PACKAGE LEAFLET: INFORMATION FOR THE USER

Clamodin 500 mg Film-coated Tablets

Clarithromycin
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Clamodin is and what it is used for
What you need to know before taking Clamodin
How to take Clamodin
Possible side effects
How to store Clamodin
Contents of the pack and other information

1. What Clamodin is and what it is used for

Clamodin contains clarithromycin, an active substance belonging to a group of medicines called macrolide antibiotics. Antibiotics are medicines that block the growth of bacteria causing infections.
Clamodin is indicated in adults and adolescents over 12 years of age for the treatment of:

respiratory tract infections, such as bronchitis and pneumonia;
throat infections (tonsillitis, pharyngitis) and infections of the paranasal sinuses;
skin and soft tissue infections, for example impetigo, folliculitis, erysipelas, furunculosis and infected wounds;
infections due to certain bacteria called Mycobacterium;
Helicobacter pylori infection (a bacterium associated with stomach and duodenal ulcers).

2. What you need to know before taking Clamodin

Do not take Clamodin if:

You are allergic to clarithromycin, to other types of macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6).
You are taking ergotamine or dihydroergotamine, medicines used for headache. Combining these medicines with Clamodin may cause serious adverse effects. Consult your doctor, who will advise alternative treatments.
You are taking a medicine containing lomitapide.
You are taking astemizole or terfenadine (medicines commonly used for hay fever or allergies) or cisapride or domperidone (medicines used for stomach disorders) or pimozide (a medicine used for mental health conditions). Combining these medicines with Clamodin may cause serious disturbances in heart rhythm. Consult your doctor, who will advise alternative treatments.
You are taking ticagrelor (a medicine used to make the blood less sticky) or ranolazine (a medicine used for heart disease). Consult your doctor, who will advise alternative treatments.
You are taking midazolam (a medicine used as an anaesthetic) or colchicine (a medicine used in gout). Combining these medicines with Clamodin may cause serious adverse effects. Consult your doctor, who will advise alternative treatments.
You are taking lovastatin or simvastatin (a type of statin), medicines used to reduce cholesterol levels in the blood. Combining these medicines with Clamodin may cause serious muscle problems. Consult your doctor, who will advise alternative treatments.
You have or have had the following heart problems: QT prolongation or ventricular cardiac arrhythmia.
You have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
You have severe liver problems associated with kidney problems.

Warnings and precautions
Talk to your doctor before taking Clamodin if:

You are elderly (over 65 years of age).
You have liver or kidney problems.
You have a fungal infection (e.g. oral thrush) or know you are at risk of developing one.
You have heart disease, for example severe heart failure or problems with the blood vessels of the heart (coronary artery disease).
You have heart rhythm problems or a slow heart rate (bradycardia).
You are taking other medicines that may cause ear damage (ototoxic). In such cases, your doctor may recommend tests to monitor vestibular and hearing function.
You are pregnant or breastfeeding.

Other medicines and Clamodin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Clamodin must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazina, colchicine, certain medicines for high cholesterol, or medicines known to cause serious disturbances in heart rhythm (see section "Do not take Clamodin if").
Do not take Clamodin if you are also taking midazolam, a medicine used as an anaesthetic.
It is particularly important that you inform your doctor if you are taking:

Medicines for heart problems such as digoxin.
Medicines used for heart rhythm (antiarrhythmics) such as quinidine, disopyramide.
Calcium channel blockers such as verapamil, amlodipine, diltiazem, used for high blood pressure.
Warfarin or any other anticoagulant, such as dabigatran, rivaroxaban, apixaban (used to thin the blood), cilostazol.
Medicines for epilepsy (phenytoin, carbamazepine, phenobarbital, valproate).
St. John’s wort, used for depression or anxiety.
Medicines used for HIV infection, such as efavirenz, etravirine, nevirapine, ritonavir, zidovudine.
Rifampicin, rifabutin, rifapentine, medicines used for bacterial infections.
Itraconazole and fluconazole, medicines used for fungal infections.
Zidovudine and saquinavir, antiviral medicines.
Triazolobenzodiazepines, such as alprazolam, triazolam, medicines used for anxiety.
Atypical antipsychotics, such as quetiapine, medicines used for schizophrenia or other mental disorders.
Sirolimus, tacrolimus and ciclosporin, medicines used to suppress the immune system.
Medicines used to lower blood sugar levels (oral hypoglycaemics/insulin), such as nateglinide and repaglinide.
Other types of statins (other than lovastatin or simvastatin), medicines used to reduce cholesterol levels in the blood.
Omeprazole, a medicine used for certain stomach disorders, such as ulcers.
Theophylline, a medicine that helps breathing.
Methylprednisolone, a corticosteroid.
Ibrutinib or vinblastine, medicines used to treat cancer.
Tolterodine, a medicine used for urinary incontinence.
Medicines that cause an electrocardiogram abnormality known as long QT syndrome or torsades de pointes.
Ergot alkaloids, used, for example, for headache.
Medicines used for erectile dysfunction such as sildenafil, tadalafil and vardenafil.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine, as the safety of Clamodin during pregnancy and breastfeeding is not known.

