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)
• have thrush, candida or any other fungal infection.

If you are not sure, talk to your doctor or pharmacist before taking Hydrocortisone Tablets.

Warnings and precautions

Talk to your doctor before taking your medicine if:

• you or any of your close family have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Hydrocortisone Tablets
• you have recently had a heart attack
• you have a heart condition called congestive heart disease
• you have septicaemia, tuberculosis (TB) or have had it in the past
• you have a stomach ulcer or other digestive problem
• you have chicken pox or shingles
• you come in contact with people who have chicken pox or shingles, especially if you have not already had these illnesses or are not sure if you have had them
• you have a herpes infection in the eye called ocular herpes simplex
• you had muscle weakness after taking steroids in the past
• you have recently visited a tropical country
• you have bowel problems such as ulcerative colitis
• you have epilepsy
• you have thrombophlebitis (swelling and redness along a vein which is extremely tender when touched)
• you have exanthematous disease (disease affecting the skin, rash)
• you have metastatic carcinoma (cancer that has spread from one part of the body to another)
• you are taking Hydrocortisone Tablets for a long time, as this increases your chance of getting infections
• you have amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse.

Also, check with your doctor if any of the following problems run in your family , or if you have any of them:

• diabetes
• heart problems
• high blood pressure
• an eye condition called 'glaucoma’
• kidney or liver problems
• a type of muscle weakening problem called 'myasthenia gravis’
• thinning of the bones (osteoporosis)
• low thyroid levels (hypothyroidism)

If you are not sure, talk to your doctor or pharmacist before taking Hydrocortisone Tablets

Mental health problems while taking Hydrocortisone Tablets

Mental health problems can happen while taking steroids like Hydrocortisone Tablets (see also section 4 Possible side effects)

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

Talk to a doctor if you (or someone taking this medicine), show any signs of mental problems.

This is particularly important if you are depressed , or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

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

Other medicines and Hydrocortisone Tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those 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.

In particular do not take these tablets and tell your doctor or pharmacist if you are taking any of the following:

• aspirin
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone
• cough and cold medicines that contain a decongestant called ephedrine
• medicines used for TB (tuberculosis) called rifabutin or rifampicin
• medicines used to thin the blood such as warfarin
• water tablets (diuretics)
• some medicines for fungal infections such as amphotericin and ketoconazole
• a medicine for cancer called aminoglutethimide
• some medicines for heart failure such as digoxin, furosemide or bumetanide
• a medicine used for some infections called erythromycin
• oral contraceptive pills and hormone replacement therapy (HRT)
• a type of growth hormone called somatropin
• some medicines for high blood pressure
• some medicines for heart disease such as guanethidine, isosorbide mononitrate, isosorbide dinitrate and theophylline
• medicines sometimes used for asthma, low blood pressure or in cough and cold remedies called sympathomimetics
• calcium supplements
• medicines for pain and inflammation called NSAIDs such as ibuprofen, diclofenac or naproxen
• a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor or consultant)
• medicines for diabetes.
• ritonavir, cobicistat (medicines used in the treatment of HIV infections)
• methotrexate (a medicine used to treat rheumatoid arthritis)
• ciclosporin (a medicine used for psoriasis or in patients who have organ transplants)

Hydrocortisone Tablets and infections

Infections are easier to get and harder to spot while you are taking Hydrocortisone Tablets.

Stay away from anyone you know with chickenpox, shingles, measles. See your doctor if you think you may have picked up an infection.

Hydrocortisone Tablets with food and drink

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

Steroids may cause a feeling of movement, even while you are still and this can cause you to feel dizzy (vertigo). 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 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 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 you are taking Hydrocortisone Tablets.

Information you should carry while you are taking Hydrocortisone Tablets

If you are taking Hydrocortisone 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 these tablets, show them your steroid card or tell

Please turn over whoever treats you that you are taking Hydrocortisone Tablets, as your dose may need to be changed.

15 mm

Hydrocortisone Tablets contain lactose

One Hydrocortisone Tablet contains 49.18 mg (for 5 mg), 98.36 mg (for 10 mg) and 196.72 mg (for 20 mg) lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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.

