Vibracina 100 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vibracina 100 mg hard capsules

Doxycycline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Vibracina is and what it is used for
2. What you need to know before taking Vibracina
3. How to take Vibracina
4. Possible side effects
5. How to store Vibracina
6. Contents of the pack and other information

1. What Vibracina is and what it is used for

Vibracina contains doxycycline, an antibiotic that belongs to a group of medicines called tetracyclines.

This medicine is used in adults, adolescents, and children over 8 years of age for:

• the treatment of the following infections:

  • Atypical pneumonia.
  • Psittacosis (a disease transmitted by certain birds, presenting 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 initially by genital ulcers followed by lymph node swelling), granuloma inguinale (purulent ulceration of the genitals), pelvic inflammatory disease, acute purulent orchiepididymitis (inflammation of the testicles, purulent, mainly affecting newborns).
  • Ocular infections such as: trachoma, inclusion conjunctivitis (eye infection with inflammation and irritation of the conjunctiva).
  • Typhus and other infections caused by microorganisms called rickettsiae.
  • Q fever.
  • Brucellosis (Malta fever).
  • Cholera (an infectious disease presenting with severe diarrhea, dehydration, and vomiting).
  • Early stages of Lyme disease (transmitted by ticks).
  • Relapsing 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 rodent disease similar to plague).
  • Bartonellosis (an infectious disease presenting with severe anemia and fever).

• alternative treatment of:

  • Anthrax (an infectious disease affecting the skin, intestine, or lungs).
  • Listeriosis (a serious infectious disease that may affect the fetus during pregnancy, newborns, and adults).
  • Actinomycosis (an infectious disease causing inflammation of lymph nodes in the mouth along with other internal complications).
  • Syphilis in patients allergic to penicillin.
  • Plague.
  • Leptospirosis (an infectious disease causing fever, headache, muscle pain, and yellowing of the skin).

• adjunctive treatment of severe vulgar acne.

• prevention of malaria (transmitted through the bite of a mosquito).

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

2. What you need to know before starting to take Vibracina

Do not take Vibracina

• if you are allergic to doxycycline, to any other tetracycline, or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you might be pregnant.
• if you are breastfeeding.
• if used concomitantly with 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 raised skin lesions with target-like appearance (erythema multiforme), inflammation of the skin and mucous membranes which may be very serious (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis), or drug rash with eosinophilia and systemic symptoms [DRESS, including skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cells)]. In such cases, you must consult your doctor immediately, who will decide whether doxycycline treatment should be discontinued.
• if during treatment with Vibracina you experience unusual 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 pressure within the skull).
• if you experience visual disturbances, seek immediate medical attention from an ophthalmologist.
• if you are taking a medicine called isotretinoin, as concomitant use may cause benign intracranial hypertension.
• if you develop severe and persistent diarrhea while being treated with doxycycline, you may have a type of antibiotic-associated colitis called pseudomembranous colitis, which can be serious. In such cases, consult your doctor, who will decide whether to discontinue doxycycline and initiate appropriate treatment.
• if you take this medicine while lying down or without sufficient water or milk, inflammation and ulcers in the esophagus may occur; therefore, it is important to follow administration instructions exactly (see section 3).
• if you have liver disease, consult your doctor. During prolonged treatment, your doctor may need to perform periodic blood tests.
• if you have an autoimmune disease causing joint pain, skin rashes, and fever (systemic lupus erythematosus). The condition may worsen when taking Vibracina.
• if you develop skin redness after exposure to sunlight or ultraviolet radiation. Use of total-block sunscreen creams is recommended, and exposure to sunlight or ultraviolet radiation should be avoided.
• if any signs of infection appear. Antibiotic use may increase the risk of infections caused by organisms not sensitive to treatment, including fungi, so your doctor will monitor for any possible signs of infection.
• if you are due to have urine tests, inform healthcare personnel that you are being treated with this medicine, as doxycycline may interfere with test results.

Children and adolescents

In children from birth up to 8 years of age, 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 illnesses) in which your doctor may decide that the benefits outweigh this risk in children under 8 years of age, and doxycycline should be prescribed.

In children over 8 years and under 12 years of age (up to 45 kg body weight), see section 3. An alternative oral suspension formulation may be more suitable depending on dose and patient characteristics.

In children over 12 years of age (over 45 kg body 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 need to take any other medicines.

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

• Penicillin (an antibiotic), as doxycycline may interfere with its effect.
• Isotretinoin (for treatment of severe acne), as concomitant use 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 relieve stomach acidity) and other medicines containing aluminium, calcium, or magnesium, and medicines containing iron salts 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 to induce anesthesia), as when used concomitantly with tetracycline antibiotics such as 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

Pregnancy

Use of this medicine during pregnancy is not recommended, as it may cause disturbances in bone development and permanent tooth discoloration in the child. Your doctor will decide whether it is appropriate to use Vibracina in such cases.

It is important to use contraceptive methods during treatment with doxycycline to avoid becoming pregnant. Oral contraceptives (hormonal) may not be effective, as taking this medicine reduces contraceptive efficacy; therefore, barrier methods are recommended.

Breastfeeding

Use of this medicine should be avoided during breastfeeding, as it may cause disturbances in bone development and permanent tooth discoloration in the infant.

Driving and using machines

There is no evidence that doxycycline impairs 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 informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Vibracina

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine how long you should take this medicine. Do not stop treatment before your doctor tells you to, even if you start to feel better.

