Dexamethasone 500 microgram Tablets

• Dexamethasone is a steroid medicine, prescribed for many different conditions, including serious 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.
• Dexamethasone can cause side effects in some people (read 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, keep taking 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 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 chickenpox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you. This leaflet was last updated in September 2020.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Dexamethasone Tablets are and what they are used for
2. What you need to know before you take Dexamethasone Tablets
3. How to take Dexamethasone Tablets
4. Possible side effects
5. How to store Dexamethasone Tablets
6. Contents of the pack and other information

• if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6)
• if you have an untreated infection affecting your whole body
• if you have a fungal infection affecting the whole of your body, e.g. thrush
• if you are to have a ‘live virus’ vaccination.

If any of the above apply to you, talk to your doctor or pharmacist.

• if you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like dexamethasone.
• if any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking dexamethasone.

Treatment with this medicine may cause pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands. Crisis can occur with following symptoms: headaches, sweating, palpitations, and hypertension. Contact your doctor immediately if you experience these signs.

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

Talk to your doctor before taking Dexamethasone Tablets: You should tell your doctor if you have any of the following conditions:

• recently suffered from a heart attack
• tuberculosis
• kidney or liver problems, including cirrhosis
• an underactive thyroid
• high blood pressure
• diabetes, or a family history of diabetes; your doctor may need to increase your dose of diabetic - treatment
• heart problems
• thinning of the bones (osteoporosis)
• raised pressure in the eye(s) (glaucoma) or a family history of glaucoma
• myasthenia gravis (which causes weakened muscles)
• intestinal or stomach problems
• had muscle weakness with steroids in the past
• an eye infection caused by herpes virus
• malaria affecting the brain
• epilepsy
• severe mental health problems or if you ever had severe depression or manic depression (bipolar disorder) or if a family member has or has ever had these problems. This includes having had depression before while taking steroids
• symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath, in case you suffer from haematological malignancy.
• if you have or are suspected of having pheochromocytoma (a tumor of the adrenal glands).

Dexamethasone should not be used routinely in preterm neonates with respiratory problems.

Long term use of steroids at high doses may cause slowing of growth in children. Your doctor may check your child’s height at intervals during treatment and reduce the dose if any effects are seen.

Mental health problems can happen while taking steroids like dexamethasone (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), 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.

These infections will become more serious during treatment with steroids, and you will require urgent specialist care if you become exposed to someone with these infections. DO NOT stop taking the tablets.

If you have not had chickenpox, shingles or measles, you should AVOID contact with anyone who has these illnesses.

If you think that you have been exposed to any of these infections, seek immediate medical attention. Do this if you are taking these tablets, or have taken them during the previous 3 months.

If you have an accident, become ill, require any surgery (including at the dentist's), or are to have any 'live virus’ vaccinations during or after treatment with Dexamethasone Tablets, you MUST tell the person treating you that you are taking or have taken steroids.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may be affected by dexamethasone or they may affect how well dexamethasone will work. Tell your doctor or pharmacist if you are taking:

• aspirin or similar medicines
• phenytoin (to treat epilepsy)
• ephedrine (a nasal decongestant)
• barbiturates (to treat sleeplessness and epilepsy)
• ketoconazole (for fungal infections)
• rifampicin and rifabutin (antibiotics used to treat tuberculosis)
• erythromycin or similar antibiotics
• anticoagulants (to thin the blood), such as warfarin
• medicines for diabetes, including insulin; your doctor may need to increase your dose of diabetic treatment
• diuretics (water tablets)
• carbamazepine (for epilepsy, pain, manic depression)
• aminoglutethimide (a cancer medicine)
• thalidomide (to treat leprosy)
• indometacin, as this may affect dexamethasone tests for certain diseases.

Some medicines may increase the effects of Dexamethasone Tablets and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Dexamethasone may pass to your unborn baby or into breast milk.

DO NOT take dexamethasone if you are pregnant, planning to become pregnant or while breast-feeding unless advised to by your doctor.

Steroids may affect sperm count and movement in men.

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.

Dexamethasone is unlikely to affect your ability to operate machinery or to drive.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Adults and the elderly

The usual starting dose is 1 to 18 tablets per day.

Your doctor will tell you the correct dose and when to take it depending on your condition, and may give you the lowest dose to reduce side effects and to control your condition.

Your doctor may change the dose during treatment.

Elderly patients will be monitored more frequently.

Use in children and adolescents

Usually a single dose on alternate days will be given. The doctor will also monitor growth and development at intervals during treatment.

During treatment: because of possible side effects, your doctor may monitor you at intervals during your treatment.

You may be given a blue 'steroid treatment card': always keep it with you and show it to any doctor, pharmacist or nurse treating you.

See your doctor if you develop any new infections while taking these tablets.

Prolonged use may lead to eye problems e.g. cataracts or glaucoma.

Withdrawal symptoms, such as fever, muscle weakness or pain, aching joints or malaise (feeling ill), may occur after stopping long term treatment with dexamethasone.

1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the tablet pack/container and any remaining tablets with you so that people can see what you have taken.
3. Do this even if you feel well.

If you forget to take a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.

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

Stopping this medicine suddenly can be dangerous, and may cause:

• low blood pressure
• a relapse of the disease for which treatment was given.

Keep taking the tablets until your doctor tells you how and when to stop.

Do not let yourself run out of medicine, especially over the weekends or on holidays.

The bottle contains a canister containing oxygen absorbing materials. Keep the canister in the bottle. Do not swallow it.

Steroids including dexamethasone 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 dexamethasone.

• 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.

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

• headache
• acne
• a feeling of dizziness or spinning
• increased sweating
• nausea
• changes in vision
• visual disturbance, loss of vision, blurred vision
• malaise (feeling ill)
• slow wound healing
• hiccoughs
• thinned, delicate skin
• fits
• difficulty swallowing, sore throat, a feeling of chest pain (which may be signs of a fungal infection in the oesophagus (gullet))
• stomach pain and discomfort, swollen abdomen
• increased appetite
• raised blood pressure
• salt imbalances, fluid retention
• swelling and weight gain of the body and face
• high blood sugar, with symptoms such as excessive thirst
• increased requirement for diabetic medication
• muscle weakness and wasting
• thinning of bone with an increased risk of fractures
• pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas
• bruising and unusual skin markings or rash
• raised pressure in the eye(s) (glaucoma), cataracts
• irregular periods or absence of periods in women
• increase in body and facial hair growth
• slow growth or development in children and adolescents
• increased frequency or severity of infections.

Blood or skin tests: tell the doctor or nurse if you are having blood tests for bacterial infection, or skin tests, as the results may be affected.

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.

• The active substance is dexamethasone. Each tablet contains 500 micrograms dexamethasone.
• The other ingredients are calcium hydrogen phosphate (E341), lactose, magnesium stearate (E572), maize starch. (See end of section 2 for further information on lactose).

Dexamethasone Tablets are round, white tablets with a break-line on one side, marked ‘41’.

Pack sizes

They are available in bottles of 28 or 100 tablets containing an oxygen absorbing canister and blister packs of 28 or 30 tablets.

Not all pack types and sizes may be marketed.