Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using HYDROCORTISONE VIATRIS?
HYDROCORTISONE VIATRIS contains the active ingredient hydrocortisone. HYDROCORTISONE VIATRIS 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.
2. What should I know before I use HYDROCORTISONE VIATRIS?
Do not use if you have ever had an allergic reaction to hydrocortisone 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.
3. What if I am taking other medicines?
Some medicines may interfere with HYDROCORTISONE VIATRIS and affect how it works.
4. How do I use HYDROCORTISONE VIATRIS?
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.
Swallow the tablets with a glass of milk, or take HYDROCORTISONE VIATRIS with food.
5. What should I know while using HYDROCORTISONE VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using HYDROCORTISONE VIATRIS
If you become pregnant while taking HYDROCORTISONE VIATRIS, 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.
Visit your doctor regularly so they can check on your progress.
Have your blood pressure checked regularly.
If you have to have any other tests, such as allergy skin tests, tell your doctor that you are taking HYDROCORTISONE VIATRIS.
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Things you should not do
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Do not stop taking HYDROCORTISONE VIATRIS without checking with your doctor
Do not have any vaccinations without first checking with your doctor.
Do not use HYDROCORTISONE VIATRIS to treat any other conditions unless your doctor tells you to.
Do not give HYDROCORTISONE VIATRIS to anyone else, even if they have the same condition as you.
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Looking after your medicine
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Keep your tablets in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the bottle until it is time to take them.
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6. Are there any 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.
In children, HYDROCORTISONE VIATRIS may slow or stop their growth especially if it is used for a long time. For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s): hydrocortisone
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using HYDROCORTISONE VIATRIS. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using HYDROCORTISONE VIATRIS.
Where to find information in this leaflet:
1. Why am I using HYDROCORTISONE VIATRIS?
HYDROCORTISONE VIATRIS contains the active ingredient hydrocortisone, which is a hormone produced by the adrenal glands, small glands that sit near the top of the kidneys. HYDROCORTISONE VIATRIS belongs to a group of medicines called corticosteroids
HYDROCORTISONE VIATRIS 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 VIATRIS for another reason. Ask your doctor if you have any questions about why HYDROCORTISONE VIATRIS has been prescribed for you.
HYDROCORTISONE VIATRIS is available only with a doctor's prescription.
There is no evidence that HYDROCORTISONE VIATRIS is addictive.
2. What should I know before I use HYDROCORTISONE VIATRIS?
Warnings
Do not use HYDROCORTISONE VIATRIS if:
you are allergic to hydrocortisone, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
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.
the expiry date (Exp.) printed on the pack has passed.
the packaging shows signs of tampering or the tablets do not look quite right.
Check with your doctor if you:
are allergic to any other medicines, foods, dyes or preservatives.
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.
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.
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.
Your doctor will discuss the risks and benefits of taking HYDROCORTISONE VIATRIS during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
HYDROCORTISONE VIATRIS passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of taking HYDROCORTISONE VIATRIS when breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with HYDROCORTISONE VIATRIS and affect how 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect HYDROCORTISONE VIATRIS.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking HYDROCORTISONE VIATRIS.
4. How do I use HYDROCORTISONE VIATRIS?
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 HYDROCORTISONE VIATRIS
Swallow the tablets with a glass of milk, or take HYDROCORTISONE VIATRIS with food.
This will lessen the chance of a stomach upset.
If you forget to use HYDROCORTISONE VIATRIS
If you miss your dose at the usual time, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
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.
If you use too much HYDROCORTISONE VIATRIS
If you think that you have used too much HYDROCORTISONE VIATRIS, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much HYDROCORTISONE VIATRIS, you may have symptoms of weakness, dizziness, convulsions, headache, nausea, vomiting and blurred vision.
5. What should I know while using HYDROCORTISONE VIATRIS?
Things you should do
Before starting any new medicine, tell your doctor or pharmacist that you are taking HYDROCORTISONE VIATRIS.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking HYDROCORTISONE VIATRIS.
If you become pregnant while taking HYDROCORTISONE VIATRIS, 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 VIATRIS 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 VIATRIS.
HYDROCORTISONE VIATRIS may affect the results of some tests.
Things you should not do
Do not stop taking HYDROCORTISONE VIATRIS without checking with your doctor. Stopping HYDROCORTISONE VIATRIS suddenly may cause unwanted side effects. Your doctor will want you to gradually reduce the amount of HYDROCORTISONE VIATRIS you are taking before stopping completely.
Do not have any vaccinations without first checking with your doctor.
If you are taking HYDROCORTISONE VIATRIS vaccines may not work as well and there is an increased risk of complications.
Do not use HYDROCORTISONE VIATRIS to treat any other conditions unless your doctor tells you to.
Do not give HYDROCORTISONE VIATRIS 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 VIATRIS.
Tell your doctor immediately if you think you may have picked up an infection while taking HYDROCORTISONE VIATRIS.
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.
Looking after your medicine
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.
Follow the instructions on the label on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking HYDROCORTISONE VIATRIS, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
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 VIATRIS may affect your bone density, making you more likely to get fractures or osteoporosis.
In children, HYDROCORTISONE VIATRIS 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.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Serious side effects
Your doctor may decide to alter your dose to help control serious side effects and organise certain tests to monitor the above effects.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What HYDROCORTISONE VIATRIS contains
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Active ingredient
(main ingredient)
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each HYDROCORTISONE VIATRIS 4 tablet contains 4 mg of hydrocortisone
each HYDROCORTISONE VIATRIS 20 tablet contains 20 mg of hydrocortisone.
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Other ingredients
(inactive ingredients)
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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.
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Potential allergens
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HYDROCORTISONE VIATRIS contains sulfites and sugars as lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What HYDROCORTISONE VIATRIS looks like
HYDROCORTISONE VIATRIS 4 round, white, scored tablet marked H/4 on one side and G on the reverse. Each bottle contains 50 tablets. (AUST R 290097)
HYDROCORTISONE VIATRIS 20 round, white, scored tablet marked H/20 on one side and G on the reverse. Each bottle contains 60 tablets. (AUST R 290098)
Who distributes HYDROCORTISONE VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in February 2022.
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