GENHYCO 20 MG TABLETS, HYDROCORTISONE 20 MG TABLETS - patient leaflet, side effects, dosage

4. possible side effects

Like all medicines, Hydrocortisone Tablets 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 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): An allergic reaction such as skin rash, swelling of the face or wheezing.
• Irregular or very fast or slow pulse, faintness.
• Muscle cramps or spasms.
• Pseudotumour cerebri in children (raised pressure within the skull, indicated by headaches with vomiting, listlessness and drowsiness); this usually occurs after treatment is stopped.
• Nausea, vomiting.
• 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).
• A worsening of sight.
• 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 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).

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.

• 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.

Tell your doctor if you experience any of the following:

Effects on your digestive system

• Swollen abdomen.
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloating.
• Hiccups.

Effects on your muscles and bones

• Muscle weakness or wasting.
• Osteoporosis (brittle bones – bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood (pain in the hip).
• Aseptic necrosis (joint inflammation in the knee and groin).
• Torn muscle tendons (pain and/or swelling).

Effects on your body water and salts

• 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).

Effects on your hormones and metabolic system

• Suppression of normal growth in children.
• Irregular or no periods in women.
• Increased hair on the body and face in women.
• Round or moon-shaped face.
• Increased appetite and weight gain.
• 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.

Effects on your skin

• Thin or delicate skin, bruising, red or purple spots.
• Slow healing of cuts or wounds.
• Acne, sweating, redness.
• Stretch marks.

Effects on your eyes

• Changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye).
• Thinning of the surface of the eye.
• Eye infections may get worse.
• Bulging eyes.

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:. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store hydrocortisone tablets

• Keep out of the sight and reach of children
• Do not store above 25°C. Store in the original package to protect from light.
• Do not put your tablets into another container, in case they get mixed up.
• Do not use Hydrocortisone Tablets after the expiry date, which is marked on the outside of the pack. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• 6. CONTENTS OF PACK AND OTHER INFORMATION

Hydrocortisone Tablets contain the active ingredient hydrocortisone. The other ingredients are lactose, magnesium stearate, maize starch.

Hydrocortisone Tablets comes in two strengths:

• White oval shaped tablet engraved “HC10” contains 10 mg hydrocortisone. The tablets are scored so that they can easily be broken into halves or quarters. This can allow you to take a lower dose of half of a tablet (5 mg) or quarter of a tablet (2.5 mg).
• White oval shaped tablet engraved “HC20” contains 20 mg hydrocortisone. The tablets are scored so that they can easily be broken into halves. This can allow you to take a lower dose of half of a tablet (10 mg).

Hydrocortisone Tablets come in blister packs and containers of 30 tablets. There is an additional pack of 100 tablets per container that may be available on the market.

Marketing authorisation Holder:

Activase Pharmaceuticals Limited,

11 Boumpoulinas 1060 Nicosia, Cyprus

Manufacturer:

DDSA Pharmaceuticals Limited,

84 Pembroke Road, London, W8 6NX, UK

For information in large print, on tape, on CD or in Braille, phone 02072010400.

This leaflet was last revised in 10/2017.

A0155–0156/O/PIL/A2

PATIENT INFORMATION LEAFLET

Hydrocortisone 10 mg Tablets

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

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Donot pass it on to others. It may harm them, even if their signs of illness are the same asyours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet.See section 4.
• Hydrocortisone Tablets are a steroid medicine, prescribed for many different conditions, includingserious illnesses.
• You need to take it regularly to get the maximum benefit.
• Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.
• Hydrocortisone Tablets can cause side effects in some people (read ‘Possible side effects’ section 4 below). Some problems such as mood changes (feeling depressed, or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keeptaking your tablets, but see your doctor straight away.
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read ‘Possible side effects’ section 4 for more information).
• If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.
• Keep away from people who have chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see yourdoctor straight away.

Now read the rest of thisleaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.

What is in this leaflet

• 1. What Hydrocortisone Tablets are and what are they 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 ARE THEY 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 regularly to get maximum benefit from it.

Hydrocortisone Tablets are indicated for replacement therapy in congenital adrenal hyperplasia in children.

Hydrocortisone Tablets are also used for the emergency treatment of severe bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema and anaphylaxis in adults and children.

Ask your doctor to explain why you have been given Hydrocortisone Tablets if you are unsure.

2. what you need to know before you take hydrocortisone tablets

Before you take Hydrocortisone Tablets

Check with your doctor first 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 Tablets.
• any of your close family has had these illnesses.

If either of these applies to you, talk to your doctor before taking Hydrocortisone Tablets.

Do not take Hydrocortisone Tablets if you:

• are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hydrocortisone Tablets.
• 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

Check with your doctor before taking your medicine if:

• 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 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; your chance of getting infections increases.
• you have amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse.
• you have a stomach ulcer or other digestive problem.

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 if any of the above run in your family, or you have them, talk to your doctor or pharmacist before taking Hydrocortisone Tablets.

Other medicines and Hydrocortisone Tablets

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. 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 this medicine 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 (a medicine 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),

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 with food and drink

Hydrocortisone Tablets can be taken with or without food.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breastfeeding.

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.

Hydrocortisone Tablets contain Lactose

Hydrocortisone Tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have intolerance to some sugars), talk to your doctor before taking this medicine.

Mental problems while taking Hydrocortisone Tablets

Mental 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 are 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), shows 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 have been lowered or stopped.

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.

3. HOW TO TAKE HYDROCORTISONE TABLETS

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

Taking this medicine

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 usual doses of Hydrocortisone Tablets are:

Replacement therapy

Children: 10–30 mg in divided doses is the normal daily requirement (see also section 4.4, Special Warnings and Precautions for Use).

In patients requiring replacement therapy, the daily dose should be given when practicable, in two doses. The first dose in the morning should be larger than the second dose in the evening, thus simulating the normal diurnal rhythm of cortisol secretion.

Acute emergencies

60–80 mg every 4–6 hours for 24 hours then gradually reduce the dose over several days. Steroids should be used cautiously in the elderly, since adverse effects are enhanced in old age (see section 4.4, Special Warnings and Precautions for Use).

When long term treatment is to be discontinued, the dose should be gradually reduced over a period of weeks or months, depending on dosage and duration of therapy (see section 4.4, Special Warnings and Precautions for Use).

Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and by administering the daily requirement as a single morning dose, or whenever possible, as a single morning dose on alternative days. Frequent patient review is required to titrate the dose against disease activity.

If you take more Hydrocortisone Tablets than you should

If you take too many tablets by mistake, contact your doctor as soon as possible.

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