Clarmac

Patient Information Leaflet

CLARMAC 500 mg film-coated tablets

Clarithromycin
Generic Medicine
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CLARMAC is and what it is used for

CLARMAC 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.
CLARMAC 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, erysipelas, folliculitis, 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 CLARMAC

Do not take CLARMAC 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 migraine headaches. Combining these medicines with Clarmac may cause serious side effects. Consult your doctor, who will advise alternative treatments;
• you are taking terfenadine or astemizole (medicines widely used for hay fever or allergies), pimozide (a medicine used for mental disorders), or cisapride or domperidone (medicines used for stomach disorders). Combining these medicines with Clarmac may cause serious disturbances in heart rhythm. Consult your doctor, who will advise alternative treatments;
• you are taking ticagrelor, ivabradine, or ranolazine (for angina or to reduce the risk of heart attack or stroke). 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 Clarmac may cause serious side 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 Clarmac may cause serious muscle problems. Consult your doctor, who will advise alternative treatments;
• you have or have had the following heart problems: QT interval prolongation or ventricular cardiac arrhythmia;
• you have low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia);
• you are taking a medicine containing lomitapide;
• you have severe liver problems associated with kidney problems.

Warnings and precautions
Talk to your doctor before taking CLARMAC 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 this condition;
• you have heart diseases, for example severe heart failure or problems with the heart's blood vessels (coronary artery disease);
• you have problems with your heart rhythm or a slow heart rate (bradycardia);
• you are taking other medicines that may cause ear damage (ototoxic). In such cases, your doctor may prescribe tests to monitor vestibular and hearing function;
• you are pregnant or breastfeeding.

Other medicines and CLARMAC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
CLARMAC must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines for high cholesterol, and medicines known to cause serious disturbances in heart rhythm (see section "Do not take CLARMAC if").
Do not take CLARMAC 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;
• oral anticoagulant medicines (blood thinners), such as warfarin or any other anticoagulant, for example dabigatran, rivaroxaban, apixaban, edoxaban, 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, and 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 cyclosporine, medicines used to suppress the immune system;
• medicines used to lower blood sugar levels (oral hypoglycaemic 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;
• corticosteroids administered orally, by injection, or by inhalation (used to help suppress the body's immune system – this is useful in treating a wide range of conditions);
• ibrutinib or vinblastine, medicines used for cancer treatment;
• tolterodine, a medicine used for urinary incontinence;
• medicines that cause an electrocardiogram alteration called long QT syndrome or torsades de pointes;
• ergot alkaloids, used, for example, for migraine headaches;
• medicines used for erectile dysfunction, such as sildenafil, tadalafil, and vardenafil;
• hydroxychloroquine or chloroquine (used for treating conditions including rheumatoid arthritis or for the treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other heart-related side effects.

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

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

Clarmac contains
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
This medicine contains 4 mg of propylene glycol per tablet, equivalent to 8 mg per maximum recommended dose (2 tablets).

3. How to take CLARMAC

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 tissue infections
The recommended dose of Clarmac for adults and adolescents over 12 years of age is 1 tablet, twice daily (every 12 hours), for 5–14 days.

For infections due to Mycobacterium
The recommended dose of Clarmac for adults is 1 tablet, twice daily. In special cases (e.g. patients with AIDS), your doctor may advise you to take other medicines in addition to Clarmac.

For infections due to Helicobacter pylori
Your doctor may prescribe one of the following treatment regimens:

• 1 tablet of Clarmac, twice daily, taken together with omeprazole (20 mg, once daily) and amoxicillin (1000 mg, twice daily), for 7–10 days;
• 1 tablet of Clarmac, twice daily, taken together with lansoprazole (30 mg, twice daily) and amoxicillin (1000 mg, twice daily), for 10 days;
• 1 tablet of Clarmac, three times daily, taken together with omeprazole (40 mg, once daily), for 14 days, followed by 1 tablet of Clarmac, three times daily, taken together with omeprazole (20–40 mg, once daily), for an additional 14 days;
• 1 tablet of Clarmac, three times daily, taken together with lansoprazole (60 mg, once daily), for 14 days.

Your doctor may use other medicines different from those listed above.

Method of administration
Clarmac is to be taken by mouth (oral use).

Patients with severe renal impairment
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
Clarmac 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 granules for oral suspension in a bottle equipped with a dosing spoon or oral syringe.

