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DEXAMETHASONE ALAPIS 0.4 MG/ ML ORAL SOLUTION

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

0.4 mg/ ml Oral Solution
Dexamethasone
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is and what it is used for
2. Before you take
3. How to take
4. Possible side-effects
5. How to store
6. Further information
1. WHAT IS AND WHAT IT IS USED FOR
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
) is an effective way to treat various illnesses involving
inflammation in the body. reduces this inflammation,
which could otherwise go on making your condition worse. You must take this
medicine regularly to get maximum benefit from it.
is used 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 as is Cushing’s syndrome (disorder of the
hormonal system).
• to reduce inflammation and suppress the immune system in a variety of
conditions, in particular:
- 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 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 (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, Hodgkins and Non-Hodgkins Disease
breast cancer that has spread around the body, Kahlers disease (cancer of
blood cells) and high calcium levels caused by this disease
- Following organ transplants and to prevent nausea and vomiting following
chemotherapy

2. BEFORE YOU TAKE
Do not take :
• if you are allergic (hypersensitive) to dexamethasone or any of the other
ingredients of or you have ever had an unusual
reaction to these substances
• if you have an infection that affects the whole body
• if you are pregnant, planning to become pregnant or breast feeding
• if you have a stomach or duodenal ulcer
• if you have an infection with tropical worms
Take special care with
Before treatment with check with your doctor:
• 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.
Mental problems while taking
Mental health problems can happen while taking steroids like Alapis>.
• 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.
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 (condition where you have repeated fits or convulsions)
• you have migraines

• 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 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 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 , you should inform the person
treating you that you are taking or have taken steroids.
If you have suppression tests (test for the amount of hormone in the body) or test 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.
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-Inflammatory drugs) 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
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
should be prescribed during pregnancy and particularly in
the first trimester only 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
, but tell your doctor immediately that you are pregnant.

Dexamethasone is excreted in breast milk. There are no known risks to infants.
Nevertheless, breastfeeding should be discontinued when using higher doses or longterm treatment.
Driving and using machines
has no influence on your ability to drive or use machines.
Important information about some of the ingredients of Alapis>
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
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.
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.
contains small amounts of ethanol (alcohol), less than
100mg per dose.
(5.51 mg ethanol / 9 mg dexamethasone).

3. HOW TO TAKE
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.
Always take exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults: initially 0.5 – 9mg daily 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 is being given to you as part of some hospital tests, the
range given will be:
0.5 mg to 2mg per dose for a short period of time.

Do not take it more or less often than prescribed
Instructions for use
Push the plastic screw cap down while turning it
Counterclockwise and remove the unscrewed cap.

Insert the syringe into the bottle.
While holding the bottom ring, pull the top ring up to the mark which corresponds to
the dose in milliliters (ml) prescribed by your doctor.

Holding the bottom ring, remove the syringe from the bottle and wipe the body of the
syringe with a tissue to clean from the solution excess.

Empty its contents directly in the mouth by pressing the plunger down.
Close the bottle with the plastic screw cap.
Wash the syringe with water and leave it to air dry
If you take more than you should
Do not exceed or take less than the stated dose.
If you take too much medicine a doctor or hospital should be contacted immediately.
If you forget to take

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.
Do not take a double dose to make up for a forgotten dose.
If you stop taking
It can be dangerous to stop taking 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 have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, can cause side effects, although not
everybody gets them.
Tell a doctor straight away if you experience serious mental health problems. They
can affect about 5 in every 100 people taking medicines like dexamethasone. These
problems 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.

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 in the body, 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 (mental disorder) may become worse, depression,
inability to sleep.

If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE
Keep out of the reach and sight of children.
Do not store above 25°C. Do not refrigerate.
After first opening, use within 3 months.
Do not use after the expiry date which is stated on the
bottle label and carton after EXP. The expiry date refers to the last day of that month.
Do not use if you notice solid particles to be present
inside the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What 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
(E331), garden mint flavour (containing: Peppermint, Spearmint, Menthol, Ethyl
Alcohol, purified water.
What looks like and contents of the pack
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, along with a 3 ml oral syringe.
Marketing Authorisation Holder
2, Aftokratoros Nikolaou str.
176 71 Athens
Greece>
Manufacturer
PNG Gerolymatos S.A.
Production Site (Plant B’)
4, Asklipiou Str., 145 68 Kryoneri,
Athens, Greece
This medicinal product is authorised in the Member States of the EEA under the
following names:

This leaflet was last approved in 09/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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