MEDIVISION CYCLOSERINE 250

Read all of this leaflet carefully before you start taking MEDIVISION CYCLOSERINE 250

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or your pharmacist.
  • MEDIVISION CYCLOSERINE 250 has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS:

S4

NAME OF THE MEDICINAL PRODUCT:

MEDIVISION CYCLOSERINE 250 CAPSULES

WHAT MEDIVISION CYCLOSERINE 250 CONTAINS:

MEDIVISION CYCLOSERINE 250:

Each capsule contains 250 mg of cycloserine.

The other ingredients are magnesium oxide and purified talc.

WHAT MEDIVISION CYCLOSERINE 250 IS USED FOR:

MEDIVISION CYCLOSERINE 250 is used together with other medicine to treat TB. MEDIVISION CYCLOSERINE 250 is given in the hospital only and should be taken under close supervision.

BEFORE YOU TAKE MEDIVISION CYCLOSERINE 250:

Do not take MEDIVISION CYCLOSERINE 250:

It is important that you tell your doctor or healthcare professional if you suffer from any of the conditions mentioned below, if you are taking MEDIVISION CYCLOSERINE 250 or have been prescribed MEDIVISION CYCLOSERINE 250.

If you are hypersensitive to MEDIVISION CYCLOSERINE 250 or to any of the ingredients.

  • If you are an alcoholic or have a history of alcoholism.
  • If you suffer from seizures or epilepsy.
  • If you have any kind of kidney disease.
  • If you suffer from any mental disorders such as depression, psychosis, severe anxiety.

Take special care with MEDIVISION CYCLOSERINE 250

  • If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.
  • If MEDIVISION CYCLOSERINE 250 causes you to feel very depressed or to have thoughts of suicide, check with your doctor immediately.
  • Do not drink alcohol when taking MEDIVISION CYCLOSERINE 250 as this would cause some side-effects such as fits or seizures to occur more readily.
  • Your doctor would sometimes call you weekly for blood tests if you suffer from any of the conditions mentioned above or have other side-effects or if you are taking more than 500 mg of MEDIVISION CYCLOSERINE 250 daily.
  • CHILDREN – The use of MEDIVISION CYCLOSERINE 250 has not been studied in children.
  • ELDERLY PATIENTS – MEDIVISION CYCLOSERINE 250 can be safely used, provided that you are not suffering from any kidney problems.

Pregnancy and Breast-feeding:

You should not use MEDIVISION CYCLOSERINE when you pregnant.You should not breast-feed your infant when using MEDIVISION CYCLOSERINE.

Driving and Using Machinery:

MEDIVISION CYCLOSERINE 250 may cause some people to become dizzy, drowsy, or less alert than they are normally. Therefore try and avoid driving or using machinery that may endanger your life if you are feeling dizzy.

Taking other medicines with MEDIVISION CYCLOSERINE 250:

When you are taking MEDIVISION CYCLOSERINE 250, it is especially important to tell your doctor or healthcare professional if you are taking any of the medicines listed below:

  • Ethionamide – may increase the risk of nervous system side effects such as fits when taken together with MEDIVISION CYCLOSERINE 250.
  • Isoniazid – can increase the risk of central nervous system toxicity such as drowsiness and dizziness.
  • The levels of vitamin B12 and folic acid can be decreased when you are taking MEDIVISION CYCLOSERINE 250 and other TB medicines. It is therefore important that the doctor checks your blood levels of vitamin B12 and maybe give you supplements of this if it is low.
  • Any other medicine bought over the counter, including complementary medicines.

If you are taking medicines on a regular basis including complementary and traditional

medicines, using MEDIVISION CYCLOSERINE 250 at the same time may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice.

HOW TO TAKE MEDIVISION CYCLOSERINE 250

Adults:

The average dose is 10 mg – 20 mg / kg daily in divided doses, with a minimum of 500 mg and a maximum of 750 mg daily, monitored by blood level determinations. The initial adult dosage most frequently given is 250 mg twice daily at 12-hour intervals for the first two weeks.
It is suggested to give pyridoxine 200 – 300 mg / day together with MEDIVISION CYCLOSERINE 250 to decrease neurotoxic effects.

MEDIVISION CYCLOSERINE 250 can be given to the elderly in the same dose as adults, but dosage should be reduced if kidney function is impaired.

If you have the impression that the effect of MEDIVISION CYCLOSERINE 250 is too strong or too weak, talk to your doctor or pharmacist

The doctor will prescribe different doses for different patients and therefore follow the orders given by your doctor or pharmacist, do not change it.

If you take more MEDIVISION CYCLOSERINE 250 than you should:

Too much MEDIVISION CYCLOSERINE 250 can cause side-effects to occur, such as anxiety, drowsiness, increased irritability or restlessness, trembling, speech problems, thoughts of suicide.

If any of the above symptoms occur, get medical help immediately by calling your nearest doctor or healthcare professional.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center

If you forget to take MEDIVISION CYCLOSERINE 250:

If you have missed a dose of MEDIVISION CYCLOSERINE 250 capsules, take it as soon as you remember. However if it is almost time for your next dose, skip the missed dose and go back to your regular scheduling. Never double your dose.

MEDIVISION CYCLOSERINE 250 may cause side-effects.

If you experience any of the following conditions you may be having an allergic reaction to MEDIVISION CYCLOSERINE:
Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing’, ‘rash or itching’.

If any of the above conditions occur, stop taking MEDIVISION CYCLOSERINE and inform your doctor immediately or go the casualty department at your nearest hospital.

The following side-effects may occur frequently. Check with your doctor as soon as possible if any of the following side-effects occur:

  • Anxiety,
  • confusion,
  • dizziness
  • drowsiness
  • increased irritability
  • increased restlessness
  • mental depression
  • muscle twitching or trembling
  • nervousness
  • nightmares
  • speech problems
  • thoughts of suicide
  • headache
  • seizures (fits)
  • numbness
  • tingling
  • burning pain
  • weakness in the hands or feet

Not all side effects reported for MEDIVISION CYCLOSERINE 250 are included in this leaflet. Should your general health worsen while taking MEDIVISION CYCLOSERINE 250, please consult your doctor, pharmacist or other health care professional for advice.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

STORAGE & DISPOSAL INORMATION FOR MEDIVISION CYCLOSERINE 250:

Store at or below 25 C

Store this medicine away from heat and moisture. Keep blister in carton until required. Do not refrigerate or freeze this medicine.
Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy.

STORE ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.

PRESENTATION:

MEDIVISION CYCLOSERINE 250:

Single aluminium blister strip containing 10 capsules. 10 blister strips are packed in a carton containing

100 capsules.

IDENTIFICATION:

MEDIVISION CYCLOSERINE 250

White to pale yellow powder contained in a size ‘1’ capsule with a maroon body and cap.

REGISTRATION NUMBER:

42/20.1.1/0542

NAME AND BUSINESS ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:

Medivision (Pty) Ltd

100 Northern Parkway Rd Crownwood Office Ormonde

DATE OF PUBLICATION THE PATIENT INFORMATION LEAFLET:

31/07/2014

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