Teva Max Strength Cold & Flu Day & Night Capsules Hard

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Document: leaflet BOOTS_PL 12063-0073 change

209.55 mm

139.7 mm

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Information Tor the user

1

Max Strength Cold & Flu Relief Day & Night Capsules

(Caffeine, Paracetamol, Phenylephrine Hydrochloride)

Read all of this leaflet carefully because it contains important information for you.

1

This medicine is available without prescription to treat minor conditions.

However, you still need to take it carefully to get the best results from it.

> If symptoms worsen or do not improve you must see a doctor

> Keep this leaflet, you may need to read it again

> Ask your pharmacist if you need more information or advice

What this medicine is for

This pack contains two types of capsule both containing Paracetamol and Phenylephrine. The Day capsules are to lake during the daytime. The Night capsules are to take at bedtime only. Paracetamol is a painkiller that also helps reduce fever. Phenylephrine Hydrochloride is a decongestant, which helps to relieve a blocked up nose. In addition, the capsule that you take in the daytime contains Caffeine, which helps relieve tiredness associated with colds and flu. Caffeine helps increase the pain relief effect of paracetamol.

This medicine can be used to relieve the symptoms of colds and flu including aches and pains, sore throat, headache, blocked nose and fever during the day and night. It can also help to relieve tiredness and drowsiness during the day.

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

A Do not take:

! • If you are allergic to any of the ingredients in this medicine ¹ If you have severe heart or blood vessel disease ¹ If you have high blood pressure • If you have a stomach ulcer, or have had one ¹ If you have an overactive thyroid

’ If you are taking monoaminepxLdaseinhibrtoreJfprdepressipn)_______

or you have taken them within the last 14 days

• If you are pregnant or breastfeeding, unless your doctor tells you to

? Talk to your pharmacist or doctor:

• If you have severe kidney or liver problems (including a disease caused by drinking alcohol)!

• If you have diabetes

• If you have been told by your doctor that you have Raynaud's Phenomenon, a condition caused by poor circulation in the hands and feet

Other important information

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

Do not take this medicine if you are dependent on alcohol.

If you take other medicines

f This medicine contains paracetamol.

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

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Metoclopramide or domperidone for feeling sick or being sick (may increase the pain relief effect of paracetamol)

• Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)!

• Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of' this medicine but talk to your doctor first before you fake it on a regular basis

• Barbiturates (for epilepsy or to help you sleep)

• Tricyclic antidepressants

• Other decongestants

• Medicines for high blood pressure, heart or circulatory problems If you are unsure about interactions with any other medicines, talk to your pharmacist.

This includes medicines prescribed by your doctor and medicine you have bought for

_ _ypyrsef, jncludingjierbal andjipmeopathic remedies.__________________

J

/How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule. This pack contains two types of capsule.

The Day capsules are for you to take during the day.

The Night capsules are for you to take at bedtime only.

Age	What to take and when
Adults and	Take two Day capsules every four to six hours,
children of	when you need to
12 years	and
and over	Take two Night capsules at bedtime only, at least four hours after the last day capsule Don’t take more than 8 capsules in any 24 hours.

Swallow each capsule whole with water. Do not chew.

Do not give to children under 12 years.

Do not take more medicine than the table tells you to.

If you do not get better, talk to your doctor.

This medicine does not contain a sleep aid.

? If you take too many capsules: 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.

Possible side effects

Most people will not have problems, but some may get some, f If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

• Difficulty breathing, swelling of the face, neck or throat (severe allergic reactions)

• Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin

• Fast, slow or irregular heartbeat

These other effects are less serious. If they bother you talk to a pharmacist

• Skin rash, tingling and coolness of the skin

• A rise in blood pressure with headache, being sick

• Unusual bruising or infections such as sore throats - this may be a sign of very rare changes in the blood

• Feeling sick, difficulty in sleeping - these effects are probably caused by the caffeine in the day capsules

Reporting ofside 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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton or on the foil edge.

What is in this medicine

The Day capsules contain Caffeine 25 mg, Paracetamol 500 mg, Phenylephrine Hydrochloride 6.1 mg, which are the active ingredients.

As well as the active ingredients, the Day capsules also contain maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, talc. The capsule shell contains gelatin and colours, which are titanium dioxide (E171), quinoline yellow (E104), patent blue V (E131), erythrosine (E127).

The Night capsules contain Paracetamol 500 mg, Phenylephrine Hydrochloride 6.1 mg, which are the active ingredients.

As well as the active ingredients the Night capsules also contain maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, talc. The capsule shell contains gelatin and colours, which are titanium dioxide (E171), erythrosine (E127), indigo carmine (E132).

The pack contains 12 red and yellow coloured day capsules, and 4 light blue and dark blue coloured night capsules.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Ltd Braunton Devon EX33 2DL Leaflet prepared November 2014

If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA

2749709

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PACK MOCK UP
Product Name: Max Strength Cold Et Flu Relief Day Et Night Capsules Product Licence No.: 12063/0073 Wording Ref: MHRAApproved v 1 dated 01/07/2011 (BTC69418vE] Status: Internally approved Pack Details: Child resistant FVC/FVdC foil
Pack Size:	16-12 Day capsules, 4 night capsules.
Version No.	Date Issued	Reason For Change
1	28/11/2014	Redesign and addition of statutory warnings

ARTWORK ONLY

Trident Reference No: BTC171875
Zen Ref:	TR901136
Category:	Healthcare
Sub-Category:	Cough Cold
Brand:	Core
Pack Type:	Leaflet
Variant:	Max Strength Cold Et Flu Relief Day Et
	Night Capsules
Action:	A
Date:	17/12/14
Country:	UK
Component Code:	2749709
Item Code:	51-51-120
CAD Ref No:	N/A
Printer:	N/A
Substrate:	White Paper

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Pharmacode No/NE: 0011110000(1263)

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