• The tablets can be divided into equal doses.
• Swallow the tablets with some liquid, with or without meals.
• If you feel that the effect of the treatment is too strong or too weak, discuss this with your doctor.

Dosage for adults for emergency treatment

• 5 mg:

Take 12 to 16 tablets (6080 mg) every 46 hours for 24 hours. Then gradually reduce the dose as instructed by the doctor over several days.

10 mg:

Take 6 to 8 tablets (6080 mg) every 46 hours for 24 hours.

Then gradually reduce the dose as instructed by the doctor over several days.

• 20 mg:

Take 3 to 4 tablets (6080 mg) every 46 hours for 24 hours.

Then gradually reduce the dose as instructed by the doctor over several days

Dosage for children and adolescents (aged 1 month to 18 years) for replacement therapy

• The doctor will determine the dose based on the patient's height and weight.
• The usual dose is 0.4 to 0.8 mg a day, for every kilogram of the child's weight.
• The dose is given as 2 or 3 separate doses each day.
• Children will be prescribed the lowest possible dose.
• The doctor will monitor their growth and development.

Dosage 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.

If you take more Hydrocortisone Tablets than you should Contact your doctor or local hospital if you have taken more tablets than your doctor has prescribed.

If you forget to take Hydrocortisone Tablets

Skip the missed dose and then take the next dose as normal.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydrocortisone Tablets

If you suddenly stop taking these tablets, you may experience withdrawal symptoms such as muscle or joint pain, fever, weakness, feeling sick, raised pressure within the skull, and low blood pressure.

You should only stop your treatment following consultation with your doctor, who will gradually reduce your dose to prevent withdrawal symptoms occurring.

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.

Side effects may be stronger in elderly patients and in children.

Serious side effects

Tell your doctor straight away if you notice any of the following side effects or if you think you are at increased risk of infection (e.g. you have been in contact with someone who has an infection):

• a possibly life-threatening allergic reaction which causes e.g. skin rash, swelling of the face or wheezing
• irregular or very fast or slow pulse, faintness
• muscle cramps or spasms
• in children, headaches with vomiting, listlessness and drowsiness. These are symptoms of pseudotumour cerebri that can raise pressure within the skull and that usually occurs after treatment is stopped
• nausea, vomiting
• burst or bleeding gut ulcers (indicated by stomach pain, especially if it seems to spread to your back, bleeding from the back passage, black stools or blood in the vomit)
• acute inflammation of the pancreas (abdominal pain, possibly accompanied by shock, i.e. low blood pressure with decreased output of urine and often loss of consciousness)
• A worsening of sight
• a blood clot in a vein (thrombosis) in your leg, symptoms of which are a swollen, red, hot, tender muscle
• a blood clot which may go to the lungs (thromboembolism), symptoms of which are sudden 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).

Serious effects: Mental health problems

The following symptoms can occur in about 5 in every 100 people taking medicines like hydrocortisone.

If you notice any of these problems, talk to a doctor straight away.

• 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 reported with hydrocortisone:

Common (may affect up to 1 in 10 people)

• high blood pressure
• increased susceptibility to infections, masked infection symptoms
• inadequate hormone secretion by the pituitary gland (adrenocortico­tropin hormone, ACTH) and by the adrenal gland (cortisol) in long-term use
• round or moon-shaped face
• worsening or development of diabetes
• 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 )
• accumulation of sodium in the body
• thin or delicate skin, slow healing of cuts and wounds, scarring, red or purple spots, acne, stretch marks, bruising
• muscle weakness or wasting, osteoporosis (brittle bones -bones that break easily).

Uncommon (may affect up to 1 in 100 people)

• increase in appetite
• mood changes, depression, mania (feeling high), psychoses (feeling, seeing or hearing things which do not exist, or having strange and frightening thoughts, changing how you act or having feelings of being alone), sleeplessness
• changes in vision as a result of cataracts or glaucoma (increased eye pressure).

Rare (may affect up to 1 in 1,000 people)

• convulsions
• breakdown of bone due to poor circulation of blood, torn muscle tendons (pain and/or swelling).

