Active ingredient
- dexamethasone sodium phosphate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0218.
Dexamethasone 10mg/5ml Oral Solution
Package leaflet: Information for the patient
Dexamethasone 10mg/5ml Oral Solution
Important information about this medicine
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 on 08/2021.
What is in this leaflet
1. 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
1. What Dexamethasone Oral Solution is and what it is used for
The full name of your medicine is Dexamethasone 10mg/5ml Oral Solution. In this leaflet the shorter name Dexamethasone is used. This belongs to a group of medicines called Corticosteroids. Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone).
Corticosteroids are hormones that are found naturally in your body that help to keep you healthy and well. Boosting your body with extra corticosteroid, such as Dexamethasone, is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone lowers inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
Dexamethasone is used as a treatment of coronavirus disease 2019 (COVID-19) in adult patients with difficulty breathing and need of oxygen therapy.
Dexamethasone can be used in adults for:
You may be using this medicine for a different reason. Ask your doctor why this medicine has been prescribed for you.
2. What you need to know before you take Dexamethasone Oral Solution
Do not take Dexamethasone:
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dexamethasone.
Mental health problems
Check with your doctor first:
Mental health problems can happen while taking steroids like Dexamethasone (see also section 4: Possible side effects).
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 were being lowered or stopped.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dexamethasone if you have:
Contact your doctor if you experience blurred vision or other visual disturbances.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Dexamethasone.
Taking a steroid medicine like Dexamethasone
Please tell your doctor, or anyone giving you treatment, that you are taking or have recently taken Dexamethasone, if any of the following things happen to you. This is because your dose of Dexamethasone may need to be increased during this time:
You should not stop taking any other steroid medications unless your doctor has instructed you to do.
Talk to your doctor, pharmacist or nurse before you take Dexamethasone.
General precautions regarding steroid use in specific diseases, masking infection, concomitant medicines etc. in line with current recommendations. If you are living in the UK, you should always carry a blue ‘steroid 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 in the past.
Chickenpox, shingles and measles:
While you are taking this kind of medicine, you should not come into contact with anyone who has chickenpox, shingles or measles if you have not had these illnesses. This is because you may need specialist treatment if you get these diseases. If you think you may have had exposure to any of these diseases, you should talk to your doctor immediately. You should also tell your doctor if you have ever had infectious diseases such as measles or chickenpox and if you have had any vaccinations for these conditions in the past.
Children and young people
This strength of dexamethasone is not recommended for use in children and young people. However if a child is taking this medicine at a doctors request, it is important that the doctor monitors their growth and development regularly. Dexamethasone should not be routinely given to premature babies with respiratory problems.
Older people
Some of the side effects of Dexamethasone may be more serious in older people. Your doctor may need to monitor you more closely for the following:
Other medicines and Dexamethasone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Dexamethasone can affect the way some other medicines work. Also, some medicines can affect the way Dexamethasone works.
Some medicines may increase the effects of Dexamethasone and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
In particular, tell your doctor if you are taking any of the following:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dexamethasone.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding. There is not enough information on the use of dexamethasone during pregnancy to know the possible side effects. For this reason, the use of Dexamethasone during pregnancy is not recommended unless advised to by your doctor.
Dexamethasone is excreted in breast milk. It may influence the growth of your baby or cause other side effects. Tell your doctor if you are or intend to breast-feed before taking Dexamethasone.
Driving and using machines
You may experience dizziness when taking this medicine (see section 4: Possible side effects). This may affect your ability to drive. If this happens, do not drive or use tools or machinery.
Dexamethasone Oral Solution contains sorbitol, maltitol, propylene glycol and benzoic acid:
3. How to take Dexamethasone Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How to take
Measuring your dose using the oral syringe provided:
1. Open the bottle: press the cap and turn it anticlockwise (figure 1).
2. Insert the syringe adaptor into the bottle neck (figure 2).
3. Take the syringe and put it in the adaptor opening (figure 2).
4. Turn the bottle upside down (figure 3).
5. Fill the syringe with a small amount of solution by pulling the piston down (figure 4A). Then push the piston upward in order to remove any possible bubbles (figure 4B). Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 4C).
6. Turn the bottle the right way up.
7. Remove the syringe from the adaptor. Put the end of the syringe into your mouth and push the piston slowly back in to take the medicine.
8. Wash the syringe with water and let it dry before you use it again.
9. Close the bottle with the plastic screw cap.
This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes only. There is further information in the SmPC, ask your doctor, pharmacist or nurse for this information.
Taking this medicine via NG or PEG tubes
1. Ensure the tube is clear before taking the medicine.
2. Flush the tube with water, a minimum flush volume of 5mL of water is required.
3. Administer the medicine into the tube with a suitable measuring device. The syringe included in the pack is only for patients who are able to swallow the medicine. Healthcare Professional (HCPs) administering this product to patients via a NG or PEG tube must use another suitable device.
4. Flush the tube with water again using a minimum volume of 5mL of water.
For use with silicone, PVC and polyurethane NG or PEG tubes only.
The usual dose for adults and older people
Take Dexamethasone as only as prescribed by your doctor. Your doctor will decide how long you should take dexamethasone for. Check with your doctor or pharmacist if you are not sure.
For the treatment of Covid-19
Adult patients are recommended to take 6 mg (3ml) once a day for up to 10 days.
If you are taking this medicine as part of hospital tests:
If you take more Dexamethasone than you should
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.
If you forget to take Dexamethasone
If you stop taking Dexamethasone
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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:
If you notice any of these problems, talk to a doctor straight away.
If you have an allergic reaction to Dexamethasone, stop taking it and seek medical help immediately.
An allergic reaction may include:
If you get any of the following side effects, stop taking Dexamethasone and see your doctor as soon as possible:
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Dexamethasone Oral Solution
6. Contents of the pack and other information
What Dexamethasone Oral Solution contains
What Dexamethasone Oral Solution looks like and contents of the pack
Marketing Authorisation Holder and Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
UK, Ireland – Dexamethasone 10mg/5ml Oral Solution
Greece – Dexamethasone/Rosemont 10mg/5ml πόσιμο διάλυμα
This leaflet was last revised in 08/2021.
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