NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
HYDROCORTISONE MYLAN
contains the active ingredient hydrocortisone
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Hydrocortisone Mylan.
It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Hydrocortisone Mylan against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What Hydrocortisone Mylan is used for
Hydrocortisone Mylan belongs to a group of medicines called corticosteroids. Hydrocortisone Mylan contains hydrocortisone, which is a hormone produced by the adrenal glands, small glands that sit near the top of the kidneys.
Hydrocortisone Mylan is used to replace the hydrocortisone in patients whose adrenal glands do not produce enough naturally. This occurs in conditions such as Addison’s disease or when the adrenal glands are damaged or not working properly.
Your doctor may have prescribed Hydrocortisone Mylan for another reason. Ask your doctor if you have any questions about why Hydrocortisone Mylan has been prescribed for you.
Hydrocortisone Mylan is available only with a doctor’s prescription.
There is no evidence that Hydrocortisone Mylan is addictive.
Before you take Hydrocortisone Mylan
When you must not take it
Do not take Hydrocortisone Mylan if you are allergic to medicines containing hydrocortisone or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.
Do not take Hydrocortisone Mylan if the expiry date (Exp.) printed on the pack has passed.
Do not take Hydrocortisone Mylan if the packaging shows signs of tampering or the tablets do not look quite right.
Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor will discuss the risks and benefits of taking Hydrocortisone Mylan during pregnancy.
Tell your doctor if you are breastfeeding or wish to breastfeed.
Hydrocortisone Mylan passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of taking Hydrocortisone Mylan when breastfeeding.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
current or recent infection, including tuberculosis, chicken pox, herpes, measles or infection in the eye
high blood pressure
recent heart attack, heart failure
kidney problems
liver problems, including cirrhosis
stomach or duodenal ulcers
inflammation of the colon
diabetes mellitus
blood clotting problems
osteoporosis or other bone diseases
chronic back problems
convulsive disorders, such as epilepsy
underactive thyroid
Cushing’s syndrome
cancer that has spread or is spreading
mental illness
skin rashes.
Your doctor may want to take special care if you have any of these conditions.
Tell your doctor if you plan to have surgery.
Your doctor may need to keep an eye on any changes to your condition caused by stress from the surgery. This may lead to adjustments to your dose.
If you have not told your doctor about any of the above, tell them before you start taking Hydrocortisone Mylan.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by Hydrocortisone Mylan, or may affect how well it works. These include:
oral contraceptives (birth control pill)
medicines used to treat epilepsy, such as phenytoin and barbiturates
rifampicin, an antibiotic used to treat and prevent infections
diuretics, also called fluid tablets
digoxin, a medicine used to treat heart conditions
aspirin
live vaccines
insulin or oral medicines for diabetes.
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Hydrocortisone Mylan.
How to take Hydrocortisone Mylan
How much to take
The dose varies from patient to patient.
Your doctor will tell you how many tablets you need to take each day and when to take them. This depends on your condition and whether or not you are taking any other medicines.
Any changes to your condition during therapy may also require your doctor to adjust your dose.
Tell your doctor if you believe that your condition is either getting better or worse.
You may require adjustments to your dose.
Tell your doctor if you feel that your current dose is not as effective as before.
Your doctor will review your situation and may recommend a dose adjustment.
Follow all directions given to you by your doctor and pharmacist carefully.
How to take it
Swallow the tablets with a glass of milk, or take Hydrocortisone Mylan with food.
This will lessen the chance of a stomach upset.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have any questions about this, check with your doctor or pharmacist.
How long to take it for
Keep taking Hydrocortisone Mylan for as long as your doctor recommends.
If treatment is to be stopped after more than a few days treatment, your doctor will reduce your dose gradually.
If you take too much (overdose)
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 you or anyone else may have taken too much Hydrocortisone Mylan. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much Hydrocortisone Mylan, you may have symptoms of weakness, dizziness, convulsions, headache, nausea, vomiting and blurred vision.
While you are taking Hydrocortisone Mylan
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are taking Hydrocortisone Mylan.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Hydrocortisone Mylan.
If you become pregnant while taking Hydrocortisone Mylan, tell your doctor.
Discuss with your doctor situations in which it may be appropriate for you to make short-term changes of dose during illness, or at a time of medical or dental procedures.
Illness or medical or dental procedures can bring on stress, which may affect your condition and require temporary dose increases.
Visit your doctor regularly so they can check on your progress.