Not known (the frequency of side effects cannot be estimated from the available data)

• increase in the number of white blood cells
• poor response to stress (like injury, surgery or illness)
• increase in blood sugar levels
• loss of potassium and calcium, loss of nitrogen due to breakdown of body protein stores, fluid retention
• mood disorders, behavioural problems, feeling irritated or anxious, having problems sleeping, difficulty in thinking (including being confused and losing your memory)
• vertigo, headache
• blurred vision, thinning of the surface of the eyes, bulging eyes
• rupture of the heart muscle following recent heart attack
• hiccups
• ulcerative inflammation of the gullet, bloating, indigestion, thrush in the gullet
• small round spots in the skin or mucous membranes, redness of the skin, permanent dilation of small blood vessels in the skin or mucous membranes, increased sweating, allergic skin inflammation, hives, increased hair on the body and face in women
• muscle disease caused by steroids, broken bones or fractures
• irregular or no periods in women
• weight gain, feeling sick, feeling of bodily discomfort and \ tiredness.

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 the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects 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 and the outer carton after EXP. The expiry date refers to the last day of that month.
• Store in the original blister in order to protect from light.
• This medicinal product does not require any special temperature storage conditions.
• 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 informationwhat hydrocortisone tablets contains the active substance is hydrocortisone. hydrocortisone tablets come in three strengths. each tablet contains 5 mg, 10 mg or 20 mg hydrocortisone.

• The other ingredients are lactose monohydrate, maize starch and magnesium stearate.

What Hydrocortisone Tablets looks like and contents of the pack

5 mg:

White to off white, oval shaped, flat faced beveled edge, uncoated tablets debossed with ‚G24‘ on one side and break line on the other with approx. 2.8mm thickness, 6.6mm length and 3.5mm breadth. The tablet can be divided into equal doses.

10 mg:

White to off white, round, flat faced beveled edge, uncoated tablets debossed with ‚G39‘ on one side and break line on the other with approx. 2.3mm thickness and 7.0mm diameter. The tablet can be divided into equal doses.

20 mg:

White to off white, oval, flat faced beveled edge, uncoated tablets debossed with ‚G361‘ on one side and break line on the other with approx. 3.3mm thickness, 10.9mm length and 7.1mm breadth. The tablet can be divided into equal doses.

Hydrocortisone Tablets are available as blister packs of 30, 50, 60 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2B Draycott Avenue

Kenton, Middlesex, Ha3 0BU

United Kingdom

Manufacturer

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park Croxley Green, Hertfordshire, WD18 8YA

United Kingdom

Przedsiebiorstwo Farmaceutyczne JELFA S.A. ul. Wincentego Pola 21, 58–500 Jelenia Gora Poland

This leaflet was last revised in 03/2020

15 mm

Hydrocortisone Tablets contain lactose

One Hydrocortisone Tablet contains 49.18 mg (for 5 mg), 98.36 mg (for 10 mg) and 196.72 mg (for 20 mg) lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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.

• The tablets can be divided into equal doses.
• Swallow the tablets with some liquid, with or without meals.
• If you feel that the effect of the treatment is too strong or too weak, discuss this with your doctor.

Dosage for adults for emergency treatment

• 5 mg:

Take 12 to 16 tablets (6080 mg) every 46 hours for 24 hours. Then gradually reduce the dose as instructed by the doctor over several days.

10 mg:

Take 6 to 8 tablets (6080 mg) every 46 hours for 24 hours.

Then gradually reduce the dose as instructed by the doctor over several days.

• 20 mg:

Take 3 to 4 tablets (6080 mg) every 46 hours for 24 hours.

Then gradually reduce the dose as instructed by the doctor over several days

Dosage for children and adolescents (aged 1 month to 18 years) for replacement therapy

• The doctor will determine the dose based on the patient's height and weight.
• The usual dose is 0.4 to 0.8 mg a day, for every kilogram of the child's weight.
• The dose is given as 2 or 3 separate doses each day.
• Children will be prescribed the lowest possible dose.
• The doctor will monitor their growth and development.

Dosage 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.

If you take more Hydrocortisone Tablets than you should Contact your doctor or local hospital if you have taken more tablets than your doctor has prescribed.

