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Product name Product type Date released
Expand Abelcet PI 20 Jun 2018
 
Expand Tenofovir Apotex CMI 14 Jun 2018
 
The name of your medicine is Tenofovir APOTEX Tablets. It contains the active ingredient tenofovir disoproxil fumarate.
It is an antiviral medication used to treat two different viruses, Chronic Hepatitis B (CHB) and Human Immunodeficiency Virus (HIV) infection.
It is a type of medicine called a HBV polymerase inhibitor and a nucleoside analog reverse transcriptase inhibitor (NRTI).

Use in the Treatment of CHB

Tenofovir disoproxil fumarate is used to treat CHB (an infection with hepatitis B virus [HBV]) in adults and paediatric patients aged 12 years and older and weighing at least 35 kg.
It works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for HBV to reproduce itself.
This medicine may help lower the amount of hepatitis B virus in your body by lowering the ability of the virus to multiply and infect new liver cells and can improve the inflammation and scar tissue caused by the hepatitis B virus in your liver. Lowering the amount of virus in your body may reduce the chance of developing cirrhosis, liver failure and liver cancer.
We do not know how long this medicine may help treat your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance.

Use in the Treatment of HIV-Infection

Tenofovir disoproxil fumarate is also used to treat HIV infection in adults and paediatric patients aged 12 years and older and weighing at least 35 kg. It is always used in combination with other anti-HIV medicines to treat people with HIV-1 infection.
HIV infection destroys CD4 (T) cells, which are important to the immune system. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.
This medicine helps to block HIV1 reverse transcriptase, a chemical (enzyme) in your body that is needed for HIV-1 to multiply. It lowers the amount of HIV-1 in the blood (called viral load) and may help to increase the number of T cells (called CD4 cells). Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).
You do not have to have HIV-infection to be treated with this medicine for HBV and vice versa.

Does this medicine cure HIV-1 or AIDS?

This medicine does not cure HIV-1 infection, or AIDS. The long-term effects of this medicine are not known at this time. People taking this medicine may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.

Does this medicine reduce the risk of passing HIV-1 or HBV to others?

Tenofovir does not reduce the risk of passing HIV-1 or HBV to others through sexual contact or blood contamination.
Continue to practice safe sex and do not use or share dirty needles.
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.
There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children less than 12 years of age.
read more
Expand Tenofovir Apotex PI 14 Jun 2018
 
Expand Kevtam (new formula) CMI 14 Jun 2018
 
KEVTAM levetiracetam is used to treat epilepsy.
Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe.
This medicine belongs to a group of medicines called antiepileptics.
These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.
KEVTAM may be used alone, or in combination with other medicines, to treat your condition.
Your doctor may have prescribed this medicine in addition to your current therapy.
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.
There is no evidence that this medicine is addictive
This medicine is available only with a doctor's prescription.
The safety and effectiveness of KEVTAM has not been established in patients less than 4 years of age.
read more
Expand Kevtam 250 Kevtam 500 Kevtam 1000 PI 13 Jun 2018
 
Expand Enoxaparin Winthrop CMI 12 Jun 2018
 
Enoxaparin Winthrop is used in a number of medical conditions. It is used to:
treat blood clots
treat certain types of heart disease (eg. angina and heart attacks), when used with aspirin
prevent blood clots forming after an operation, during hospitalisation or extended bed rest or during purification of the blood by an artificial kidney (haemodialysis).
Enoxaparin Winthrop is one of a group of medicines called low molecular weight heparins (LMWH). These medicines work by reducing blood clotting activity.
Your doctor may have prescribed Enoxaparin Winthrop for another reason.
Ask your doctor if you have any questions about why Enoxaparin Winthrop has been prescribed for you.
There is no evidence that Enoxaparin Winthrop is addictive.
This medicine is only available with a doctor's prescription.
read more
Expand Dosulepin Mylan CMI 08 Jun 2018
 
Dosulepin Mylan is used to treat depression.
Dosulepin Mylan 25 mg capsules can be used at any stage in the treatment of depression. However, the higher strength Dosulepin Mylan 75 mg tablets are approved only for the maintenance treatment of depression (after your symptoms have improved).
Dosulepin Mylan belongs to a group of medicines called tricyclic antidepressants (TCAs). TCA medicines work by correcting the imbalance of certain chemicals in the brain. These chemicals, called amines, are involved in controlling mood. By correcting this imbalance, TCAs can help relieve the symptoms of depression.
Ask your doctor if you have any questions about why Dosulepin Mylan has been prescribed for you.
Your doctor may have prescribed Dosulepin Mylan for another reason.
Dosulepin Mylan is not approved for use in children and adolescents below 18 years of age for the treatment of depression.
The safe use and effectiveness of Dosulepin Mylan in treating depression, for this age group has not been established.
Dosulepin Mylan is available only with a doctor's prescription.
read more
Expand Dosulepin Mylan PI 07 Jun 2018
 
