Nitrofurantoin Capsules USP 100mg Taj Pharma

Name of the medicinal product

Nitrofurantoin Capsules USP 25mg Taj Pharma
Nitrofurantoin Capsules USP 50mg Taj Pharma
Nitrofurantoin Capsules USP 100mg Taj Pharma

Qualitative and quantitative composition

a) Nitrofurantoin Capsules USP 25mg Taj Pharma
Each hard gelatin capsule contains:
Nitrofurantoin USP 25mg
Excipients: Q.S.

b) Nitrofurantoin Capsules USP 50mg Taj Pharma
Each hard gelatin capsule contains:
Nitrofurantoin USP 50mg
Excipients: Q.S.

c) Nitrofurantoin Capsules USP 100mg Taj Pharma
Each hard gelatin capsule contains:
Nitrofurantoin USP 100mg
Excipients: Q.S.

Excipients with known effect

Lactose-207mg per capsule

For the full list of excipients, see section 6.1.

Pharmaceutical form

The 25mg, 50mg and 100mg hard gelatin capsule has an opaque yellow cap and opaque yellow body with divided between the body and the cap.

Clinical particulars

Therapeutic indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures. It is indicated in adults, children and infants over 3 months old.

Nitrofurantoin Taj Pharma is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli, enterococci, staphylococci, Citrobacter, Klebsiella and Enterobacter.

Posology and method of administration

Posology

Adults

Acute Uncomplicated Urinary Tract Infections (UTIs): 50mg four times daily for seven days.
Severe chronic recurrence (UTIs): 100mg four times daily for seven days.
Long term suppression: 50-100mg once a day.
Prophylaxis: 50mg four times daily for the duration of procedure and for three days thereafter.

Paediatric population

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg day in four divided doses for seven days.

Suppressive – 1mg/kg, once a day.

For children under 25 kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal impairment, in which Nitrofurantoin Taj Pharma is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (see section 4.8).

Renal impairment

Nitrofurantoin Taj Pharma is contraindicated in patients with renal dysfunction and in patients with an eGFR of less than 45 ml/minute (see sections 4.3 & 4.4).

Method of administration

For oral use

Contraindications

Hypersensitivity to the active substance, other nitrofurans or to any of the excipients listed in section 6.1.
Patients suffering from renal dysfunction with an eGFR of less than 45 ml/minute.
G6PD deficiency (see also Section 4.6)
Acute porphyria.
In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the newborn infant due to immature erythrocyte enzyme systems.

Special warnings and precautions for use

Nitrofurantoin Taj Pharma is not effective for the treatment of parenchymal infections of unilaterally nonfunctioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

Nitrofurantoin Taj Pharma may be used with caution as short-course therapy only for the treatment of uncomplicated lower urinary tract infection in individual cases with an eGFR between 30-44 ml/min to treat resistant pathogens, when the benefits are expected to outweigh the risks.

Since pre-existing conditions may mask adverse reactions, Nitrofurantoin Taj Pharma should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.

Peripheral neuropathy and susceptibility to peripheral neuropathy which may become severe or irreversible has occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesia).

Nitrofurantoin Taj Pharma should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

Acute, subacute and chronic pulmonary reactions have been observed in patients treated with Nitrofurantoin Taj Pharma. If these reactions occur, Nitrofurantoin Taj Pharma should be discontinued immediately.

Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis ) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary condition of patients receiving long-term therapy is warranted (especially in the elderly).

Patient should be monitored closely for signs of hepatitis (particularly in long term use). Urine may be coloured yellow or brown after taking Nitrofurantoin Taj Pharma. Patients on Nitrofurantoin Taj Pharma are susceptible to false positive urinary glucose (if tested for reducing substances).

Nitrofurantoin Taj Pharma should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydrogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.

Discontinue treatment with Nitrofurantoin Taj Pharma if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

Capsule contain lactose

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interaction with other medicinal products and other forms of interaction

Increased absorption with food or agents delaying gastric emptying.
Decreased absorption with magnesium trisilicate.
Decreased renal excretion of Nitrofurantoin Taj Pharma by probenecid and sulfinpyrazone.
Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.
Anti-bacterial antagonism by quinolone anti-infectives.
Interference with some tests for glucose in urine.
As Nitrofurantoin Taj Pharma belongs to the group of Antibacterials, it will have the following interactions:

Typhoid Vaccine (oral): Antibacterials inactivate oral typhoid vaccine.

Fertility, pregnancy and lactation

Pregnancy

Animal studies with Nitrofurantoin Taj Pharma have shown no teratogenic effects. Nitrofurantoin Taj Pharma has been in extensive clinical use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for a specific indication, only after careful assessment.

Nitrofurantoin Taj Pharma is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants’ immature red cells.

Breast-feeding

Breast feeding an infant known or suspected to have an erythrocyte enzyme deficiency (including G6PD deficiency), must be temporarily avoided, since Nitrofurantoin Taj Pharma is detected in trace amounts in breast milk.

Effects on ability to drive and use machines

Nitrofurantoin Taj Pharma may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

Undesirable effects

A tabulated list of undesirable effects is outlined below:
The undesirable effects are listed according to organ systems and following frequencies:

Rare (≥1/10,000 to <1/1,000)

Not known (cannot be estimated from the available data)

System organ class	Frequency	Adverse reaction
Infections and infestations	Not known	Superinfections by fungi or resistant organisms such as Pseudomonas. However, these are limited to the genitourinary tract
Blood and lymphatic system disorders	Rare Not known	Aplastic anaemia Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia,glucose¬6-phosphatedehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia
Immune system disorders	Not known	Allergic skin reactions, angioneurotic oedema and anaphylaxis
Psychiatric disorders	Not known	depression, euphoria, confusion, psychotic reactions
Nervous system disorders	Not known	Peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness. Benign intracranial hypertension
Cardiac	Rare	Collapse and cyanosis
Respiratory, thoracic and mediastinal disorders	Not known	Acute pulmonary reactions, Subacute pulmonary reactions* Chronic pulmonary reactions Cough, Dyspnoea , Pulmonary fibrosis; possible association with lupus-erythematous-like syndrome.
Gastrointestinal disorders	Not known	Sialadenitis, Pancreatitis, Nausea, Anorexia, Emesis, Abdominal pain and Diarrhea.
Hepatobiliary disorders	Not known	Cholestatic jaundice, Chronic active hepatitis (fatalities have been reported), Hepatic necrosis, autoimmune hepatitis
Skin and subcutaneous tissue disorders	Not known	Transient alopecia Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome), maculopapular, erythematous or eczematous eruptions,urticaria, rash, and pruritus. Lupus-like syndrome associated with pulmonary reaction. Drug Rash With Eosinophilia And Systemic Symptoms (DRESS syndrome), cutaneous vasculitis,
Renal and urinary disorders	Not known	Yellow or brown discolouration of urine
General disorders and administration site conditions	Not known	Asthenia, fever, chills, drug fever and arthralgia
Investigations	Not known	False positive urinary glucose

*Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions

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

Symptoms

Symptoms and signs of overdose include gastric irritation, nausea and vomiting.

Management

There is no known specific antidote. However, Nitrofurantoin Taj Pharma can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

Pharmacological properties

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, nitrofuran derivatives

Mechanism of action

Nitrofurantoin Taj Pharma is a broad spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis

Citrobacter Species

Clinically most common urinary pathogens are sensitive to Nitrofurantoin Taj Pharma.

Most strains of proteus and serratia are resistant. All pseudomonas strains are resistant.

Pharmacokinetic properties

The Nitrofurantoin Taj Pharma macrocrystals are specially formulated. The controlled crystal size is designed to control the speed of absorption and thus reduce the incidence of nausea. Clinical and animal studies indicate that Nitrofurantoin Taj Pharma therapy decreases the likelihood of nausea in patients who might experience these symptoms on Nitrofurantoin Taj Pharma therapy. This special formulation of Nitrofurantoin Taj Pharma had not caused any decrease in antibacterial efficacy.

Absorption

Orally administered Nitrofurantoin Taj Pharma is readily absorbed in the upper gastrointestinal tract at a slower rate and to reduced extent when compared to microcrystalline Nitrofurantoin Taj Pharma. Blood concentrations at therapeutic dosage are usually low.

Elimination

Maximum urinary excretion usually occurs 4-5 hours after administration of macrocrystalline Nitrofurantoin Taj Pharma. Urinary drug dose recoveries of about 25-30% are obtained. It has an elimination half-life of about 30 minutes or less.

Preclinical safety data

Carcinogenic effect of Nitrofurantoin Taj Pharma in animal studies was observed. However, human data and extensive use of Nitrofurantoin Taj Pharma over 50 years do not support such observations.

Pharmaceutical particulars

List of excipients

The capsule fill contains lactose monohydrate, maize starch and purified talc. The capsule shell contains Quinoline Yellow, Titanium Dioxide, Gelatin, Sodium Lauryl Sulphate. The printing ink contains shellac and Black Iron Oxide.

Incompatibilities

Not applicable

Shelf life

Three years

Special precautions for storage

Storage temperature must not exceed 30°C.

Nature and contents of container

Nitrofurantoin Taj Pharma 25mg, 50mg and 100mg capsules, hard are supplied in a PVC/aluminium foil blister pack of 30. Each pack comprises 3 blister cards containing 10 capsules on each card.

Special precautions for disposal and other handling

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

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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4
The name of your medicine is Nitrofurantoin Taj Pharma 50mg or 100mg capsules, Hard. It will be referred to as Nitrofurantoin Taj Pharma capsules for ease hereafter.

What is in this leaflet:

What Nitrofurantoin Taj Pharma Capsules are and what they are used for
What you need to know before you take Nitrofurantoin Taj Pharma Capsules
How to take Nitrofurantoin Taj Pharma Capsules
Possible side effects
How to store Nitrofurantoin Taj Pharma Capsules
Contents of the pack and other information

1.WHAT NITROFURANTOIN TAJ PHARMA CAPSULES ARE AND WHAT THEY ARE USED FOR

Nitrofurantoin Taj Pharma (the active substance in Nitrofurantoin Taj Pharma Capsules) is an antibiotic.

It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.

You must talk to a doctor if you do not feel better or if you feel worse.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN TAJ PHARMA CAPSULES

DO NOT TAKE Nitrofurantoin Taj Pharma Capsules:

if you are allergic to Nitrofurantoin Taj Pharma, other medicines containing Nitrofurantoin Taj Pharma or to any of the other ingredients of this medicine (listed in Section 6)
if you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure)
if you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby
if you suffer from a blood disorder called porphyria • if you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase)
if your child under three months of age
if you are breast feeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).

Tell your doctor if you are not sure about any of the above.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Nitrofurantoin Taj Pharma Capsules:

if you have diabetes
if you are suffering from any illness causing severe weakness
if you have anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness); or a lack of vitamin B or abnormal levels of salts in your blood (your doctor will be able to advise you)
if you have a history of allergic reactions
if you have any problems with your kidneys.

The above conditions may increase the chance of developing a side effect which results in damage to the nerves, causes altered sense of feeling, pins and needles.

if you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Middle Eastern or Asian origin. Your doctor will know)
if you have any disease of the lungs, liver or nervous system. If you need to take Nitrofurantoin Taj Pharma Capsules for a number of months, your doctor may want to regularly check how your lungs and liver are working.
as this medicine may interfere with urine tests for glucose, causing the test to give a “false positive” result. That is, the test may say that glucose is present in the urine even if it is not. This medicine may also cause your urine to turn yellow or brown.

Other medicines and Nitrofurantoin Taj Pharma Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If they are taken with Nitrofurantoin Taj Pharma Capsules their effect or the effect of Nitrofurantoin Taj Pharma Capsules may be changed.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

Antacids for indigestion (e.g. magnesium trisilicate)
Medicines for gout (e.g. probenecid or sulfinpyrazone)
Medicines which slow the passage of food through the stomach (e.g. atropine, hyoscine)
Medicines for raised pressure in the eye (glaucoma), such as carbonic anhydrase inhibitors (e.g. acetazolamide)
Medicines which make the urine less acidic (e.g. potassium citrate mixture)
Medicines for infections, known as quinolones • Typhoid vaccine, which is given for the prevention of typhoid.

If you are in doubt about any of these medicines ask your doctor or pharmacist.

Nitrofurantoin Taj Pharma Capsules may interfere with the results of some tests for glucose in the urine.

Nitrofurantoin Taj Pharma Capsules with food and drink:

Nitrofurantoin Taj Pharma Capsules should be taken at meal times with food or milk. This will help to avoid stomach upset and also to help the absorption.

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 this medicine.

As far as it is known Nitrofurantoin Taj Pharma Capsules may be used in pregnancy. However, it should not be used during labour or delivery because there is a possibility that use at this stage may affect the baby. If you want to breast feed, please consult your doctor first.

Driving and using machines:

Nitrofurantoin Taj Pharma Capsules may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.

Nitrofurantoin Taj Pharma Capsules contain lactose

This medicine contains lactose. If you have been told by your doctor that you are intolerant to some sugars and have to avoid them, contact your doctor before taking this medicine.

HOW TO TAKE NITROFURANTOIN TAJ PHARMA CAPSULES

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

Adults:

The normal dosage depends on the type of infection you have and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions are not clear. The usual doses are:

For treatment of infections: Either one 50mg capsule or one 100mg capsule four times a day for seven days
For prevention of further infections: Either one 50mg capsule or one 100mg capsule at bedtime • For prevention of infections during surgery: One 50mg capsule four times a day on the day of the operation and three days thereafter.

Use in children and infants over three months of age:

The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instructions exactly.

Children below 3 months of age should not take Nitrofurantoin Taj Pharma Capsules.

Medical Checks:

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.

Nitrofurantoin Taj Pharma Capsules may interfere with the results of some tests for glucose in the urine.

Method of administration

Nitrofurantoin Taj Pharma Capsules should be taken with food or milk.

If you take more Nitrofurantoin Taj Pharma Capsules than you should:

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over capsules with you, as well as the container and label, so that the medical staff knows what you have taken.

If you forget to take Nitrofurantoin Taj Pharma Capsules:

Do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose take the normal dose on the next day. Do not take a double dose to make up for a forgotten capsule. If you are not sure ask your doctor or pharmacist.

If you stop taking Nitrofurantoin Taj Pharma Capsules:

Your doctor will tell you how long to take the treatment. Do not stop earlier than you are told, even if you feel better.

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

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking Nitrofurantoin Taj Pharma Capsules.

All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately. If you experience any of the side effects detailed below stop taking Nitrofurantoin Taj Pharma Capsules and consult your doctor.
Your lungs may react to Nitrofurantoin Taj Pharma Capsules. This may develop quickly, within a week of starting treatment or very slowly, especially in elderly patients. This may produce fever, chills, cough and shortness of breath
Jaundice (inflammation of the liver causing yellowing of the skin or whites of the eyes)
The nerves outside the spinal cord may be affected causing changes to the sense of feeling and the use of muscles. In addition headache, extreme changes of mood or mental state, confusion, weakness, blurred vision may occur. These effects may be severe and in some instances permanent
Raised pressure in the skull (causing severe headaches)
Severe reduction in blood cells which can cause weakness, bruising or make infections more likely
Blue or purple coloration of the skin due to low oxygen levels. A condition known as cyanosis
Symptoms of fever, flu, abdominal pain, diarrhea, blood in your stool and weakness. These could be signs of a condition known as cutaneous vasculitis
Symptoms of jaundice, fatigue, abdominal pain, joint pain and swelling. These could be signs of a condition known as autoimmune hepatitis.

Please note that while taking Nitrofurantoin Taj Pharma Capsules your urine may become dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine.

Other side effects include:

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

Loss of consciousness (collapse).

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

Feeling sick (nausea) and headache
Loose stools
Loss of appetite, stomach ache, and being sick (vomiting)
Dizziness, drowsiness
Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anaemia, and a susceptibility to colds or persistent cold
A variety of skin rashes or reactions have occurred in some patients. These may appear as flaking skin, a red rash or fever accompanied by rapid heart rate and severe rash with blistering. Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas (causing severe abdominal pain) and joint pains
Short-term hair loss
Urinary infection by germs which are not sensitive to Nitrofurantoin Taj Pharma Capsules.

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

HOW TO STORE NITROFURANTOIN TAJ PHARMA CAPSULES

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

Do not store above 30°C. Store in the original package to protect from light and moisture.

Do not use Nitrofurantoin Taj Pharma Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Nitrofurantoin Taj Pharma Capsules contains:

The active substance is Nitrofurantoin Taj Pharma. Nitrofurantoin Taj Pharma Capsules are available in two strengths, containing either 25mg, 50mg or 100mg Nitrofurantoin Taj Pharma.

The other ingredients are Talc, Maize starch, Lactose Monohydrate. The capsule shell contains gelatin, Sodium Lauryl Sulphate, Quinoline Yellow and Titanium Dioxide. The printing ink contains shellac and black iron oxide.

What Nitrofurantoin Taj Pharma Capsules looks like and contents of the pack:

Nitrofurantoin Taj Pharma 25mg and 50mg capsule is a no. 3 size hard gelatin capsule with an opaque yellow cap and white opaque body.

Nitrofurantoin Taj Pharma 100mg capsule is a no. 2 size hard gelatin capsule with an opaque yellow cap and yellow opaque body.

The capsules are available in blister packs of 30.