If you take more CLARMAC than you should
If you take too much of this medicine, contact your doctor immediately or go to the nearest hospital.
In case of overdose, you may experience stomach or intestinal problems.
If you take high doses of CLARMAC, or if a child accidentally swallows some tablets, contact your doctor immediately or go to the nearest hospital.

If you forget to take CLARMAC
If you forget to take a 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 tablet.

If you stop treatment with CLARMAC
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 doubts 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 gets them.
Stop taking Clarmac immediately and contact your doctor if you experience any of the following:

• severe allergic reactions: swelling (angioedema) of the face, eyes, lips, tongue, or throat; breathing difficulties; increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions);
• severe skin rashes with redness, blistering, and skin peeling; mouth, lip, or skin ulcers (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• skin rash with fever and blood abnormalities or involvement of lungs, 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, presence of blood in diarrhoeal 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 pustules and blisters (exanthematous pustulosis). The frequency of this reaction is unknown (cannot be estimated from the available data).
Contact your doctor if, during treatment with Clarmac, you notice any of 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;
• changes in liver function tests;
• excessive sweating;
• development of skin rash.

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

• Candida infections, vaginal infections;
• reduction in the number of white blood cells in the blood or in the number of certain types of white blood cells called neutrophils (which may increase the risk of infections);
• increase in the number of certain white blood cells called eosinophils (eosinophilia);
• anorexia, decreased appetite;
• anxiety, dizziness, vertigo, drowsiness, tremor;
• ringing in the ears (tinnitus), hearing disturbances;
• changes in electrocardiogram (prolongation of QT interval), sensation of "pounding heart";
• inflammation of the mouth or tongue, dry mouth, inflammation of the stomach (gastritis), abdominal bloating, 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;
• changes in blood tests: increased blood alkaline phosphatase, increased blood lactate dehydrogenase, increased transaminases (alanine aminotransferase and aspartate aminotransferase), increased gamma-glutamyltransferase.

Other side effects
Not known (frequency cannot be estimated from the available data):

• 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);
• loss of hearing;
• 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 kidney inflammation or kidney failure;
• changes in certain laboratory tests such as: increased international normalized ratio (INR), prolonged prothrombin time.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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.

5. How to store CLARMAC

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 CLARMAC contains
The active substance is clarithromycin. Each film-coated tablet contains 500 mg of
clarithromycin.
The other components are:
Tablet core: croscarmellose sodium, pregelatinized starch, microcrystalline cellulose,
anhydrous colloidal silicon dioxide, povidone, stearic acid, magnesium stearate, talc.
Coating: hypromellose, propylene glycol, sorbitan monoleate, vanillin, titanium dioxide (E-
171), hydroxypropyl-cellulose, sorbic acid.
Description of the appearance of CLARMAC and pack contents
Film-coated tablets for oral use. This medicinal product is available in a pack containing 14 white, oval, biconvex film-coated tablets with a breakline. The breakline is intended only to facilitate breaking the tablet for easier swallowing and not to divide it into two equal parts.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) – Italy.
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 - Anagni (FR) – Italy.

Package leaflet: Information for the patient

CLARMAC 250 mg film-coated tablets

Clarithromycin
Generic Medicine
Please read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What CLARMAC is and what it is used for
2. What you need to know before taking CLARMAC
3. How to take CLARMAC
4. Possible side effects
5. How to store CLARMAC
6. Package contents and other information

1. What CLARMAC is and what it is used for

CLARMAC 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.
CLARMAC 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, erysipelas, folliculitis, furunculosis, and infected wounds;
• infections of the mouth and teeth.

2. What you need to know before taking CLARMAC

Do not take CLARMAC 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 migraine headaches. Combining these medicines with Clarmac may cause serious adverse effects. Consult your doctor, who will advise alternative treatments;
• you are taking terfenadine or astemizole (widely used medicines for hay fever or allergies), pimozide (a medicine used for mental disorders), or cisapride or domperidone (medicines used for stomach disorders). Combining these medicines with Clarmac may cause serious disturbances in heart rhythm. Consult your doctor, who will advise alternative treatments;
• you are taking ticagrelor, ivabradine, or ranolazine (for angina or to reduce the risk of heart attack or stroke). Consult your doctor, who will advise alternative treatments;
• you are taking midazolam (a medicine used as an anaesthetic) or colchicine (a medicine used for gout). Combining these medicines with Clarmac 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 lower blood cholesterol levels. Combining these medicines with Clarmac may cause serious muscle problems. Consult your doctor, who will advise alternative treatments;
• you have or have had the following heart problems: QT interval prolongation or ventricular cardiac arrhythmia;
• you have low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia);
• you are taking a medicine containing lomitapide;
• you have severe liver problems associated with kidney problems.

