What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL12063/0073.


Boots Max Strength Cold & Flu Relief Day & Night Capsules

Package leaflet: Information for the user

Boots Pharamceuticals

Max Strength Cold & Flu Relief Day & Night Capsules

(Caffeine, Paracetamol, Phenylephrine Hydrochloride)

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 have told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for

This medicine contains:

  • paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever
  • phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily.

The Day capsules also contain:

  • caffeine which helps to increase the pain relief from paracetamol and makes you more alert.

These capsules are used for the relief of the symptoms of colds and flu, including aches and pains, sore throat, headache, nasal congestion (blocked nose) and feverishness (high temperature). The Day capsules can also relieve tiredness and drowsiness.

2. What you need to know before you take this medicine

Do not take this medicine if you:

  • are allergic to paracetamol, caffeine, phenylephrine or any of the other ingredients
  • have a serious heart condition or cardiovascular disorder(s)
  • have high blood pressure (hypertension)
  • have a history of stomach ulcers
  • have an overactive thyroid
  • are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or have taken them within the last 14 days - these are medicines such as phenelzine and isocarboxazid.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

  • are pregnant or breast-feeding
  • suffer from kidney or liver problems, including alcoholic liver disease
  • have diabetes
  • have circulatory disorders such as a condition called Raynaud’s Phenomenon, which results from poor circulation in the fingers and toes.

Other medicines and this medicine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:

  • medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine
  • medicines to control feeling sick or being sick such as metoclopramide or domperidone
  • medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins – you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis
  • barbiturates (for epilepsy or to help you sleep), such as phenobarbitones
  • tricyclic antidepressants such as imipramine, amitriptyline
  • medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)
  • other decongestant drugs such as ephedrine or xylometazoline.

Contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

This medicine with food and alcohol

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3. How to take this medicine

Swallow the capsules whole with water. Do not chew.

Adults, the elderly and children aged 16 years and over:

Take 2 Day capsules every 4 to 6 hours during the daytime, as required

and

Take 2 Night capsules at bedtime.

Leave at least 4 to 6 hours between doses.

Do not take more than 8 capsules (4 doses) in any 24 hour period.

Do not give to children under 16 years.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

Do not take for longer than 3 day, unless advised by your doctor.

The Day time capsules contain caffeine which may disrupt sleep if taken at night.

If you take more of this medicine 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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

4. Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

Rare side effects are:

  • allergic reactions such as skin rash
  • tingling and coolness of the skin
  • a faster or slower heart beat
  • a rise in blood pressure with headache, vomiting (being sick) and irregular heart beat (palpitations)
  • nausea (feeling sick) (Day Capsule only)
  • difficulty sleeping (insomnia) (Day Capsule only).

Very rare cases of serious skin reactions have been reported.

More rarely, the following side effects can happen:

You may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

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 this medicine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

Do not store above 25°C.

6. Contents of the pack and other information

What this medicine contains

Day Capsules:

The active ingredients are paracetamol, phenylephrine hydrochloride and caffeine.

Each Day capsule contains paracetamol 500 mg, caffeine 25 mg and phenylephrine hydrochloride 6.1 mg.

The other ingredients in the Day capsules are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours: quinoline yellow (E104), titanium dioxide (E171), patent blue V (E131) and erythrosine (E127).

Night Capsules:

The active ingredients are paracetamol and phenylephrine hydrochloride.

Each Night capsule contains paracetamol 500 mg and phenylephrine hydrochloride 6.1 mg.

The other ingredients in the Night capsules are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), erythrosine (E127) and indigo carmine (E132).

What this medicine looks like and contents of the pack

The pack contains 12 red and yellow coloured Day capsules and 4 dark blue and light blue coloured Night capsules.

Marketing Authorisation Holder & Manufacturer:

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by the Marketing Authorisation holder

Wrafton Laboratories Ltd
Braunton
Devon
EX33 2DL
UK

PL 12063/0073

This leaflet was last revised in January 2017

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Artwork reference: BTC275329A