Package Insert: Information for the User

CLARITROMYCIN TECNIGEN 500 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 from the group of macrolides, active against many germs that cause infections of the stomach or intestine, respiratory tract or skin, and those produced by less common germs.

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

1. Peptic ulcer and duodenal ulcer.
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 the 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 erysipela (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

quinidina (for heart disorders). If you take those medications with clarithromycin, you may have serious heart problems (see “Use of other medications”).

• If you are taking ergotamine or dihydroergotamine (for migraines).
• If you are taking a medication with lomitapida.
• If you have abnormally low levels of potassium or magnesium in your blood (hypopotasemia or hypomagnesemia).
• if you are taking medications called ticagrelor, ivabradina or ranolazina (for angina pectoris or to reduce the risk of myocardial infarction or stroke).

Be especially careful with Claritromicina TECNIGEN:

• If you have any liver disease.
• If you have any kidney disease (moderate to severe renal insufficiency).
• If you are elderly.
• If you are taking colchicine because it may cause toxicity.
• If you have taken other macrolide antibiotics or lincomycin or clindamicina and the infection has not been resolved because it is 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 germ causing the infection may also be resistant to clarithromycin. Consult your doctor about any doubts you may have.
• If you are being treated for an infection caused byMycobacterium avium(which usually occurs in people with AIDS or manifests as a pulmonary disease) because you should have an audiometry test before starting treatment and your hearing should be monitored during treatment. You should also have regular checks on your white blood cell and platelet count. Additionally, if you are also taking rifabutina (another antibiotic) during treatment, be aware that it increases the risk of uveitis (an eye disorder) so you should have the necessary controls.
• If you have 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 microorganismClostridium difficileand your doctor should rule out this diagnosis.
• If you are taking lovastatina or simvastatina to lower your cholesterol level, because taking them with clarithromycin may increase the risk of rhabdomyolysis (a disorder that affects your muscles).
• If you are taking oral anticoagulants because you should have your prothrombin time monitored.

Use of other medications

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

• The following medications should not be taken with clarithromycin TECNIGEN: astemizol and terfenadine (for allergies), cisaprida (for gastrointestinal problems), disopyramide and quinidina (for heart disorders) and pimozida (for psychiatric disorders), as these medications, 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 experience 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.

The following medications should be taken with caution during treatment with clarithromycin and should be consulted with your doctor beforehand, as it may be necessary to reduce the dose and have close monitoring:

• Oral anticoagulants (warfarin or another anticoagulant, for example, dabigatrán, rivaroxabán, apixabán, edoxabán). There may be an increased risk of bleeding.
• Medications that reduce cholesterol levels of the lovastatina and simvastatina class.

The risk of rhabdomyolysis (muscle disorder) is increased.

• Antiepileptics, for epilepsy: phenytoin, carbamazepine, valproate.
• Certain immunosuppressants, which reduce the body's ability to defend against foreign elements and are used, for example, in organ transplants: cyclosporine, tacrolimus and rapamune.
• Certain anticancer agents, such as vinca alkaloids: vinblastine.
• Benzodiazepines, for anxiety and insomnia: alprazolam, midazolam, triazolam.
• Antifungals, for fungal infections: fluconazol, itraconazol, ketoconazol.
• Antiretrovirals, for HIV infection: zidovudine.

Treatment with clarithromycin and zidovudine may cause a decrease in the blood levels of zidovudine due to clarithromycin interfering with the oral absorption of zidovudine. Therefore, it is recommended to space the administration of the doses of both medications.

• Others: digoxin (for the heart), theophylline (for asthma), rifabutina (antibiotic), sildenafil (for erectile dysfunction), methylprednisolone (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 diseases 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 severe 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 elevates the blood levels of both medications.
• Ritonavir (for HIV infection). The concomitant administration of ritonavir and clarithromycin produces a significant reduction in 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, interactions have been observed between the following medications that have a similar metabolism and erythromycin or clarithromycin: astemizol, cisaprida, disopyramide, ergotamine, dihydroergotamine, lovastatina, pimozida, quinidina, simvastatina and terfenadine.
• Clarithromycin may negatively affect the efficacy of antibiotics known as

“betalactámicos” to which belong the penicillins (amoxicilina, ampicilina, etc.) and the cefalosporins (cefuroxima, cefaclor, etc), as well as with the effects of the antibiotics lincomicina and clindamicina.

Taking Claritromicina TECNIGEN with food and drinks

Claritromicina 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 medication.

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 Claritromicina TECNIGEN without consulting your doctor 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 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 2,610 mg of propylene glycol in each tablet.

Claritromicina TecniGen contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; that is, 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, 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 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 the 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 consult your doctor or pharmacist immediately, 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 eruptions.

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 of which 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 that any of the side effects you are experiencing are 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 thrown into the drains or 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 500 mg tablets

The active ingredient is clarithromycin. Each tablet contains 500 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 500 mg tablets are oblong, biconvex, white or almost white, coated tablets.

The tablets are presented in PVC/PVDC blisters attached to an aluminum sheet. This medication is presented in packages of 14, 21, 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