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Product name Product type Date released
Expand BiResp Spiromax PI 27 Jul 2021
 
Expand BiResp Spiromax CMI 27 Jul 2021
 
Do not use if you have ever had an allergic reaction to any medicine containing formoterol or budesonide 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 BIRESP SPIROMAX? in the full CMI.
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Expand Rukobia Tablets PI 22 Jul 2021
 
Expand Breztri Aerosphere CMI 21 Jul 2021
 
Do not use if you have ever had an allergic reaction to BREZTRI AEROSPHERE or any of the ingredients listed at the end of 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 BREZTRI AEROSPHERE? in the full CMI.
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Expand Flagyl S CMI 21 Jul 2021
 
Do not use if you have ever had an allergic reaction to Flagyl S 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 Flagyl S? in the full CMI.
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Expand Breztri Aerosphere PI 21 Jul 2021
 
Expand Eferas CMI 06 Jul 2021
 

Warnings

Do not use EFERAS if:

you are allergic to deferasirox, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

have any other medical conditions such as kidney or liver problems
have low platelet or white blood cell counts
have an advanced stage of myelodysplastic syndrome (MDS) or advanced cancer
take any medicines for any other condition
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

Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
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Expand Eferas PI 05 Jul 2021
 
Expand Octreotide Depot CMI 01 Jul 2021
 
Octreotide Depot is a long acting form of octreotide injection. It is injected into the buttocks once every 4 weeks, instead of having frequent injections of the octreotide under the skin.
Octreotide Depot is used to treat acromegaly
In people with acromegaly the body makes too much growth hormone which controls the growth of tissues, organs and bones. Too much growth hormone leads to enlargement of the bones, especially of the hands and feet. Other symptoms include headaches, increased sweating, tiredness, numbness of the hands and feet, pain and stiffness in the joints and loss of sexual function. By blocking the excess growth hormone, Octreotide Depot can relieve many of these symptoms.
Octreotide Depot is used to relieve symptoms of certain types of cancer such as carcinoid tumour and VIPoma.
By blocking hormones that are over-produced in these conditions, Octreotide Depot can relieve symptoms such as flushing of the skin and severe diarrhoea. Octreotide Depot contains octreotide, a man-made medicine derived from somatostatin. Somatostatin is a substance found in the human body which controls the effects of certain hormones such as insulin and growth hormone. Octreotide Depot is used instead of somatostatin because its effects are stronger and last longer.
Octreotide Depot is used to treat advanced neuroendocrine tumours located in the gut (eg appendix, small intestine or colon).
Neuroendocrine tumours are rare tumours which can be found in different parts of the body. Octreotide Depot is also used to control the growth of these tumours, when they are located in the gut (eg appendix, small intestine or colon).
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.
There is very little information on the use of this medicine in children.
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Expand Octreotide Depot PI 01 Jul 2021
 
Expand DBL Sodium Acetate Concentrated Injection CMI 29 Jun 2021
 
Sodium acetate can be added to total parenteral nutrition (TPN) solutions as a source of sodium and acetate ions, or to increase the pH of the solution.
Sodium acetate can also be used to treat low blood sodium (hyponatraemia).
Your doctor may have prescribed sodium acetate for another reason. Ask your doctor if you have any questions about why sodium acetate has been prescribed for you.
DBL Sodium Acetate Concentrated Injection is not addictive.
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Expand Famciclovir Mylan (formerly Ezovir) genital herpes CMI 28 Jun 2021
 
FAMCICLOVIR MYLAN is an antiviral medicine for adults and adolescents. It is used to treat outbreaks of genital herpes and also to suppress (prevent) recurrent outbreaks of the condition.
Genital herpes is a viral infection caused by herpes simplex 1 or herpes simplex 2. It is usually transmitted through sexual contact.
Symptoms include tingling, burning or itching of the genitals, followed by blisters that may be painful.
People who have frequent episodes of genital herpes can also take FAMCICLOVIR MYLAN to help prevent the attacks.
Although FAMCICLOVIR MYLAN does not cure the viral infection, it helps to relieve the symptoms and shorten their duration.
The best results are obtained if the medicine is started as soon as possible after the first symptoms begin to appear.
Taking FAMCICLOVIR MYLAN does not prevent you from spreading the herpes virus to another person.
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.
FAMCICLOVIR MYLAN is only available with a doctor's prescription. It is not addictive.
This medicine is not recommended for use in children under 12 years of age.
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Expand Famciclovir Mylan (formerly Ezovir) CSR PI 28 Jun 2021
 
Expand Famciclovir Mylan (formerly Ezovir) CSR CMI 28 Jun 2021
 
FAMCICLOVIR MYLAN Cold Sore Relief is an antiviral medicine that is used to treat recurrent outbreaks of cold sores in adults who have a normal immune system (the body system which fights against harmful bacteria, viruses and fungi).
Cold sores are an infection caused by a virus called herpes simplex type I (HSV-1). Cold sores usually begin on or around the lips, mouth, and nose. After redness and swelling develop, the small red bumps turn into fluid-filled blisters.
The blisters may weep or burst, and this can be tender and painful. A shallow ulcer and yellow crust form as the cold sore dries. The crust eventually falls off, exposing new pink-coloured skin. Generally, the sores heal without scarring.
The infection is most commonly acquired as a baby or child from physical contact with parents or relatives that have a cold sore, often by kissing. After the initial infection has healed, the virus becomes dormant in nerve cells.
Cold sores can be unpredictable. Even after many years, some people may experience recurring cold sores due to viral reactivation. Some common triggers to a cold sore may include:
sun exposure
stress
fatigue
menstrual periods
fever
illness
dry chapped lips
skin trauma
a cold
Many people who get cold sores know when one is coming by a tingling, burning, itchy or painful sensation or redness in the area. This can happen very rapidly.
Although FAMCICLOVIR MYLAN Cold Sore Relief does not cure the viral infection, it helps to relieve the symptoms and shorten their duration of an outbreak.
The best results are obtained if the medicine is started as soon as possible after the onset of symptoms occur. These may include tingling, itching or burning, or the appearance of the first signs, such as redness or swelling. This is when the virus is reproducing rapidly.
Ask your pharmacist or doctor if you have any questions about why this medicine has been prescribed for you.
FAMCICLOVIR MYLAN Cold Sore Relief is only available from your pharmacist. The cold sores pack may be purchased without a doctor's prescription. It is not addictive.

