Package Insert: Information for the Patient

Vibracina 10 mg/ml Oral Suspension

Doxycycline

Read this package insert carefully before starting to take this 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 causes 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 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, swollen lymph nodes, and elevated eosinophils). In these cases, you should immediately consult your doctor, who will decide whether to discontinue doxycycline treatment.
• 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 process affecting the brain due to increased intracranial pressure).
• you experience visual disturbances, seek immediate attention from an ophthalmologist.
• you are taking isotretinoin, as taking it together with doxycycline can cause benign intracranial hypertension.
• you experience persistent and severe diarrhea while taking doxycycline, you may have 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 treatment and initiate appropriate treatment.
• you ingest this medication while lying down or without sufficient water or milk, it can cause esophageal inflammation and ulcers, 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 controls.
• you have a systemic immune disorder that causes joint pain, skin rashes, and fever (systemic lupus erythematosus). The condition may worsen when taking Vibracina.
• you experience skin redness after exposure to the sun or ultraviolet radiation. It is recommended to use sunscreen with a total sunblock and avoid exposure to the sun or ultraviolet radiation.
• you experience any signs of infection. The use of antibiotics can 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.
• you need to undergo urine analysis, you should inform the healthcare staff that you are taking this medication, as doxycycline can 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 can cause permanent tooth discoloration, as well as 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 and prescribe doxycycline.

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

In children over 12 years (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 change 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 can interfere with its effect.
• Isotretinoin (for severe acne), as taking it together with doxycycline can cause benign intracranial hypertension.
• Oral contraceptives, as doxycycline can reduce their effectiveness.
• Anticoagulants (such as warfarin), as doxycycline can alter their effect.
• Antacids (medications used to calm stomach acid) and other medications containing aluminum, calcium, or magnesium, and medications containing iron or bismuth salts, as they can reduce the effect of doxycycline.
• Antiepileptics and barbiturates (medications for severe insomnia and seizures), as they can reduce the effect of doxycycline.
• Methoxyflurane (an anesthetic medication), as when used together with antibiotics in the tetracycline group, such as doxycycline, it can 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 can 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 while taking doxycycline. Oral contraceptives (hormonal) may not be effective, as taking this medication reduces their effectiveness, and it is recommended to use barrier methods.

Breastfeeding

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

Driving and operating machinery

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

Important information about some of the components of Vibracina:

Vibracina contains sodium metabisulfite, propylparaben, butylparaben, sorbitol, sodium, propylene glycol, and ethanol.

This medication can cause severe allergic reactions and bronchospasm (sudden sensation of choking) due to sodium metabisulfite.

It can cause delayed allergic reactions due to propylparaben and butylparaben.

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

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

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

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

Follow the exact administration instructions for 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 of age and older):

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 your doctor based on 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, an antimalarial agent with rapid action, 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 dosages available for various dosing regimens.

Pediatric population

Children 8 years of age and youngeror less

Doxycycline should be used for the treatment of acute infections in children 8 years of age and younger, 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 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 an 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 under 8 years of age

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

The pediatric dosing regimen for 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 administered 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. Prevention may begin 1 or 2 days before traveling to areas with endemic malaria and continue for 4 weeks after leaving the endemic area.

• Prophylaxis after exposure to 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 liver dysfunction

Doxycycline should be administered with caution in patients with liver dysfunction.

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

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

Alterations in digestion (gastritis).

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

Severe destruction of red blood cells (hemolytic anemia), decreased platelet count (thrombocytopenia), alteration in white blood cell count: decreased neutrophil count (neutropenia) or increased eosinophil count (eosinophilia), drug-induced 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 microscopical discoloration of the thyroid gland, decreased appetite, possible symptoms of benign intracranial hypertension that include headache, nausea, vomiting, visual disturbances (including blurred vision) and dizziness, transient fontanelle bulging in young children, localized visual field defect surrounded by a normal visual field (scotoma), double vision (diplopia), and possible permanent vision loss, tinnitus, facial flushing,pancreatitis,alteration in 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), target-shaped erythematous lesions, widespread skin inflammation with desquamation (exfoliative dermatitis), round or oval skin lesions with erythema and edema, vesicular eruptions, and pruritus that typically recur in the same locations with re-exposure to the medication (fixed drug eruption), skin darkening, nail loss (photoonycholysis), arthralgia, and myalgia, elevated blood urea.

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 prospectus. 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 medication.

Keep this medication out of the 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at 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 principle is doxycycline. Each ml of suspension contains 10mg of doxycycline (as hyclate).

• Each 2.5ml of suspension contains 25mg of doxycycline (as hyclate).
• Each 5ml of suspension contains 50mg of doxycycline (as hyclate).

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

Appearance of the product and content of the container

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

A 2.5 ml and 5 ml spoon is included.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Hospira Invicta, S.A.

Avenida de Europa, 20 B,

Parque Empresarial La Moraleja,

28108, Alcobendas (Madrid).

Responsible for manufacturing

Farmasierra Manufacturing S.L.

Irún Highway, 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 holder of the marketing authorization:

Pfizer, S.L. Avenida de Europa, 20-B. Parque Empresarial La Moraleja. 28108, Alcobendas (Madrid).

Revision 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.