Vicks Medinite
Vicks Cold & Flu Care Medinite Complete Syrup
Paracetamol 2.0%w/v, Pseudoephedrine HCl 0.2% w/v, Dextromethorphan HBr 0.05% w/v, Doxylamine succinate 0.025% w/v
Patient information leaflet In this leaflet:
1. What Vicks Cold & Flu Care Medinite Complete Syrup is and what it is used for
2. Before you take Vicks Cold & Flu Care Medinite Complete Syrup
3. How to take Vicks Cold & Flu Care Medinite Complete Syrup
4. Possible side effects
5. How to store Vicks Cold & Flu Care Medinite Complete Syrup
6. Further information
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 Vicks Cold & Flu Care MediniteComplete Syrup 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.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Vicks Cold & Flu Care Medinite Complete Syrup is and what it is used for
Vicks Cold & Flu Care Medinite Complete Syrup relieves symptoms of the common cold such as runny nose, sneezing, headache, body ache, sore throat, cough and nasal congestion. It contains four active ingredients:
• Paracetamol is a well known pain killer (analgesic) and can also reduce fever (antipyretic)
• Pseudoephedrine hydrochloride relieves nasal congestion to help you breathe more easily
• Dextromethorphan hydrobromide suppresses a cough
• Doxylamine succinate helps stop a runny nose and relieve sneezing.
2. Before you take Vicks Cold & Flu Care Medinite Complete Syrup
Do not take Vicks Cold & Flu Care Medinite Complete Syrup if you:
• are allergic to any of the above listed actives or other ingredients (see section 6)
• have heart disease (including previous heart attack or angina)
• have thyroid problems
• have severe liver disease or kidney disease
• are taking monoamine oxidase inhibitors (MAOIs - a type of antidepressant) or have stopped taking them in the last 14 days
• have epilepsy
• have suffered a brain injury or disease
• are taking selective serotonin reuptake inhibitors (SSRIs)
• are taking other sympathomimetic decongestants
• are taking beta blockers (see below ‘Taking other medicine’)
• suffer from closed narrow angle glaucoma
• suffer from a tumour of the adrenal glands
> Do not give Vicks Cold & Flu CareMedinite Complete Syrup to children under 12 years of age.
> IMPORTANT Contains Paracetamol.
Do not take with 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 other cough and cold medicines. Do not exceed the recommended dose.
> Take special care with Vicks Cold & Flu Care Medinite Complete Syrup
Talk to your doctor or pharmacist before taking this medicine if you are under the care of your doctor, are taking continual prescribed medication or suffer from the following conditions:
• Reduced liver function (including alcoholic liver disease)
• Occlusive vascular disease
• Enlargement of the prostate
• Risk of having glaucoma
• Diabetes
Ask your doctor before use if you have the following:
• A cough with excessive phlegm (mucus)
• A chronic or persistent cough such as occurs with smoking
• Emphysema
• Asthma
If any of the following occur, Vicks Cold & Flu Care Medinite Complete Syrup should be stopped:
• hallucinations
• restlessness
• sleep disturbances
Taking other medicines
Please inform your doctor or pharmacist before you take Vicks Cold & Flu Care Medinite Complete Syrup if you are taking medicine:
• for nausea and vomiting (such as metoclopramide or domperidone)
• for high cholesterol (such as cholestyramine)
• for depression or Parkinson’s disease (called monoamine oxidase inhibitors or MAOIs) -Do not take Vicks Cold & Flu Care Medinite Complete Syrup if you have taken MAOIs during the last 14 days or stopped taking MAOIs (such as phenalzine) or reversible monoamine oxidase inhibitors (RIMAs such as moclobemide)
• for thinning the blood (also called anticoagulants) such as warfarin and other coumarins
• for high blood pressure (also called anti hypertensives) such as methyldopa
• for heart complaints called beta blockers
• called chloramphenicol (a common antibiotic used to treat eye and ear infections).
• for depression (such as amitriptyline and clomipramine), appetite suppression (such as orlistat and sibutramine) and amphetamine-like psychostimulants
• for migraine (ergotamine and methysergide)
• for heart problems (cardiac glycosides such as digoxin)
• for Parkinson’s disease such as bromocriptine
If you are taking any of the following medicines, please inform your doctor, as they may be affected by Vicks Cold & Flu Care Medinite Complete Syrup: amiodarone, quinidine, haloperidol, propafenone, thioridazine; increased effects may be observed with antihistamines, barbiturates, opioid analgesics, psychotropics, hypnotics or sedatives.