If you forget to take Hydrocortisone Tablets

Skip the missed dose and then take the next dose as normal.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydrocortisone Tablets

If you suddenly stop taking these tablets, you may experience withdrawal symptoms such as muscle or joint pain, fever, weakness, feeling sick, raised pressure within the skull, and low blood pressure.

You should only stop your treatment following consultation with your doctor, who will gradually reduce your dose to prevent withdrawal symptoms occurring.

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.

Side effects may be stronger in elderly patients and in children.

Serious side effects

Tell your doctor straight away if you notice any of the following side effects or if you think you are at increased risk of infection (e.g. you have been in contact with someone who has an infection):

• a possibly life-threatening allergic reaction which causes e.g. skin rash, swelling of the face or wheezing
• irregular or very fast or slow pulse, faintness
• muscle cramps or spasms
• in children, headaches with vomiting, listlessness and drowsiness. These are symptoms of pseudotumour cerebri that can raise pressure within the skull and that usually occurs after treatment is stopped
• nausea, vomiting
• burst or bleeding gut ulcers (indicated by stomach pain, especially if it seems to spread to your back, bleeding from the back passage, black stools or blood in the vomit)
• acute inflammation of the pancreas (abdominal pain, possibly accompanied by shock, i.e. low blood pressure with decreased output of urine and often loss of consciousness)
• A worsening of sight
• a blood clot in a vein (thrombosis) in your leg, symptoms of which are a swollen, red, hot, tender muscle
• a blood clot which may go to the lungs (thromboembolism), symptoms of which are sudden 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).

Serious effects: Mental health problems

The following symptoms can occur in about 5 in every 100 people taking medicines like hydrocortisone.

If you notice any of these problems, talk to a doctor straight away.

• 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 reported with hydrocortisone:

Common (may affect up to 1 in 10 people)

• high blood pressure
• increased susceptibility to infections, masked infection symptoms
• inadequate hormone secretion by the pituitary gland (adrenocortico­tropin hormone, ACTH) and by the adrenal gland (cortisol) in long-term use
• round or moon-shaped face
• worsening or development of diabetes
• 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 )
• accumulation of sodium in the body
• thin or delicate skin, slow healing of cuts and wounds, scarring, red or purple spots, acne, stretch marks, bruising
• muscle weakness or wasting, osteoporosis (brittle bones -bones that break easily).

Uncommon (may affect up to 1 in 100 people)

• increase in appetite
• mood changes, depression, mania (feeling high), psychoses (feeling, seeing or hearing things which do not exist, or having strange and frightening thoughts, changing how you act or having feelings of being alone), sleeplessness
• changes in vision as a result of cataracts or glaucoma (increased eye pressure).

Rare (may affect up to 1 in 1,000 people)

• convulsions
• breakdown of bone due to poor circulation of blood, torn muscle tendons (pain and/or swelling).

Not known (the frequency of side effects cannot be estimated from the available data)

• increase in the number of white blood cells
• poor response to stress (like injury, surgery or illness)
• increase in blood sugar levels
• loss of potassium and calcium, loss of nitrogen due to breakdown of body protein stores, fluid retention
• mood disorders, behavioural problems, feeling irritated or anxious, having problems sleeping, difficulty in thinking (including being confused and losing your memory)
• vertigo, headache
• blurred vision, thinning of the surface of the eyes, bulging eyes
• rupture of the heart muscle following recent heart attack
• hiccups
• ulcerative inflammation of the gullet, bloating, indigestion, thrush in the gullet
• small round spots in the skin or mucous membranes, redness of the skin, permanent dilation of small blood vessels in the skin or mucous membranes, increased sweating, allergic skin inflammation, hives, increased hair on the body and face in women
• muscle disease caused by steroids, broken bones or fractures
• irregular or no periods in women
• weight gain, feeling sick, feeling of bodily discomfort and \ tiredness.

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 the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects 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 and the outer carton after EXP. The expiry date refers to the last day of that month.
• Store in the original blister in order to protect from light.
• This medicinal product does not require any special temperature storage conditions.
• 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.
• The other ingredients are lactose monohydrate, maize starch and magnesium stearate.