Warnings and precautions
Talk to your doctor before taking CLARMAC 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 this condition;
• you have heart diseases, for example severe heart failure or problems with the heart's blood vessels (coronary heart 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 prescribe tests to monitor vestibular and hearing function;
• you are pregnant or breastfeeding.

Other medicines and CLARMAC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
CLARMAC must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines for high cholesterol, or medicines known to cause serious disturbances in heart rhythm (see section "Do not take CLARMAC if").
Do not take CLARMAC 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;
• oral anticoagulant medicines (blood thinners), such as warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban, edoxaban, 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, and 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 cyclosporine, 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 lower blood cholesterol levels;
• omeprazole, a medicine used for certain stomach disorders, e.g. ulcers;
• theophylline, a medicine that helps breathing;
• methylprednisolone, a corticosteroid;
• corticosteroids administered orally, by injection, or by inhalation (used to help suppress the body's immune system – useful in treating a wide range of conditions);
• ibrutinib or vinblastine, medicines used for cancer treatment;
• tolterodine, a medicine used for urinary incontinence;
• medicines that cause an electrocardiogram alteration called long QT syndrome or torsades de pointes;
• ergot alkaloids, used, for example, for migraine headaches;
• medicines used for erectile dysfunction, such as sildenafil, tadalafil, and vardenafil;
• hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis or for the treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other adverse effects affecting the heart.

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

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

Clarmac contains
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
This medicine contains 2.5 mg of propylene glycol per tablet, equivalent to 5 mg for the maximum recommended dose (2 tablets).

3. How to take CLARMAC

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 Clarmac for adults and adolescents over 12 years of age is 1 tablet, twice daily (every 12 hours), for 5–14 days.
In case of severe infections, your doctor may increase the dose up to 2 tablets, twice daily (every 12 hours).

For mouth and dental infections
The recommended dose of Clarmac for adults and adolescents over 12 years of age is 1 tablet, twice daily (every 12 hours), for 5 days.

Method of administration
Clarmac should 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 those indicated above.

Children
Clarmac 250 mg 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 spoon or dosing syringe.

If you take more CLARMAC than you should
If you take an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
In case of overdose, you may experience stomach or intestinal problems.
If you take high doses of CLARMAC, or if a child accidentally swallows some tablets, contact your doctor immediately or go to the nearest hospital.

If you forget to take CLARMAC
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 tablet.

If you stop taking CLARMAC
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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• 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 skin peeling, mouth, lip and skin ulcerations (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• skin rash with fever and abnormalities in blood, lungs, 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 develop a severe skin reaction: red, scaly rash with 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 Clarmac, you notice any of 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;
• changes in liver function tests;
• excessive sweating;
• skin rash

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

• Candida infections, vaginal infections;
• reduction in the number of white blood cells in the blood or in the number of certain types of white blood cells called neutrophils (which may increase the risk of infections);
• 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 (tinnitus), hearing disturbances;
• changes in electrocardiogram (ECG) (prolongation of the QT interval), sensation of "heart pounding";
• 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;
• changes in blood tests: increased blood alkaline phosphatase, increased blood lactate dehydrogenase, increased transaminases (alanine aminotransferase and aspartate aminotransferase), increased gamma-glutamyltransferase.

Other side effects
Not known (frequency cannot be determined from available data):

• 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 kidney inflammation or kidney failure;
• changes in certain laboratory tests such as: increased international normalized ratio (INR), prolonged prothrombin time.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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.

5. How to store CLARMAC

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 medicines 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 CLARMAC contains
The active substance is clarithromycin. Each film-coated tablet contains 250 mg of
clarithromycin.
The other components are:
Tablet core: croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, anhydrous colloidal silica, povidone, stearic acid, magnesium stearate, talc.
Coating: hypromellose, propylene glycol, sorbitan monooleate, vanillin, titanium dioxide (E-171), hydroxypropyl-cellulose, sorbic acid.
Description of the appearance of CLARMAC and pack contents
Film-coated tablets for oral use. This medicine is available in a pack containing 12 white, oval, biconvex film-coated tablets with a break line. The break line is intended only to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into two equal parts.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) – Italy.
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 - Anagni (FR) – Italy.