Progermina Suspension
Therapy Area
Gastrointestinal
1.0 Generic name
Bacillus clausii Spores Suspension
2.0 Qualitative and quantitative composition
Each 5 ml oral suspension contains:
Bacillus clausii Spores 2 Billion Spores
Purified Water IP q.s.
3.0 Dosage form and strength
Suspension 2 Billion spores / 5 ml
4.0 Clinical particulars
4.1 Therapeutic indication
Progermina is indicated for restoration of the altered intestinal bacterial flora.
4.2 Posology and method of administration
Adult: Swallow the contents of 2-3 mini bottles per day.
Children: Swallow the contents of 1-2 mini bottles per day.
4.3 Contraindications
Should not be used in individuals hypersensitive to the active ingredients.
4.4 Special warnings and precautions for use
This medicine is for oral use only. Do not inject or administer in any other way. Severe anaphylactic reactions, such as anaphylactic shock, have occurred with incorrect route of administration.
There have been reports of bacteremia, septicemia or sepsis in patients taking Bacillus clausii who are immunocompromised or are hospitalized due to a serious illness. Progermina should be used in these patients only if the potential benefits outweigh the potential risks.
During treatment with antibiotics, it is recommended that the preparation be administered between antibiotic doses. Contact your doctor if the condition worsens after 2-3 days of usage.
4.5 Drugs interactions
No known drug-drug interaction.
4.6 Use in special populations
Pregnancy
Limited data are available on the use of probiotics including Progermina in pregnant women. However, no conclusions can be drawn regarding whether or not Progermina is safe for use during pregnancy. Progermina should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus.
Lactation
There are limited available data on the presence of Progermina in human milk, milk production, or the effects on the breastfed infant. However, no conclusions can be drawn regarding whether or not Progermina is safe for use during breastfeeding. Progermina should be used during breastfeeding only if the potential benefits to the mother outweigh the potential risks, including those to the breastfed child.
4.7 Effects on ability to drive and use machines
Progermina has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Skin and subcutaneous tissue disorders
During post marketing experience, hypersensitivity reactions, including rash, urticaria and angioedema have been reported.
Infections and infestations
Not known: Bacteremia, septicemia or sepsis in immunocompromised patients or those hospitalized due to a serious illness.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com Website: https://www.zuventus.com/drug-safety-reporting
By reporting side effects, you can help provide more information on the safety of this medicine.
4.9 Overdose
There is no data available for Progermina suspension overdosage. If any patient consumes excess of drug, it should be managed symptomatically.
5.0 Pharmacological properties
5.1 Mechanism of Action/ Pharmacodynamic properties
Progermina is a suspension of Bacillus clausii spores in purified water. These spores contain anti- diarrhoeal microorganisms which are useful for treatment of intestinal bacterial flora disorders. Besides, these also modulate immune activity by increasing production of secretary immunoglobulin A (IgA). Resistance of the spores to multiple antibiotics renders its use as a conjugant during antibiotic treatment of other pathogens. Normal gut flora of intestine acts as a barrier against harmful bacteria. Progermina restores the balance of intestinal flora that is upset during treatment with antibiotics or chemotherapeutic products and thereby helps to correct consequent dysvitaminosis conditions.
5.2 Pharmacokinetic properties
In human study, Bacillus Clausii spores persist in the intestine and can be found in faeces until 12 days after a single oral administration. The administration of Progermina helps to restore the intestinal microbial flora altered by dysmicrobism, also known as dysbiosis, resulting from antibiotic therapy and which may be associated with gastrointestinal symptoms, e.g. diarrhoea, abdominal pain and increased air in the intestine.
6.0 Clinical particulars
6.1 Animal Toxicology or Pharmacology
Not available.
7.0 Description
Progermina Suspension is a probiotic used to treat diarrhoea caused due to infections, medicines, consumption of poisonous substances, etc.
8.0 Pharmaceutical particulars
8.1 Incompatibilities
Not applicable
8.2 Shelf-life
Refer on pack
8.3 Packaging information
A mini bottle of 5 ml.
8.4 Storage and handing instructions
- Store in a cool, dry place at temperature not exceeding 25°C.
- Keep out of reach of children.
- Shake the mini bottle before use
9.0 Patient counselling information
- Avoid taking Progermina Bottle Oral Suspension (5ml Each) along with steroids (medications that weaken the immune system) as they might increase the chances of getting sick.
- Take Progermina Bottle Oral Suspension (5ml Each) at least 2 hours before or after antibiotics. This is because taking Progermina Bottle Oral Suspension (5ml Each) along with the antibiotics can reduce their effectiveness.
- Notify your doctor if you are pregnant.
- Notify your doctor if you are breast-feeding.
12. Date of revision
16.10.2024
About leaflet
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
- What Progermina suspension is and what it is used for
- What you need to know before you use Progermina suspension
- How to use Progermina suspension
- Possible side effects
- How to store Progermina suspension
- Contents of the pack and other information
1. What Progermina suspension is and what it is used for
Progermina is an oral suspension containing polyantibiotic-resistant spores* of B. clausii.
Progermina is a probiotic which is useful for the treatment of imbalance of intestinal bacterial flora due to diverse causes.
(*Polyantibiotic-resistant means resistant to a certain number of antibiotics. It is an extremely important characteristic of Progermina that allows it to be administered during antibiotic treatment with penicillin, cephalosporins, tetracycline, macrolides, aminoglycosides, novobiocin, chloramphenicol, thiamphenicol, lincomycin, isoniazid, cycloserine, rifampicin, nalidixic acid and pipemidic acid).
Progermina is used for treating the alterations of the intestinal bacterial flora, Progermina restores the equilibrium of the intestinal flora changed during diarrhoea or in the course of therapies with antibiotics or chemotherapy, contributing to correct the consequent dysvitaminosis (that is the imbalance of production and assimilation of the vitamins).
2. What you need to know before you take Progermina suspension
Do not take Progermina
if you are allergic to spores of polyantibiotic-resistant Bacillus clausii or any of the other ingredients of this medicine
Warnings and precautions
Talk to your doctor before taking Progermina
- if your doctor informed you that your immune system may be weakened (reduced body natural defences)
- before giving Progermina to a pre-term infant.
This medication is for oral use only. Do not inject or administer through other routes. Improper use of the medicine has resulted in severe anaphylactic reactions such as anaphylactic shock.
During treatment with antibiotics, ingest Progermina between one administration and the other of the antibiotic.
If you notice the possible presence of corpuscles, or of tiny particles in the Progermina mini bottles, that does not mean that the product has been impaired, as these are simply clusters of Bacillus clausii spores.
There have been reports of bacteremia, septicemia or sepsis in patients taking Bacillus clausii who are immunocompromised or are hospitalized due to a serious illness. Progermina should be used in these patients only if the potential benefits outweigh the potential risks.
Other medicines and Progermina
Inform your doctor or your pharmacist if you are taking, have recently taken or could take any other medication, including over-the-counter medication.
No disorders (interactions) are envisaged concerning the association between Progermina and other medicines.
Pregnancy and breast-feeding
If you are pregnant, may be pregnant, are planning to become pregnant, or are breast-feeding, talk to your doctor or pharmacist before taking this medicine. During pregnancy and breastfeeding, take this medicine only when absolutely necessary and under the supervision of your doctor.
Fertility
No data are available on the effect of Progermina on human fertility.
Driving and using machines
Progermina has no or negligible influence on the ability to drive or operate machinery.
3. How to take Progermina suspension
Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you have any doubts.
Take Progermina at regular intervals during the day.
Dosage:
Adults: from 2 to 3 mini bottles a day
Children: from 1 to 2 mini bottles a day
Infants: from 1 to 2 mini bottles a day
Use is recommended for short periods of time till the symptoms subsides.
Caution: Do not exceed the indicated doses without the advice of the physician.
Administration
Take Progermina at regular intervals during the day. Consult the physician if the condition recurs or if you have noticed any recent change in the nature of symptoms.
The medicinal product is for oral use only.
Do not inject or administer in any other way.
Instructions for use
It is necessary to shake the mini bottle before use. To open the mini bottle, rotate the upper part and detach it. Take the content as such or dilute it in sweetened water, milk, tea, orange juice. Once open, consume the medicine within a short period to avoid contamination of the suspension.
If you take more Progermina than you should
Excessive doses of Progermina do not produce side effects. However, it is better to follow the recommended doses. In case of accidental ingestion/administration of an overdose of Progermina immediately notify your doctor or go to the nearest hospital.
If you forget to take Progermina
Do not take a double dose to make up for a missed dose.
Proper and regular intake of this medicine promotes a better therapeutic effect.
If you stop taking Progermina
No particular effects have been reported, apart from the lack of therapeutic effect.
If you have any doubts regarding the use of this medicine, speak to your doctor or pharmacist.
4. Possible side effects
As with all medicines, this medicine can cause undesirable effects, although not everyone is affected. Contact your doctor immediately if you notice any of the following serious side effects.
Limited and mostly temporary swelling (hours or days) of the skin or mucous membranes, accompanied or not by itching (angioedema). When localized to the face, lips and throat it can make swallowing and breathing difficult.
Other side effects include: Unknown frequencies side effects (may affect less than 1 in 10,000 people):
- allergic reactions (hypersensitivity), including skin rash and urticaria.
- In case of reduced body’s defence mechanisms or serious illness and you are taking Progermina.
Bacillus clausii may be found in your blood and may lead to a serious blood infection.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.com and click the tab “Drug Safety Reporting” located on the top end of the home page. Website link: https://www.zuventus.com/drug-safety-reporting By reporting side effects, you can help provide more information on the safety of this medicine. You can also report the side effect with the help of your treating physician.
5. How to store Progermina suspension
- Do not store above 30 °C.
- KEEP OUT OF THE REACH OF CHILDREN
- Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
- The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Progermina suspension contains:
1 Progermina oral suspension mini bottle (5 ml) contains:
Bacillus clausii IHS……………...2 billion Spores
Purified Water IP………………. qs