Fromilid Uno

Package Leaflet: Information for the Patient

Fromilid Uno, 500 mg, Modified Release Tablets

Clarithromycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package 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 an antibiotic belonging to the macrolide group, acting bacteriostatically by inhibiting protein synthesis. Fromilid Uno acts on many species of aerobic and anaerobic bacteria, both Gram-positive and Gram-negative.
Clarithromycin in the form of modified 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 subcutaneous 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, ivabradine, ranolazine (medicines used in the treatment of angina pectoris or to reduce the risk of myocardial infarction or stroke);
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, in migraines);
• statins - lovastatin, simvastatin (medicines used to lower blood cholesterol levels);
• midazolam administered orally (a medicine used in anxiety and insomnia);
• colchicine (a medicine used in gout);

Warnings and precautions

Before starting treatment with Fromilid Uno, 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 problems,
• you have coronary artery disease, severe heart failure, bradycardia,
• you are taking any of the medicines listed in the "Fromilid Uno and other medicines" section.

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

• severe allergic reactions, such as rash, urticaria, purpura, laryngeal edema, bronchospasm - seek medical attention immediately;
• diarrhea, especially acute or prolonged; tell your doctor as soon as possible. If necessary, your doctor will prescribe appropriate treatment; do not take anti-diarrheal medicines;
• symptoms of liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or abdominal pain; stop treatment and consult your doctor;
• new infection (superinfection) with bacteria resistant to clarithromycin or fungi, especially during prolonged antibiotic treatment - your doctor will prescribe appropriate treatment.

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

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

Fromilid Uno and other medicines

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

You must inform your doctor if you 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, ivabradine, ranolazine (medicines used in the treatment of angina pectoris or to reduce the risk of myocardial infarction or stroke);
• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, in migraines);
• statins - lovastatin, simvastatin (medicines used to lower blood cholesterol levels);
• midazolam administered orally (a medicine used in anxiety and insomnia);
• colchicine (a medicine used in gout).

You should inform your doctor if you 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 administered intravenously or orally (medicines used in anxiety or insomnia);
• warfarin or other anticoagulant medicines, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (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);
• cyclosporin, 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);
• sulfonylureas, nateglinide, repaglinide, insulin (medicines used in diabetes);
• ototoxic medicines (damaging hearing), especially aminoglycoside antibiotics used in bacterial infections.

This is also important if you are taking medicines with the following names:

• hydroxychloroquine or chloroquine (used in the treatment of, among others, rheumatoid arthritis, or in the treatment or prevention of malaria). Taking these medicines 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 the treatment of many diseases).

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 with food.

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 Uno can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risks 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 your ability to drive and use machines. Do not drive or operate machinery if you experience these symptoms.

Fromilid Uno contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, contact your 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet whole, with at least half a glass of liquid. Do not chew or divide the tablets. Fromilid Uno should be taken with food.
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

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.
Patients with renal impairment
In patients with renal impairment, the dose of clarithromycin should be reduced by half, i.e., to 250 mg once a day or, in the treatment of severe infections, to 250 mg twice a day. In these patients, treatment should not last longer than 14 days. In this population of patients, clarithromycin should not be used in the form of modified-release tablets, due to the lack of possibility of dividing the tablet and reducing the dose of 500 mg per day.
Children under 12 years old
It is recommended to administer clarithromycin 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, contact your doctor or pharmacist immediately.
Overdose of the medicine may cause gastrointestinal disturbances (nausea, vomiting, abdominal pain). In case of overdose, the doctor will administer 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, take it as soon as possible.
However, if it is close to the time of taking 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 Uno

Do not stop taking the medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• anaphylactic shock - a life-threatening allergic reaction, which may include confusion, pallor, hypotension, sweating, oliguria, tachypnea, weakness, and syncope
• allergic reactions: rash (frequent), itching, urticaria (uncommon), angioedema of the face, tongue, lips, eyes, and throat, difficulty breathing
• severe skin reactions:
• acute generalized exanthematous pustulosis - a red, scaly rash with bumps under the skin and blisters
• Stevens-Johnson syndrome - a condition characterized by a sudden onset of fever and blisters, which resolve spontaneously after discontinuation of the medicine; a severe disease characterized by blisters and erosions on the skin, in the mouth, eyes, and genital areas, 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 plates, and fever
• DRESS syndrome - a severe (life-threatening) drug reaction that occurs with an increase in the 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, you should also contact your doctor.
• jaundice, skin irritation, pale stools, dark urine, itching, or abdominal pain. These may be signs of liver dysfunction.
• 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 concomitantly with other medicines known to cause rhabdomyolysis, such as lipid-lowering agents (e.g., statins, fibrates) or 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 have been reported (may occur in 1 to 10 out of 100 patients):

• 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 1,000 patients):

• candidiasis (fungal infection), 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 energy).

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, tooth staining;
• 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 related to 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, dry mouth;
• headache, hearing disturbances;
• rash;
• dyspnea, insomnia;
• abnormal laboratory test results: increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity, increased blood urea nitrogen, and decreased platelet and white blood cell count.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
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 medicine.

5. How to store Fromilid Uno

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C, in the original packaging.
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.
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 Uno contains

• The active substance of the medicine is clarithromycin. Each modified-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, iron oxide yellow (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

Modified-release tablets 500 mg are oval, biconvex, yellow-brown in color with the inscription U on one side.
The packaging contains modified-release tablets in PVC/PVDC/Aluminum blisters, in a cardboard box.
Pack sizes: 5 modified-release tablets (1 blister of 5 tablets), 7 modified-release tablets (1 blister of 7 tablets), 10 modified-release tablets (2 blisters of 5 tablets), and 14 modified-release tablets (2 blisters of 7 tablets).

Marketing authorization holder

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
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Poland
phone: +48 22 573 75 00

Date of last revision of the leaflet: