Package Insert: Information for the Patient

Vibracina 100 mg Hard Capsules

Doxiciclina

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Doxycycline contains doxiciclina, an antibiotic that belongs to a group of medications called tetraciclinas.

This medication is used in adults, adolescents, and children over 8 years old for:

• the treatment of the following infections:
• • Atypical pneumonia.
  • Psittacosis (a disease transmitted by certain birds that presents as pneumonia accompanied by fever and cough).
  • Urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix), proctitis (inflammation of the rectum), lymphogranuloma venereum (an infection characterized by ulcers on the genitals followed by lymph node inflammation), genital granuloma (purulent ulceration of the genitals), pelvic inflammatory disease, acute epididymo-orchitis (inflammation of the testicles, purulent, and primarily affecting newborns).
  • Eye infections such as trachoma, inclusion conjunctivitis (eye infection with conjunctival inflammation and irritation)..
  • Typhus and other infections caused by microorganisms called rickettsias.
  • Q fever.
  • Brucellosis (Malta fever).
  • Cholera (an infectious disease that presents with severe diarrhea, dehydration, and vomiting).
  • Early stages of Lyme disease (transmitted by ticks).
  • Recurring fevers transmitted by lice and ticks.
  • Malaria (a febrile infectious disease with chills and sweating, caused by microorganisms that parasitize red blood cells).
  • Tularemia (a disease of rodents similar to the plague).
  • Bartonellosis (an infectious disease that presents with severe anemia and fever).

• alternative treatment for:
• • Carbuncle (an infectious disease affecting the skin, intestines, or lungs).
  • Listeriosis (a severe infectious disease that can affect the fetus during pregnancy, the newborn, and the adult).
  • Actinomycosis (an infectious disease causing lymph node inflammation of the mouth, along with other internal complications).
  • Syphilis in patients allergic to penicillin.
  • The plague.
  • Leptospirosis (an infectious disease that presents with fever, headache, muscle pain, and yellow discoloration of the skin).

• adjunctive treatment for severe acne vulgaris.

• prevention of malaria (transmitted through mosquito bites).

• prevention of anthrax after exposure to bacteria causing this disease.

Do not take Vibracina

• if you are allergic to doxycycline, any other tetracycline, or any of the other ingredients in this medication (listed in section 6).
• if you are pregnant or think you may be pregnant.
• if you are breastfeeding.
• if you are using it together with methoxyflurane (an anesthetic medication), as it can cause severe kidney toxicity with fatal results.

Warnings and precautions

Consult your doctor or pharmacist:

• if you experience severe skin reactions such as: widespread skin inflammation with peeling (dermatitis exfoliativa), red and swollen skin lesions in the shape of a target (erythema multiforme), severe skin and mucous membrane inflammation (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis), and drug-induced rash with eosinophilia and systemic symptoms (DRESS, which includes skin rash, lymph node inflammation, and elevated eosinophils). In these cases, you should immediately consult your doctor, who will decide whether to discontinue doxycycline treatment.
• if during treatment with Vibracina you experience abnormal headaches accompanied by dizziness, blurred vision, ringing in the ears, nausea, or vomiting, consult your doctor, as these may be symptoms of benign intracranial hypertension (a condition affecting the brain due to increased intracranial pressure).
• if you experience visual disturbances, seek immediate attention from an ophthalmologist.
• if you are taking isotretinoin (a medication for severe acne), as taking it together with doxycycline may cause benign intracranial hypertension.
• if you experience persistent and severe diarrhea while taking doxycycline, you may have antibiotic-associated colitis, which can be severe. In these cases, you should consult your doctor, who will decide whether to discontinue doxycycline treatment and initiate appropriate treatment.
• if you take this medication lying down or without sufficient water or milk, it may cause esophageal inflammation and ulcers, so it is essential to follow the administration instructions exactly (see section 3).
• if you have liver disease, consult your doctor. In prolonged treatments, your doctor may need to perform periodic analytical controls.
• if you have a systemic immune disorder that causes joint pain, skin eruptions, and fever (systemic lupus erythematosus). The condition may worsen when taking Vibracina.
• if you experience skin redness after exposure to the sun or ultraviolet radiation. It is recommended to use sunscreen with a high sun protection factor and avoid exposure to the sun or ultraviolet radiation.
• if you experience any signs of infection. The use of antibiotics may increase the risk of developing infections caused by microorganisms that are not sensitive to treatment, including fungi, so your doctor will monitor for any possible signs of infection.
• if you need to undergo urine analysis, you should inform the healthcare staff that you are taking this medication, as doxycycline may interfere with the results.

Children and adolescents

In children from birth to 8 years of age, the use of Vibracina is not recommended because it may cause permanent tooth discoloration and delayed bone development. However, there may be situations (e.g., severe or potentially life-threatening diseases) in which your doctor may decide that the benefits outweigh the risks in children under 8 years old and prescribe doxycycline.

In children over 8 years old and under 12 years old (up to 45 kg of weight), see section 3. There is another oral suspension presentation that may be more suitable depending on the dose and patient.

In children over 12 years old (over 45 kg of weight), it is recommended to use the same dose as in adults (see section 3).

Taking Vibracina with other medications

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

Certain medications may interact with Vibracina. In these cases, it may be necessary to adjust the dose or discontinue treatment with one of the medications. It is especially important to inform your doctor if you are using any of the following medications:

• Penicillin (antibiotic), as doxycycline may interfere with its effect.
• Isotretinoin (for severe acne), as taking it together with doxycycline may cause benign intracranial hypertension.
• Oral contraceptives, as doxycycline may reduce their effectiveness.
• Anticoagulants (such as warfarin), as doxycycline may alter their effect.
• Antacids (medications used to calm stomach acidity) and other medications containing aluminum, calcium, or magnesium, and medications containing iron or bismuth salts, as they may reduce the effect of doxycycline.
• Antiepileptics and barbiturates (medications for severe insomnia and seizures), as they may reduce the effect of doxycycline.
• Methoxyflurane (an anesthetic medication), as when used together with antibiotics from the tetracycline group, such as doxycycline, it may cause severe kidney toxicity.

Taking Vibracina with food, drinks, and alcohol

You should avoid consuming alcohol during treatment with this medication, as alcohol reduces the effect of Vibracina.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

Pregnancy

The use of this medication during pregnancy is not recommended, as it may cause bone development disorders and permanent tooth discoloration in the child. Your doctor will decide whether to use Vibracina in these cases.

It is essential to use contraceptive methods to avoid pregnancy during treatment with doxycycline. Oral contraceptives (hormonal) may not be effective, as taking this medication reduces their effectiveness, so it is recommended to use barrier methods.

Breastfeeding

The use of this medication during breastfeeding is not recommended, as it may cause bone development disorders and permanent tooth discoloration in the infant.

Driving and operating machinery

There is no evidence that doxycycline affects the ability to drive or operate machinery.

Important information about some components of Vibracina:

Vibracina contains lactose and sodium.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will inform you of the duration of treatment with this medication. Do not discontinue treatment until your doctor tells you to, even if you start to feel better.

Remember to take your medication. It is essential to take this medication regularly, at the same time of day.

Adults and adolescents (12 years to less than 18 years of age)

The usual dose of doxycycline is 200 mg on the first day of treatment (administered as a single dose or divided into two doses every 12 hours), followed by a maintenance dose of 100 to 200 mg/day depending on the severity of the infection (administered as a single dose or divided into two doses every 12 hours). Treatment should continue for at least 24 to 48 hours after the disappearance of symptoms and fever.

The dose will be established by the doctor according to your individual characteristics and the type of infection. As a general rule, the usual dose and administration frequency is as follows:

(1) Due to the potential severity of the infection, a rapid-acting antimalarial such as quinine should always be administered in combination with doxycycline. Quinine dosage recommendations vary by geographic area.

(2) Doxycycline is the treatment of choice

There are different doses available for the various dosing regimens.

Pediatric population

Children aged 8 years to less than 12 yearsold

Doxycycline should be used for the treatment of acute infections in children aged 8 years and less than 12 years, in situations where other medications are not available or may not be effective or are contraindicated.

The usual doses are:

• Children weighing 45 kg or less:

First day: 4.4 mg/kg of body weight (administered as a single dose or divided into two equal doses every 12 hours)

From the 2nd day: 2.2 mg/kg of body weight (as a single dose or divided into two equal doses). The treatment duration will depend on the infection being treated.

In more severe infections, a dose of up to 4.4 mg/kg of body weight may be administered throughout the treatment.

There is another presentation, in the form of oral suspension, which may be more suitable for adjusting doses for children ≤ 45 kg of body weight.

• Children weighing more than 45 kg:

It is recommended to use the same dose as in adults, 200 mg on the first day and then 100 mg daily. The treatment duration will depend on the infection being treated.

Newborns, infants, and children less than 8 years old

Doxycycline should not be used in children aged 8 years or less due to the risk of tooth discoloration.

The dosing regimen in pediatric patients for the treatment or prophylaxis of specific infections is:

• Treatment of Rocky Mountain spotted fever: 2.2 mg/kg twice daily. Patients should receive treatment until at least 3 days after the fever disappears and until there is evidence of clinical improvement. The treatment duration should be at least 5-7 days.

• Treatment of cutaneous, intestinal, or pulmonary carbuncle: 2.2 mg/kg every 12 hours intravenously followed by the same dose orally twice daily for 60 days. The treatment duration should be 60 days, except in the case of cutaneous carbuncle without systemic involvement (not reaching the bloodstream), in which case the treatment duration may be reduced to 7-10 days. In the case of pulmonary carbuncle, the use of two antibiotics in combination (see section 4.4) should be considered.

• Malaria prophylaxis: 2 mg/kg of body weight administered once daily, without exceeding the adult dose. The prophylaxis may begin 1 or 2 days before traveling to endemic areas and continue during the trip and for 4 weeks after leaving the endemic area.

• Post-exposure prophylaxis against Bacillus anthracis: 2.2 mg/kg of body weight (without exceeding the adult dose) administered orally, twice daily, for 60 days.

Geriatric patients

No dose adjustment is necessary.

Patients with renal impairment

Doxycycline does not require dose adjustment in patients with renal impairment.

Patients with hepatic impairment

Doxycycline should be administered with caution in patients with hepatic impairment.

Administration form

Oral administration.

If you take more Vibracina than you should

Information for healthcare professionals: In case of overdose, discontinue administration, initiate symptomatic treatment, and supportive measures.

Peritoneal dialysis does not alter the plasma elimination half-life and, therefore, would not be beneficial in the treatment of overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Vibracina

If you forget to take a dose, take the next one at the usual time. Do not take a double dose to compensate for the missed doses.

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

If you experience any of the side effects listed below, speak with your doctor as soon as possible:

• Jarisch-Herxheimer reaction, which is characterized by fever, chills, headache, muscle pain, and skin rash, and usually resolves spontaneously. It occurs shortly after starting treatment with doxycycline for spirochetal infections, such as Lyme disease.

The following side effects have been observed in patients taking tetracyclines, including doxycycline, listed in order of their frequency of occurrence:

Frequent side effects (may affect up to 1 in 10 people):

Hypersensitivity, allergic reactions (including anaphylactic shock, anaphylactic and anaphylactoid reactions, angioedema, exacerbation of systemic lupus erythematosus, pericarditis, serum disease, Schönlein-Henoch purpura, hypotension, dyspnea, tachycardia, peripheral edema, erythematous skin lesions, elevated and itchy, urticaria, headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, skin rash (including erythematous and maculopapular types).

Rare side effects (may affect up to 1 in 100 people):

Digestive disturbances (gastritis).

Very rare side effects (may affect up to 1 in 10,000 people):

Severe hemolysis (anemia hemolítica), thrombocytopenia, alteration in the number of white blood cells: neutropenia or eosinophilia, drug-induced rash with eosinophilia and systemic symptoms (DRESS), which includes skin rash, lymph node inflammation, and elevated eosinophils, brown-black microscopical discoloration of the thyroid gland, decreased appetite, possible symptoms of benign intracranial hypertension, including headache, nausea, vomiting, visual disturbances (including blurred vision), dizziness, transient fontanelle bulging in young children, localized visual field defect surrounded by a normal visual area (scotoma), double vision (diplopia), and possible permanent vision loss, tinnitus, facial redness, pancreatitis, altered stool volume or consistency (diarrhea, pseudomembranous colitis), esophageal ulcers, esophagitis, inflammatory intestinal lesions, anogenital inflammatory lesions, dysphagia, abdominal pain, glossitis, tooth discoloration, liver dysfunction, hepatitis, and liver damage, toxic epidermal necrolysis, severe skin and mucous membrane inflammation (Stevens-Johnson syndrome), multiform erythema, extensive skin exfoliation, round or oval skin lesions with redness and swelling, vesicular eruptions, and pruritus that usually recur in the same locations upon re-exposure to the medication (fixed drug eruption), skin darkening, onycholysis, arthralgia, and myalgia, elevated urea in the blood.

Side effects of unknown frequency (cannot be estimated from available data):

Teeth discoloration and/or failure to grow.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

Store below 30°C. Store in the original packaging.

Do not use this medication 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. Dispose of packaging and unused medications at the SIGRE collection point of 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 Vibracina

• The active ingredient is doxiciclina. Each capsule contains 100 mg of doxiciclina (as hyclate).
• The other components are:
• • Capule content: lactose monohydrate, magnesium stearate, sodium lauryl sulfate, cornstarch, alginic acid.
  • Capule composition: iron oxide yellow (E-172), indigotin (indigo carmine) (E-132), titanium dioxide (E-171), gelatin, shellac lacquer.

Appearance of the product and contents of the packaging

Vibracina is presented in the form of hard, dark green capsules with the word “Pfizer” printed in white on the cap and the word “Vibracina” printed in white on the body of the capsule.

Each package contains 14 capsules conditioned in a cardboard box.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Hospira Invicta, S.A.

Avda de Europa, 20 B

Parque Empresarial La Moraleja

28108, Alcobendas (Madrid).

Responsible for manufacturing

Farmasierra Manufacturing S.L.

Ctra. de Irún, km 26, 200

28700, San Sebastián de los Reyes. Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Pfizer, S.L. Avda. de Europa, 20-B. Parque Empresarial La Moraleja. 28108, Alcobendas. Spain.

Last review date of this leaflet: 06/2024.

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