Patient leaflet - AJUTA COLD & FLU LEMON FLAVOUR 500 MG / 12.2 MG POWDER FOR ORAL SOLUTION
Package leaflet: Information for the patient
(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.
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– Keep this leaflet. You may need to read it again.
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– Ask your pharmacist if you need more information or advice.
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– 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
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1. What Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg is and what it is used for
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2. What you need to know before you take Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
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3. How to take Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
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4. Possible side effects
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5. How to store Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
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6. Contents of the pack and other information
Warnings and precautions
Talk to your doctor before taking Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
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– if you have Raynaud’s Phenomenon, a condition caused by poor blood-circulation in the fingers and toes.
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– if you have Diabetes mellitus, a condition associated with high levels of blood-sugar.
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– if you suffer from moderate and severe renal insufficiency.
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– if you suffer from liver function disorders:
mild to moderate hepatocellular insufficiency (including Gilbert’s syndrome), concomitant treatment with medicinal products affecting hepatic functions.
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– if you suffer from haemolytic anaemia (a reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness).
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– if you suffer from dehydration.
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– if you suffer from chronic malnutrition.
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– if you suffer from glutathione depletion due to metabolic deficiencies.
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– 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
Other medicines and Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg
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
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.
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.
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
If you take more Ajuta Cold & Flu Lemon Flavour 500 mg/12.2 mg than you should
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.
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)
Skin and subcutaneous tissue disorders: Very rare cases of serious skin reactions have been reported.
Phenylephrine
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 disorder s: Insomnia (difficulty in sleeping), nervousness, tremor (shaking), anxiety, restlessness, confusion, irritability, dizziness and headache may occur
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 Yellow Card Scheme, Website:. By reporting side effects you can help provide more information on the safety of this medicine.
6. Content of the pack and other information
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/Munchen
Germany
Telephone: +49 89 791020
Telefax: +49 89 79102280
Manufacturer
Hermes Pharma Ges.m.b.H,
Schwimmschulweg 1a,
9400 Wolfsberg
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 Losung zum Einnehmen
This leaflet was last revised
05/2020
Page 7/7