Expand Dicloxacillin Mylan CMI 07 Jun 2018
 
Dicloxacillin Mylan is used to treat infections in different parts of the body caused by bacteria.
Dicloxacillin Mylan is an antibiotic that belongs to a group of medicines called penicillins. These medicines work by killing the bacteria that are causing your infection.
Dicloxacillin Mylan will not work against infections caused by viruses, such as colds or flu.
Ask your doctor if you have any questions about why Dicloxacillin Mylan has been prescribed for you.
Your doctor may have prescribed Dicloxacillin Mylan for another purpose.
Dicloxacillin Mylan is not recommended for use in newborn infants as its safety and effectiveness have not been established in this age group.
Dicloxacillin Mylan is available only with a doctor's prescription.
There is no evidence that Dicloxacillin Mylan is addictive.
read more
Expand Adrenaline Mylan CMI 07 Jun 2018
 
ADRENALINE MYLAN is only to be used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also known as ANAPHYLAXIS). Your doctor or pharmacist will explain what this is like, so that you know when you must use ADRENALINE MYLAN.
ADRENALINE MYLAN is used to treat people who have a severe allergic reaction caused by, for example, hypersensitivity to
food
medicines
stinging insects
insect bites
latex or
other allergens, possibly unidentified.
See Side effects for information regarding allergy to sodium metabisulfite.
Avoidance of known allergens is most important in preventing severe allergic reactions.
A severe allergic reaction, otherwise known as anaphylaxis, is overwhelming and life-threatening.
It affects the whole body, in particular the
heart and blood circulation.
This may cause, for example, low blood pressure and collapse, or abnormal heart beat or function.
air passages and lungs.
This causes difficulty in breathing, with noisy wheezing or gasping, possibly with sneezing and a very runny nose.
stomach and bowels.
This may cause nausea, vomiting, diarrhoea and abdominal cramps, often severe.
skin (very common).
This causes flushing, itching, skin rash, hives or swelling, which may be widespread or in one part of the body.
brain.
There may be fits or confusion due to lack of oxygen.
Usually several parts of the body are affected. The patient feels extremely unwell.
It is important to act quickly to treat a severe allergic reaction.
The adrenaline in ADRENALINE MYLAN treats allergic emergencies. It
shrinks abnormally wide blood vessels and
makes the heart beat strongly.
This helps improve the very low blood pressure and poor circulation that occur in a severe allergic reaction.
Adrenaline also
relaxes the lungs. This eases breathing and lessens wheezing.
helps stop
- swelling, for example, of the face and lips
- skin rash and/or
- itching.
The ADRENALINE MYLAN Auto-Injector is intended for use in people who have been assessed and advised by their doctor or pharmacist as needing an ADRENALINE MYLAN Auto-Injector to treat their severe allergic reaction and who
weigh more than 30 kg, and
are having a severe allergic reaction.
Note: Selection of the appropriate dosage is determined according to patient body weight.
For a person who weighs from 15 kg up to 30 kg, the doctor or pharmacist may assess their severe allergic reaction as needing the larger dosage of adrenaline as provided by an ADRENALINE MYLAN Auto-Injector. (The ADRENALINE JR MYLAN Auto-Injector delivers a smaller amount of adrenaline).
If you have any questions about this, talk to your doctor or pharmacist.
ADRENALINE MYLAN
provides convenient first-aid
may be self-administered or administered by a carer
has a spring-activated, hidden needle
automatically injects one pre-measured dose of adrenaline
is for single use only.
ADRENALINE MYLAN may be prescribed by your doctor. You can also purchase it directly from a pharmacy.
read more
Expand Adrenaline Jr Mylan CMI 07 Jun 2018
 
