Clarithromycin Tecnigen 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CLARITHROMYCIN TECNIGEN 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine

• 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 other people, even if they have the same symptoms, as it may harm them.
  • If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

1. What CLARITROMYCIN TECNIGEN 500 mg tablets is and what it is used for

Clarithromycin TECNIGEN 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.

Clarithromycin TECNIGEN 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. Before taking CLARITROMYCIN TECNIGEN 500 mg tablets

Do not take Clarithromycin TECNIGEN:

• If you are allergic (hypersensitive) to clarithromycin or to 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 allergy), disopyramide and
  quinidine (for heart disorders). If you take these medicines together with clarithromycin, you could experience heart problems that may become serious (see “Use with other medicines”).
• If you are taking ergotamine or dihydroergotamine (for migraine).
• If you are taking a medicine containing lomitapide.
• If you have abnormally low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia).
• If you are taking medicines called ticagrelor, ivabradine or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke).

Take special care with Clarithromycin TECNIGEN:

• If you have any liver disease.
• If you have any kidney disease (moderate to severe renal impairment).
• If you are elderly.
• If you are taking colchicine, as toxicity may occur.
• 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 resistant organisms, 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 organism causing your infection may also be resistant to clarithromycin. Consult your doctor about any concerns in this regard.
• If you are being treated for an infection caused by Mycobacterium avium (which commonly occurs in patients with AIDS or manifests as a lung disease), because you must undergo an audiometry test before starting treatment and your hearing ability should be monitored during treatment. It is also recommended that periodic monitoring of white blood cell and platelet counts be performed. In addition, if you are also taking rifabutin (another antibiotic) for the treatment of these infections, be aware that the risk of developing uveitis (an eye disorder) increases, so appropriate monitoring is required.
• If you develop diarrhoea, because treatment with clarithromycin, as with 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 lovastatin or simvastatin to lower your cholesterol level, because taking them together with clarithromycin may increase the risk of rhabdomyolysis (a disorder affecting your muscles).
• If you are taking oral anticoagulants, because monitoring of your prothrombin time is recommended.

Use of other medicines

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

• The following medicines must not be taken together 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 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 cause ergotism (acute toxicity caused by drugs derived from ergot fungus), characterized by vasospasm (contraction of arterial walls making blood flow difficult) and ischemia (lack of oxygen) in 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 beforehand, as dose reduction and close monitoring may be necessary:

• Oral anticoagulants (warfarin or other anticoagulants, for example, dabigatran, rivaroxaban, apixaban, edoxaban). The risk of bleeding may be increased.
• Medicines that reduce cholesterol levels of the lovastatin and simvastatin class.

The risk of rhabdomyolysis (muscle breakdown) is increased.

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

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

• Others: digoxin (for heart conditions), theophylline (for asthma), rifabutin (antibiotic), sildenafil (for erectile dysfunction), methylprednisolone (corticosteroid), cilostazol (antiplatelet agent), and in general, any medicines that have a similar metabolism.
• There have been reports of colchicine toxicity when taken together with clarithromycin, especially in elderly patients, some of whom had renal impairment.
• 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 likelihood 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 treating 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 digestive disorders such as ulcers and gastroesophageal reflux). Concomitant administration of clarithromycin and omeprazole increases blood levels of both medicines.
• Ritonavir (for HIV infection). Concomitant administration of ritonavir and clarithromycin causes a significant reduction in the elimination of clarithromycin, so that it remains unchanged 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. Nevertheless, if you have kidney disease (creatinine clearance between 30–60 ml/min and < 30 ml/min), your doctor should adjust the clarithromycin dose by 50% and 75%, respectively.
• During post-marketing experience, interactions have been observed between the following medicines, which have a similar metabolism, and 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", which include penicillins (amoxicillin, ampicillin, etc.) and cephalosporins (cefuroxime, cefaclor, etc.), as well as the effects of the antibiotics lincomycin and clindamycin.

Taking Claritromycin TECNIGEN with food and drink

Claritromycin TECNIGEN tablets may be taken before, during, or after meals, as the presence of food in the digestive tract does not alter the drug's activity.

Pregnancy and lactation

• The safety of clarithromycin during pregnancy has not been established. If you are pregnant or think you may be pregnant, do not take Claritromycin TECNIGEN without first consulting your doctor, who will decide whether or not you should take it.
• 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 medication.

Driving and use of machinery

No known effects on the ability to drive vehicles or operate machinery have been reported.

Claritromycin TecniGen contains propylene glycol

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

Claritromycin TecniGen contains sodium

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

3. How to take CLARITROMYCIN TECNIGEN 500 mg tablets

Clarithromycin TECNIGEN is administered orally.

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

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

Triple therapy: 500 mg clarithromycin twice daily, together with 1000 mg amoxicillin twice daily and 20 mg omeprazole once daily for 10 days; or 500 mg clarithromycin, 1000 mg amoxicillin and 20 mg omeprazole, all administered twice daily for 7 days.
Dual therapy: 500 mg clarithromycin three times daily, together with 40 mg omeprazole once daily for 2 weeks. To ensure healing in patients with duodenal ulcer showing poor therapeutic response, treatment with 40 mg omeprazole may be prolonged up to 4 weeks.

The recommended average 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 physician.

For the treatment of respiratory tract, skin, and soft tissue infections, the duration of treatment should be determined by the physician and depends on the severity and type of infection. It typically 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 one tablet of Clarithromycin TECNIGEN 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 your treatment should last. Do not stop treatment prematurely, as even if you feel better, your condition could worsen or recur.

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

If you take more Claritromicina TECNIGEN than you should

If you have taken more Claritromicina TECNIGEN than you should have, gastrointestinal disturbances may occur. Contact your doctor or pharmacist immediately, as steps should be taken to rapidly eliminate the clarithromycin that has not yet been absorbed by your body. Hemodialysis and 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 medication and the amount ingested.

If you forget to take Claritromycin TECNIGEN

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

If you interrupt treatment with Claritromycin TECNIGEN

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

4. Possible adverse effects

Like all medicines, Clarithromycin TECNIGEN may have adverse effects, although not everyone experiences them.

Adverse 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 adverse effects that occur more frequently (at least 1 in 100 patients) are related to the gastrointestinal system, such as nausea, diarrhea, and vomiting. Other adverse reactions include headache, altered taste, hearing loss (usually reversible upon discontinuation of treatment), tinnitus, and mild skin rashes.

Less frequently (at least 1 in 1,000 patients), a decrease in white blood cells or platelets in the blood has been observed, as well as liver disorders (which are usually reversible), changes in liver function tests, allergic reactions ranging from itching to, in rare cases, severe allergies, transient central nervous system effects (dizziness, anxiety, insomnia, nightmares, confusion, hallucinations, and convulsions, although a causal relationship has not been established), disturbances in smell usually accompanied by altered taste, gum inflammation, superficial inflammation of the tongue, tongue discoloration, as well as tooth discoloration (this discoloration usually disappears with professional dental cleaning), pancreatitis, abdominal pain, and gastric discomfort or indigestion.

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

Rarely (at least 1 in 10,000 patients), cases of increased blood creatinine levels or generalized allergic reactions have been observed.

Rarely (at least 1 in 10,000 patients), disorientation, psychosis, or depersonalization have been reported (although a causal relationship has not been established).

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

It is also rare (at least 1 in 10,000 patients) for dizziness, fungal infection of the mouth, or liver damage (which in rare cases may be fatal and is usually associated with the patient having another serious illness and receiving other medications) to occur.

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

There have been reports of colchicine toxicity when taken concomitantly with clarithromycin (some of which resulted in fatalities, primarily in elderly patients with renal impairment).

Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of CLARITHROMYCIN TECNIGEN 500 mg tablets

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use Clarithromycin TECNIGEN after the expiry date stated on the packaging after EXP. The expiry date refers to 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 unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Clarithromycin Tecnigen 500 mg tablets

The active substance 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 contents of the pack

Clarithromycin Tecnigen 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 medicine is available in pack sizes of 14, 21 or 500 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACÉUTICA, 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 last reviewed in March 2024