Fromilid uno

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Fromilid Uno and what is it used for
2. Important information 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 is Fromilid Uno and what is it used for

Fromilid Uno contains clarithromycin as the active substance, which is an antibiotic belonging to the macrolide group, acting antibacterially by inhibiting protein synthesis. Fromilid Uno is active against many species of aerobic and anaerobic bacteria, 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 soft 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 non-extended 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 for psychiatric disorders) o ticagrelor (a platelet aggregation inhibitor); o ranolazine (a cardiac medicine);

o ergot alkaloids such as ergotamine or dihydroergotamine (medicines used, among others, in migraine);

o lovastatin, simvastatin (statins, medicines used to reduce blood cholesterol levels);

• if the patient is taking a medicine containing lomitapid;

• 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 any of the following apply to the patient:

• the patient is pregnant or suspects she may be pregnant,
• the patient has renal or hepatic dysfunction,
• the patient has coronary artery disease, severe heart failure, or bradycardia,
• the patient is taking any of the medicines listed in the section "Fromilid Uno with other medicines".

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

• severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal oedema, or bronchospasm – immediate medical attention is required and appropriate treatment should be initiated;
• diarrhoea, especially if acute or prolonged; the patient should inform the doctor as soon as possible. If necessary, the doctor will recommend appropriate treatment; antidiarrhoeal medicines should not be used;
• symptoms suggesting hepatic dysfunction, such as loss of appetite, jaundice, dark urine, pruritus, or abdominal pain; treatment should be discontinued and the patient should 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 show resistance to other macrolide antibiotics, as well as to lincosamides and clindamycin).

Fromilid Uno with other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to take.
It is essential to inform the doctor if the patient is taking any of the following medicines, as their use together 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 for psychiatric disorders);
• ticagrelor, ranolazine (medicines used in cardiovascular diseases);
• ergot alkaloids such as ergotamine or dihydroergotamine (medicines used, among others, in migraine);
• statins – lovastatin, simvastatin (medicines that lower 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 together with Fromilid Uno:

• rifampicin, rifapentine, rifabutin (antibiotics used in the treatment of tuberculosis);
• fluconazole, itraconazole (antifungal medicines);
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used in the treatment of HIV infection);
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used in the treatment of cardiac arrhythmias or hypertension);
• alprazolam, triazolam, intravenous or buccal midazolam (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 that lower blood cholesterol levels);
• methylprednisolone (an anti-inflammatory medicine);
• omeprazole (a medicine that reduces gastric acid secretion);
• cilostazol (a medicine used in intermittent claudication, characterised by pain in the lower limb muscles during exercise, 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 during a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 opinion of the doctor, 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 intolerance to certain sugars, the patient 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 controlling dietary sodium intake.

3. How to take Fromilid Uno

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed whole with at least half a glass of liquid. Do not chew or divide the tablets. Fromilid Uno should be taken during a meal.
The dosage and duration of treatment depend on the type and site 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 doctor may increase the dose to 1 g once daily (two 500 mg tablets).
Treatment usually lasts from 5 to 14 days. In pneumonia and sinusitis, the medicine should be taken for 6 to 14 days.
For patients with renal impairment, the doctor may recommend an adjusted dosage.

Children under 12 years of age
Clarithromycin is recommended in the form of granules for oral suspension.

If you take more Fromilid Uno than you should
If you take more tablets than prescribed, 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, haemodialysis or peritoneal dialysis do not significantly reduce serum concentrations of clarithromycin.

If you forget to take Fromilid Uno
If you miss a dose, 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 forgotten dose.

