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Product name Product type Date released
Expand Cinacalcet Mylan PI 22 Jan 2021
 
Expand Cinacalcet Mylan CMI 22 Jan 2021
 
Cinacalcet Mylan is used to treat:
a condition called secondary hyperparathyroidism (high-perpara-THIGH-royd-izm) in people with kidney disease who require dialysis treatment.
a condition called primary hyperparathyroidism when surgical removal of the parathyroid gland is not a treatment option.
high blood calcium levels in people with cancer of the parathyroid gland.

Secondary hyperparathyroidism

Kidney disease can cause a condition called secondary hyperparathyroidism, which can have a big impact on your health. Four small glands located behind the thyroid gland in your neck are called parathyroid glands. They make a hormone called parathyroid hormone (PTH). Normally, PTH makes sure you have just enough calcium and phosphorus in your blood to keep your bones, heart, muscles, nerves and blood vessels working well. When your kidneys are working properly, PTH keeps your calcium and phosphorus levels normal by moving the right amounts of calcium and phosphorus in and out of your bones.
When your kidneys aren't working properly, the calcium and phosphorus balance in your body is upset, and your parathyroid glands send out too much PTH to your body. This condition is called secondary hyperparathyroidism, and it can cause bone disease and also may be a risk factor for heart disease and abnormal calcium deposits in blood vessels and other parts of the body. This medicine lowers PTH by telling your parathyroid glands to stop releasing too much PTH into your blood. It also lowers your calcium and phosphorus levels.

Primary hyperparathyroidism/ Cancer of the parathyroid gland

An overactive parathyroid gland results in a condition called primary hyperparathyroidism, which can impact your health. Four small glands located behind the thyroid gland in your neck are called parathyroid glands. They make a hormone called parathyroid hormone (PTH). When your parathyroid glands are working normally, PTH keeps your calcium levels normal by moving the right amounts of calcium in and out of your bones.
Primary hyperparathyroidism is caused by an enlargement of one or more of the parathyroid glands occasionally due to cancer of the parathyroid gland. In primary hyperparathyroidism, your parathyroid glands send out too much PTH to your body and your blood level of calcium becomes high. This medicine lowers PTH by telling your parathyroid glands to stop releasing too much PTH into your blood. It also lowers your calcium and phosphorus levels.
Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.
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Expand Rabeprazole Mylan CMI 22 Jan 2021
 
RABEPRAZOLE MYLAN contains the active ingredient rabeprazole sodium.
RABEPRAZOLE MYLAN belongs to a group of medicines called proton pump inhibitors (PPIs).
RABEPRAZOLE MYLAN works by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place. Your food will still be digested in the same way.

Gastro-oesophageal reflux disease

RABEPRAZOLE MYLAN is used to treat gastro-oesophageal reflux disease (GORD), commonly known as ‘reflux’. This can be caused by food and acid from the stomach flowing the wrong way (reflux) back up 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.
RABEPRAZOLE MYLAN is also used to help stop gastro-oesophageal reflux disease from coming back or relapsing.

Peptic Ulcers

RABEPRAZOLE MYLAN is used to treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach.
These ulcers can be caused by too much acid being made in the stomach.
Most people who have a peptic ulcer also have a bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (clarithromycin and amoxicillin) for you. When RABEPRAZOLE MYLAN is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal.

Chronic Gastritis

The presence of the bacteria Helicobacter pylori may cause the stomach to become inflamed, resulting in pain, nausea and vomiting; all of which are signs of chronic gastritis.
When RABEPRAZOLE MYLAN tablets are taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal.
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.
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Expand Rabeprazole Mylan PI 22 Jan 2021
 
Expand Humira CMI 21 Jan 2021
 
Check the list of ingredients at the end of the CMI. Do not use Humira if you have ever had an allergic reaction to any of them.
Talk to your doctor before you take this medicine if he/she is not aware that 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 Humira? in the full CMI.
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Expand Spironolactone Mylan PI 15 Jan 2021
 
Expand Spironolactone Mylan CMI 15 Jan 2021
 
Spironolactone Mylan is used:
to treat essential hypertension (high blood pressure with an unknown cause)
to treat oedematous disorders (swelling with fluid), including congestive cardiac failure
to help bring potassium levels in the blood back to normal when the levels become too low
to treat hyperaldosteronism (a hormone disorder causing fluid retention)
as add on therapy in malignant hypertension (a very serious form of high blood pressure)
treat excess facial or body hair in women.
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 available only with a doctor's prescription.
There is no evidence that Spironolactone Mylan is addictive.

