CLAMELLE 500MG TABLETS

Active substance: AZITHROMYCIN DIHYDRATE

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500mg Tablets
Azithromycin

Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to take Clamelle carefully to get the best results from it.
• Keep this leaflet. You may

need to read it again.
• If any of the side effects

gets serious, or if you notice
any side effect not listed in
this leaflet, please tell your
doctor or pharmacist.

• Ask your pharmacist if you

need more information or
advice.
• You must contact a

doctor or specialist if you
develop symptoms.

3. How to take Clamelle

In this leaflet
1. 
What Clamelle is and what it
is used for
2. Before you take Clamelle
3. How to take Clamelle
4. Possible side effects
5. How to store
6.  urther information on
F
Clamelle
7. mportant information about
I
chlamydia and other sexual
health advice

The pack contains two tablets.
Take both tablets together as a
single dose with a glass of water
before you go to bed and at least
2 hours after food or any other
drink besides water. If you are sick
(vomit) within 3 hours of taking
your dose, they might not work
properly, so ask your pharmacist
or doctor for advice.
You should not delay treatment.
If you have to wait before taking
them, see section 5 for storage
conditions.

1.  hat Clamelle is and
W
what it is used for

After treatment

The ingredient which makes this
medicine work is a ‘macrolide’
antibiotic called azithromycin.

•  ontact your doctor, GenitoC
Urinary Medicine (GUM) clinic or
community sexual health clinic
if you think you have come into
contact with chlamydia again
or if symptoms develop.
•  nsure any sexual partners
E
are also tested and treated
before you have sex with them,
otherwise you are at risk of
catching chlamydia again.
• f you, or your partner have
I
been treated for chlamydia do
not have sex (oral, vaginal, anal
or using sex toys), even with a
condom for 7 days after taking
Clamelle.

Clamelle is used to treat the
sexually transmitted infection (STI)
called Chlamydia trachomatis
in people aged 16 years or
over, who have tested positive
but have no symptoms and in
treatment of their sexual partners.
To buy Clamelle you must have
had a positive chlamydia test
result and have no symptoms
or be a sexual partner of
someone who has had a
positive chlamydia test result,
and have no symptoms. If you
have symptoms contact your
pharmacist for advice.

4. Possible side effects

Like many medicines, Clamelle
may occasionally cause
side effects. However, this is
usually with longer courses of
azithromycin treatment. Do not
be alarmed by this list, you may
not experience any of them. If
you are worried speak to your
pharmacist.

2. Before you take Clamelle
Do not take Clamelle but see
a doctor instead if you:

•  re allergic to azithromycin,
a
other ‘macrolide’ antibiotics or
any ingredient in the product
(see section 6)
• 
are under 16 years of age
•  ave tested positive and also
h
have symptoms of chlamydia
such as
–  ain when urinating or having
p
sex
–  nusual vaginal discharge (in
u
women) or discharge from
penis (in men)
–  leeding after sex or between
b
periods (in women)
–  ain below your belly button
p
(in women) or in your testicles
(in men)
•  ymptoms suggestive of other
s
STIs, such as unusual lumps,
bumps, blisters or sores around
the genital or anal area
•  re or may be pregnant or are
a
breast feeding
•  ave liver, kidney or heart
h
problems
•  ave myasthenia gravis.
h

Contact your doctor or nearest
casualty department immediately
if you have a rare but serious
allergic reaction such as swelling
of the body, face, lips or throat.
Very occasionally, these effects
may be severe causing shortness
of breath, shock or collapse.
Tell your doctor if you notice any
of the following side effects or
notice any other effects not listed:
•  ery common (occurs in more
V
than 1 in 10 users): diarrhoea,
stomach pain, feeling sick, wind.
•  ommon (occurs in less than
C
1 in 10 users): lack of appetite
(anorexia), dizziness, headache,
sensation of pins and needles
or numbness (paraesthesia),
changes in your sense of taste,
visual impairment, deafness,
being sick, indigestion, rash,
itchy rash (pruritis), joint pain,
tiredness, change in the
quantity of the white blood
cells and the concentration of
bicarbonate in the blood.
•  ncommon (occurs in less than
U
1 in 100 users): reduction in the
number of white blood cells,
increase in the number of white
blood cells, thrush (candidiasis),
oral thrush, vaginal infection,
pneumonia, fungal infection,
bacterial infection, inflammation
of the throat (pharyngitis),
stomach flu (gastroenteritis),
breathlessness, chest pain,
wheeze and cough (respiratory
disorder), inflammation of the
mucous membrane inside the
nose (rhinitis), nervousness,
having difficulty sleeping
(insomnia), reduced sense
of touch, feeling drowsy
(somnolence), hearing loss or
ringing in your ears, ear disorder,
‘spinning’ sensation (vertigo),
palpitations, hot flushes,
difficulty breathing, nosebleed,
constipation, inflammation of
the stomach lining (gastritis),
difficulty swallowing, swollen
abdomen, dry mouth, belching,
mouth ulcer, increased salivary
flow, inflammation of the liver
(hepatitis) causing yellowing of
the skin or eyes or tiredness, pain
in abdomen, joint or muscles,
Stevens Johnson Syndrome
(more severe form of erythema
multiforme), sensitivity to
sunlight, itchy skin rash caused
by allergic reaction - pale or
red irregular raised patches
with severe itching (urticaria),
inflammation of the skin
(dermatitis), dry skin, excessive
sweating, pain, swelling and
reduced motion in your joints
(osteoarthritis), muscle pain,
back pain, neck pain, painful
urination, pain in your kidney,
spotting, testicular disorder,
face swelling, chest pain, fever,
nerve pain, swelling (oedema),
general feeling of being unwell,
weakness, change in liver
enzyme levels and blood levels,
post procedural complications.
•  are (occurs in less than 1
R
in 1,000 users): agitation,
restlessness, changes in liver

