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Product name Product type Date released
Expand Urocarb Tablets CMI 30 Jul 2021
 
Do not use if you have ever had an allergic reaction to bethanechol chloride or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take UROCARB? in the full CMI.
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Expand Esipram PI 30 Jul 2021
 
Expand Telfast Decongestant PI 29 Jul 2021
 
Expand Betadine Antiseptic Liquid Spray CMI 29 Jul 2021
 

Warnings

BETADINE ANTISEPTIC LIQUID SPRAY IS FOR EXTERNAL USE ONLY.

Do not use Betadine Antiseptic Spray:

if you are allergic to povidone or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
If you have a known hypersensitivity to povidone iodine, polyvinylpyrrolidone or to any excipient listed in product description section. If irritation, redness or swelling develops, discontinue treatment and consult a doctor.
if you currently have or have ever had, a thyroid problem, including swelling (nodular colloid goitre, endemic goitre or Hashimoto’s thyroiditis), as using Betadine Antiseptic Liquid Spray in these circumstances can further affect the concurrent lithium therapy or mercury derivatives therapy
for 4 weeks prior to treatment for cancer of the thyroid.
if you are pregnant or breastfeeding.
in children below 2 years of age.
DO NOT USE IF CAP SEAL IS BROKEN OR AFTER EXPIRY DATE.

Povidone-iodine preparations are expected to react with unsaturated organic compounds (e.g. blood, pus) and can lead to ineffectiveness of the preparation.

Prolonged use of Betadine Antiseptic Liquid Spray may cause irritation or rarely, severe skin reactions.

Medical advice should be sought for the treatment of more serious burns.

Betadine Antiseptic Liquid Spray should only be applied after at least 10 minutes of rapid cooling of the affected area

Do not mix with other detergents or other chemicals

If you are not sure whether any of the above apply to you, speak to your doctor or pharmacist before using.

Check with your doctor if you:

have any other medical conditions
take any medicines for any other conditions
have ever had a kidney problem as using this product may cause toxic levels of iodine to be absorbed into your blood, avoid inhalation and avoid contact with eyes
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Betadine Antiseptic Liquid Spray is not recommended during pregnancy. Check with your doctor if you are pregnant or intend to become pregnant.
Betadine Antiseptic Liquid Spray is not recommended during breastfeeding. Talk to your doctor if you are breastfeeding or intend to breastfeed.
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Expand DBL Pentamidine Isethionate PI 29 Jul 2021
 
Expand Lorstat (New Formulation) PI 29 Jul 2021
 
Expand Lorstat (New Formulation) CMI 29 Jul 2021
 
LORSTAT is used to treat
lowers high cholesterol levels
to reduce the risk of having a heart attack or stroke in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD. Examples of risk factors for CHD include diabetes, a history of stroke, or small blood vessel disease.

What is cholesterol

Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as building cell walls, making bile acids (which help to digest food) and some hormones. However, too much cholesterol can be a problem.
Cholesterol is present in many foods and is also made in your body by the liver. If your body makes too much cholesterol or you have too much cholesterol in your diet, then your cholesterol level becomes too high.
High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.
There are different types of cholesterol. LDL, or low-density lipoprotein, is the 'bad' cholesterol that can block your blood vessels. HDL, or high density lipoprotein cholesterol is the 'good' cholesterol that is thought to remove the 'bad' cholesterol from the blood vessels.
When you have high levels of 'bad' cholesterol in your blood, 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 plaques) on the walls of your blood vessels, making it more difficult for the blood to flow. Sometimes, the plaque can detach from the vessel wall and float in the bloodstream; it can then reach a smaller vessel and completely block it. This blocking of your blood vessels can lead to several types of blood vessel disease, heart attack, angina and stroke.
There is another type of fat called triglyceride, which is a source of energy. However, high levels of be associated with low level of 'good' cholesterol and may increase your risk of heart disease.
In some patients, LORSTAT is used to treat high cholesterol and high triglycerides together.
In most people, there are no symptoms of abnormal cholesterol or triglyceride levels. Your doctor can measure your levels with a simple blood test.

How LORSTAT works

LORSTAT belongs to a group of medicines known as HMG-CoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. LORSTAT 'bad' cholesterol and can raise the 'good' cholesterol. LORSTAT also helps to protect you from a heart attack or stroke.
When you are taking LORSTAT, you also need to follow a low fat diet and other measures, such as exercise and weight control.
LORSTAT may be used alone, or in combination with other medicines, to treat your condition.
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.
This medicine is not expected to affect your ability to drive a car or operate machinery.
There is not enough information to recommend the use of this medicine for children.
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Expand Aurorix PI 29 Jul 2021
 
Expand Aurorix CMI 29 Jul 2021
 
The name of your medicine is AURORIX. It contains the active ingredient called moclobemide.
AURORIX belongs to a group of medicines called antidepressants. Antidepressants are used to treat depression and work on the central nervous system. They are thought to work by their action on brain chemicals called amines, which are involved in controlling mood.
There are many different types of medicines used to treat depression. AURORIX belongs to a group of medicines called reversible inhibitors of monoamine oxidase A.
Your doctor, however, may have prescribed AURORIX for another purpose.
Ask your doctor if you have any questions about why AURORIX has been prescribed for you.
This medicine is available only with a doctor's prescription.
Do not give AURORIX to children or adolescents under 18 years of age.
The safety and effectiveness of AURORIX in this age group has not been established.
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Expand Amira 150 and Amira 300 PI 29 Jul 2021
 
Expand Amira 150 and Amira 300 CMI 29 Jul 2021
 
The name of your medicine is AMIRA 150 or AMIRA 300. The medicine contains the active ingredient called moclobemide.
AMIRA 150 and AMIRA 300 belong to a group of medicines called antidepressants. Antidepressants are used to treat depression and work on the central nervous system. They are thought to work by their action on brain chemicals called amines, which are involved in controlling mood.
There are many different types of medicines used to treat depression. AMIRA 150 and AMIRA 300 belong to a group of medicines called reversible inhibitors of monoamine oxidase A.
Your doctor, however, may have prescribed AMIRA 150 or AMIRA 300 for another purpose.
Ask your doctor if you have any questions about why AMIRA 150 or AMIRA 300 has been prescribed for you.
This medicine is available only with a doctor's prescription.
Do not give AMIRA 150 or AMIRA 300 to children or adolescents under 18 years of age.
The safety and effectiveness of AMIRA 150 or AMIRA 300 in this age group has not been established.
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Expand Keytruda PI 28 Jul 2021
 
Expand Telfast Decongestant CMI 27 Jul 2021
 
Do not use if you have ever had an allergic reaction to Telfast Decongestant or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Telfast Decongestant? in the full CMI.
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Expand Kiovig PI 27 Jul 2021
 
Expand Kiovig CMI 27 Jul 2021
 
KIOVIG is used for:
Treatment of patients who do not have sufficient antibodies (replacement therapy):
Primary immunodeficiency disorders
Disease or medical treatment that leads to a lack of antibody production and frequent infection (secondary hypogammaglobulinaemia).
Treatment of patients with certain inflammatory disorders (immunomodulation):
Idiopathic thrombocytopenic purpura (ITP, a disease where patients do not have enough blood platelets), who are at high risk of bleeding or prior to surgery to correct the platelet count.
Guillain Barré syndrome (a disease with multiple inflammations of the nervous system of the whole body)
Kawasaki disease (a disease which results in multiple inflammations of several organs)
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in adults
Multifocal motor neuropathy
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Expand Gold Cross Codeine Linctus PI 26 Jul 2021
 
Expand Spinraza PI 26 Jul 2021
 
Expand Azep CMI 26 Jul 2021
 
AZEP NASAL SPRAY is used to relieve runny nose, sneezing, itching or blocked nose caused by allergies, such as to pollen (hay fever) house dust mites or pet hair.
AZEP NASAL SPRAY belongs to a group of medicines called antihistamines. It works by blocking the action of histamine and other substances produced by the body, which are causing your allergies.
AZEP NASAL SPRAY is not addictive.
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Expand Comirnaty CMI 23 Jul 2021
 
You should not be given COMIRNATY if you have had an allergic reaction to any of the ingredients in COMIRNATY. See list at the end of the CMI.
Check with your doctor if you have had: a severe allergic reaction or breathing problems after any other vaccine or after being given COMIRNATY in the past; fainted following any needle injection; a severe illness or infection with high fever; a weakened immune system or are on a medicine that affects your immune system; a bleeding disorder, bruise easily or are on a blood thinning medicine.
As with any vaccine, COMIRNATY may not fully protect all those who receive it and it is not known how long you will be protected.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
COMIRNATY should not be given to children under 12 years. For more information, see Section 2. What should I know before I am given COMIRNATY? in the full CMI.
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Expand Comirnaty PI 23 Jul 2021