Fromilid uno

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Fromilid Uno
500 mg, prolonged-release tablets
Clarithromycinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

1. What Fromilid Uno is and what it is used for

Fromilid Uno contains clarithromycin as the active substance, which is an antibiotic belonging to the macrolide group and exerts antibacterial action by inhibiting protein synthesis. Fromilid Uno is active against many aerobic and anaerobic bacterial species, both Gram-positive and Gram-negative.
Clarithromycin in the form of prolonged-release tablets is indicated for the treatment of the following infections caused by microorganisms sensitive to clarithromycin:

• upper respiratory tract infections (e.g. pharyngitis, sinusitis),
• otitis media,
• lower respiratory tract infections (e.g. bronchitis and pneumonia),
• skin and subcutaneous tissue infections (e.g. folliculitis, cellulitis and erysipelas).

2. Important information before taking Fromilid Uno

When not to take Fromilid Uno

• if the patient is allergic to clarithromycin or other macrolide antibiotics (such as azithromycin, erythromycin), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe renal impairment (creatinine clearance less than 30 ml/min), because dose reduction is not possible (the tablet cannot be divided). In these patients, treatment with Fromilid in a formulation with unmodified release of the active substance is recommended;
• if the patient is taking any of the following medicines:
• medicines that may cause severe cardiac arrhythmias, including:
• astemizole or terfenadine (medicines used in allergy)
• cisapride (a medicine used for gastrointestinal motility disorders)
• pimozide (a medicine used in psychiatric disorders)
• ticagrelor (an antiplatelet agent);
• ranolazine (a heart medicine);
• ergot alkaloids such as ergotamine or dihydroergotamine (medicines used, among others, in migraine);
• lovastatin, simvastatin (statins, medicines used to reduce blood cholesterol levels);
• if the patient is taking a medicine containing lomitapide;
• midazolam administered orally (a medicine used in anxiety and insomnia);
• colchicine (a medicine used in the treatment of gout);
• if the patient has low blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia);
• if the patient has, or there is a family history of, cardiac arrhythmias (ventricular arrhythmias, including torsade de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome";
• if the patient has severe hepatic impairment associated with renal impairment.

Warnings and precautions
Before starting treatment with Fromilid Uno, consult a doctor if the patient:

• is pregnant or suspects she may be pregnant,
• has impaired kidney or liver function,
• has coronary artery disease, severe heart failure, or bradycardia (slow heart rate),
• is taking any of the medicines listed in the section "Fromilid Uno with other medicines".

If any of the following occur during treatment with Fromilid Uno, inform the doctor immediately:

• severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, or bronchospasm – seek immediate medical attention; appropriate treatment will be initiated;
• diarrhoea, especially if acute or prolonged; inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment; do not use anti-diarrhoeal medicines;
• symptoms suggesting liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain; discontinue treatment and consult a doctor;
• new infection (superinfection) with bacteria resistant to clarithromycin or fungi, particularly during prolonged antibiotic use – the doctor will recommend appropriate treatment.

Additionally, during treatment with Fromilid Uno, the following may occur:

• bacterial cross-resistance (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics, as well as to lincomycin and clindamycin).

Fromilid Uno with other medicines
Inform the doctor about all medicines currently taken, recently taken, or planned for use.
It is essential to inform the doctor if the patient is taking any of the following medicines, as concomitant use with Fromilid Uno is contraindicated:

• astemizole or terfenadine (medicines used in allergy);
• cisapride or domperidone (medicines used for gastrointestinal motility disorders);
• pimozide (a medicine used in psychiatric disorders);
• ticagrelor, ranolazine (medicines used in heart and circulatory diseases);
• ergot alkaloids such as ergotamine or dihydroergotamine (medicines used, among others, in migraine);
• statins – lovastatin, simvastatin (medicines lowering blood cholesterol levels);
• midazolam administered orally (a medicine used in anxiety and insomnia);
• colchicine (a medicine used in gout).

