VIBRACINA 100 mg HARD CAPSULES

2. What you need to know before you take Vibracina

Do not take Vibracina

• if you are allergic to doxycycline, any other tetracycline, or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.
• if you are breast-feeding.
• if you are taking methoxyflurane (a medicine used for anesthesia), as severe kidney toxicity with fatal outcome may occur.

Warnings and precautions

Consult your doctor or pharmacist:

• if you experience severe skin reactions such as widespread skin inflammation with peeling (exfoliative dermatitis), red and swollen skin lesions with a target-like appearance (erythema multiforme), inflammation of the skin and mucous membranes that can be very severe (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis), and drug 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 administration.
• if during treatment with Vibracina you notice 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 process affecting the brain due to increased pressure within the skull).
• if you experience visual disturbances, immediately consult an ophthalmologist.
• if you are taking a medicine called isotretinoin, as taking it together with doxycycline may cause benign intracranial hypertension.
• if you experience severe and prolonged diarrhea while being treated with doxycycline, you may have a type of antibiotic-associated colitis called pseudomembranous colitis, which can be severe. In these cases, you should consult your doctor, who will decide whether to discontinue doxycycline administration and initiate appropriate treatment.
• if you take this medicine while lying down or without accompanying it with sufficient water or milk, esophageal inflammation and ulcers may occur, 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 tests.
• if you have a disease of the immune system that causes joint pain, skin rashes, and fever (systemic lupus erythematosus). The condition may worsen when taking Vibracina.
• if you experience skin redness after sun exposure or ultraviolet radiation. It is recommended to use total sunblock creams and avoid sun exposure or ultraviolet radiation.
• if any signs of infection appear. The use of antibiotics can increase the risk of developing infections by microorganisms that are not sensitive to treatment, including fungi, so your doctor will monitor the appearance of any possible signs of infection.
• if you are going to have any urine tests, inform the healthcare staff that you are being treated with this medicine, as doxycycline can interfere with the test results.

Children and adolescents

In children from birth to 8 years of age, the use of Vibracina is not recommended because it can 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 this risk in children under 8 years of age, and doxycycline may be prescribed.

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

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

Taking Vibracina with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Penicillin (antibiotic), as doxycycline may interfere with its effect.
• Isotretinoin (for severe acne), as taking it 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 (medicines used to calm stomach acidity) and other medicines containing aluminum, calcium, or magnesium, and medicines containing iron or bismuth salts, as they may reduce the effect of doxycycline.
• Antiepileptics and barbiturates (medicines for severe insomnia and seizures), as they may reduce the effect of doxycycline.
• Methoxyflurane (a medicine used for anesthesia), as when used together with tetracycline antibiotics like doxycycline, severe kidney toxicity may occur.

Taking Vibracina with food, drinks, and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

The use of this medicine is not recommended during pregnancy, as it may cause disorders in bone development 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 during treatment with doxycycline to avoid becoming pregnant. Hormonal contraceptives may not be effective, as taking this medicine reduces the contraceptive effect, and therefore, barrier methods are recommended.

Breast-feeding

The use of this medicine should be avoided during breast-feeding, as it may cause disorders in bone development and permanent tooth discoloration in the infant.

Driving and using machines

There is no evidence that doxycycline alters the ability to drive or use machines.

Important information about some of the ingredients of Vibracina

Vibracina contains lactose and sodium.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to Take Vibracina

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will indicate the duration of treatment with this medication. Do not suspend treatment until your doctor indicates it, even if you have started to improve.

Remember to take your medication. It is essential to take this medication regularly, at the same time every 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 in 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 in a single dose or divided into two doses every 12 hours). Treatment should continue until at least 24 to 48 hours after the disappearance of symptoms and fever.

The dose will be established by the doctor based on individual characteristics and the type of infection. As a general rule, the usual dose and frequency of administration are 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 in different geographic areas.

(2) Doxycycline is the treatment of choice

There are different doses available for different dosing regimens.

Pediatric population

Children from 8 years to less than 12 years of age

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

In these cases, the usual doses are:

• Children weighing 45 kg or less:

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

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

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

There is another presentation, in the form of an oral suspension, which could be more suitable for dose adjustment for children weighing ≤ 45 kg.

• Children weighing more than 45 kg:

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

Newborns, infants, and children under 8 years of age

Doxycycline should not be used in children under 8 years of age due to the risk of tooth discoloration.

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

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

• Treatment of cutaneous, intestinal, or pulmonary anthrax: 2.2 mg/kg every 12 hours intravenously followed by the same dose orally 2 times a day for 60 days. The duration of treatment should be 60 days, except in the case of cutaneous anthrax without systemic involvement, in which case the duration of treatment may be reduced to 7-10 days. In the case of pulmonary anthrax, the use of two antibiotics in combination should be considered (see section 4.4).

• Malaria prophylaxis: 2 mg/kg of weight administered once a day, not exceeding the adult dose. Prophylaxis can start 1 or 2 days before traveling to areas with endemic malaria and until 4 weeks after leaving such an area.

• Post-exposure prophylaxis to Bacillus anthracis: 2.2 mg/kg of weight (not exceeding the adult dose) administered orally, 2 times a day, for 60 days.

Elderly patients

No dose adjustment is necessary.

Patients with renal impairment

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

Patients with hepatic impairment

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

Method of administration

Oral route.

If you take more Vibracina than you should

Information for healthcare professionals: In case of overdose, administration should be discontinued, and symptomatic treatment and supportive measures should be initiated.

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 make up for forgotten doses.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

If you experience any of the following adverse effects, talk to your doctor as soon as possible:

• Jarisch-Herxheimer reaction, which occurs with 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 adverse effects have been observed in patients who have taken tetracyclines, including doxycycline, ordered by their frequency of occurrence:

Frequent adverse 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 sickness, Schönlein-Henoch purpura, hypotension, dyspnea, tachycardia, peripheral edema, urticaria, headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, skin rash (including erythematous and maculopapular).

Uncommon adverse effects (may affect up to 1 in 100 people):

Gastrointestinal disorders (heartburn/gastritis).

Rare adverse effects (may affect up to 1 in 1,000 people):

Increased destruction of red blood cells (hemolytic anemia), decreased platelet count (thrombocytopenia), alteration of white blood cell count: decreased neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), drug rash with eosinophilia and systemic symptoms [DRESS, which includes skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell)], brown-black microscopic discoloration of the thyroid gland, decreased appetite, possible symptoms of benign intracranial hypertension (increased pressure inside the skull) including headache, nausea, vomiting, visual disturbances (including blurred vision) and dizziness, bulging fontanelle (transitory bulging of the non-ossified space in the skull in young children), localized defect in the visual field surrounded by a normal vision area (scotoma), double vision (diplopia) and possible vision loss, in some cases even permanent, tinnitus (ringing in the ears), facial flushing (rubefaction), pancreatitis, alteration in stool volume or consistency (diarrhea, pseudomembranous colitis), esophageal ulcers, esophagitis, intestinal inflammation, inflammatory lesions in the anogenital area, difficulty swallowing (dysphagia), abdominal pain, tongue inflammation (glossitis), tooth color change, liver function alteration, hepatitis, and liver damage, toxic epidermal necrolysis, severe skin and mucous membrane inflammation (Stevens-Johnson syndrome), erythema multiforme, widespread skin inflammation with exfoliation (exfoliative dermatitis), round or oval patches with redness and swelling of the skin, blister formation (urticaria) and itching, which usually reappear in the same places with re-exposure to the medication (fixed drug eruption), skin darkening, nail loss (photo-onycholysis), joint pain (arthralgia) and muscle pain (myalgia), increased blood urea.

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

Discoloration and/or lack of tooth growth.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Vibracina

Keep this medication out of sight and reach of children.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Vibracina composition

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

Product appearance and package contents

Vibracina is presented in the form of hard capsules of dark green color 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 packaged in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Hospira Invicta, S.A.

Avda de Europa, 20 B

Parque Empresarial La Moraleja

28108, Alcobendas (Madrid).

Manufacturer

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 marketing authorization holder:

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

Date of the last revision of this leaflet: 06/2024.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.