Patient leaflet - Vicks Medinite
1. What Vicks Cold & Flu Care Medinite Complete Syrup 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.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know 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 paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, doxylamine succinate or any of the other ingredients of this medicine (listed in section 6)
- have high blood pressure and/or heart disease (including previous heart attack or angina)
- have thyroid problems
- suffer from closed narrow angle glaucoma
- 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
- suffer from a tumour of the adrenal glands
- are taking selective serotonin reuptake inhibitors (SSRIs)
- are taking other sympathomimetic decongestants
- are taking beta blockers (see below ‘Taking other medicine’).
- have seizures (epilepsy)
- have suffered a brain injury or disease with symptoms of drowsiness, dizziness, balance disorder.
Do not give Vicks Cold & Flu Care Medinite Complete Syrup to children under 12 years of age.
IMPORTANT Contains Paracetamol.
Do not take with other paracetamol-containing products.
Do not exceed the recommended dose. Immediate medical advice should be sought in the event of an overdose. Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
Do not take with other cough and cold medicines.
Warnings and precautions
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
- slow metabolism of enzyme CYP2D6 or use CYP2D6 inhibitors.
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, asthma or emphysema.
If any of the following occur, Vicks Cold & Flu Care Medinite Complete Syrup should be stopped:
- hallucinations
- restlessness
- sleep disturbances.
If you develop reddening and/or reddish-purple patches on large areas of the skin with fever , stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4.
Reduction of blood flow to your optic nerve may occur with Vicks Cold & Flu Care Medinite Complete Syrup. If you develop sudden loss of vision, stop taking Vicks Cold & Flu Care Medinite Complete Syrup and contact your doctor or seek medical attention immediately. See section 4.
Talk to your pharmacist before taking this medicine if you:
- are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
Taking this medicine regularly, particularly for a long time, can lead to addiction. Only use this medicine as described in the leaflet.
Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Speak to your doctor if you experience withdrawal symptoms.
Talk to your doctor or pharmacist if you are taking medicines such as certain antidepressants or antipsychotics, as Vicks Cold & Flu Care Medinite Complete may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g nausea, vomiting, diarrhoea).
Sudden abdominal pain or rectal bleeding may occur with Vicks Cold & Flu Care Medinite Complete Syrup, due to inflammation of the colon (ischemic colitis). If you develop these gastro-intestinal symptoms, stop taking Vicks Cold & Flu Care Medinite Complete Syrup and contact your doctor or seek medical attention immediately. See section 4.
Other medicines and Vicks Cold & Flu Care Medinite Complete Syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines:
- for nausea and vomiting (such as metoclopramide or domperidone)
- for high cholesterol (such as cholestyramine)
- for thinning the blood (also called anticoagulants) such as warfarin and other coumarins
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 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 Parkinson's disease such as bromocriptine
- for heart problems (cardiac glycosides such as digoxin)
- for migraine (ergotamine and methysergide)
used to inhibit the enzyme CYP2D6 such as selective serotonin reuptake inhibitors SSRIs
(such as fluoxetine and paroxetine), quinidine and terbinafine.
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, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine; increased effects may be observed with antihistamines, barbiturates, opioid analgesics, psychotropics, hypnotics or sedatives.
Vicks Cold & Flu Care Medinite Complete Syrup with food, drink and alcohol
Do not take this product with alcoholic drinks.
Pregnancy, breast-feeding and fertility
Do not take Vicks Cold & Flu Care Medinite Complete Syrup if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 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:
- the medicine has been prescribed to treat a medical or dental problem and
- you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- 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.
Vicks Cold & Flu Care Medinite Complete Syrup contains the excipients:
18% vol. alcohol (ethanol). Each 30 ml adult dose contains 4.1 g of alcohol. This is approximately one third of a standard measure of wine (standard =125 ml). The amount of alcohol in this medicinal product:
- may be harmful for those suffering from alcoholism
- should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy
- may alter the effects of other medicines
- may impair your ability to drive or use machines.
- sugar (sucrose) – Each 30 ml adult dose contains 8.25 g of sucrose. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicinal product. May be harmful to your teeth.
salt (sodium). This medicine contains 75 mg sodium (main component of cooking/table salt)
in each 30 ml dose. This is equivalent to 4% of the recommended maximum daily dietary intake of sodium for an adult.
- benzoate salt. This medicine contains 30 mg benzoate salt in each 30 ml which is equivalent to 1 mg per ml.
3. How to take Vicks Cold & Flu Care Medinite Complete Syrup
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage:
This syrup is to be taken by mouth. Shake well before use. The recommended dose is given below.
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.
You may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, somnolence, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (rapid heart beating), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe breathing problems, and convulsions.
Contact your doctor or hospital straight away if you experience any of the above symptoms.
If you forget to take Vicks Cold & Flu Care Medinite 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, this medicine can cause side effects, although not everyone gets them.
The below listed side effects are potentially serious. If you experience any of them stop taking the medicine and seek urgent medical advice immediately:
- severe allergic reaction to taking this medicine. Symptoms of an allergic reaction include skin rash, urticaria (hives) or breathing difficulties
- serious skin reactions
sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of
Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment (see section 2).
The following side effects have also been reported:
- certain blood disorders may occur very rarely. Symptoms of these may include bruising or bleeding, infections or tiredness.
- dependence and addiction may occur, but the frequency is not known (see section “How do I know if I am addicted?)
drowsiness, headache, blurred vision, dizziness, lack of coordination, sleep disturbance
(insomnia), anxiety, restlessness, excitability or nervousness and tremor
- depression and hallucinations have been reported rarely
- palpitations, increased heart rate, irregular heartbeat, high blood pressure or low blood pressure may occur rarely
- dry mouth, loss of appetite or stomach upsets such as nausea, vomiting, stomach pains, increased acid reflux diarrhoea, constipation
- inflammation of the colon due to insufficient blood supply (ischemic colitis) may occur but the frequency is not known
- urinary retention or difficulty passing urine.
- Reduction of blood flow to the optic nerve (Ischaemic optic neuropathy) (frequency not known)
Drug Withdrawal
When you stop taking Vicks Cold & Flu Care Medinite Complete, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
How do I know if I am addicted?
If you notice any of the following signs whilst taking <product name>, it could be a sign that you have become addicted.
- You need to take the medicine for longer than advised
- You feel you need to use more than the recommended dose
- You are using the medicine for reasons other than those indicated
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
If you notice any of these signs, it is important you talk to your doctor or pharmacist.
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 website 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 Vicks Cold & Flu Care Medinite Complete Syrup
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not take this medicine after the expiry date which is stated on the bottle or carton. The expiry date refers to the last day of the month stated.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other 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 96%, sodium citrate, citric acid monohydrate, sodium benzoate (E 211), polyethylene glycol 6000, sucrose, glycerol (E 422), anethole, quinoline yellow (E 104), indigotin blue (E 132), purified water (see also ‘Vicks Cold & Flu Care Medinite Complete Syrup contains the excipients’ in section 2).
What Vicks Cold & Flu Care Medinite Complete Syrup looks like and contents of the pack
Vicks Cold & Flu Care Medinite Complete is a clear, slightly viscous green syrup and is available in a 180 ml clear glass bottle with a plastic screw cap and a 30 ml plastic measuring cup.
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
This leaflet was last revised in July 2020