Fromilid Uno

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Fromilid Uno

500 mg, prolonged-release tablets

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to 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 any 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 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 the active substance clarithromycin, which is a macrolide antibiotic that works by inhibiting bacterial protein synthesis. Fromilid Uno acts on 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 clarithromycin-sensitive microorganisms:

• 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

• astemizole or terfenadine (medicines used in allergies)
• cisapride or domperidone (medicines used in gastrointestinal disorders)
• pimozide (a medicine used in psychiatric disorders)
• tikagrelor, ranolazine (medicines used in heart and circulation diseases)
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, in migraines)
• statins - lovastatin, simvastatin (medicines used to lower cholesterol levels in the blood)
• midazolam taken orally (a medicine used in anxiety and insomnia)
• colchicine (a medicine used in gout)

o if the patient is taking a medicine containing lomitapide;
o if the patient is taking oral midazolam;
o if the patient is taking colchicine (a medicine used in gout);

Warnings and precautions

Before starting to take Fromilid Uno, the patient should discuss the following with their doctor:

• if the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child;
• if the patient has kidney or liver problems;
• if the patient has coronary artery disease, severe heart failure, or bradycardia;
• if the patient is taking any of the medicines listed in the section "Fromilid Uno and other medicines".

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

• severe allergic reactions, such as rash, urticaria, purpura, angioedema, 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 function disorders, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain; the patient should stop treatment and consult a doctor;
• new infection (superinfection) with bacteria insensitive to clarithromycin or fungi, especially during long-term use of antibiotics - the doctor will prescribe appropriate treatment.

In addition, while taking Fromilid Uno, 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 Uno 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 Uno is contraindicated:

• astemizole or terfenadine (medicines used in allergies)
• cisapride or domperidone (medicines used in gastrointestinal disorders)
• pimozide (a medicine used in psychiatric disorders)
• tikagrelor, ranolazine (medicines used in heart and circulation diseases)
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, in migraines)
• statins - lovastatin, simvastatin (medicines used to lower cholesterol levels in the blood)
• midazolam taken orally (a medicine used in anxiety and insomnia)
• colchicine (a medicine used in gout)

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 Uno:

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 heart rhythm disorders or hypertension)
• alprazolam, triazolam, midazolam taken intravenously or orally
• warfarin or other anticoagulant medicines, e.g., dabigatran, rivaroxaban, apixaban
• quetiapine or other atypical antipsychotic medicines
• carbamazepine, valproate, phenytoin (antiepileptic medicines)
• atorvastatin, rosuvastatin (statins - medicines used to lower cholesterol levels in the blood)
• methylprednisolone (an anti-inflammatory medicine)
• omeprazole (a medicine that reduces stomach acid production)
• cilostazol (a medicine used in intermittent claudication, which is characterized by leg pain during exercise that disappears after a short rest)
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, after transplants)
• sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction)
• ibrutinib or vinblastine (medicines used in chemotherapy)
• theophylline (a medicine used in asthma)
• tolterodine (a medicine used in urinary incontinence)
• phenobarbital (an antiepileptic medicine)
• St. John's Wort (Hypericum perforatum) (a herbal medicine used in mild depression)
• sulfonylurea, nateglinide, repaglinide, insulin (medicines used in diabetes)
• ototoxic medicines (damaging hearing), especially aminoglycoside antibiotics used in bacterial infections

Taking Fromilid Uno with food and drink

The tablet should be swallowed whole, with a liquid. Do not chew or divide it. Fromilid Uno should be taken during a meal.

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 Uno 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 Uno.

Driving and using machines

Fromilid Uno may cause dizziness, confusion, and disorientation, which may affect the ability to drive and 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 some sugars, they should contact their doctor before taking the medicine.
Each tablet contains 12.85 mg of sodium. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".
The medicine contains 25.7 mg of sodium (the main component of table salt) in the maximum daily dose.
This corresponds to 1.28% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients controlling their sodium intake.

3. How to take Fromilid Uno

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed whole, with at least half a glass of liquid. The tablets should 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 the infection, the patient's age, and their response to treatment.

Recommended dose

Adults and adolescents over 12 years old
The recommended dose is 1 tablet of 500 mg, once a day. In severe infections, the doctor may increase the dose to 1 g, once a day (two tablets of 500 mg).
Treatment usually lasts 5 to 14 days. Only in pneumonia and sinusitis should the medicine be taken for 6 to 14 days.
The doctor may prescribe a different dose for patients with renal impairment.
Children under 12 years old
Clarithromycin is recommended in the form of granules for oral suspension.

