Active ingredient
- hydrocortisone sodium phosphate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31862/0033 .
Hydrocortisone 10mg soluble tablets
Package leaflet: Information for the user
Hydrocortisone 10 mg and 20 mg Soluble Tablets
Hydrocortisone
Important things you need to know about Hydrocortisone
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that may be especially important for you.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Hydrocortisone tablets are and what they are used for
2. What you need to know before you take Hydrocortisone tablets
3. How to take Hydrocortisone tablets
4. Possible side effects
5. How to store Hydrocortisone tablets
6. Contents of the pack and other information
1. What Hydrocortisone tablets are and what they are used for
Hydrocortisone 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 tablets) is an effective way to treat various illnesses involving inflammation in the body. Hydrocortisone tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine as prescribed by your doctor in order to get the maximum benefit from it.
Hydrocortisone is a steroid medicine, prescribed for use as replacement therapy for children with congenital adrenal hyperplasia (which affects the body’s natural production of steroids), emergency treatment of asthma, the treatment of drug reactions, serum sickness (hypersensitivity reaction to proteins), localised swelling of the skin and/or mucous membranes (angioedema) and severe allergic reactions in adults and children.
It is also used for the treatment of adrenal insufficiency in children and adolescents less than 18 years of age.
Hydrocortisone which is contained in this product is also authorised to treat other sub-groups of patients which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
2. What you need to know before you take Hydrocortisone tablets
Do not take the Hydrocortisone tablets if you:
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Hydrocortisone tablets if:
If either of these apply to you, talk to your doctor before taking this medicine.
Also check with your doctor before taking this medicine if:
Also talk to your doctor if any of the following problems run in your family, or if you have any of them:
If you are not sure if any of the above run in your family, or you have them, talk to your doctor or pharmacist before taking a tablet.
Your doctor may suggest that you reduce the amount of salt you eat and that you take potassium supplements. You can ask your doctor if this applies to you.
Mental health problems while taking hydrocortisone tablets
Problems with mental health can occur or be seen whilst taking steroids like Hydrocortisone tablets (see also section 4 Possible Side Effects).
Talk to a doctor if you (or someone taking this medicine), shows any signs of mental health problems. This is particularly important if you are depressed or might be experiencing suicidal thoughts. In a few cases, mental health problems have occurred when doses are being reduced or stopped.
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Hydrocortisone tablets
Please tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Hydrocortisone tablets can affect the way some medicines work. Also, some other medicines can affect the way Hydrocortisone tablets work.
Some medicines may increase the effects of Hydrocortisone tablets and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
In particular, do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hydrocortisone tablets.
Hydrocortisone tablets and infections
Infections are easier to get and harder to spot while you are taking Hydrocortisone tablets.
Avoid contact with anyone you know to have viral infections such as:
See your doctor if you think you may have picked up an infection.
Hydrocortisone tablets with food, drink and alcohol
Hydrocortisone tablets can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Hydrocortisone may cause you to feel dizzy (vertigo). Changes in your eyesight or muscle weakness may also occur. If you are affected you should not drive or operate machinery.
Having vaccines or tests while you are taking Hydrocortisone tablets
Tell your doctor that you are taking Hydrocortisone tablets if you are to receive any vaccinations or have any diagnostic or laboratory tests. This is because steroids can reduce the effectiveness of some vaccines and affect the results of some tests.
Having surgery while you are taking Hydrocortisone tablets
If you are having surgery requiring an anaesthetic tell your doctor or dentist you are taking these tablets.
Information you should carry while you are taking Hydrocortisone tablets
If you are taking Hydrocortisone tablets for more than three weeks you will be given a blue steroid alert card by your pharmacist. It shows what medication 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 tablets, show them your steroid card, or tell whoever treats you that you are taking these tablets, because your dose may need to be adjusted.
Hydrocortisone tablets contain sodium benzoate and sodium.
This medicine contains 2.53 mg sodium benzoate in each 10 mg soluble tablet and 5.06 mg sodium benzoate in each 20 mg soluble tablet.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
This medicine contains 18.53 mg sodium (main component of cooking/table salt) in each 10 mg soluble tablet which is equivalent to 0.9 % of recommended maximum daily dietary intake of sodium for adult and 37.08 mg sodium in each 20 mg soluble tablet which is equivalent to 1.9 % of the recommended maximum daily intake.
3. How to take Hydrocortisone tablets
Always take this medicine exactly as your doctor or pharmacist 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.
Dosage for Acute Emergencies
The recommended dose for adults is 60-80 mg every 4 to 6 hours for 24 hours then gradually reducing the dose over several days.
Use in children and adolescents (aged 1 month to 18 years) for replacement therapy
Hydrocortisone Soluble Tablets can be used in children aged from 1 month to 18 years where the dose of 10 mg or 20 mg soluble tablet formulation is considered appropriate.
Use in special patient groups or special situations
Your doctor may want to change the dose or monitor your treatment carefully if you are elderly, have liver problems, or problems with the adrenal glands, stress, injuries or infections, or if a surgery is planned for you.
Method of administration
Hydrocortisone Soluble Tablets should be dissolved in water (at least 50 ml) before use.
Once dissolved, take immediately.
If you take more Hydrocortisone tablets than you should
If you take too many tablets by mistake, contact your doctor as soon as possible.
If you forget to take Hydrocortisone tablets
If you stop taking Hydrocortisone tablets
It is dangerous to reduce your dose of Hydrocortisone tablets too quickly. Stopping Hydrocortisone tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as:
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you are taking the medicine as a replacement steroid, you should be less likely to get side effects than people taking steroids for other illnesses. Your doctor will want to review you to look out for these effects.
Tell your doctor straight away 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) need surgery or you are involved in an accident:
Steroids including Hydrocortisone 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 tablets. They can happen while you are taking steroids or when you stop taking them.
Tell your doctor if you experience any of the following:
Effects on your digestive system
Effects on your muscles and bones
Effects on your body water and salts
Effects on your hormones and metabolic system
Effects on your skin
Effects on your eyes
Other effects
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme.
Website: 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 tablets
6. Contents of the pack and other information
What Hydrocortisone tablets contain
What Hydrocortisone tablets look like and contents of the pack
Hydrocortisone 10 mg Soluble Tablets are pink, flat, round tablets marked with “HS 10” with diameter of approx. 7mm.
Hydrocortisone 20 mg Soluble Tablets are pink, biconvex, oblong tablets marked with “HS 20” with length of approx. 11mm.
They are available in aluminium/aluminium blisters in pack sizes of 4, 10, 20, 30, 50 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in December 2019.
CRE-HYD10/20-PIL-441_05
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