Fromilid Uno

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Fromilid Uno

500 mg, prolonged-release tablets

Clarithromycin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging 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 protein synthesis. Fromilid Uno is effective 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 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

• medicines that can cause severe heart rhythm disturbances, including:
• 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 blood cholesterol levels);
• midazolam taken orally (a medicine used in anxiety and insomnia);
• colchicine (a medicine used in gout);

Warnings and precautions

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

• if the patient is pregnant or thinks they may be pregnant,

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

• severe allergic reactions, such as rash, urticaria, petechiae, angioedema of the throat, 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 infections (superinfections) 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 blood cholesterol levels);
• 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 taking 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 (medicines used in anxiety or insomnia);
• warfarin or other anticoagulant medicines, such as dabigatran, rivaroxaban, apixaban (medicines used to thin the blood);
• quetiapine or other atypical antipsychotic medicines;
• carbamazepine, valproate, phenytoin (antiepileptic medicines);
• atorvastatin, rosuvastatin (statins - medicines used to lower blood cholesterol levels);
• 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 and relieved by 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 for cancer);
• 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. It should not be chewed or divided. 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.
Since clarithromycin passes into breast milk, breastfeeding women should exercise caution when taking Fromilid Uno.

Driving and operating machines

Fromilid Uno may cause dizziness, confusion, and disorientation, which can affect the ability to drive vehicles and operate machines. The patient should not drive vehicles or operate machines 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 sodium intake in 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 as directed 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 recommend a different dosage 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 other things, confusion, pallor, low blood pressure, sweating, oliguria, tachypnea, weakness, and fainting
• allergic reactions: rash (frequent), itching, urticaria (not very frequent), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• severe skin reactions:
• acute generalized exanthematous pustulosis - a red, scaly rash with nodules under the skin and blisters
• Stevens-Johnson syndrome, manifested by sudden onset of fever and blisters, quickly and spontaneously resolving after discontinuation of the medicine; a severe disease characterized by blisters and erosions on the skin, in the mouth, eyes, and genital organs, fever, and joint pain
• toxic epidermal necrolysis - a severe, rapidly progressing disease characterized by bursting giant subepidermal blisters, extensive erosions on the skin, exfoliation of large skin flakes, and fever
• DRESS syndrome - a severe (life-threatening) drug rash progressing 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, pale 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 frequent side effects (may occur in 1 to 10 out of 100 patients) were reported:

• 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 1000 patients):

• candidiasis (fungal infection), gastritis, vaginal infection;
• decreased white blood cell count;
• hypersensitivity;
• anorexia, decreased appetite;
• restlessness;
• dizziness, drowsiness, tremors;
• balance disorders, hearing impairment, tinnitus;
• palpitations, changes in ECG (QT interval prolongation);
• epistaxis;
• gastroesophageal reflux disease, gastritis, proctitis, 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, dysgeusia, 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 diagnostic test results (increased INR, prolonged prothrombin time, abnormal urine color).

Patients with impaired immunity
In addition to symptoms resulting from the course of the disease, the following side effects have been observed in adult patients with impaired immunity:

• nausea, vomiting, changes in taste, constipation, abdominal pain, diarrhea, flatulence, 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 level, and decreased platelet and white blood cell count.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, more information can be collected 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 packaging 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 of the tablet are: core: sodium alginate, sodium-calcium alginate, lactose monohydrate, povidone, polysorbate 80, colloidal silica, magnesium stearate, talc; coating: hypromellose, talc, yellow iron oxide (E 172), titanium dioxide (E 171), propylene glycol.

What Fromilid Uno looks like and what the packaging contains

The prolonged-release tablets, 500 mg, are oval, biconvex, yellow-brown in color with the inscription "U" on one side.
The packaging contains prolonged-release tablets in PVC-PVDC/Al blisters, in a cardboard box.
Packaging sizes: 7 prolonged-release tablets and 14 prolonged-release tablets.
For more detailed information, the patient should contact the marketing authorization holder or the 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export: 9268/2016/02
9268/2016/03

Parallel import authorization number: 141/24

Date of leaflet approval: 03.04.2024

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