einnehmen

This leaflet was last revised
06/2012

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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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