PATIENT LEAFLET: INFORMATION FOR THE USER

KRUKLAR 500 mg film-coated tablets

Clarithromycin
Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What KRUKLAR is and what it is used for

KRUKLAR contains the active substance clarithromycin, an antibiotic belonging to the macrolide group, which
blocks the growth of bacteria responsible for infections.
KRUKLAR is indicated for the treatment of the following infections caused by bacteria sensitive to clarithromycin:

tonsillitis and pharyngitis (infections of the throat);
sinusitis (infection of the paranasal sinuses, which are cavities located within the facial bones surrounding the eyes, nose, and cheeks);
respiratory tract infections, such as bronchitis, bacterial pneumonia, and atypical pneumonia;
skin infections (impetigo, characterized by crusts and blisters), erysipelas (manifesting as raised, hardened, and painful lesions), folliculitis (inflammation of hair follicles), furunculosis (small red skin elevations containing pus), and infected wounds;
localized or disseminated infections caused by the bacteria Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium chelonae, fortuitum or kansasii, which cause tuberculosis (an infection primarily affecting the lungs but which may also involve other parts of the body);
eradication of Helicobacter pylori, a bacterium that can cause gastritis (inflammation of the stomach) and peptic ulcers (lesions in the stomach or the first part of the intestine).

2. What you need to know before taking KRUKLAR

Do not take KRUKLAR if:

you are allergic (hypersensitive) to clarithromycin or to other antibiotics of the macrolide class such as erythromycin or azithromycin, or to any of the other ingredients of this medicine listed in section 6;
you have severe hepatic insufficiency (impaired liver function) associated with renal damage (kidney problems);
you have hypokalemia or hypomagnesemia (reduced concentration of potassium and magnesium in the blood);
you have previously experienced disturbances in the electrical activity of the heart such as QT prolongation, ventricular arrhythmia, or torsades de pointes;
you are being treated with:
- astemizole and terfenadine (antihistamines used to treat allergies),
- cisapride and domperidone (medicines used to stimulate stomach and intestinal motility),
- pimozide (an antipsychotic, used for mental disorders),
- ticagrelor (an antiplatelet agent, medicines that prevent platelet aggregation),
- ivabradine or ranolazine (medicines used to treat heart conditions),
- midazolam (a medicine that induces sedation, reduces pain sensitivity, and causes muscle relaxation),
- ergotamine or dihydroergotamine (used for migraine, a neurological disease characterized by headache),
- lomitapide, lovastatin, and simvastatin (medicines that reduce cholesterol, a type of fat in the blood),
- colchicine (a medicine used for gout, a disease causing joint pain and swelling).

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

you have liver problems;
you have kidney problems;
you are over 65 years old;
you suffer from coronary artery disease (a heart disease occurring due to reduced blood flow caused by narrowing of the coronary arteries);
you have severe heart failure (a serious condition in which the body cannot compensate for reduced cardiac contractile function);
you have heart rhythm disorders;
you suffer from bradycardia (reduced heart rate);
you have heart vessel problems (coronary artery disease);
you have unstable/compensated heart failure or severe cardiac decompensation;
you are pregnant, especially during the first trimester.

Contact your doctor if, during treatment, you notice anorexia (reduced or lack of appetite), jaundice (yellowing of the skin and eyes), dark urine, itching, or abdominal pain.
Stop treatment with KRUKLAR and inform your doctor:

Contact your doctor if diarrhea develops during treatment or if you experience hearing disturbances or dizziness.
Inform your doctor and stop treatment with KRUKLAR immediately if you develop severe allergic reactions presenting as skin irritation, itching, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty breathing or swallowing, shortness of breath, chest pain, or chest tightness.

Other medicines and KRUKLAR
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription.
Some medicines may alter the effect of KRUKLAR or the effect of these medicines may be altered by KRUKLAR. This type of interaction may reduce the effect of one or both medicines or may increase the risk or severity of side effects.
Inform your doctor if you are being treated with:

Digoxin (a medicine used to treat heart diseases);
Carbamazepine, valproate, phenytoin, phenobarbital (used to control epilepsy, a disease causing loss of consciousness and violent involuntary muscle contractions);
Antiarrhythmics such as quinidine and disopyramide (used to treat heart rhythm disorders);
Oral anticoagulants such as warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban (medicines that delay blood clotting);
Lovastatin, simvastatin, and lomitapide (medicines that reduce cholesterol, a type of fat in the blood);
Cisapride and domperidone (medicines used to stimulate stomach and intestinal motility);
Pimozide and quetiapine (antipsychotics, used for mental disorders);
Astemizole and terfenadine (antihistamines used to treat allergies);
Ergotamine or dihydroergotamine (used for migraine, a neurological disease characterized by headache);
Colchicine (a medicine used for gout, a disease causing joint pain and swelling);
Ticagrelor (an antiplatelet agent, medicines that prevent platelet aggregation);
Ranolazine (a medicine used to treat heart conditions);
Theophylline (a medicine that relaxes bronchial muscles);
Triazolam, temazepam, and nitrazepam (hypnotics, medicines that induce sleep);
Alprazolam and lorazepam (anxiolytics, medicines that reduce anxiety);
Midazolam (a sedative, medicine that induces sedation, reduces pain sensitivity, and causes muscle relaxation);
Cilostazol (used to treat pain caused by insufficient blood supply to the legs occurring during walking);
Omeprazole (for the treatment of stomach disorders and lesions);
Methylprednisolone (a medicine used to treat inflammatory conditions and allergies);
St. John's Wort (used for depression);
Vinblastine and ibrutinib (used to treat tumors);
Sildenafil, vardenafil, and tadalafil, used for erectile dysfunction and pulmonary hypertension (high blood pressure in the lung vessels);
Cyclosporine, sirolimus, tacrolimus (medicines that prevent organ transplant rejection or are used for certain immune system diseases);
Efavirenz, etravirine, nevirapine, zidovudine, ritonavir, atazanavir, and saquinavir (antiviral medicines used to treat HIV infections);
Nateglinide and repaglinide (medicines used to treat diabetes, a disease characterized by high blood sugar levels);
Rifabutin, rifampicin, and rifapentine (antibiotics used to treat tuberculosis, a lung infection that can also affect other body parts);
Fluconazole and itraconazole (used to treat fungal infections);
Tolterodine, used to treat incontinence (inability to retain urine);
Verapamil, amlodipine, diltiazem (medicines used to treat high blood pressure or heart rhythm disorders);
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 heart-related side effects;
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).

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as the safety of KRUKLAR during pregnancy and breastfeeding has not been established.
Pregnancy
Administration of KRUKLAR during pregnancy and breastfeeding should only be considered if the expected benefit to the mother outweighs the risk to the unborn child.
Breastfeeding
Clarithromycin is excreted in breast milk in small amounts.
Fertility
Studies conducted in rats have shown no evidence of harmful effects on fertility.

Driving and using machines:
KRUKLAR may cause dizziness, vertigo, confusion, and disorientation; this may affect your ability to drive or operate machinery.

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

KRUKLAR contains propylene glycol
KRUKLAR contains 4 mg of propylene glycol per tablet.

3. How to take KRUKLAR

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Respiratory tract infections (bronchitis, bacterial pneumonia, atypical pneumonia), throat infections (tonsillitis
and pharyngitis), paranasal sinus infections (sinusitis), skin infections (impetigo, erysipelas, folliculitis, furunculosis
and infected wounds)
Since the tablet cannot be divided into two equal parts, when a 250 mg dosage is required, it is necessary to use other products containing clarithromycin that allow such dosing.
The recommended dose for adults and adolescents over 12 years of age is 1 tablet of 250 mg every 12 hours.
In cases of severe infections, the dose may be increased up to 500 mg every 12 hours.
The duration of treatment is 5–14 days, except for community-acquired pneumonia and sinusitis, which require 6–14 days.
Infections due to Mycobacterium
The initial dose is 500 mg twice daily.
In the treatment of disseminated infections caused by Mycobacterium avium complex and in patients with AIDS, it is recommended to continue treatment until clinical or microbiological improvement is achieved, or as otherwise determined by the treating physician. Clarithromycin must be used in combination with other antimycobacterial agents.
Infections due to Helicobacter pylori
Your doctor may prescribe one of the following treatment regimens:

1 tablet of KRUKLAR twice daily, omeprazole 20 mg once daily, and amoxicillin 1000 mg twice daily, for 14 days;
1 tablet of KRUKLAR twice daily, lansoprazole 30 mg twice daily, and amoxicillin 1000 mg twice daily, for 14 days.
Your doctor may use medications different from those listed above.

Method of administration
KRUKLAR is to be taken orally (by mouth).
The tablets are not divisible.
The score line is intended only to facilitate breaking the tablet in case of difficulty swallowing it whole.
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, for example 250 mg once daily, or 250 mg twice daily in case of severe infections.
Under these circumstances, treatment should not exceed 14 days.
Children
KRUKLAR is not recommended for children under 12 years of age. In such cases, use another medicinal product containing the same active substance (clarithromycin) available in a pharmaceutical form suitable for children (oral granules for oral suspension in a bottle with dosing spoon or oral syringe).
If you take more KRUKLAR than you should
If you have taken more KRUKLAR than prescribed, contact your doctor immediately. Take this patient information leaflet, the container, and any remaining tablets with you and go to the nearest hospital.
Gastrointestinal disturbances may occur following the ingestion of high doses of clarithromycin.
If you forget to take KRUKLAR
If you forget to take a dose of KRUKLAR, take it as soon as you remember.
However, if it is almost time for your next dose, do not take the missed dose; instead, take only the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking KRUKLAR
Continue treatment for the full duration prescribed by your doctor. Only in this way can you achieve complete recovery. If you stop treatment earlier than prescribed, the infection may return, as the bacteria causing the infection may not have been completely eradicated.
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 everybody will experience them.
If you experience any of the following conditions during treatment, stop taking the tablets immediately and contact your doctor immediately or go to the nearest hospital emergency department:

Angioedema (swelling of the face, eyes, lips, tongue, and throat which may cause difficulty in breathing and swallowing);
Anaphylactic reaction (severe allergic reaction, signs of which may include difficulty breathing, chest pain or tightness in the chest and/or dizziness/fainting, severe skin itching or raised skin rashes, swelling of the face, lips, tongue, and/or throat, which may potentially be life-threatening);
Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin and mucous membrane reactions with redness, blistering, and peeling);
Drug rash with eosinophilia and systemic symptoms or DRESS (skin rash with fever and abnormalities in blood, lungs, heart, or liver);
Acute generalized exanthematous pustulosis or AGEP (rash with redness and pus, which may lead to peeling);
Hepatitis, cholestasis, liver failure, and hepatocellular jaundice (severe loss of liver function manifesting as anorexia, reduced or absent appetite), jaundice (yellowing of the eyes or skin), dark urine, pale stools, itching, or abdominal pain;
Clostridioides difficile diarrhea (severe and prolonged diarrhea with blood in the stool, even up to 2 months after the last dose).

Other side effects that may occur after taking KRUKLAR
Common (may affect up to 1 in 10 people):

Headache,
Dysgeusia (altered taste),
Insomnia (difficulty sleeping),
Diarrhea,
Nausea,
Abdominal pain,
Dyspepsia (indigestion),
Vomiting,
Hyperhidrosis (excessive sweating),
Rash,
Abnormal liver function laboratory tests.

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

Candidiasis (fungal infection affecting the skin or mucous membranes),
Vaginal infections,
Leukopenia (reduced number of white blood cells),
Neutropenia (reduced number of a type of white blood cells called neutrophils),
Thrombocytopenia (reduced number of platelets),
Eosinophilia (increased number of a type of white blood cells called eosinophils),
Hypersensitivity (allergy),
Anorexia (reduced or absent appetite),
Anxiety,
Dizziness,
Somnolence (drowsiness),
Tremor,
Vertigo (sensation of movement or spinning),
Hearing disturbances,
Tinnitus (persistent perception of noise in the ear),
Palpitations (awareness of heartbeats),
Gastritis (inflammation of the stomach),
Stomatitis (inflammation of the mucous membranes lining the mouth),
Abdominal distension,
Constipation,
Dry mouth,
Eructation (belching),
Flatulence (passing gas through the anus),
Urticaria (hives),
Pruritus (itching),
Malaise,
Asthenia (weakness),
Chest pain,
Chills,
Fatigue,
Prolongation of the QT interval on electrocardiogram (ECG recording of the heart's electrical activity),
Changes in certain blood tests: increased alkaline phosphatase, increased lactate dehydrogenase, increased transaminases (alanine aminotransferase and aspartate aminotransferase), increased gamma-glutamyl transferase.

Not known (frequency cannot be estimated from available data):

Erysipelas (raised, hardened, and painful skin lesions),
Agranulocytosis (severe reduction in a type of white blood cells),
Thrombocytopenia (reduced number of platelets),
Psychotic disorder (altered perception and interpretation of reality),
Confusional state,
Depersonalization (feeling of detachment from the surrounding environment),
Depression (feeling of sadness and reduced interest in activities),
Disorientation,
Hallucinations (perception of things that are not real),
Abnormal dreams,
Mania (state of excitement),
Seizures (involuntary, sudden, and uncontrolled muscle movements),
Ageusia (loss of taste),
Parosmia (inability to correctly perceive odors),
Anosmia (loss of smell),
Paresthesia (numbness or tingling sensation in hands and feet),
Deafness,
Torsades de pointes, ventricular tachycardia, ventricular fibrillation (abnormalities in the heart's electrical activity),
Hemorrhage (bleeding),
Acute pancreatitis (inflammation of the pancreas),
Discoloration of the tongue,
Discoloration of teeth,
Acne (inflammation of hair follicles resulting in pimples),
Myopathy (abnormal muscle structure and function),
Rhabdomyolysis (muscle damage),
Renal failure (reduced kidney function),
Interstitial nephritis (kidney disease),
Chromaturia (abnormal urine color),
Abnormal laboratory tests assessing blood coagulation: increased INR and PT.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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 KRUKLAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 KRUKLAR contains
The active substance is clarithromycin.
The other ingredients are:
Croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, anhydrous colloidal silicon dioxide, povidone,
stearic acid, magnesium stearate, talc, hypromellose, propylene glycol, sorbitan monoleate, vanillin,
titanium dioxide, hydroxypropyl-cellulose, sorbic acid.
Description of the appearance of KRUKLAR and pack sizes
Film-coated tablets.
Pack size: 14 tablets in PVC/PVDC blisters.
Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Roma
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy