Patient leaflet - Hitoden 20 mg tablets, Hydrocortisone Accord 20 mg tablets, Hydrocortisone 20 mg tablets, Hydrocortone 20 mg tablets
1. What Hydrocortisone Accord Tablets are and what are they used for
Hydrocortisone Accord Tablets contain a medicine
called hydrocortisone. This belongs to a group
of medicines called ‘steroids’. Their full name is
corticosteroids. These corticosteroids occur naturally
in the body and help to maintain health and well-being.
Boosting your body with extra corticosteroid (such as
Hydrocortisone Accord Tablets) is an effective way to
treat various illnesses involving inflammation in the
body.
Hydrocortisone Accord Tablets reduce this
inflammation, which could otherwise go on making your
condition worse. You must take this medicine regularly
to get maximum benefit from it. Hydrocortisone Accord
Tablets are used for:
adding hydrocortisone usually made naturally in
the body because part of the adrenal gland is not
working properly
adding hydrocortisone after injuries, surgery or other
stressful events
- some other types of illness.
Ask your doctor to explain why you have been given
Hydrocortisone Accord Tablets if you are unsure.
2. What you need to know before taking Hydrocortisone Accord Tablets
Do not take Hydrocortisone Accord Tablets if you:
- are allergic to hydrocortisone or any of the other ingredients in this medicine (listed in section 6).
- have thrush, candida or any other fungal infection.
- have any other infections.
- have been vaccinated recently or are going to have any vaccinations.
If you are not sure, talk to your doctor or pharmacist before taking Hydrocortisone Accord Tablets.
Warnings and precautions
Talk to your doctor before taking Hydrocortisone Accord Tablets if you:
- have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Hydrocortisone Accord Tablets or if any of your close family have had these illnesses
- have recently had a heart attack
- have a heart condition called congestive heart disease
- have septicaemia, tuberculosis (TB) or have had it in the past
- have a stomach ulcer or other digestive problem
- have chicken pox or shingles
- come in contact with people who have chicken pox, shingles or measles, especially if you have not already had these illnesses or are not sure if you have had them
- Aseptic necrosis - broken bones or fractures; breakdown of bone due to poor circulation of blood (pain in the hip); joint inflammation in the knee and groin; risk of torn tendons (pain and/or swelling).
- Cushing’s syndrome – reddish stretch marks; rounded red face; weak muscles and bones; swollen abdomen and ‘Buffalo hump’ from fat deposits around the stomach and neck; mood changes; headache.
Steroids including Hydrocortisone Accord Tablets can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Hydrocortisone Accord Tablets.
- Feeling depressed, including thinking about suicide.
- Feeling high (mania) or moods that go up and down.
- Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
- Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
Other side effects
Tell your doctor if you experience any of the following: Not known (frequency cannot be estimated from the available data):
- if you are getting infections more frequently
- increase in white blood cell count
- oral thrush
- ulcers in the gullet (discomfort on swallowing)
- indigestion
- bloating
- feeling sick
- high blood pressure
- feeling excited or excessively happy
- low mood (depression)
- insomnia
- worsening of epilepsy
- muscle weakness or wasting
- osteoporosis (brittle bones – bones that break easily)
- cramps and spasms due to the loss of the potassium salts from your body. In rare cases, loss of potassium can lead to palpitations (an uneven beating of your heart that you become aware of)
- irregular or no periods in women
- increased hair on the body and face in women
- increased appetite and weight increased
- increase in blood sugar levels, breakdown of body protein stores (loss of weight and muscle loss in arms or legs), loss of calcium and nitrogen
- thin or delicate skin, bruising, red or purple spots
- slow healing of cuts or wounds
- acne, redness
- stretch marks
- worsening of sight or changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye); thinning of the surface of the eye; blurred vision
eye infections may get worse.
Driving and using machines
Hydrocortisone Accord Tablets may have minor influence on your ability to drive and use machines. Extreme tiredness and episodes of short-lasting dizziness (vertigo) have been reported. Poorly treated or untreated adrenal insufficiency reduces your ability to concentrate and will affect your ability to drive and use machines. Changes in your eyesight or muscle weakness may also happen. If you are affected, you should not drive or operate machinery.
Having vaccines or tests while you are taking Hydrocortisone Accord Tablets
Tell your doctor that you are taking Hydrocortisone Accord Tablets if you are to receive any vaccinations or have any diagnostic or laboratory tests. This is because steroids can affect the results of some tests.
Having surgery while you are taking Hydrocortisone Accord Tablets
If you are having surgery requiring an anaesthetic, tell your doctor you are taking Hydrocortisone Accord Tablets.
Information you should carry while you are taking Hydrocortisone Accord Tablets
If you are taking Hydrocortisone Accord Tablets, get a steroid card from your pharmacist, and carry it with you. It shows what you are taking and who your doctor is in case of an emergency.
If you have an accident, fall ill or see a different doctor while taking Hydrocortisone Accord Tablets, show them your steroid card or tell whoever treats you that you are taking Hydrocortisone Accord Tablets, because your dose may need to be changed.
Hydrocortisone Accord Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Hydrocortisone Accord Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should take this medicine by mouth. The amount you take each day will depend on your illness. The number of tablets to be taken will be on the label of your medicine. If you are unsure about the dose you should take, you must talk to your doctor or pharmacist.
The recommended dose is Adults
- 20 to 30mg a day.
- Sometimes it is taken twice a day with 4 to 6g of salt (sodium chloride) or 50 to 300 micrograms of fludrocortisone.
Children and adolescents
- 0.4 to 0.8mg a day, for every kilogram of your child’s weight in two or three separate doses.
- Children will be prescribed the lowest possible dose.
- The doctor will keep an eye on their growth and development.
Hydrocortisone Accord Tablets can be taken with or without food.
If you take more Hydrocortisone Accord Tablets than you should
If you take too many tablets by mistake, contact your doctor as soon as possible. Symptoms of overdose include feeling or being sick, salt and fluid retention, high blood sugar and gastrointestinal bleeding.
If you forget to take Hydrocortisone Accord Tablets
- If you forget to take your dose, skip the missed dose.
- Take the next dose as normal.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Hydrocortisone Accord Tablets
It is dangerous to reduce your dose of Hydrocortisone Accord Tablets too quickly. Stopping Hydrocortisone Accord Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as:
- pains in muscles or joints
- fever
- general discomfort.
Your doctor or pharmacist will give you advice on how to reduce the number of tablets you take if you need to do this. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. People taking steroids to replace similar naturally occurring hormones should be less likely to get side effects than people taking steroids for other illnesses. Your doctor will want to see you now and then to look out for these effects.
Tell your doctor immediately if you notice any of these problems, or if you think you are at increased risk of infection (e.g. you have been in contact with someone who has an infection):
Not known (frequency cannot be estimated from the available data):
- An allergic reaction such as itching or skin rash; swelling of the face, lips or throat; or difficulty in breathing or wheezing.
- Pseudotumourcerebri in children - raised pressure within the skull, indicated by headaches with vomiting, listlessness and drowsiness; this usually occurs after treatment is stopped.
- Burst or bleeding ulcers - indicated by stomach pain especially if it seems to spread to your back, bleeding from the back passage, black stools or vomiting with blood in the vomit.
- Acute pancreatitis - abdominal pain, possibly accompanied by shock, i.e. low blood pressure with decreased output of urine and often loss of consciousness.
- Thrombosis - a blood clot in a vein in your leg, symptoms of which are a swollen, red, hot, tender muscle.
- Thromboembolism - a blood clot which may go to the lung, symptoms of which are sudden shortness of breath and chest pain and coughing up blood.
Heart failure - problems with the pumping of your heart indicated by swollen ankles, chest pain, difficulty in breathing and palpitations or irregular beating of the heart, irregular or very fast or slow pulse; hypertension (high blood pressure, indicated by headaches, or generally feeling unwell).
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Additional side effects in children
Not known (frequency cannot be estimated from the available data):
- suppression of normal growth in children
- thickening of the heart muscle (hypertrophic cardiomyopathy) in prematurely born babies. Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Hydrocortisone Accord Tablets
- Keep this medicine out of the sight and reach of children.
- Do not store above 25°C. Store them in the original package and out of the light.
- Do not put your tablets into another container, in case they get mixed up.
- Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Hydrocortisone Accord Tablets contain
The active substance is hydrocortisone.
The other ingredients are lactose, magnesium stearate, maize starch.
What Hydrocortisone Accord Tablets look like and contents of the pack
Hydrocortisone Accord Tablets are available in two strengths.
- 10mg tablets: White, quarter-scored tablets, marked ‘HYD 10’. The tablets are scored so that they can be divided into equal halves or quarters. This can allow you to take lower doses of half of a tablet (5mg) or quarter of a tablet (2.5mg).
- 20mg tablets: White, half-scored tablets, marked ‘HYD 20’. The tablets are scored so that they can be divided into equal doses. This can allow you to take a lower dose of half of a tablet (10mg).
Hydrocortisone Accord Tablets come in packs of 30 tablets.
Marketing Authorisation Holder: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Manufacturers: Tiofarma BV, Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, The Netherlands.
Tiofarma BV, Hermanus Boerhaavestraat 1, 3261 ME Oud-Beijerland, The Netherlands.
Further information about your condition may be available from The Pituitary Foundation, P.O. Box 1944, Bristol, BS99 2UB Telephone: 0845 450 0375.
(The Pituitary Foundation is an independent organisation, it is not associated with Accord Healthcare Limited).
If you would like a leaflet with larger text, please contact 01271 385257.
This leaflet was last revised in June 2021
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