KLACID UNIDIA 500mg MODIFIED-RELEASE TABLETS

2. What you need to know before you take Klacid unidia 500 mg modified-release tablets

Do not take Klacid unidia 500 mg modified-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 heartbeat.
• If you have severe kidney and liver problems.
• If you are taking ergotamine or dihydroergotamine or using ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for alternative medications.
• If you are taking medications called terfenadine, astemizole (medication for hay fever or allergies), cisapride or domperidone (used for stomach problems) or pimozide (medication used to treat certain psychiatric disorders), as taking these medications with clarithromycin can cause serious 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) ivabradine or ranolazine (for angina pectoris).
• If you are taking other medications known to cause serious 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 have a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormalities in the electrocardiogram (ECG, electrical recording of the heart) called "QT prolongation syndrome".
• If you are taking medications called lovastatin or simvastatin (to lower cholesterol levels), as the combination of these medications can increase the risk of side effects. Consult your doctor for alternative medications.
• If you are taking colchicine (for gout)
• If you are taking a medication with lomitapide

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), lovastatin, simvastatin.
• If you are diabetic and taking hypoglycemic agents (medications to lower blood sugar levels such as nateglinide, pioglitazone, rosiglitazone, and repaglinide, sulfonylureas, or insulin) and clarithromycin may lower blood sugar levels too much. Close monitoring of blood sugar levels 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 apply to you, consult your doctor before taking clarithromycin.

Children and adolescents

Do not administer this medication to children under 12 years of age.

Elderly patients

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

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications, including those obtained without a prescription.

Do not take Klacid unidia with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medications for high cholesterol, and medications known to cause serious heart rhythm disturbances (see Do not take Klacid unidia).

This is especially important if you are taking medications for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Thinning the blood (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 medication 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).
• Cyclosporin (immunosuppressant).
• Rifabutin (for treatment of certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (for treating impotence in adult men or for pulmonary arterial hypertension).

• Zidovudine (for treating viruses).
• St. John's Wort (herbal product for treating depression).
• Phenobarbital (medication for treating epilepsy).
• Nevirapine and efavirenz may decrease clarithromycin levels.
• Rifampicin or rifapentine (for treating tuberculosis).
• Omeprazole (for treating stomach acid and stomach or intestinal ulcers).
• Ritonavir (antiviral medication used in HIV treatment) may increase clarithromycin levels. The concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medications used in HIV treatment) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.

• Itraconazole (an antifungal) taken with clarithromycin may increase the levels of both medications.
• Fluconazole, another antifungal medication, may increase clarithromycin levels.
• Tolterodine (for treating symptoms of overactive bladder). 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 (medications for treating high blood pressure).

• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis or to treat or prevent malaria). Taking these medications at the same time as clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse reactions affecting the heart.
• Corticosteroids, administered orally, by injection, or inhaled (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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of clarithromycin during pregnancy has not been established, so your doctor will 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 interrupted during treatment with clarithromycin.

Driving and using machines

Since clarithromycin can cause dizziness, vertigo, confusion, and disorientation, you should be cautious when driving or using hazardous machinery during treatment with clarithromycin.

Klacid unidia 500 mg modified-release tablets contain lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Klacid unidia 500 mg modified-release tablets contain sodium.

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

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

Klacid unidia is administered orally.

Follow the administration instructions for Klacid unidia 500 mg exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults, adolescents from 12 to 18 years, and children over 12 years:the usual recommended dose of Klacid unidia 500 mg is 1 tablet of 500 mg, once a day, taken 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 the treatment of community-acquired pneumonia and sinusitis, which require 6 to 14 days of therapy.

Do not crush or chew Klacid unidia tablets.

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

Renal impairment

In patients with renal impairment 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 to 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 clarithromycin modified-release tablet per day.

Use in children and adolescents

Children under 12 years:

The suitable presentations for children from 6 months 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 think the effect of Klacid unidia 500 mg is too strong or too weak, consult your doctor or pharmacist.

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

If you have taken more Klacid unidia 500 mg than you should, you can expect the appearance of digestive disorders, 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 Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

If you forget to take Klacid unidia 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 every day at the same time.

If you stop taking Klacid unidia 500 mg modified-release tablets

Do not stop treatment before, as even if you are feeling better, your illness could worsen or come back. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, Klacid unidía 500 mg may produce adverse effects, although not all people suffer from them.

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

Common and very common adverse reactions related to treatment with clarithromycin, in both adults and children, are abdominal pain, diarrhea, nausea, vomiting, and alteration of taste. These adverse reactions are usually mild 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 the patient population with or without pre-existing mycobacterial infections.

Summary of Adverse Effects

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

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

? With all medications containing clarithromycin, the following have been frequently observed (may affect up to 1 in 10 patients):

• Digestive system: diarrhea, vomiting, gastric disorder that makes digestion difficult (dyspepsia), nausea, abdominal pain.
• Nervous system: alteration of taste, headache, alteration of taste.
• Skin: mild skin rashes, excessive sweating.
• Psychiatric disorders: insomnia.
• Vascular disorders: dilation of blood vessels in the body (vasodilation).
• Liver disorders: abnormal liver function tests.
• Disorders at the administration site: pain and inflammation at the injection site (only with the intravenous injection formulation).

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

• Infections: cellulitis (only with the intravenous injection formulation), candidiasis (fungal infection), gastroenteritis (only with prolonged-release tablets), infection (only with oral suspension granules), vaginal infection.
• Blood disorders: decrease in white blood cells, decrease in neutrophils (a type of white blood cell, only with immediate-release tablets), increase in platelets and, to a lesser extent, red and white blood cells in the blood (only with oral suspension granules), increase in eosinophils (a type of white blood cell, only with immediate-release tablets).
• Immune system: anaphylactoid reaction (generalized allergic reaction, only with the intravenous injection formulation), hypersensitivity (exaggerated allergic reaction to external agents).
• Eating 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 the intravenous injection formulation), dizziness, drowsiness, tremors.
• Ear and balance: vertigo, hearing problems, tinnitus.
• Heart disorders: cardiac arrest and alteration of heart rhythm (atrial fibrillation) (both effects, only with the intravenous injection formulation), prolongation of the QT interval (indicator of ventricular arrhythmias), extrasystoles (premature heartbeat, only with the intravenous injection formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest oppression, and nocturnal or early morning cough, only with the intravenous injection formulation), nasal bleeding (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 the intravenous injection formulation).
• Gastrointestinal disorders: esophagus inflammation (only with the intravenous injection formulation), gastroesophageal reflux disease (damage to the esophagus that causes a burning sensation, chronic cough, shortness of breath, and difficulty swallowing, only with prolonged-release tablets), stomach mucosa inflammation (gastritis), pain in the anus and rectum (only with prolonged-release tablets), oral mucosa inflammation, tongue inflammation, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.
• Liver disorders: decrease or suppression of bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increase in alanine aminotransferase (liver enzyme), aspartate aminotransferase (another liver enzyme), and gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: bullous dermatitis (blistering rashes, only with the intravenous injection formulation), itching, urticaria (edematous, red, and very itchy skin lesions), maculopapular rash (skin lesion with a papule or wart on a patch, only with oral suspension granules).
• Muscle disorders: muscle spasms (only with oral suspension granules), musculoskeletal stiffness (only with the intravenous injection formulation), muscle pain (only with prolonged-release tablets).
• Kidney disorders: increase in serum creatinine and serum urea (both effects, indicating poorer kidney function, only with the intravenous injection formulation).
• General disorders: discomfort (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 the intravenous injection formulation), increase in serum alkaline phosphatase and increase in lactate dehydrogenase in blood (the last two, only with immediate-release tablets).

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

• Infections: pseudomembranous colitis (diarrhea that can become severe), erysipelas (redness of the skin of variable extent that can cause pain, itching, and fever).
• Blood disorders: decrease in neutrophils (a type of white blood cell), decrease in platelets.
• Immune system: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).
• Metabolism: decrease in blood glucose concentration.
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, daydreaming (attenuated perceptions of external stimuli).
• Nervous system: convulsions, decrease or loss of sense of taste, alteration of sense of smell, loss or decrease of sense of smell, sensation of tingling, numbness, or prickling 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/minute with at least 3 consecutive irregular beats).
• Vascular disorders: hemorrhage.
• Digestive disorders: acute pancreatitis (inflammation of the pancreas), discoloration of the tongue, discoloration of the teeth.
• Liver disorders: liver failure, hepatocellular jaundice (yellowing of the skin and eyes).
• Skin: Stevens-Johnson syndrome (generalized rash with blisters and peeling of the skin, mainly affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (generalized scaly red rash with bumps under the skin and blisters, accompanied by fever, mainly located in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (generalized rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals, causing generalized skin peeling (more than 30% of body surface area) and symptoms like flu, fever, lymph node inflammation, 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 such reactions occur, treatment with clarithromycin should be immediately discontinued, and a doctor should be consulted to establish appropriate treatment.
• Muscle disorders: rhabdomyolysis (muscle breakdown that can cause kidney damage), myopathy (muscle disease of multiple causes).
• Kidney disorder: kidney failure, interstitial nephritis (inflammation of the renal tubules).
• Laboratory tests: increase in international normalized ratio (calculation to detect blood coagulation), prolongation of prothrombin time (indicates a deficit in blood coagulation), and abnormal urine color.

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.

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

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

There have been rare reports that clarithromycin prolonged-release tablets appear in the feces; many of these cases have occurred in patients with gastrointestinal anatomical disorders [including ileostomy or colostomy (surgery to expel intestinal waste artificially from the ileum or colon)] or functional disorders (caused by a defect in the body) with shortened gastrointestinal transit time. In several reports, tablet residues have appeared in the context of diarrhea. It is recommended that patients who present with tablet residues in the feces and who do not experience any improvement change to another clarithromycin formulation (e.g., suspension) or to another antibiotic.

Adverse Effects in Children and Adolescents:

It is expected that the frequency, type, and severity of adverse reactions in children will be the same as in adults.

Immunocompromised Patients

In patients with AIDS and in other patients with a damaged immune system, treated with the highest doses of clarithromycin for long periods of time for mycobacterial infections, it is often difficult to distinguish adverse effects possibly associated with the administration of clarithromycin from those caused by the disease or by other diseases that the patient may have along 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 that appeared were: nausea, vomiting, alteration of taste, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, hearing disorders, and elevations in transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently, difficulty breathing, insomnia, and dry mouth appeared. The incidences were similar in patients treated with 1,000 mg and 2,000 mg, but in general were 3 to 4 times more frequent in those who received a total daily dose of 4,000 mg of clarithromycin.

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

Contact a doctor as soon as possible if you experience a severe skin reaction: a red and scaly rash with bumps under the skin and blisters (pustular exanthematous). 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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5. Storage of Klacid unidía 500 mg Modified-Release Tablets

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C. Keep in the original packaging to protect 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.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

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6. Package Contents and Additional Information

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, aluminum lake of quinoline yellow (E104).

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

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

Date of the last revision of this prospectus: March 2024

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