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Product name Product type Date released
Expand Pamisol CMI 23 Apr 2021
 
This medicine is to treat:
cancer of the bone that has spread from breast cancer or advanced multiple myeloma (a cancer of the bone marrow)
high calcium levels in the blood due to cancer
Paget’s disease (a disease in which sections of bone break down excessively and are repaired incorrectly by the body).
This medicine belongs to a group of medicines called bisphosphonates.
It works by binding to bones and preventing them from being broken down excessively. This reduces the amount of calcium released into the blood. It can also reduce bone pain, prevent fractures (breaks) and reduce
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.
read more
Expand Marvelon PI 20 Apr 2021
 
Expand Marvelon CMI 20 Apr 2021
 
Marvelon 28 is an oral contraceptive, commonly known as a "Birth Control Pill" or "The Pill" that has been prescribed to prevent you from getting pregnant.
Marvelon 28 prevents pregnancy in several ways:
It inhibits the egg release by stopping it maturing.
Changing the cervical mucus consistency making it difficult for the sperm to reach the egg.
Changing the lining of the uterus making it less suitable for implantation.
Marvelon 28 consists of 21 large white tablets, each containing 2 active ingredients: 30 micrograms of ethinylestradiol (an estrogen) and 150 micrograms of desogestrel (a progestogen) and 7 small white inactive tablets (first row of the blister pack).
Because of the small amounts of different female hormones in the active tablets, Marvelon 28 is considered a low-dose combined oral contraceptive.
Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets) the chance of becoming pregnant is very low.
The following non-contraceptive health benefits have been associated with the combined Pill:
Your periods may be lighter and shorter. As a result, the risk of anaemia may be lower.
Your period pains may become less severe or may completely disappear.
In addition, some serious disorders have been reported to occur less frequently in users of Pills containing 50 micrograms of ethinylestradiol ('high-dose Pills'). These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease), ectopic pregnancy (pregnancy in which the embryo implants outside of the womb) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for low-dose Pills but so far this has only been confirmed for endometrial and ovarian cancer.
Marvelon 28 is available only with a doctor's prescription.
read more
Expand Maxalt PI 20 Apr 2021
 
Expand Maxalt CMI 20 Apr 2021
 
MAXALT Wafers are used to relieve the headache pain and other symptoms of migraine attacks. MAXALT Wafers do not work for other types of headaches.
Migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. Some people may have visual symptoms before the headache, called an aura. An aura can include flashing lights or wavy lines.
Migraine attacks last anything from two hours to two days and they can return frequently. The severity and frequency of migraine attacks may vary.
Migraine occurs in about one out of every 10 people. It is three times more common in women than men.
Six out of ten migraine sufferers have their first attack before the age of 20.
There is no single cause of migraine. It tends to run in families. Certain things, singly or in combination, can trigger migraine attacks in some people. Some of these triggers are:
certain foods or drinks, for example, cheese and other dairy products, chocolate, citrus fruit, caffeine, alcohol (especially red wine)
stress, anger, worry
changes in routine, for example, under or over sleeping, missing a meal, change in diet
bright light or loud noises
hormonal changes in women, for example, during menstrual periods
If you understand what triggers your attacks, you may be able to prevent migraine attacks or reduce their frequency. Keeping a headache diary will help you identify and monitor all of the possible migraine triggers you encounter. Once the triggers are identified, you and your doctor can modify your treatment and lifestyle appropriately.
Ask your doctor if you have any questions about why MAXALT has been prescribed for you.

How MAXALT Wafers work

During a migraine attack, blood vessels in the brain dilate, or widen, resulting in a throbbing pain. MAXALT Wafers decrease this widening, returning the blood vessels to their normal size, and therefore helps to relieve the pain. MAXALT Wafers also block the release of certain chemicals from nerve endings that cause more pain and other symptoms of migraine.
read more
Expand Livial PI 20 Apr 2021
 
