Leaflet: information for the user

CLARITROMICIN ALMUS 500 mg film-coated tablets

Read this leaflet carefully before you start taking the 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 or pharmacist.

-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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start takingClaritromicina ALMUS 500 mg tablets

3.How to takeClaritromicina ALMUS 500 mg tablets

4.Possible side effects

5.Storage ofClaritromicina ALMUS 500 mg tablets

6.Contents of the pack and additional information

Claritromicina ALMUSis a macrolide antibiotic, active against many germs that cause stomach or intestinal infections, respiratory tract infections, or skin infections, and those produced by less common germs..

Claritromicina ALMUSis used for the treatment of infections caused by sensitive germs in:

1.Gastric and duodenal ulcers.

2.Prevention and treatment of infections produced by mycobacteria.

3.Upper respiratory tract infections, such as pharyngitis (infection of the pharynx that causes 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), exacerbation of chronic bronchitis (prolonged or repeated inflammation of the lungs) and bacterial pneumonias (inflammation of the lungs 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).

Do not take Claritromicina ALMUS

•If you are allergic to clarithromycin or any of the other ingredients of this medicine (including those 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 (hypopotasemia or hypomagnesemia).

•If you are taking other medicines such as cisapride (for gastrointestinal problems), pimozide (for psychiatric disorders), terfenadine or astemizol (for allergies or hay fever).

•If you have a history of heart rhythm disorders (ventricular arrhythmia, including torsade de pointes) or abnormal electrocardiogram (ECG) findings such as prolonged QT syndrome.

•If you are taking other medicines known to cause severe heart rhythm disorders.

•If taking these medicines with clarithromycin could cause serious heart problems. Consult your doctor for advice on an alternative medicine.

•If you are taking ergotamine or dihydroergotamine (for migraines).

•If you are taking simvastatin or lovastatin (to reduce cholesterol),

•If you have a severe liver disorder with renal disorder at the same time.

•If you are taking ticagrelor, ivabradine or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke).

•If you have hypopotasemia (low levels of potassium in the blood).

•If you are taking colchicine (to prevent gout).

•If you are taking a medicine with lomitapida.

Warnings and precautions:

Consult your doctor before starting to take Claritromicina Almus.

•If you are pregnant, especially if you are less than 3 months pregnant. (See section Pregnancy and lactation).

•If you have kidney disease (moderate to severe renal insufficiency).

•If you have liver disease.

•If you have heart problems, especially heart rhythm disorders (for example, prolonged QT syndrome).

•If you experience diarrhea because the treatment with clarithromycin, like most antibiotics, can cause pseudomembranous colitis (inflammation of the large intestine that causes diarrhea and abdominal pain) by 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 the ear. Your doctor will make an audiogram during and after treatment.

•If you have taken other macrolide antibiotics or lincomycin or clindamicina and the infection has not been resolved because it was caused by a resistant germ, or you were unable to 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 germ causing your infection may also be resistant to clarithromycin. Consult your doctor about any doubts you may have. Cases of antibiotic resistance such as macrolides have been detected in infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus pneumoniae.

•If you suffer from an acute reaction such as anaphylaxis, Stevens-Johnson syndrome or toxic epidermal necrolysis (skin disease), your doctor will stop the treatment immediately.

•If you were taking lovastatin or simvastatin to reduce your cholesterol level, because taking them with clarithromycin may increase the risk of rhabdomyolysis (a disorder that affects your muscles).

•If you take insulin and/or hypoglycemic agents (medicines that reduce blood sugar levels) you should have a careful control of your blood glucose levels.

•If you take certain medicines that may reduce the effectiveness of clarithromycin (inducers of the enzyme cytochrome CYP3A4).

•If you are taking oral anticoagulants because you should have your prothrombin time checked.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine.

•The following medicines should not be taken with clarithromycin ALMUS: astemizol and terfenadine (for allergies) and cisaprida (for gastrointestinal problems), as these medicines if taken with clarithromycin may increase the risk of serious heart problems.

•You should not use ergotamine or dihydroergotamine because if you take them with clarithromycin you may suffer from ergotism (acute toxicity caused by ergot alkaloids) characterized by vasospasm (contraction of the walls of the arteries that makes it difficult for blood to pass through them) and ischemia (lack of oxygen) of the extremities and other tissues, including the central nervous system.

•Medicines that reduce cholesterol levels of the class of lovastatin and simvastatin.

The risk of rhabdomyolysis (muscle disorder) is increased.

The following medicines should be taken with caution during treatment with clarithromycin and consult your doctor before taking them because it may be necessary to reduce the dose and have a close follow-up:

•Oral anticoagulants (warfarin or other anticoagulant, for example, 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.

•Fenobarbital, used as a sedative and anticonvulsant.

•Certain immunosuppressants, which reduce the ability to defend against foreign elements 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 infections caused by fungi: fluconazole, itraconazole, ketoconazole.

•Antiretrovirals, for HIV infection: zidovudine, efavirenz, nevirapine, atazanavir, saquinavir, etravirine.

The simultaneous treatment with clarithromycin and zidovudine may cause a decrease in the blood levels 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 blockers such as verapamil, amlodipine, diltiazem, because there is a risk of hypotension.

•Rifampicin, rifabutin or rifapentine.

•Other: digoxin (for the heart), theophylline (for asthma), tolterodine (for overactive bladder).

•There have been reports of colchicine toxicity (medicine used to treat gout) when taken with clarithromycin, especially in the elderly, some of whom had renal 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 reactions that affect the heart.

•Corticosteroids, administered orally, by injection or inhaled (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). The simultaneous administration of clarithromycin and omeprazole elevates the blood levels of both medicines.

•Ritonavir (for HIV infection). The simultaneous administration of ritonavir and clarithromycin produces a significant reduction in the elimination of clarithromycin, so it remains unchanged in the body for a longer time, although due to the wide therapeutic margin of clarithromycin it should not be necessary to adjust the dose if you have normal renal function. However, if you have kidney disease (creatinine clearance between 30-60 ml/min and <30

•During postmarketing, interactions have been observed between the following medicines that have a similar metabolism and erythromycin or clarithromycin: alprazolam, astemizol, carbamazepine, cilostazol, cisaprida, disopyramide, ergotamine, dihydroergotamine, lovastatin, methylprednisolone, midazolam, omeprazole, pimozide, quinidine, sildenafil, tadalafil, terfenadine, triazolam and vardenafil.

•Clarithromycin may negatively affect the effectiveness of antibiotics known as "beta-lactams" to which penicillins (amoxicillin, ampicillin, etc.) and cephalosporins (cefuroxime, cefaclor, etc.) belong, as well as with the effects of the antibiotics lincomycin and clindamicina.

Taking Claritromicina ALMUS with food and drinks

Claritromicina ALMUS tablets can be taken before, during or after meals, as the presence of food in the digestive tract does not modify the activity of the medicine.

Pregnancy and lactation

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

No safety of clarithromycin has been established during pregnancy and during lactation. Clarithromycin is excreted in breast milk. If you are breastfeeding, do not take this medicine.

Driving and operating machinery

No evidence has been found that clarithromycin affects the ability to drive or operate machinery. If you experience dizziness, vertigo, confusion and disorientation, avoid driving or operating machinery.

Claritromicina Almus 500 mg tablets contain propylene glycol and sodium

This medicine contains2,610 mg of propylene glycol (E1520) in each tablet.

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

Claritromicina ALMUS is administered orally.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults: in patients with peptic ulcer associated withHelicobacter pylorithe recommended treatments are:

The triple therapy: 500 mg ofclaritromycin,twice a day, with 1000 mg of amoxicillin twice a day and 20 mg of omeprazole once a day, for 10 days, or 500 mg ofclaritromycin,with 1000 mg of amoxicillin and 20 mg of omeprazole, administered all of them twice a day, for 7 days.

