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ERYTHROLAR (ERYTHROMYCIN) TABLETS 250MG

Active substance(s): ERYTHROMYCIN STEARATE

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

141011/2

Colours Used

Customer

Ennogen

Black

Description

Erythromycin Leaflet

Keyline

Market

UK

Language

English

Size

160 x 330 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

30

Date

16-01-18

Software

Coreldraw 1 2

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Erythrolar (Erythromycin) Tablets 250mg and 500mg
[Erythromycin]

Read all of this leaflet carefully before you start
for early stages of syphilis during pregnancy,
taking this medicine because it contains
and your child is under 1 year and is prescribed
important information for you.
erythromycin, consult your doctor before giving
!
Keep this leaflet. You may need to read it
erythromycin to your child
again.
!
Are treating a young child with antibiotics and
!
If you have any further questions, ask your
they are irritable or vomit when fed, you should
doctor, pharmacist or nurse.
contact your doctor immediately
!
This medicine has been prescribed for you
!
Suffer from a condition called myasthenia
only. Do not pass it on to others. It may harm
gravis, which causes muscle weakness,
consult your doctor before receiving
them, even if their signs of illness are the same
erythromycin
as yours.
!
!
Have previously experienced diarrhoea
If you get any side effects, talk to your doctor,
following the use of antibiotics
pharmacist or nurse. This includes any possible
!
Suffer with porphyria
side effects not listed in this leaflet. See section
4.
Other medicines and Erythrolar Tablets
Tell your doctor or pharmacist if you are taking,
What is in this leaflet:
have recently taken or might take any other
1. What Erythrolar Tablets are and what they
medicines, including those obtained without a
are used for
prescription.
2. What you need to know before you take
This is especially important if you are taking
Erythrolar Tablets
medicines from the following families:
3. How to take Erythrolar Tablets
4. Possible side effects
!
Astemizole, terfenadine or mizolastine (used to
5. How to store Erythrolar Tablets
treat allergies such as hayfever)
6. Contents of the pack and other information
!
Pimozide or amisulpride (used to treat mental
problems)
1. WHAT ERYTHROLAR TABLETS ARE AND
!
Ergotamine or dihydroergotamine (used to
WHAT THEY ARE USED FOR
relieve migraine)
!
Cisapride (used to treat stomach disorders)
!
Statins (used to lower cholesterol levels e.g.
Erythrolar Tablets are from the group of medicines
simvastatin and lovastatin)
called antibiotics and are useful in the treatment of
!
Protease inhibitors (used to treat viral infections
and prevention of bacterial infections including:
!
e.g. saquinavir)
Infections of the upper respiratory tract i.e.
!
Oral contraceptives
tonsillitis, pharyngitis, laryngitis, sinusitis and
!
Domperidone (used to treat nausea (feeling
secondary infections in colds and flu
!
sick) and vomiting (being sick)).
Infections of the lower respiratory tract i.e.
tracheitis, bronchitis and pneumonia
!
This is also important if you are taking medicines
Mouth infections i.e. gingivitis (inflamed gums)
!
called:
Eye infections i.e. blepharitis (inflammation of
!
Colchicine (used to treat gout and arthritis)
the eyelids)
!
!
Cimetidine and omeprazole (used to treat acid
Ear infections i.e. otitis media, otitis externa
reflux and related conditions)
and mastoiditis
!
!
Clarithromycin, rifabutin, or rifampicin
Skin and soft tissue infections
!
(medicnes used to treat different types of
Genito-urinary infections i.e. urethritis,
bacterial infection)
gonorrhoea, prostatitis
!
!
Fluconazole, ketoconazole and itraconazole
Prophylaxis pre- and post-operative trauma,
(medicnes used to treat fungal infections)
burns, rheumatic fever
!
!
Digoxin, quinidine or disopyramide (used to
Other infections such as scarlet fever,
diphtheria and infections of the bones
treat heart problems)
!
Cilostazol (a medicine used to treat peripheral
(osteomyelitis).
circulation problems)
2. WHAT YOU NEED TO KNOW BEFORE YOU
!
Hexobarbitone, phenobarbital or midazolam
TAKE ERYTHROLAR TABLETS
(used as sedatives)
!
Warfarin and acenocoumarol (used to help thin
the blood)
Do not take Erythrolar Tablets if you:
!
!
Valporate, carbamazepine or phenytoin (used
Are allergic to erythromycin or other macrolide
to control epilepsy)
antibiotics such as clarithromycin or
!
Theophylline (used to treat asthma and other
azithromycin or any of the other excipients of
breathing problems)
this medicine (listed in section 6)
!
!
Ciclosporin or tacrolimus (used following organ
Are taking antihistamines for allergies such as
transplants)
astemizole, terfenadine and mizolastine
!
!
Bromocriptine (used to treat Parkinsons
Are taking pimozide or amisulpride - medicines
disease)
to treat mental illness
!
!
Zopiclone or triazolam/alprazolam (used to help
Are taking ergotamine or dihydroergotamine for
you sleep or relieve states of anxiety)
migraine
!
!
Alfentanil (used for pain relief)
Are taking tolterodine to treat urinary
!
Methylprednisolone (used to help suppress the
incontinence
!
body's immune system, this is useful in treating
Are taking cisapride for stomach disorders
!
a wide range of conditions)
Are taking simvastatin to lower your cholesterol
!
!
St John's Wort (a herbal medicine used to treat
Are taking domperidone for nausea (feeling
depression)
sick) and vomiting (being sick).
!
Verapamil (used to treat high blood pressure
and chest pain)
Warnings and Precautions
!
Vinblastine (used to treat certain types of
Talk to your doctor before taking these tablets if
cancer)
you:
!
!
Sildenafil (used to treat erectile dysfunction).
Have any liver problems or have been told that
any drugs you are taking can cause liver
If you or your child goes for any medical tests,
problems
tell your doctor that you are taking Erythrolar
!
Are pregnant and have been told that you have
Tablets, as this may interfere with some test
a sexually transmitted disease called syphilis.
results.
In this case, erythromycin may not be effective
for preventing the transfer of this infection to
your baby. Consult your doctor before receiving
erythromycin. Alternatively if you were treated

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

141011/2

Colours Used

Customer

Ennogen

Black

Description

Erythromycin Leaflet

Keyline

Market

UK

Language

English

Size

160 x 330 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

30

Date

16-01-18

Software

Coreldraw 1 2

Packaging Development

Quality Assurance (QA)

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
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.
Erythromycin passes into breast milk. Talk to your
doctor before breastfeeding if you are taking these
tablets.
Driving and using machines
Do not drive or use machinery if you think you may
be affected by these tablets.
Erythrolar Tablets contain tartrazine (E102)
This 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. HOW TO TAKE ERYTHROLAR TABLETS
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
Adults : The usual dosage is 1000mg (4 x 250mg
or 2 x 500mg tablets) to 2000mg (8 x 250mg
tablets or 4 x 500mg 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 or with meals.
Use in children and adolescents: Follow your
doctor's instructions. Children are normally given
Erythromycin Suspension. However if tablets are
prescribed 30mg daily is given per kg of the child's
weight in divided doses. In severe infections the
dose may be raised to 50mg daily per kg of the
child's weight in divided doses.
If 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.
An overdose of Erythrolar could cause temporary
hearing loss, nausea, vomiting and diarrhoea.
If you stop taking Erythrolar Tablets
You may feel better after a few days, but you
should keep taking your tablets until the prescribed
course is finished. Your symptoms may come back
if you stop your treatment too soon.
If you forget to take Erythrolar Tablets
If 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 to make up for a
forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everyone gets them.

Quality Control (QC)

Production

Serious skin reaction: a red scaly rash
!
with bumps under the skin and blisters
(exanthematous pustulosis). The
frequency of this side effect is not
known (cannot be estimated from the
available data).

Other reported reactions include:
Changes in the blood (eosinophilia).
!
Symptoms include rashes, itching
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)
Reversible loss of hearing (usually associated
!
with high doses or in patients with kidney
problems)
Feeling sick, being sick, abdominal pain, loss of
!
appetite (anorexia)
Fever, feeling tired (malaise)
!
Confusion, seizures and vertigo (feeling that
!
everything around you is spinning)
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)
Vomiting and irritability in young children
!
between the age of 1 month and 12 months
!
Visual impairment/blurred vision (Mitochondrial
optic neuropathy).
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 the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play or Apple
App Store.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE ERYTHROLAR TABLETS
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the label. The expiry date refers
to the last day of that month.
Store in a cool dry place.
Do not use this medicine if you notice any visible
signs of deterioration.
Do not throw away any medicines via waste water
or household waste. Ask your pharmacist how to
throw away any medicines you no longer use.
These measures help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
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)
(see section 2) and red/erythrosine (E127). The
500mg tablets also contain amberlite and sodium
citrate.

If any of the following occur, STOP taking the
medicine and contact a doctor immediately:
What Erythrolar Tablets look like and contents
!
Allergic reactions may occur with symptoms
of the pack
such as rash, itching, swelling of the face,
Erythrolar Tablets 250mg are pink tablets supplied
wheeziness, shortness of breath, tightness in
in bulk pots of 500 tablets.
the chest, fever, low blood pressure and feeling
Erythrolar Tablets 500mg are pink tablets supplied
dizzy when standing up
in bulk pots of 100 tablets.
!
Severe skin reactions such as erythema
However, the amount dispensed will be changed
multiforme (a red rash caused by
according to your prescription.
hypersensitivity to a drug, disease or allergen),
Steven's Johnson syndrome (a severe
inflammatory eruption of the skin and mucous
Marketing Authorisation Holder
membranes) and Toxic Epidermal Necrolysis
Ennogen Pharma Limited
(large areas of the skin become intensely red
Unit G4, Riverside Industrial Estate,
and begin to peel)
Riverside Way, Dartford, DA1 5BS, UK.
!
Liver problems, a yellow discolouration of the
eyes and skin (jaundice) and abnormal liver
The manufacturer and batch release site
function tests. These will be picked up by the
Regent-gm Laboratories Limited
doctor
Cunard Road, North Acton, London
!
Diarrhoea which may be severe or prolonged
and may contain blood or mucus
NW10 6PN, United Kingdom
!
Severe abdominal pain (pancreatitis)
!
Abnormal heart rhythms including palpitations
This leaflet was last revised in January 2018.
(torsade de pointes)

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