Patient leaflet - Care Cold & Flu Relief 600 mg powder for oral solution
1. What Care Cold and Flu Remedy 600mg powder for solution is and what it is used for
Care Cold and Flu Remedy 600mg powder for solution is a medicine used for relief of symptoms of influenza and feverish colds (incl. headache, aches and pains) menstrual pain and toothache.
For children aged 12 years or older, adolescents and adults.
2. What you need to know before you take CARE COLD AND FLU REMEDY 600MG POWDER FOR SOLUTION
DO NOT take Care Cold and Flu Remedy 600mg powder for solution
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Care Cold and Flu Remedy 600mg powder for solution if you:
- suffer from chronic alcoholism
- suffer from impaired liver function (liver inflammation, Gilbert’s syndrome)
- have existing kidney damage
- are using other medicines that are known to affect the liver
- have a deficiency of a certain enzyme called glucose-6-phosphatedehydrogenase
- have haemolytic anaemia (abnormal breakdown of red blood cells)
- suffer from reduced glutathione levels
- are dehydrated or have impaired nutritional state e.g. caused by alcohol abuse, anorexia or wrong nutrition
During treatment with Care Cold and Flu Remedy 600mg powder for solution, tell your doctor straight away if:
- you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
You must contact a doctor if your symptoms worsen or do not improve after 3 days, or if you develop a high fever.
To avoid the risk of overdosing, it should be ensured that medicines taken at the same time as Care Cold and Flu Remedy 600mg powder for solution do not contain paracetamol.
Prolonged use
You should not use Care Cold and Flu Remedy 600mg powder for solution over prolonged periods or at high doses without the advice of a doctor or dentist.
During prolonged, improper use of high-dose painkillers, headache can occur, which must not be treated by increased doses of the medicine.
In general, habitual use of painkillers may lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy), particularly if several painkilling drugs are combined.
Other medicines and Care Cold and Flu Remedy 600mg powder for solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions are possible with:
- probenecid, a drug used in gout: If taken at the same time, the dose of Care Cold and Flu Remedy 600mg powder for solution should be lowered, as there may be a delay in the breakdown of paracetamol, the active substance in Care Cold and Flu Remedy 600mg powder for solution
- phenobarbital (sleeping medication), phenytoin and carbamazepine (used in epilepsy), rifampicin (used in tuberculosis), as well as other drugs that can damage the liver. There is a greater risk of liver damage if Care Cold and Flu Remedy 600mg powder for solution is taken at the same time
- metoclopramide and domperidone (used to treat nausea) can speed up the absorption and onset of action of paracetamol
- colestyramine (used to lower high blood fat levels) can reduce absorption of paracetamol, thereby making it less effective
- medicines that slow down gastric emptying, e.g. propantheline, can delay the absorption and onset of action of paracetamol
- zidovudine (used to treat HIV infections) - susceptibility to neutropenia (reduced number of white blood cells) is increased. Medical advice is therefore needed before taking Care Cold and Flu Remedy 600mg powder for solution at the same time as zidovudine
- medicines used to thin the blood such as warfarin and other coumarins. The effect of blood thinning drugs may be increased by regular use of Care Cold and Flu Remedy 600mg powder for solution over a longer period.
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
Effects of taking Care Cold and Flu Remedy 600mg powder for solution on laboratory tests
Tests to determine uric acid and blood sugar levels may be affected.
Please remember that this information may also apply to recently used medications (which may still be in your body).
Care Cold and Flu Remedy 600mg powder for solution with alcohol
Care Cold and Flu Remedy 600mg powder for solution must not be taken at the same time as alcohol.
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.
Pregnancy
If necessary, Care Cold and Flu Remedy 600mg powder for solution can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.
Breast-feeding
Paracetamol passes into breast milk. It is not known to affect the baby adversely, so discontinuation of breast-feeding is generally not required during short-term use.
Driving and using machines
Care Cold and Flu Remedy 600mg powder for solution has no effect on the ability to drive and use machines. However, caution is always advised after taking any painkillers.
Care Cold and Flu Remedy 600mg powder for solution contains sucrose and aspartame (E951)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Contains 3.8 g sucrose (sugar) per sachet. This should be taken into account in patients with diabetes mellitus.
This medicine contains 95 mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
3. How to take Care Cold and Flu Remedy 600mg powder for solution
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
Unless otherwise prescribed by the doctor, the recommended dose is 1 sachet (600 mg paracetamol) taken as a single dose; maximum of 4 doses in 24 hours with at least 6 hours between doses.