Remember to take your medicine. It is important to take this medicine regularly, at the same time each day.

Adults and adolescents (from 12 years to under 18 years of age)

The usual dose of doxycycline is 200 mg on the first day of treatment (given 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 (given as a single daily 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 determined by your doctor according to your individual characteristics and the type of infection. As a general rule, the usual dose and frequency of administration is as follows:

(1) Due to the potentially severe nature of the infection, a rapidly acting antimalarial such as quinine should always be administered in combination with doxycycline. Quinine dosing recommendations vary across different geographic regions.

(2) Doxycycline is the treatment of choice.

Various dosage strengths are available for different dosing regimens.

Paediatric population

Children aged 8 years to less than 12 years of age

Doxycycline should be used for the treatment of acute infections in children aged 8 years and under 12 years, in situations where other medications are unavailable, 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 body weight (administered as a single dose or divided into two equal doses every 12 hours)

From day 2 onwards: 2.2 mg/kg body weight (as 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 the entire treatment period.

An alternative formulation, as an oral suspension, may be more suitable for dose adjustment in children weighing ≤ 45 kg.

• Children weighing more than 45 kg:

The same adult dose is recommended: 200 mg on the first day, followed by 100 mg daily. The duration of treatment will depend on the infection being treated.

Neonates, 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.

Dosage in paediatric patients for the treatment or prophylaxis of specific infections is as follows:

• Treatment of Rocky Mountain spotted fever: 2.2 mg/kg twice daily. Patients should be treated for at least 3 days after defervescence 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 twice daily for 60 days. The duration of treatment should be 60 days, except in cases of cutaneous anthrax without systemic involvement, where treatment duration may be reduced to 7–10 days. In cases of pulmonary anthrax, combination therapy with two antibiotics should be considered (see section 4.4).

• Malaria prophylaxis: 2 mg/kg body weight once daily, not exceeding the adult dose. Prophylaxis may be initiated 1 or 2 days before travel to malaria-endemic areas and continued for up to 4 weeks after leaving such areas.

• Post-exposure prophylaxis for Bacillus anthracis: 2.2 mg/kg body weight (not exceeding the adult dose) administered orally twice daily for 60 days.

Elderly patients

Dose adjustment is not 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 dose at the usual time. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

The following adverse effects have been observed in patients taking tetracyclines, including doxycycline, listed according to their frequency of occurrence:

Common adverse effects (may affect up to 1 in 10 people):

Hypersensitivity, allergic reactions (including anaphylactic shock, anaphylactic and anaphylactoid reactions, skin and mucosal swelling (angioedema), exacerbation of systemic lupus erythematosus, inflammation of the tissue surrounding the heart (pericarditis), serum sickness, Schönlein-Henoch purpura, low blood pressure (hypotension), difficulty breathing (dyspnea), rapid heartbeat (tachycardia), fluid retention in the limbs (peripheral edema), red, raised, itchy skin lesions (urticaria), headache, nausea, vomiting, exaggerated skin reaction to sunlight or ultraviolet radiation, skin rash (including erythematous and maculopapular types).

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

Digestive disturbances (heartburn/gastritis).

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

Excessive destruction of red blood cells (hemolytic anemia), decreased number of platelets (thrombocytopenia), changes in white blood cell count: reduced number of neutrophils (neutropenia) or increased number of eosinophils (eosinophilia), drug rash with eosinophilia and systemic symptoms [DRESS, including skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell)], microscopic brown to black discoloration of the thyroid gland, loss of appetite, possible symptoms of benign intracranial hypertension (increased pressure within the skull), including headache, nausea, vomiting, visual disturbances (including blurred vision), and dizziness, bulging fontanelle (transient protrusion of the soft spot on the skull in young children), localized defect in the visual field surrounded by a normal visual area (scotoma), double vision (diplopia), and possible vision loss, in some cases even permanent, ringing in the ears (tinnitus), facial redness (rubefaction), inflammation of the pancreas (pancreatitis), changes in the volume or consistency of stools (diarrhea, pseudomembranous colitis), esophageal ulcers, inflammation of the esophagus, intestinal inflammation, inflammatory lesions in the anogenital area, difficulty swallowing (dysphagia), abdominal pain, inflammation of the tongue (glossitis), tooth discoloration, impaired liver function, liver inflammation (hepatitis), liver damage, skin inflammation with blistering (toxic epidermal necrolysis), skin and mucous membrane inflammation that may be severe (Stevens-Johnson syndrome), red, raised skin lesions with target-like appearance (erythema multiforme), widespread skin inflammation with peeling (exfoliative dermatitis), round or oval-shaped spots with redness and swelling of the skin, blister formation (urticaria), and itching, which typically recur in the same locations upon re-exposure to the medication (fixed drug eruption), darkening of an area of skin, nail loss (photo-onycholysis), joint pain (arthralgia), and muscle pain (myalgia), increased blood urea levels.

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

Discoloration and/or failure of tooth development.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vibracina

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vibracina

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

Appearance of the product and contents of the container

Vibracina is presented as hard greenish-dark 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 packed 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), Spain.

Manufacturer

Farmasierra Manufacturing S.L.

Ctra. de Irún, km 26,200

28700, San Sebastián de los Reyes, Spain.

For further information about this medicine, please contact 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 most recent review of this leaflet: 06/2024.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es.