Patient leaflet - Clamelle 500 mg tablets
1. What Clamelle is and what it is used for
Clamelle contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics known as macrolides, which block the growth of susceptible bacteria.
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, erythromycin, any macrolide or ketolide antibiotic, 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.
Warnings and precautions
Talk to your doctor or, pharmacist before taking Clamelle if you have or have had any of the following conditions:
- heart problems (e.g. problems with your heart rhythm or cardiac insufficiency) or low levels of potassium or magnesium in your blood: these conditions may contribute to serious cardiac side effects of azithromycin
Read all of this leaflet carefully before you take this medi cine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told 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 talk to a doctor if you do not feel better or if you feel worse.
- liver problems: your doctor may need to monitor your liver function or stop the treatment
- severe diarrhoea after administration of any other antibiotics
- localised muscle weakness (myasthenia gravis), as the symptoms of this disease may worsen during treatment
- if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with Clamelle.
Stop taking this medicine and contact your doctor immediately (see also “Serious side effects” in section 4):
- if you feel you are having an allergic reaction (e.g. difficulty in breathing, swelling of the face or throat, rash, blistering).
- if you notice any of the symptoms as described in section 4 related to serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which have been reported in association with azithromycin treatment.
- if you feel you have an abnormal heartbeat or palpitations, get dizzy or faint when taking Clamelle.
- if you develop signs of liver problems (e.g. dark urine, loss of appetite or yellowing of the skin or whites of the eyes).
if you develop severe diarrhoea during or after treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues or reappears within
the first weeks after treatment, please also inform your doctor.
Superinfection
Your doctor may observe you for signs of additional bacterial or fungal infections that cannot be treated with Clamelle (superinfection).
Sexually transmitted infections
Your doctor may test for and exclude a potential infection with syphilis, a sexually transmitted disease that may otherwise progress undetected and be diagnosed delayed. Furthermore, in any case of sexually transmitted bacterial infections your doctor will initiate laboratory follow-up tests to monitor the success of therapy.
If you weigh less than 45 kg, other medicinal products containing azithromycin exist that may be more convenient for you to take.
Other medicines and Clamelle
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Clamelle if you are taking any of these other medicines:
- disopyramide (for irregular heartbeat)
- terfenadine (for hayfever or allergies)
- azithromycin for any other infections e.g. chest, sinuses, ear, skin.
Taking Clamelle at the same time as some other medicines may result in side effects. Therefore, it is particularly important that you tell your doctor or pharmacist if you are using any of the following 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.
- nelfinavir (for HIV infection)
- atorvastatin and other medicines from the statins group (to lower blood cholesterol and prevent heart disease, including heart attacks and strokes)
- ciclosporin (to prevent rejection of organ transplants by the body)
- colchicine (to treat gout and familial Mediterranean fever)
- dabigatran (to prevent and treat blood clot formation (anticoagulant))
- digoxin (to treat heart diseases)
- warfarin or similar medicines used to thin the blood (anticoagulants)
medicines that may cause the heart muscle to take longer to contract and relax than usual (QT prolongation), such as the following:
quinidine, procainamide, dofetilide, amiodarone and sotalol (to treat an irregular heartbeat,
including a too fast or too slow heartbeat - cardiac arrhythmia)
- pimozide (to treat mental illness)
- citalopram (to treat depression)
- moxifloxacin and levofloxacin (antibiotics)
- cisapride (to treat disorders in the gastrointestinal tract)
- hydroxychloroquine or chloroquine (to treat autoimmune diseases including rheumatoid
arthritis, or to treat or prevent malaria)
If you are taking any regular medication and are unsure, check with your doctor or pharmacist.
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 or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will decide if you should take this medicine during pregnancy, only after making sure that the benefits outweigh the potential risks.
Breast-feeding
Clamelle passes into breast milk. Your doctor will decide therefore whether you should stop breast-feeding or should avoid treatment with Clamelle taking into account both the benefit of breast-feeding for your child and the benefit of therapy for you.
Driving and using machines
Clamelle has a moderate influence on the ability to drive and use machines. Clamelle has been reported to cause dizziness, drowsiness and seizures, as well as problems with seeing and hearing in some people. These possible side effects may have an influence on your ability to drive and use machines.
3. How to take Clamelle
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The pack contains two tablets.
Take both Clamelle tablets together as a single dose. These should be taken by mouth, swallowed whole with some water, with or without a meal. Taking this medicine just before a meal may help make it easier on your stomach. 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.
If your weight is less than 45 kg or you are not able to swallow this medicinal product, ask your doctor or pharmacist as other medicinal products containing azithromycin are also available that may be more appropriate for you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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.
Stop using Clamelle and seek medical attention immediately if you notice any of the following symptoms:
- sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching especially affecting the whole body (anaphylactic reaction, frequency not known)
- rapid or irregular heartbeat (cardiac arrhythmia or torsades de pointes tachycardia, frequency not known)
- dark urine, loss of appetite or yellowing of the skin or whites of the eyes, which are signs of liver disorders (hepatic failure or hepatic necrosis (frequency not known))
- severe diarrhoea with abdominal cramps, bloody stools and/or fever may mean that you have an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take medicines against diarrhoea that inhibit the bowel movements (antiperistaltics).
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis, frequency not known).
- widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare (may affect up to 1 in 1,000 people)).
- a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis, rare (may effect up to 1 in 1,000 people)).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Very common (may affect more than 1 in 10 people):
- diarrhoea
Common (may affect up to 1 in 10 people):
- headache
- being sick (vomiting), stomach pain, feeling sick (nausea)
- changes in blood test results (lymphocyte count decreased, eosinophil count increased, basophil count increased, monocyte count increased, neutrophil count increased, blood bicarbonate decreased)
Uncommon (may affect up to 1 in 100 people):
- thrush (candidiasis) - a fungal infection of the mouth and vagina, other fungal infections
- pneumonia, bacterial infection of the throat, inflammation of the gastrointestinal tract, respiratory disorder, inflammation of the mucous membrane inside the nose, vaginal infection
- changes in the number of white blood cells (leukopenia, neutropenia, eosinophilia)
- platelet count increased
- reduction in the proportion of all blood cells in the total blood volume (hematocrit decreased)
- allergic reactions, swelling of the hands, feet and face (angiooedema)
- lack of appetite
- nervousness, difficulty sleeping (insomnia)
- feeling dizzy, feeling drowsy (somnolence), change in your sense of taste (dysgeusia), sensation of pins and needles or numbness (paraesthesia)
- impaired vision
- ear disorder
- spinning sensation (vertigo)
- feeling your heartbeat (palpitations)
- hot flush
- sudden wheeziness, bleeding from the nose
- constipation, wind, impaired digestion (dyspepsia), inflammation of the lining of the stomach (gastritis), difficulty in swallowing (dysphagia), swollen belly, dry mouth, belching (eructation), mouth ulceration, increased salivation
- rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
- swelling and pain in the joints (osteoarthritis), muscle pain, back pain, neck pain
- painful urination (dysuria), kidney pain
- menstrual bleeding at irregular intervals (metrorrhagia), testicular disorder
- swelling due to fluid retention, especially of the face, ankles and feet (oedema, face oedema, peripheral oedema)
- weakness, tiredness, general feeling of being unwell, fever
- chest pain, pain
- abnormal laboratory test results (e.g. blood or liver tests)
- postprocedural complication
Rare (may affect up to 1 in 1,000 people):
- feeling irritated
- liver problems, yellowing of the skin or eyes
- increased sensitivity to sunlight
Not known (frequency cannot be estimated from the available data):
- reduced number of red blood cells due to increased cell breakdown which can cause tiredness and pale skin (haemolytic anaemia)
- reduction in number of platelets which can lead to bleeding and bruising (thrombocytopenia)
- feeling angry, aggressive, feeling of fear and concern (anxiety), acute confusional state (delirium),
- hallucination
- fainting (syncope)
- fits (seizures)
- reduced sensation to touch, pain and temperature (hypoaesthesia)
- feeling hyperactive
- change in your sense of smell (anosmia, parosmia)
- total loss of your sense of taste (ageusia)
- muscle weakness (myasthenia gravis)
- abnormal electrocardiogramm (ECG) heart tracing (QT prolongation)
- deafness, reduced hearing or ringing in your ears (tinnitus)
- low blood pressure
- inflammation of the pancreas causing severe pain in the belly and back (pancreatitis)
- your tongue changes colour
- joint pain (arthralgia)
- kidney inflammation (interstitial nephritis) and kidney failure
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 Website: 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 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, 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 2026