If you have diarrhoea or suffer
from stomach problems after
taking Clamelle, please see your
doctor or pharmacist.

Do not take Clamelle if you
are taking any of these other
medicines:
•  rgotamine or
e
dihydroergotamine (for
migraine or poor blood flow)
•  arfarin (to thin the blood)
w
•  isopyramide (for irregular heart
d
beat)
• ifabutin (for tuberculosis)
r
•  iclosporin (to help prevent
c
rejection of transplanted
organs, or for use in arthritis or
skin problems)
•  igoxin (for heart disorders)
d
•  heophylline (for asthma)
t
•  erfenadine (for hayfever or
t
allergies)
•  zithromycin for any other
a
infections e.g. chest, sinuses,
ear, skin.

You can still take Clamelle
but may need to take extra
care if you are taking these
medicines:

•  ral contraceptives (the ‘pill’) –
o
if you get sickness or diarrhoea
whilst taking Clamelle your ‘pill’
may not prevent you becoming
pregnant. You will need to read
the ‘pill’ instruction leaflet to
take the right action. Do not
have sex, even with a condom,
for seven days after taking
Clamelle (see section 3).
• ndigestion remedies – take
i
Clamelle at least 1 hour before
or 2 hours after the indigestion
remedy. Clamelle will not work
as well if both are taken too
close together.
•  imozide (for mental illness)
p
•  elfinavir (for HIV infection)
n
If you are taking any regular
medication and are unsure,
check with your doctor or
pharmacist.

Driving and operating
machinery:
Clamelle can cause dizziness and
sleepiness. Make sure you are
not affected before you drive or
operate machinery.

Continued top of next column
AAAF5339

Continued over page

Azithromycin (Clamelle) 500mg tablets PIL - UK
item no:
print proof no:
origination date:

AAAF5339
4
20.06.13

originated by:
approved for print/date

7.8.13

1. Black
110 x 500

min pt size:

revised by:
supplier:

db
PLIVA

2. Cyan
3. Magenta

pharmacode:

4.
7pt

5.
6.

DR

revision date:

dimensions:

colours/plates:

Non Printing Colours

Technical Approval
date sent:

20.06.13

technically app. date:

25.06.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

500mg Tablets
Azithromycin

function or jaundice (yellowing
of the skin or whites of the eyes).
•  ot known: reduction of red
N
blood cells due to destruction
(haemolytic anaemia),
reduction in number of
platelets (thrombocytopenia),
inflammation of the
lining of large intestine
(pseudomembranous colitis,
you might get diarrhoea,
stomach cramps, fever, blood in
the stools), aggression, anxiety,
confusion, hallucination,
fainting, fits, muscle spasms,
changes in smell and taste,
disorder characterised by
muscle weakness, difficulty
chewing or swallowing and
slurred speech (myasthenia
gravis), changes of the
heart rhythm found by an
electrocardiogram (QT
prolongation and torsade
de pointes), rapid or irregular
heart beat, low blood pressure,
inflammation of the pancreas
causing pain and tenderness
in the abdomen and back,
discoloration of the tongue, liver
failure (which has rarely resulted
in death) or liver disease, toxic
epidermal necrolysis (red painful
rash that looks like a scald and
may cause peeling of the skin),
erythema multiforme (raised
red patches on the skin which
may blister), kidney failure or
inflammation (increased need
to urinate at night, muscle
twitching and cramps, loss of
appetite, feeling or being sick,
unpleasant taste in mouth).

If you have symptoms or you think
you may have another infection,
consult your doctor or local GUM
clinic or community sexual health
clinic for further investigation and
treatment.

Why is treatment important?
It is very important to get treated
for chlamydia. If left untreated
the infection can spread to other
parts of the body and develop
into more serious problems such
as:

In women:
•  elvic inflammatory disease
p
which can seriously affect the
womb or fallopian tubes
•  carring or damage to the
s
fallopian tubes causing pain
or infertility (problems getting
pregnant)
• ncreased risk of ectopic
i
pregnancies (when pregnancy
develops outside the womb)
• nfection in the liver, causing
i
pain and inflammation.