> Pregnancy and breast-feeding
Do not take Vicks Cold & Flu Care Medinite Complete Syrup during pregnancy or if breast feeding unless your doctor has advised you to do so.
> Driving and using machines
This product may cause drowsiness. Do not drive or operate machinery as your reactions may be slowed.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
> Taking Vicks Cold & Flu Care Medinite Complete Syrup with food and drink
Do not take this product with alcoholic drinks.
> Important information about some of the ingredients of Vicks Cold & Flu Care Medinite Complete Syrup
This medicine contains:
• 18% vol. alcohol (ethanol). Each 30 ml adult dose contains 4.3g of alcohol. This is approximately one third of a standard measure of wine (standard =125 ml). Alcohol may modify or increase the effect of other medicines.
• sugar (sucrose) - Each 30 ml adult dose contains 8.25 g of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.
3. How to take Vicks Cold & Flu Care Medinite Complete Syrup
Always use Vicks Cold & Flu Care Medinite Complete Syrup exactly as your doctor or pharmacist has told you; check with them if you are not sure about anything.
> Dosage:
This syrup is to be taken by mouth. Shake well before use.
Adults and children over 12 years: 30ml in the measuring cup provided, to be taken before bedtime.
Do not give this medicine to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, speak to your pharmacist or doctor.
If you take more Vicks Cold & Flu Care Medinite Complete Syrup than you should Seek medical advice immediately if you accidentally take more syrup than you should or give a child more syrup than is recommended, even if you/the child feel well because of the risk of delayed, serious liver damage. Symptoms of overdose in the first 24 hours include paleness, nausea, vomiting, change in appetite and abdominal pain.
> If you forget to take Vicks Cold & Flu CareMedinite Complete Syrup
If you accidentally miss a dose, do not take a double dose, just take the next dose the following night as normal.
If you have any further questions on the use of this product, ask your pharmacist.
4. Possible side effects
Like all medicines, Vicks Cold & Flu Care Medinite Complete Syrup can cause side effects, although not everyone gets them.
These may include:
• Palpitations, increased heart rate, irregular heart beat, high blood pressure or low blood pressure may occur rarely.
• Drowsiness, headache, blurred vision, dizziness, lack of coordination, sleep disturbance (insomnia), anxiety, restlessness or excitability.
• Depression and hallucinations have been reported rarely.
• Loss of appetite, stomach upsets (nausea, vomiting and diarrhoea).
• Urinary retention
• Allergic reactions such as skin rash or urticaria (hives) may occur rarely. Very rare cases of serious skin reactions have been reported.
• Certain blood disorders may occur very rarely. Symptoms of these may include bruising or bleeding, infections or tiredness.
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 Medinite Complete Syrup
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not take Vicks Cold & Flu Care Medinite Complete Syrup after the expiry date which is printed on the bottle or carton. The expiry date refers to the last day of the month stated.
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.
6. Further information
What Vicks Cold & Flu Care Medinite Complete Syrup contains Each 30ml adult dose contains the active ingredients:
paracetamol 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 15mg and doxylamine succinate 7.5mg.
The other ingredients are: ethanol, sodium citrate, citric acid monohydrate, sodium benzoate (E211), polyethylene glycol 6000, sucrose, glycerol (E422), anethole, quinoline yellow (E104), indigotin blue (E132), water (see also section ‘Important information about some of the ingredients in Vicks Cold & Flu Care Medinite Complete Syrup’ in section 2).
This pack contains 180ml of syrup to be taken orally (6 adult doses) with a 30ml plastic measuring cup, in a clear glass bottle with a plastic screw cap.
Marketing Authorisation Holder
Procter & Gamble (Health & Beauty Care) Limited, Weybridge, Surrey, KT13 0XP, UK (send all enquiries to this address).
Manufacturer: Procter & Gamble Manufacturing GmbH, Procter & Gamble Strasse 1, 64521 Gross-Gerau, Germany.
PL 00129/0029R
Text Revised: 10/2014