How Spironolactone Mylan works

In fluid build-up and high blood pressure
Spironolactone Mylan is a fluid tablet or diuretic. It helps reduce the amount of excess fluid in the body by increasing the amount of urine produced. This also helps to lower blood pressure.
In hyperaldosteronism and low potassium levels in the blood
In hyperaldosteronism, the adrenal glands produce too much of a hormone called aldosterone. Spironolactone Mylan works by stopping the effects of aldosterone.
By stopping the effects of aldosterone, Spironolactone Mylan also helps to maintain normal levels of potassium in the blood by retaining potassium in the body.
In women with excess hair
All women produce small amounts of the male sex hormone, testosterone. Women with excess facial or body hair tend to be especially sensitive to the action of testosterone on hair growth. Spironolactone Mylan reduces the growth of hair by stopping the effects of testosterone. Increased urine flow is unlikely to be a problem when Spironolactone Mylan is used to treat hirsutism. This is because aldosterone levels are not normally high in patients with hirsutism.
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Expand Androfeme 1 PI 12 Jan 2021
 
Expand Androfeme 1 CMI 12 Jan 2021
 
Do not use if you have ever had an allergic reaction to testosterone, tree nuts (almond oil) or any of the ingredients listed at the end of the CMI. Do not use if you have or have had any of the following:
breast cancer or any other cancer which your doctor has described as being caused or stimulated by androgen
kidney disease known as nephrotic syndrome
blockage of a blood vessel by a blood clot (thromboembolism)
high calcium levels in the blood (hypercalcaemia)
Do not use if you: still mensurate; are pregnant or breastfeeding; are a child.
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 information, see Section 2. What should I know before I use ANDROFEME 1? in the full CMI.
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Expand Enerzair PI 11 Jan 2021
 
Expand Enerzair Breezhaler CMI 11 Jan 2021
 
Your doctor has prescribed this medicine to treat asthma in adults.
Asthma is a serious, long-term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction), swollen and irritated (inflammation). Symptoms come and go, and include shortness of breath, wheezing, chest tightness and cough.
Enerzair capsules for inhalation contains three active substances called indacaterol, glycopyrronium and mometasone furoate.
Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They relax the muscles of the small airways in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When they are taken regularly, it helps the small airways to remain open.
Mometasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They reduce the swelling and irritation in the small airways in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma.
The pack contains an inhaler (Breezhaler®) and capsules (in blister cards) that contain the medicine as inhalation powder. The inhaler enables you to inhale (breathe into the lungs) the medicine contained in a capsule. Only use the inhaler provided in the pack.
You should use ENERZAIR BREEZHALER every day as directed by your doctor and not only when you have breathing problems or other symptoms of asthma. This will make sure that it works properly in controlling your asthma. It should not be used to relieve a sudden attack of breathlessness or wheezing.
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.
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Expand Atectura Breezhaler CMI 11 Jan 2021
 
Your doctor has prescribed this medicine to treat asthma in adults and adolescents 12 years of age and older.
Asthma is a serious, long-term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction), swollen and irritated (inflammation). Symptoms come and go, and include shortness of breath, wheezing, chest tightness and cough.
Atectura capsules for inhalation contains two active substances called indacaterol and mometasone furoate.
Indacaterol belong to a group of medicines called bronchodilators. They relax the muscles of the small airways in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When they are taken regularly, it helps the small airways to remain open.
Mometasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They reduce the swelling and irritation in the small airways in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma.
The pack contains an inhaler (Breezhaler®) and capsules in blister cards that contain the medicine as inhalation powder. The inhaler enables you to inhale (breathe into the lungs) the medicine contained in a capsule. Only use the inhaler provided in the pack.
You should use ATECTURA BREEZHALER every day as directed by your doctor and not only when you have breathing problems or other symptoms of asthma. This will make sure that it works properly in controlling your asthma. It should not be used to relieve a sudden attack of breathlessness or wheezing.
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.
read more
Expand Atectura Breezhaler PI 11 Jan 2021
 
Expand Spiriva Respimat (with dose indicator) CMI 04 Jan 2021
 
Spiriva Respimat is used to make breathing easier for patients with:
chronic obstructive pulmonary disease (COPD)
asthma.
When used to treat asthma you should use Spiriva Respimat in addition to other medicines called inhaled corticosteroids.
COPD is a serious lung condition that can cause difficulty in breathing and constant coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Spiriva Respimat helps to improve your COPD condition and to prevent exacerbations (periodic worsening of symptoms) from occurring.
Asthma is a serious lung condition where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke or other irritants.
Spiriva Respimat improves breathing by relaxing the breathing tubes or air passages that carry air to and from the lungs.
Spiriva Respimat contains the active ingredient tiotropium bromide monohydrate. It belongs to a group of medicines called anticholinergics.
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.
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Expand Spiriva Respimat (with dose indicator) PI 04 Jan 2021
 
Expand Spiolto Respimat (with dose indicator) CMI 04 Jan 2021
 
Spiolto Respimat is used for the treatment of Chronic Obstructive Pulmonary Disease, also called COPD.
COPD is a serious lung condition that can cause difficulty in breathing and constant coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema.
Symptoms of COPD include shortness of breath, cough, chest discomfort and coughing up phlegm.
Spiolto Respimat contains the active ingredients, tiotropium (as bromide monohydrate) and olodaterol (as hydrochloride). Tiotropium belongs to a group of medicines called anticholinergics. Olodaterol belongs to a group of medicines called long-acting bronchodilators. These medicines are used to relax the breathing tubes or air passages that carry air to and from the lungs and to keep the air passages in the lungs open and make breathing easier.
Each dose of Spiolto Respimat will keep your air passages open for 24 hours.
Regular use of Spiolto Respimat can also help when you have ongoing shortness of breath related to your disease, and will help minimise the effects of the disease on your everyday life.
Spiolto Respimat is for oral inhalation only. The solution for inhalation is contained in the Spiolto Respimat cartridge and inhaled using the Spiolto Respimat re-usable inhaler supplied with the medicine.
As COPD is a long-term condition, you should take Spiolto Respimat every day even if you do not have breathing problems or other symptoms of COPD.
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 available only with a doctor's prescription.
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Expand Nurofen Plus PI 17 Dec 2020
 
Expand Solifenacin Mylan PI 17 Dec 2020
 
Expand Solifenacin Mylan CMI 17 Dec 2020
 
SOLIFENACIN MYLAN is used to treat the symptoms of overactive bladder. These symptoms include needing to rush to the toilet to urinate without warning, needing to urinate frequently, or wetting yourself because you did not get to the toilet in time.
SOLIFENACIN MYLAN belongs to a group of medicines called anticholinergic medicines. It works by acting on specialised cells to reduce the activity of your bladder and help you control your bladder.
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.
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Expand Zoely CMI 04 Dec 2020
 
ZOELY is an oral contraceptive, commonly known as a "Birth Control Pill" or "The Pill" that has been prescribed to prevent you from getting pregnant.
ZOELY 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.
ZOELY consists of 24 white tablets, each containing 2 active ingredients: 2.5 milligrams of nomegestrol acetate (a progestogen) and 1.5 milligrams of estradiol (the natural estrogen) and 4 yellow inactive tablets. ZOELY contains estradiol, the natural estrogen, compared with most Pills which contain the synthetic estrogen ethinylestradiol.
Oral contraceptives are an 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.
ZOELY is available only with a doctor's prescription.
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