Klacid Unidia 500 mg modified-release tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

KLACID UNIDÍA 500 mg modified-release tablets

Clarithromycin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Klacid Unidía 500 mg modified-release tablets are and what they are used for
2. What you need to know before taking Klacid Unidía 500 mg modified-release tablets
3. How to take Klacid Unidía 500 mg modified-release tablets
4. Possible side effects
5. How to store Klacid Unidía 500 mg modified-release tablets

Pack contents and additional information

1. What Klacid Unidía 500 mg modified-release tablets are and what they are used for

Klacid Unidía 500 mg is an antibiotic belonging to the macrolide group, active against germs causing respiratory tract or skin infections.

Klacid Unidose 500 mg is used for the treatment of infections caused by susceptible microorganisms in adults, adolescents aged 12 to 18 years, and children over 12 years of age:

• Upper respiratory tract infections, such as pharyngitis (infection of the pharynx causing sore throat), tonsillitis (infection of the tonsils), and sinusitis (infection of the paranasal sinuses located around the forehead, cheeks, and eyes).
• Lower respiratory tract infections, such as acute bronchitis (infection and inflammation of the bronchi), acute exacerbation of chronic bronchitis (worsening of long-term or recurrent lung inflammation), and bacterial pneumonias (lung inflammation caused by bacteria). (see section Warnings and precautions)
• Mild skin and soft tissue infections, such as folliculitis (infection of one or more hair follicles), cellulitis (acute inflammation of the skin), and erysipelas (a type of skin infection). (see section Warnings and precautions)

Klacid Unidose 500 mg is an antibiotic belonging to the macrolide group, active against microorganisms causing respiratory tract or skin infections.

Klacid Unidose 500 mg is used for the treatment of infections caused by susceptible microorganisms in adults, adolescents aged 12 to 18 years, and children over 12 years of age:

• Upper respiratory tract infections, such as pharyngitis (infection of the pharynx causing sore throat), tonsillitis (infection of the tonsils), and sinusitis (infection of the paranasal sinuses located around the forehead, cheeks, and eyes).
• Lower respiratory tract infections, such as acute bronchitis (infection and inflammation of the bronchi), acute exacerbation of chronic bronchitis (worsening of long-term or recurrent lung inflammation), and bacterial pneumonia (lung inflammation caused by bacteria). (see section Warnings and Precautions)
• Mild skin and soft tissue infections, such as folliculitis (infection of one or more hair follicles), cellulitis (acute inflammation of the skin), and erysipelas (a type of skin infection). (see section Warnings and Precautions)

2. What you need to know before taking Klacid Unidose 500 mg modified-release tablets

Do not take Klacid Unidose 500 mg modified-release tablets

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6).
• If your creatinine clearance is less than 30 ml/min.
• If you have an irregular heartbeat.
• If you suffer from severe kidney or liver problems.
• If you are taking ergotamine or dihydroergotamine, or using ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for advice on alternative medications.
• If you are taking medicines known as terfenadine, astemizole (medicines for hay fever or allergies), cisapride or domperidone (used for stomach problems), or pimozide (a medicine used to treat certain psychiatric conditions), as taking these with clarithromycin may cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medications.
• If you are taking ticagrelor (to prevent blood clots and used in heart attacks and other heart problems), ivabradine, or ranolazine (for angina).
• If you are taking other medicines known to cause serious disturbances in heart rhythm.
• If you are undergoing treatment with oral midazolam (for anxiety or to help sleep).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormalities on the electrocardiogram (ECG, electrical recording of the heart) known as "QT prolongation syndrome".
• If you are taking medicines called lovastatin or simvastatin (to lower cholesterol levels), as combining these medicines may increase the risk of adverse effects. Consult your doctor for advice on alternative medications.
• If you are taking colchicine (for gout).
• If you are taking a medicine containing lomitapide.

Warnings and precautions

Consult your doctor or pharmacist before starting Klacid Unidose

• If you have heart, kidney, or liver problems.
• If you have or are prone to fungal infections (e.g., thrush).
• If you are pregnant or breastfeeding.
• If you are taking medicines known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, or simvastatin.
• If you are diabetic and taking hypoglycaemics (medicines to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, repaglinide, sulfonylureas, or insulin), as clarithromycin may excessively lower blood glucose levels. Careful monitoring of glucose is recommended.
• If you are taking a medicine called warfarin (a blood thinner).
• If you have myasthenia gravis, a condition in which your muscles become weak and tire easily.
• If you develop severe or prolonged diarrhoea during or after taking clarithromycin, consult your doctor immediately.

If any of these situations apply to you, consult your doctor before taking clarithromycin.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Elderly patients

Since clarithromycin is eliminated via the liver and kidneys, caution should be exercised in patients with hepatic impairment, moderate or severe renal impairment, and in elderly patients.

Taking Klacid Unidose 500 mg modified-release tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Klacid Unidose must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines for high cholesterol, or medicines known to cause serious disturbances in heart rhythm (see "Do not take Klacid Unidose").

This is especially important if you are taking medicines for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Blood thinning (e.g., warfarin or other anticoagulants such as dabigatran, rivaroxaban, apixaban, edoxaban).
• Migraine (e.g., ergotamine or dihydroergotamine).
• Epilepsy or bipolar disorder (carbamazepine, valproate, phenobarbital, or phenytoin).
• High cholesterol (e.g., simvastatin or lovastatin).

Or if you are taking any medicine called:

• Theophylline (used in patients with breathing difficulties such as asthma).

• Triazolam, alprazolam, or midazolam (sedatives).

• Cilostazol (for poor circulation).

• Methylprednisolone (a corticosteroid).

• Ibrutinib or vinblastine (for cancer treatment).

• Cyclosporine (an immunosuppressant).

• Rifabutin (for treating certain infections).

• Tacrolimus or sirolimus (for organ transplants and severe eczema).

• Sildenafil, tadalafil, or vardenafil (to treat impotence in adult men or pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs)).

• Zidovudine (to treat viruses).

• St. John's wort (a herbal product used to treat depression).

• Phenobarbital (a medicine to treat epilepsy).

• Nevirapine and efavirenz may decrease clarithromycin levels.

• Rifampicin or rifapentine (to treat tuberculosis).

• Omeprazole (to treat stomach acidity and stomach or intestinal ulcers).

• Ritonavir (an antiviral medicine used in the treatment of HIV infection) may increase clarithromycin levels. Concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medicines used in the treatment of HIV infection) with clarithromycin may increase levels of both atazanavir (or saquinavir) and clarithromycin.

• Itraconazole (an antifungal) taken together with clarithromycin may increase levels of both medicines.

• Fluconazole, another antifungal medicine, may increase clarithromycin levels.

• Tolterodine (to treat symptoms of overactive bladder syndrome). In some patients, tolterodine levels may increase when taken with clarithromycin.

• Quetiapine (for schizophrenia or other psychiatric conditions).

• Beta-lactam antibiotics (certain penicillins and cephalosporins).

• Aminoglycosides (used as antibiotics to treat infections).

• Calcium channel blockers (medicines to treat high blood pressure).

• Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse effects affecting the heart.

• Corticosteroids, administered orally, by injection, or by inhalation (used to suppress the immune system; this is useful in treating a wide range of diseases).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of clarithromycin during pregnancy has not been established, so your doctor must carefully weigh the benefits against the potential risks, especially during the first three months of pregnancy.

Clarithromycin passes into breast milk, so breastfeeding should be discontinued during treatment with clarithromycin.

Driving and using machines

Since clarithromycin may cause dizziness, vertigo, confusion, and disorientation, you should exercise extreme caution when driving or operating dangerous machinery during treatment with clarithromycin.

Klacid Unidose 500 mg modified-release tablets contain lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Klacid Unidose 500 mg modified-release tablets contain sodium.

This medicine contains 15.3 mg of sodium (main component of table/cooking salt) per tablet. If you take two modified-release tablets per day, the total sodium intake is 30.6 mg per dose. This corresponds to 1.5% of the maximum recommended daily sodium intake for an adult.

3. How to take Klacid unidía 500 mg modified-release tablets

Klacid unidía is administered orally.

Follow exactly the instructions for use of Klacid unidía 500 mg provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults, adolescents aged 12 to 18 years, and children over 12 years: the usual recommended dose of Klacid unidía 500 mg is 1 tablet of 500 mg taken once daily with food. In more severe infections, the dose may be increased up to 1000 mg once daily (2 x 500 mg). The usual duration of treatment is 5 to 14 days, excluding treatment for community-acquired pneumonia and sinusitis, which require 6 to 14 days of therapy.

Do not crush or chew Klacid unidía tablets.

The 20-tablet pack has 2 blisters allowing the simultaneous removal of 2 tablets (1 g).

Renal impairment

In patients with renal impairment and a creatinine clearance of less than 30 ml/min, the clarithromycin dose should be reduced by half, i.e., 250 mg once daily, or 250 mg twice daily in more severe infections. In these patients, treatment should be discontinued after 14 days. Since the tablet cannot be divided, the daily dose cannot be less than 500 mg/day; therefore, Klacid unidía 500 mg should not be administered to this patient group. For patients with moderate renal function (creatinine clearance of 30 to 60 ml/min), a 50% reduction in dosage should be implemented, resulting in a maximum dose of one modified-release clarithromycin tablet per day.

Use in children and adolescents

Children under 12 years:

Appropriate formulations for children from 6 months of age and adolescents under 12 years are: Klacid 25 mg/ml granules for oral suspension and Klacid 50 mg/ml granules for oral suspension.

