Clarithromycin Almus 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CLARITHROMYCIN ALMUS 500 mg film-coated tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Clarithromycin ALMUS 500 mg tablets are and what they are used for
2. What you need to know before taking Clarithromycin ALMUS 500 mg tablets
3. How to take Clarithromycin ALMUS 500 mg tablets
4. Possible side effects
5. How to store Clarithromycin ALMUS 500 mg tablets
6. Contents of the pack and other information

1. What Claritromicina ALMUS 500 mg tablets is and what it is used for

Claritromicina ALMUS is an antibiotic belonging to the macrolide group, active against many microorganisms that cause infections of the stomach or intestine, respiratory tract, skin, and those caused by less common microorganisms.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Claritromicina ALMUS is used to treat infections caused by susceptible microorganisms in:

1. Gastric and duodenal ulcers.
2. Prevention and treatment of infections caused by mycobacteria.
3. 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).
4. 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).
5. 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).

2. What you need to know before taking Clarithromycin ALMUS 500 mg tablets

Do not take Clarithromycin ALMUS

• If you are allergic to clarithromycin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to macrolide antibiotics.
• If your doctor has told you that you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
• If you are taking other medicines such as cisapride (for gastrointestinal problems), pimozide (for psychiatric disorders), terfenadine or astemizole (for allergy or hay fever).
• If you have a history of heart rhythm disorders (ventricular arrhythmia, including torsade de pointes) or abnormalities on the electrocardiogram (ECG) such as "long QT syndrome".
• If you are taking other medicines known to cause serious heart rhythm disturbances.
• If you take these medicines together with clarithromycin, you may experience heart problems which could be serious. Consult your doctor for advice on an alternative medicine.
• If you are taking ergotamine or dihydroergotamine (for migraine).
• If you are taking simvastatin or lovastatin (to lower cholesterol).
• If you have severe liver disease associated with kidney impairment.
• If you are taking ticagrelor, ivabradine or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke).
• If you have hypokalaemia (low potassium levels in blood).
• If you are taking colchicine (to prevent gout).
• If you are taking a medicine containing lomitapide.

Warnings and precautions

Talk to your doctor before starting to take Clarithromycin ALMUS.

• If you are pregnant, especially if you are less than 3 months pregnant. (See section Pregnancy and breastfeeding).
• If you have kidney disease (moderate to severe renal impairment).
• If you have liver disease.
• If you have heart problems, especially heart rhythm disorders (e.g., long QT syndrome).
• If you develop diarrhoea, because treatment with clarithromycin, like most antibiotics, may cause pseudomembranous colitis (inflammation of the large intestine causing diarrhoea and abdominal pain) due to the microorganism Clostridium difficile, and your doctor must rule out this diagnosis.
• If you are taking triazolam or midazolam (sedatives).
• If you are taking any medicine that may affect hearing. Your doctor will monitor your hearing during and after treatment.
• If you have previously taken other antibiotics from the macrolide group or the antibiotics lincomycin or clindamycin and the infection has not resolved due to resistance, or you could not use these antibiotics for this reason. There is a possibility that clarithromycin may not be effective and the infection may not be cured because the causative organism may also be resistant to clarithromycin. Discuss any concerns with your doctor. Cases of resistance to macrolide antibiotics have been reported in infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus pneumoniae.
• If you experience an acute reaction such as anaphylaxis, Stevens-Johnson syndrome or toxic epidermal necrolysis (skin disease), your doctor will immediately stop treatment.
• If you are taking lovastatin or simvastatin to lower your cholesterol level, because when taken together with clarithromycin it may increase the risk of rhabdomyolysis (a disorder affecting your muscles).
• If you are taking insulin and/or hypoglycaemic agents (medicines that reduce blood sugar levels), careful monitoring of blood glucose levels is recommended.
• If you are taking certain medicines that may reduce the effectiveness of clarithromycin (inducers of the cytochrome CYP3A4 enzyme).
• If you are taking oral anticoagulants, as monitoring of prothrombin time is recommended.

Taking other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

• The following medicines must not be taken together with Clarithromycin ALMUS: astemizole and terfenadine (for allergy) and cisapride (for gastrointestinal problems), as these medicines, when administered together with clarithromycin, may increase the risk of serious heart problems.
• You must not use ergotamine or dihydroergotamine either, as taking them together with clarithromycin may lead to ergotism (acute toxicity caused by drugs derived from ergot) characterised by vasospasm (contraction of artery walls making blood flow difficult) and ischaemia (lack of oxygen) in the extremities and other tissues, including the central nervous system.
• Medicines that lower cholesterol levels of the lovastatin and simvastatin class.