Inform the doctor if the patient is taking any of the following medicines, as special caution is required when using them concomitantly with Fromilid Uno:

• rifampicin, rifapentine, rifabutin (antibiotics used in tuberculosis treatment);
• fluconazole, itraconazole (antifungal medicines);
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in HIV infection treatment);
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in treatment of cardiac arrhythmias or hypertension);
• alprazolam, triazolam, midazolam administered intravenously or orally mucosally (medicines used in anxiety or insomnia);
• warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban (medicines used to thin the blood);
• quetiapine or other atypical antipsychotics;
• carbamazepine, valproate, phenytoin (antiepileptic medicines);
• atorvastatin, rosuvastatin (statins – medicines lowering blood cholesterol levels);
• methylprednisolone (an anti-inflammatory medicine);
• omeprazole (a medicine reducing gastric acid secretion);
• cilostazol (a medicine used in intermittent claudication, characterised by leg muscle pain during exertion, subsiding after brief rest);
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, after organ transplantation);
• sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction);
• ibrutinib or vinblastine (medicines used in cancer chemotherapy);
• theophylline (a medicine used in bronchial asthma);
• tolterodine (a medicine used in urinary incontinence);
• phenobarbital (an anticonvulsant medicine);
• St John’s wort ([ Hypericum perforatum ] herbal medicine used in mild depression);
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes);
• ototoxic medicines (damaging hearing), particularly aminoglycoside antibiotics used in bacterial infections.

Taking Fromilid Uno with food and drink
The tablet should be swallowed whole with liquid. Do not chew or divide the tablet. Fromilid Uno should be taken with food.

Pregnancy and breastfeeding
If the patient is pregnant or suspects she may be pregnant, is breastfeeding, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The safety of clarithromycin during pregnancy and breastfeeding has not been established. Fromilid Uno may be used in pregnant women only if, in the doctor’s opinion, the benefit to the mother outweighs the potential risk to the foetus.
Since clarithromycin passes into human milk, women who are breastfeeding should exercise particular caution when taking Fromilid Uno.

Driving and operating machinery
Fromilid Uno 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 these symptoms occur.

Fromilid Uno contains lactose monohydrate and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult a doctor before taking this medicine.
Each tablet contains 12.85 mg of sodium. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
The medicine contains 25.7 mg of sodium (main component of table salt) in the maximum daily dose. This corresponds to 1.28% of the maximum recommended daily sodium intake in the adult diet. This should be taken into account in patients who are monitoring their dietary sodium intake.

3. How to take Fromilid Uno

This medicine should always be taken as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The tablet should be swallowed whole with at least half a glass of liquid. Tablets must not
be chewed or divided. Fromilid Uno should be taken during a meal.
The dosage and duration of treatment depend on the type and location of infection, the patient's age, and their response to treatment.
Recommended dose
Adults and adolescents over 12 years of age
The recommended dose is 1 tablet of 500 mg once daily. In severe infections, the physician may increase
the dose to 1 g once daily (two 500 mg tablets).
Treatment usually lasts from 5 to 14 days. Only in pneumonia and sinusitis should the medicine be taken for 6 to
14 days.
For patients with renal impairment, the physician may recommend an adjusted dosage.
Children under 12 years of age
Clarithromycin is recommended in the form of granules for oral suspension.
Taking more Fromilid Uno than recommended
If you take more medicine 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.
As with other macrolide antibiotics, hemodialysis and peritoneal dialysis do not reduce serum concentrations of clarithromycin.
Missed dose of Fromilid Uno
If you miss a dose at the scheduled time, take it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Fromilid Uno
Do not stop taking this medicine without consulting your doctor. Stopping treatment too early may lead to recurrence of the infection.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in the patient at any stage of taking the medicine,
stop taking Fromilid Uno and consult a doctor immediately:

