DEXAMETHASONE 500 MICROGRAMSTABLETS - Patient leaflet, side effects, dosage

1. What this medicine is and what it is used for

• 2. Before you take Dexamethasone Tablets

3. How to take Dexamethasone Tablets

4. Possible side effects

5. How to store Dexamethasone Tablets

• 6. Further information

1 ) What this medicine is and what it is used for

Dexamethasone 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 dexamethasone) is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. Some of the illnesses and conditions that dexamethasone is used for include:

• swelling of the brain and increased pressure in the brain caused by a tumour
• severe allergic reactions
• blood disorders such as leukaemia and haemolytic anaemia (a reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness)
• sarcoidosis, an immune disease that can lead to excessive levels of calcium and vitamin D in the body
• inflammation of the heart in association with heart or heart surgery
• intestinal disorders, e.g. Crohn’s disease, ulcerative colitis
• respiratory disorders such as asthma
• tuberculosis (together with appropriate chemotherapy)
• certain inflammatory skin and muscular disorders
• inflammation of the eye
• rheumatoid arthritis
• kidney inflammation caused by SLE, a disease of the immune system

2j Before you take Dexamethasone Tablets

Do NOT take Dexamethasone Tablets if you:

• are allergic to dexamethasone or any of the other ingredients (see Section 6)
• have an untreated infection affecting your whole body
• have a fungal infection affecting the whole of your body, e.g. thrush
• are to have a ‘live virus’ vaccination

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

Check with your doctor first

• 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.

Warnings and Precautions

• Before taking the tablets, tell your doctor if you have any of these conditions as additional monitoring may be required: 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) if a family member has or has ever had these problems. This includes having had depression before while taking steroids
• have 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

Pay attention when using Dexamethasone

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

Use in children

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 problems while taking dexamethasone

• Mental health problems can happen while taking steroids like dexamethasone (see 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.

Chickenpox, shingles, measles

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.

Surgery or other treatment by a doctor, dentist or nurse

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal preparations. 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
• medicines used to treat HIV, such as ritonavir and cobicistat
• 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)
• indomethacin, as this may affect dexamethasone tests for certain diseases

Pregnancy and breast-feeding

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.

Ask your doctor for advice before taking any medicine.

Driving and using machines

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

Important information about some of the ingredients of Dexamethasone Tablets

• Lactose

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 Dexamethasone Tablets

Always take Dexamethasone Tablets exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.

• Swallow the tablets with plenty of water, with or immediately after a meal to prevent upset stomach.
• Take the tablets regularly as advised by your doctor to obtain the maximum benefit.

Dose

Adults and the elderly:

The usual dexamethasone starting dose is 500mcg to 9mg 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.

Children: 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.

Taking dexamethasone long term

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.

If you take more than you should

• 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

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 missed dose.

If you stop taking

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.

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

N Possible side effects

Like all medicines, Dexamethasone Tablets can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. Some side effects only happen after weeks or months.

Seek medical help immediately if you have any of the following allergic reactions:

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps

Also seek immediate medical attention if you have come in contact with anyone suffering from chickenpox, shingles or measles.

Serious effects: tell a doctor straight away

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.

Tell your doctor if you get any of the following symptoms:

• headache
• acne
• a feeling of dizziness or spinning
• increased sweating
• nausea
• changes in vision including visual disturbances or loss of 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 a blood test for bacterial infection, or skin test, as the results may be affected.

If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Dexamethasone Tablets

• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the blister and the carton. 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 it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.

• 6) Further information

What Dexamethasone Tablets contain

• The active ingredient is dexamethasone.
• Dexamethasone 500 microgram Tablets contain 500 micrograms of Dexamethasone.
• Dexamethasone 2mg Tablets contain 2mg of Dexamethasone.
• The other ingredients are: Lactose monohydrate, maize starch, magnesium stearate.

What Dexamethasone Tablets look like and contents of the pack

Dexamethasone 500 microgram Tablets are round, white tablets, 6mm in diameter.

Dexamethasone 500 microgram Tablets are available in packs of 30 tablets (3 blisters of 10 tablets) or 28 tablets (2 blisters of 14 tablets).

Dexamethasone 2mg Tablets are round, white tablets, 6mm in diameter, and with the letters D2 on one side.

Dexamethasone 2mg Tablets are available in packs of 50 tablets (5 blisters of 10 tablets) or 28 tablets (2 blisters of 14 tablets).

Marketing Authorisation Holder:

Aspire Pharma Limited

Unit 4 Rotherbrook Court

Bedford Road

Petersfield, Hampshire

GU32 3QG

United Kingdom

Manufacturer:

BalkanPharma-Razgrad AD 68, Aprilsko Vastanie Blvd. 7200 Razgrad, Bulgaria.

This leaflet was last revised in 05/2021

Aspire

1010533 -P3.2 PHARMA