FROMILID 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Fromilid 250, 250 mg, film-coated tablets
3. Fromilid 500, 500 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Fromilid and what is it used for
5. Important information before taking Fromilid
   1. When not to take Fromilid
   2. Warnings and precautions
   3. Fromilid and other medicines
   4. The patient must inform their doctor if they are taking any of the following medicines, as their use with Fromilid is contraindicated:
   5. The patient should inform their doctor if they are taking any of the following medicines, as special caution is required when using them with Fromilid:
   6. Fromilid:
   7. Taking Fromilid with food and drink
   8. Pregnancy and breastfeeding
   9. Driving and using machines
6. How to take Fromilid
   1. Recommended dose
   2. Taking a higher dose of Fromilid than recommended
   3. Missing a dose of Fromilid
   4. Stopping treatment with Fromilid
7. Possible side effects
   1. Other side effects:
   2. Reporting side effects
8. How to store Fromilid
9. Contents of the pack and other information
   1. What Fromilid contains
   2. What Fromilid looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Fromilid 250, 250 mg, film-coated tablets

Fromilid 500, 500 mg, film-coated tablets

Clarithromycin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fromilid and what is it used for

Fromilid belongs to a group of antibiotics called macrolides with broad-spectrum antibacterial activity. Clarithromycin, the active substance of Fromilid, is a derivative of erythromycin, and has antibacterial activity against both standard bacterial strains and strains isolated from patients. Clarithromycin is effective against many aerobic and anaerobic Gram-positive and Gram-negative bacteria.

• tonsillitis and pharyngitis;
• acute maxillary sinusitis;
• otitis media;
• exacerbation of chronic bronchitis;
• pneumonia;
• uncomplicated skin and soft tissue infections;
• systemic infections caused by mycobacteria.

Fromilid is also used to eradicate (eliminate) Helicobacter pylori bacteria in patients with duodenal or gastric ulcers. In this indication, the doctor will prescribe Fromilid in combination with drugs that reduce gastric acid secretion and another antibiotic.

2. Important information before taking Fromilid

When not to take Fromilid

• if the patient is allergic to clarithromycin, other macrolide antibiotics (such as azithromycin, erythromycin) or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking ergot alkaloids, such as ergotamine or dihydroergotamine (used for migraine) or midazolam orally (used for anxiety and insomnia);
• if the patient is taking drugs that may cause severe heart rhythm disturbances;
• if the patient is taking astemizole or terfenadine (used for allergies), cisapride or domperidone (used for gastrointestinal disorders), pimozide (used for psychiatric disorders), as concurrent use with Fromilid may cause severe heart rhythm disturbances;
• if the patient is taking ticagrelor, ivabradine, or ranolazine (used for angina pectoris or to reduce the risk of myocardial infarction or stroke);
• if the patient has low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia);
• if the patient is taking lovastatin, simvastatin (statins used to lower blood cholesterol levels);
• if the patient is taking a medicine containing lomitapide;
• if the patient has severe liver failure with concomitant renal failure;
• if the patient or their family members have a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or abnormalities in the electrocardiogram (ECG, a recording of the heart's electrical activity) known as "long QT syndrome";
• if the patient is taking colchicine (used to treat gout).

Warnings and precautions

Before starting treatment with Fromilid, the patient should discuss the following with their doctor:

• if the patient is pregnant or thinks they may be pregnant,
• if the patient has kidney or liver problems,
• if the patient has coronary artery disease, severe heart failure, or slow heart rate,
• if the patient is taking any of the medicines listed in the "Fromilid and other medicines" section.

If any of the following situations occur while taking Fromilid, the patient should tell their doctor:

• severe allergic reactions, such as rash, urticaria, purpura, throat swelling, bronchospasm - the patient should immediately consult a doctor who will provide appropriate treatment;
• diarrhea, especially acute or prolonged; the patient should tell their doctor as soon as possible. If necessary, the doctor will prescribe appropriate treatment; the patient should not take anti-diarrheal medicines;
• symptoms of liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain; the patient should stop treatment and consult a doctor;
• new infections (superinfections) caused by bacteria resistant to clarithromycin or fungi, especially during prolonged antibiotic treatment - the doctor will prescribe appropriate treatment.

In addition, while taking Fromilid, the following may occur:

• cross-resistance of bacteria (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics and lincosamides and clindamycin),
• antibiotic resistance (e.g., treatment of Helicobacter pylori infection may lead to the development of resistant microorganisms).

If symptoms of hearing organ or balance disorders occur (see section 4), it is recommended to perform relevant control tests after completing treatment.

Fromilid and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient must inform their doctor if they are taking any of the following medicines, as their use with Fromilid is contraindicated:

• ergot alkaloids, such as ergotamine or dihydroergotamine (used for migraine);
• astemizole or terfenadine (used for allergies);
• cisapride or domperidone (used for gastrointestinal disorders);
• pimozide (used for psychiatric disorders);
• ticagrelor, ivabradine, or ranolazine (used for angina pectoris or to reduce the risk of myocardial infarction or stroke);
• colchicine (used to treat gout);
• statins - lovastatin, simvastatin (used to lower blood cholesterol levels);
• midazolam orally (used for anxiety or insomnia).

The patient should inform their doctor if they are taking any of the following medicines, as special caution is required when using them with Fromilid:

Fromilid:

• rifampicin, rifapentine, rifabutin (antibiotics used to treat tuberculosis);
• fluconazole, itraconazole (antifungal medicines);
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used to treat HIV infection);
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used to treat heart rhythm disorders or hypertension);
• alprazolam, triazolam, midazolam intravenously or orally (used for anxiety or insomnia);
• warfarin or other anticoagulant medicines, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood);
• quetiapine or other atypical antipsychotic medicines;
• carbamazepine, valproate, phenytoin (antiepileptic medicines);
• methylprednisolone (anti-inflammatory medicine);
• omeprazole (medicine that reduces gastric acid secretion);
• cilostazol (used to treat intermittent claudication, which is characterized by leg pain during exercise that subsides after a short rest);
• cyclosporine, tacrolimus, sirolimus (used for organ transplantation);
• sildenafil, tadalafil, vardenafil (used for erectile dysfunction);
• ibrutinib or vinblastine (used for cancer chemotherapy);
• theophylline (used for asthma);
• tolterodine (used for urinary incontinence);
• phenobarbital (antiepileptic medicine);
• St. John's Wort (Hypericum perforatum, a herbal medicine used for mild depression);
• sulfonylurea, nateglinide, repaglinide, insulin (used for diabetes);
• ototoxic medicines (which can damage hearing), especially aminoglycoside antibiotics used for bacterial infections.

This is also important if the patient is taking medicines with the following names:

• hydroxychloroquine or chloroquine (used to treat rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart.

• corticosteroids taken orally, by injection, or inhaled (used to suppress the immune system, which is useful in treating many different diseases)

Taking Fromilid with food and drink

Fromilid can be taken with or without food. The tablets should not be divided. The tablets should be swallowed whole, with a drink of water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The safety of clarithromycin during pregnancy and breastfeeding has not been established. Fromilid can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus. As clarithromycin passes into breast milk, breastfeeding women should exercise caution when taking Fromilid.

Driving and using machines

Fromilid may cause dizziness, confusion, and disorientation, which may affect the ability to drive or operate machines. The patient should not drive or operate machines if they experience these symptoms.

3. How to take Fromilid

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The tablets should not be divided. The tablets should be swallowed whole, with a drink of water. The dosage and duration of treatment depend on the type and location of the infection, the patient's age, and their response to treatment.

Recommended dose

Adults and adolescents over 12 years
The recommended dose is 250 mg every 12 hours.
Children under 12 years
Clinical trials in children aged 6 months to 12 years were conducted with clarithromycin in the form of an oral suspension. Therefore, in children, clarithromycin is recommended in the form of an oral suspension.
In the treatment of sinusitis, more severe infections, and when the infection is caused by Haemophilus influenzae, 500 mg is given every 12 hours.
Treatment usually lasts from 6 to 14 days.
When using clarithromycin to eradicate H. pylori in patients with gastric or duodenal ulcers, the daily dose is 500-1000 mg. Clarithromycin is usually given in 2 divided doses for 7-14 days. To eradicate H. pylori, it is necessary to take other medicines concurrently.
Patients with renal impairment
In patients with renal impairment, the dose of clarithromycin should be reduced by half, i.e., 250 mg once a day or, in severe infections, 250 mg twice a day. The medicine should not be taken for more than 14 days.

Taking a higher dose of Fromilid than recommended

If the patient has taken more than the recommended dose of the medicine, they should contact their doctor or pharmacist immediately. Overdose may cause gastrointestinal disturbances (nausea, vomiting, abdominal pain). In case of overdose, the doctor will provide appropriate symptomatic treatment. Like other macrolide antibiotics, hemodialysis or peritoneal dialysis does not reduce the concentration of clarithromycin in the blood.

Missing a dose of Fromilid

If the patient misses a dose of the medicine at the scheduled time, they should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose and continue with the usual dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Fromilid

The patient should not stop taking the medicine without consulting their doctor. Stopping treatment too early may cause the illness to recur. If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fromilid can cause side effects, although not everybody gets them. If the patient experiences any of the following side effects, they should stop taking Fromilid and consult their doctor immediately:

• anaphylactic shock - a life-threatening allergic reaction characterized by confusion, pallor, low blood pressure, sweating, decreased urine output, rapid breathing, weakness, and fainting
• allergic reactions: rash (frequent), itching, urticaria (uncommon), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• severe skin reactions:
• acute generalized exanthematous pustulosis - a red, scaly rash with bumps under the skin and blisters
• Stevens-Johnson syndrome - a severe condition characterized by a sudden onset of fever and blisters that heal quickly and spontaneously after stopping the medicine; a severe disease characterized by blisters and ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain
• toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by bursting giant subepidermal blisters, extensive skin ulcers, and fever
• DRESS syndrome - a severe (life-threatening) drug reaction characterized by an increased number of eosinophils and involvement of internal organs
• severe or prolonged diarrhea, which may contain blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even after two months after completing treatment with clarithromycin. In this case, the patient should also consult their doctor.

• jaundice, skin irritation, pale stools, dark urine, itching, or abdominal tenderness. These may be signs of liver dysfunction, cholestasis (increased levels of bile components in the blood), or hepatitis (inflammation of the liver). These reactions occur with an unknown frequency, unless otherwise specified.

Other side effects:

In clinical trials and after the introduction of clarithromycin to the market, the following commonside effects have been reported (may occur in 1 to 10 out of 100 patients):

• insomnia;
• taste disturbances, headache;
• diarrhea, vomiting, nausea, abdominal pain;
• abnormal liver function tests;
• excessive sweating.

Uncommonside effects (may occur in 1 to 10 out of 1,000 patients):

• candidiasis (fungal infection), vaginal infection;
• decreased white blood cell count, decreased neutrophil count, and increased eosinophil count;
• anorexia, decreased appetite;
• restlessness;
• dizziness, drowsiness, tremors;
• balance disorders, hearing loss, tinnitus;
• palpitations, changes in ECG (QT interval prolongation);
• gastritis, oral mucositis, glossitis, abdominal distension, constipation, dry mouth, eructation, flatulence;
• increased liver enzyme activity: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase;
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue;
• increased enzyme activity: alkaline phosphatase and lactate dehydrogenase.

The following side effects have been reported with an unknown frequency(frequency cannot be estimated from available data) after the introduction of clarithromycin tablets and suspension to the market:

• rosacea;
• agranulocytosis (decreased neutrophil count), thrombocytopenia (decreased platelet count);
• acne;
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania;
• seizures, loss of taste, abnormal smell, loss of smell, paresthesia (numbness, tingling);
• deafness;
• heart rhythm disturbances of the torsades de pointes type, ventricular tachycardia, atrial fibrillation;
• bleeding;
• acute pancreatitis, tongue discoloration, tooth discoloration;
• liver failure, jaundice;
• myopathy (muscle disease with muscle weakness);
• kidney failure, interstitial nephritis;
• changes in laboratory test results (increased INR, prolonged prothrombin time, abnormal urine color).

Patients with impaired immune systems
In addition to symptoms related to the progression of the disease, the following side effects have been observed in adult patients with impaired immune systems:

• nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, flatulence, dry mouth;
• headache, hearing disturbances;
• rash;
• dyspnea, insomnia;
• abnormal laboratory test results: increased aspartate aminotransferase and alanine aminotransferase, increased blood urea nitrogen, and decreased platelet and white blood cell counts.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Fromilid

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fromilid contains

• The active substance of Fromilid is clarithromycin. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin.
• The other ingredients are: cornstarch, microcrystalline cellulose, anhydrous colloidal silica, pregelatinized starch, potassium polacrilin, talc, magnesium stearate.
• The coating contains: hypromellose 6 cps, talc, iron oxide, yellow (E 172), propylene glycol, titanium dioxide (E 171).

What Fromilid looks like and contents of the pack

The tablet is oval, slightly convex on both sides, and has a light brown-yellow color. The packaging contains film-coated tablets in PVC/PVDC/Aluminum blisters, in a cardboard box. Fromilid 250: 10 film-coated tablets (1 blister of 10 tablets), 14 film-coated tablets (2 blisters of 7 tablets). Fromilid 500: 14 film-coated tablets (2 blisters of 7 tablets), 28 film-coated tablets (4 blisters of 7 tablets).

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. For more information about this medicine, the patient should contact the local representative of the marketing authorization holder: KRKA-Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland, tel.: (22) 57 37 500.

Date of last revision of the leaflet: