Medine.co.uk

The Co-Operative Max Strength Cold & Flu Capsules

Document: leaflet MCNEIL PRODUCTS_PL 12063-0066 change

COLD & FLU

MAX STRENGTH CAPSULES

paracetamol, caffeine, phenylephrine hydrochloride

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it.

■    Keep this leaflet as 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.

■    You must talk to a doctor if you do not feel better or if you feel worse after 7 days

What is in this leaflet?

1.    What is Benylin Cold & Flu Max Strength Capsules and what is it used for

2.    What you need to know before you take Benylin Cold & Flu Max Strength Capsules

3.    How to take Benylin Cold & Flu Max Strength Capsules

4.    Possible side-effects

5.    How to store Benylin Cold & Flu Max Strength Capsules

6.    Contents of the pack and other information

1    What is Benylin Cold & Flu Max Strength Capsules and what is it used for

Benylin Cold & Flu Max Strength Capsules relieve the symptoms of colds and flu, including headache, fever, nasal congestion, sore throat, fatigue and drowsiness, aches and pains.

The capsules contain paracetamol, an analgesic and antipyretic to relieve pain and fever; caffeine, a stimulant to help combat the tiredness associated with a cold and to help increase the pain relief; and phenylephrine, a decongestant to relieve nasal congestion.

2    What you need to know before you take Benylin Cold & Flu Max Strength Capsules

This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

□ Do not use this medicine...

■ If you are allergic to paracetamol, caffeine, phenylephrine or any of the other ingredients listed in section 6._

■    If you have ever had a bad reaction to any of the ingredients.

■    If you have high blood pressure, severe heart disease, circulatory problems, or an overactive thyroid gland.

■    If you have a history of stomach ulcers.

■    If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs).

■    If you are pregnant or breast-feeding, unless advised by your doctor.

■    If you are taking tricyclic antidepressants, such as imipramine, amitriptyline.

■    In children under 12 years old.

A Talk to your doctor or

pharmacist...

■    If you suffer from liver or kidney problems.

■    If you suffer from alcoholic liver disease or alcohol dependence

■    If you have diabetes.

■    If you have a condition called Raynaud's Phenomenon (which results from poor circulation in the fingers and toes).

■    If you are taking alcohol or have alcohol dependence.

Other medicines and Benylin Cold & Flu Max Strength Capsules

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

■    colestyramine (used to lower blood cholesterol).

■    metoclopramide or domperidone (used to treat nausea and vomiting).

■    tricyclic antidepressants (used to treat depression).

■    barbiturates (a kind of sleeping tablet) such as phenobarbitones

■    sympathomimetic drugs (used to treat congestion and asthma).

■    medicines to treat migraines such as ergotamine or methylsergide.

■    antihypertensives (drugs used to treat high blood pressure such as beta blockers).

■    anticoagulants (drugs used to thin the blood such as warfarin or coumarins).

■    other decongestant drugs such as ephedrine or xylometazoline.

If you are not sure about any of the medicines you are taking, show the pack to your pharmacist.

If any of these bullet points apply, talk to a doctor or pharmacist.

A If you are pregnant or breast-feeding

Do not take this product if you are pregnant. Ask your doctor or pharmacist for advice before taking any medicine. Benylin Cold & Flu Max Strength Capsules contains paracetamol.

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

A Benylin Cold & Flu Max Strength

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

3    How to take Benylin Cold &

Flu Max Strength Capsules

Check the table below to see how many capsules to take.

■    For oral use only.

■    Swallow whole with water. Do not chew.

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

Children and adolescents Do not give to children under 12 years.

a Adults and children aged 12 years and over

Age    Dose

Adults and children Take two capsules aged 12 years    up to four times    a

and over    day if necessary.

■    Leave at least four hours between doses.

■    Do not take more than eight capsules a day.

■    If symptoms persist, talk to your doctor or pharmacist.

A Taking this medicine with food and drink:

You should avoid too much caffeine in drinks like coffee and tea. If you are also consuming other medicines or food that contains caffeine (coffee, tea, cola drinks, chocolate) you may have a high caffeine intake and might have difficulty sleeping, start shaking and/or have an uncomfortable feeling in the chest.

A If anyone has too much

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.

A If you forget to take the medicine If you forget to take a dose, take the next dose when needed provided that the last dose was taken at least 4 hours ago.

Do not take a double dose.

4    Possible side-effects

Benylin Cold & Flu Max Strength Capsules can have side-effects, like all medicines, although these don’t affect everyone and are usually mild and temporary.

If you experience any of the following, stop using the medicine and tell your doctor or pharmacist:

Unknown side-effects are:

■    bronchospasm

■    restlessness, anxiety, nervousness, irritability, agitation

Rare side-effects are:

■    allergic reactions such as skin rash

■    nausea (feeling sick) or vomiting (being sick) or diarrhoea

■    headache, tremor, dizziness

■    difficulty sleeping (insomnia)

■    fast, slow or irregular heart beat (palpitations)

■    high blood pressure

■    glaucoma

■    problems or pain passing urine

■    sudden weight loss, loss of appetite and yellowing of the eyes and skin

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.

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 theYellow 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 Benylin Cold & Flu Max Strength Capsules

Do not store this product above 25°C.

Keep the product out of the sight and reach of children.

Do not use your medicine after the date shown as an expiry date on the packaging.

6    Contents of the pack and other information

What’s in this medicine?

The active ingredients in Benylin Cold & Flu Max Strength Capsules are:

Paracetamol 500 mg, caffeine 25 mg, and phenylephrine hydrochloride 6.1 mg.

Other ingredients are: Maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, talc, gelatin, quinoline yellow (E104), titanium dioxide (E171), Patent Blue V (E13 I) and erythrosine (E127).

What the medicine looks like Benylin Cold & Flu Max Strength Capsules are red/yellow capsules available in a 16 capsule pack. Marketing Authorisation holder:

Wrafton Laboratories Ltd.,Wrafton, Braunton, Devon, EX33 2DL,UK.

Manufacturer:

Wrafton Laboratories Ltd.,Wrafton, Braunton, Devon, EX33 2DL,UK.

This leaflet was revised February 2016.

Benylin is a registered trade mark.

16-0029 2752947