Lemsip Cough Max For Mucus Cough & Cold 500mg/100mg/6.1mg Capsules

Document: leaflet MAH BRAND 2_PL 00063-0551 change

Reckitt Benckiser

Pharmacode Reads This Way

Package leafleUTnformafion for the user i

¹ Lemsin Cough Max for Mucus Cough & Cold 500 mg/100me/6.1mg Capsules |

Each capsule contains Paracetamol, Guaifenesin and Phenylephrine Hydrochloride '

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

“[This inecticme is" avallaBFe withdut prescripfioh.Tlowever^ you still need fo”take this medicine carefully i to get the best results from it.

r Keep this leaflet. You may need to read it again. j

]- Ask your pharmacist if you need more information or advice. i

^L You must contact your doctor if your symptoms worsen or do not improve after 3 days. j

i- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please j - 4ell yeur-docter-or-pharmaeist;--------------------------------------------------1 -

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 i 4. Possible side effects

! 5. How to store this medicine

j-----------6.-Further-infbrmatien-------------------------------------------

!l. 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 Jcongestion, lowering of temperature and chesty cough.

Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains, including 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)

reduces swelling in the passages of the nose, relieving nasal congestion and reducing pressure which ¹ — - - jnay cause a headache.

_____, 2- BEFOSE-YOU TAKE IHIS-MEDICINE________________________________________

Do not take this medicine if:

* You are pregnant or breast-feeding.

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

_!•_ You_haye_a_s_eripus heart con<htion,_or_an_pveractiyeJhyroid._____________________________

i* You have a high blood pressure (hypertension).

* You are taking or have taken within the last 14 days a medicine called a monoamine oxidase

i inhibitor (MAOI), usually used to treat depression.

Take special care with this medicine if:

r You suffer from liver or kidney prohlemSj heart disease.________________________________

i* You suffer from Raynaud’s syndrome (poor blood circulation which makes the fingers or toes pale I and numb), or diabetes mellitus.

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

| liver disease.

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

i* 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.

H-------------------------------------------------------------------------

* Do not take with any other product used for relief of colds, flu or congestion.

If you are taking any of the following medicines, talk to your doctor or pharmacist before taking iLemsip Cough Max for Mucus Cough & Cold 500 mg/100mg/6.1mg Capsules:

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

Tricyclic anti-depressants (a^_specificrclass^_ofdrugs'usedto treat depression),^- other decongestants,—r i or barbiturates (used to treat sleep problems or epilepsy)

!■ Some drugs may affect the way paracetamol works, including those used to treat blood cholesterol , i (cholestyramine) and nausea and vomiting (metoclopramide and domperidone). Some drugs may ] affect the way in which phenylephrine works (digoxin and cardiac glycosides) '

f The effect of blood thinning drugs (warfarin and other coumarins) may be increased by paracetamol.^

¹ I

Taking this medicine with food and drink: i

^ Do not take with large quantities of alcohol. i

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1.3.2 Mock-up

Lemsip All In one DCP capsules 0211405

Lemsip All In one DCP capsules 0211405 amendment

3. HOW TO TAKE THIS MEDICINE

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

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

Age	Dose and how often to take
Adults and children 16 years and over	Take two capsules every 4-6 hours. Do not exceed eight capsules in a total of 24 hours.
Children 12 to 15 years	Take one capsule every 4-6 hours. Do not exceed four capsules in a total of 24 hours.
Do not give to children under 12 years of age

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 | much paracetamol can cause delayed, serious liver damage.

If you forget to take this medicine: i

- Irhis-product-should-only be used when neeessary_r Drmot take-a double desageTe make np-for a-----l

[forgotten dose. i

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

l4. POSSIBLE SIDE EFFECTS |

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

-1- - Allergie reactions-(whieh may-inelude-skin-rashesj swelling-of Tace; lips,-tengue-or-diffieulty-ifi----¹-

| breathing)

i Stop taking the medicine at once and seek medical attention should any of the symptoms occur. 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), leucopoenia, pancytopenia, neutropenia and i agranulocytosis (reduction in white blood cells which make infections more likely). I

_ I__ _ __ ________ __ _ _______________________________________________!

» High blood pressure with headache.

]• Nausea and vomiting. i

i i

r Stomach discomfort ¹

1 ¹

'• Irregular or fast heartbeats.

l _ Difficulty in passing^urine (in men only^__________________________________________i_

^f any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell' your doctor or pharmacist. Also you can help to make sure that medicines remain as safe as possible byl reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you] can call Freephone 0808 100 3352 (available from 10am to 2pm Mondays to Fridays) or fill in a paper 1 [form available from your local pharmacy. 1

- HOW-TO-STORE IHIK MEDICINE-------------------------------------------l

po not store above 25°C. I

Keep out of the reach and sight of children. 1

Po not use this medicine after the expiry date which is stated on the carton and blister after EXP. 1 iThe expiry date refers to the last day of that month.

- Medieines should nof be- disposed-ofvia wastewater-or household waste.-Ask yourpharmaeist how To - ]-dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

ftVhat this medicine contains: 1

1 1

r The active ingredients per capsule are: paracetamol 500mg, guaifenesin lOOmg and phenylephrine ¹

- ]- - hydrochloride fklmg.--------------------------------------------------------h

^L The other ingredients are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium ]

1 stearate, talc, gelatin, titanium dioxide (E171), yellow and red iron oxide (E172), brilliant blue - ¹

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

1 ¹

What the medicine looks hke and the contents of the pack:

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

[NZ: The product is available in cartons of 16 capsules. 1