Unitro 50 mg/100 mg Capsules

UNITRO contain a medicine called nitrofurantoin. This belongs to a group of antibacterial medicine. UNITRO is used to treat and prevent the recurrence of specific uncomplicated lower urinary tract infections like pyelonephritis, pyelitis (inflammation of the kidney and/ pelvis or its part by the result of bacterial infection) and cystitis (inflammation of the urinary bladder).

Do not take UNITRO:

• If you are allergic or sensitive to UNITRO or any of the ingredients of UNITRO.
• If your kidney completely failure to produce urine or produce a small amount of urine.
• If you are a pregnant.
• Do not administer if your baby is below one year.
• If you have deficiency of glucose 6 - phosphate Dehydrogenase or nursing a baby with this deficiency. (It is a hereditary condition in which red blood cells break down (haemolysis) when the body is exposed to certain foods, drugs, infections or stress. It occurs when a person is missing or has low levels of the enzyme glucose - 6 - phosphate dehydrogenase)

Take special care with UNITRO:

• A course of therapy should not exceed 14 days.
• If your doctor suggest to take repeated doses, it should be separated by rest periods.
• If you are older age patient.
• If you are asthma patient (a respiratory condition marked by attacks of spasm in the bronchi of the lungs, causing difficulty in breathing.), because pulmonary function monitoring is required for prolonged therapy.
• If you observe any abnormal paleness or lack of colour of the skin, yellowish skin, eyes, and mouth (jaundice), dark-coloured urine, fever, weakness, dizziness or confusion tell your doctor. These are symptom of haemolysis (destruction of red blood cells), the UNITRO should be discontinued.
• If you are a pulmonary (lung) disease patient or experience any lung related condition, treatment should be discontinued and your doctor should be consulted immediately.
• If you are liver impairment patient.
• If you are neurological disorder (disorder pertaining to the nervous system) patient.

Tell your doctor, if you have any of the following conditions:

• If you are suffering from anaemia (deficiency of red blood cells).
• If you are suffering from diabetes mellitus (elevated blood glucose levels in the blood).
• If you are electrolyte imbalance patient.
• If you are vitamin B deficient patient.

Do not share medicines prescribed for you with any other person. Always take UNITRO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with UNITRO will last. If you have the impression that the effect of UNITRO is too strong or too weak, talk to your doctor or pharmacist.

Taking UNITRO with food and drink: UNITRO can be taken with food or milk.

Adult dose: For acute urinary tract infection: 50 to 100 mg four times a day. For prevent recurrences: 50 to 100 mg per day.

Children dose: The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instructions exactly. For acute urinary tract infection: Should be calculated on the basis of 5 to 7 mg/kg of body mass per 24 hours to be given in divided doses four times a day. For prevent recurrences: 1 mg/kg/day for long-term therapy. Your doctor will tell you how long your treatment with UNITRO will last. Do not stop treatment early because this may reoccurrence of your condition. If you have the impression that the effect of UNITRO is too strong or too weak, tell your doctor or pharmacist.

Not all side effects reported for UNITRO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. UNITRO can have 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 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 UNITRO and go to a doctor immediately if you experience the following:

• If you notice any sudden wheeziness,
• difficulty in breathing,
• swelling of the eyelids, face or lips,
• rash or itching (especially affecting your whole body)

If you experience any of the side effects detailed below stop taking Nitrofurantoin Capsules and consult your doctor.

• Your lungs may react to Nitrofurantoin 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, diarrhoea, 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 Capsules your urine may become dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine. Other less frequent side effects include:

• Aplastic anemia (Blood stops producing enough blood cells),
• Cyanosis(a bluish discoloration of the skin),
• Loss of consciousness (collapse)
• Frequency unknown:
• Superinfections (Fungi or resistant organisms caused infections),
• Granulocytopenia (loss of neutrophils in circulating blood),
• Leukopenia (lowered white blood cell count),
• Megaloblastic anemia (many large immature and dysfunctional red blood cells),
• Thrombocytopenia (deficiency of platelets in the blood),
• Aplastic anemia (deficiency of all types of blood cells in blood),
• Haemolytic anemia (abnormal breakdown of red blood cells),
• A variety of skin rashes or reactions have occurred in some patients.
• Flaking skin,
• a red rash or fever accompanied by rapid heart rate,
• Severe rash with blistering.
• Feeling sick (nausea)
• Depression,
• Confusion,
• Psychiatric reactions,
• Headache
• Loose stools
• Loss of appetite,
• Stomach ache,
• 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,
• A susceptibility to colds or persistent cold,
• Other reactions may include inflammation of salivary glands (causing facial pains),
• Inflammation of the pancreas (causing severe abdominal pain) Joint pains
• Short-term hair loss
• Urinary infection by germs which are not sensitive to Nitrofurantoin Capsules.
• Inflammation of small blood vessel walls,
• Skin lesions
• Liver inflammation due to turn of immune system against liver cells,
• Inflammation of kidney tissue surrounding tubules,
• Renal impairment,
• Stevens - Johnson syndrome (a serious systemic (body-wide) allergic reaction with a characteristic rash involving the skin and mucous membranes, including the inside of the mouth, conjunctiva, and genital areas. The symptoms of this condition are fever, body aches, red rash, cough, blisters and sores on the skin and on mucus membranes of the mouth, throat, eyes, genitals, and anus, peeling skin, drooling (because closing the mouth is painful), eyes sealed shut (due to blisters and swelling).

Reporting of side effects If you get 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 via https://www.sahpra.org.za/documents/86422f1b6.04_ARF1_Jul16_v4.pdf. By reporting side effects, you can help provide more information on the safety of this medicine.

Store at or below 25 °C. Keep the blisters in the carton until required for use. Keep HDPE containers tightly closed. STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).