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Product name Product type Date released
Expand Ultomiris 100mg/ml CMI 18 Aug 2022
 
Ultomiris is a medicine that affects your body’s defence system and so can lower the ability of your immune system to fight infections. Using this medicine increases your risk of severe infection and sepsis (infection of the blood). You must be vaccinated against meningococcal infection and be aware of the signs and symptoms of a meningococcal infection. You must always carry a “Patient Safety Card” with you.
Talk to your doctor if you have an infection or have had an allergic reaction to any of the ingredients listed at the end of the CMI.
For more information, see Section 2. What should I know before I use Ultomiris? in the full CMI.
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Expand Ultomiris 100 mg/ml PI 18 Aug 2022
 
Expand Olmesartan/Amlodipine-MYL PI 18 Aug 2022
 
Expand Mayzent CMI 18 Aug 2022
 
Do not use if you have ever had an allergic reaction to Mayzent 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 Mayzent? in the full CMI.
read more
Expand Olmesartan/Amlodipine-MYL CMI 17 Aug 2022
 
OLMESARTAN/ AMLODIPINE - MYL is used to treat high blood pressure which is sometimes called hypertension.
Everyone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.

How OLMESARTAN/ AMLODIPINE - MYL works

OLMESARTAN/ AMLODIPINE - MYL contains olmesartan medoxomil, which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. OLMESARTAN/ AMLODIPINE - MYL blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure.
OLMESARTAN/ AMLODIPINE - MYL also contains amlodipine besilate, a calcium channel blocker. This reduces the movement of calcium into the cells of the heart and blood vessels. This also helps to lower blood pressure as it relaxes the blood vessels and increases the supply of blood and oxygen to the heart.
Your doctor may have prescribed OLMESARTAN/ AMLODIPINE - MYL for another reason. Ask your doctor if you have any questions about why OLMESARTAN/ AMLODIPINE - MYL has been prescribed for you.
OLMESARTAN/ AMLODIPINE - MYL is not addictive.
This medicine is available only with a doctor's prescription.
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Expand Sevikar CMI 17 Aug 2022
 
SEVIKAR is used to treat high blood pressure which is sometimes called hypertension.
Everyone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.

How SEVIKAR works

SEVIKAR contains olmesartan medoxomil, which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. SEVIKAR blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure.
SEVIKAR also contains amlodipine besilate, a calcium channel blocker. This reduces the movement of calcium into the cells of the heart and blood vessels. This also helps to lower blood pressure as it relaxes the blood vessels and increases the supply of blood and oxygen to the heart.
Your doctor may have prescribed SEVIKAR for another reason. Ask your doctor if you have any questions about why SEVIKAR has been prescribed for you.
SEVIKAR is not addictive.
This medicine is available only with a doctor's prescription.
read more
Expand Olmesartan - MYL CMI 17 Aug 2022
 
OLMESARTAN - MYL is used to treat high blood pressure which is sometimes called hypertension.
Everyone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.

How OLMESARTAN - MYL works

OLMESARTAN - MYL belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. OLMESARTAN - MYL blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure.
Your doctor may have prescribed OLMESARTAN - MYL for another reason. Ask your doctor if you have any questions about why OLMESARTAN - MYL has been prescribed for you.
OLMESARTAN - MYL is not addictive.
This medicine is available only with a doctor's prescription.
read more
Expand Olmetec CMI 17 Aug 2022
 
OLMETEC is used to treat high blood pressure which is sometimes called hypertension.
Everyone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.