The risk of rhabdomyolysis (muscle damage) is increased.

The following medicines should be taken with caution during treatment with clarithromycin and you should consult your doctor beforehand, as dose reduction and close monitoring may be necessary:

• Oral anticoagulants (warfarin or another anticoagulant, e.g., dabigatran, rivaroxaban, apixaban and edoxaban (to thin the blood)). The risk of bleeding may be increased.
• Antiarrhythmics such as quinidine or disopyramide.
• Antiepileptics, for epilepsy: phenytoin, carbamazepine, valproate.
• Phenobarbital, used as a sedative and anticonvulsant.
• Certain immunosuppressants, which reduce the body's defence against foreign substances and are used, for example, in organ transplantation: cyclosporine, tacrolimus and sirolimus.
• Certain anticancer agents such as vinca alkaloids: vinblastine.
• Benzodiazepines, for anxiety and insomnia: alprazolam, midazolam, triazolam.
• St John's wort, used to treat depression.
• Antifungals, for fungal infections: fluconazole, itraconazole, ketoconazole.
• Antiretrovirals, for HIV infection: zidovudine, efavirenz, nevirapine, atazanavir, saquinavir, etravirine.

Concurrent treatment with clarithromycin and zidovudine may result in decreased blood concentrations of zidovudine because clarithromycin appears to interfere with the oral absorption of zidovudine. Therefore, it is recommended to space the administration of the doses of both medicines.

• Insulin, glibenclamide, repaglinide, medicines used to treat diabetes.
• Calcium channel antagonists such as verapamil, amlodipine, diltiazem, as there is a risk of hypotension.
• Antibiotics such as rifampicin, rifabutin or rifapentine.
• Others: digoxin (for the heart), theophylline (for asthma), tolterodine (for overactive bladder).
• There have been reports of colchicine toxicity (a medicine used for gout) when taken together with clarithromycin, especially in elderly patients, some of whom had kidney problems.
• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as 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 the treatment of a wide variety of diseases).

The following medicines increase the amount of clarithromycin absorbed from the administered dose, so you should consult your doctor before taking them:

• Omeprazole (for gastrointestinal disorders such as ulcers and gastroesophageal reflux). Co-administration of clarithromycin and omeprazole increases blood levels of both medicines.
• Ritonavir (for HIV infection). Co-administration of ritonavir and clarithromycin results in a significant reduction in the elimination of clarithromycin, so it remains unaltered in the body for a longer time. However, due to the wide therapeutic margin of clarithromycin, dose adjustment should not be necessary if you have normal kidney function. However, if you have kidney disease (creatinine clearance between 30–60 ml/min and < 30 ml/min), your doctor should adjust the dose of clarithromycin by 50% and 75%, respectively.
• During post-marketing surveillance, interactions have been observed between the following medicines, which have a similar metabolism, and erythromycin or clarithromycin: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, disopyramide, ergotamine, dihydroergotamine, lovastatin, methylprednisolone, midazolam, omeprazole, pimozide, quinidine, sildenafil, tadalafil, terfenadine, triazolam and vardenafil.
• Clarithromycin may negatively affect the efficacy of antibiotics known as "beta-lactams", which include penicillins (amoxicillin, ampicillin, etc.) and cephalosporins (cefuroxime, cefaclor, etc.), as well as the effects of the antibiotics lincomycin and clindamycin.

Taking Clarithromycin ALMUS with food and drinks

Clarithromycin ALMUS tablets may be taken before, during or after meals, as the presence of food in the digestive tract does not alter the activity of the medicine.

Pregnancy and breastfeeding

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

The safety of clarithromycin during pregnancy and breastfeeding has not been established. Clarithromycin is excreted in breast milk. If you are breastfeeding, do not take this medicine.

Driving and using machines

There is no evidence that Clarithromycin has effects on the ability to drive or use machines. If dizziness, vertigo, confusion or disorientation occur, avoid driving or operating machinery.

Clarithromycin ALMUS 500 mg tablets contain propylene glycol and sodium

This medicine contains 2,610 mg of propylene glycol (E1520) in each tablet.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Clarithromycin ALMUS 500 mg tablets

Clarithromycin ALMUS is administered orally.