ADRENALINE JR MYLAN is only to be used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also known as ANAPHYLAXIS). Your doctor or pharmacist will explain what this is like, so that you know when you must use ADRENALINE JR MYLAN
ADRENALINE JR MYLAN is used to treat children who have a severe allergic reaction caused by, for example, hypersensitivity to
food
medicines
stinging insects
insect bites
latex or
other allergens, possibly unidentified.
See Side effects for information regarding allergy to sodium metabisulfite.
Avoidance of known allergens is most important in preventing severe allergic reactions.
A severe allergic reaction, otherwise known as anaphylaxis, is overwhelming and life-threatening.
It affects the whole body, in particular the
heart and blood circulation.
This may cause, for example, low blood pressure and collapse, or abnormal heart beat or function.
air passages and lungs.
This causes difficulty in breathing, with noisy wheezing or gasping, possibly with sneezing and a very runny nose.
stomach and bowels.
This may cause nausea, vomiting, diarrhoea and abdominal cramps, often severe.
skin (very common).
This causes flushing, itching, skin rash, hives or swelling, which may be widespread or in one part of the body.
brain.
There may be fits or confusion due to lack of oxygen.
Usually several parts of the body are affected. The patient feels extremely unwell.
It is important to act quickly to treat a severe allergic reaction.
The adrenaline in ADRENALINE JR MYLAN treats allergic emergencies. It
shrinks abnormally wide blood vessels and
makes the heart beat strongly.
This helps improve the very low blood pressure and poor circulation that occur in a severe allergic reaction.
Adrenaline also
relaxes the lungs. This eases breathing and lessens wheezing.
helps stop
swelling, for example, of the face and lips
skin rash and/or
itching.
The ADRENALINE JR MYLAN Auto-Injector is intended for use in children who have been assessed and advised by their doctor or pharmacist as needing an ADRENALINE JR MYLAN Auto-Injector to treat their severe allergic reaction and who
weigh from 15 kg up to 30 kg, and
are having a severe allergic reaction.
NOTE: Selection of the appropriate dosage is determined according to patient body weight.
For a child who weighs from 15 kg up to 30 kg, the doctor or pharmacist may assess their severe allergic reaction as needing the larger dosage of adrenaline as provided by an ADRENALINE MYLAN Auto-Injector. (The ADRENALINE JR MYLAN Auto-Injector delivers a smaller dosage of adrenaline). Similarly, there may be instances where the doctor or pharmacist will recommend the use of ADRENALINE JR MYLAN in some adults, based on careful medical assessment.
If you have any questions about this, talk to your doctor or pharmacist.
ADRENALINE JR MYLAN
provides convenient first-aid
may be self-administered or administered by a carer to the child
has a spring-activated, hidden needle
automatically injects one pre-measured dose of adrenaline
is for single use only.
ADRENALINE JR MYLAN may be prescribed by your doctor. You can also purchase it directly from a pharmacy.
read more
Expand APO-Aciclovir CMI 06 Jun 2018
 
The name of your medicine is APO-Aciclovir. It contains the active ingredient aciclovir.
The 200mg strength is used to
treat genital herpes. It makes an outbreak of genital herpes shorter and less severe
prevent or reduce the number of outbreaks and/or severity of genital herpes in people who experience them often.
The 800mg strength is used:
to treat shingles, also known as herpes zoster. Shingles is caused by the same virus which causes chicken pox. It usually involves nerve pain and a blistery rash, limited to one area of the body. If taken within 72 hours of first getting the rash, aciclovir makes an outbreak of shingles shorter and less severe
as part of the management program for certain infections in people who have the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Aciclovir does not cure AIDS or get rid of the HIV virus from your body, but it may prevent further damage to the immune system by stopping production of the herpes viruses.
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

Aciclovir belongs to a group of medicines called "anti-virals". It works by stopping the production of the virus that causes herpes and shingles.
Aciclovir does not get rid of the virus from your body.
There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children.
read more
Expand APO-Aciclovir PI 06 Jun 2018
 
Expand APO-Moxonidine Tablets CMI 06 Jun 2018
 
The name of your medicine is APO-Moxonidine, which is also known as moxonidine.
APO-Moxonidine lowers high blood pressure, which doctors call hypertension.
There are usually no symptoms of hypertension. The only way of knowing if you have hypertension is to have your blood pressure checked regularly. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.
Ask your doctor if you have any questions about why it has been prescribed for you.
Your doctor may have prescribed APO-Moxonidine for another use.
This medicine is only available with a doctor's prescription.
This medicine is not addictive.
read more
Expand APO-Moxonidine Tablets PI 06 Jun 2018
 
Expand Adrenaline Jr Mylan PI 06 Jun 2018
 
Expand Adrenaline Mylan PI 06 Jun 2018
 
Expand Gabitril PI 06 Jun 2018
 
Expand Gabitril CMI 06 Jun 2018
 
This medicine is used with other medicines to control some types of seizures (fits) in people with epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe.
This medicine belongs to a group of medicines called antiepileptics or anticonvulsants.
It works by increasing the level of a chemical in the brain (gamma-aminobutyric acid, or GABA). This controls the signals in nerve cells so that seizures do not happen.
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.
It is available only with a doctor’s prescription.
There is not enough information to recommend the use of this medicine for children under the age of 12 years.
read more
Expand Kalixocin Tablets PI 06 Jun 2018