1. Name of the medicinal product

Refaximin Tablets USP 200mg Taj Pharma
Refaximin Tablets USP 550mg Taj Pharma

  1. Qualitative and quantitative composition

a) Refaximin Tablets USP 200mg  Taj Pharma
Each film-coated tablet contains:
Rifaximin USP 200mg
Excipients: Q.S.

b) Refaximin Tablets USP 550mg  Taj Pharma
Each film-coated tablet contains:
Rifaximin USP 550mg
Excipients: Q.S.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet.

  1. Clinical particulars
  • Therapeutic indications

Refaximin Taj Pharma is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age (see section 5.1).

In the pivotal study, 91% of the patients were using concomitant lactulose.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

  • Posology and method of administration

Posology

Recommended dose: 550mg twice a day. The clinical benefit was established from a controlled study in which subjects were treated for 6 months. Treatment beyond 6 months should take into consideration the individual balance between benefits and risks, including those associated with the progression of hepatic dysfunction (see sections 4.4, 5.1 and 5.2).

Refaximin Taj Pharma can be administered with or without food.

Paediatric population

The safety and efficacy of Refaximin Taj Pharma in paediatric patients (aged less than 18 years) have not been established.

Elderly

No dosage adjustment is necessary as the safety and efficacy data of Refaximin Taj Pharma showed no differences between the elderly and the younger patients.

Hepatic impairment

No dosage adjustment is necessary for patients with hepatic insufficiency (see section 4.4).

Renal impairment

Although dosing change is not anticipated, caution should be used in patients with impaired renal function (see section 5.2).

Method of administration

Orally with a glass of water.

  • Contraindications
  • Hypersensitivity to Refaximin Taj Pharma, rifamycin-derivatives or to any of the excipients listed in section 6.1.
  • Cases of intestinal obstruction.

Special warnings and precautions for use

Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including Refaximin Taj Pharma. The potential association of Refaximin Taj Pharma treatment with CDAD and pseudomembranous colitis (PMC) cannot be ruled out.

Due to the lack of data and the potential for severe disruption of gut flora with unknown consequences, concomitant administration of Refaximin Taj Pharma with other rifamycins is not recommended.

Patients should be informed that despite the negligible absorption of the drug (less than 1%), like all rifamycin derivatives, Refaximin Taj Pharma may cause a reddish discolouration of the urine.

Hepatic Impairment: use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score > 25 (see section 5.2).

Caution should be exercised when concomitant use of Refaximin Taj Pharma and a P-glycoprotein such as ciclosporin is needed (see section 4.5).

Both decreases and increases in international normalized ratio (in some cases with bleeding events) have been reported in patients maintained on warfarin and prescribed Refaximin Taj Pharma. If co-administration is necessary, the international normalized ratio should be carefully monitored with the addition or withdrawal of treatment with Refaximin Taj Pharma. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5).

  • Interaction with other medicinal products and other forms of interaction

There is no experience regarding administration of Refaximin Taj Pharma to subjects who are taking another rifamycin antibacterial agent to treat a systemic bacterial infection.

In vitro data show that Refaximin Taj Pharma did not inhibit the major cytochrome P-450 (CYP) drug metabolizing enzymes (CYPs1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4). In in vitro induction studies, Refaximin Taj Pharma did not induce CYP1A2 and CYP 2B6 but was a weak inducer of CYP3A4.

In healthy subjects, clinical drug interaction studies demonstrated that Refaximin Taj Pharma did not significantly affect the pharmacokinetics of CYP3A4 substrates, however, in hepatic impaired patients it cannot be excluded that Refaximin Taj Pharma may decrease the exposure of concomitant CYP3A4 substrates administered (e.g. warfarin, antiepileptics, antiarrhythmics, oral contraceptives), due to the higher systemic exposure with respect to healthy subjects.

Both decreases and increases in international normalized ratio have been reported in patients maintained on warfarin and prescribed Refaximin Taj Pharma. If co-administration is necessary, the international normalized ratio should be carefully monitored with the addition or withdrawal of Refaximin Taj Pharma. Adjustments in the dose of oral anticoagulants may be necessary.

An in vitro study suggested that Refaximin Taj Pharma is a moderate substrate of P-glycoprotein(P-gp) and metabolized by CYP3A4. It is unknown whether concomitant drugs which inhibit P-gp and/or CYP3A4 can increase the systemic exposure of Refaximin Taj Pharma.

In healthy subjects, co-administration of a single dose of ciclosporin (600mg), a potent P-glycoprotein inhibitor, with a single dose of Refaximin Taj Pharma (550mg) resulted in 83-fold and 124-fold increases in Refaximin Taj Pharma mean Cmax and AUC∞. The clinical significance of this increase in systemic exposure is unknown.

The potential for drug-drug interactions to occur at the level of transporter systems has been evaluated in vitro and these studies suggest that a clinical interaction between Refaximin Taj Pharma and other compounds that undergo efflux via P-gp and other transport proteins is unlikely (MRP2, MRP4, BCRP and BSEP).

  • Fertility, pregnancy and lactation

Pregnancy

There is no or limited data from the use of Refaximin Taj Pharma in pregnant women.

Animal studies showed transient effects on ossification and skeletal variations in the foetus (see section 5.3).

As a precautionary measure, use of Refaximin Taj Pharma during pregnancy is not recommended.

Breastfeeding

It is unknown whether Refaximin Taj Pharma/metabolites are excreted in human milk.

A risk to the breast-fed child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Refaximin Taj Pharma therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to male and female fertility.

  • Effects on ability to drive and use machines

Dizziness has been reported in clinical controlled trials. However, Refaximin Taj Pharma has negligible influence on the ability to drive and use machines.

  • Undesirable effects

Clinical Trials:

The safety of Refaximin Taj Pharma in patients in remission from hepatic encephalopathy (HE) was evaluated in two studies, a randomised, double-blind, placebo-controlled phase 3 study RFHE3001 and a long-term, open-label study RFHE3002.

Study RFHE3001 compared 140 patients treated with Refaximin Taj Pharma (dose of 550mg twice daily for 6 months) to 159 patients treated with placebo, while study RFHE3002 treated 322 patients, of whom 152 from the RFHE3001 study, with Refaximin Taj Pharma 550mg twice daily for 12 months (66% of patients) and for 24 months (39% of patients), for a median exposition of 512.5 days.

In addition, in three supportive studies 152 HE patients were treated with varying doses of Refaximin Taj Pharma from 600mg to 2400mg per day for up to 14 days.

All adverse reactions that occurred in patients treated with Refaximin Taj Pharma at an incidence ≥ 5% and at a higher incidence (≥1%) than placebo patients in RFHE3001 are reported in the following table.

Table 1: Adverse reactions occurring in ≥ 5% of patients receiving Refaximin Taj Pharma and at a higher incidence than placebo in RFHE3001

MedDRA

System Organ Class

Event Placebo

N=159

Rifaximin

N= 140

n % n %
Blood and lymphatic system disorders Anaemia 6 3.8 11 7.9
Gastrointestinal disorders Ascites 15 9.4 16 11.4
Nausea 21 13.2 20 14.3
Abdominal pain upper 8 5.0 9 6.4
General disorders and administration site conditions Oedema peripheral 13 8.2 21 15.0
Pyrexia 5 3.1 9 6.4
Musculoskeletal and connective tissue disorders Muscle spasms 11 6.9 13 9.3
Arthralgia 4 2.5 9 6.4
Nervous system disorders Dizziness 13 8.2 18 12.9
Psychiatric disorders Depression 8 5.0 10 7.1
Respiratory, thoracic and mediastinal disorders Dyspnoea 7 4.4 9 6.4
Skin and subcutaneous tissue disorders Pruritus 10 6.3 13 9.3
Rash 6 3.8 7 5.0

Table 2 includes adverse reactions observed in the placebo-controlled study RFHE3001, long term study RFHE3002 and from post-marketing experience, listed by MedDRA system organ class and frequency category.

Frequency categories are defined using the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 2: Adverse reactions listed by MedDRA system organ class and frequency category.

MedDRA System Organ Class Common Uncommon Rare Not known
Infections and infestations Clostridial infection, urinary tract infection, candidiasis Pneumonia, cellulitis, upper respiratory tract infections, rhinitis
Blood and lymphatic system disorders Anaemia Thrombocytopenia
Immune system disorders Anaphylactic reactions, angioedemas, hypersensitivity
Metabolism and nutrition disorders Anorexia, hyperkalaemia Dehydration
Psychiatric disorders Depression Confusional state, anxiety, hypersomnia, insomnia
Nervous system disorders Dizziness, headache Balance disorders, amnesia, convulsion, attention disorders, hypoesthesia, memory impairment
Vascular disorders Hot flush Hypertension, hypotension Presyncope, syncope
Respiratory, thoracic, and mediastinal disorders Dyspnoea Pleural effusion Chronic obstructive pulmonary disease
Gastrointestinal disorders Abdominal pain upper, abdominal distension, diarrhoea, nausea, vomiting, ascites Abdominal pain, oesophageal varices haemorrhage, dry mouth, stomach discomfort Constipation
Hepatobiliary disorders Liver function tests abnormalities
Skin and subcutaneous tissue disorders Rashes, pruritus Dermatitis, eczema
Musculoskeletal and connective tissue disorders Muscle spasms, arthralgia Myalgia Back pain
Renal and urinary disorders Dysuria, pollakiuria Proteinuria,
General disorders and administration site conditions Oedema peripheral Oedema, pyrexia Asthenia
Investigations International normalised ratio abnormalities
Injury, poisoning and procedural complications Fall Contusions, procedural pain

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.

  • Overdose

No case of overdose has been reported.

In clinical trials with patients suffering from traveller’s diarrhoea doses of up to 1800mg/day have been tolerated without any severe clinical sign. Even in patients/subjects with normal bacterial flora Refaximin Taj Pharma in dosages of up to 2400mg/day for 7 days did not result in any relevant clinical symptoms related to the high dosage.

In case of accidental overdose, symptomatic treatment and supportive care are suggested.

  1. Pharmacological properties

Refaximin Taj Pharma contains Refaximin Taj Pharma (4-desoxy-4’methyl pyrido (1′,2′-1,2) imidazo (5,4-c) rifamycin SV), in the polymorphic form α.

  • Pharmacodynamic properties

Pharmacotherapeutic group: intestinal, anti-infective – antibiotics –

Mechanism of action

Rifaximin is an antibacterial drug of the rifamycin class that irreversibly binds the beta sub-unit of the bacterial enzyme DNA-dependent RNA polymerase and consequently inhibits bacterial RNA synthesis.

Rifaximin has a broad antimicrobial spectrum against most of the Gram-positive and negative, aerobic and anaerobic bacteria, including ammonia producing species. Rifaximin may inhibit the division of urea-deaminating bacteria, thereby reducing the production of ammonia and other compounds that are believed to be important to the pathogenesis of hepatic encephalopathy.

Mechanism of resistance

The development of resistance to Refaximin Taj Pharma is primarily a reversible chromosomal one-step alteration in the rpoB gene encoding the bacterial RNA polymerase.

Clinical studies that investigated changes in the susceptibility of intestinal flora of patients affected by traveller’s diarrhoea failed to detect the emergence of drug resistant Gram-positive (e.g. enterococci) and Gram-negative (E. coli) organisms during a three-day course of treatment with Refaximin Taj Pharma.

Development of resistance in the normal intestinal bacterial flora was investigated with repeated, high doses of Refaximin Taj Pharma in healthy volunteers and Inflammatory Bowel Disease patients. Strains resistant to Refaximin Taj Pharma developed, but were unstable and did not colonise the gastrointestinal tract or replace Refaximin Taj Pharma-sensitive strains. When treatment was discontinued resistant strains disappeared rapidly.

Experimental and clinical data suggest that the treatment with Refaximin Taj Pharma of patients harbouring strains of Mycobacterium tuberculosis or Neisseria meningitidis will not select for rifampicin resistance.

Susceptibility

Rifaximin is a non-absorbed antibacterial agent. In vitro susceptibility testing cannot be used to reliably establish susceptibility or resistance of bacteria to Refaximin Taj Pharma. There are currently insufficient data available to support the setting of a clinical breakpoint for susceptibility testing.

Rifaximin has been evaluated in vitro on several pathogens including ammonia producing bacteria as Escherichia coli spp, Clostridium spp, EnterobacteriaceaeBacteroides spp. Due to the very low absorption from the gastro-intestinal tract Refaximin Taj Pharma is not clinically effective against invasive pathogens, even though these bacteria are susceptible in vitro.

Clinical efficacy

The efficacy and safety of Refaximin Taj Pharma 550mg twice daily in adult patients in remission from HE was evaluated in a phase 3 pivotal, 6-month, randomised, double-blind, placebo-controlled study RFHE3001.

Two-hundred ninety-nine subjects were randomised to treatment with Refaximin Taj Pharma 550mg twice daily (n=140) or placebo (n= 159) for 6 months. More than 90% of the subjects in both groups received concomitant lactulose. No patients were enrolled with a MELD score > 25.

The primary endpoint was the time to first breakthrough overt HE episode and patients were withdrawn after a breakthrough overt HE episode. Thirty-one of 140 subjects (22%) of Refaximin Taj Pharma group and 73 of 159 (46%) subjects of placebo group experienced a breakthrough overt HE episode during the 6-month period. Rifaximin reduced the risk of HE breakthrough by 58% (p< 0.0001) and the risk of HE-related hospitalizations by 50% (p< 0.013), compared with placebo.

The longer-term safety and tolerability of Refaximin Taj Pharma 550mg twice daily administered for at least 24 months was evaluated in 322 subjects in remission from HE in study RFHE3002. One hundred fifty-two subjects rolled over from RFHE3001 (70 from the Refaximin Taj Pharma group and 82 from the placebo), and 170 subjects were new. Eighty-eight percent of patients were administered concomitant lactulose.

Treatment with Refaximin Taj Pharma for periods up to 24 months (OLE study RFHE3002) did not result in any loss of effect regarding the protection from breakthrough overt HE episodes and the reduction of the burden of hospitalization. Time to first breakthrough overt HE episode analysis showed long-term maintenance of remission in both groups of patients, new and continuing Refaximin Taj Pharma.

  • Pharmacokinetic properties

Absorption

Pharmacokinetic studies in rats, dogs and humans demonstrated that after oral administration Refaximin Taj Pharma in the polymorph α form is poorly absorbed (less than 1%). After repeated administration of therapeutic doses of Refaximin Taj Pharma in healthy volunteers and patients with damaged intestinal mucosa (Inflammatory Bowel Disease), plasma levels are negligible (less than 10 ng/mL). In HE patients, administration of Refaximin Taj Pharma 550mg twice a day showed mean Refaximin Taj Pharma exposure approximately 12-fold higher than that observed in healthy volunteers following the same dosing regimen. A clinically irrelevant increase of Refaximin Taj Pharma systemic absorption was observed when administered within 30 minutes of a high-fat breakfast.

Distribution

Rifaximin is moderately bound to human plasma proteins. In vivo, the mean protein binding ratio was 67.5% in healthy subjects and 62% in patients with hepatic impairment when Refaximin Taj Pharma 550mg was administered.

Biotransformation

Analysis of faecal extracts demonstrated that Refaximin Taj Pharma is found as the intact molecule, implying that it is neither degraded nor metabolised during its passage through the gastrointestinal tract.

In a study using radio-labelled Refaximin Taj Pharma, urinary recovery of Refaximin Taj Pharma was 0.025% of the administered dose, while <0.01% of the dose was recovered as 25-desacetylRefaximin Taj Pharma, the only Refaximin Taj Pharma metabolite that has been identified in humans.

Elimination

A study with radio-labelled Refaximin Taj Pharma suggested that 14C-Refaximin Taj Pharma is almost exclusively and completely excreted in faeces (96.9 % of the administered dose). The urinary recovery of 14C-Refaximin Taj Pharma does not exceed 0.4% of the administered dose.

Linearity/non-linearity

The rate and extent of systemic exposure of humans to Refaximin Taj Pharma appeared to be characterized by non-linear (dose-dependent) kinetic which is consistent with the possibility of dissolution-rate-limited absorption of Refaximin Taj Pharma.

Special Populations

Renal impairment

No clinical data are available on the use of Refaximin Taj Pharma in patients with impaired renal function.

Hepatic impairment

Clinical data available for patients with hepatic impairment showed a systemic exposure higher than that observed in healthy subjects. The systemic exposure of Refaximin Taj Pharma was about 10-, 13-, and 20-fold higher in those patients with mild (Child-Pugh A), moderate (Child-Pugh B), and severe (Child-Pugh C) hepatic impairment, respectively, compared to that in healthy volunteers. The increase in systemic exposure to Refaximin Taj Pharma in subjects with hepatic impairment should be interpreted in light of Refaximin Taj Pharma gastrointestinal local action and its low systemic bioavailability, as well as the available Refaximin Taj Pharma safety data in subjects with cirrhosis.

Therefore no dosage adjustment is recommended because Refaximin Taj Pharma is acting locally.

Paediatric population

The pharmacokinetics of Refaximin Taj Pharma has not been studied in paediatric patients of any age. Population studied in both the reduction in recurrence of hepatic encephalopathy (HE) and in the acute treatment of HE included patients aged ≥ 18 years.

  • Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

In a rat embryofetal development study, a slight and transient delay in ossification that did not affect the normal development of the offspring, was observed at 300mg/kg/day (2.7 times the proposed clinical dose for hepatic encephalopathy, adjusted for body surface area). In the rabbit, following oral administration of Refaximin Taj Pharma during gestation, an increase in the incidence of skeletal variations was observed (at doses similar to those proposed clinically for hepatic encephalopathy). The clinical relevance of these findings is unknown.

  1. Pharmaceutical particulars
    • List of excipients

Tablet core:

Sodium starch glycolate type A

Glycerol distearate

Colloidal anhydrous silica

Talc

Microcrystalline cellulose

Film coat (opadry oy-s-34907):

Hypromellose

Titanium dioxide

Disodium edetate

Propylene glycol

Red iron oxide

  • Incompatibilities

Not applicable.

  • Shelf life

3 years.

  • Special precautions for storage

This medicinal product does not require any special storage conditions.

  • Nature and contents of container

PVC-PE-PVDC/Aluminium foil blisters in cartons of 14, 28, 42, 56, 98, 360 and 500 tablets.

Not all pack-sizes may be marketed.

  • Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Refaximin Tablets USP 200mg Taj Pharma
(film coated)

Package Leaflet: Information for the user

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 further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. 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. See section 4.

What is in this leaflet:

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

1.What Refaximin Taj Pharma is and what it is used for

Rifaximin Taj Pharma contains the active substance rifaximin. Rifaximin Taj Pharma is an antibiotic that destroys bacteria, which can cause a disease called hepatic encephalopathy (symptoms include agitation, confusion, muscle problems, difficulty in speaking and in some cases coma).

Rifaximin Taj Pharma is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy.

Rifaximin Taj Pharma can either be used alone or more commonly together with medicines containing lactulose (a laxative).

  1. What you need to know before you take Refaximin Taj Pharma

Do not take Rifaximin Taj Pharma:

  • if you are allergic to:
  • rifaximin
  • similar types of antibiotics (such as rifampicin or rifabutin) any of the other ingredients of this medicine (listed in section 6).
  • if you have a blockage in your intestine

Warnings and precautions

Talk to your doctor or pharmacist before taking Rifaximin Taj Pharma.

While you are taking Rifaximin Taj Pharma your urine may turn a reddish colour. This is quite normal.

Treatment with any antibiotic including rifaximin may cause severe diarrhoea. This can happen several months after you have finished taking the medicine. If you have severe

diarrhoea during or after using Rifaximin Taj Pharma you should stop taking Rifaximin Taj Pharma and contact your doctor immediately.

If your liver problems are severe your doctor will need to observe you carefully.

Children and adolescents

Rifaximin Taj Pharma is not recommended for children and adolescents aged under 18 years. This medicine has not been studied in children and adolescents.

Other medicines and Rifaximin Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Please tell your doctor if you are taking any of the following medicines:

  • antibiotics (medicines to treat infections)
  • warfarin (medicine to prevent blood clotting)
  • antiepileptics (medicines for the treatment of epilepsy)
  • antiarrhythmics (medicines to treat abnormal heart beat)
  • ciclosporin (immunosuppressor)
  • oral contraceptives

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

It is not known if Rifaximin Taj Pharma can harm your unborn baby. Rifaximin Taj Pharma is therefore not to be used if you are pregnant.

It is not known if rifaximin may be passed to your baby in breast milk. Rifaximin Taj Pharma is therefore not to be used if you are breast-feeding.

Driving and using machines

Rifaximin Taj Pharma does not normally affect the ability to drive and use machines, but may cause dizziness in some patients. If you feel dizzy you should not drive or operate machinery.

  1. How to take Refaximin Taj Pharma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 tablet twice a day taken with a glass of water.

Your doctor will assess the need for you to continue treatment after 6 months.

If you take more Rifaximin Taj Pharma than you should

If you take more than the recommended number of tablets, even if you do not notice any problems, please contact your doctor.

If you forget to take Rifaximin Taj Pharma

Take the next dose at its normal time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rifaximin Taj Pharma

Do not stop taking Rifaximin Taj Pharma without talking to your doctor first because your symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Rifaximin Taj Pharma and tell your doctor IMMEDIATELY if you have any of the following side effects:

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

  • If you have bleeding from swollen blood vessels in your throat (oesophageal varices).
  • If you have severe diarrhoea during or after using this medicine. This may be due to an infection of the intestine.

Not known (frequency cannot be estimated from the available data):

  • If you get an allergic reaction, hypersensitivity or angioedema. Symptoms include:
    • swelling of the face, tongue or throat
    • swallowing difficulties
    • hives and breathing difficulties.
    • If you have any unexpected or unusual bleeding or bruising. This may be due to a decrease in the platelets in your blood which increases the risk of bleeding. Frequency is not known (cannot be estimated from the available data).

Other side effects that may occur

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

 Depressed mood

 Dizziness

 Headache

 Shortness of breath

 Feeling or being sick

 Stomach ache or bloating/swelling

 Diarrhoea

 Accumulation of fluid in the abdominal cavity (ascites)

 Rash or itching

 Muscle cramps

 Joint pain

 Swelling of ankles, feet or fingers

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

  • Yeast infections (such as thrush)
  • Urinary infection (such as cystitis)
  • Anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
  • Loss of appetite
  • Hyperkalaemia (high level of potassium in the blood)
  • Confusion
  • Anxiety
  • Feeling sleepy
  • Difficulty sleeping
  • Feeling unsteady
  • Loss of or poor memory
  • Loss of concentration
  • Reduced sense of touch
  • Convulsions (fits)
  • Hot flushes
  • Fluid around the lungs (pleural effusion)
  • Abdominal pain
  • Dry mouth
  • Muscle pain
  • Needing to pass urine more often than usual
  • Difficulty or pain passing urine
  • Fever
  • Oedema (swelling due to too much fluid in the body)
  • Falls

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

  • Chest infections including pneumonia
  • Cellulitis (inflammation of tissue under skin)
  • Upper respiratory tract infections (nose, mouth, throat)
  • Rhinitis (inflammation inside the nose)
  • Dehydration (body water loss)
  • Changes in blood pressure
  • Constant breathing problems (such as chronic bronchitis)
  • Constipation
  • Back pain
  • Protein in the urine
  • Feeling weak
  • Bruising
  • Pain following surgery

Not known (frequency cannot be estimated from the available data):

 Fainting or feeling faint

 Skin irritation, eczema (itchy, red, dry skin)

 Reduction in platelets (seen in the blood)

 Changes in the way the liver is working (seen in blood test)

 Changes in blood coagulation (International Normalised Ratio seen in blood test)

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. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Refaximin Taj Pharma

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

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month. Rifaximin Taj Pharma does not require any special storage conditions.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

  1. Contents of the pack and other information

What Rifaximin Taj Pharma contains

The active substance is rifaximin. Each tablet contains 200mg and 550mg Rifaximin.

The other ingredients are:

  • Tablet core: Sodium Starch Glycolate (Type A), Glycerol Distearate, Colloidal Anhydrous Silica, Talc, Microcrystalline Cellulose.
  • Tablet coat (opadry oy-s-34907): Hypromellose, Titanium dioxide, Disodium Edetate, Propylene Glycol, Red Iron Oxide.

What Rifaximin Taj Pharma looks like and contents of the pack

Rifaximin Taj Pharma 200mg film-coated tablets
Rifaximin Taj Pharma 550mg film-coated tablets

Rifaximin Taj Pharma is available in cartons of 14, 28, 42, 56, 98, 360 and 500 tablets.

Not all pack-sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com