Reckitt Benckiser

Package leaflet :Thformafion for the user Lemsip Cough Max for Chestv Cough and Cold Relief Capsules

(Paracetamol, Guaifenesin and Phenylephrine Hydrochloride)

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

“This medicine is”avallaBre withdut pfescripfioh. However” you still need fo”take Bus medicine 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 your doctor if your symptoms worsen or do not improve after 3 days.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please -tell yeur-doctor-or-pharmaeisfc--------------------------------------------------

In this leaflet:

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

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6. -Furthermfbrmatien------------------

Pharmacode Reads This Way

,1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR

(Capsules for oral use.

'This medicine is a combination of active ingredients which are effective in relieving the symptoms associated with colds and flu, including relief of aches and pains, sore throats, headache, nasal [congestion, lowering of temperatureand_chesty cough.

Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains, including -a-headache and can also reduce a fever (antipyretic). Guaifenesin (expectorant) allows you to cough up —phlegm when suffering from a chesty cough. Phenylephrine hydrochloride (nasal decongestant)

■ 1^3 reduces swelling in the passages of the nose, relieving nasal congestion and reducing pressure which — - - (nay cause a headache.

_____2- BEFORE-YOII TAKE IHIS-MEDICINE_______________________________________

Do not take this medicine if:

You are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride or any of the other ingredients listed in Section 6

You have a serious heart condition, or an overactive thyroid

You have a high blood pressure (hypertension)______________________________________

You are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), usually used to treat depression.

[Take special care with this medicine if:

You suffer from liver or kidney problems, heart disease

Yqllsuffer from Raynaud’s syndrome_(poor_hlood circulation which.makes.the imgers_ar_toes.pale _ _[ and numb), or diabetes mellitus

You have non-cirrhotic (liver disease that is not associated with changes to the structure of the liver) liver disease

You are a woman with a history of pre-eclampsia (a condition of high blood pressure and swelling in pregnancy)

You have glaucoma or enlarged prostate, if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. [Taking other medicines

Do not take with any other paracetamol-containing products, if you are taking any of the following medicines, talk to your doctor or pharmacist before taking

•    Beta-blockers for high blood pressure, or vasodilators (drugs used to treat high blood pressure, leg pain due to vascular problems or Raynaud's syndrome)

*    Tricyclic anti-depressants (a specific class of drugs used to treat depression), other decongestants, or barbiturates (used to treat sleep problems or epilepsy)

>- -Cholestyramine (to -treat high-bleed ehelester-ol)-, meteclepr-amide and demperidene (to treat nausea -[ and vomiting)

^Taking this medicine with food and drink

Do not take with large quantities of alcohol.

[Pregnancy or breast-feeding

If you are-pregnant or breast-feeding-ask-your doetor or pharmacist for-adviee-befere-taking-this— medicine.

RB131228

1.3.1 Package Leaflet

Lemsip Cough Max for Chesty Cough and Cold Capsules National 500mg 6.1 mg 100mg

3. HOW TO TAKE THIS MEDICINE

i

[The capsule should be swallowed whole with water. Do not chew.

lit is important to drink plenty of liquid when suffering from colds and flu.

if symptoms persist for more than three days, or worsen, consult your doctor.

[If you take more of this medicine than you should    i

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too l much paracetamol can cause delayed, serious liver damage.

If you forget to take this medicine    i

This product should only be used when necessary. Do not take a double dosage to make up for a [forgotten dose.    ¹

If you have any further questions on the use of this product, ask your doctor or pharmacist.    [

[4. POSSIBLE SIDE EFFECTS

Like all medicines this product can cause side effects, although not everybody gets them.    [

_!? .Allergic reactions, (which may.include .skiiLrashes, swelling of face, lips,.tongue, or. difEculty.in____1_

i breathing). Stop taking the medicine at once and seek medical attention should any of the i | symptoms occur.    [ r

I    I ¹

i* Changes in the number of blood cells, such as thrombocytopenia (reduction in blood platelets which | might mean that you bleed or bruise more easily) or agranulocytosis (reduction in white blood cells [

| which make infections more likely),

-1* -Highrbloodpressurcwith headache,----------------------------------------------V

I

i® Nausea and vomiting,    |

|* Stomach discomfort,    i

i• Irregular or fast heartbeats,    '

'Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side    1

effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: [ lwww.mhra.gov.uk/yellowcard    i

[By reporting side effects, you can help provide more information on the safety of this medicine. ,

15. HOW TO STORE THIS MEDICINE    !

I

■ [Do~nofstore above 25°C.-------------------------------------------------------'r

[Keep out of the sight and reach of children.    i

[Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

[The expiry date refers to the last day of that month.    ¹

[Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to ¹ - [dispose- ofmedkines JW-longer-required. These measures will help-protect the-enviromnent--------l

6. FURTHER INFORMATION

I

[What this medicine contains:    i

_r The active ingredients per capsule are: paracetamol 500mg, guaifenesin lOOmg and phenylephrine '

[ hydrochloride 6. lmg.    i

_ l: _ The other ingredients .are: .maize starch, crqscarmello.se sodium, .sodium laurilsulfate., magnesium _ _ [_ i stearate, talc, gelatin, titanium dioxide (E171), yellow and red iron oxide (E172), brilliant blue -    ¹

[ FD&C blue 1 (E133) and shellac (E904).    [

[What the medicine looks like and the contents of the pack:

I

'The product is a hard gelatin capsule with a green body and a red cap with Lemsip printed on the cap. [ The product is available in cartons of 8 and 16 capsules.    [

[Marketing Authorisation Holder and Manufacturer:

jReckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS.    [

Product licence number: PL 00063/0716.

[Alternative format patient information for the visually impaired is available on request from the i jmarketing authorisation holder.    [

[Leaflet last revised June 2015_L_________________Lemsip, LemsipMax and (Q are trade marks._____|_

RB131228