Patient leaflet - VICKS MEDINITE
Package leaflet: Information for the patient
paracetamol 2.0% w/v, pseudoephedrine hydrochloride 0.2% w/v, dextromethorphan hydrobromide 0.05% w/v, doxylamine succinate 0.025% w/v
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 has 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 any get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
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– You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
4. Possible side effects
6. Contents of the pack and other information
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Other medicines and Vicks Cold & Flu Care Medinite Complete Syrup
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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.
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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.
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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.
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– You need to take the medicine for longer than advised
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– You feel you need to use more than the recommended dose
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– You are using the medicine for reasons other than those indicated
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– When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
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 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.
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
VV-LAB-015718 v1.0