Your will need to have regular blood tests to measure your potassium and calcium levels. If your levels are low, you may need to take dietary supplements.
Have your blood pressure checked regularly.
Hydrocortisone Mylan may increase your blood pressure due to an increase in the amount of salt in your body. You may need to restrict the amount of salt in your diet.
If you have to have any other tests, such as allergy skin tests, tell your doctor that you are taking Hydrocortisone Mylan.
Hydrocortisone Mylan may affect the results of some tests.
Things you must not do
Do not stop taking Hydrocortisone Mylan without checking with your doctor Stopping Hydrocortisone Mylan suddenly may cause unwanted side effects. Your doctor will want you to gradually reduce the amount of Hydrocortisone Mylan you are taking before stopping completely.
Do not have any vaccinations without first checking with your doctor.
If you are taking Hydrocortisone Mylan vaccines may not work as well and there is an increased risk of complications.
Do not use Hydrocortisone Mylan to treat any other conditions unless your doctor tells you to.
Do not give Hydrocortisone Mylan to anyone else, even if they have the same condition as you.
Things to be careful of
Avoid contact with people who have infections, such as chicken pox, measles or herpes.
Infections are easier to get and harder to spot while you take Hydrocortisone Mylan.
Tell your doctor immediately if you think you may have picked up an infection while taking Hydrocortisone Mylan.
Infections can bring on stress, which may affect your condition and require temporary dose adjustments.
If you are a diabetic, monitor your blood sugar levels regularly.
Your doctor may need to adjust your dose of insulin or tablets.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Hydrocortisone Mylan.
Like all other medicines, Hydrocortisone Mylan may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
If you are over 65 years of age or are a postmenopausal woman, you may have an increased chance of getting side effects.
Long term therapy with Hydrocortisone Mylan may affect your bone density, making you more likely to get fractures or osteoporosis.
In children, Hydrocortisone Mylan may slow or stop their growth especially if it is used for a long time. Your child’s doctor will discuss the risks and benefits involved.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
nausea
increased appetite, weight gain
dizziness
headaches
insomnia (trouble sleeping)
skin rashes, acne or blotchy skin
thin fragile skin
bruising or bleeding more easily than normal, purplish-blue spots or lines under the skin
facial redness
increase in body or facial hair
increased sweating
irregular menstrual periods.
Tell your doctor as soon as possible if you notice any of the following:
severe upper stomach pain with nausea and vomiting
fits or convulsions, loss of consciousness
weakness, loss of muscle mass
wounds that will not or take longer to heal
increased thirst and frequent urination
severe indigestion with stomach pain and discomfort
signs of infection such as fever, chills, sore throat or mouth ulcers
blurred vision, changes in vision
swelling of the face, hands, ankles or feet
confusion, hallucinations, depression or mood swings
swelling and redness along a vein which is tender to touch.
Your doctor may decide to alter your dose to help control serious side effects and organise certain tests to monitor the above effects.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.
After taking Hydrocortisone Mylan
Storage
Keep Hydrocortisone Mylan 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.
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store Hydrocortisone Mylan or any other medicine in the bathroom or near a sink.
Do not leave Hydrocortisone Mylan in the car or on window sills.
Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking Hydrocortisone Mylan, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Hydrocortisone Mylan comes in 2 strengths of tablets:
Hydrocortisone Mylan 4 round, white, scored tablet marked H/4 on one side and G on the reverse. Each bottle contains 50 tablets.
Hydrocortisone Mylan 20 round, white, scored tablet marked H/20 on one side and G on the reverse. Each bottle contains 60 tablets.
Ingredients
The active ingredient in Hydrocortisone Mylan is hydrocortisone.
each Hydrocortisone Mylan 4 tablet contains 4 mg of hydrocortisone
each Hydrocortisone Mylan 20 tablet contains 20 mg of hydrocortisone.
The 4 mg tablets also contain:
lactose monohydrate
povidone
maize starch
magnesium stearate.
The 20 mg tablets also contain:
lactose monohydrate
povidone
maize starch
magnesium stearate
macrogol 8000.
Sponsor
Hydrocortisone Mylan is supplied by:
Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
ABN 93 002 359 739
www.mylan.com.au
Medical Information
Phone: 1800 028 365
Australian registration numbers:
Hydrocortisone Mylan 4 – AUST R 290097
Hydrocortisone Mylan 20 – AUST R 290098
This leaflet was prepared on
14 August 2017.
Hydrocortisone Mylan_cmi/Aug17
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