VIBRACINA 10 mg/ml ORAL SUSPENSION

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 components of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.
• if you are breastfeeding.

• if you are taking metoxiflurane (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 or systemic symptoms [DRESS, which includes skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell)]. In these cases, you should immediately consult your doctor, who will decide whether to discontinue doxycycline administration.
• you notice abnormal headaches accompanied by dizziness, blurred vision, ringing in the ears, nausea, or vomiting during treatment with Vibracina, consult your doctor, as these may be symptoms of benign intracranial hypertension (a process that affects the brain due to increased pressure inside the skull).
• you experience visual disturbances, immediately consult an ophthalmologist.
• you are taking a medicine called isotretinoin, as taking it together with doxycycline may cause benign intracranial hypertension.
• you have 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.
• you ingest 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).
• you have liver disease, consult your doctor. In prolonged treatments, your doctor may need to perform periodic analytical tests.
• 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.
• 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.
• you notice any sign of infection. 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 sign of infection.
• you are going to have any urine tests, inform the healthcare staff that you are being treated with this medicine, as doxycycline may 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 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 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 capsule form that may 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 that you 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 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 (medicines used to calm stomach acidity) and other medicines that contain aluminum, calcium, or magnesium, and medicines that contain iron or bismuth salts, as they may reduce the effect of doxycycline.
• Antiepileptics and barbiturics (medicines for severe insomnia and seizures), as they may reduce the effect of doxycycline.
• Metoxiflurane (a medicine used for anesthesia), as severe kidney toxicity may occur when used together with antibiotics from the tetracycline group, such as doxycycline.

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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 on the convenience of using Vibracina in these cases.

It is essential that during treatment with doxycycline, you use contraceptive methods to avoid becoming pregnant. Oral contraceptives (hormonal) may not be effective, as taking this medicine reduces the contraceptive effect, and therefore, it is recommended to use barrier methods.

Breastfeeding

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

Driving and using machines

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

Important information about some of the components of Vibracina:

Vibracina contains sodium metabisulfite, propyl parahydroxybenzoate, butyl parahydroxybenzoate, sorbitol, sodium, propylene glycol, and ethanol.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate and butyl parahydroxybenzoate.

This medicine contains 7142.86 mg of sorbitol in each 10 ml of oral suspension, equivalent to 714.29 mg/ml.

This medicine contains 28.51 mg of sodium (main component of table salt/cooking salt) in each 10 ml of oral suspension. This is equivalent to 1.43% of the maximum recommended daily sodium intake for an adult.

This medicine contains 4.56 mg of propylene glycol in each ml of suspension, equivalent to 91.20 mg per 200 mg dose.

This medicine contains 0.06% ethanol (alcohol), which corresponds to 5.88 mg per 10 ml of oral suspension.

3. How to take Vibracina

Follow the administration instructions of 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 stop 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 of day.

Adults and adolescents (over 12 years to 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 years to less than 12 years of age, in situations where other medications are not available or may not be effective.

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 can 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 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 anthrax: 2.2 mg/kg every 12 hours intravenously followed by the same dose orally 2 times a day for 60 days. The treatment duration should be 60 days, except in the case of cutaneous anthrax without systemic involvement, in which case the treatment duration can 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 impaired renal function.

Patients with hepatic impairment

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

Method of administration

Oral route.

If you take more Vibracina than you should

Information for the healthcare professional: In case of overdose, administration should be discontinued, 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 side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of the side effects listed below, talk to 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 who have taken tetracyclines, including doxycycline, ordered by their frequency of occurrence:

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

Gastrointestinal disorders (heartburn/gastritis).

Rare side 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 (transient 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), flushing, pancreatitis, alteration in stool volume or fluidity (diarrhea, pseudomembranous colitis), esophageal ulcers, esophagitis, intestinal inflammation, inflammatory lesions in the anogenital area, difficulty swallowing (dysphagia), abdominal pain, tongue inflammation (glossitis), tooth discoloration, alteration of liver function, 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, blistering (fixed drug eruption) and itching, which usually reappear in the same places with re-exposure to the medication, skin darkening, nail loss (photo-onycholysis), joint pain (arthralgia) and muscle pain (myalgia), increased blood urea.

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

Tooth discoloration and/or lack of tooth growth.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side 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 side 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.

Once opened: 30 days. No special storage conditions are required.

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 in drains or trash. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Vibracina composition

• The active ingredient is doxycycline. Each ml of suspension contains 10 mg of doxycycline (as hyclate).

• Each 2.5 ml of suspension contains 25 mg of doxycycline (as hyclate).

• Each 5 ml of suspension contains 50 mg of doxycycline (as hyclate).

• Other components are: sodium saccharin (E-954ii), sodium hydroxide (E-524), calcium chloride dihydrate (E-509), simethicone emulsion, propyl parahydroxybenzoate (E216), erythrosine (E127), carmine (E120), propylene glycol (E1520), hydrochloric acid (for pH adjustment), sodium metabisulfite (E223), butyl parahydroxybenzoate, povidone, aluminum and magnesium silicate, sorbitol (E420), glycerol (E422), raspberry flavor (contains ethanol), apple flavor (contains ethanol), purified water.

Product appearance and packaging contents

Vibracina is presented as a homogeneous red suspension, in 60 ml amber glass bottles and packaged in a cardboard box.

A 2.5 ml and 5 ml spoon is included.

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,

28709, 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 (Madrid).

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.