Patient leaflet - Vicks Cold & Flu Care Daymed Plus Hot Drink
1. WHAT VICKS COLD & FLU CARE DAYMED PLUS HOT DRINK IS AND WHAT IT IS USED
FOR
Vicks Cold & Flu Care Daymed Plus Hot Drink is designed for the relief of symptoms of colds and flu. It contains three active ingredients:
a. Paracetamol is a well-known pain killer (analgesic). It is effective against aches and pains including headache and sore throat and can also reduce fever (antipyretic).
b. Guaifenesin (an expectorant) loosens phlegm which helps relieve chesty coughs. c. Phenylephrine hydrochloride (a nasal decongestant) reduces swelling in the passages of the nose and so relieves a blocked nose.
You should only use Vicks Cold & Flu Care Daymed Plus Hot Drink if you have pain/or fever, nasal congestion, and chesty cough.
You must talk to your doctor if you do not feel better or feel worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VICKS COLD & FLU CARE DAYMED PLUS HOT DRINK
Do not take Vicks Cold & Flu Care Daymed Plus Hot Drink:
- if you are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride, or to any of the ingredients (see section 6)
- if you have heart disease
- if you have high blood pressure (hypertension)
- if you have a problem with your liver or severe kidney disease
- if you have overactivity of the thyroid gland
- if you are diabetic
- if you have glaucoma (increased pressure in the eye) of the narrow-angle type
- if you have porphyria, which is a hereditary disorder of characterised by excessive amounts of pigments in the urine
- if you are taking tricyclic antidepressants
- if you are taking beta blockers
if you are taking monoamine oxidase inhibitors (MAOIs) - used in treatment of depression or
Parkinson’s disease or have taken them in the last 14 days
- if you are taking medicines to lower your blood pressure or treat angina
Do not give Vicks Cold & Flu Care Daymed Plus Hot Drink to children under 12 years of age.
Warnings and precautions
Important: 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.
Talk to your doctor or pharmacist before taking Vicks Cold & Flu Care Daymed Plus Hot Drink:
- if you have a problem with your liver functions
- if you are male and have an enlarged prostate gland, as you may have more difficulty passing water
- if you have a blood circulation problem (including Raynaud’s syndrome)
- if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
- if you have severe haemolytic anaemia, glucose-6-dehydrogenase deficit, chronic nutrition disorder or if you are dehydrated.
During treatment with Vicks Cold & Flu Care Daymed Plus Hot Drink, 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).
Children and adolescents
Do not give Vicks Cold & Flu Care Daymed Plus Complete Hot Drink to children under 12 years of age.
Other medicines and Vicks Cold & Flu Care Daymed Plus Hot Drink
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist before you take Vicks Cold & Flu Care Daymed Plus Hot Drink if you are taking:
- medicine containing paracetamol or other decongestants for colds and flu. If you are taking these, do not take Vicks Cold & Flu Care Daymed Plus Hot Drink.
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called high anion gap metabolic acidosis) that must have urgent treatment (see section 2).
- monoamine oxidase inhibitors (MAOIs) used in the treatment of depression or Parkinson’s disease. Do not take Vicks Cold & Flu Care Daymed Plus Hot Drink if you have taken MAOIs in the last 14 days.
- tricyclic antidepressants for depression, such as amitriptyline or imipramine.
- medicine for high blood pressure (antihypertensives), including beta-blockers, or for improving heart function or correcting abnormal heart rhythms (digoxin, lanoxin, digitoxin).
phenothiazines (which are used either as antipsychotic drugs to treat conditions such as schizophrenia or
paranoia, or to prevent nausea and vomiting).
- medicine for nausea and vomiting (such as metoclopramide or domperidone).
- medicine for thinning the blood (anticoagulants), such as warfarin or other coumarins.
- medicine for high cholesterol (such as cholestyramine).
- sedatives (barbiturates).
- probenecid or AZT (zidovudine).
- isoniazid (used to treat or prevent tuberculosis).
Vicks Cold & Flu Care Daymed Plus Hot Drink with food and drink
Do not take this product with alcoholic drinks.
