Umbulali Ntshulube 937,50 mg/5 ml

UMBULALI NTSHULUBE is used to treat worm infestations. It is used for the elimination (removal) of roundworm and threadworm.

Do not take UMBULALI NTSHULUBE :

• If you are hypersensitive (allergic) to piperazine citrate or any of the ingredients of UMBULALI NTSHULUBE (listed in section 6).
• If you have epilepsy.
• If you have serious kidney damage.

Warnings and precautions

Take special care with UMBULALI NTSHULUBE:

• If you are allergic to tartrazine or aspirin as allergic type reactions may occur including asthma.
• If you have nervous system disorders
• If you have kidney problems
• If you have impaired liver function

If your health worsens while taking UMBULALI NTSHULUBE, see a doctor or pharmacist.

Children

Children under one year of age can only take UMBULALI NTSHULUBE if told to do so by a doctor.

Other medicines and UMBULALI NTSHULUBE

Always tell your healthcare provider if you are administering any other medicine. (This includes complementary or traditional medicines).

• Do not take UMBULALI NTSHULUBE with other de-worming medicines.
• UMBULALI NTSHULUBE may increase the adverse effects of phenothiazines such as chlorpromazine.

Pregnancy and Breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Pregnancy :

If you are pregnant do not use UMBULALI NTSHULUBE unless your doctor has told you to do so.

Breastfeeding :

If you are breastfeeding, take a dose of UMBULALI NTSHULUBE immediately after breast feeding, then do not breast feed for the next 8 hours. Express and discard the breast milk during this time.

Driving and using machines

UMBULALI NTSHULUBE may cause drowsiness, dizziness and blurred vision. Do not drive or use machinery until you know how UMBULALI NTSHULUBE affects you.

UMBULALI NTSHULUBE contains Brilliant Blue (C.I. 42090), ethanol, glycerol, peppermint oil, purified water, sucrose and tartrazine.

• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking UMBULALI NTSHULUBE.
• UMBULALI NTSHULUBE contains sucrose which may have an effect on the control of your blood sugar if you have diabetes mellitus.

Do not share medicines prescribed for you with any other person. Always take UMBULALI NTSHULUBE exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

For the Elimination of Roundworm.

Adults and children weighing 19,0 kg or more should take a single dose of 30 ml (6 medicine measures) of UMBULALI NTSHULUBE before supper.

For infants and children weighing under 19,0 kg the dose is 20 ml (4 medicine measures) of UMBULALI NTSHULUBE before supper.

In cases of constipation, a saline laxative should be given the following morning.

For the Elimination of Threadworm.

Take UMBULALI NTSHULUBE daily after food for seven days.

Dosage Schedule For The Treatment Of Threadworm:

Age Weight Dosage To be continued for seven days

• 9 - 24 months 6,5 – 9,5 kg ½ medicine measure daily (2,5 ml)
• 2 – 4 years 9,5 – 12,5 kg 1 medicine measure daily (5,0 ml)
• 4 – 7 years 12,5 – 19,0 kg 1½ medicine measures daily (7,5 ml)
• 7 – 13 years 19,0 – 38,0 kg 2 medicine measures daily (10,0 ml)
• 13 years to adult over 38,0 kg 3 medicine measures daily (15,0 ml)

If necessary the course may be repeated after one week. It is recommended to check all members of a household and treat all positive cases at the same time to prevent spread of the worms and reinfestation.

If you take more UMBULALI NTSHULUBE than you should:

An overdose of UMBULALI NTSHULUBE can cause dizziness, blurred vision or nausea. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forgot to take UMBULALI NTSHULUBE :

Do not double the dose. Skip the missed dose and continue with the next dose as directed.

UMBULALI NTSHULUBE can have side effects. Not all side effects reported for UMBULALI NTSHULUBE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking UMBULALI NTSHULUBE, please consult your health care provider for advice.

If any of the following side effects happen, stop taking UMBULALI NTSHULUBE and tell your doctor or go to the casualty department at your nearest hospital:

• shortness of breath, tight chest,
• skin rashes, itchy skin, tingling sensation of the skin,
• seizures, loss of muscle coordination, weakness, twitching, shaking, loss of reflexes, involuntary eye movement,
• symptoms similar to that of inflamed liver (hepatitis), due to infection caused by a virus, such as fever, rash, tiredness, nausea, vomiting, poor appetite, joint pain, and headaches,
• nose bleeds and coughing up blood,

These are all serious side effects and you may need urgent medical attention.

Tell your doctor if you notice any of the following:

• sleepiness, dizziness,
• headaches,
• nausea, vomiting, diarrhoea, abdominal pain,
• blurred vision and clouding of the lens in the eye.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8.

By reporting side effects, you can help provide more information on the safety of UMBULALI NTSHULUBE.

• Store at or below 25 °C
• Keep the bottle tightly closed and protect from light.
• Keep bottle in unit carton until prior to use
• Do not use after the expiry date stated on the label.
• 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)