Package Insert: Information for the User

CLARITROMICIN TECNIGEN 250 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication

- Keep this package insert, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Claritromicina TECNIGEN is an antibiotic belonging to the macrolide group, active against many germs that cause stomach or intestinal infections, respiratory tract infections, or skin infections, and those produced by less common germs.

Claritromicina TECNIGEN is 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 (worsening of prolonged or repeated 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).

Do not take Claritromicina TECNIGEN:

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

If you are taking ergotamine or dihydroergotamine (for migraines), lomitapida (for a specific condition), or have abnormally low levels of potassium or magnesium in your blood (hypopotasemia or hypomagnesemia), or are taking ticagrelor, ivabradina, or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke), consult your doctor before taking Claritromicina 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 it may cause toxicity.
• If you have taken other macrolide antibiotics or lincomycin or clindamicina and the infection has not been resolved due to resistance, 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 is also resistant to clarithromycin. Consult your doctor about any doubts you may have.
• If you are being treated for an infection caused by Mycobacterium avium (which usually occurs in people with AIDS or manifests as a lung disease), as you will need to have an audiometry test before starting treatment and your hearing will need to be monitored during treatment. You will also need to have regular checks on your white blood cell and platelet counts. Additionally, if you are also taking rifabutina (another antibiotic), you should be aware that this increases the risk of uveitis (an eye disorder), so you will need to have regular checks.
• If you experience diarrhea, as the treatment with clarithromycin, like most antibiotics, may cause pseudomembranous colitis (inflammation of the large intestine that causes diarrhea and abdominal pain) by the microorganism Clostridium difficile, and your doctor will need to rule out this diagnosis.
• If you are taking lovastatina or simvastatina to lower your cholesterol levels, as taking these medications with clarithromycin may increase the risk of rhabdomyolysis (a muscle disorder).
• If you are taking oral anticoagulants, as you will need to have your prothrombin time monitored.

Use of other medications

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

• The following medications should not be taken with clarithromycin TECNIGEN: astemizol and terfenadine (for allergies), cisapride (for gastrointestinal problems), disopyramide and quinidine (for heart disorders), and pimozide (for psychiatric disorders), as these medications may increase the risk of serious heart problems.
• You should also not take ergotamine or dihydroergotamine, as taking these medications with clarithromycin may cause ergotism (acute toxicity caused by ergot alkaloids), characterized by vasospasm (contraction of blood vessel walls that makes it difficult for blood to flow through them) and ischemia (lack of oxygen) of the extremities and other tissues, including the central nervous system.

The following medications should be taken with caution during treatment with clarithromycin and you should consult your doctor before taking them, as you may need to reduce the dose and have close monitoring:

• Oral anticoagulants (warfarin or other anticoagulants, such as dabigatrán, rivaroxabán, apixabán, edoxabán). There may be an increased risk of bleeding.
• Medications that lower cholesterol levels, such as lovastatina and simvastatina. There may be an increased risk of rhabdomyolysis (muscle disorder).

There may be an increased risk of rhabdomyolysis (muscle disorder).

• Antiepileptic medications, such as phenytoin, carbamazepine, and valproate.
• Certain immunosuppressants, such as ciclosporina, tacrolimus, and rapamune.
• Certain anticancer medications, such as vinblastine.
• Benzodiazepines, such as alprazolam, midazolam, and triazolam.
• Antifungal medications, such as fluconazol, itraconazol, and ketoconazol.
• Antiretroviral medications, such as zidovudina.

There may be a decrease in the levels of zidovudina in the blood due to the interaction with clarithromycin, which may interfere with the oral absorption of zidovudina. It is recommended to space the administration of the doses of both medications.

• Other medications, such as digoxina (for the heart), theophylline (for asthma), rifabutina (antibiotic), sildenafilo (for erectile dysfunction), prednisolone (corticosteroid), cilostazol (anticoagulant), and in general, those medications 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 conditions such as rheumatoid arthritis or to treat or prevent malaria). Taking these medications with 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 medications increase the amount of clarithromycin absorbed from the administered dose, so you should consult your doctor before taking them:

• Omeprazol (for gastrointestinal disorders such as ulcers and gastroesophageal reflux). The concomitant administration of clarithromycin and omeprazol increases the levels of both medications in the blood.
• Ritonavir (for HIV infection). The concomitant administration of ritonavir and clarithromycin reduces the elimination of clarithromycin, so it remains unchanged in the body for a longer period, although due to the wide therapeutic margin of clarithromycin, it may not be necessary to adjust the dose if you have normal kidney function. However, if you have kidney disease (creatinine clearance between 30-60 ml/min and <30
• In post-marketing surveillance, interactions have been observed between the following medications that have a similar metabolism and erythromycin or clarithromycin: astemizol, cisaprida, disopiramida, ergotamina, dihidroergotamina, lovastatina, pimozida, quinidina, simvastatina, and terfenadina.
• Clarithromycin may negatively affect the efficacy of antibiotics known as “betalactámicos”, to which penicillins (amoxicilina, ampicilina, etc.) and cefalosporins (cefuroxima, cefaclor, etc.) belong, as well as the effects of lincomicina and clindamicina.

Taking Claritromicina TECNIGEN with food and beverages

Claritromicina TECNIGEN tablets can be taken before, during, or after meals, as the presence of food in the digestive tract does not affect the activity of the medication.

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 Claritromicina TECNIGEN without consulting your doctor, and they will decide whether you should take it or not.
• The safety of clarithromycin during lactation has not been established. Clarithromycin is excreted in breast milk. If you are breastfeeding, do not take this medication.
• Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Claritromicina TecniGen contains propylene glycol

This medication contains 1,305 mg of propylene glycol in each tablet.

Claritromicina TecniGen contains sodium

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

Clarithromycin TECNIGEN is administered orally.

Follow exactly 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, administered all of them 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 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 of clarithromycin, 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 ranges from 6 to 14 days. The patient should strictly follow the doctor's instructions even if symptoms disappear. The usual recommended dose for adults is one Clarithromycin TECNIGEN tablet, 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.

If you feel that 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 digestive disturbances and immediately consult your doctor or pharmacist, as they should 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 Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Clarithromycin TECNIGEN

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 Clarithromycin TECNIGEN

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

Like all medicines, Claritromicina TECNIGEN can have side effects, although not everyone will experience them.

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

Side effects that may occur more frequently (in at least 1 in 100 patients) are related to the digestive system, such as nausea, diarrhea, and vomiting. Other adverse reactions include headaches, altered taste, hearing loss (usually reversible with treatment interruption), tinnitus, and mild skin rashes.

With less frequency (in at least 1 in 1,000 patients), a decrease in white blood cells or platelets in the blood, liver alterations (which are usually reversible), liver function test alterations, allergic reactions that can range from itching to, in rare cases, severe allergies, transient adverse effects of the central nervous system (dizziness, anxiety, insomnia, nightmares, confusion, hallucinations, and seizures, although no cause-and-effect relationship has been established), normal alteration of the sense of smell usually accompanied by altered taste, inflammation of the gums, superficial inflammation of the tongue, tongue discoloration, as well as tooth discoloration (this discoloration usually disappears with a professional dental cleaning), pancreatitis, abdominal pain, and gastric or indigestive discomfort.

In rare cases (in at least 1 in 10,000 patients), low blood sugar levels have been described, in some cases associated with the use of diabetes medications.

Rarely (in at least 1 in 10,000 patients), cases of elevated creatinine in the blood or generalized allergic reaction have been observed.

Rarely (in at least 1 in 10,000 patients), disorientation, psychosis, or depersonalization have been described (although no cause-and-effect relationship has been established).

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

It is also rare (in at least 1 in 10,000 patients) for vertigo, fungal infection of the mouth, or liver damage (which, in rare cases, can be fatal and is usually associated with another underlying disease and concomitant medication) to occur.

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

Reports of colchicine toxicity have been received when taken with claritromycin (some of which had a fatal outcome, mainly in the elderly with renal problems).

Consult a doctor 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 the available data).

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

This medication does not require special conditions for conservation.

Do not use Claritromicina TECNIGEN after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Claritromicina Tecnigen 250 mg tablets

The active ingredient is clarithromycin. Each tablet contains 250 mg of clarithromycin.

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

Appearance of the product and contents of the package

Claritromicina Tecnigen 250 mg tablets are round, biconvex, white or almost white, coated.

The tablets are presented in PVC/PVDC blisters attached to an aluminum sheet. This medication is presented in packages of 12 or 500 tablets.

Holder of the marketing authorization and responsible for manufacturing Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas (Madrid), Spain

Responsible for manufacturing:

BLUEPHARMA – Indústria Farmacêutica, S.A.

S. Martinho do Bispo. 3045-016 Coimbra

Portugal

This leaflet was revised in March 2024.