Use in Children

This medicine is not recommended for use in infants, children or adolescents under 18 years of age.
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Expand Famciclovir Mylan (formerly Ezovir) (shingles) CMI 28 Jun 2021
 
FAMCICLOVIR MYLAN is an antiviral medicine that is used to treat shingles in adults and adolescents.
Shingles is a condition that is caused by a herpes virus called varicella zoster, the same virus that causes chicken pox. The virus can become active again in the body, even after many years, resulting in shingles. The main symptom is a rash that can cause pain, burning and blisters.
Although FAMCICLOVIR MYLAN does not cure the viral infection, it helps to relieve the symptoms and shorten their duration.
The best results are obtained if the medicine is started as soon as possible after the first symptoms begin to appear.
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.
FAMCICLOVIR MYLAN is only available with a doctor's prescription. It is not addictive.
This medicine is not recommended for use in children under 12 years of age.
read more
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Expand Famciclovir Mylan (formerly Ezovir) (cold sores) CMI 28 Jun 2021
 
FAMCICLOVIR MYLAN is an antiviral medicine used to treat recurrent outbreaks of cold sores in adults and adolescents who have a normal immune system (the body system which fights against harmful bacteria, viruses and fungi).
Cold sores are an infection caused by a virus called herpes simplex type I (HSV-1). The infection is most commonly acquired as a baby or child from contact with parents or relatives, often from kissing.
Cold sores usually begin on or around the lips, mouth, and nose as small red bumps that turn into fluid-filled blisters. Cold sores can be tender and painful. Many people who get cold sores know when one is coming by a tingling, burning, itchy or painful sensation or redness in the area. This can happen very rapidly.
After redness and swelling develop, blisters form. The blisters may weep or burst and this can be painful. Then a shallow ulcer and yellow crust form as the cold sore dries. The crust eventually falls off, exposing new pink-coloured skin. Generally the sores heal without scarring.
After the initial infection has healed, the virus becomes dormant in nerve cells.
Cold sores can be unpredictable. The virus can become active again in the body, even after many years, resulting in recurrent outbreaks.
Even after many years, some people may experience recurring cold sores due to viral reactivation. Some common triggers to a cold sore may include:
sun exposure
stress
fatigue
menstrual periods
fever
illness
dry chapped lips
skin trauma
a cold
Although FAMCICLOVIR MYLAN does not cure the viral infection, it helps to relieve the symptoms and shorten the duration of an outbreak.
The best results are obtained if the medicine is started as soon as possible after the onset of symptoms of a cold sore, such as tingling, itching or burning, or the appearance of the first signs, such as redness or swelling. This is when the virus is reproducing rapidly.
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.
FAMCICLOVIR MYLAN is only available with a doctor's prescription. It is not addictive.
This medicine is not recommended for use in infants, children or adolescents under 18 years of age.
read more
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Expand Famciclovir Mylan (formerly Ezovir) PI 28 Jun 2021
 
Expand Crestor PI 21 Jun 2021
 
Expand Crestor CMI 21 Jun 2021
 
CRESTOR is used to lower high cholesterol levels.
Even though you may have normal cholesterol, CRESTOR can also be used to reduce the risk of you having a stroke or heart attack if you are a man 50 or more years old or a women 60 or more years old and have at least 2 risk factors for having a heart attack or stroke, such as high blood pressure, low levels of good cholesterol (HDL), smoking or a family history of premature coronary heart disease. Your doctor may also do a blood test to measure a substance called C Reactive Protein to help decide if you should be given CRESTOR for this use.

Cholesterol and triglycerides

Everyone has cholesterol and triglycerides in their blood. They are fatty substances needed by the body for many things.
Triglycerides are an energy source for the body. Cholesterol is used for such things as building cells, making bile acids (which help to digest foods) and making some hormones.
There are different types of cholesterol. Too much of the "bad" cholesterol (LDL) can block the blood vessels that supply your heart and brain with blood, and can cause heart attack, angina and stroke. The "good" cholesterol (HDL) helps to remove the bad cholesterol from the blood vessels. High levels of triglycerides can be associated with a low level of "good" cholesterol and may increase the risk of heart disease.

How CRESTOR works

CRESTOR belongs to a group of medicines known as HMG-CoA reductase inhibitors (also known as 'statins'). It lowers the "bad" cholesterol, and raises the "good" cholesterol when exercise and changes to diet are not enough on their own.
Cholesterol is present in many foods and is also made by your body. CRESTOR does not reduce the cholesterol that comes from fat in food. Because of this, when you are taking CRESTOR, you need to follow a low-fat diet, control your weight and exercise regularly.
High cholesterol is also more likely to occur with certain diseases or if you have a family history of high cholesterol.
Your doctor will have explained why you are being treated with CRESTOR and told you what dose to take. Your doctor may need to check your cholesterol levels before prescribing CRESTOR or changing your dose.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
CRESTOR is not addictive.
CRESTOR is not recommended for use in children as its effects in children have not been established.
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Expand DBL Sodium Acetate Concentrated Injection PI 21 Jun 2021