Taking a higher dose of Fromilid Uno than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately contact their doctor or pharmacist.
Overdose of the medicine may cause gastrointestinal disorders (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 Uno

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 of taking the next dose, the patient should skip the missed dose and continue according to the usual schedule of taking the medicine.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Fromilid Uno

The patient should not stop taking the medicine without consulting their doctor. Stopping treatment too early may cause the disease to recur.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• anaphylactic shock - a life-threatening allergic reaction, manifested by, among others, confusion, pallor, low blood pressure, sweating, decreased urine production, rapid breathing, weakness, and fainting
• allergic reactions: rash (common), itching, urticaria (uncommon), angioedema, facial, lingual, or laryngeal edema, difficulty breathing
• severe skin reactions: o acute generalized exanthematous pustulosis - a red, scaly rash with bumps under the skin and blisters o Stevens-Johnson syndrome, manifested by sudden onset of fever and blisters, which quickly and spontaneously resolve after discontinuation of the medicine; severe disease manifested by blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain o toxic epidermal necrolysis (Lyell's syndrome) - a severe, rapidly progressing disease manifested by large, bursting subepidermal blisters, extensive erosions on the skin, shedding of large skin flakes, and fever o DRESS syndrome - a severe (life-threatening) drug rash, which progresses with an increased number of eosinophils and involvement of internal organs
• severe or prolonged diarrhea, with possible blood or mucus in the stool (pseudomembranous colitis). Diarrhea may occur even two months after the end of treatment with clarithromycin. In such a case, the patient should also consult their doctor.
• jaundice, skin irritation, light-colored stools, 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 disease symptoms caused by muscle tissue breakdown). In some cases of rhabdomyolysis, clarithromycin was administered simultaneously with other medicines known to cause rhabdomyolysis, such as lipid-lowering medicines, e.g., statins, fibrates; medicines used in the treatment of gout, e.g., colchicine or allopurinol. 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 were reported (may occur in 1 to 10 out of 100 patients):

• insomnia;
• taste disorders, headache;
• diarrhea, vomiting, nausea, abdominal pain;
• abnormal liver function test results;
• excessive sweating.

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

• candidiasis (thrush), gastritis, vaginal infection;
• decreased white blood cell count;
• hypersensitivity;
• anorexia, decreased appetite;
• restlessness;
• dizziness, drowsiness, tremors;
• balance disorders, hearing loss, tinnitus;
• palpitations, changes in ECG (QT interval prolongation);
• epistaxis;
• gastroesophageal reflux disease, gastritis, abdominal pain, stomatitis, glossitis, constipation, dry mouth, eructation, flatulence;
• increased liver enzyme activity;
• muscle pain;
• asthenia (weakness, lack of strength).

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

• rosacea;
• agranulocytosis (decreased granulocyte count in the blood), 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 disorders, ventricular tachycardia, atrial fibrillation;
• hemorrhage;
• acute pancreatitis, tooth discoloration, tongue discoloration;
• myopathy (muscle disease with muscle weakness), muscle pain;
• renal 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 resulting from the course 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 with gas release, dry mouth;
• headache, hearing disorders;
• rash;
• dyspnea, insomnia;
• abnormal laboratory test results: increased activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT), increased blood urea nitrogen, and decreased platelet and white blood cell count.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 side effects will help to gather more information on the safety of the medicine.

5. How to store Fromilid Uno

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 month.
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 pack and other information

What Fromilid Uno contains

• The active substance of the medicine is clarithromycin. Each prolonged-release tablet contains 500 mg of clarithromycin.
• The other ingredients are: core:sodium alginate, sodium-calcium alginate, lactose monohydrate, povidone, polysorbate 80, colloidal silica anhydrous, 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

The prolonged-release tablets, 500 mg, are oval, biconvex, yellow-brown, with the inscription U on one side.
The packaging contains prolonged-release tablets in PVC-PVDC/Al blisters, in a cardboard box.
Pack sizes: 7 prolonged-release tablets (1 blister of 7 tablets), 14 prolonged-release tablets (2 blisters of 7 tablets).
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 9268/2016/02
9268/2016/03
Parallel import authorization number: 45/24

Date of leaflet approval: 30.01.2024

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