The double therapy: 500 mg ofclaritromycin,three times a day, with 40 mg of omeprazole, once a day, for 2 weeks. To ensure healing in patients with duodenal ulcer with poor therapeutic response, the treatment can be prolonged with 40 mg of omeprazole for up to 4 weeks.

The recommended average dose for the prevention and treatment of infections caused by mycobacteria is 500 mg ofclaritromycin,every 12 hours. The duration of treatment should be established by the doctor.

In the treatment of respiratory, skin, and soft tissue infections, the duration of treatment should be established by the doctor and depends on the severity and type of infection.

It oscillates between 6 and 14 days. The patient should follow the doctor's instructions strictly, even if the discomfort disappears.The usual recommended dose for adults is 250 mg twice a day. In more severe infections, the dose can be increased to 500 mg twice a day.

Remember to take your medication. Take the tablets at the same time every day.

Your doctor will indicate the duration of your treatment. Do not stop treatment before, as your disease could worsen or recur even if you feel better.

If you think the effect of Claritromicina ALMUS is too strong or too weak, consult your doctor or pharmacist.

If you take more Claritromicina ALMUS than you should

If you have taken more Claritromicina ALMUS than you should, you can expect digestive disturbances and consult your doctor or pharmacist immediately, as they should try to quickly eliminate the claritromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis are 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 forgot to take Claritromicina ALMUS

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 Claritromicina ALMUS

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

Side 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 1,000 people).

Common (may affect up to 1 in 10 people)

- Insomnia

- Headache, alteration of taste

- Diarrhea, vomiting, nausea, abdominal pain, intestinal mobility disorders

- Rash, excessive sweating

- Abnormal liver function test results

Uncommon (may affect up to 1 in 100 people)

- Candidiasis, vaginal infection

- Alteration of some blood cell levels

- Hypersensitivity

- Anorexia, decreased appetite

- Anxiety

- Drowsiness, dizziness, tremors

- Vertigo, hearing loss, ringing in the ears

- Prolongation of a specific interval in electrocardiogram, called QT interval prolongation, palpitations

- Inflammation of the stomach lining, constipation, gas, dry mouth, belching, abdominal swelling or inflammation

- Elevated levels of some liver enzymes

- Increased serum levels of alkaline phosphatase or lactate dehydrogenase.

- Urticaria, itching

- Discomfort, fatigue, chest pain, muscle weakness or pain, chills

Unknown frequency (cannot be estimated from available data)

- Infections such as: Pseudomembranous colitis, erysipelas

- Decreased levels of some blood cells

- Anaphylactic reaction, skin and mucous membrane inflammation

- Psychosis, confusion, feeling of loss of identity, depression, hallucinations, nightmares

- Seizures, loss of taste, loss or alteration of sense of smell, paresthesia

- Deafness

- Rapid or irregular heartbeat

- Bleeding

- Discoloration of the tongue or teeth, pancreatitis

- Liver failure

- Acne, skin diseases, rash with blood alterations (which may be a sign of a hypersensitivity syndrome called DRESS)

- Muscle disease, rhabdomyolysis

- Kidney failure, kidney disorders caused by inflammation of parts of it

- Abnormal urine color.

Seek medical attention as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines for Human Use Pharmacovigilance System Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date appearing on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Claritromicina ALMUS 500 mg tablets

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

The other components (excipients) are: maize pregelatinized 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 contents of the packaging

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

The tablets are presented in PVC/PVDC blisters attached to an aluminum foil. This medication is presented in packs of 14, 21 or 500 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

BLUEPHARMA – Indústria Farmacêutica, S.A.

S. Martinho do Bispo. 3045-016 Coimbra

Portugal

Last review date of this leaflet: February 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/