PATIENT INFORMATION LEAFLET

KLACID UNIDÍA 500 mg Modified Release Tablets

Clarithromycin

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

• Keep this leaflet, as 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Klacid unidía 500 mg is an antibiotic belonging to the macrolide group, active against germs that cause respiratory or skin infections.

Klacid unidía 500 mg is used for the treatment of infections caused by sensitive germs in adults, adolescents aged 12 to 18 years, and children over 12 years:

- 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), exacerbation of chronic bronchitis (worsening of lung inflammation over a prolonged or repeated period) and bacterial pneumonias (inflammation of the lungs caused by bacteria). (see warnings and precautions section)

- 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 warnings and precautions section)

Klacid unidía 500 mg is an antibiotic belonging to the macrolide group, active against germs that cause respiratory or skin infections.

Klacid unidía 500 mg is used for the treatment of infections caused by sensitive germs in adults, adolescents aged 12 to 18 years, and children over 12 years:

- 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), exacerbation of chronic bronchitis (worsening of lung inflammation over a prolonged or repeated period) and bacterial pneumonias (inflammation of the lungs caused by bacteria). (see warnings and precautions section)

- 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 warnings and precautions section)

Do not take Klacid unidía 500 mgmodified-release tablets

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6).
• If you have a creatinine clearance of less than 30 ml/min.
• If you have an irregular heart rhythm.
• If you have severe kidney or liver problems.
• If you are taking ergotamine or dihydroergotamineor using ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for alternative medications.
• If you are taking medications called terfenadine, astemizol (allergy or hay fever medication), cisaprida or domperidona (used for stomach problems) or pimozida (used to treat certain psychiatric disorders) as taking these medications with clarithromycin may cause severe heart rhythm disturbances. Consult your doctor for alternative medications.
• If you are taking ticagrelor (to prevent blood clots in your veins and used in heart attacks and other heart problems) ivabradina or ranolazina (for angina pectoris).
• If you are taking other medications that are known to cause severe heart rhythm disturbances.
• If you are being treated with midazolam oral (for anxiety or to help you fall asleep)
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormal electrocardiogram (ECG, heart electrical recording) called "prolongation of QT syndrome).
• If you are taking medications called lovastatina or simvastatina (to lower cholesterol levels), as the combination of these medications may increase the risk of adverse effects. Consult your doctor for alternative medications.
• If you are taking colchicine (for gout)
• If you are taking a medication with lomitapida

Warnings and precautions

Consult your doctor or pharmacist before starting to take Klacid unidia

• 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 medications known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatina, simvastatina.
• If you are diabetic and taking hypoglycemic medications (medications to lower blood sugar such as nateglinida, pioglitazona, rosiglitazona, and repaglinida, sulfonilureas, or insulin) and clarithromycin may lower blood sugar too much. Careful monitoring of blood sugar is recommended.
• If you are taking a medication called warfarin (blood thinner).
• If you have myasthenia gravis, a condition where your muscles weaken and tire easily.
• If you develop severe or prolonged diarrhea, during or after taking clarithromycin, consult your doctor immediately.

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

Children and adolescents

Do not administer this medication to children under 12 years old

Older patients

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

Taking Klacid unidia 500 mg modified-release tablets with other medications

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

Do not take Klacid unidia with ergot alkaloids, astemizol, terfenadine, cisaprida, domperidona, pimozida, ticagrelor, ranolazina, colchicine, certain cholesterol-lowering medications, or medications known to cause severe heart rhythm disturbances (see Do not take Klacid unidia).

This is especially important if you are taking medications for:

Or if you are taking any medication called:

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 medication.

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

Clarithromycin passes into breast milk, so it is recommended to stop breastfeeding during treatment with clarithromycin.

Driving and operating machinery

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

Klacid unidia 500 mgmodified-release tabletscontain lactose.

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Klacid unidia 500 mg modified-release tablets contain sodium.

This medication contains 15.3 mg of sodium (main component of table salt/for cooking) in each tablet. If you take two tablets per day, the total sodium content is 30.6 mg per dose. This is equivalent to 1.5% of the recommended daily maximum sodium intake for an adult.

Klacid unidía is administered orally.

Follow exactly the administration instructions for Klacid unidía 500 mg as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Do not crush or chew the tablets of Klacid unidía.

The 20-tablet pack has 2 compartments that allow you to extract the 2 tablets (1 g) at the same time.

Renal insufficiency

In patients with renal insufficiency and a creatinine clearance of less than 30 ml/min, the dose of clarithromycin should be reduced to half, i.e., 250 mg once a day, or 250 mg twice a day 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, so Klacid unidia 500 mg should not be administered in this group of patients. 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 tablet of modified-release clarithromycin per day.