Driving and using machines:
Clamodin may cause dizziness, vertigo, confusion and disorientation. Make sure you do not experience these adverse effects before driving or operating machinery.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Clamodin

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
For respiratory infections, throat or sinus infections, skin or soft tissue infections
The recommended dose of Clamodin for adults and children over 12 years of age is 1 tablet, taken
twice daily (every 12 hours), for 5–14 days.
For infections due to Mycobacterium
The recommended dose of Clamodin for adults is 1 tablet, taken twice daily. In special cases (e.g.
patients with AIDS), your doctor may advise you to take additional medicines together with Clamodin.
For infections due to Helicobacter pylori
Your doctor may prescribe one of the following treatment regimens:

1 tablet of Clamodin, taken twice daily together with omeprazole (20 mg once daily) and amoxicillin (1000 mg twice daily), for 7–10 days;
1 tablet of Clamodin, taken twice daily together with lansoprazole (30 mg twice daily) and amoxicillin (1000 mg twice daily), for 10 days;
1 tablet of Clamodin, taken three times daily together with omeprazole (40 mg once daily), for 14 days, followed by 1 tablet of KLACID, taken three times daily together with omeprazole (20–40 mg once daily), for another 14 days;
1 tablet of Clamodin, taken three times daily together with lansoprazole (60 mg once daily), for 14 days. Your doctor may use other medicines different from those listed above.

Method of administration
Clamodin is to be taken by mouth (oral use).
Patients with severe kidney problems
If you have severe kidney problems (creatinine clearance value less than 30 ml/min), your doctor will
prescribe a lower dose than that indicated above.
Children
Clamodin 500 mg film-coated tablets are not recommended for children and adolescents under 12
years of age. In such cases, use clarithromycin 125 mg/5 ml or 250 mg/5 ml oral granules for suspension in
a bottle equipped with a dosing spoon or oral syringe.
If you take more Clamodin than you should
You may experience stomach or intestinal problems.
If you take high doses of Clamodin, or if a child accidentally swallows some tablets, contact your
doctor immediately or go to the nearest hospital.
If you forget to take Clamodin
If you forget to take your dose at the scheduled time, take it as soon as possible.
However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to
make up for the forgotten one.
If you stop taking Clamodin
It is important that you continue taking this medicine for the full duration prescribed by your doctor. Do
not stop treatment just because you feel better, as your symptoms may return or worsen.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Clamodin immediately and contact your doctor if you experience any of the following conditions:

Severe allergic reactions: swelling (angioedema) of the face, eyes, lips, tongue and throat, breathing difficulties, increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions).
Severe skin rashes with redness, blistering and peeling, mouth, lip and skin ulcers (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Skin rash with fever and abnormalities in blood or lungs or heart or liver (DRESS syndrome).
Weight loss, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain (possible signs of liver problems such as hepatitis, cholestasis, liver failure).
Severe or prolonged diarrhoea, blood in diarrhoeic stools, even up to 2 months after the last dose (possible signs of pseudomembranous colitis caused by a bacterium called Clostridioides difficile).

Contact your doctor immediately if you experience a severe skin reaction: red, scaly rash with formation of pustules and blisters (exanthematous pustulosis). The frequency of this reaction is unknown (cannot be estimated from available data).
Contact your doctor if, during treatment with Clamodin, you notice the following:

Common side effects (may affect up to 1 in 10 people):

Difficulty falling asleep (insomnia).
Changes in taste sensation, headache.
Diarrhoea, vomiting, nausea, indigestion, abdominal pain.
Abnormal liver function tests.
Excessive sweating.
Skin rash.

Uncommon side effects (may affect up to 1 in 100 people):

Candida infections, vaginal infections.
Reduced number of white blood cells in the blood or reduced number of certain types of white blood cells called neutrophils (which may increase the risk of infections).
Increased number of certain types of white blood cells called eosinophils (eosinophilia).
Anorexia, decreased appetite.
Anxiety, dizziness, vertigo, drowsiness, tremor.
Ringing in the ears (tinnitus), hearing disturbances.
Changes in electrocardiogram (prolonged QT interval), sensation of "pounding heart".
Inflammation of the mouth or tongue, dry mouth, inflammation of the stomach (gastritis), abdominal distension, difficulty passing stools (constipation), belching, presence of gas in the intestine (flatulence).
Itching, urticaria.
Malaise, feeling of lack of strength (asthenia), fatigue, chest pain, chills.
Abnormal blood tests: increased blood alkaline phosphatase, increased blood lactate dehydrogenase, increased transaminases (alanine aminotransferase and aspartate aminotransferase), increased gamma-glutamyltransferase.

Other side effects

Skin infection (erysipelas).
Reduced platelet levels in the blood (increasing the risk of bruising or bleeding).
Decreased number of certain types of white blood cells called granulocytes (agranulocytosis).
Changes in perception of reality (psychotic disorder) or of self (depersonalization), confusion, depression, disorientation, hallucinations (seeing things that are not real), abnormal dreams, mania, seizures, disturbances in smell (ageusia, parosmia, anosmia), numbness or a "tingling" sensation (paraesthesia).
Hearing loss.
Changes in heart rhythm (torsades de pointes, ventricular tachycardia, ventricular fibrillation).
Bleeding.
Inflammation of the pancreas.
Change in the colour of the tongue or teeth.
Acne.
Muscle disorders (myopathy) such as loss of muscle tissue (rhabdomyolysis). Abnormal urine colour, kidney problems such as inflammation or kidney failure.
Changes in certain laboratory tests: increased international normalized ratio, prolonged prothrombin time.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clamodin

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the
last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clamodin contains
The active substance is clarithromycin.
Each Clamodin film-coated tablet contains 500 mg of clarithromycin.
The other components of the tablet are:
sodium croscarmellose, pregelatinized starch, microcrystalline cellulose, anhydrous colloidal silica, povidone,
stearic acid, magnesium stearate, talc, hypromellose, propylene glycol, sorbitan monoleate, vanillin, titanium
dioxide (E-171), hydroxypropyl-cellulose, sorbic acid.
Description of the appearance of Clamodin and contents of the pack
Film-coated tablets.
Carton pack containing 14 tablets in blisters.
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy