Fromilid

Leaflet accompanying the packaging: patient information

Fromilid, 125 mg/5 ml, granules for oral suspension

Clarithromycin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 packaging 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.
Fromilid in the form of oral suspension is intended for children from 6 months to 12 years old.
Clarithromycin in the form of oral suspension is indicated for the treatment of the following infections caused by microorganisms susceptible to clarithromycin:

• upper respiratory tract infections (e.g. streptococcal pharyngitis);
• acute otitis media;
• lower respiratory tract infections (e.g. bronchitis, pneumonia);
• skin and soft tissue infections (e.g. infectious eczema, folliculitis, cellulitis, abscesses);
• disseminated or localized infections caused by Mycobacterium aviumor Mycobacterium intracellulare; localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii.

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 oral midazolam (used for anxiety and insomnia);
• if the patient is taking medicines 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 concomitant 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 heart attack or stroke);
• if the patient has low potassium or magnesium levels in the blood (hypokalemia or hypomagnesemia);
• if the patient is taking lovastatin or simvastatin (statins used to lower 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 torsade de pointes) or electrocardiogram (ECG) abnormalities known as "QT interval prolongation";
• if the patient is taking colchicine (used for 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 function disorders,
• if the patient has coronary artery disease, severe heart failure, bradycardia,
• if the patient is taking any of the medicines listed in the "Fromilid and other medicines" section.

If any of the following situations occur during treatment with Fromilid, the patient should tell their doctor:

• severe hypersensitivity reactions, such as maculopapular rash, urticaria, purpura, laryngeal edema, bronchospasm - the patient should immediatelyconsult 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 function disorders, such as loss of appetite, jaundice, dark urine, itching, or abdominal tenderness; the patient should stop treatment and consult a doctor;
• new infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during prolonged antibiotic treatment - the doctor will prescribe appropriate treatment.

In addition, during treatment with 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).

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, ranolazine (used for angina pectoris or to reduce the risk of heart attack or stroke);
• colchicine (used for gout);
• statins - lovastatin, simvastatin (used to lower cholesterol levels);
• oral midazolam (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 for tuberculosis);
• fluconazole, itraconazole (antifungal medicines);
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used for HIV treatment);
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used for heart rhythm disorders or hypertension);
• alprazolam, triazolam, midazolam (given intravenously or orally);
• 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 stomach acid production);
• cilostazol (used for intermittent claudication);
• cyclosporin, 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] herbal medicine used for mild depression);
• sulfonylurea, nateglinide, repaglinide, insulin (used for diabetes);
• ototoxic medicines (damaging to hearing), especially aminoglycosides, e.g. gentamicin.

This is also important for medicines with the following names:

• hydroxychloroquine or chloroquine (used for rheumatoid arthritis, or for the treatment or prevention of malaria). Taking these medicines with clarithromycin may increase the risk of heart rhythm disturbances and other serious side effects affecting the heart.
• oral, injectable, or inhaled corticosteroids (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. It is recommended that the patient drinks a glass of water after taking the medicine. The suspension contains granules that the child should not chew, as they have a bitter taste.

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 when the benefit to the mother outweighs the potential risk 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 machinery. The patient should not drive or operate machinery if they experience these symptoms.

Fromilid contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Each 5 ml of oral suspension contains 1.66 g of sucrose. The medicine contains 13.28 g of sucrose in the maximum daily dose. This should be taken into account in patients with diabetes.

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 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 for children and adolescents

The recommended daily dose of Fromilid in the form of oral suspension is 7.5 mg/kg body weight twice a day (see the table - Children under 12 years old), with a maximum dose of 500 mg twice a day for the treatment of infections not caused by mycobacteria.
The treatment duration is usually 5 to 10 days, depending on the type of microorganism and the course of the disease. The medicine can be given with or without food. The medicine can be given with milk.
Children under 12 years old
The dose of Fromilid will be determined by the doctor based on the child's body weight.
*For children with a body weight of less than 8 kg, the dose is calculated based on body weight (7.5 mg/kg body weight twice a day).
Dosing in patients with renal impairment
In patients with renal impairment, the dose of clarithromycin should be reduced by half, i.e. to 250 mg once a day or, in the treatment of more severe infections, to 250 mg twice a day. In these patients, treatment should not last longer than 14 days.
Dosing in patients with mycobacterial infections
In children with disseminated or localized infections caused by Mycobacterium(M. avium, M. intracellulare, M. chelonae, M. fortuitum, M. kansasii), the recommended daily dose of clarithromycin is 15 to 30 mg/kg body weight in two divided doses.
The maximum dose is 500 mg twice a day.
Treatment should be continued for as long as clinical improvement is observed. It may be necessary to add other medicines that are effective against Mycobacterium.

