150 mm

150 mm

FRONT

•<-10mm->j

BACK

t

E

E

0

1

rf I ^Focus Pharma

ceuticals Ltd

Package Leaflet: Information for the user

Dexamethasone 2mg/5ml Oral Solution

Dexamethasone

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 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 side effects not listed in this leaflet.

What is in this leaflet:

. What Dexamethasone Oral Solution is and what it is used for

2.    What you need to know before you take Dexamethasone Oral Solution

3.    How to take Dexamethasone Oral Solution

4.    Possible side-effects

5.    How to store Dexamethasone Oral Solution

6.    Contents of the pack and other information

<D-

395 mm

1. What Dexamethasone Oral Solution is and what it is used for

Dexamethasone Oral Solution contains the active substance dexamethasone. Dexamethasone belongs to a group of medicines called steroids (the full name is corticosteroids). 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 Oral Solution reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Dexamethasone Oral Solution is used for one of the following:

where your natural corticosteroid levels have been reduced and you need to replace them where swelling of the brain has occurred if you are having tests for diseases which may decrease your natural corticosteroid level, such as Cushing's syndrome (a hormonal disorder) to reduce inflammation and suppress the immune system in:

■    allergy (hypersensitivity)

■    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 (cancer of the blood), myeloma (bone marrow tumour)

■    Crohn's disease, ulcerative colitis (inflammation of the bowel), hepatitis

■    polymyositis (inflammation of 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 (painful joint disease), 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, Hodgkin's and Non-Hodgkin's lymphoma, breast cancer that has spread around the body, Kahler's disease (cancer of blood cells) and high calcium levels caused by this disease

■    after organ transplants and to prevent nausea and vomiting following chemotherapy

2. What you need to know before you take Dexamethasone Oral Solution Do not take Dexamethasone Oral Solution:

•    if you are allergic (hypersensitive) to dexamethasone or any of the other ingredients of Dexamethasone Oral Solution or you have ever had an unusual reaction to these substances

•    if you have an infection that affects the whole body (unless you are receiving treatment)

•    if you have a fungal infection that affects the whole body

•    if you have a stomach or duodenal ulcer

•    if you have an infection with worms after travelling to a tropical area

Warnings and precautions

Talk to your doctor or pharmacist before taking

Dexamethasone Oral Solution:

•    if you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like dexamethasone.

•    if any of your close family has had these illnesses.

•    if the treatment is for a premature baby. Dexamethasone should not be routinely used in preterm neonates with respiratory problems.

Mental health problems while taking Dexamethasone Oral Solution

Mental health problems can happen while taking

steroids like Dexamethasone Oral Solution.

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

Talk to your doctor before taking this medicine if:

•    you have a bacterial or viral infection (such as hepatitis, poliomyelitis) 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 (ulcerative colitis or diverticulitis), have recently had an operation on your bowel or a stomach (peptic gastrointestinal) ulcer

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

you have epilepsy (condition where you have repeated fits or convulsions) you have migraines

you have an underactive thyroid gland you have an infection with parasites (worms) or an internal fungal infection

you have tuberculosis (TB) or have recently had c reaction to a vaccination for TB you have septicaemia

you have a fungal infection in the eye, an injury to your eye or an ulcer on the surface of your eye (corneal ulceration) you have cerebral malaria you have herpes (cold sores or genital herpes) you have asthma This may affect the dose you are given or your doctor may want you to take other medicines at the same time

More Important Information about taking this medicine

-    Taking this medicine may increase your risk of getting an infection. It may also mask the symptoms of an existing or developing infection and make it harder to find out what is wrong. If you develop an infection whilst on this medicine you should talk to your doctor.

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

-    If you have an allergy test, a suppression test (test for hormone levels) or a test for an infection, you should inform the person performing the test that you are taking dexamethasone as it may interfere with the results.

-    If you need a vaccination tell your doctor as it may not be effective or you may have a greater chance of getting an infection from a ‘live vaccine.

-    If you have a doping test when taking this medicine you may get a positive result.

-    Your doctor may want to perform regular check ups on you while you are taking Dexamethasone Oral Solution;

•    They may be more frequent if you have othei health problems (such as diabetes or kidney problems) or if you are elderly as any side effects may be more serious for you.

•    If a child is taking this medicine, it is important that their growth and development is checked at frequent intervals as dexamethasone can cause children to grow more slowly.

•    If you are taking this medicine for a long time regular (every 3 months) checks of your vision are recommended.

•    If you are taking high doses your doctor may monitor the levels of potassium in your blood. 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.

Dexamethasone and Viral Infections

-    It is important that whilst you are taking this medicine you avoid contact with anybody who has chickenpox, shingles or measles. 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 if you have had any vaccinations for these diseases in the past.

Taking other medicines and Dexamethasone Oral Solution

Tell your doctor or pharmacist if you are taking or have recently taken any 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, coumarin)

•    aspirin or similar (non-steroidal anti-inflammatory drugs) e.g. indometacin

•    medicines used to treat diabetes

•    medicines used to treat high blood pressure

•    diuretics (water tablets)

•    amphotericin B injection_(continued overleaf)

E

E

LO

O'.

no

phenytoin, carbamazepine (epilepsy medication) rifabutin, rifampicin (antibiotics used to treat tuberculosis) antacids or charcoal

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 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) isoniazid for tuberculosis

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice if you are pregnant, planning to get pregnant or breast- feeding. Dexamethasone Oral Solution should only be prescribed during pregnancy, particularly in the first trimester, if the benefit outweighs the risks for the mother and child. If you become pregnant during the use of the product, do not stop using it, but tell your doctor immediately that you are pregnant. Dexamethasone is excreted in breast milk. There are no known risks to infants. Nevertheless, breast-feeding should be discontinued when using higher doses or long-term treatment.