Pregnancy, breast- feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If necessary and only if advised by a doctor or pharmacist, Vicks Cold & Flu Care Daymed Plus Hot Drink 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.
Driving and using machines
This product may cause dizziness or confusion. If you are affected do not drive or operate machinery.
Vicks Cold & Flu Care Daymed Plus Hot Drink contains Aspartame, Sucrose and Sodium:
- Aspartame (E951). This medicine contains 6 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.
- 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.
- Sodium. This medicine contains 157 mg sodium (the main component of cooking/table salt) in each sachet. This is equivalent to 7.85% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 3 or more sachets daily for a prolonged period especially if you have been advised to follow a low salt (sodium) diet.
3. HOW TO TAKE VICKS COLD & FLU CARE DAYMED PLUS HOT DRINK
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and children over 12 years:
1 sachet every 4-6 hours as required. Do not take more than 4 sachets in any 24-hour period.
Do not exceed the stated dose.
Do not take this medicine with alcoholic drinks.
Use in children and adolescents
Do not give to children under 12 years of age.
Method of administration
This medicine is a powder to be dissolved in water and taken as a hot drink.
Pour one sachet of powder into a mug of standard size and fill with hot, but not boiling water (approx. 250ml). Allow to cool to a drinkable temperature and drink the opalescent
yellow solution with citrus/menthol odour and taste.
Duration of treatment
Long term use of the product is not recommended.
If symptoms persist for more than 3 days or worsen, consult your doctor.
If you take more Vicks Cold & Flu Care Daymed Plus Hot Drink than you should:
Seek medical advice immediately if you accidentally take more than you should or give a child more than is recommended, even if you/the child feel well because of the risk of delayed, serious liver damage.
If you have any further questions on the use of this product, ask your pharmacist.
If you forget to take Vicks Cold & Flu Care Daymed Plus Hot Drink
Do not take a double dose to make up for a forgotten sachet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking the medicine immediately and seek urgent medical advice:
- Very rare cases of serious skin reactions have been reported. Severe allergic reactions (anaphylaxis), wheezing or breathing difficulties may occur rarely. (Rare: affects less than 1 in 1000 people, but more than 1 in 10,000 people; Very rare: affects less than 1 in 10,000 people).
- Certain disorders of the blood cells and pancreatitis (inflammation of the pancreas) may occur very rarely with paracetamol (affect less than 1 in 10,000 people).
Other side effects
| Frequency | Side effect |
| Common (affect less than 1 in 10 people, but more than 1 in 100 people). | Loss of appetite, nausea, or vomiting |
| Rare (affect less than 1 in 1000 people, but more than 1 in 10,000 people). | Mild allergic reactions (such as skin rashes or hives) Stomachache, diarrhoea Headache, dizziness Rapid heartbeat (palpitations), high blood pressure Difficulty sleeping (insomnia), nervousness, shaking (tremor), irritability, restlessness, confusion or anxiety. |
| 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). |
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE VICKS COLD & FLU CARE DAYMED PLUS HOT DRINK
Keep this medicine out of the sight and reach of children.
Store below 25 OC.
Do not use this medicine after the expiry date which is printed on the sachet or carton. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vicks Cold & Flu Care Daymed Plus Hot Drink contains
The active substances are paracetamol, guaifenesin and phenylephrine hydrochloride. Each sachet of this medicine provides a single dose containing the active ingredients: paracetamol 500mg, guaifenesin 200mg and phenylephrine hydrochloride 10 mg.
The other ingredients are: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate, aspartame (E951), acesulfame potassium (E950), powdered menthol, lemon flavour, lemon juice flavour, quinoline Yellow (E104). See end of section 2.
What Vicks Cold & Flu Care Daymed Plus Hot Drink looks like and contents of the pack
Vicks Cold & Flu Care Daymed Plus Hot Drink is an off-white-coloured powder which is packed in laminated sachets in a carton box. The product is available in cartons of 5 and 10 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Procter & Gamble (Health & Beauty Care) Limited
The Heights Brooklands
Weybridge KT13 0XP UK
PL 00129/0350
Manufacturer
Procter & Gamble Manufacturing GmbH
Procter & Gamble Strasse 1,
64521 Gross Gerau, Hessen Germany