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Erythrolar (Erythromycin) Tablets 250mg

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PACKAGE LEAFLET: INFORMATION FORTHE USER


_ _ _ _ _ n nogen PharmaI


| Erythrolar (Erythromycin) Tablets 250mg and 500mg

[Erythromycin]


|Read all of this leaflet carefully before you start taking this medicine because it contains limportant information for you.

•    Keep this leaflet. You may need to read it again.

» If you have any further questions, ask your 1 doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only.

I Do not pass it on to others. It may harm them,

, even if their signs of illness are the same as I yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

I

In this leaflet:

|1. What Erythrolar Tablets are and what they are used for

|2. What you need to know before you take Erythrolar Tablets |3. How to take Erythrolar Tablets 4. Possible side effects i5. Howto store ErythrolarTablets 6. Contents of the pack and further information


1. WHAT ERYTHROLAR TABLETS ARE AND WHATTHEYARE USED FOR


Erythrolar Tablets are from the group of medicines balled antibiotics and are useful in the treatment of and prevention of bacterial infections including:

|# Infections of the upper respiratory tract i.e.

tonsillitis, pharyngitis, laryngitis, sinusitis and | secondary infections in colds and flu

•    Infections of the lower respiratory tract i.e.

| tracheitis, bronchitis and pneumonia

•    Mouth infections i.e. gingivitis (inflamed gums)

•    Eye infections i.e. blepharitis (inflammation of the eyelids)

b Ear infections i.e. otitis media, otitis externa and 1 mastoiditis

•    Skin and soft tissue infections

l Genito-urinary infections i.e. urethritis,

I gonorrhoea, prostatitis

l Prophylaxis pre- and post-operative trauma, burns, rheumatic fever

L Other infections such as scarlet fever, diptheria and infections of the bones (osteomyelitis).


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROLARTABLETS


|Do not take ErythrolarTablets if you:

• Are hypersensitive (allergic) to erythromycin or any of the other ingredients of Erythrolar Tablets. (See section 6)

b Are taking antihistamines for allergies such as 1 astemizole, terfenadine and mizolastine b Are taking pimozide or amisulpride - medicines to ' treat mental illness

b Are taking ergotamine or dihydroergotamine for I migraine

b Are taking tolterodine to treat urinary I incontinence

b Are taking cisapride for stomach disorders b Are taking simvastatin to loweryourcholesterol.

gamings and Precautions

Talk to your doctor before taking these tablets if you: b Have liver problems


b A muscle disorder called myasthenia gravis b Have previously experienced diarrhoea following the use of antibiotics.

Other medicines and ErythrolarTablets.

Please tell your doctor or pharmacist or nurse if you are taking or have recently taken, any other medicines, including those obtained without a prescription.

In particular, tell yourdoctor ifyou are taking any of the following:

b anticoagulants to thin your blood e.g. warfarin, acenocoumarol

b the antibiotic clarithromycin, used to treat certain bacterial infections

b zopiclone, a medicine used to help you sleep b theophylline, a medicine used to treat breathing disorders such as asthma b alfantanil, hexobarbitone used as anaesthetics b bromocriptine used in the treatment of parkinsons disease, neuroleptic malignant syndrome

b carbamazepine, phenytoin, phenobarbital, valproate used to treat epilepsy b cyclosporin, tacrolimus used after organ transplants

b digoxin, disopyramide, quinidine, verapamil used to treat heart disorders b midazolam, triazolam, alprazolam used to treat insomnia

b cilostazol used to treat muscle pain b methylprednisolone used to treat arthritis, bronchitis

b omeprazole used to treat dyspepsia b rifabutin used to treat tuberculosis b sildenafil used to treat erectile dysfunction b vinblastine used to treat certain cancers b fluconazole, ketoconazole, itraconazole used to treat fungal infections

b rifampicin, penicillin, cephalosporins, clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines, colistin used to treat bacterial infections

b herbal remedies e.g. St John's wort used to treat depression b contraceptive pill b colchicine used to treat gout b cimetidine used to treat stomach disorders.

DO NOT TAKE Erythrolar Tablets ifyou are also taking astemizole, terfenadine, mizolastine, pimozide, amisulpride, ergotamine, dihydroergotamine, tolterodine, cisapride or simvastatin.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant or are breastfeeding.

If you are pregnant and treated with Erythrolar Tablets for early syphilis, you should talk to your doctor as erythromycin may not be effective in preventing the infection affecting the baby.

Driving and using machines

Do not drive or use machinery ifyou think you may be affected by these tablets.


Important information about one of the ingredients

This medicine contains tartrazine (E102) which may cause allergic reactions. If you have been told by your doctor that you have an intolerance to or are allergic to tartrazine you should talk to your doctor before taking this medicine.


