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CLAMELLE 500MG TABLETS

Active substance(s): AZITHROMYCIN DIHYDRATE / AZITHROMYCIN DIHYDRATE / AZITHROMYCIN DIHYDRATE

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Package leaflet: Information for the patient
Clamelle® 500mg Tablets
Azithromycin
Read all of this leaflet carefully before you take this medicine 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 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.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor or specialist if you develop symptoms.
What is in this leaflet
1. What Clamelle is and what it is used for
2. What you need to know before you take Clamelle
3. How to take Clamelle
4. Possible side effects
5. How to store Clamelle
6. Contents of the pack and other information
7. Important information about chlamydia and other sexual health advice
1. What Clamelle is and what it is used for
The ingredient which makes this medicine work is a ‘macrolide’ antibiotic called azithromycin.
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.
2.

What you need to know before you take Clamelle
Do not take Clamelle but see a doctor instead if you:
• are allergic to azithromycin, other ‘macrolide’ antibiotics or any of the other ingredients of this
medicine(listed in section 6)
• are under 16 years of age
• have tested positive and also have symptoms of chlamydia such as
– pain when urinating or having sex
– unusual vaginal discharge (in women) or discharge from penis (in men)
– bleeding after sex or between periods (in women)
– pain below your belly button (in women) or in your testicles (in men)
• symptoms suggestive of other STIs, such as unusual lumps, bumps, blisters or sores around the genital or
anal area
• are or may be pregnant or are breast feeding
• have liver, kidney or heart problems
• have myasthenia gravis.
If you have diarrhoea or suffer from stomach problems after taking Clamelle, please see your doctor
or pharmacist.
Other medicines and Clamelle
Do not take Clamelle if you are taking any of these other medicines:
• ergotamine or dihydroergotamine (for migraine or poor blood flow)
1

• warfarin (to thin the blood)
• disopyramide (for irregular heart beat)
• rifabutin (for tuberculosis)
• ciclosporin (to help prevent rejection of transplanted organs, or for use in arthritis or skin problems)
• digoxin (for heart disorders)
• theophylline (for asthma)
• terfenadine (for hayfever or allergies)
• azithromycin for any other 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
• oral contraceptives (the ‘pill’) – 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).
• indigestion remedies – take 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.
• pimozide (for mental illness)
• nelfinavir (for HIV infection)
If you are taking any regular medication and are unsure, check with your doctor or pharmacist.
Driving and using machines
Clamelle can cause dizziness and sleepiness. Make sure you are not affected before you drive or operate
machinery.
3. How to take Clamelle
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.
After treatment
• Contact your doctor, Genito-Urinary Medicine (GUM) clinic or community sexual health clinic if you
think you have come into contact with chlamydia again or if symptoms develop.
• Ensure any sexual partners are also tested and treated before you have sex with them, otherwise you are at
risk of catching chlamydia again.
• 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.
4. Possible side effects
Like many medicines, this medicine can cause side effects, although not everybody gets them. 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.
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
• skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of
internal organs (liver, lungs, heart, kidneys and large intestine ) as they may be signs of a hypersensitivity
reaction (drug reaction or rash with eosinophilia and systemic symptoms (DRESS))
• severe skin rash that causes blistering (this can affect the mouth and tongue). These may be signs of a
condition known as Stevens Johnson syndrome (SJS), or toxic epidermal necrolysis (TEN).

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Very common (occurs in more than 1 in 10 users): diarrhoea, stomach pain, feeling sick, wind.
• Common (occurs in less than 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.
• Uncommon (occurs in less than 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, 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.
• Rare (occurs in less than 1 in 1,000 users): agitation, restlessness, changes in liver function or jaundice
(yellowing of the skin or whites of the eyes).
• Not known: reduction of red 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,
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).
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Clamelle
Keep this medicine out of the sight and reach of children. Store below 25°C (room temperature) in the
original package. Do not use this medicine after the expiry date which is stated on the carton after EXP. The
expirty date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Clamelle tablets contain
• The active substance is 500mg of azithromycin.
• The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, maize starch,
pregelatinised starch, microcrystalline cellulose, sodium laurylsulfate, magnesium stearate, polysorbate 80,
talc, indigotin (E132) and titanium dioxide (E171).
What Clamelle looks like and contents of the pack
Pale blue, oblong, biconvex film-coated tablets, with imprint PLIVA on one side and 500 on the other side.
Blisters (PVC/Al foil) packed in a carton box containing 2 tablets.

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.
How do you get it?
Chlamydia is easily passed from one person to another through sexual contact. The infection is most
commonly spread through:
• unprotected vaginal, anal or oral sex
• sharing sex toys if you don’t 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.
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:
• pelvic inflammatory disease which can seriously affect the womb or fallopian tubes
• scarring or damage to the fallopian tubes causing pain or infertility (problems getting pregnant)
• increased risk of ectopic pregnancies (when pregnancy develops outside the womb)
• infection in the liver, causing pain and inflammation.
In men:
• painful infection in the testicles and possible reduced fertility.
In men and women:
• rarely, inflammation of the 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.

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.
Other important sexual health advice
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.

Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
PLIVA, Hrvatska d.o.o./PLIVA Croatia Ltd
Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia

This leaflet was last revised in February 2017

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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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