Expand Lukair PI 20 Apr 2021
 
Expand Lukair CMI 20 Apr 2021
 
LUKAIR is used to prevent asthma symptoms, including those that occur during the day and at night-time. It also prevents the narrowing of airways triggered by exercise.
If you have seasonal allergic rhinitis (hay fever), LUKAIR also treats your allergic rhinitis symptoms.
It can be used in children 2 years of age and older, teenagers and adults.
LUKAIR tablets are not used to treat an acute attack of asthma. If an acute attack occurs, follow your doctor's instructions for your reliever medicine, and keep taking your LUKAIR each night or as prescribed.
As a preventive medicine for asthma, LUKAIR can be used alone or in combination with other preventive medicines, such as inhaled corticosteroids. Your doctor may reduce your dose of inhaled corticosteroid while you are taking LUKAIR.
Asthma is a lung disease and has the following characteristics:
narrowed airways causing breathing to become difficult
inflamed airways, which means the lining of airways become swollen
sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air.
Symptoms of asthma include coughing, wheezing and chest tightness. Not all people with asthma wheeze. For some, coughing may be the only symptom of asthma. Symptoms often occur during the night or after exercise.
For further information about asthma, contact the Asthma Foundation in your state on 1800 645 130, or www.asthmaaustralia.org.au
Seasonal allergic rhinitis (also known as hay fever) is an allergic response often caused by airborne pollens from trees, grasses, and weeds. The daytime and night-time symptoms of seasonal allergic rhinitis typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.

How LUKAIR works

LUKAIR belongs to a group of medicines called leukotriene receptor antagonists. It works by blocking substances in your lungs called leukotrienes that cause narrowing and swelling of airways. Blocking leukotrienes improves asthma symptoms and helps prevent asthma attacks. Leukotrienes also cause allergic rhinitis symptoms. By blocking leukotrienes, LUKAIR improves seasonal allergic rhinitis symptoms.
Your doctor may have prescribed LUKAIR for another reason. Ask your doctor if you have any questions about why LUKAIR has been prescribed for you.
LUKAIR is not addictive.
read more
Expand Livial CMI 20 Apr 2021
 
Livial tablets contain the active ingredient tibolone, which is a synthetic steroid medicine used for hormone replacement therapy (HRT). It mimics the activity of the female sex hormones in the body.
Livial contains tibolone, a substance that has favourable effects on different tissues in the body, such as brain, vagina and bone. Livial is used in postmenopausal women at least 12 months since their last natural period.
Livial is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of estrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Livial alleviates these symptoms after menopause. You will only be prescribed Livial if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can take Livial to prevent osteoporosis after menopause.
Livial is not a contraceptive.
Livial has no effect on alertness and concentration as far as is known.
A doctor's prescription is required to obtain this medicine.
read more
Expand Nasonex PI 20 Apr 2021
 
Expand Nasonex CMI 20 Apr 2021
 
NASONEX contains the active ingredient mometasone furoate. This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation.
Allergic Rhinitis (hayfever):
NASONEX is sprayed into the nose to help relieve symptoms that may occur with hayfever or other year- round allergies, including stuffiness (congestion) in the nose, discharge, itching and sneezing. Your doctor may also prescribe this medicine to help prevent these symptoms two to four weeks before the beginning of the pollen season.
Nasal Polyps:
Swollen tissue in the nose can cause grape-like swellings called 'polyps'. Polyps can cause nasal stuffiness, discomfort and loss of smell.
NASONEX can be used for the treatment of nasal polyps in patients over 18 years of age.
Acute Rhinosinusitis:
Rhinosinusitis is the swelling of the sinuses resulting in stuffiness of the nose, large quantities of mucus from the nose, cough, face pain and/or fever. These symptoms usually last for less than 4 weeks. NASONEX is used to treat the symptoms of rhinosinusitis in adults and children 12 years of age and older, who do not have the signs or symptoms of a severe bacterial infection.
Your doctor may have prescribed it for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.
There is no evidence that this medicine is addictive.
This medicine is available only with a doctor's prescription.
read more
Expand Pamisol PI 20 Apr 2021
 
Expand Hadlima pre-filled syringe CMI 19 Apr 2021
 
The active ingredient in this medicine is adalimumab, which is a fully human monoclonal antibody. Monoclonal antibodies are proteins made by a type of blood cell to fight a foreign protein in the body.
Adalimumab recognises and binds to a specific protein (tumour necrosis factor or TNF-alpha), which is present at higher levels in some inflammatory diseases.
Hadlima is used for the treatment of a number of inflammatory diseases:
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. Signs and symptoms of rheumatoid arthritis include joint pain, tenderness, swelling and stiffness.
Hadlima is used to reduce the signs and symptoms of moderate to severely active rheumatoid arthritis, as well as to slow down and protect the joints from further damage to help them move more freely.
Your doctor will decide if Hadlima should be used with another medicine called methotrexate, or on its own.
Hadlima can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
pJIA is an inflammatory disease of the joints. Hadlima is used to reduce the signs and symptoms of moderate to severely active pJIA, in patients 2 years of age and older, when other medicines are not appropriate. Your doctor will decide whether Hadlima should be used with another medicine called methotrexate or used alone.
Enthesitis-related arthritis (ERA)
ERA is an inflammatory disease of the joints and the places where tendons join the bone. Hadlima is used to treat ERA in children.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you haven’t responded well enough to these medicines.
Psoriatic arthritis (PsA)
PsA is an inflammatory disease of the joints that is usually associated with psoriasis. Signs and symptoms include joint pain, tenderness and swelling. Hadlima is used to reduce the signs and symptoms, of moderate to severely active PsA, as well as to slow down and protect the joints from further damage, to help them move more freely.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you haven’t responded well enough to these medicines.
Ankylosing spondylitis
Ankylosing spondylitis is an inflammatory disease of the spine. Signs and symptoms of ankylosing spondylitis include back pain and stiffness. Hadlima is used to reduce the signs and symptoms in patients with active disease.
Crohn's Disease
Crohn's disease is an inflammatory disease of the digestive tract. Hadlima is used to treat moderate to severe Crohn’s disease, in adults and children aged 6 years and over to reduce the signs and symptoms of the disease and to induce and maintain periods where the symptoms are no longer present (remission).
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you may either have not responded well enough, or you may have lost response or cannot tolerate these medicines.
Ulcerative Colitis
Ulcerative colitis is an inflammatory disease of the large intestine (bowel).
Hadlima is used to treat moderate to severe ulcerative colitis when other medicines are not appropriate.
Psoriasis
Psoriasis is an inflammatory disease of the skin. Plaque psoriasis, the most common form, is a skin condition that causes red, flaky, crusty patches of the skin covered with silvery scales. Plaque psoriasis can also affect nails, causing them to crumble, thicken and lift away from the nail bed which can be painful. Hadlima is used to treat moderate to severe forms of the disease in adults and severe forms in children and adolescents from 4 years of age for whom topical therapy (such as creams, lotions and ointments) and phototherapy (also known as light therapy) have either not worked very well, or are not suitable.
Hidradenitis suppurativa (HS)
HS (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus, which can have an unpleasant odour. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.
Hadlima is used for the treatment of adults and adolescents from 12 years of age with active moderate to severe HS, Hadlima can reduce the number of nodules and abscesses caused by the disease, and the pain that is often associated with it.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you haven’t responded well enough to these medicines.
Your doctor will schedule follow-up appointments to check on your progress to determine whether you should continue treatment.
Uveitis
Uveitis is an inflammatory disease affecting certain parts of the eye. This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Hadlima is used to treat non-infectious intermediate, posterior and pan-uveitis.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you may either have not responded well enough, or you have lost response or cannot tolerate these medicines.
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 only available with a doctor's prescription.
The long term effects of adalimumab on the growth and development of children are not known.
read more
Expand Hadlima PushTouch auto-injector CMI 19 Apr 2021
 
The active ingredient in this medicine is adalimumab, which is a fully human monoclonal antibody. Monoclonal antibodies are proteins made by a type of blood cell to fight a foreign protein in the body.
Adalimumab recognises and binds to a specific protein (tumour necrosis factor or TNF-alpha), which is present at higher levels in some inflammatory diseases.
Hadlima is used for the treatment of a number of inflammatory diseases:
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. Signs and symptoms of rheumatoid arthritis include joint pain, tenderness, swelling and stiffness.
Hadlima is used to reduce the signs and symptoms of moderate to severely active rheumatoid arthritis, as well as to slow down and protect the joints from further damage to help them move more freely.
Your doctor will decide if Hadlima should be used with another medicine called methotrexate, or on its own.
Hadlima can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
pJIA is an inflammatory disease of the joints. Hadlima is used to reduce the signs and symptoms of moderate to severely active pJIA, in patients 2 years of age and older, when other medicines are not appropriate. Your doctor will decide whether Hadlima should be used with another medicine called methotrexate or used alone.
Enthesitis-related arthritis (ERA)
ERA is an inflammatory disease of the joints and the places where tendons join the bone. Hadlima is used to treat ERA in children.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you haven’t responded well enough to these medicines.
Psoriatic arthritis (PsA)
PsA is an inflammatory disease of the joints that is usually associated with psoriasis. Signs and symptoms include joint pain, tenderness and swelling. Hadlima is used to reduce the signs and symptoms, of moderate to severely active PsA, as well as to slow down and protect the joints from further damage, to help them move more freely.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you haven’t responded well enough to these medicines.
Ankylosing spondylitis
Ankylosing spondylitis is an inflammatory disease of the spine. Signs and symptoms of ankylosing spondylitis include back pain and stiffness. Hadlima is used to reduce the signs and symptoms in patients with active disease.
Crohn's Disease
Crohn's disease is an inflammatory disease of the digestive tract. Hadlima is used to treat moderate to severe Crohn’s disease, in adults and children aged 6 years and over to reduce the signs and symptoms of the disease and to induce and maintain periods where the symptoms are no longer present (remission).
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you may either have not responded well enough, or you may have lost response or cannot tolerate these medicines.
Ulcerative Colitis
Ulcerative colitis is an inflammatory disease of the large intestine (bowel).
Hadlima is used to treat moderate to severe ulcerative colitis when other medicines are not appropriate.
Psoriasis
Psoriasis is an inflammatory disease of the skin. Plaque psoriasis, the most common form, is a skin condition that causes red, flaky, crusty patches of the skin covered with silvery scales. Plaque psoriasis can also affect nails, causing them to crumble, thicken and lift away from the nail bed which can be painful. Hadlima is used to treat moderate to severe forms of the disease in adults and severe forms in children and adolescents from 4 years of age for whom topical therapy (such as creams, lotions and ointments) and phototherapy (also known as light therapy) have either not worked very well, or are not suitable.
Hidradenitis suppurativa (HS)
HS (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus, which can have an unpleasant odour. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.
Hadlima is used for the treatment of adults and adolescents from 12 years of age with active moderate to severe HS, Hadlima can reduce the number of nodules and abscesses caused by the disease, and the pain that is often associated with it.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you haven’t responded well enough to these medicines.
Your doctor will schedule follow-up appointments to check on your progress to determine whether you should continue treatment.
Uveitis
Uveitis is an inflammatory disease affecting certain parts of the eye. This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Hadlima is used to treat non-infectious intermediate, posterior and pan-uveitis.
You may have already been given other medicines to treat your condition. Your doctor has prescribed Hadlima for you as you may either have not responded well enough, or you have lost response or cannot tolerate these medicines.
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 only available with a doctor's prescription.
The long term effects of adalimumab on the growth and development of children are not known.
read more
Expand Hadlima PI 19 Apr 2021
 
Expand Implanon NXT CMI 19 Apr 2021
 

What does it contain?

Implanon NXT is a contraceptive implant preloaded in a disposable applicator. The implant contains 68 mg of the active substance etonogestrel. Etonogestrel is a synthetic female hormone resembling progesterone. A small amount of the hormone etonogestrel is continuously released into the bloodstream for three years. The rod itself is made of ethylene vinyl acetate copolymer, a plastic that will not dissolve in the body. It also contains small amounts of barium sulfate (which renders it visible under X-ray) and magnesium stearate.
Although the implant may be removed at any time, it must be removed no later than three years after insertion.

How does Implanon NXT work?

