NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
CINACALCET MYLAN
Cinacalcet hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about this medicine.
It does not contain all the available information.It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.Your doctor has weighed the risks of you taking this medicine against the benefits he/she expects it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Read this leaflet carefully before
you start Cinacalcet Mylan and keep it with the medicine.
You may need to read it again.
What this medicine is used for
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.
Before you take this medicine
When you must not take it
Do not take this medicine if you are allergic to the active ingredient or any of the ingredients in this medicine listed at the end of this leaflet.
Symptoms of an allergic reaction
may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
skin rash, itching or hives.
Talk to your doctor, nurse or pharmacist if you have any questions about this information.
Do not give this medicine to a child.
There is not enough information at present to recommend use of this medicine in children.
Do not take this medicine after the expiry date (Exp.) stamped on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn or shows signs of tampering or if the tablets do not look quite right.
Before you start to take it
Tell your doctor if:
1.you have or have had any medical conditions, including:
seizures (sometimes called fits or convulsions, see ‘Side effects’ section).
heart failure (or a heart condition, see ‘Side effects’ section).
intolerance to sugars (sometimes called lactose intolerance, see ‘Ingredients’ section).
ulcers (stomach or intestinal), serious vomiting, inflammation of the stomach and swallowing tube.
2.you are pregnant or intend to become pregnant.
Your doctor will discuss the risks and benefits of taking this medicine if you are pregnant.
3.you are breastfeeding or planning to breastfeed.
It is not known whether this medicine passes into breast milk.
4.Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any medicines you buy without a prescription from a pharmacy, supermarket or health food shop (for example St John’s Wort).
If you have not told your doctor about any of the above, tell him/ her before you take this medicine.
Taking other medicines
Tell your doctor if you are taking ketoconazole, erythromycin, itraconazole, rifampicin, phenytoin, amitriptyline, flecainide, vinblastine, thioridazine or medicines known as tricyclic antidepressants.
Some of these medicines can affect how this medicine works, while others are affected by this medicine.
Driving and using machines
Dizziness and seizures have been reported by patients taking Cinacalcet Mylan. If you experience these side effects, do not drive or operate machines.
How to take this medicine
This medicine must be taken orally either with, or shortly after food. The tablets must be taken whole and are not to be divided. Follow all directions given to you by your doctor, nurse and pharmacist carefully.
They may differ from the information in this leaflet.
If you do not understand the instructions below, ask your doctor, nurse or pharmacist for help.
How much this medicine to take
If you are being treated for secondary hyperparathyroidism
The usual starting dose for this medicine is 30 mg (one tablet) once per day.
Your doctor will take regular blood samples to measure how you are responding to this medicine and will adjust your dose as necessary in order to control your parathyroid hormone, calcium and phosphate levels.
Once your condition is under control, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your parathyroid hormone, calcium and phosphate levels.
If you are being treated for primary hyperparathyroidism/ cancer of the parathyroid gland
The usual starting dose for this medicine is 30 mg (one tablet) twice per day.
Your doctor will take regular blood samples to measure how you are responding to this medicine and will adjust your dose as necessary in order to control your calcium levels.
Once your condition is under control, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your calcium levels.
If you forget to take this medicine
If you have forgotten a dose of this medicine, you should take your next dose as normal.
If you take more Cinacalcet Mylan than you should (overdose)
If you take more this medicine than you should you must contact your doctor, nurse or pharmacist immediately.
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.
While you are using this medicine
Things you must do
Always follow your doctor’s instructions carefully. If you are about to start using a new medicine, tell your doctor, nurse and pharmacist that you are taking this medicine.
If you become pregnant while you are taking this medicine, tell your doctor.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Things you must not do
Do not take this medicine to treat any other complaint unless your doctor says so. Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Side effects
Tell your doctor as soon as possible if you have any problems while taking Cinacalcet Mylan, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, Cinacalcet Mylan may cause side effects. Some side effects may be serious and need medical attention. Other side effects are minor and are likely to be temporary.
Cinacalcet Mylan lowers your calcium level. If calcium levels become too low, you might get hypocalcaemia.
Signs of hypocalcaemia include numbness or tingling around the mouth, muscle aches or cramps and seizures. If you have any of these symptoms, you should tell your doctor straight away. People with kidney disease not requiring dialysis are at increased risk of developing hypocalcaemia.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
If any of the following happens, stop taking this medicine and go straight to the hospital, as you may need urgent medical attention:
Allergic reaction
Skin rash over a large area of the body
Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
Shortness of breath
Wheezing
Faintness, rapid pulse or sweating.
Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:
Nausea and vomiting.
People taking this medicine may have a greater chance of developing nausea and /or vomiting. If nausea or vomiting is making it difficult to take your medicines or is of any concern to you, you should tell your doctor.
Seizure (also known as a fit or convulsion).
The risk of having seizures is greater in people who have had seizures before. Lowering the calcium level too much may also increase the risk of having a seizure. If you have a seizure you should tell your doctor straight away.
Dizziness or light headedness, or worsening of a heart condition.
This medicine may cause low blood pressure or affect the heart’s function in people who have a heart condition (heart failure). If you know you have a heart condition, tell your doctor.
Rash.
Pinkish, itchy swellings on the skin, also called hives or nettle rash. Itchy rash.
Bleeding from the stomach or intestines.
Bleeding from the stomach or intestines may occur in some patients. You may experience severe pain or tenderness in the stomach, vomit blood or material that looks like coffee grounds, or have black or tar-like stools
Tell your doctor, nurse or pharmacist if you notice anything that worries you or that is making you feel unwell, even if it is not on this list.
Other side effects not listed above may occur in some people.
After taking this medicine
Storage
Keep your medicine in a cool place, under 25 degrees C.
The expiry date (Exp.) for your medicine is stamped on the outer box and the blister label. Do not take this medicine after this date, the last day of the month shown.
As with all medicines, you should keep it out of the reach and sight of children.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
Cinacalcet Mylan 30 mg tablets:
green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and C130 on the other side. (AUST R 289379)
Cinacalcet Mylan 60 mg tablets:
green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and C160 on the other side. (AUST R 289380)
Cinacalcet Mylan 90 mg tablets:
green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and C190 on the other side. (AUST R 289381)
Ingredients
Active ingredient:
The active ingredient in Cinacalcet Mylan is cinacalcet hydrochloride.
Other ingredients
The other ingredients of Cinacalcet Mylan are:
microcrystalline cellulose
colloidal anhydrous silica
crospovidone
povidone
magnesium stearate
OPADRY complete film coating system 03K51674 GREEN
Sponsor
Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
This leaflet was prepared in Jan 2021.
cinacalcet_cmi\Jan 21/00
Source: Read Full Article