CLARITROL 500 mg Фильм-Coated Таблетки

Содержание инструкции

1. CLARITROL 500 mg film-coated tablets
   1. What is CLARITROL and what is it used for
   2. What you need to know before taking CLARITROL
2. CLARITROL contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially ‘sodium-free’
   1. How to take CLARITROL
   2. Possible side effects
   3. How to store CLARITROL
   4. Contents of the pack and other information

CLARITROL 500 mg film-coated tablets

Clarithromycin
Generic medicine

Read this leaflet carefully before you start 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 CLARITROL is and what it is used for
• 2. What you need to know before you take CLARITROL
• 3. How to take CLARITROL oral suspension granules
• 4. Possible side effects
• 5. How to store CLARITROL
• 6. Contents of the pack and other information

1. What is CLARITROL and what is it used for

Clarithromycin belongs to a group of antibiotics called macrolides. Clarithromycin acts by destroying some types of bacteria that cause certain infections.

• Clarithromycin can be used to treat infections caused by bacteria in the chest (bronchitis, bacterial pneumonia and atypical pneumonia)
• Infections of the rhino-pharyngeal tract (tonsillitis, pharyngitis)
• Infections of the paranasal sinuses
• Infections of the skin and layers of subcutaneous tissue (impetigo, erysipelas, folliculitis, furunculosis and infected wounds).
• Microbacterial infections, localized or widespread, caused by Mycobacterium avium or Mycobacterium intracellulare.
• Localized infections due to Mycobacterium chelonae, fortuitum or kansasii.

Clarithromycin, in the presence of reduced gastric acidity, is indicated in the eradication of Helicobacter pylori, producing a consequent decrease in the recurrence of peptic ulcer.

2. What you need to know before taking CLARITROL

Do not take CLARITROL if:

• You are allergic to clarithromycin, to other macrolide antibiotics or to any of the other ingredients of this medicine (listed in section 6).
• You are taking medicines called ergotamine or dihydroergotamine (for migraine);
• You are taking medicines called terfenadine or astemizole (widely used for hay fever or allergies) or cisapride (for stomach disorders) or pimozide (for mental problems) because the combination with these medicines can sometimes cause serious heart rhythm disorders;
• You are taking lovastatin or simvastatin (for high cholesterol);
• You are taking ticagrelor or ranolazine (for heart or circulation problems);
• If you are taking colchicine (usually taken for gout).
• You or someone in your family has a history of heart rhythm disorders (ventricular arrhythmia, including torsade de pointes) or an abnormality in the electrocardiogram (ECG, electrical recording of the heart) called "prolongation of the QT interval".
• You have abnormally low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia)
• You suffer from severe liver disorders combined with kidney disorders
• You are taking a medicine containing lomitapide

If any of the above conditions apply to you, consult your doctor for advice on an alternative medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking CLARITROL if:

• You suffer from liver or kidney problems.
• You are resistant to other antibiotics such as clindamycin, lincomycin.
• You suffer from heart problems.

Prolonged use of antibiotics, including clarithromycin, can lead to the development of resistant organisms.
In anticipation of the spread of resistance of Streptococcus pneumoniaeto macrolides, it is important that sensitivity tests are performed when prescribing clarithromycin for community-acquired pneumonia. In nosocomial pneumonias, clarithromycin should be used in combination with adequate additional antibiotics.
Mild to moderate skin and soft tissue infections are most often caused by Staphylococcus aureusand Streptococcus pyogenes, both potentially resistant to macrolides. Therefore, it is important that sensitivity tests are performed. In cases where beta-lactam antibiotics (e.g. allergy) cannot be used, other antibiotics, such as clindamycin, may be drugs of first choice.
If a severe acute hypersensitivity reaction occurs, such as anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis, therapy with clarithromycin must be stopped immediately and urgent appropriate treatment must be started.
The concomitant use of clarithromycin and lovastatin or simvastatin is contraindicated (see section “Contraindications”). Caution is required when prescribing clarithromycin with other statins.
Rhabdomyolysis has been reported in patients who have taken clarithromycin and statins. Patients should be monitored for signs and symptoms of myopathy.
In situations where the concomitant use of clarithromycin and statins cannot be avoided, it is recommended to prescribe the lowest available dose of statin. The use of a statin (e.g. fluvastatin) whose metabolism is not dependent on CYP3A should be considered (see section “Interactions”).
The concomitant use of clarithromycin and oral hypoglycemic agents (such as sulfonylureas) and/or insulin can cause significant hypoglycemia. Careful monitoring of blood glucose is recommended (see section “Interactions”).
When co-administering clarithromycin and warfarin, there is a risk of severe bleeding, a significant increase in the International Normalized Ratio (INR) and a significant increase in prothrombin time (see section “Interactions”). INR and prothrombin time should be monitored frequently when patients receive clarithromycin and oral anticoagulants concurrently.
Prolonged use of the drug, as with other antibiotics, can determine colonization by an increased number of bacteria and fungi that are not susceptible. If superinfections develop, appropriate therapy should be started immediately.
The doctor should not prescribe clarithromycin to pregnant women without a thorough risk/benefit assessment, especially during the first three months of pregnancy (see section “Pregnancy and Breastfeeding”).
Clarithromycin should be used with caution when administered concomitantly with medicines known to be inducers of the cytochrome CYP3A4 enzyme (see section “Interactions”).
Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of almost all antibacterial agents, including clarithromycin, which can manifest with varying severity from mild diarrhea to fatal colitis.
Caution is recommended in the concomitant administration of clarithromycin and other ototoxic medicines, especially with aminoglycosides.
Monitoring of vestibular and auditory function should be performed during and after completion of therapy.
Currently, macrolides, including clarithromycin ,are considered appropriate only in some skin and soft tissue infections, such as those caused by Corynebacterium minutissimum