3. HOWTO TAKE ERYTHROLARTABLETS


^Iways take Erythrolar Tablets exactly as your doctor has instructed you. You should check with your poctor or pharmacist if you are unsure.

Adults: The usual dosage is 1000mg (4 x 250mg or 2 x500mg tablets) to 2000mg (8 x 250mg tablets or 4 x i500mg tablets) per day. This is divided into 6, 8 or 12 hourly doses. The dose may be increased to up to 4000mg (16 x 250mg tablets or 8 x 500mg tablets) per day for severe infections. Tablets should be |taken before orwith meals.

Children: Follow your doctor's instructions. Children ere normally given Erythromycin Suspension. However if tablets are prescribed 30mg daily is given her kg of the child's weight in divided doses. In severe infections the dose may be raised to 50mg baily per kg of the child's weight in divided doses.


Changes in your heart beat and rhythm, chest pains, dizziness, palpitations, low) blood pressure

Hearing disorders including deafness and a ringing in the ears (tinnitus)

Feeling sick, being sick, abdominal pain, loss of appetite Fever, feeling tired (malaise)

Confusion, seizures and vertigo (feeling that everything around you is spinning)    I

Seeing or hearing things that are not— — there (hallucinations)    |

Kidney disorders such as interstitial nephritis (a disorder where spaces between the kidney| tubules become swollen or inflamed).


Reporting of side effects

If you get any side effects, talk to your doctorj 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.    I

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


5. STORING ERYTHROLAR TABLETS


|lf you take more Erythrolar Tablets than you should

This medicine is to be taken at regular intervals, as determined by the physician. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.


You may feel better after a few days, but you should keep taking yourtablets until the prescribed course is finished. Your symptoms may come back if you stop ^ourtreatmenttoo soon.

If you forget to take Erythrolar Tablets

|lf you have forgotten to take a dose, take the missed dose as soon as you remember, unless it is almost |time for your next dose, and carry on as before. Do not take a double dose.


Do not take this medicine after the expiry date stated| on the label.

Store in a cool dry place.    |

In case of any visible signs of deterioration, you should discard the package.    |

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to| dispose of medicines no longer required. These measures help to protect the environment.    I

Keep out of the sight and reach of children |


6. CONTENTS OF THE PACK AND OTHER INFORMATION


4. POSSIBLE SIDE EFFECTS


Like all medicines, Erythrolar Tablets can cause side pffects, although not everyone gets them.

.If any of the following occur, STOP taking the medicine and contact a doctor immediately:

.• Allergic reactions may occur with symptoms such as rash, itching, swelling of the face, wheeziness, shortness of breath, tightness in the I chest, fever, low blood pressure and feeling dizzy when standing up

|* Severe skin reactions such as erythema multiforme (a red rash caused by hypersensitivity | to a drug, disease or allergen), Steven's Johnson syndrome (a severe inflammatory eruption of the skin and mucous membranes) and Toxic Epidermal Necrolysis (large areas of the skin i become intensely red and begin to peel

Liver problems, a yellow discolouration of the i eyes and skin (jaundice) and abnormal liver I function tests. These will be picked up by the I doctor

L Diarrhoea which may be severe or prolonged and may contain blood or mucus

•    Severe abdominal pain (pancreatitis)

•    Abnormal heart rhythms including palpitations I (torsade depointes).

Other reported reactions include:

•    Changes in the blood (eosinophilia). Symptoms | include rashes, itching


What Erythrolar Tablets contain:

Erythrolar Tablets 250mg and 500mg contain the| active substance erythromycin stearate equivalent to erythromycin BP 250mg and 500mg in each tablet] respectively.

The other ingredients are: povidone, magnesium stearate, maize starch, talc, microcrystalline| cellulose, cellulose acetate phthalate, polyethylene glycol 6000, castor oil, triacetin, tartrazine (E102)| and red/erythrosine (E127). The 500mg tablets also contain amberlite and sodium citrate.    |

What Erythrolar Tablets look like and contents of] the pack

Erythrolar Tablets 250mg are pink tablets supplied ini bulk pots of 500 tablets

Erythrolar Tablets 500mg are pink tablets supplied ini bulk pots of 100 tablets.

However, the amount dispensed will be changed] according to your prescription.

MarketingAuthorisation Holder

Ennogen Pharma Limited UnitG4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.    |

The manufacturer and batch release site    |

Regent-gm Laboratories Limited Cunard Road, North Acton, London NW10 6PN, United Kingdom

This leafletwas last amended in July 2013.    .


SIZE :160X 270 (mm) Back