Note: the documents on this web site are PDF files. If you do not have a PDF reader, you can download one now.

Product name Product type Date released
Expand Renflexis CMI 21 Apr 2017
 
RENFLEXIS contains the active ingredient, infliximab.
RENFLEXIS is a biosimilar medicine. Comparability in safety, efficacy and quality between RENFLEXIS and the reference product has been established.
Infliximab is a monoclonal antibody that is produced from human and mouse proteins by recombinant technology. Monoclonal antibodies are proteins that recognise and bind to certain special proteins in the body.
Infliximab acts by binding to a special protein in the body called tumour necrosis factor alpha (TNFα). In people with diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis, the body produces too much TNFα, which can cause the body's immune system to attack normal healthy parts of the body. RENFLEXIS can block the damage caused by too much TNFα.
 
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. RENFLEXIS is used to reduce the signs and symptoms of rheumatoid arthritis and to prevent damage to the joints. You will also be given a disease-modifying medicine called methotrexate.
 
Ankylosing Spondylitis
Ankylosing spondylitis is an inflammatory disease of the spine. RENFLEXIS can reduce the signs and symptoms of ankylosing spondylitis, thereby improving physical function.
 
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints in which psoriasis usually occurs in association with arthritis. Often the fingers and toes are affected, although it may occur in other parts of the body. RENFLEXIS is used to reduce the signs and symptoms of psoriatic arthritis and improve the physical function in adults who have not responded well enough to previous treatments with other disease-modifying anti-rheumatic drugs (DMARDS). RENFLEXIS may be given alone or in combination with methotrexate.
 
Psoriasis
Psoriasis is an inflammatory disease of the skin. RENFLEXIS is used to treat patients with moderate to severe psoriasis who have not responded well enough to treatments such as phototherapy or conventional systemic treatments, or when these treatments are not appropriate.
 
Crohn's disease
Crohn's disease is a chronic inflammatory disease of the bowel. It may also affect any part of the gut. RENFLEXIS is used to treat moderate to severe Crohn's disease in adult patients and in children and adolescent patients (6 to 17 years old) who have not responded well enough to other treatments.
RENFLEXIS can also reduce the number of abnormal openings from the bowel through the skin (called draining enterocutaneous fistula), a common complication of Crohn's disease.
 
Ulcerative Colitis
Ulcerative colitis is an inflammatory disease of the bowel. RENFLEXIS is used to treat the signs and symptoms of ulcerative colitis in adult patients and in children and adolescent patients (6 to 17 years old) who have not responded well enough to other treatments.
Do not give RENFLEXIS to children with Crohn's disease or ulcerative colitis who are younger than 6 years.
Do not give RENFLEXIS to children and adolescents with any other disease.
Your doctor, however, may prescribe RENFLEXIS for another purpose.
Ask your doctor if you have any questions about why RENFLEXIS has been prescribed for you.
read more
  • Download PDF Standard Print
  • Download PDF Large Print
Expand Moxifloxacin APOTEX CMI 19 Apr 2017
 
The name of your medicine is Moxifloxacin APOTEX tablets. It contains the active ingredient moxifloxacin, which is an antibiotic belonging to a group of medicines called quinolones. These antibiotics work by killing the bacteria that are causing your infection.
Moxifloxacin will not work against infections caused by viruses such as colds or the flu.
It is used to treat infections of the lungs, airways and sinuses in adults. In certain infections, you may require treatment with moxifloxacin injection followed by a course of moxifloxacin tablets e.g. severe and complicated skin and skin structure infections.
Even if you have read the Consumer Medicine Information for moxifloxacin injection, you should read this leaflet as well as it contains information specific to the tablets.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.

How it works

The antibacterial action of moxifloxacin works by interrupting the pathways that allow bacterial DNA to replicate and repair. At the correct dose moxifloxacin can kill susceptible bacteria.
There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children.
read more
Expand Moxifloxacin APOTEX PI 19 Apr 2017
 
Expand APO-Sumatriptan CMI 13 Apr 2017
 
The name of your medicine is APO-Sumatriptan. It contains the active ingredient sumatriptan (as sumatriptan succinate).
This medicine belongs to a group of drugs called serotonin agonists. It is used to relieve a migraine attack. It should not be used to prevent migraine attacks from occurring. This medicine may be used for migraine headaches with or without what is known as 'aura'.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.

How it works

It is thought that a migraine headache is due to widening of certain blood vessels in the head. This medicine works by narrowing the affected vessels, to ease the symptoms of migraine.
This medicine does not work in other types of headache which are not a migraine.
There is no evidence that this medicine is addictive.

Use in children

The effectiveness of this medicine has not been established in adolescents between 12 and 17; and the safety and effectiveness of this medicine in children under the age of 12 years has not been established.

Use in the elderly

It is not recommended that people over 65 use this medicine.
read more
  • Download PDF Standard Print
  • Download PDF Large Print
Expand APO-Sumatriptan PI 13 Apr 2017
 
Expand Arianna 1 CMI 13 Apr 2017
 
Arianna 1 is a non-steroidal aromatase inhibitor, which reduces the amount of oestrogen (female sex hormone) made by the body. In some types of breast cancer, oestrogen can help the cancer cells grow. Arianna 1 may slow or stop the growth of cancer by blocking oestrogen.
Arianna 1 is used to treat breast cancer in women who no longer have their menstrual periods either naturally, due to their age or after surgery, radiotherapy or chemotherapy.
Follow all directions given to you by your doctor.
They may differ from the information contained in this leaflet.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed Arianna 1 for another reason.
Arianna 1 is only available with a doctor's prescription.
Arianna 1 is not addictive.
read more
Expand Arianna 1 PI 13 Apr 2017
 
Expand Moxicam Capsules PI 10 Apr 2017
 
Expand Moxicam Capsules CMI 10 Apr 2017
 
The name of your medicine is Moxicam. It contains the active ingredient meloxicam.
It is used to treat the symptoms of
Osteoarthritis
rheumatoid arthritis
Both diseases mainly affect the joints causing pain and swelling.
Although meloxicam can relieve the symptoms of pain and inflammation, it will not cure your condition.

How it works

Meloxicam belongs to a family of medicines called Non-Steroidal Anti- inflammatory Drugs (NSAIDs).
These medicines work by relieving pain and inflammation.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
read more
  • Download PDF Standard Print
  • Download PDF Large Print
Expand LanPro CMI 10 Apr 2017
 
This medicine is used to treat lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure.
Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye. There are usually no symptoms of glaucoma. If glaucoma is not treated it can lead to serious problems, including total blindness. In fact, untreated glaucoma is one of the most common causes of blindness.
It contains the active ingredient latanoprost. Latanoprost belongs to a group of medicines called prostaglandin agonists.
It works by lowering the pressure in the eye by allowing more fluid to flow out from within your eye.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
LanPro is not recommended for use in children.
Safety and effectiveness in children has not been established.
read more
  • Download PDF Standard Print
  • Download PDF Large Print
Expand APO-Clonidine PI 06 Apr 2017
 
Expand APO-Naltrexone CMI 06 Apr 2017
 
The name of your medicine is APO-NALTREXONE Tablets. It contains the active ingredient Naltrexone Hydrochloride. It is an opiate antagonist. This means it fights the effects of opiate drugs (such as heroin) on the body and, blocks the euphoria ("high") due to these opiates.
It is used:
as part of a treatment programme for alcohol dependence.
as adjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids such as diamorphine (heroin) and morphine
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.

How it works

Naltrexone Hydrochloride blocks the effects of opioids by competitive binding (i.e., analogous to competitive inhibition of enzymes) at opioid receptors.
There is no evidence that this medicine is addictive.
read more
  • Download PDF Standard Print
  • Download PDF Large Print
Expand APO-Naltrexone PI 06 Apr 2017
 
Expand Risperidone Sandoz PI 06 Apr 2017
 
Expand APO-Tranexamic Acid PI 06 Apr 2017
 
Expand APO-Tranexamic Acid CMI 06 Apr 2017
 
APO-TRANEXAMIC ACID is used to prevent bleeding in patients with:
Traumatic hyphaema (bleeding into the front part of the eye)
Blood clotting disorders, who are having minor surgery
Heavy periods
Hereditary angioneurotic oedema (periodic swelling of the throat)
APO-TRANEXAMIC ACID contains tranexamic acid. Tranexamic acid is an antifibrinolytic that works by slowing the processes that cause bleeding.
read more
  • Download PDF Standard Print
  • Download PDF Large Print
Expand Zarontin PI 05 Apr 2017
 
Expand Zarontin CMI 05 Apr 2017
 
Zarontin is used to control epilepsy in children and adults. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.
Zarontin is used to control petit mal seizures.
Zarontin belongs to a group of medicines called anticonvulsants. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.
Zarontin may be used alone, or in combination with other medicines, to treat your condition.
Your doctor may have prescribed Zarontin for another reason. Ask your doctor if you have any questions about why Zarontin has been prescribed for you.
There is no evidence that Zarontin is addictive.
This medicine is available only with a doctor's prescription.
read more
  • Download PDF Standard Print
  • Download PDF Large Print
Expand Ristempa PI 31 Mar 2017
 
Expand Ristempa CMI 30 Mar 2017
 
Ristempa is used following chemotherapy to help fight infection.
Some chemotherapy will reduce the number of neutrophils in your body. Although Ristempa is not a treatment for cancer, it does help the body to make new neutrophils. This will reduce your chance of developing infections that might require antibiotics and/or hospital stays. It may even increase your chance of receiving your chemotherapy on time and at the right dose.

How it works

Ristempa is a long acting form of Recombinant Human Granulocyte Colony Stimulating Factor or G-CSF. Using gene technology, Ristempa is produced in a specific type of bacteria, called E. coli.
G-CSF is produced in the bone marrow and assists in the production of neutrophils, which are a type of white blood cell. Neutrophils help the body fight infections by surrounding and destroying the bacteria that cause the infections.
G-CSF also helps neutrophils to do this work better.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine is available only with a doctor's prescription.
read more
  • Download PDF Standard Print
  • Download PDF Large Print