Use in children and adolescents

Children under 12 years old:

The suitable presentations for children, from 6 months, and adolescents under 12 years old are: Klacid 25 mg/ml granulated for oral suspension and Klacid 50 mg/ml granulated for oral suspension.

If you think 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 tablets than you should

If you have taken more Klacid unidía 500 mg than you should, you can expect gastrointestinal disturbances and consult your doctor or pharmacist immediately, as they will try to quickly eliminate the clarithromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis is not effective.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Klacid unidía 500 mg tablets

Do not take a double dose to compensate for the missed doses.Take the tablet as soon as possible and continue taking it every day at the same time.

If you interrupt treatment with Klacid unidía 500 mg

Do not stop treatment prematurely, as although you may be feeling better, your disease could worsen or recur. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Side effects are classified as very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients) and unknown frequency (cannot be estimated from available data).

The most common and more common adverse reactions related to treatment with clarithromycin, both in adults and children, are abdominal pain, diarrhea, nausea, vomiting, and altered taste. These adverse reactions are usually mild in intensity and coincide 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 patients with or without pre-existing mycobacterial infections.

Summary of side effects

Side effects are described in order of decreasing severity within the same body system:

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

?With all clarithromycin-containing medicines, the following have been observed with frequency (may affect up to 1 in 10 patients):

- Digestive system: diarrhea, vomiting, gastrointestinal disorder that makes digestion difficult (dyspepsia), nausea, abdominal pain.

- Nervous system: altered taste, headache, altered taste.

- Skin: mild skin eruptions, excessive sweating.

- Psychiatric disorders: insomnia.

- Vascular disorders: vasodilation.

- Liver disorders: abnormal liver function tests.

- Administration site disorders: pain and inflammation at the injection site (only with the intravenous formulation).

?Less frequently (may affect up to 1 in 100 patients) the following have been observed:

- Infections: cellulitis (only with the intravenous formulation), candidiasis (infection by a type of fungus), gastroenteritis (only with prolonged-release tablets), infection (only with oral suspension granules), vaginal infection.

- Blood abnormalities: decreased white blood cells, decreased neutrophils (a type of white blood cell, only with immediate-release tablets), increased platelets and, to a lesser extent, red and white blood cells in the blood (only with oral suspension granules), increased eosinophils (a type of white blood cell, only with immediate-release tablets).

- Immune system: anaphylactoid reaction (generalized allergic reaction, only with intravenous formulation), hypersensitivity (exaggerated allergic reaction to external agents).

- Nutritional disorders: anorexia, decreased appetite.

- Psychiatric disorders: anxiety and nervousness (the latter only with oral suspension granules).

- Nervous system: loss of consciousness and difficulty moving (both effects, only with intravenous formulation), dizziness, somnolence, tremors.

- Ear and balance: vertigo, hearing problems, tinnitus.

- Heart disorders: cardiac arrest and altered heart rhythm (fibrillation of the auricle) (both effects, only with intravenous formulation), prolongation of the QT interval (indicator of the electrocardiogram that arrhythmias may occur), extrasystoles (premature heartbeat, only with intravenous formulation), palpitations (alterations in heartbeats).

- Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or morning cough, only with intravenous formulation), nasal hemorrhages (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery that causes chest pain on one side, cough, and difficulty breathing, only with intravenous formulation).

- Gastrointestinal disorders: esophageal inflammation (only with intravenous formulation), gastroesophageal reflux disease (damage to the esophagus that causes burning sensation, chronic cough, lack of air, and difficulty swallowing, only with prolonged-release tablets), gastric mucosal inflammation, anal and rectal pain (only with prolonged-release tablets), oral mucosal inflammation, tongue inflammation, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.

- Liver disorders: decreased or suppressed bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increased alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).

- Skin: pemphigus (vesicular eruptions, only with intravenous formulation), pruritus, urticaria (edematous, red, and itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart on a patch, only with oral suspension granules).

- Muscular disorders: muscle spasms (only with oral suspension granules), musculoskeletal rigidity (only with intravenous formulation), muscle pain (only with prolonged-release tablets).

- Kidney disorders: increased serum creatinine and 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 latter three, only with immediate-release tablets).

- Laboratory tests: abnormal albumin-globulin ratio (only with intravenous formulation), increased serum alkaline phosphatase, and increased lactate dehydrogenase in the blood (both effects, only with immediate-release tablets).

?Unknown frequency (frequency cannot be determined from available data) the following have been observed:

- Infections: pseudomembranous colitis (diarrhea that can be severe), erysipelas (skin redness of variable extent that can cause pain, itching, and fever).

- Blood abnormalities: decreased neutrophils (a type of white blood cell), decreased platelets.

- Immune system: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).

- Metabolism: decreased blood glucose concentration.

- Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, daydreaming (attenuated perceptions of external stimuli).

- Nervous system: convulsions, decreased or lost sense of taste, altered sense of smell, lost or decreased sense of smell, paresthesia, numbness, or tingling in hands, feet, arms, or legs.

- Ear: deafness.

- Heart disorders:torsades de pointes(a type of ventricular tachycardia), ventricular tachycardia (acceleration of heartbeats with more than 100 beats per minute with at least 3 consecutive irregular beats).

- Vascular disorders: hemorrhage.

- Gastrointestinal disorders: acute pancreatitis (inflammation of the pancreas), discoloration of the tongue, discoloration of the teeth.

- Liver disorders: liver dysfunction, icteric hepatitis (yellow discoloration of the skin and eyes).

- Skin: Stevens-Johnson syndrome (generalized eruption with blisters and skin peeling, mainly affecting genital, oral, and trunk areas), generalized acute exanthematous pustulosis (generalized scaly eruption with red color, with subcutaneous nodules and blisters, accompanied by fever, mainly located in skin folds, trunk, and upper limbs), toxic epidermal necrolysis (generalized eruption with blisters and skin peeling, particularly around the mouth, nose, eyes, and genital areas, causing generalized skin peeling (more than 30% of the body surface) and systemic symptoms such as fever, inflammation of glands, and abnormal blood test results (such as eosinophilia and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)] , acne.In the event of these reactions, discontinue clarithromycin treatment immediately and consult your doctor to establish an appropriate treatment.

- Muscular disorders: rhabdomyolysis (muscle breakdown that can cause kidney damage), myopathy (muscle disease of multiple causes).

- Kidney disorders: kidney dysfunction, interstitial nephritis (inflammation of the renal tubules).

- Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates a deficiency in blood coagulation), and abnormal urine color.

Specific side effects

Flebitis 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.

After marketing, reports have been received of effects on the central nervous system (e.g., somnolence and confusion) with the simultaneous use of clarithromycin and triazolam. It is suggested to monitor the patient.

In some of the reports of rhabdomyolysis (muscle disease that can cause kidney damage), clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (seeDo not take Klacid unidía 500 mg prolonged-release tabletsandWarnings and precautions).

Rarely, there have been reports of clarithromycin prolonged-release tablets appearing in the stool, many of these cases have occurred in patients with anatomical or functional gastrointestinal disorders (including ileostomy or colostomy) or with shortened gastrointestinal transit time. In several reports, the remnants of tablets have appeared in the context of diarrhea. It is recommended that patients who present tablet remnants in the stool and do not experience any improvement switch to another clarithromycin formulation (e.g., suspension) or to another antibiotic.

Side 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 in other patients with damaged immune systems, treated with high doses of clarithromycin for long periods of time for mycobacterial infections, it is often difficult to distinguish adverse reactions possibly associated with clarithromycin administration from those caused by the disease or other diseases that the patient may have with AIDS.

In adult patients treated with daily total doses of 1,000 mg and 2,000 mg of clarithromycin, the most common adverse reactions that appeared were: nausea, vomiting, altered taste, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, altered hearing, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle damage). Less frequently, difficulty breathing, insomnia, and dry mouth appeared. Incidences were similar in patients treated with 1,000 mg and 2,000 mg, but generally were 3 to 4 times more frequent in those who received a daily total dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, around 2% to 3% who received daily 1,000 mg or 2,000 mg of clarithromycin presented severely abnormal elevated transaminases, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups had elevated blood urea nitrogen (which may indicate impaired kidney function). In patients who received daily 4,000 mg, slightly higher incidences of abnormal values in all parameters, except white blood cell count, were observed.

Consult a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with subcutaneous nodules and blisters (pustular exanthema). The frequency of this adverse effect is considered unknown (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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C. Store in the original packaging to protect it from light.

Do not use Klacid unidía 500 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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Composition of Klacid unidía 500 mg modified-release tablets

The active ingredient of Klacid unidía 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, and aluminium quinoline yellow lake (E104).

Appearance of the product and contents of the packaging

Modified-release, oval-shaped, intense yellow tablets. Each package contains 7, 14, or 20 tablets. There is also a clinical package with 500 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Responsible manufacturer: AbbVie S.R.L. -04011 Campoverde di Aprilia (Italy)

You can request more information about this medication by contacting the local representative of the marketing authorization holder: :

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last reviewed date of this leaflet: March 2024

“Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es ”