Driving and using machines

Dexamethasone Oral Solution has no influence on your ability to drive or use machines.

Important information about some of the ingredients of Dexamethasone Oral Solution

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

Dexamethasone Oral Solution contains these kinds of sugar:

0.14 g sorbitol in each ml. When taken according to the dosage recommendations each dose supplies up to 3.15 g of sorbitol.

0.275 g maltitol in each ml. When taken according to the dosage recommendations each dose supplies up to 6.2 g of maltitol.

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

Dexamethasone Oral Solution contains 0.09 g propylene glycol in each ml. When taken according to the dosage recommendations each dose supplies up to 2 g of propylene glycol.

3. How to take Dexamethasone Oral Solution

Dexamethasone Oral Solution is only to be taken by mouth.

Your doctor will decide your dose, depending on the disease being treated.

Take this medicine exactly as your doctor has told you. These instructions will have been added to the dispensing label by your pharmacist. You should check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults: initially 0.5 - 9mg daily, then a maintenance dose of 1.5mg daily. The total dose can be split into two or three smaller doses to be taken throughout the day.

Children: a single dose on alternate days.

If Dexamethasone Oral Solution is being given to you as part of some hospital tests, the range given will be:

0.5 mg to 2mg per dose, given for a short period of time. Do not exceed or take less than the stated dose.

Do not take it more or less often than prescribed.

If you take more Dexamethasone Oral Solution than you should

If you take too much medicine contact a doctor or hospital immediately.

If you forget to take Dexamethasone Oral Solution

If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose.

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

If you stop taking Dexamethasone Oral Solution

It can be dangerous to stop taking this medicine abruptly. The symptoms that have been reported when treatment has been stopped too quickly include low blood pressure and sometimes, relapse of the disease for which the medicine 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). 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.

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

■    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.

•    have an allergic reaction to Dexamethasone Oral Solution. Talk to your doctor immediately or go to hospital straight away if you experience any of the following side effects:

■    red and lumpy skin rash

■    difficulty in breathing

■    swelling of the face, mouth, lips or eyelids

Other side effects may include:

•    mental health problems: a feeling of dependence a severe headache with visual disturbances (linked to withdrawal of treatment), worsening of schizophrenia (where you may sense, see or hear things that do not exist, become withdrawn or have mistaken beliefs or suspicions)

•    stomach and bowel problems: nausea, vomiting hiccups, increased appetite, stomach discomfort swollen abdomen, inflammation and ulcers in the oesophagus, heartburn, stomach ulcers that may bleed, inflamed pancreas (causing pain in the back and abdomen), tearing of the bowel particularly if you have inflammatory bowel disease, unusual fat deposits

•    metabolism and problems with salt levels: weight gain, salt imbalances, water retention in the body potassium loss due to low carbon dioxide levels (hypokalaemic alkalosis), loss of protein and calcium balance, increased need for diabetic medication, increased cholesterol levels

•    heart and blood problems: blood clots, congestive heart failure in susceptible people, heart muscle rupture (especially if you have recently had a heart attack), high blood pressure, raised or lowered levels of red and white blood cells, inflammation and thickening of the veins or arteries

•    muscle, bone and skin problems: thinning of the bones with an increased risk of fractures, bone disease, ruptured tendons, muscle wasting weakness, excess body hair (particularly in women) 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, thinning of the hair

•    immune system problems: thrush, greater chance of picking up infections, recurrence of tuberculosis if you have already had it, blood disorders due to infection

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

•    reproductive system problems: irregular or lack of menstruation (periods), impotence

•    hormonal problems: impairment of the body's regulation of hormones, slow growth in children and teenagers, swelling and weight gain of the body and face (Cushingoid state)

•    nervous system problems: fits and worsening of epilepsy, dizziness, headache

•    other general effect: a change in the effectiveness of the medicine following stress and trauma surgery or illness, withdrawal effects (fever, muscle and joint pain, inflammation of the eye or nose itchy skin and weight loss)

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 www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dexamethasone Oral Solution

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not refrigerate.

After first opening, use within 3 months.

Do not use this medicine after the expiry date printed on the bottle label and carton after EXP. The expiry date means the last day of that month.

Do not use this medicine if you notice solid particles inside the solution.

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.

<D-

-A-

t

E

E

0

1

4. Possible side-effects

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

Tell a doctor straight away if you:

• experience serious mental health problems. They can affect people taking medicines like dexamethasone. These problems include:

■    feeling depressed, including thinking about suicide

■    feeling high (mania) or moods that go up and down

6. Contents of the pack and other information

What Dexamethasone Oral Solution contains

The active substance is dexamethasone.

Each ml of solution contains 0.4 mg of dexamethasone (as dexamethasone sodium phosphate).

The other ingredients are: benzoic acid (E210), propylene glycol (E1520), citric acid monohydrate (E330), liquid maltitol (E965), liquid sorbitol (non-crystallising) (E420), sodium citrate dihydrate (E331), mint flavour, purified water.

What Dexamethasone Oral Solution looks like and contents of the pack

Dexamethasone Oral Solution is a colourless to faint yellow oral solution with mint flavour. It comes in an amber glass bottle, holding 150 ml of solution, with child resistant screw-cap.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited, Capital House, 1st

Floor, 85 King William Street, London EC4N 7BL, UK.

Tel: 00 44 1283 495 280 Fax: 00 44 1283 495 290 Email: medinfo@focuspharma.co.uk Manufacturer Vianex SA, Production Site (Plant A') 12th klm National Road Athens-Lamia, 14451 Metamorfosi, Attiki, Greece

For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email medinfo@focuspharma.co.uk.

This leaflet was last revised in 06/2015