mum, acne vulgaris, erysipelas and in situations where penicillin therapy cannot be performed.

Other medicines and CLARITROL
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription. This is because CLARITROL can affect the mechanism of action of other medicines, and some medicines can have an effect on CLARITROL.
In particular, if you are taking:

• Ergotamine or dihydroergotamine (for migraine)
• Astemizole (antihistamine), terfenadine (for hay fever or allergy). Cisapride (for stomach disorders)
• Ticagrelor or ranolazine (for heart attack, chest pain or angina)
• Lovastatin, simvastatin or atorvastatin (treatments to lower cholesterol levels in the blood)
• Colchicine (usually taken for gout).
• Oral hypoglycemic agents (repaglinide, nateglinide) and/or insulin
• Warfarin or any other anticoagulant, for example dabigatran, rivaroxaban, apixaban (used to thin the blood)
• Rifampicin, phenytoin, carbamazepine, phenobarbital, products containing St. John's Wort, rifabutin (CYP3A inducers)
• Efavirenz, ritonavir, zidovudine, nevirapine, etravirine, atazanavir or saquinavir (antiviral medicines used to treat HIV
• Alprazolam (for anxiety)
• Fluconazole (medicines for fungal infections)
• Cilostazol (antiplatelet agent)
• Cyclosporine (organ rejection drug)
• Disopyramide (antiarrhythmic)
• Methylprednisolone (a corticosteroid)
• Midazolam (sedative/hypnotic)
• Pimozide (antipsychotic)
• Vinblastine (for cancer treatment)
• Sildenafil, tadalafil and vardenafil (to treat impotence in adult men)
• Tolterodine (medicine for the treatment of urinary incontinence
• Omeprazole (for the treatment of indigestion and stomach ulcers)
• Verapamil, diltiazem or amlodipine (medicines for high blood pressure)
• Aminoglycosides (a group of antibiotics)

You are taking other medicines that are known to cause serious heart rhythm disturbances.
The levels in the blood and therefore the side effects of the medicines listed below may

• Quetiapine (a medicine known as an atypical antipsychotic)
• Digoxin, Quinidine (heart drugs)
• Tacrolimus (for organ transplants)
• Triazolam (sedative)
• Theophylline (a drug that helps breathing)
• Valproate (a drug for epilepsy)
• Itraconazole (antifungal drug)
• Oral anticoagulants

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine
Pregnancy
The safety of clarithromycin in use during pregnancy has not been established.
Therefore, use during pregnancy is not recommended without a careful assessment of the risk/benefit ratio.
Breastfeeding
The safety of the use of clarithromycin during breastfeeding has not been established. Clarithromycin is excreted through breast milk.

Driving and using machines
There are no data on the effects of clarithromycin on the ability to drive or operate machinery.
The possibility that dizziness, vertigo, confusion and loss of orientation may occur with the use of the medicine must be considered before patients drive or use machinery.

CLARITROL contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially ‘sodium-free’

sodio’.

3. How to take CLARITROL

Take this medicine following exactly the instructions of your doctor or pharmacist.

Severe infections: 500 mg every 12 hours. The administration should be continued, depending on the
severity of the infection, for up to 6-14 days.

Patients with renal insufficiency:the dosage should be reduced by half. In these patients, the
administration should not be continued for more than 14 days.
Infections caused by mycobacteria: the starting dose is 500 mg twice a day. If no clinical or
bacteriological improvements occur within 3-4 weeks, the daily dose may be increased to
1000 mg twice a day.
In the treatment of disseminated infections caused by Mycobacterium Avium Complex in patients with AIDS,
continue treatment until clinical or microbiological results are obtained and in any case at the discretion of the treating physician.
Dosage regimen in the eradication of Helycobacter pylori:

Triple therapy:
Claritromicina 500 mg twice a day in association with amoxicillin 1000 mg twice a day and omeprazole 20 mg a day for a period between 7 and 10 days.
Claritromicina 500 mg twice a day in association with lansoprazole 30 mg twice a day and amoxicillin 1000 mg twice a day for 10 days.

Dual therapy:
Claritromicina 500 mg three times a day in association with omeprazole 40 mg a day for 14
days, followed by omeprazole 20 mg or 40 mg a day for a further 14 days.
Claritromicina 500 mg three times a day in association with lansoprazole 60 mg a day for 14
days. Further suppression of acid secretion may be required to reduce
the ulcer.
Claritromicina has also been used in the following therapeutic regimens:

• claritromicina + tinidazole and omeprazole or lansoprazole
• claritromicina + metronidazole and omeprazole or lansoprazole
• claritromicina + tetracycline, bismuth subsalicylate, and ranitidine
• claritromicina + amoxicillin and lansoprazole
• claritromicina + ranitidine bismuth citrate

If you take more CLARITROL than you should
If you have accidentally taken more medicine than you should, consult your doctor or go immediately
to the nearest hospital emergency room.
what you have taken. Gastric lavage may be necessary.

If you forget to take CLARITROL
Take the medicine as soon as you remember. However, if it is almost time for the next dose, skip
the missed dose and take the next one at the correct time.
Do not take a double dose to make up for a missed dose.

If you stop taking CLARITROL
Do not stop taking it before your doctor tells you to, even if you feel better,
because the symptoms may return.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, CLARITROL can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
The following side effects have been observed and reported with the following frequencies:

• very common (≥ 10%)
• common (≥ 1% < 10%)
• uncommon (≥ 0.1% < 1%)
• rare (≥ 0.01% < 0.1%)
• very rare (< 0.01%) including isolated cases

Very common

• Phlebitis at the injection site

Common

• Insomnia
• Dysgeusia, headache, altered taste
• Vasodilation
• Diarrhea, vomiting, dyspepsia, nausea, abdominal pain
• Altered liver function tests
• Skin rash, hyperhidrosis
• Pain at the injection site, inflammation at the injection site

Uncommon

• Cellulitis, candidiasis, gastroenteritis, infection, vaginal infection
• Leukopenia, neutropenia, thrombocytemia, eosinophilia
• Anaphylactoid reaction, hypersensitivity
• Anorexia, decreased appetite
• Anxiety, nervousness, urge to shout
• Loss of consciousness, dyskinesia, dizziness, somnolence, tremor
• Dizziness, hearing impairment, tinnitus
• Cardiac arrest, atrial fibrillation, electrocardiogram with QT interval prolongation, extrasystoles, palpitations
• Epistaxis, pulmonary embolism
• Esophagitis, gastroesophageal reflux, gastritis, proctalgia, stomatitis, glossitis, abdominal distension, constipation, dry mouth, eructation, flatulence
• Cholestasis, hepatitis, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyl transferase
• Bullous dermatitis, pruritus, urticaria, maculopapular rash
• Muscle spasms, musculoskeletal rigidity, myalgia, arthralgia
• Increased blood creatinine, increased blood urea
• Malaise, pyrexia, asthenia, chest pain, chills, fatigue
• Alteration of albumin globulin ratio, increased blood alkaline phosphatase, increased blood lactate dehydrogenase

Not known

• Pseudomembranous colitis, erysipelas
• Agranulocytosis, thrombocytopenia
• Anaphylactic reaction, angioedema
• Psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, abnormal dreams
• Convulsions, ageusia, parosmia, anosmia, paresthesia
• Deafness
• Torsades de pointes, ventricular tachycardia
• Ventricular fibrillation
• Hemorrhage
• Acute pancreatitis, tongue discoloration, tooth discoloration
• Hepatic failure, hepatocellular jaundice
• Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acne
• Red and scaly skin rash with formation of pustules and vesicles (exanthematic pustulosis).
• Rhabdomyolysis, myopathy
• Renal failure, interstitial nephritis
• Increased international normalized ratio, prolonged prothrombin time, altered urine color

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store CLARITROL

Do not use this medicine after the expiry date which is reported on the label and on the package.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children

6. Contents of the pack and other information

Each film-coated tablet contains:
Active ingredient: clarithromycin 500 mg
Other ingredients: sodium croscarmellose, pregelatinized starch, microcrystalline cellulose, anhydrous colloidal silicon dioxide, povidone, stearic acid, magnesium stearate, talc, hypromellose, propylene glycol, sorbitan monoleate, vanillin, titanium dioxide (E-171), hydroxypropylcellulose, sorbic acid.

Description of the appearance of CLARITROL and contents of the pack
Film-coated tablets for oral use. Blisters of 14 tablets.

Marketing Authorisation Holder
S.F. GROUP S.r.l.
Via Tiburtina, n° 1143 - 00156 Rome

Manufacturer
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, n° 1 - 03012 Anagni (FR)