In men:
•  ainful infection in the testicles
p
and possible reduced fertility.

In men and women:
• arely, inflammation of the
r
joints (reactive arthritis). This is
sometimes accompanied by
inflammation of the urethra and
the eye, when it is known as
Reiter’s syndrome.
Each time you have chlamydia
you are at increased risk of serious
problems. If you have already
had chlamydia in the last 6
months you should see a doctor. If
left untreated you can also infect
your partner.

You can help make sure that
medicines remain as safe
as possible by reporting any
unwanted side effects via the
internet at www.mhra.gov.uk/
yellowcard; alternatively you can
call Freephone 0808 100 3352
(available between 10am to 2pm
Monday to Friday) or fill in a paper
form available from your local
pharmacy.

Can it be prevented?
Use a condom during sex to
reduce the risk of getting or
passing on not just chlamydia,
but other sexually shared
infections, such as HIV, syphilis and
gonorrhoea.
If you, or your partner have been
treated for chlamydia do not
have sex (oral, vaginal, anal
or using sex toys), even with a
condom for 7 days after taking
Clamelle, otherwise you can
become re-infected. Avoid using
sex toys. If you do share them,
wash them or cover them with a
new condom before anyone else
uses them.

5. How to store Clamelle

Keep in a secure place out of
reach and sight of children. Store
below 25°C (room temperature)
in the original package. Do not
use after the expiry date shown
on the pack.

Other important sexual health
advice

6. Further information on
Clamelle

Using a condom will help reduce
your risk of getting or passing on
chlamydia and other sexually
shared infections (STIs).
If you have tested positive for
chlamydia, you are also at higher
risk of other STIs. It is important
that you visit your GUM clinic or
community sexual health clinic
to be tested for these. Your
pharmacist can tell you how to
go about this.
If you have tested positive for
chlamydia, then it is important
that your current sexual partner
and any previous, but recent
partners are also tested and
treated. They should also receive
advice from a healthcare
professional. There are a number
of ways that partners can be
contacted confidentially- your
pharmacist can tell you how to
go about this. You are strongly
advised to tell your partner(s), but
it is not compulsory.

What Clamelle tablets
contain

•  ach tablet contains 500mg
E
of azithromycin (the active
ingredient that makes the tablet
work).
•  he tablets also contain
T
calcium hydrogen phosphate
(anhydrous), hypromellose,
maize starch, pregelatinised
starch, microcrystalline cellulose,
sodium laurylsulfate, magnesium
stearate, polysorbate 80, talc,
indigotin (E132) and titanium
dioxide (E171).

7. More about chlamydia
and other important sexual
health advice
What is it?
Chlamydia is an extremely
common sexually transmitted
infection (STI) caused by a
bacteria called Chlamydia
trachomatis which is found in
the semen and vaginal fluids of
men and women who have the
infection. It infects the neck of
womb (cervix) in women, the
tube that drains the bladder of
urine (urethra) and the back
passage (rectum) in both women
and men.
Chlamydia affects between 1
in 10 and 1 in 100 people and is
most common in people aged 16
to 25 years.

Marketing Authorisation Holder
Actavis Group PTC ehf,
Reykjavíkurvegi 76-78,
220 Hafnarfjörður, Iceland.
Manufacturer
Teva Operations Poland Sp. z o.o,
ul, Mogilska 80, 31-546 Krakow,
Poland.
This leaflet was last revised in
August 2013

How do you get it?
Chlamydia is easily passed from
one person to another through
sexual contact. The infection is
most commonly spread through:
•  nprotected vaginal, anal or
u
oral sex
•  haring sex toys if you don’t
s
wash them or cover them with a
new condom each time they’re
used.
It can also be passed on fingers
to your eyes after touching the
genital area. A mother can also
pass the infection to her baby
during childbirth.

Are there any symptoms?
Chlamydia is a ‘silent’ condition;
as many as 70% of infected
individuals have no symptoms,
so it can stay hidden for many
months or years. Those who do
have symptoms may have any of
the following:
In women: unusual vaginal
discharge, a need to pass urine
more often, pain when passing
urine or during sexual intercourse,
pain below the belly button or
bleeding between periods or
after sex.
In men: pain and/or burning
when passing urine, discharge
from the penis, irritation at the tip
of the penis or swelling and pain
in the testicles.
In men and women: if the
infection is in the rectum, there
are rarely any symptoms but
it may cause discomfort and
discharge.

Azithromycin (Clamelle) 500mg tablets PIL - UK
item no:
print proof no:
origination date:

AAAF5339
4
20.06.13

originated by:
approved for print/date

7.8.13

1. Black
110 x 500

min pt size:

revised by:
supplier:

db
PLIVA

2. Cyan
3. Magenta

pharmacode:

4.
7pt

5.
6.

DR

revision date:

dimensions:

colours/plates:

Non Printing Colours

Technical Approval
date sent:

20.06.13

technically app. date:

25.06.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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