CLAMODIN 250 mg Tabletki Powlekane

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1. Clamodin 500 mg Film-coated Tablets
   1. What is Clamodin and what it is used for
   2. What you need to know before taking Clamodin
   3. How to take Clamodin
   4. Possible side effects
   5. How to store Clamodin
   6. Contents of the pack and other information

Clamodin 500 mg Film-coated Tablets

Clarithromycin
Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1.What Clamodin is and what it is used for
• 2.What you need to know before you take Clamodin
• 3.How to take Clamodin
• 4.Possible side effects
• 5.How to store Clamodin
• 6.Contents of the pack and other information

1. What is Clamodin and what it is used for

Clamodin contains clarithromycin, an active ingredient belonging to a group of medicines called
macrolide antibiotics. Antibiotics are medicines that stop the growth of bacteria that cause infections.
Clamodin is indicated in adults and adolescents over the age of 12 years to treat:

• respiratory infections, such as bronchitis and pneumonia;
• throat infections (tonsillitis, pharyngitis) and infections of the paranasal sinuses;
• skin and tissue infections, for example impetigo, folliculitis, erysipelas, furuncles and infected wounds;
• infections caused by some bacteria called Mycobacterium;
• infection by Helicobacter pylori(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 headaches. The combination of these medicines with Clamodin can cause serious side effects. Consult your doctor who will advise you on alternative medicines.
• You are taking a medicine containing lomitapide.
• You are taking astemizole or terfenadine (medicines widely used for hay fever or allergies) or cisapride or domperidone (medicines used for stomach disorders) or pimozide (medicine used for mental problems). The combination of these medicines with Clamodin can cause serious heart rhythm disturbances. Consult your doctor who will advise you on alternative medicines.

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• You are taking ticagrelor (medicine used to make the blood more fluid) or ranolazine (medicine used for heart disease). Consult your doctor who will advise you on alternative medicines.
• You are taking midazolam (medicine used as an anesthetic) or colchicine (medicine used for gout). The combination of these medicines with Clamodin can cause serious side effects. Consult your doctor who will advise you on alternative medicines.
• You are taking lovastatin or simvastatin (a type of statin), medicines used to reduce cholesterol levels in the blood. The combination of these medicines with Clamodin can cause serious muscle problems. Consult your doctor who will advise you on alternative medicines.
• You have or have had the following heart problems: prolongation of the QT interval or ventricular cardiac arrhythmia.
• You have abnormally low levels of potassium or magnesium in the 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 old).
• You have liver or kidney problems.
• You have a fungal infection (e.g., thrush) or know that you are at risk for this condition.
• You have heart disease, for example, you suffer from severe heart failure or have problems with the blood vessels of the heart (coronary artery disease).
• You have heart rhythm problems or have a slowing of the heartbeat (bradycardia).
• You are taking other medicines that can cause damage to the ears (ototoxic). In this case, your doctor may prescribe tests to check your vestibular and hearing functions.
• 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 available without a prescription.
Clamodin must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone,
pimozide, ticagrelor, ranolazine, colchicine, some medicines for the treatment of high cholesterol and
medicines known to cause serious heart rhythm disturbances (see the section “Do not take Clamodin if”).
Do not take Clamodin if you are also taking midazolam, a medicine used as an anesthetic.
It is particularly important that you tell 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 in bacterial infections.
• Itraconazole and fluconazole, medicines used in fungal infections.
• Zidovudine and saquinavir, medicines against viruses.
• Triazolobenzodiazepines, for example alprazolam, triazolam, medicines used for anxiety.
• Atypical antipsychotics, for example quetiapine, medicines used for schizophrenia or other mental disorders. Pag. 2 a 6
• Sirolimus, tacrolimus and cyclosporine, medicines used to suppress the immune system.
• Medicines used to lower blood sugar levels (oral hypoglycemic agents/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 for cancer treatment.
• Tolterodine, a medicine used for urinary incontinence.
• Medicines that cause a change in the electrocardiogram called prolonged QT syndrome or torsade de pointes.
• Ergot alkaloids, used for example for headaches.
• Medicines used in impotence such as sildenafil, tadalafil and vardenafil.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine as the safety of Clamodin during
pregnancy and breastfeeding is unknown.

Driving and operating machinery:
Clamodin can cause dizziness, vertigo, confusion and disorientation. Make sure you do not experience these
side effects before driving vehicles 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

For respiratory infections, throat infections or sinus infections, skin or tissue infections
The recommended dose of Clamodin for adults and children over 12 years of age is 1 tablet, 2 times a
day (every 12 hours), for 5-14 days.

For infections due toMycobacterium
The recommended dose of Clamodin for adults is 1 tablet, 2 times a day. In particular cases (e.g.
patients with AIDS), your doctor may advise you to take other medicines together with Clamodin.

