CLARITHROMYCIN TECNIGEN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets are and what they are used for
2. Before you take CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets
3. How to take CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets
4. Possible side effects
5. Storage of CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets
6. Further information

1. What CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets are and what they are used for

Clarithromycin TECNIGEN is a macrolide antibiotic, active against many germs that cause stomach or intestinal infections, respiratory tract infections, skin and soft tissue infections, or those produced by less common germs.

Clarithromycin TECNIGEN is used to treat 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 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 (worsening of prolonged or recurrent lung inflammation), 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).

2. Before taking CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets

Do not take Clarithromycin TECNIGEN:

• If you are allergic (hypersensitive) to clarithromycin or any of the other components of this medicine.
• If you are allergic to macrolide antibiotics.
• If you are taking other medicines such as cisapride (for gastrointestinal problems), pimozide (for psychiatric disorders), terfenadine or astemizole (for allergies), disopyramide, and quinidine (for heart disorders). If you take these medicines with clarithromycin, you may have serious heart problems (see "Use of other medicines").

If you take these medicines with clarithromycin, you may have serious heart problems (see "Use of other medicines").

• If you are taking ergotamine or dihydroergotamine (for migraines).
• If you are taking a medicine with lomitapide.
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you take ticagrelor, ivabradine, or ranolazine (for angina pectoris or to reduce the risk of myocardial infarction or stroke).

Be careful with Clarithromycin TECNIGEN:

• If you have any liver disease.
• If you have kidney disease (moderate to severe renal insufficiency).
• If you are elderly.
• If you are taking colchicine, as toxicity may occur.
• If you have taken other macrolide antibiotics or lincomycin and clindamycin antibiotics and the infection has not been resolved due to being caused by a resistant germ, or if you have not been able 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 causative germ of your infection is also resistant to clarithromycin. Consult your doctor about any questions you may have.
• If you are being treated for an infection caused by Mycobacterium avium (which usually occurs in AIDS patients or manifests as a pulmonary disease) because you should have an audiometry before starting treatment and your hearing should be monitored during treatment. It is also recommended that you have periodic monitoring of your white blood cell and platelet count. Additionally, if you are taking rifabutin (another antibiotic) in the treatment of these infections, you should be aware that the risk of uveitis (an eye condition) increases, so you should have adequate monitoring.
• If you experience diarrhea, as treatment with clarithromycin, like most antibiotics, can cause pseudomembranous colitis (inflammation of the large intestine that causes diarrhea and abdominal pain) due to the microorganism Clostridium difficile, and your doctor should rule out this diagnosis.
• If you are taking lovastatin or simvastatin to lower your cholesterol levels, as taking them with clarithromycin can increase the risk of rhabdomyolysis (a muscle disorder).
• If you are taking oral anticoagulants, as it is recommended that your prothrombin time be monitored.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

• The following medicines should not be taken with clarithromycin TECNIGEN: astemizole and terfenadine (for allergies), cisapride (for gastrointestinal problems), disopyramide and quinidine (for heart disorders), and pimozide (for psychiatric disorders), as these medicines can increase the risk of serious heart problems when administered with clarithromycin.
• You should not use ergotamine or dihydroergotamine, as taking them with clarithromycin can cause ergotism (acute toxicity caused by ergot-derived drugs) 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.

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

• Oral anticoagulants (warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, edoxaban). The risk of bleeding may increase.
• Cholesterol-lowering medicines of the lovastatin and simvastatin class.

The risk of rhabdomyolysis (muscle disorder) increases.

• Antiepileptics, for epilepsy: phenytoin, carbamazepine, valproate.
• Certain immunosuppressants, which reduce the body's defense against foreign substances and are used, for example, in organ transplants: cyclosporine, tacrolimus, and rapamycin.
• Certain anticancer agents, such as vinca alkaloids: vinblastine.
• Benzodiazepines, for anxiety and insomnia: alprazolam, midazolam, triazolam.
• Antifungals, for fungal infections: fluconazole, itraconazole, ketoconazole.
• Antiretrovirals, for HIV infection: zidovudine.

Concomitant treatment with clarithromycin and zidovudine may result in a decrease in zidovudine blood levels due to clarithromycin interfering with the oral absorption of zidovudine. Therefore, it is recommended to space out the administration of both medicines.

• Others: digoxin (for the heart), theophylline (for asthma), rifabutin (antibiotic), sildenafil (for erectile dysfunction), methylprednisolone (corticosteroid), cilostazol (anticoagulant), and in general, those medicines that have a similar metabolism.
• There have been reports of colchicine toxicity when taken with clarithromycin, especially in the elderly, 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 possibility 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 range 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 digestive disorders such as ulcers and gastroesophageal reflux). Concomitant administration of clarithromycin and omeprazole increases the blood levels of both medicines.
• Ritonavir (for HIV infection). Concomitant administration of ritonavir and clarithromycin results in 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, a 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.< li>
• In post-marketing, interactions have been observed between the following medicines, which have a similar metabolism to erythromycin or clarithromycin: astemizole, cisapride, disopyramide, ergotamine, dihydroergotamine, lovastatin, pimozide, quinidine, simvastatin, and terfenadine.
• Clarithromycin may negatively affect the efficacy of antibiotics known as "beta-lactams" to which penicillins (amoxicillin, ampicillin, etc.) and cephalosporins (cefuroxime, cefaclor, etc.) belong, as well as the effects of lincomycin and clindamycin antibiotics.

Taking Clarithromycin TECNIGEN with food and drinks

Clarithromycin TECNIGEN 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 breastfeeding

• The safety of clarithromycin during pregnancy has not been established. If you are pregnant or think you may be pregnant, do not take Clarithromycin TECNIGEN without consulting your doctor first, and he will decide whether you should take it or not.
• The safety of clarithromycin during breastfeeding has not been established. Clarithromycin is excreted in breast milk. If you are breastfeeding, do not take this medicine.
• Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No effects on the ability to drive vehicles and use machinery are known.

Clarithromycin TecniGen contains propylene glycol

This medicine contains 2.610 mg of propylene glycol in each tablet.

Clarithromycin TecniGen contains sodium

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

3. How to take CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets

Clarithromycin TECNIGEN is administered orally.

Follow the administration instructions for Clarithromycin TECNIGEN indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Triple therapy: 500 mg of clarithromycin, 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 of clarithromycin, with 1000 mg of amoxicillin and 20 mg of omeprazole, all administered twice a day, for 7 days. Double therapy: 500 mg of clarithromycin, 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, treatment with 40 mg of omeprazole may be extended up to 4 weeks.

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

In the treatment of respiratory tract, skin, and soft tissue infections, the duration of treatment should be determined by the doctor and depends on the severity and type of infection. It ranges from 6 to 14 days. The patient should strictly follow the doctor's instructions, even if the discomfort disappears. The usual recommended dose for adults is one Clarithromycin TECNIGEN 500 mg tablet, twice a day. In more severe infections, the dose may be increased to 500 mg, twice a day.

Remember to take your medicine. 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 illness could worsen or reappear.

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

If you take more Clarithromycin TECNIGEN than you should

If you have taken more Clarithromycin TECNIGEN 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 medicine and the amount ingested.

If you forget to take Clarithromycin TECNIGEN

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 Clarithromycin TECNIGEN

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

4. Possible side effects

Like all medicines, Clarithromycin TECNIGEN can have side effects, although not everyone gets them.

Side effects can be classified as very common (at least 1 in 10 patients), common (at least 1 in 100 patients), uncommon (at least 1 in 1,000 patients), rare (at least 1 in 10,000 patients), and very rare (less than 1 in 10,000 patients).

The most common side effects (at least 1 in 100 patients) are related to the digestive system, such as nausea, diarrhea, and vomiting. Other adverse reactions include headaches, taste disturbances, hearing loss (usually reversible with treatment discontinuation), tinnitus, and mild skin rashes.

Less common side effects (at least 1 in 1,000 patients) include decreased white blood cell or platelet count in the blood, liver disorders (which are generally reversible), alterations in liver function tests, allergic reactions that can range from itching to, in rare cases, severe allergies, transient central nervous system effects (dizziness, anxiety, insomnia, nightmares, confusion, hallucinations, and convulsions, although a cause-and-effect relationship has not been established), altered sense of smell usually accompanied by altered sense of taste, gum inflammation, superficial tongue inflammation, tongue discoloration, as well as tooth discoloration (this discoloration usually disappears with a professional dental cleaning), pancreatitis, abdominal pain, and gastrointestinal discomfort or indigestion.

Rarely (at least 1 in 10,000 patients), low blood sugar levels have been described, sometimes associated with the use of diabetes medicines.

Very rarely (at least 1 in 10,000 patients), elevated creatinine levels in the blood or generalized allergic reactions have been observed.

Very rarely (at least 1 in 10,000 patients), disorientation, psychosis, or depersonalization have been described (although a cause-and-effect relationship has not been established).

Rarely (at least 1 in 10,000 patients), alterations in the electrocardiogram or heart rhythm have been described.

It is also rare (at least 1 in 10,000 patients) to experience vertigo, oral thrush, or liver damage (which can be fatal in rare cases and is usually associated with the patient having another serious illness and receiving other medication).

Isolated cases (frequency cannot be determined with available data) of interstitial nephritis (kidney disorder caused by inflammation of parts of the kidney) have been observed.

There have been reports of colchicine toxicity when taken with clarithromycin (some of which had a fatal outcome, mainly in elderly patients with kidney problems).

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 eruption). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets

Keep out of the reach and sight of children.

This medicine does not require special storage conditions.

Do not use Clarithromycin TECNIGEN after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Clarithromycin Tecnigen 500 mg tablets

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

The other components (excipients) are: pregelatinized corn starch, sodium croscarmellose, povidone, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide, talc, propylene glycol.

Appearance of the product and packaging content

Clarithromycin Tecnigen 500 mg tablets are oblong, biconvex, white or almost white, coated.

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.

Marketing authorization holder and manufacturer Responsible:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid), Spain

Manufacturer:

BLUEPHARMA – Indústria Farmacêutica, S.A.

• Martinho do Bispo. 3045-016 Coimbra

Portugal

This leaflet was revised in March 2024