Stopping Fromilid Uno treatment
Do not stop taking this medicine without consulting your doctor. Stopping treatment too early may result in 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 medicinal product can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in a patient at any time during treatment,
stop taking Fromilid Uno and consult a doctor immediately:

• Anaphylactic shock – an acute, life-threatening allergic reaction characterized, among others, by confusion, pale skin, drop in blood pressure, sweating, reduced urine output, rapid breathing, weakness, and fainting
• Allergic reactions: rash (frequent), itching, urticaria (not common), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• Severe skin reactions:
  • Acute generalized exanthematous pustulosis – red, peeling rash with subcutaneous nodules and blisters
  • Erythema multiforme (Stevens-Johnson syndrome) – suddenly appearing fever and blisters, resolving spontaneously after discontinuation of the drug
  • Severe disease characterized by blisters and erosions on the skin, in the oral cavity, eyes, and genital organs, accompanied by fever and joint pain
  • Toxic epidermal necrolysis (Lyell's syndrome) – a severe, rapidly progressing disease characterized by rupturing of giant subepidermal blisters, extensive skin erosions, large-scale peeling of the epidermis, and fever
  • DRESS syndrome – severe (life-threatening) drug-induced rash associated with increased eosinophil count 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 cases, contact a doctor immediately.
• 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 indicate rhabdomyolysis (a syndrome caused by breakdown of muscle tissue). In some cases of rhabdomyolysis, clarithromycin was administered concomitantly with other drugs known to cause rhabdomyolisis, such as lipid-lowering agents (e.g. statins, fibrates) or drugs used in gout treatment (e.g. colchicine or allopurinol). These adverse reactions occur with unknown frequency unless otherwise stated.

Other adverse reactions:
The following common adverse reactions (may affect 1 to 10 in 100 patients) have been reported in clinical trials and post-marketing surveillance of clarithromycin:

• Insomnia
• Taste disturbances, headache
• Diarrhoea, vomiting, dyspepsia, nausea, abdominal pain
• Abnormal liver function test results
• Excessive sweating

Uncommon adverse reactions (may affect 1 to 10 in 1,000 patients):

• Candidiasis (fungal infection), gastritis, enteritis, vaginal infection
• Leukopenia (reduced white blood cell count)
• Hypersensitivity
• Anorexia, decreased appetite
• Restlessness
• Dizziness, somnolence, tremor
• Balance disorders, hearing loss, tinnitus
• Palpitations, ECG changes (prolongation of QT interval)
• Epistaxis (nosebleed)
• Gastroesophageal reflux disease, gastritis, enteritis, anal pain, stomatitis, glossitis, constipation, dry mouth, belching, flatulence
• Increased liver enzyme activity
• Muscle pain
• Asthenia (weakness, lack of energy)

The following adverse reactions have been reported after marketing authorization of clarithromycin in tablet and suspension forms, with frequency not known (frequency cannot be estimated from available data):

• Roseola
• Agranulocytosis (reduced granulocyte count in blood), thrombocytopenia (reduced platelet count)
• Acne
• Psychotic disorders, 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
• Arrhythmias, ventricular tachycardia, ventricular fibrillation
• Haemorrhage
• Acute pancreatitis, tongue discoloration, tooth discoloration
• Myopathy (muscle disease with reduced muscle strength), muscle pain
• Renal failure, interstitial nephritis
• Changes in diagnostic test results (elevated International Normalized Ratio (INR), prolonged prothrombin time, abnormal urine color)

Patients with impaired immunity
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, flatulence, dry mouth
• Headache, hearing disturbances
• Rash
• Dyspnoea (shortness of breath), 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 those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Fromilid Uno

Keep this 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 container. 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 measures help protect the environment.

6. Contents of the packaging and other information

What Fromilid Uno contains

• The active substance is clarithromycin. Each prolonged-release tablet contains 500 mg of clarithromycin.
• Other ingredients are: core: sodium alginate, sodium-calcium alginate, lactose monohydrate, povidone, polysorbate 80, colloidal anhydrous silica, magnesium stearate, talc; coating: hypromellose, talc, yellow iron oxide (E 172), titanium dioxide (E 171), propylene glycol. See section 2 "Fromilid Uno contains lactose monohydrate and sodium".

What Fromilid Uno looks like and contents of the pack
Prolonged-release tablets, 500 mg, are oval, biconvex, brownish-yellow in colour, with the inscription "U" on one side.
The packaging contains prolonged-release tablets in blisters made of PVC-PVDC/Al, packed in a cardboard box.
Pack sizes: 7 prolonged-release tablets (1 blister with 7 tablets), 14 prolonged-release tablets (2 blisters with 7 tablets each).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Romania, the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Romania, the country of export: 9268/2016/02
9268/2016/03
Parallel Import Licence Number: 45/24