How OLMETEC works

OLMETEC belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. OLMETEC blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure.
Your doctor may have prescribed OLMETEC for another reason. Ask your doctor if you have any questions about why OLMETEC has been prescribed for you.
OLMETEC is not addictive.
This medicine is available only with a doctor's prescription.
read more
Expand Sevikar PI 17 Aug 2022
 
Expand Olmesartan - MYL PI 17 Aug 2022
 
Expand Olmetec PI 17 Aug 2022
 
Expand Breztri Aerosphere CMI 17 Aug 2022
 
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.
read more
Expand Actilyse PI 17 Aug 2022
 
Expand Actilyse CMI 17 Aug 2022
 
Actilyse is used to treat a number of conditions caused by blood clots forming within blood vessels, including:
heart attacks caused by blood clots in the arteries of the heart (myocardial infarction)
blood clots in the arteries of the lungs (pulmonary embolism)
stroke caused by a blood clot in an artery of the brain (acute ischaemic stroke).
Actilyse contains the active ingredient alteplase. It belongs to a group of medicines called thrombolytic agents.
Actilyse works by dissolving clots in the blood vessels. These clots cause disease by interfering with normal blood flow.
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.
read more
Expand Somac Heartburn Relief PI 17 Aug 2022
 
Expand Somac Heartburn Relief CMI 17 Aug 2022
 
Somac Heartburn Relief is used for lasting symptomatic relief of frequent heartburn and stomach acid complaints due to gastro-oesophageal reflux disease (GORD).
These symptoms can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus.
Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.
Frequent heartburn is when you have heartburn for two or more days a week. Heartburn that occurs frequently is a typical symptom of GORD.
Somac Heartburn Relief is not the right medicine for you if you suffer heartburn only occasionally (one episode of heartburn a week or less), or if you want immediate relief of heartburn.
Somac Heartburn Relief will start to suppress acid within a few hours, however it is not intended to provide instant symptom relief. For effective, lasting relief, you should take a full course of Somac Heartburn Relief (see 'How to take Somac Heartburn Relief' below).
Somac Heartburn Relief belongs to a group of medicines called proton pump inhibitors (PPIs). This medicine works by decreasing the amount of acid the stomach makes to give relief from the symptoms.
Somac Heartburn Relief is not addictive.
Somac Heartburn Relief is for use by adults over 18 years of age.
Do not give Somac Heartburn Relief to children or adolescents under 18 years of age.
read more
Expand Breztri Aerosphere PI 17 Aug 2022
 
Expand Telnasal Allergy Spray CMI 17 Aug 2022
 

Warnings

Do not use Telnasal Allergy Spray if:

you are allergic to mometasone furoate monohydrate, or any of the ingredients listed at the end of this leaflet
you have a tendency to bleed or recurrent nose bleeding
you have severe nose infection, especially fungal infection
you have had recent nose injury or nose surgery; you may wait until healing has occurred before using this medicine
you have active or inactive tuberculous infections of the respiratory tract, bacterial, systemic viral infections or in herpes simplex.
the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering
Always check the ingredients to make sure you can use this medicine.

Check with your doctor or pharmacist if you:

have any other medical conditions especially the following ones:
infection of the nose, sinus, mouth, throat, lungs or eye
sores in the nose
recent injury or surgery to your nose
open sores in your nose
take any medicines for any other condition including CYP3A inhibitors (medicines for metabolic conditions) including cobicistat-containing products
taking other corticosteroid medicines, either by mouth, as eye drops, as an asthma inhaler or by injection
have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
have or recently suffered from any bacterial or viral infection, avoid coming into contact with anyone who has measles or chickenpox especially while you are using cortisone-type medicines. Tell your doctor if you do.
If you suddenly discontinue use of this medicine then reoccurrence of the underling condition, adrenocortical insufficiency or steroid withdrawal syndrome may occur. The risk may vary as per the potency of the steroid.
Typical signs and symptoms can be either systemic such as muscle or joint pain, tremors, weight loss and anxiety or nasal bleeding and nasal drip.
Following the use of intranasal corticosteroids, instances of increased eye pressure have occurred.
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 or pharmacist if you are pregnant or intend to become pregnant.
Your doctor or pharmacist will discuss the possible risks and benefits of using this medicine during pregnancy. Breastfeeding is not recommended during treatment with this medicine.

Use in Children

Do not use in children under 12 years of age.
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed and discussed with your doctor or pharmacist.
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Expand DBL Dobutamine CMI 17 Aug 2022
 
Do not use if you have ever had an allergic reaction to dobutamine hydrochloride, sodium metabisulfite or any of the other 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.
read more
Expand Coumadin PI 16 Aug 2022