Do not exceed the stated dose - a single dose of 1 sachet at a time may not be exceeded.
If other medicines containing paracetamol are taken at the same time, make sure that this won't exceed the maximum recommended daily dose of paracetamol. Please ask your doctor or pharmacist if the medicines you are taking contain the active ingredient paracetamol. He/she will inform you about the dosing and the best time to take such medicines while you are taking Care Cold and Flu Remedy 600mg powder for solution.
Patients with liver impairment and mild kidney impairment
Dose must be reduced by prolongation of dosing interval in patients with impaired liver or kidney function and Gilbert's syndrome.
Patients with severe kidney dysfunction
In cases of severe kidney dysfunction (creatinine clearance < 10 ml/min), there must be an interval of at least 8 hours between each dose.
Older people
No specific dose adjustment is required.
Use in adults with a low body weight
Care Cold and Flu Remedy 600mg powder for solution must not be used in patients weighing less than 40 kg as the dosage strength is not suitable for these patients. More appropriate dosage strengths and/or formulations of paracetamol (e.g. syrup or suppositories) are available for this patient group.
Use in children and adolescents
Care Cold and Flu Remedy 600mg powder for solution must not be used in children under 12 years of age. More appropriate dosage strengths and/or formulations of paracetamol (e.g. syrup or suppositories) are available for this patient group.
Method of administration
First, bring water to boil and let cool for about 10 minutes.
Empty the content of one sachet into a cup, top with the hot water and stir well. A slightly cloudy, colourless to light yellowish solution will be obtained.
Drink after sufficient cooling down to a drinkable temperature.
Dosing after meals may lead to a delayed onset of action.
Duration of treatment
Do not take Care Cold and Flu Remedy 600mg powder for solution for more than 3 days without the advice of a doctor or dentist. A doctor should be consulted if symptoms persist for more than 3 days.
If you take more Care Paracetamol 600mg powder for oral solution than you should
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. In treating an overdose, the doctor will be guided by the symptoms and will take all appropriate courses of action.
In the event of overdose with Care Cold and Flu Remedy 600mg powder for solution, the following symptoms can occur:
- nausea
- vomiting
- loss of appetite
- paleness
- stomach ache
- sweating
- drowsiness
- malaise (general feeling of being unwell)
Liver damage and even hepatic coma, heart muscle damage and pancreatitis can occur in the event of severe overdose.
If you forget to take Care Cold and Flu Remedy 600mg powder for solution
Do not take a double dose to make up for a forgotten dose.
If you stop taking Care Cold and Flu Remedy 600mg powder for solution
If Care Cold and Flu Remedy 600mg powder for solution has been used correctly, there are no special considerations.
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.
Rare (may affect up to 1 in 1,000 people):
- slight increase in liver enzymes (serum transaminases)
Very rare (may affect up to 1 in 10,000 people):
changes in the blood count such as reduction in blood platelets (thrombocytopenia) or a
pronounced reduction in certain white blood cells (agranulocytosis)
- allergic reactions, from simple skin rash or nettle rash (urticaria) to a shock reaction
- airway constriction (analgesic-induced asthma) can be triggered in sensitive patients
- very rare cases of serious skin reactions have been reported
Not known (frequency cannot be estimated from the available data):
- a serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)
In the event of an allergic shock reaction, seek immediate help from the nearest available doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Care Cold and Flu Remedy 600mg powder for solution
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 outer carton and sachet after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original package in order to protect from 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 protect the environment.
6. Contents of the pack and other information
What Care Cold and Flu Remedy 600mg powder for solution contains
The active substance is paracetamol.
Each sachet contains 600 mg paracetamol.
The other ingredients are:
ascorbic acid, aspartame (E951), citric acid, ethylcellulose, colloidal anhydrous silica, sucrose, lemon flavouring (consisting of citral, citronella oil, coriander seed oil, gum arabic and lime oil distilled).
What Care Cold and Flu Remedy 600mg powder for solution looks like and contents of the pack
Powder for oral solution in sachet, and is white to slightly yellow with the smell of lemon.
Care Cold and Flu Remedy 600mg powder for solution is available in packs of 5 and 10 sachets.
Marketing Authorisation Holder and Manufacturer
Thornton & Ross Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
England
This medicinal product is authorised in the Member States of the EEA under the following names:
UK (NI): Care Cold and Flu Remedy 600mg powder for solution
CZ: Paracetamol STADA 600 mg prášek pro perorální roztok v sáčku
IE: Paralief Hot Lemon Drink 600 mg powder for oral solution in sachet
SK: Grippostad horúci nápoj