Implanon NXT is used to prevent pregnancy.
Implanon NXT is placed directly under the skin at the inner side of the non-dominant upper arm.
Implanon NXT prevents pregnancy in two ways:
It prevents the release of an egg cell from the ovaries (ovulation)
It causes changes to cervical mucus that makes it difficult for sperm to enter the womb.
As a result, Implanon NXT protects you against pregnancy for a period of three years, but if you are overweight the doctor may advise you to replace the implant earlier. Implanon NXT is one of several means of preventing pregnancy. Another frequently used birth control method is the combined Pill. Implanon NXT differs from combined Pills in that it contains no oestrogen and you do not have to remember to take a pill every day.
Implanon NXT has several important advantages:
It is one of the most reliable birth control methods (over 99% effective).
It does not interfere with having sex.
Once you stop using it you can expect your previous fertility to return quickly.
Furthermore, compared to the combined Pill, Implanon NXT has some additional advantages, but also some disadvantages:
Advantages
You do not have to worry about taking a tablet each day; the implant should be replaced every 3 years.
Implanon NXT may be used by women who do not tolerate oestrogens.
In some circumstances Implanon NXT may be used by breast-feeding women. Check with your doctor for advice.
Disadvantages
Your menstrual bleeding may change and become absent, irregular, infrequent, frequent, prolonged, or rarely heavy. The bleeding pattern that you experience during the first three months generally indicates your future bleeding pattern. (see also 'Menstrual bleeding')
On rare occasions, the implant moves from its original position. This may complicate removal (see also 'Insertion and removal related events').
If in rare cases the implant is not inserted correctly or is not inserted at all, you may not be protected against pregnancy.
Implanon NXT must be inserted and removed by a doctor. A small scar may remain.
A doctor's prescription is required to obtain this medicine.
Before you have Implanon NXT inserted or removed, confirm that your doctor is familiar with the technique. For uncomplicated removals, it is necessary that Implanon NXT be inserted directly under the skin. Incorrect insertion may lead to complicated removals that may result in scarring.

Ability to drive

There are no indications of any effect of Implanon NXT on alertness and concentration.
read more
Expand Implanon NXT PI 19 Apr 2021
 
Expand Lipex PI 19 Apr 2021
 
Expand Lipex CMI 19 Apr 2021
 
LIPEX helps to lower cholesterol and triglyceride levels.
LIPEX is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease).
LIPEX may be used in these people, regardless of their cholesterol level to:
help prolong life by reducing the risk of a heart attack
reduce the risk of stroke
reduce the need for surgery to increase blood flow to the heart
reduce the need for hospitalisation due to angina.

Cholesterol

Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem.
Your body makes cholesterol, but it also comes from food.
Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in fat, your body may not keep this balance and your cholesterol levels rise.
High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.
When you have high levels of cholesterol, it may 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas, called plaque, on the walls of blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to coronary heart disease (such as heart attack and angina), and stroke.
In people with CHD, LIPEX may slow down the hardening of blood vessels and reduce the risk of developing new plaques.
There are different types of cholesterol, called LDL and HDL cholesterol. LDL cholesterol is the 'bad' cholesterol that can block your blood vessels. HDL cholesterol, on the other hand, is the 'good' cholesterol that is thought to remove the bad cholesterol from the blood vessels.

Triglycerides

Triglycerides are an energy source for the body. However, as with cholesterol, too much triglycerides can be a problem.

How LIPEX works

LIPEX belongs to a group of medicines known as HMG-CoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. In terms of good and bad cholesterol, LIPEX reduces the bad cholesterol and raises the good cholesterol.
LIPEX does not reduce the cholesterol and triglycerides that come from fat in food.
Therefore, when you are taking LIPEX, you also need to follow a low fat diet and other measures, such as exercise and weight control.
In most people, there are no symptoms of high cholesterol or triglycerides. Your doctor can measure your cholesterol and triglycerides with a simple blood test.
Safety and effectiveness have been studied in 10-17 year old boys and in girls, who had started their menstrual period at least one year before (see How to take LIPEX). LIPEX has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Your doctor may have prescribed LIPEX for another reason. Ask your doctor if you have any questions about why LIPEX has been prescribed for you.
LIPEX is not addictive.
read more
Expand Ezalo Composite Pack PI 19 Apr 2021