If you feel that the effect of Klacid unidía 500 mg is too strong or too weak, consult your doctor or pharmacist.

If you take more Klacid unidía 500 mg modified-release tablets than you should

If you have taken more Klacid unidía 500 mg than you should, gastrointestinal disturbances may be expected. Contact your doctor or pharmacist immediately, as steps should be taken to rapidly eliminate any clarithromycin not yet absorbed by your body. Hemodialysis or peritoneal dialysis are not effective.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Klacid unidía 500 mg modified-release tablets

Do not take a double dose to make up for forgotten doses. Take the tablet as soon as possible and continue taking it at the same time each day.

If you stop treatment with Klacid unidía 500 mg modified-release tablets

Do not stop treatment early, as even if you feel better, your illness may worsen or recur. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Klacid unidía 500 mg can cause adverse effects, although not everyone will experience them.

Adverse effects are classified as very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), and frequency not known (cannot be estimated from the available data).

Frequent and very frequent adverse reactions associated with clarithromycin treatment, in both adults and children, include abdominal pain, diarrhoea, nausea, vomiting, and taste disturbance. These adverse reactions are usually mild in intensity and consistent with the known safety profile of macrolide antibiotics (see below).

There were no significant differences in the incidence of these gastrointestinal adverse reactions during clinical trials between patient populations with or without pre-existing mycobacterial infections.

Summary of adverse effects

Adverse effects are listed in decreasing order of severity within each body system:

? Very commonly observed (may affect more than 1 in 10 patients, with the intravenous injection formulation): phlebitis (vein inflammation) at the injection site.

? Frequently observed (may affect up to 1 in 10 patients) with all medicines containing clarithromycin:

• Gastrointestinal system: diarrhoea, vomiting, indigestion (dyspepsia), nausea, abdominal pain.
• Nervous system: altered taste, headache, taste disturbance.
• Skin: mild skin rashes, excessive sweating.
• Psychiatric disorders: insomnia.
• Vascular disorders: vasodilation (dilation of blood vessels).
• Hepatic disorders: abnormal liver function tests.
• Administration site reactions: pain and inflammation at the injection site (only with intravenous formulation).

? Less frequently observed (may affect up to 1 in 100 patients):

• Infections: cellulitis (only with intravenous formulation), candidiasis (fungal infection), gastroenteritis (only with prolonged-release tablets), infection (only with granules for oral suspension), vaginal infection.
• Blood disorders: decreased white blood cells, decreased neutrophils (a type of white blood cell, only with immediate-release tablets), increased platelets and, to a lesser extent, increased red and white blood cells in blood (only with granules for oral suspension), increased eosinophils (a type of white blood cell, only with immediate-release tablets).
• Immune system disorders: anaphylactoid reaction (generalized allergic reaction, only with intravenous formulation), hypersensitivity (exaggerated allergic reaction to external agents).
• Eating disorders: anorexia, decreased appetite.
• Psychiatric disorders: anxiety and nervousness (the latter only with granules for oral suspension).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with intravenous formulation), dizziness, somnolence, tremor.
• Ear and balance disorders: vertigo, hearing problems, tinnitus.
• Cardiac disorders: cardiac arrest and arrhythmia (atrial fibrillation) (both effects, only with intravenous formulation), QT interval prolongation (an ECG indicator of possible ventricular arrhythmias), extrasystoles (premature heartbeat relative to normal heart rate, only with intravenous formulation), palpitations (irregular heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with intravenous formulation), epistaxis (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery causing one-sided chest pain, cough, and breathing difficulty, only with intravenous formulation).
• Gastrointestinal disorders: oesophagitis (only with intravenous formulation), gastro-oesophageal reflux disease (damage to the oesophagus causing burning sensation, chronic cough, shortness of breath, and difficulty swallowing, only with prolonged-release tablets), gastric mucosal inflammation (gastritis), anal and rectal pain (only with prolonged-release tablets), oral mucosal inflammation, glossitis, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.
• Hepatic disorders: decreased or suppressed bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increased alanine aminotransferase (liver enzyme), increased aspartate aminotransferase (another liver enzyme), and increased gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: bullous dermatitis (blistering rash, only with intravenous formulation), pruritus, urticaria (edematous, red, itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart on a spot, only with granules for oral suspension).
• Musculoskeletal disorders: muscle spasms (only with granules for oral suspension), musculoskeletal rigidity (only with intravenous formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and serum urea (both effects indicating impaired kidney function, only with intravenous formulation).
• General disorders: malaise (only with immediate-release tablets), chest pain, chills, and fatigue (the last three only with immediate-release tablets).
• Laboratory tests: abnormal albumin-globulin ratio (only with intravenous formulation), increased serum alkaline phosphatase and increased blood lactate dehydrogenase (the last two only with immediate-release tablets).

? With frequency not known (frequency cannot be estimated from available data):

• Infections: pseudomembranous colitis (diarrhoea that may become severe), erysipelas (skin redness of variable extent that may cause pain, itching, and fever).
• Blood disorders: decreased neutrophil count (a type of white blood cell), decreased platelets.
• Immune system disorders: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).
• Metabolism: decreased blood glucose concentration.
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, hypnagogic hallucinations (attenuated perception of external stimuli).
• Nervous system: seizures, decreased or loss of taste sensation, olfactory disturbance, loss or decreased sense of smell, tingling, numbness, or burning sensations in hands, feet, arms, or legs.
• Ear: deafness.
• Cardiac disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (accelerated heartbeat over 100 beats per minute with at least 3 consecutive irregular beats).
• Vascular disorders: haemorrhage.
• Gastrointestinal disorders: acute pancreatitis (acute inflammation of the pancreas), tongue discoloration, tooth discoloration.
• Hepatic disorders: liver failure, hepatocellular jaundice (yellowing of the skin and eyes).
• Skin: Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, mainly affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (widespread scaly red rash with bumps under the skin and blisters, accompanied by fever, mainly localized in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin detachment (more than 30% of body surface), flu-like symptoms with skin rash, fever, lymphadenopathy, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)], acne. If any of these reactions occur, treatment with clarithromycin must be stopped immediately and you should consult your doctor for appropriate management.
• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that may lead to kidney damage), myopathy (muscle disease of various causes).
• Renal disorders: kidney failure, interstitial nephritis (inflammation of renal tubules).
• Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates coagulation deficiency), and abnormal urine colour.

Specific adverse effects

Phlebitis at the injection site, pain at the injection site, pain at the venipuncture site, and inflammation at the injection site are specific to the intravenous formulation of clarithromycin.

Following marketing of the medicine, reports of central nervous system effects (e.g. somnolence and confusion) have been received with concomitant use of clarithromycin and triazolam. Patient monitoring is recommended.

In some reports of rhabdomyolysis (muscle disease that may lead to renal failure), clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take Klacid unidía 500 mg modified-release tablets and Warnings and precautions).

Rarely, there have been reports of prolonged-release clarithromycin tablets appearing in faeces. Many of these cases occurred in patients with gastrointestinal anatomical disorders [including ileostomy or colostomy (surgery to artificially divert intestinal waste from the ileum or colon)] or functional disorders (disorders caused by a bodily defect) with shortened gastrointestinal transit time. In several reports, tablet residues appeared in the context of diarrhoea. It is recommended that patients who notice tablet residues in their faeces and who do not experience improvement switch to another formulation of clarithromycin (e.g. suspension) or to another antibiotic.

Adverse effects in children and adolescents:

The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.

Immunocompromised patients

In patients with AIDS and other immunocompromised patients treated with high doses of clarithromycin over long periods for mycobacterial infections, it is often difficult to distinguish adverse effects possibly associated with clarithromycin administration from those caused by the disease or other conditions associated with AIDS.

In adult patients treated with total daily doses of 1,000 mg and 2,000 mg of clarithromycin, the most frequent adverse reactions were: nausea, vomiting, taste disturbance, abdominal pain, diarrhoea, skin rash, flatulence, headache, constipation, hearing disturbances, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently observed were respiratory difficulty, insomnia, and dry mouth. Incidence rates were similar in patients treated with 1,000 mg and 2,000 mg, but generally 3 to 4 times higher in those receiving a total daily dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, approximately 2% to 3% receiving 1,000 mg or 2,000 mg daily of clarithromycin developed severely abnormal elevations in transaminase levels, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups also had increased blood urea nitrogen levels (which may indicate reduced kidney function). In patients receiving 4,000 mg daily, slightly higher incidences of abnormal values were observed for all parameters except white blood cell count.

Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered not known (cannot be estimated from available data).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Klacid unidía 500 mg modified-release tablets

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Keep in the original packaging to protect from light.

Do not use Klacid unidía 500 mg after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Klacid Unidose 500 mg modified-release tablets

The active substance of Klacid Uniday 500 mg is clarithromycin. Each tablet contains 500 mg of clarithromycin.

The other components (excipients) are: anhydrous citric acid, sodium alginate, calcium sodium alginate, lactose monohydrate, povidone, talc, stearic acid, magnesium stearate, hypromellose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide (E171), sorbic acid, quinoline yellow aluminum lake (E104).

Product appearance and contents of the container

Modified-release tablets, oval-shaped, bright yellow in color. Each package contains 7, 14, or 20 tablets. A clinical pack containing 500 tablets is also available.

Marketing Authorization Holder and Manufacturing Responsible

Title Holder:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin

Manufacturer responsible: AbbVie S.R.L. -04011 Campoverde di Aprilia (Italy)

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent review of this leaflet: March 2024

“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”