What is a Patient Information Leaflet and why is it useful?

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 20046/0302.


Hydrocortisone 10 mg Tablets (Focus)

Package leaflet: Information for the user

Hydrocortisone 10 mg Tablets

Hydrocortisone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only.
    Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Hydrocortisone 10 mg Tablets. It will be referred to as Hydrocortisone Tablets for ease hereafter.

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 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) is an effective way to treat various illnesses involving inflammation in the body.

Hydrocortisone reduces this inflammation, which could otherwise go on making your condition worse.

You must take this medicine regularly to get maximum benefit from it.

It is indicated

  • for use as replacement therapy for children with congenital adrenal hyperplasia which affects your body’s natural production of steroids.
  • pre-operatively and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve.

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 Hydrocortisone Tablets:

  • if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, swollen face or lips or shortness of breath;
  • if you have thrush, Candida or any other fungal infection;
  • if you have any other infections;
  • if you have been vaccinated recently or are going to have any vaccinations.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Hydrocortisone Tablets:

  • if you ever had severe depression or manic depressive illness (bipolar disorder).This includes having had symptoms of depression in the past while taking steroid medicines like Hydrocortisone Tablets;
  • if any of your close family has had these illnesses.

Check with your doctor before taking this medicine if you have or have had any of the following:

  • tuberculosis (TB);
  • liver problems;
  • kidney problems;
  • high blood pressure;
  • heart problems including recent heart attacks;
  • diabetes (or a family history of diabetes);
  • osteoporosis (thinning of the bones);
  • glaucoma (increased pressure in the eye) or family history of glaucoma;
  • epilepsy;
  • stomach ulcers or other digestive problems;
  • muscle weakness with steroids;
  • existing or previous history of severe mood-related disorders;
  • thyroid problems;
  • chickenpox, shingles or measles;
  • a weakened immune system;
  • amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse by Hydrocortisone Tablets.

You should see your doctor if you develop any new infections whilst taking these tablets. Taking hydrocortisone for a long period of time increases your chance of getting infections, which might be worse than normal and may very rarely be fatal.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

It is important that the doctor monitors growth and development at intervals during treatment of children.

If you are taking or have recently taken (within the last 3 months) Hydrocortisone Tablets and you become ill, suffer stress, get injured or are about to have a surgical procedure you must tell your doctor immediately that you are taking Hydrocortisone Tablets. Your dose of hydrocortisone may need to be increased (or you may have to start taking it again for a short time) to prevent a sharp fall in blood pressure.

If you have been on Hydrocortisone Tablets for longer than 3 weeks and wish to stop taking them, do not stop suddenly as this could result in a severe drop in blood pressure which could be fatal. Your doctor will advise on how to reduce the number of tablets you are taking.

It is important to avoid exposure to people who have chickenpox, measles or shingles, especially if you have not already had these illnesses or are not sure if you have had them. Hydrocortisone increases the risk of a severe bout of chickenpox. If exposed you must contact your doctor immediately.

Mental Health Problems while taking hydrocortisone

Mental health problems can occur while taking steroids like hydrocortisone (see also Section 4).

  • These illnesses can be severe;
  • Usually they start within a few days or weeks of starting the medicine;
  • They are more likely to happen at high doses;
  • Most of those problems go away if the dose is lowered or the medicine is stopped. However, if problems do occur they might need treatment.

Talk to a doctor if you (or someone taking this medicine) show any signs of mental health problems. This is particularly important if you are depressed or might be thinking about suicide. In a few cases, mental health problems have happened when doses are being lowered or the medicine stopped altogether.

Important-Steroid Treatment Card

All patients taking steroids for more than a few weeks should carry a Steroid Treatment Card, which is available from your doctor or pharmacist. These cards have the details of the medicine you are taking. Always keep it with you and show it to any doctor or nurse treating you.

Other medicines and Hydrocortisone Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because some medicines can affect or be affected by the use of Hydrocortisone Tablets.

The side effects of this medicine may be increased if certain medicines are taken at the same time. On the other hand, this medicine may increase or decrease the effect of other medicines or increase their side effects when taken at the same time.

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).

Please tell your doctor or pharmacist if you are taking:

  • anticoagulants such as warfarin (medicines used to thin the blood);
  • salicylates such as aspirin;
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac or naproxen (medicines used to treat mild to moderate pain);
  • cough and cold medicines that contain a decongestant called ephedrine;
  • medicines for diabetes (including insulin);
  • erythromycin (a medicine used to treat bacterial infections);
  • an oral contraceptive pill;
  • somatropin (a type of growth hormone);
  • acetazolamide (a medicine used to treat glaucoma);
  • amphotericin or ketoconazole (used to treat fungal infections);
  • mifepristone (a medicine used to assist medical termination of pregnancy);
  • diuretics (water tablets);
  • carbenoxolone (a medicine used to treat ulcers);
  • methotrexate (a medicine used to treat rheumatoid arthritis);
  • medicines used to treat epilepsy such as phenytoin, phenobarbital, carbamazepine and primidone;
  • rifabutin and rifampicin (antibiotics used to treat TB);
  • aminoglutethimide (a medicine used in the treatment of cancer);
  • cardiac glycosides such as digoxin (used to treat heart failure and irregular heartbeat);
  • theophylline and sympathomimetics such as bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline (used to treat asthma and other breathing problems);
  • antihypertensives (medicines used to treat high blood pressure).

Test results while taking Hydrocortisone Tablets

Hydrocortisone Tablets could affect the results of some tests performed by your doctor or in hospital, so tell your doctor or nurse that you are taking these tablets before any tests are carried out.

Hydrocortisone with food, drink and alcohol

Hydrocortisone 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 or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will decide whether you should take Hydrocortisone Tablets during this time.

Breast-feeding

Small amounts of hydrocortisone may pass into breast milk. Please ask your doctor for advice before taking these tablets if you are breast-feeding or intend to breast-feed.

Driving and using machines

Hydrocortisone 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. It is therefore important to take this medicine as directed by your doctor when driving or using machines. If you are affected do not drive or use machines, until you have discussed the issue with your doctor.

Hydrocortisone Tablets contains lactose

This medicine contains lactose (a kind of sugar). 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 Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist gives you this and has filled out the details including the dose and how long you will have treatment.

Method of administration

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 tablet can be divided into equal doses.

The recommended dose is:

Use in children and adolescents

The recommended dose is 0.4 to 0.8 mg/kg given as two or three doses per day.

Children will be prescribed the lowest possible dose.

The doctor will keep an eye on their growth and development.

If you take more Hydrocortisone Tablets than you should

If you take more Hydrocortisone Tablets than you should, contact your doctor or nearest hospital/emergency department.

If you forget to take Hydrocortisone Tablets

If you forget to take a dose, wait and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydrocortisone Tablets

Do not stop taking this medicine just because you feel better. You must follow your doctor's instructions on stopping these tablets. Your doctor may want you to reduce gradually the number of tablets before you finally stop taking them. Never let your tablets run out before receiving the next prescription. It may be dangerous to stop treatment without your doctor’s advice (See Section 2).

Stopping Hydrocortisone Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as fever, muscle and joint pain, blocked/runny nose, swelling of the eye, painful itchy skin rash and weight loss.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

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.

Tell your doctor immediately if you notice:

  • itching or skin rashes;
  • swelling of the face, lips or throat;
  • difficulty in breathing or wheeziness.

These may be signs of an allergic reaction.

Severe side effects:

Steroids including hydrocortisone can cause severe mental health problems. These side effects are common in both adults and children. They can affect about 5 in every 100 people taking medicines like hydrocortisone.

Tell your doctor immediately if you are:

  • depressed, including thinking about suicide;
  • high (mania) or having moods that go up and down;
  • anxious, having problems sleeping, having 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;
  • suffering from symptoms of reddish stretch marks, rounded red face, weak muscles and bones, mood changes and headache. These could be signs of a condition known as Cushing’s syndrome;
  • suffering from symptoms of chest pain and shortness of breath, especially if you have recently had a heart attack. These could be signs of a condition known as myocardial rupture;
  • suffering from symptoms of stomach pain, bleeding from the back passage, black stools or being sick with blood present. This could be signs of a bleeding ulcer;
  • suffering from symptoms of abdominal pain, stomach pain and discomfort, bloated feeling, infection or ulcers. These could be signs of inflammation of your pancreas;
  • suffering from symptoms of broken bones or fractures, hip or shoulder pain due to poor blood circulation, risk of torn tendons, joint inflammation in the knee and groin. These could be signs of a condition known as aseptic necrosis.

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;
  • oral thrush;
  • an increase in your white blood cell count;
  • swelling in your hands and legs;
  • increased appetite;
  • feeling excited or excessively happy;
  • low mood (depression);
  • insomnia;
  • worsening of another condition known as epilepsy;
  • feeling confused;
  • anxiety;
  • blurred vision;
  • cataracts;
  • bulging eyes;
  • worsening of any eye infections;
  • high blood pressure;
  • blood clots;
  • indigestion;
  • feeling sick;
  • slow healing of wounds;
  • redness on your skin;
  • bruising;
  • stretch marks;
  • hair growth;
  • decreased bone strength;
  • muscle weakness.

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. 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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Hydrocortisone Tablets contains

  • the active substance is hydrocortisone. Each tablet contains 10 mg of hydrocortisone;
  • the other ingredients are lactose monohydrate, maize starch and magnesium stearate.

What Hydrocortisone Tablets looks like and contents of the pack

Hydrocortisone Tablets are white, oval, tablets, engraved with ‘HC 10’ on one side and break-marked on both sides.

These are available in blister packs containing 30 tablets.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited
Capital House
85 King William Street
London
EC4N 7BL
UK

Manufacturer

Anfarm Hellas SA
Sximatari Viotias 32009
Greece

For any information about this medicine, please contact the Marketing Authorisation Holder, details provided above.

This leaflet was last revised in May 2019.

LF-118211-01