• shock – acute, life-threatening allergic reaction characterized, among others, by confusion, pale skin, drop in blood pressure, sweating, low urine output, rapid breathing, weakness and fainting
• allergic reactions: rash (common), itching, urticaria (not common), angioedema of the face, tongue, lips, eyes and throat, difficulty breathing
• severe skin reactions:
• acute generalized pustular eruption – red, scaling rash with subcutaneous nodules and blisters
• erythema multiforme bullosum (Stevens-Johnson syndrome) characterized by sudden onset of fever and blisters, resolving spontaneously and rapidly after discontinuation of the drug; severe disease characterized by blisters and erosions on the skin, in the oral cavity, eyes and genital organs, fever and joint pain
• toxic epidermal necrolysis (Lyell's syndrome) – severe, rapidly progressing disease characterized by rupturing giant subepidermal blisters, extensive skin erosions, shedding of large epidermal sheets and fever
• DRESS syndrome – severe (life-threatening) drug-induced rash with eosinophilia and internal organ involvement
• severe or prolonged diarrhoea, possibly with blood or mucus in the stool (pseudomembranous colitis). Diarrhoea may occur even up to two months after completion of clarithromycin treatment. In such a case, contact a doctor.
• yellowing of the skin (jaundice), skin irritation, pale stool, dark urine, abdominal tenderness or loss of appetite. These may be symptoms of liver failure.
• muscle swelling, cramps and muscle pain which may be symptoms of rhabdomyolysis (a syndrome of disorders caused by breakdown of muscle tissue). In some cases of rhabdomyolysis, clarithromycin was administered concomitantly with other drugs known to cause rhabdomyolysis, such as: drugs used in the treatment of lipid disorders, e.g. statins, fibrates; drugs used in the treatment of gout, e.g. colchicine or allopurinol. These reactions occur with unknown frequency, unless otherwise stated.

Other adverse reactions:
In clinical trials and following marketing of clarithromycin, the following common adverse reactions have been reported (may occur in 1 to 10 out of 100 patients):

• insomnia;
• taste disturbances, headache;
• diarrhoea, vomiting, dyspepsia, nausea, abdominal pain;
• abnormal liver function test results;
• excessive sweating.

Uncommon adverse reactions (may occur in 1 to 10 out of 1000 patients):

• candidiasis (fungal infection), gastritis and enteritis, vaginal infection;
• decreased white blood cell count;
• hypersensitivity;
• anorexia, decreased appetite;
• anxiety;
• dizziness, somnolence, tremor;
• loss of balance, hearing loss, tinnitus;
• palpitations, changes in ECG (prolongation of QT interval);
• nosebleed;
• gastroesophageal reflux disease, gastritis and enteritis, anal pain, stomatitis, glossitis, constipation, dry mouth, belching, bloating with gas release;
• increased liver enzyme activity;
• muscle pain;
• asthenia (weakness, lack of strength).

The following adverse reactions have been reported after marketing of clarithromycin in tablet and suspension form and are of unknown frequency (frequency cannot be estimated from available data):

• roseola;
• agranulocytosis (reduction in number of granulocytes in blood), thrombocytopenia (reduction in platelet count);
• acne;
• psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, unusual dreams, mania;
• seizures, ageusia (loss of taste), parosmia (distorted sense of smell), anosmia (loss of smell), paresthesia (numbness, tingling);
• deafness;
• cardiac arrhythmias, ventricular tachycardia, ventricular fibrillation;
• haemorrhage;
• acute pancreatitis, tongue discoloration, tooth discoloration;
• myopathy (muscle disease with muscle weakness), muscle pain;
• renal failure, interstitial nephritis;
• changes in diagnostic test results (increased international normalized ratio (INR), prolonged prothrombin time, abnormal urine color).

Immunocompromised patients
In addition to symptoms related to the underlying disease, the following adverse reactions have been observed in immunocompromised adult patients:

• nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhoea, bloating with gas release, dry mouth;
• headache, hearing disturbances;
• rash;
• dyspnoea, insomnia;
• abnormal laboratory test results: increased aspartate aminotransferase (AspAT) and alanine aminotransferase (AlAT) activity, increased blood urea nitrogen, decreased platelet and white blood cell counts.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fromilid Uno

Keep the medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What the medicine Fromilid Uno contains

• The active substance is clarithromycin. Each prolonged-release tablet contains 500 mg of clarithromycin.
• Other ingredients of the tablet are: core: sodium alginate, sodium-calcium alginate, lactose monohydrate, povidone, polysorbate 80, colloidal anhydrous silica, magnesium stearate, talc; coating: hypromellose, talc, iron oxide yellow (E 172), titanium dioxide (E 171), propylene glycol.

What Fromilid Uno looks like and contents of the pack
Prolonged-release tablets, 500 mg, are oval, biconvex, brownish-yellow in colour, with the imprint “U” on one side.
The packaging contains prolonged-release tablets in PVC-PVDC/Al blisters, packed in a cardboard box.
Pack sizes: 7 prolonged-release tablets and 14 prolonged-release tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation numbers in Romania, country of export: 9268/2016/02
9268/2016/03
Parallel import authorisation number: 141/24