Dexsol 2mg / 5ml Oral Solution

Dexsol 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



• Dexsol can cause side effects in some people (read section 4: Possible side effects). 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 medicine, 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, in the UK, 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 your doctor straight away.

Now read the rest of the 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 on 11/03/08.

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 further questions, please ask your doctor or your pharmacist.


• This medicine has been prescribed for you personally and you should not pass it on to others.
  
  
  It may harm them, even if their symptoms are the same as yours.
  

In this leaflet:

• 1. What Dexsol is and what it is used for


• 2. Before you take Dexsol


• 3. How to take Dexsol


• 4. Possible side-effects


• 5. Storing Dexsol


• 6. Further information

DEXSOL 2mg/5 ml Oral Solution

Active substance: Dexamethasone Sodium Phosphate.

Dexsol is a colourless to faint yellow oral liquid which contains Dexamethasone Sodium Phosphate which is equivalent to 2mg Dexamethasone per 5ml.

The medicine also contains: benzoic acid, propylene glycol, citric acid monohydrate, liquid maltitol, garden mint flavour (containing isopropanol and propylene glycol), liquid sorbitol non-crystallising, sodium citrate and purified water.

The medicine is available in a 150ml pack.

The licences (PL 00427/0137 and PA 312/9/1) are held by and the product is manufactured by:-

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

What Dexsol Is And What It Is Used For

Dexsol – benefit information

Dexsol 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 Dexsol) is an effective way to treat various illnesses involving inflammation in the body. Dexsol reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

This medicine will have been given to you for one of the following:-

• where natural corticosteroid levels have been reduced and you need replacement therapy



• in certain cases where swelling of the brain has occurred



• if you are having diagnostic tests for diseases which may have an effect on natural corticosteroid production e.g. Cushing’s syndrome



• to reduce inflammation and suppress the immune system in a variety of conditions, in particular:
  
  
  • allergy
  
  
  
  • Polymyalgia rheumatica (chronic inflammation of the larger arteries), Polyarteritis nodosa (chronic inflammation of small and medium arteries)
  
  
  
  • blood disorders including haemolytic anaemia (disorder which breaks down red blood cells), Leukaemia, Myeloma (bone tumour)
  
  
  
  • Crohn’s disease, ulcerative colitis (inflammation of the bowel particularly the rectum), hepatitis
  
  
  
  • Polymyositis (inflammation of many muscles)
  
  
  
  • increased pressure in the head not linked to tumours, worsening of multiple sclerosis
  
  
  
  • inflammation of the eye
  
  
  
  • inflammation of the kidney
  
  
  
  • breathing problems including chronic bronchial asthma and chronic obstructive pulmonary disease (COPD) which may show as shortness of breath during exercise, difficulty breathing in and out deeply and persistent cough. Disorders where there is inflammation of the lung.
  
  
  
  • Rheumatoid arthritis (including Felty’s syndrome, Sjörgen’s syndrome and juvenile), rheumatism, inflammation of a wide area of the body
  
  
  
  • chronic and severe diseases of the skin (including Stevens- Johnson syndrome and a rare condition known as mycosis fungoides)
  
  
  
  • Leukaemia of the lymphatic system, Hodgkins and Non-Hodgkins Disease breast cancer that has spread around the body, Kahlers disease and high calcium levels caused by this disease
  
  
  
  • Following organ transplants and to prevent nausea and vomiting following chemotherapy
  
  

Before You Take Dexsol

Particular caution is necessary when taking Dexsol

You must not take this medicine and you should consult your doctor if:

• you have ever had an unusual reaction to dexamethasone or any of the ingredients in this medicine


• you have an infection that affects the whole body


• you are pregnant, planning to become pregnant or breast feeding


• you have a stomach or duodenal ulcer


• you have an infection with tropical worms

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 Dexsol.

Mental problems while taking Dexsol

Mental health problems can happen while taking steroids like Dexsol (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.

Please inform any doctor, dentist or person who may be giving you treatment that you are currently taking steroids or have taken them in the past.

If you are a patient in the UK, you should always carry a ‘Steroid treatment’ card which gives clear guidance on the special care to be taken when you are taking this medicine. Show this to any doctor, dentist or person who may be giving you treatment. Even after your treatment has finished you must tell anyone who is giving you treatment that you have taken steroids.

You should consult your doctor before taking this medicine if:

• you have kidney or liver problems


• you have high blood pressure, heart disease or you have recently had a heart attack


• you have diabetes or there is a family history of diabetes


• you have osteoporosis (thinning of the bones), particularly if you are a female who has been through the menopause


• you have suffered from muscle weakness with this or other steroids in the past


• you have glaucoma (raised eye pressure) or there is a family history of glaucoma


• you have myasthenia gravis (a condition causing weak muscles)


• you have a bowel disorder or a stomach (peptic) ulcer


• you have psychiatric problems or you have had a psychiatric illness which was made worse by this type of medicine


• you have epilepsy


• you have migraines


• you have had an allergy or unusual reaction to corticosteroids


• you have an underactive thyroid gland


• you have a parasitic infection


• you have tuberculosis, septicaemia or a fungal infection in the eye


• you have cerebral malaria


• you have herpes (cold sores or genital herpes)


• you have asthma

If you develop an infection whilst on this medicine you should talk to your doctor.

NOTE: It is important that whilst you are taking this medicine you avoid contact with anybody who is suffering from chickenpox/ shingles or measles as you may need specialist treatment. If you think you may have had exposure to any of these diseases, you should consult your doctor immediately. You should also inform your doctor if you have ever had infectious diseases such as measles or chickenpox and of any vaccinations.

If you have an accident, are ill, or require any surgery (even at the dentists) or you require a vaccination (particularly with ‘live virus’ vaccines) whilst taking or when you have finished taking this medicine, you should inform the person treating you that you are taking or have taken steroids.

If you have suppression tests or tests for infection you should inform the person performing the test that you are taking dexamethasone as it may interfere with the results.

If a child is taking this medicine, it is important that the doctor monitors their growth and development at frequent intervals.

You may also find that your doctor will reduce the amount of salt in your diet and give you a potassium supplement whilst you are taking this medicine.

Important information about some of the ingredients of Dexsol:

This medicine contains benzoic acid which may cause mild irritation to the skin, eyes and mucous membranes.

It may also increase the risk of jaundice in new-born babies.

This medicine contains 0.7g sorbitol in each 5ml spoonful. When taken according to the dosage
recommendations each dose supplies up to 3.1g of sorbitol. At maintenance, the dosage will reduce to about
0.5g daily. It is unsuitable for patients who have hereditary fructose intolerance. It can also cause stomach
upset and diarrhoea.

Liquid maltitol may also cause diarrhoea.

Taking other medicines

If you are taking any of the following medicines, you should consult your doctor before taking dexamethasone:

• Anticoagulant medicines which thin the blood (e.g. warfarin)



• Aspirin or similar (Non-Steroidal Anti-Inflammatories) e.g. indometacin



• Medicines used to treat diabetes



• Medicines used to treat high blood pressure



• Diuretics (water tablets)



• Amphotericin B injection



• Phenytoin, Carbamazepine, Primidone (epilepsy medication)



• Rifabutin, Rifampicin (antibiotics used to treat tuberculosis)



• Antacids – particularly those containing magnesium trisilicate



• Barbiturates (medication used to aid sleep and relieve anxiety)



• Aminoglutethimide (anti-cancer treatment)



• Carbenoxolone (used in the treatment of stomach ulcers)



• Ephedrine (nasal decongestant)



• Acetazolamide (used for glaucoma and epilepsy)



• Hydrocortisone, cortisone and other corticosteroids



• Ketoconazole (for fungal infections)



• Ritonavir (for HIV)



• Antibiotics including erythromycin



• Medicines that help muscle movement in myasthenia gravis (e.g. neostigmine)



• Colestyramine (for high cholesterol levels)



• Estrogen hormones including the contraceptive pill



• Tetracosactide used in the test for adrenocortical function



• Sultopride used to calm emotions



• Ciclosporin used to prevent rejection after transplants



• Thalidomide



• Praziquantel given for certain worm infections

How To Take Dexsol

This medicine is only to be taken by mouth. Take this medicine exactly as directed by the doctor. These instructions will have been added to the dispensing label by your pharmacist.

Do not exceed or take less than the stated dose.

Do not take it more or less often than prescribed.

The usual dose is:

Adults:

Initially 0.5 – 9mg in divided doses depending upon the severity of your condition then a maintenance dose of 1.5mg daily.

Children:

A single dose on alternate days.

If this medicine is being given to you as part of some hospital tests, the range given will be:

500 micrograms to 2mg per dose for a short period of time.

If you forget to take a dose, take it as soon as you remember unless it is almost time for the next one then carry on as before. Never take two doses together.

NOTE: It can be dangerous to stop taking this medicine abruptly. If your treatment is to be stopped follow your doctor’s advice. He may tell you to reduce the amount of medicine you are taking gradually until you stop taking it altogether. The symptoms that have been reported when treatment has been stopped too quickly have included low blood pressure and in some cases, relapse of the disease for which the treatment was given.

A ‘withdrawal syndrome’ may also occur which includes fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and inflammation of the eye (conjunctivitis). Your doctor should gradually reduce the dose.

If you take too much medicine a doctor or hospital should be contacted immediately.

Possible Side-Effects

Along with its desired effect, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. If you have any of these side effects or any others you should inform your doctor.

Serious side 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. These include:

• 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 that 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.

Other side effects may be:

• a bad reaction to the medicine (which may show as a rash and swelling and in severe cases difficulty in breathing)



• nausea, vomiting, hiccups, increased appetite, stomach discomfort and swollen abdomen, inflammation and ulcers in the oesophagus, peptic ulcers that may split and bleed, inflamed pancreas (which may show as pain in the back and abdomen), tearing of the bowel particularly if you have inflammatory bowel disease, changes to the number and movement of sperm, unusual fat deposits.



• salt imbalances, water retention, potassium loss due to low carbon dioxide levels (hypokalaemic alkalosis), loss of protein and calcium balance



• congestive heart failure in susceptible people, high blood pressure



• thinning of the bone with an increased risk of fractures, bone disease, ruptured tendons, muscle wasting, weakness



• thrush, greater chance of picking up infections, recurrence of tuberculosis if you have already had this infection, blood disorder due to infection



• slow wound healing, thinned delicate skin, unusual marks on the skin, bruising, redness and inflammation of the skin, stretch marks, visible swollen capillaries, acne, increased sweating, impaired reaction to skin tests, skin rash, swelling, thinning of the hair



• cataracts, increased pressure in the eye, swelling of the eye, thinning of the eye membranes, worsening of existing eye infections, protrusion of the eyeballs



• blood clots



• irregular and absence of menstrual cycles (periods), impairment of the body’s regulation of hormones, stunted growth in children and teenagers, swelling and weight gain of the body and face – ‘Cushingoid state’, development of excess body hair (particularly in women), weight gain, increased requirement for diabetic medication, change in effectiveness of the medicine following stress and trauma, surgery or illness.



• fits and worsening of epilepsy, dizziness, headache, severe unusual headache with visual disturbances linked with the withdrawal of treatment, extreme mood swings, schizophrenia may become worse, depression, inability to sleep.

Storing Dexsol

Keep out of the reach and sight of children.

Do not store above 25°C. Do not refrigerate.

Use within 3 months of opening.

The label on the bottle shows an expiry date (month, year). Do not use this product after this date. Do not keep outdated medicine or medicine that is no longer wanted. Take it to your pharmacist for safe disposal.

Always keep the medicine in the bottle in which it was originally given to you.

If you notice any defects, or any signs of deterioration in the medicine you should consult your pharmacist.

Further information

This Patient Information Leaflet was last approved in March 2008.

Ref: PIL/UK/Eire1

P0391