Fromilid

Warnings and precautions

Before starting treatment with Fromilid, discuss with your doctor if you have any of the following conditions:

• you are pregnant or think you may be pregnant,
• you have kidney or liver function disorders,
• you have coronary artery disease, severe heart failure, bradycardia,
• you are taking any of the medications listed in the "Fromilid and other medications" section.

If you experience any of the following situations while taking Fromilid, tell your doctor:

• severe allergic reactions, such as rash, urticaria, purpura, angioedema, bronchospasm - you should immediatelyconsult a doctor who will provide appropriate treatment;
• diarrhea, especially acute or prolonged; you should inform your doctor as soon as possible. If necessary, the doctor will prescribe appropriate treatment; do not take anti-diarrheal medications;
• symptoms of liver function disorders, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain; you should discontinue treatment and consult a doctor;
• new infection (superinfection) with bacteria insensitive to clarithromycin or fungi, especially during long-term antibiotic use - the doctor will prescribe appropriate treatment.

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

• cross-resistance of bacteria (bacteria insensitive to clarithromycin may also be resistant to other macrolide antibiotics and lincosamides and clindamycin).

Fromilid and other medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

You must inform your doctor if you are taking any of the following medications, 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 myocardial infarction or stroke);
• colchicine (used for gout);
• statins - lovastatin, simvastatin (used to lower cholesterol levels);
• midazolam orally (used for anxiety or insomnia).

You should inform your doctor if you are taking any of the following medications, as special caution is required when using them with Fromilid:

Fromilid:

• rifampicin, rifapentine, rifabutin (antibiotics used for tuberculosis);
• fluconazole, itraconazole (antifungal medications);
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used for HIV infection);
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used for heart rhythm disorders or hypertension);
• alprazolam, triazolam, midazolam intravenously or orally (used for anxiety or insomnia);
• warfarin or other anticoagulant medications, such as dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood);
• quetiapine or other atypical antipsychotic medications;
• carbamazepine, valproate, phenytoin (antiepileptic medications);
• methylprednisolone (anti-inflammatory medication);
• omeprazole (medication that reduces stomach acid production);
• cilostazol (medication used for intermittent claudication);
• cyclosporine, tacrolimus, sirolimus (medications used for organ transplantation);
• sildenafil, tadalafil, vardenafil (medications used for erectile dysfunction);
• ibrutinib or vinblastine (medications used for cancer chemotherapy);
• theophylline (medication used for asthma);
• tolterodine (medication used for urinary incontinence);
• phenobarbital (antiepileptic medication);
• St. John's Wort ([Hypericum perforatum] herbal remedy used for mild depression);
• sulfonylurea, nateglinide, repaglinide, insulin (medications used for diabetes);
• ototoxic medications (damaging to hearing), especially aminoglycosides, such as gentamicin.

This is also important for medications with the following names:

• hydroxychloroquine or chloroquine (used for rheumatoid arthritis, or for the treatment or prevention of malaria). Taking these medications 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 medication. The suspension contains granules that children should not chew, as they have a bitter taste.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of clarithromycin during pregnancy and breastfeeding has not been established. Fromilid should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.
Since 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 and use machines. Patients should not drive or operate machinery if these symptoms occur.

Fromilid contains sucrose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Each 5 ml of oral suspension contains 1.28 g of sucrose. The maximum daily dose contains 5.12 g of sucrose. This should be taken into account in patients with diabetes.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which is considered "sodium-free".

3. How to take Fromilid

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The dose 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 oral suspension is 7.5 mg/kg body weight twice daily (see table - Dosing in children by body weight), with a maximum dose of 500 mg twice daily for the treatment of infections not caused by mycobacteria.
Treatment usually lasts from 5 to 10 days, depending on the type of microorganism and the course of the disease. The medication can be administered with or without food. The medication can be given with milk.
The dose of Fromilid will be determined by your doctor based on the child's body weight.

*For children weighing less than 8 kg, the dose is calculated based on body weight (7.5 mg/kg twice daily).
Dosing in patients with renal impairment
In patients with renal impairment, the clarithromycin dose should be reduced by half, i.e. to 250 mg once daily or, in the treatment of more severe infections, to 250 mg twice daily. In these patients, treatment should not last longer than 14 days.
Dosing in patients with mycobacterial infections
In children with disseminated or localized mycobacterial infections (Mycobacterium avium, M. intracellulare, M. chelonae, M. fortuitum, M. kansasii), the recommended daily dose of clarithromycin is 15-30 mg/kg body weight in two divided doses. The maximum dose is 500 mg twice daily.
Treatment should be continued as long as clinical improvement is observed. It may be necessary to add other medications effective against mycobacteria.

Preparation of the suspension

To prepare 60 ml of suspension (250 mg/5 ml), always use boiled and cooled water.
First, turn the bottle upside down and gently shake it to distribute the powder. To prepare the suspension, fill the bottle with water to about half the volume marked on the bottle. Close the bottle and shake until the powder is fully dissolved. Wait a moment and then slowly fill the bottle with water to the marked line and shake vigorously again. Shake the bottle 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 the mouth after taking the medication, the suspension can be rinsed with water.
5 ml of suspension measured with the applicator provided with the packaging contains 250 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 medication than recommended, contact your 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 serum.

Missing a dose of Fromilid

If you miss a dose at the scheduled time, take it as soon as possible. However, if it is close to the time of the next dose, skip the missed dose and continue with the usual dosing schedule.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Fromilid

Do not stop taking the medication without consulting your doctor. Stopping treatment too early may cause the disease to recur.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fromilid can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop takingFromilid and consult your doctor immediately:

• anaphylactic shock - a life-threatening allergic reaction, manifested by confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and syncope
• allergic reactions: rash (frequent), pruritus, urticaria (infrequent), angioedema, bronchospasm
• severe skin reactions:
• acute generalized exanthematous pustulosis - a red, scaly rash with papules and pustules under the skin
• Stevens-Johnson syndrome - a severe disease manifested by sudden onset of fever and pustules, which resolve spontaneously after discontinuation of the medication; 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, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after completion of clarithromycin treatment. In such cases, consult your doctor.
• jaundice, skin irritation, dark urine, itching, or abdominal pain. These may be signs of liver failure.
• severe abdominal pain, nausea, vomiting, diarrhea, and fever. These may be signs of acute pancreatitis.

These side effects occur with unknown frequency, unless otherwise specified.

Other side effects:

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

• 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 1000 patients):

• infection, candidiasis (fungal infection), vaginal infection;
• decreased white blood cell count, increased platelet count;
• anorexia, decreased appetite;
• anxiety, nervousness;
• dizziness, somnolence, tremors;
• balance disorders, hearing disturbances, tinnitus;
• palpitations, ECG changes (QT interval prolongation);
• gastritis, stomatitis, glossitis, constipation, dry mouth, eructation, flatulence;
• increased activity of liver enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT);
• 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, mania;
• seizures, ageusia, parosmia, anosmia, paresthesia (numbness, tingling);
• deafness;
• heart rhythm disturbances of the torsades de pointes type, 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 INR, prolonged prothrombin time, abnormal urine color).

Patients with impaired immune function
In addition to symptoms related to the course of 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 AST and ALT, increased blood urea nitrogen, and decreased platelet and white blood cell counts.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Fromilid

Keep this medicine out of the sight and reach of children.
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fromilid contains

• The active substance of Fromilid is clarithromycin. 5 ml of suspension contains 250 mg of clarithromycin.
• The other ingredients are: carbomer, povidone, hypromellose (HP55), talc, castor oil, xanthan gum, orange flavor, citric acid, potassium sorbate, silica colloidal anhydrous, titanium dioxide, sucrose, Sucram PH 280: sodium saccharin, ammonium glycyrrhizinate, neohesperidin dihydrochalcone. See section 2 "Fromilid contains sucrose and sodium".

What Fromilid looks like and contents of the pack

Granules for oral suspension 250 mg/5 ml are white to almost white, small, non-uniform granules with an orange flavor.
Available packs: 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 on this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA - Polska Sp. z o.o.,
ul. Równoległa 5,
02-235 Warszawa,
Polska
tel.: (22) 57 37 500

Date of last revision of the package leaflet: