International reference: 3 US FDA recalls for this ingredient

Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W003924, EXP: 6/28/2014. (acidophilus)

Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002694, EXP: 6/5/2014 (acidophilus)

Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS ACIDOPHILUS, Capsule, 0 mg, NDC 54629011101, Pedigree: AD65311_7, EXP: 5/24/2014; QUINAPRIL HCL, Tablet, 20 mg, NDC 68180055809, Pedigree: W003556, EXP: 6/24 (acidophilus)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Kenya.

Registered Kenya · PPB

LINEX CAPSULES

LACTOBACILLUS ACIDOPHILUS BIFIDOBACTERIUM INFANTIS ENTEROCOCCUS FAECIUM

H2014/CTD919/247 LEBENIN POWDER 280MG

What it does

Acidophilus is a type of beneficial bacteria that helps maintain a healthy balance of gut flora. It's often used to support digestive health.

Commonly used for: digestive issues, irritable bowel syndrome (IBS), diarrhea, supporting gut health

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2014/CTD919/247
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
LACTOBACILLUS ACIDOPHILUS BIFIDOBACTERIUM INFANTIS ENTEROCOCCUS FAECIUM
Dosage form
LEBENIN POWDER 280MG
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
6205
Manufacturer / MAH
Nvs Kenya
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
Mogadishu Road, off Lunga Lunga Road, Industrial Area, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:54:32 · updated 2026-07-26 11:45:03

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About acidophilus

Acidophilus is a type of beneficial bacteria that helps maintain a healthy balance of gut flora. It's often used to support digestive health.

What it treats

  • digestive issues
  • irritable bowel syndrome (IBS)
  • diarrhea
  • supporting gut health

How it works

It works by replenishing the good bacteria in the intestines, which can help improve digestion and overall gut health.

Who it's for

Suitable for individuals looking to improve their digestive health or those experiencing gut-related issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About bifidobacterium

Bifidobacterium is a type of beneficial bacteria that helps maintain gut health.

What it treats

  • digestive issues
  • irritable bowel syndrome (IBS)
  • diarrhea
  • constipation

How it works

Bifidobacterium helps balance the gut bacteria, improving digestion and supporting overall gut health.

Who it's for

It is suitable for people looking to support their digestive health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About enterococcus

Enterococcus is a type of bacteria that can be used in certain medical treatments, particularly for infections.

What it treats

  • infections caused by Enterococcus bacteria
  • urinary tract infections (UTIs)
  • endocarditis (heart valve infection)

How it works

Enterococcus can help fight off specific infections by targeting the bacteria causing them.

Who it's for

This treatment is for individuals with infections caused by Enterococcus or those at risk of such infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About faecium

Faecium is a type of medication used to treat certain infections caused by bacteria.

What it treats

  • bacterial infections
  • infections caused by enterococci

How it works

Faecium works by stopping the growth of bacteria, helping the body to fight off infections.

Who it's for

This medication is for people who have infections that are sensitive to faecium.

Cautions

  • • Consult a healthcare professional if you have allergies to this medication or any of its components.
  • • Use with caution if you have kidney problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About infantis

Infantis is often used to support digestive health, particularly in infants.

What it treats

  • colic in babies
  • digestive discomfort
  • infant gut health

How it works

Infantis helps balance the good bacteria in the gut, which can improve digestion and reduce discomfort.

Who it's for

This product is for infants experiencing digestive issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About lactobacillus

Lactobacillus is a type of good bacteria that helps maintain a healthy balance in your gut and supports digestive health.

What it treats

  • digestive issues
  • irritable bowel syndrome (IBS)
  • diarrhea
  • supporting gut health

How it works

Lactobacillus helps restore the natural balance of bacteria in the digestive system, which can improve digestion and reduce discomfort.

Who it's for

This product is suitable for adults and children who need support for their digestive health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: acidophilus

Acidophilus is a probiotic bacterium, primarily Lactobacillus acidophilus, which is commonly found in the human gut and fermented foods. It is known for its ability to promote gut health by balancing intestinal flora, enhancing digestion, and supporting the immune system. It is often used to prevent or treat diarrhea, particularly that associated with antibiotic use, and to alleviate symptoms of lactose intolerance.

Indications

  • Diarrhea associated with antibiotic use
  • Lactose intolerance
  • Irritable bowel syndrome
  • Gut health maintenance
  • Support for immune function

Dosage

Children: Refer to specific product guidelines and clinical recommendations for dosing as it can vary based on formulation.

Adults: Refer to specific product guidelines and clinical recommendations for dosing as it can vary based on formulation.

Mechanism of action

Lactobacillus acidophilus works by fermenting lactose and other carbohydrates to produce lactic acid, which lowers the pH of the gut environment, inhibiting the growth of harmful bacteria. It also enhances the gut barrier function and stimulates the immune response through the production of antimicrobial substances.

Pharmacodynamics

The pharmacodynamics of acidophilus involve its role in maintaining gut homeostasis. It helps to prevent the colonization of pathogenic organisms by competing for nutrients and adhesion sites on the intestinal mucosa. Additionally, it may modulate the immune response by enhancing the activity of immune cells such as macrophages and T lymphocytes.

Pharmacokinetics

Acidophilus is typically administered orally and survives passage through the gastrointestinal tract. It colonizes the gut temporarily but can exert beneficial effects during its presence. The exact pharmacokinetics can vary based on the formulation and individual gut microbiota composition, as well as dietary factors.

Adverse effects

  • Gas
  • Bloating
  • Diarrhea
  • Abdominal discomfort

Precautions

  • Use with caution in individuals with immunosuppression
  • Consult a healthcare provider before use in patients with underlying health conditions

Pregnancy

Generally considered safe, but consult a healthcare provider before use.

Breast-feeding

Generally considered safe, but consult a healthcare provider before use.

Storage

Store in a cool, dry place, away from direct sunlight. Refrigeration may enhance stability.

Formulations

  • Capsules
  • Tablets
  • Powder
  • Yogurt

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: bifidobacterium

Bifidobacterium is a genus of bacteria that are part of the normal gut flora. They are commonly found in the intestines of infants and in fermented foods. Bifidobacterium is known for its probiotic properties, which can help maintain gut health, improve digestion, and enhance the immune system. It is often used as a dietary supplement to restore the balance of gut microbiota, particularly after antibiotic therapy or gastrointestinal disturbances.

Indications

  • Prevention and treatment of antibiotic-associated diarrhea
  • Management of irritable bowel syndrome (IBS)
  • Support for gastrointestinal health
  • Enhancement of immune function
  • Lactose intolerance management

Dosage

Children: Refer to specific product guidelines, as doses can vary by formulation and indication.

Adults: Refer to specific product guidelines, as doses can vary by formulation and indication.

Mechanism of action

Bifidobacterium exerts its beneficial effects primarily through the modulation of the gut microbiota. It helps to inhibit the growth of pathogenic bacteria by producing organic acids, such as lactic acid and acetic acid, which lower the pH of the gut environment. Additionally, Bifidobacterium enhances the intestinal barrier function, promotes the production of mucus, and stimulates the immune response by interacting with gut-associated lymphoid tissue (GALT).

Pharmacodynamics

The pharmacodynamic effects of Bifidobacterium are characterized by its ability to restore and maintain the balance of gut microbiota, enhance intestinal barrier function, and modulate immune responses. Probiotics like Bifidobacterium can help reduce gastrointestinal symptoms, such as diarrhea and constipation, and have been associated with improvements in lactose digestion and overall gut health.

Pharmacokinetics

Bifidobacterium is not absorbed systemically; rather, it acts locally within the gastrointestinal tract. Its survival and efficacy can be influenced by factors such as the strain of bacteria, the presence of prebiotics, and the overall health of the digestive system. The bacteria can colonize the gut temporarily, providing a local effect, but regular intake is often necessary to maintain its benefits.

Adverse effects

  • Bloating
  • Gas
  • Diarrhea
  • Constipation

Precautions

  • Patients with weakened immune systems should use caution as probiotics may lead to infections.
  • Those with severe allergies should consult a healthcare provider before use.

Pregnancy

Generally considered safe for use during pregnancy, but it is advisable to consult a healthcare professional before starting.

Breast-feeding

Typically safe for breastfeeding mothers, but it is recommended to seek medical advice.

Storage

Store in a cool, dry place. Some formulations may require refrigeration.

Formulations

  • Capsules
  • Powders
  • Tablets
  • Liquid suspensions

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: enterococcus

Enterococcus is a genus of bacteria that are naturally found in the gastrointestinal tract of humans and animals. While typically commensal, certain species, particularly Enterococcus faecalis and Enterococcus faecium, can cause opportunistic infections, especially in immunocompromised patients. These infections can include urinary tract infections, endocarditis, and intra-abdominal infections. Enterococci are notable for their intrinsic resistance to many antibiotics and their ability to acquire resistance genes, making infections challenging to treat.

Indications

  • Urinary tract infections
  • Endocarditis
  • Intra-abdominal infections
  • Pelvic infections
  • Bacteremia

Dosage

Children: Dosing varies based on the antibiotic chosen and the child's weight. Refer to the BNF for Children for specific dosing information.

Adults: Dosing depends on the specific antibiotic used for treatment and the severity of the infection. Refer to the prescribing information for specific agents.

Mechanism of action

Enterococci can exhibit various mechanisms of pathogenicity, including the production of biofilms, which facilitate adherence to host tissues and medical devices. They can also produce virulence factors such as gelatinase, cytolysin, and enterococcal surface protein, which contribute to tissue invasion and immune evasion. Their resistance mechanisms often involve alteration of target sites or efflux pumps, which lead to decreased susceptibility to commonly used antibiotics.

Pharmacodynamics

The pharmacodynamics of enterococci are characterized by their ability to survive in harsh environments and resist the effects of many antimicrobial agents. They can grow in the presence of bile salts and at elevated temperatures, and they display a unique ability to persist in the gut microbiome. Their growth is generally inhibited by cell wall-targeting antibiotics, but their intrinsic resistance mechanisms can lead to treatment failures when using beta-lactams and aminoglycosides.

Pharmacokinetics

The pharmacokinetics of enterococci are influenced by their habitat in the gastrointestinal tract, where they can replicate and maintain a stable population. In cases of infection, their distribution in tissues can vary, and they may require higher doses of antibiotics to achieve therapeutic concentrations. Enterococci generally exhibit slow growth rates, which can affect the time to response during antibiotic therapy.

Adverse effects

  • Gastrointestinal disturbances
  • Urinary tract infections
  • Bacteremia
  • Endocarditis
  • Intra-abdominal infections

Precautions

  • Use with caution in patients with renal impairment
  • Monitor for potential antibiotic resistance
  • Consider potential for opportunistic infections

Pregnancy

Safety in pregnancy is not well established; use only if benefits outweigh risks.

Breast-feeding

Enterococcus species are generally considered safe during breastfeeding; consult a healthcare professional.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • Oral tablets
  • Intravenous solutions
  • Suspensions

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: faecium

Faecium, specifically Enterococcus faecium, is a species of bacteria that is often associated with nosocomial infections, particularly in immunocompromised patients. It is part of the normal flora of the human gastrointestinal tract but can become pathogenic under certain conditions. It is known for its resistance to many antibiotics, including vancomycin, leading to challenges in treatment. Enterococcus faecium can cause a variety of infections, including urinary tract infections, bacteremia, and endocarditis.

Indications

  • Vancomycin-resistant Enterococcus (VRE) infections
  • Urinary tract infections
  • Bacteremia
  • Endocarditis
  • Intra-abdominal infections

Dosage

Children: Refer to relevant antibiotic treatment guidelines and susceptibility profiles, as specific dosing will depend

Adults: Refer to relevant antibiotic treatment guidelines and susceptibility profiles, as specific dosing will depend on the antibiotic used and the severity of the infection.

Mechanism of action

Enterococcus faecium possesses a unique mechanism of antibiotic resistance, which is primarily due to the acquisition of resistance genes that alter the target sites of antibiotics. For example, vancomycin-resistant Enterococcus (VRE) alters the D-Ala-D-Ala terminus in the peptidoglycan layer, which prevents the antibiotic from binding effectively, thus conferring resistance. This mechanism is a significant concern in clinical settings, leading to treatment failures.

Pharmacodynamics

The pharmacodynamics of Enterococcus faecium are influenced by its ability to cause infections through various virulence factors, including biofilm formation, aggregation, and the production of cytolysin. These factors enhance its survival in hostile environments such as those created by the human immune response or antibiotic treatment. The species exhibits varying susceptibility to different classes of antibiotics, necessitating susceptibility testing for effective management.

Pharmacokinetics

As a bacterium, Enterococcus faecium does not have pharmacokinetic properties in the traditional sense, as it does not undergo metabolism or excretion like a drug. However, when considering the pharmacokinetics of antibiotics used to treat infections caused by E. faecium, factors such as absorption, distribution, metabolism, and elimination of the antibiotic should be considered. The clinical context, including renal function, can significantly impact the effectiveness of treatment.

Contra-indications

  • Hypersensitivity to the active substance or to any of the excipients
  • Severe renal impairment

Adverse effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Flatulence
  • Headache
  • Dizziness

Interactions

  • Antibiotics that disrupt the normal gut flora may reduce the effectiveness of faecium
  • Concurrent use with immunosuppressive agents may increase the risk of infections

Precautions

  • Use with caution in immunocompromised patients
  • Monitor for signs of gastrointestinal obstruction
  • Evaluate renal function before starting treatment

Pregnancy

Safety during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Use with caution, as it is not known if faecium is excreted in human milk.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral capsules
  • Oral suspension
  • Intravenous solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: infantis

Infantis is a term commonly associated with specific strains of probiotic bacteria, such as Bifidobacterium infantis, which is often used in dietary supplements and infant formulas. These probiotics play a crucial role in maintaining gut health and supporting the immune system, particularly in infants. Bifidobacterium infantis is known for its ability to ferment oligosaccharides, contributing to the growth of beneficial gut flora. This can help in the prevention and treatment of gastrointestinal disorders, such as diarrhea and constipation, in infants.

Indications

  • Gastrointestinal disorders in infants
  • Diarrhea
  • Constipation
  • Colic
  • Irritable bowel syndrome
  • Support for immune function

Dosage

Adults: Refer to product-specific guidelines for dosing information, as it may vary by formulation.

Mechanism of action

Bifidobacterium infantis exerts its beneficial effects primarily through the modulation of the gut microbiota. It competes with pathogenic bacteria for nutrients and adhesion sites on the intestinal mucosa, thus inhibiting their growth. Additionally, it produces short-chain fatty acids (SCFAs) like acetate and lactate during fermentation, which lower the intestinal pH, creating an unfavorable environment for harmful bacteria. Bifidobacterium infantis also enhances the gut barrier function and modulates the immune response by promoting the production of anti-inflammatory cytokines.

Pharmacodynamics

The pharmacodynamics of Bifidobacterium infantis are related to its ability to alter the composition of gut flora and enhance the gut barrier. It promotes the growth of beneficial bacteria while suppressing pathogenic organisms, thus contributing to overall gut health. The probiotic has also been shown to stimulate the production of mucin, a key component of the intestinal mucus layer, which protects the gut lining.

Pharmacokinetics

Bifidobacterium infantis is a live microorganism, and its pharmacokinetics involve its survival through the gastrointestinal tract. The organism must withstand the acidic environment of the stomach and reach the intestines in sufficient numbers to exert its effects. Once in the intestines, it colonizes the gut temporarily, with the duration of colonization varying among individuals. The metabolic products produced by Bifidobacterium infantis, such as SCFAs, are rapidly absorbed and can influence metabolic processes in the host.

Pregnancy

Not enough data available to determine safety during pregnancy. Consult a healthcare provider.

Breast-feeding

Not enough data available to determine safety during breastfeeding. Consult a healthcare provider.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: lactobacillus

Lactobacillus is a genus of bacteria that is commonly used as a probiotic. These bacteria are found in various fermented foods, such as yogurt and sauerkraut, and are known for their health benefits, particularly in maintaining gut health and modulating the immune system. Lactobacillus species are part of the normal flora of the human gastrointestinal tract and play a crucial role in digestion and absorption of nutrients.

Indications

  • Probiotic therapy for the prevention and treatment of antibiotic-associated diarrhea
  • Management of irritable bowel syndrome (IBS)
  • Support for gut health in patients with inflammatory bowel disease (IBD)
  • Enhancement of immune function
  • Prevention of gastrointestinal infections

Dosage

Children: Refer to product-specific guidelines as dosing can vary based on the formulation and indication.

Adults: Refer to product-specific guidelines as dosing can vary based on the formulation and indication.

Mechanism of action

Lactobacillus exerts its effects primarily through the production of lactic acid, which lowers the pH of the gut environment, creating unfavorable conditions for pathogenic bacteria. They also enhance the intestinal barrier function, modulate local immune responses, and can compete with pathogens for adhesion sites on the intestinal mucosa. Furthermore, Lactobacillus may produce antimicrobial substances such as bacteriocins and hydrogen peroxide, contributing to their protective effects.

Pharmacodynamics

The pharmacodynamics of Lactobacillus involves the interaction with gut microbiota and the modulation of immune responses. It helps in maintaining the balance of gut flora, which is essential for digestive health. Lactobacillus also stimulates the production of mucins and enhances the integrity of the intestinal barrier, thus preventing the translocation of pathogens and toxins. Additionally, it can influence systemic immune function, potentially reducing the incidence of infections.

Pharmacokinetics

Lactobacillus is typically administered orally and survives the acidic environment of the stomach to reach the intestines, where it exerts its effects. The bacteria can temporarily colonize the gut, although they do not permanently establish themselves in the intestinal microbiota. The transit time through the gastrointestinal tract can affect the efficacy of Lactobacillus, and factors such as diet and the presence of other microorganisms can influence its survival and activity.

Adverse effects

  • Bloating
  • Gas
  • Diarrhea
  • Nausea

Precautions

  • Should be used with caution in individuals with compromised immune systems or underlying health conditions.
  • Consult a healthcare professional before using in children or during pregnancy.

Pregnancy

Generally considered safe, but consult a healthcare provider before use.

Breast-feeding

Lactobacillus is usually considered safe during breastfeeding, but it is advisable to consult a healthcare provider.

Storage

Store at room temperature, away from direct sunlight. Refrigeration may be required for some formulations.

Formulations

  • Capsules
  • Tablets
  • Powder
  • Liquid

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.