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FEDRIL NIGHT COLD AND FLU ORAL SOLUTION

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE / PARACETAMOL / PROMETHAZINE HYDROCHLORIDE

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Important information about some of the ingredients of Lloydspharmacy Night Cold and Flu Relief Oral Solution.
The product contains
Ethanol: up to 3.5ml per measured dose, equivalent to 70ml of beer, or 29ml of wine. Harmful for those suffering from alcoholism. To be
taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with epilepsy.
Liquid maltitol (hydrogenated glucose syrup): 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 up to 23.52mg of sodium per 20ml dose. To be taken into consideration by patients on a controlled
sodium diet.

PATIENT INFORMATION LEAFLET

Night Cold & Flu Relief Oral Solution
Paracetamol 1000mg/20ml,
Promethazine Hydrochloride 20mg/20ml,
Dextromethorphan Hydrobromide 15mg/20ml

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 Lloydspharmacy Night Cold and Flu Relief Oral Solution 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 after a few days.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lloydspharmacy Night Cold and Flu Relief Oral Solution is and what it is used for
2. Before you take Lloydspharmacy Night Cold and Flu Relief Oral Solution
3. How to take Lloydspharmacy Night Cold and Flu Relief Oral Solution
4. Possible side effects
5. How to store Lloydspharmacy Night Cold and Flu Relief Oral Solution
6. Further information

The usual dose is:
Adults and children aged 12 years and over:

One 20ml dose to be taken just before going to bed.

Children under 12:

Do not give to children under 12 years of age.

Elderly:

Dose as for 'Adults' above.

Do not take anything else containing paracetamol while taking this medicine. Do not take with any other flu, cold or decongestant product.
If you have taken other Paracetamol containing products during the day, this night time dose is considered as part of the maximum daily dose and
should not be taken if you have already taken four doses of Paracetamol during the day.
DO NOT TAKE MORE MEDICINE THAN THE LABEL TELLS YOU TO.

1. WHAT LLOYDSPHARMACY NIGHT COLD AND FLU RELIEF ORAL SOLUTION IS AND WHAT IT IS USED FOR
Lloydspharmacy Night Cold and Flu Relief Oral Solution provides night time relief from the symptoms of colds, chills and 'flu'. These include headache,
shivers, sore throat pain, runny nose, tickly cough, aches and pains. It contains paracetamol to reduce fever, promethazine to dry up a runny nose, ease
breathing and dextromethorphan which relieves a tickly cough.
2. BEFORE YOU TAKE LLOYDSPHARMACY NIGHT COLD AND FLU RELIEF ORAL SOLUTION
Do not take Lloydspharmacy Night Cold and Flu Relief Oral Solution if you
• are allergic (hypersensitive) to paracetamol, promethazine hydrochloride, dextromethorphan hydrobromide or any of the other ingredients of
Lloydspharmacy Night Cold and Flu Relief Oral Solution (see Section 6 and end of Section 2).
• have kidney or liver problems.
Do not take with any other paracetamol containing products.
Do not take with any other flu, cold or decongestant product.
Take special care with Lloydspharmacy Night Cold and Flu Relief Oral Solution
Tell your doctor if you:
• have asthma or other breathing problems
• have difficulty in passing urine (urinary retention)
• have glaucoma
• have prostate problems
• have heart problems
• have epilepsy
• have alcohol problems
If you do not get better, talk to your doctor.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
In particular, tell your doctor if you are taking medicines which:
• thin the blood (e.g. warfarin).
• control nausea or vomiting (e.g. domperidone or metoclopramide).
• reduce levels of cholesterol and other fats in the blood (e.g. cholestyramine).
• have been prescribed by your doctor to improve sleep, for anxiety or depression (including monoamine oxidase inhibitors (MAOIs) and antimuscarinic drugs).
Do not consume alcoholic drinks while you are taking Lloydspharmacy Night Cold and Flu Relief Oral Solution.
Promethazine may interfere with pregnancy tests to produce false results.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines during pregnancy.
If you are, or are likely to become pregnant, or are breast-feeding, Lloydspharmacy Night Cold and Flu Relief Oral Solution should only be taken when
advised by your doctor.
Driving and using machines
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

If you take more Lloydspharmacy Night Cold and Flu Relief Oral Solution than you should:
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.
Also seek immediate medical advice if you take other paracetamol-containing medicines by mistake.
If you forget to take Lloydspharmacy Night Cold and Flu Relief Oral Solution:
If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lloydspharmacy Night Cold and Flu Relief Oral Solution can cause side effects, although not everybody gets them.
You may notice the following:
• rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop taking Lloydspharmacy
Night Cold and Flu Relief Oral Solution immediately.
• mental and physical slowness
• inability to pass urine, dry mouth, blurred vision
• disorientation or dizziness
• restlessness
• upset stomach
• sensitivity to light
• feeling sleepy (drowsiness)
Very rare cases of serious skin reactions have been reported.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LLOYDSPHARMACY NIGHT COLD AND FLU RELIEF ORAL SOLUTION
Do not store above 25˚C.
Keep out of the sight and reach of children.
Store in the original container and keep the bottle in the outer carton (in order to protect from light).
Do not use after one month from first opening.
Do not use Lloydspharmacy Night Cold and Flu Relief Oral Solution after the expiry date which is stated on the label or carton. The expiry date refers to
the last day of the month.
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
Each 20ml of Lloydspharmacy Night Cold and Flu Relief Oral Solution contains:
• The active substances: 1000mg paracetamol, 20mg promethazine hydrochloride, 15mg dextromethorphan hydrobromide.
• The other ingredients are: ethanol, propylene glycol, liquid maltitol (E965), sodium citrate, ascorbic acid, acesulfame K, citric acid monohydrate,
natural mint flavour, patent blue V (E131), quinoline yellow (E104), purified water.
What Lloydspharmacy Night Cold and Flu Relief Oral Solution looks like and contents of the pack:
Lloydspharmacy Night Cold and Flu Relief Oral Solution is a clear green, mint flavoured sugar-free solution, available in 200ml clear glass bottles with
child resistant caps. A measuring cup is provided.

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3. HOW TO TAKE LLOYDSPHARMACY NIGHT COLD AND FLU RELIEF ORAL SOLUTION
Always use the measuring cup supplied with the pack. Shake the bottle before use. Always take the product exactly as directed. You should check
with your doctor or pharmacist if you are not sure.

Marketing Authorisation Holder and Manufacturer:
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0053
This leaflet was last updated in: August 2014

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V18-140808

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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