Always follow exactly the instructions provided by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults: In patients with peptic ulcer associated with Helicobacter pylori, the recommended treatments are:

Triple therapy: 500 mg of clarithromycin twice daily, together with 1000 mg of amoxicillin twice daily and 20 mg of omeprazole once daily for 10 days; or 500 mg of clarithromycin, 1000 mg of amoxicillin, and 20 mg of omeprazole, all administered twice daily for 7 days.

Dual therapy: 500 mg of clarithromycin three times daily, together with 40 mg of omeprazole once daily for 2 weeks. To ensure healing in patients with duodenal ulcer and poor therapeutic response, treatment with 40 mg of omeprazole may be extended up to 4 weeks.

The recommended average dose for prevention and treatment of mycobacterial infections is 500 mg of clarithromycin every 12 hours. The duration of treatment must be determined by the physician.

For the treatment of respiratory tract, skin, and soft tissue infections, the duration of treatment must be determined by the physician and depends on the severity and type of infection.

It ranges from 6 to 14 days. The patient must strictly follow the doctor's instructions, even if symptoms disappear. The usual recommended dose for adults is 250 mg twice daily. In more severe infections, the dose may be increased to 500 mg twice daily.

Remember to take your medicine. Take the tablets at the same time each day.

Your doctor will determine how long you should take the treatment. Do not stop treatment early, as even if you feel better, your condition could worsen or recur.

If you feel that the effect of Clarithromycin ALMUS is too strong or too weak, consult your doctor or pharmacist.

If you take more Clarithromycin ALMUS than you should

If you have taken more Clarithromycin ALMUS than prescribed, gastrointestinal disturbances may occur. 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 medicine and the amount ingested.

If you forget to take Clarithromycin ALMUS

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

If you stop treatment with Clarithromycin ALMUS

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects can be 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), rare (may affect up to 1 in 1,000 people), and very rare (may affect up to 1 in 10,000 people).

Common (may affect up to 1 in 10 people)

• Insomnia
• Headache, altered sense of taste
• Diarrhea, vomiting, nausea, abdominal pain, intestinal motility disorders
• Rash, excessive sweating
• Abnormal liver function test results

Uncommon (may affect up to 1 in 100 people)

• Candidiasis, vaginal infection
• Changes in levels of certain blood cells
• Hypersensitivity
• Anorexia, decreased appetite
• Anxiety
• Drowsiness, dizziness, tremors
• Vertigo, hearing loss, tinnitus (ringing in the ears)
• Prolongation of a specific interval in the electrocardiogram, known as QT interval prolongation, palpitations
• Inflammation of the inner lining of the stomach, constipation, flatulence, dry mouth, belching, bloating or abdominal swelling
• Elevated levels of certain liver enzymes
• Increased serum levels of alkaline phosphatase or lactate dehydrogenase
• Urticaria, itching
• Malaise, fatigue, chest pain, muscle weakness or pain, chills

Frequency not known (cannot be estimated from available data)

• Infections such as: Pseudomembranous colitis, erysipelas
• Decrease in certain blood cells
• Anaphylactic reaction, inflammation of the skin and mucous membranes
• Psychosis, confusion, feeling of loss of identity, depression, hallucinations, nightmares
• Seizures, loss of taste, loss or alteration of sense of smell, tingling
• Deafness
• Fast or irregular heartbeat
• Bleeding
• Discoloration of the tongue or teeth, pancreatitis
• Liver failure
• Acne, skin disorders, rash with blood abnormalities (which may be a sign of a hypersensitivity syndrome known as DRESS)
• Muscle disease, rhabdomyolysis
• Renal failure, kidney disorders caused by inflammation of parts of the kidney
• Abnormal urine color

Contact a doctor as soon as possible if you experience a serious 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, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clarithromycin ALMUS 500 mg tablets

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Claritromycin ALMUS 500 mg tablets

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

The other components (excipients) are: pregelatinized maize starch, sodium croscarmellose (E468), povidone, microcrystalline cellulose (E460), anhydrous colloidal silica (E550), magnesium stearate (E573), hypromellose (E464), titanium dioxide (E171), talc (E533b), propylene glycol (E1520).

Appearance of the product and pack contents

Claritromycin ALMUS 500 mg tablets are oblong, biconvex, white or almost white, coated tablets.

The tablets are presented in PVC/PVDC blisters sealed with an aluminum foil. This medicinal product is available in packs of 14, 21 or 500 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

BLUEPHARMA – Indústria Farmacêutica, S.A.

• Martinho do Bispo, 3045-016 Coimbra

Portugal

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/