Properties
What is it?
Enterogermina® Forte, 4 billion spores/5 ml, oral suspension (antibiotic-polyresistant spores of Bacillus clausii) Read the package leaflet carefully before you start using this medicine as it contains important information for you. Keep the leaflet. You may need to read it again. Always use this medicine exactly as described in this leaflet or as your doctor has told you. If you have any further questions, ask your doctor. If you get any side effects, including any that are not listed in this leaflet, tell your doctor. If your condition does not improve, or if it gets worse, or if you need treatment for more than 14 days, consult your doctor. Contents of the leaflet: 1. What Enterogermina® Forte is and what it is used for. 2. What you need to know before using Enterogermina® Forte. 3. How to use Enterogermina® Forte. 4. Possible side effects. 5. How to store Enterogermina® Forte. 6. What Enterogermina® Forte contains and what it is for. 1. What Enterogermina® Forte is and what it is used for Enterogermina® Forte is a medicinal product containing spores of Bacillus clausii. Bacillus clausii spores are found in the intestine and do not have pathogenic properties. Pharmacotherapeutic group: Antidiarrheal microorganisms. Enterogermina® Forte is used: • For the prevention and treatment of intestinal dysbacteriosis; intestinal dysbacteriosis is a change in the intestinal microflora that manifests as intestinal disorders: diarrhea, abdominal pain and bloating, as well as vitamin deficiency resulting from disturbances in the normal balance of intestinal microflora (endogenous avitaminosis); • To restore the altered intestinal microbial flora during treatment with antibiotics or chemotherapy; the intestinal bacterial flora is a natural protective barrier against pathogenic bacteria. Its balance can be disrupted by intestinal infections, poisoning, dietary disorders, changes in diet, or the use of antibiotics. If there is no improvement in your condition, or if symptoms worsen after short-term treatment, consult your doctor. Attention: Without a doctor's prescription, the medicine is used for short-term treatment only. See also: Enterogermina 2 billion/5 ml 10 2. What you need to know before using Enterogermina® Forte Contraindications Do not use Enterogermina® Forte if you are allergic to antibiotic-polyresistant spores of Bacillus clausii or any of the other ingredients listed in paragraph 6. Special warnings and precautions Talk to your doctor before using Enterogermina® Forte: • If your doctor has told you that you may have a weakened immune system (reduced natural defenses of the body) (see paragraph 4); • In premature infants and infants before using Enterogermina® Forte. Take the medicine only orally! Do not inject! It cannot be taken by any other route! Incorrect use of the medicine can cause serious allergic reactions, such as anaphylactic shock. If you are taking antibiotics, it is recommended to take Enterogermina® Forte between antibiotic doses (e.g., 2-3 hours after taking the antibacterial medicine). The presence of visible particles in the vials is due to aggregates of Bacillus clausii spores and does not affect the efficacy of the medicine. Shake the vial before use. Other medicines and Enterogermina® Forte Tell your doctor if you are taking, have recently taken, or might take any other medicines. No studies have been conducted on interactions with other medicinal products. Interactions with food and drink Take the contents of the vials undiluted or dilute them in water or other liquids (e.g., milk, tea, orange juice). Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Use of the medicine during pregnancy and breastfeeding is only possible on doctor's prescription and under his supervision. There is no data on the effect of Enterogermina® Forte on human fertility. Ability to drive and use machines The medicine does not affect the ability to drive or use machines. 3. How to use Enterogermina® Forte Always use this medicine exactly as described in this leaflet or as your doctor has told you. If you are unsure about anything, ask your doctor. Recommended dosage Adults: 1 vial per day. Your doctor may recommend a different daily dose depending on your condition. Children: 1 vial per day. In children, including infants, if less than 4 billion spores of Bacillus clausii are prescribed per day, the Enterogermina® Forte 4 billion/5 ml vial does not provide adequate dosing, so a preparation with a lower concentration of Bacillus clausii spores is required. How to use The medicine is for oral use only! Do not inject! It cannot be taken by any other route! Do not store the medicine after opening the vial. Shake the vial before use. To open the vial, twist and remove the top. Take the contents of the vial immediately after opening. Take the contents of the vial undiluted or dilute them in water or other liquids (e.g., milk, tea, orange juice). Precautions: Do not exceed the recommended doses without your doctor's advice. Use the medicine for short-term treatment only. Consult your doctor if the disorder is recurrent or if you notice any changes in its characteristics. If you take more Enterogermina® Forte than you should If you take more Enterogermina® Forte than you should, contact your doctor or the nearest medical facility immediately. If you forget to take Enterogermina® Forte If you forget to take Enterogermina® Forte, do not take a double dose to make up for a missed dose. If you stop taking Enterogermina® Forte No special effects, other than the absence of therapeutic effect, are known. If you have any questions about the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. Seek immediate medical attention if you notice any of the following serious side effects: localized and predominantly temporary (hours or days) swelling of the skin or mucous membranes with or without itching (angioedema). If the swelling is localized to the face, lips and throat, it may cause difficulty swallowing or breathing. Other side effects: Frequency unknown (may affect less than 1 in 10,000 people): - Allergic reactions (hypersensitivity reactions), including rash, hives. - If the body's defense mechanisms are weakened or in case of severe illness, Bacillus clausii can enter the bloodstream and cause a severe infectious disease (see paragraph 2). Reporting of side effects If you get any side effects, talk to your doctor. This applies to any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Enterogermina® Forte Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the vial and the carton. The expiry date is the last day of the month indicated. The expiry date on the vial and carton is valid only if the packaging is intact and storage conditions are met. Store at a temperature not exceeding 30°C. Do not dispose of medicines down the drain (in the sink). Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. What Enterogermina® Forte contains and what it is for Each vial of Enterogermina® Forte contains the active substance: antibiotic-polyresistant spores of Bacillus clausii bacteria. The excipient is purified water. Each vial contains 4 billion spores of Bacillus clausii. Description and contents of Enterogermina® packaging The medicine is available as an oral suspension in 5 ml polyethylene vials. 10 vials in a cardboard box with instructions for use. Dispensing category: Pharmaceutical product group III, available without prescription.
