Prodiof Syrup
1.0 Generic name
Bacillus subtilis (HU58*) 2 Billion CFU / 5 ml & Bacillus coagulans (SC208Ψ) 1 Billion CFU / 5 ml
2.0 Qualitative and quantitative composition
Per 5 ml mini bottle contains:
Bacillus subtilis (HU58*) 2 Billion CFU
Bacillus coagulans (SC208Ψ) 1 Billion CFU
HU58* is a trademark of Synergia Life Sciences Pvt. Ltd.
Original Research of Royal Holloway, University of London.
ΨSC208 is a trademark of Synergia Life Sciences Pvt. Ltd
3.0 Dosage form and strength
Oral suspension
Bacillus subtilis (HU58*) 2 Billion CFU / 5 ml & Bacillus coagulans (SC208Ψ) 1 Billion CFU / 5 ml
4.0 Clinical particulars
4.1 Therapeutic Indication
Helps in the restoration of intestinal flora altered during diarrhoea, constipation and course of antibiotic therapy.
4.2 Posology and method of administration
One - Two serving sizes daily
4.3 Contraindications
Ascertained hypersensitivity towards the components of the product
4.4 Special warnings and precautions for use
- Shake well before use.
- Not to exceed the recommended daily usage.
- To be given under medical advice by a recognized medical doctor or dietician or nutritionist for children 2 to 5 year.
- This product is not intended to mitigate, treat, cure or prevent any disease.
- This product is not to be used as a substitute for a varied diet.
- This medicine is for oral use only. Do not inject or administer in any other way
4.5 Drugs interactions
There are no known medicinal interactions subsequent to the concomitant administration of other drugs
4.6 Use in special populations
Pregnancy and lactation
Pregnant or lactating women or anyone with a medical condition should consult with a healthcare professional before consuming this product
4.7 Effects on ability to drive and use machines
The drug does not interfere with the ability to drive or use machinery.
4.8 Undesirable effects
During post marketing experience, hypersensitivity reactions, including rash urticaria and angioedema have been reported. 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.co.in/drug-safety-reporting
By reporting side effects, you can help provide more information on the safety of this medicine.
4.9 Overdose
Up to the present time no clinical manifestations of overdose have been reported. However, in case of accidental overdose, contact a healthcare professional.
5.0 Pharmacological properties
5.1 Pharmacodynamic Properties
Bacillus subtilis and Bacillus coagulans help to re-establish the gut microbalance or help to prevent the imbalance of intestinal microbial flora due to various causes including diarrhea, constipation and antibiotic use. Bacillus coagulans helps in improving gut health and enhancing immune system by producing lactic acid. Bacillus coagulans also helps in digestion of lactose, fructose and proteins.
5.2 Mechanism of Action
Spores of Bacillus subtilis & Bacillus coagulans pass the acid barrier of the gastric juices intact and reach the intestinal tract where they are transformed to metabolically active vegetative cells. These spores are also resistant to many chemical and physical agents. Once converted to vegetative cells, these spores help to alter the intestinal micoflora, help to restore the normal flora and thereby helps to correct the microflora imbalance. They also help improving immunity.
6.0 Nonclinical properties
6.1 Animal Toxicology or Pharmacology
No known animal toxicology data
7.0 Description
The preparation consists of spores of Bacillus subtilis & Bacillus coagulans which are normal non-pathogenic inhabitants of the intestine.
8.0 Pharmaceutical particulars
8.1 Incompatibilities
None
8.2 Shelf-life
Refer the pack
Viability at the end of shelf life: 3 billion CFU per 5 ml.
8.3 Packaging information
Net quantity: 30ml
6 mini bottles of 5 ml each
8.4 Storage and handing instructions
Store at a temperature below 30°C, protect from direct sunlight
Product is required to be stored out of reach of children.
Consume immediately after opening.
Do not use if cap / seal broken of the bottle.
9.0 Patient Counselling Information
- ProDiof help to maintain a healthy intestinal microflora and supports healthy digestion.
- They help to restore the equilibrium of the intestinal flora altered during diarrhea, constipation and during the course of antibiotic therapy.
- Tell patients that after the mini bottle has been opened, the preparation should be consumed within a very short period of time to avoid deterioration of the suspension.
- Tell the patients if they get any side effects, talk to the doctor. This includes any possible side effects not listed in this leaflet. Advice patients if they have any further questions, ask the doctor or pharmacist.
12.0 Date of revision of text
04-07-2024
About Leaflet
Read all of this leaflet carefully before your child starts taking 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 your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
- If your child gets 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?
1.What ProDiof® liquid is and what it is used for?
2.What you need to know before you take ProDiof® Liquid?
3.How to take ProDiof® Liquid?
4.Possible side effects
5.How to store ProDiof® Liquid?
6.Contents of the pack and other information
1. What ProDiof liquid is and what it is used for?
ProDiof Liquid is probiotic health supplement containing good bacteria Bacillus subtilis (HU58) 2 Billion CFU per 5 ml and Bacillus coagulans (SC208Ψ)1 Billion CFU per 5 ml.
Probiotics assist to restore the intestinal microbial flora, altered during the use of antibiotics. Supportive supplement during antibiotic use
1. Assist in protecting the gut of children during microbial imbalance from side effects such as diarrhoea and abdominal discomfort
2. Assist in restoring alterations of intestinal flora and bacterial flora
3. Assist in the natural balance of bacterial flora, balancing the presence of good and bad bacteria and thus targeting the root of intestinal disorders
4. Support gut health when normal intestinal flora has been disrupted.
ProDiof liquid is used to treat alterations of the intestinal bacterial flora that occur during diarrhea, constipation or as a result of therapies involving antibiotics or chemotherapy. It helps correct the consequent dysvitaminosis, which is an imbalance in the production and assimilation of vitamins.
2. What you need to know before you take ProDiof Liquid?
Do not take ProDiof if you are allergic to any of its ingredients listed in section 6.
Warnings and Precautions:
- Do not exceed the recommended daily dose
- This product is not intended to treat, cure, or prevent any disease
- During antibiotic therapy, the product should be administered in the interval between one dose of antibiotic and the next
- Do not use as a substitute for a varied diet
- This medicinal product is for oral use only
- Do not inject or administer in any other way
Pregnancy and Breastfeeding:
Consult your doctor before taking ProDiof liquid if you are pregnant or breastfeeding. There are no relevant data available on the use of ProDiof liquid in pregnant and breastfeeding women.
Children:
Consult a healthcare professional before giving to children aged 2-5 years
Other medicines and ProDiof Liquid:
ProDiof has no known interactions with other medicines. This means that it can generally be taken alongside other medications without any issues. However, it's always important to be cautious and consult your healthcare provider if you are taking any other medications.
Driving and using machines
ProDiof has no influence on the ability to drive and use machines.
3. How to take ProDiof Liquid?
Take 1-2 servings daily, as directed by your healthcare professional
Use is recommended for short periods of time till the symptoms subsides.
Instructions:
- Shake well before use
- For oral use only
- ProDiof should be consumed shortly after opening to avoid deterioration
If you take more ProDiof liquid than you should:
No overdose has been reported; however, it is advisable to go to the nearest casualty department or contact your doctor immediately. Take the carton with you.
If you forget to take ProDiof Liquid:
Do not take a double dose to make up for a forgotten dose, take your usual dose at the usual time.
If you stop taking ProDiof Liquid:
Before stopping any supplement, including ProDiof, it’s a good idea to talk to your healthcare provider.
If you have any further questions on the use of this supplement, ask your doctor or pharmacist.
4. Possible side-effects
- Some people may experience allergic reactions such as rash, hives, or swelling
- In rare cases, especially in immunocompromised individuals or those with serious illnesses, it may cause severe infections like bacteremia or sepsis
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.co.in and click the tab “Safety Reporting” located on the top end of the home page.
Website link: https://www.zuventus.co.in/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 ProDiof Liquid?
- Store below 30°C and protect from direct sunlight
- Keep out of reach of children
- Do not use if the bottle cap or seal is broken\
- Do not use after the expiry date printed on the container/ label.
6. Contents of the pack and other information
Net quantity: 30ml (6 mini bottles of 5 ml each)
Per 5 ml mini bottle contains:
Bacillus subtilis (HU58*) 2 Billion CFU
Bacillus coagulans (SC208Ψ) 1 Billion CFU
Marketing Authorisation Holder
Zuventus Heathcare Ltd.
Zuventus House, Plot Y2, CTS No: 358/A2,
Near Nahur Railway Station,
Nahur (West), Mumbai 400 078.
This leaflet was last revised in July 2024.