For infections due toHelicobacter pylori
Your doctor may prescribe one of the therapieslisted below:

• 1 tablet of Clamodin, 2 times a day taken together with omeprazole (20 mg, 1 time a day) and amoxicillin (1000 mg, 2 times a day), for 7-10 days;
• 1 tablet of Clamodin, 2 times a day taken together with lansoprazole (30 mg, 2 times a day) and amoxicillin (1000 mg, 2 times a day), for 10 days;
• 1 tablet of Clamodin, 3 times a day taken together with omeprazole (40 mg, 1 time a day), for 14 days. Subsequently 1 tablet of KLACID, 3 times a day taken together with omeprazole (20-40 mg, 1 time a day), for another 14 days;
• 1 tablet of Clamodin, 3 times a day taken together with lansoprazole (60 mg, 1 time a day), for 14 days. It is possible that your doctor may use other medicines different from those listed above. Pages 3 to 6

Method of administration
Clamodin must 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 the one indicated above.

Children
Clamodin 500 mg coated tablets are not recommended for children and adolescents under 12
years of age. In this case, use clarithromycin 125 mg/5 ml or 250 mg/5 ml granules for oral suspension in
a bottle equipped with a teaspoon or dosing 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 the dose of medicine at the scheduled time, take it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to
make up for the forgotten one.

If you stop the treatment with Clamodin
It is important that you take this medicine until the end of the treatment prescribed by your doctor. Do not
stop treatment just because you feel better, as your symptoms may return or
worsen.
If you have any doubts about 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 everybody gets them.
Stop taking Clamodin immediately and contact your doctor if any of the following
conditions occur:

• Severe allergic reactions: swelling (angioedema) of the face, eyes, lips, tongue and throat, difficulty breathing, increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions).
• Severe skin rashes with redness, blistering and peeling, ulceration of the mouth, lips and skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Skin rash with fever and changes in blood or lungs or heart or liver (DRESS syndrome)
• Weight loss, yellowish discoloration 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 diarrhea, presence of blood in diarrheal stools, even 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 and
scaly rash with the formation of pustules and blisters (pustular exanthematous rash). The frequency of this reaction is
not known (cannot be assessed based on available data).

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Contact your doctor if you notice the appearance of the following during therapy with Clamodin:

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

• Difficulty falling asleep (insomnia).
• Changes in taste, headache.
• Diarrhea, vomiting, nausea, indigestion, abdominal pain.
• Changes in liver function tests.
• Excessive sweating.
• Appearance of a rash.

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

• Infections due to Candida, vaginal infections.
• Reduction in the number of white blood cells in the blood or the number of certain types of white blood cells called neutrophils (which may make infections more likely).
• Increase in the number of certain types of white blood cells called eosinophils (eosinophilia).
• Anorexia, decreased appetite.
• Anxiety, dizziness, vertigo, drowsiness, tremor.
• Ringing in the ears, hearing impairment.
• Changes in the electrocardiogram (prolongation of the QT interval), feeling of “heart racing”.
• Inflammation of the mouth or tongue, dry mouth, inflammation of the stomach (gastritis), abdominal distension, difficulty evacuating (constipation), belching, presence of gas in the intestine (flatulence).
• Itching, hives.
• Feeling unwell, lack of strength (asthenia), fatigue, chest pain, chills.
• Changes in blood tests: increased blood alkaline phosphatase, increased lactic dehydrogenase, increased transaminases (alanine aminotransferase and aspartate aminotransferase), increased gamma-glutamyl transferase.

Other side effects

• Skin infection (erysipelas).
• Reduction in platelet levels in the blood (with increased risk of bruising or bleeding).
• Decrease in the number of certain types of white blood cells called granulocytes (agranulocytosis).
• Changes in the perception of reality (psychotic disorder) or of oneself (depersonalization), confusion, depression, disorientation, hallucinations (seeing things that are not real), abnormal dreams, mania, convulsions, changes in smell (ageusia, parosmia, anosmia), numbness or a sensation of “pins and needles” (paresthesia).
• Hearing loss.
• Changes in heart rhythm (torsade de pointes, ventricular tachycardia, ventricular fibrillation).
• Bleeding.
• Inflammation of the pancreas.
• Change in the color of the tongue or teeth.
• Acne.
• Muscle disorders (myopathy) such as loss of muscle tissue (rhabdomyolysis). Abnormal urine color, kidney problems such as inflammation or failure.
• Changes in certain laboratory tests such as: increased international normalized ratio, prolonged prothrombin time.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at 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.

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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 pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clamodin contains
The active ingredient is clarithromycin.
Each film-coated tablet of Clamodin 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.
Cardboard box containing 14 tablets in blisters.

Marketing Authorisation 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

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