Preparation of the suspension

To prepare 60 ml of suspension (125 mg/5 ml), always use boiled and cooled water.
The bottle should be turned upside down and shaken gently to distribute the powder. To prepare the suspension, the bottle should be filled with water to about half the volume marked on the bottle. The bottle should be closed and shaken until the powder is fully dissolved. After a while, the foam should be allowed to settle, and the bottle should be slowly filled with water to the marked line and shaken again vigorously. The bottle should be shaken before each use.
After preparing the suspension, small granules are visible, which is a normal phenomenon. The granules should not be chewed, as they have a bitter taste.
If the patient feels the granules in their mouth after taking the medicine, the suspension can be rinsed with water.
5 ml of suspension measured with the applicator provided with the packaging contains 125 mg of clarithromycin.
Storage conditions for the suspension - see section 5: How to store Fromilid.

Taking a higher dose of Fromilid than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
Overdose of the medicine 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

In case of missing a dose of the medicine at the scheduled time, the patient should take it as soon as possible.
However, if it is close to the time for the next dose, the missed dose should be skipped and the patient should continue with their regular 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 disease to recur.
If the patient has any further doubts about taking this medicine, they should consult 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 takingFromilid and consult their doctor immediately:

• anaphylactic shock - a life-threatening allergic reaction, characterized by confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• allergic reactions: rash (frequent), itching, urticaria (uncommon), angioedema of the face, tongue, lips, eyes, and larynx, difficulty breathing
• severe skin reactions:
• acute generalized exanthematous pustulosis - a red, scaly rash with papules and blisters
• Stevens-Johnson syndrome - a severe disease characterized by sudden onset of fever and blisters, which resolve spontaneously after discontinuation of the medicine; a severe disease characterized by blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and arthralgia
• toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by large, rupturing subepidermal blisters, extensive erosions on the skin, 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 two months after completion of clarithromycin treatment. In such cases, the patient should also consult their doctor.
• jaundice, skin irritation, dark urine, itching, or abdominal tenderness. These may be signs of liver failure.
• severe abdominal pain, nausea, vomiting, diarrhea, and fever. These may be signs of acute pancreatitis.

These reactions occur with unknown frequency, unless otherwise specified.

Other side effects:

In clinical trials and after marketing of clarithromycin, 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 test results;
• excessive sweating.

Uncommonside effects (may occur in 1 to 10 out of 1000 patients):

• infection, candidiasis (fungal infection), vaginal infection;
• decreased white blood cell count, increased platelet count;
• anorexia, decreased appetite;
• anxiety, nervousness;
• dizziness, drowsiness, tremors;
• balance disorders, hearing loss, tinnitus;
• palpitations, ECG changes (QT interval prolongation);
• gastritis, oral thrush, glossitis, constipation, dry mouth, belching, flatulence;
• increased activity of liver enzymes aspartate aminotransferase and alanine aminotransferase;
• maculopapular rash;
• muscle spasms;
• fever, asthenia (weakness, lack of energy).

The following side effects have been reported with unknown frequency(frequency cannot be estimated from available data) after marketing of clarithromycin in the form of oral suspension:

• rosacea;
• agranulocytosis (decreased granulocyte count), thrombocytopenia (decreased platelet count);
• acne;
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams;
• seizures, ageusia, dysgeusia, anosmia, paresthesia (numbness, tingling);
• deafness;
• heart rhythm disturbances of the torsade de pointestype, ventricular tachycardia, atrial fibrillation;
• hemorrhage;
• discoloration of the tongue, tooth discoloration;
• myopathy (muscle disease with muscle weakness);
• renal failure, interstitial nephritis;
• changes in laboratory test results (increased international normalized ratio (INR), prolonged prothrombin time, abnormal urine color).

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

• nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, flatulence;
• headache, hearing disturbances;
• rash;
• dyspnea, insomnia;
• abnormal laboratory test results: increased activity of aspartate aminotransferase and alanine aminotransferase, increased blood urea nitrogen levels, 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Fromilid

The medicine should be stored out of sight and reach of children.
The granules for oral suspension should be stored at a temperature not exceeding 30°C.
The prepared suspension is suitable for use for 14 days. The prepared suspension should be stored at a temperature not exceeding 25°C, protected from light.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fromilid contains

• The active substance of Fromilid is clarithromycin. 5 ml of suspension contains 125 mg of clarithromycin.
• The other ingredients are: carbomer 934 P, povidone, hypromellose (HP55), talc, castor oil, xanthan gum, banana flavor, citric acid, potassium sorbate, silica colloidal anhydrous, titanium dioxide, sucrose. See section 2 "Fromilid contains sucrose".

What Fromilid looks like and contents of the packaging

The granules for oral suspension 125 mg/5 ml are white to almost white, small, non-uniform granules with a banana flavor.
Available packaging: a bottle containing 25 g of granules to prepare 60 ml of suspension, together with a 5 ml applicator, in a cardboard box.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto,
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia
To obtain more detailed 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
phone: (22) 57 37 500

Date of last revision of the leaflet: