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AJUTA MAX STRENGTH COLD & FLU LEMON FLAVOUR POWDER FOR ORAL SOLUTION
Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE
Ajuta Max Strength Cold & Flu Lemon Flavour
(Paracetamol 1000 mg, Phenylephrine Hydrochloride 12.2 mg)
Powder for Oral Solution, sachet
Each sachet contains Paracetamol 1000mg and Phenylephrine Hydrochloride 12.2mg
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Ajuta Max Strength Cold &
Flu Lemon Flavour carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve after 3 days.
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.
In this leaflet:
What Ajuta Max Strength Cold & Flu Lemon Flavour is and what it is used for
Before you take Ajuta Max Strength Cold & Flu Lemon Flavour
How to take Ajuta Max Strength Cold & Flu Lemon Flavour
Possible side effects
How to store Ajuta Max Strength Cold & Flu Lemon Flavour
WHAT Ajuta Max Strength Cold & Flu Lemon Flavour IS AND WHAT IT IS USED FOR
Ajuta Max Strength Cold & Flu Lemon Flavour contains paracetamol, an analgesic which relieves pain and
reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose.
Ajuta Max Strength Cold & Flu Lemon Flavour is used for the relief of the symptoms of colds and influenza,
including the relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.
BEFORE YOU TAKE Ajuta Max Strength Cold & Flu Lemon Flavour
Do not take Ajuta Max Strength Cold & Flu Lemon Flavour:
if you are allergic (hypersensitive) to paracetamol and phenylephrine hydrochloride or any of other
ingredients of Ajuta Max Strength Cold & Flu Lemon Flavour.
if you have severe coronary heart disease
if you have high blood pressure
if you have glaucoma (a disorder of the eyes often associated with increased pressure of the fluid in
if your thyroid gland is overactive (Hyperthyroidism)
if you are taking monoamine oxidase inhibitors or
if you are taking tricyclic antidepressants (for dpression) or have taken them within the last 14 days
Take special care with Ajuta Max Strength Cold & Flu Lemon Flavour
if you have Raynaud’s Phenomenon, a condition caused by poor blood-circulation in the fingers and
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
if you suffer from 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 acetyl salicylic acid (for pain relief or for blood-dilution).
You may also be hypersensitive to Ajuta Max Strength Cold & Flu Lemon Flavour.
Important: His 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
Please contact your doctor, if your symptoms are not relieved or even deteriorated within 3 days of therapy
with Ajuta Max Strength Cold & Flu Lemon Flavour.
Taking other medicines
Do not use Ajuta Max Strength Cold & Flu Lemon Flavour if you are taking monoamine oxidase inhibitors
(MAO inhibitors, such as moclobemide or tranylcypromin) or tricyclic antidepressants (such as amitryptiline,
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 Max Strength 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
- beta-blockers and other antihypertensives
- Drugs, which may potentiate the effect of phenylephrine on the bloodvessels, 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 Max Strength
Cold & Flu Lemon Flavour and may increase the toxic effects of Paracetamol on the liver, as
- barbiturates (sedatives),
- anticonvulsants (for epilepsy) such as phenytoine, phenobarbital, methylphenobarbital and
- 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
Max Strength Cold & Flu Lemon Flavour have no significant effect.Regular use of paracetamol may
increase the toxic effects of Zidovudine (AZT) (for treatment for HIV)
Taking Ajuta Max Strength Cold & Flu Lemon Flavour with food and drink
Do not drink alcohol (e.g. wine, beer, spirits) whilst taking Ajuta Max Strength Cold & Flu Lemon Flavour.
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
Ask your doctor or pharmacist for advice before taking any medicine.
Ajuta Max Strength Cold & Flu Lemon Flavour is not recommended during pregnancy and breastfeeding.
Driving and using machines
There have been no reports on negative influence of Ajuta Max Strength Cold & Flu Lemon Flavour on the
ability to drive and to use machines up to date.
Important information about some of the ingredients of Ajuta Max Strength Cold & Flu Lemon
This medicine contains aspartame (E951) which is a source of phenylalanine. May be harmful for people
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.
HOW TO TAKE Ajuta Max Strength Cold & Flu Lemon Flavour
Dissolve the contents of the sachet in a mug (250 ml of hot, but not boiling, water). Stir until dissolved and
drink the lemon flavour and coulorless solution.
The usual dose is:
Adults and Adolescents over 16
years of age who weigh more than
The dose may be repeated in 4 to
Do not take more than 3 sachets
in 24 hours.
Please observe that higher doses than those recommended may result in a risk of very serious liver damage.
Use in children
Ajuta Max Strength Cold & Flu Lemon Flavour is not recommended for use in children below 16 years of
age without medical advice.
There is no indication that the dosage needs to be modified in the elderly.
If you take more Ajuta Max Strength Cold & Flu Lemon Flavour than you should
If you or someone else took too much of Ajuta Max Strength 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 Ajuta Max Strength 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 product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Ajuta Max Strength Cold & Flu Lemon Flavour 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: may affect more than 1 in 10 people
Common: may affect up to1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
In therapeutic doses, the undesirable effects of paracetamol occur rarely and with mild clinical course.
Blood and lymphatic system disorders blood disorders which may be seen as unexplained bruising, paleness
or poor restistance to infections: Blood dyscrasias including platelet disorders, agranulocytosis, leucopenia,
thrombocytopenia, haemolytic anaemia, pancytopenia.
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, angioedema
Immune system disorders
Allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis (serious allergic
reaction which causes difficulty in breathing or dizziness)
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
Acute pancreatitis (Inflammation of the pancreas which causes severe pain in the abdomen or back)
Loss of appetite, nausea and vomiting
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)
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.
HOW TO STORE Ajuta Max Strength Cold & Flu Lemon Flavour
Keep out of the reach and sight of children and adolescents.
Do not use Ajuta Max Strength Cold & Flu Lemon Flavour after the expiry date which is stated on the
carton and sachet. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. Store in original package.
The reconstituted solution in hot water is stable for 60 min at room temperature.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
What Ajuta Max Strength Cold & Flu Lemon Flavour contains
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 (Lemon flavour
contains: natural lemon oils and flavouring substances, maltodextrin, mannitol, gluconolactone, acacia
gum, sorbitol (E420) α – tocopherol (E307) and silica colloidal anhydrous ), Saccharin sodium, Silica
colloidal, Citric acid, and Sodium citrate.
What Ajuta Max Strength Cold & Flu Lemon Flavour looks like and contents of the pack
Ajuta Max Strength Cold & Flu Lemon Flavour is a white coloured powder which is packed in laminated
sachets in a carton box. The product is available in cartons of 10 sachets.
Marketing Authorisation Holder
Hermes Arzneimittel GmbH,
Georg-Kalb-Str. 5-8, 82049 Grosshesselohe/München
Telephone: +49 89 791020
Telefax: +49 89 79102280
Hermes Pharma Ges.m.b.H,
Allgäu 36, 9400 Wolfsburg
This medicinal product is authorised in the Member States of the EEA under the following names:
Sweden Paracetamol/Phenylephrine Hermes 1000 mg/10 mg, pulver till oral lösning
This leaflet was last approved in 05/10/2011
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.