1 mg and 4 mg tablets
dexamethasone
What Dexamethasone Abcur is and what it is used for
The active substance in Dexamethasone Abcur is dexamethasone. Dexamethasone belongs to a group of medicines called corticosteroids ( cortisone ).
Dexamethasone is mainly used in emergency care to treat inflammation and certain allergic reactions. Dexamethasone is also used in the treatment of, for example, inflammation in connection with cancer diseases and to counteract vomiting in treatment with chemotherapy drugs. Dexamethasone is used for cerebral edema and swelling of the brain caused by a brain tumor.
Dexamethasone Abcur can also be used to control the function of the adrenal cortex and pituitary gland.
Dexamethasone contained in Dexamethasone Abcur may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Dexamethasone Abcur
Do not take Dexamethasone Abcur:
- if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
- if you have a fungal infection that affects your whole body.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Dexamethasone Abcur if you have:
- diabetes
- tuberculous
- osteoporosis (osteoporosis)
- mental illness
- gastric ulcer or ulcer of duodenum a
- high blood pressure
- migraine
- heart failure
- heart problems after a recent heart attack
- kidney failure
- eye diseases
- an infection.
- If you are going to be vaccinated, inform the person who is going to vaccinate you that you are using Dexamethasone Abcur.
- Contact your doctor if you have a fever or feel stressed as these conditions may require a dose change.
- Dexamethasone Abcur should not be given in connection with head injury or stroke.
- When you stop taking Dexamethasone Abcur, do so step by step.
Tell your doctor if you have any of the following:
Symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or visual disturbances, and shortness of breath, if you have malignant disease.
Contact a doctor if you experience blurred vision or other visual disturbances.
Dexamethasone should not be used routinely in premature babies with respiratory problems.
Children and young people
Dexamethasone Abcur may affect the growth of children.
Other medicines and Dexamethasone Abcur
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if other medicines are taken at the same time as Dexamethasone Abcur. Your doctor should therefore be aware of such concomitant medication.
Concomitant treatment with antiepileptic drugs (phenobarbital, phenytoin, carbamazepine, primidone) and tuberculosis (rifampicin) and infections(itraconazole) may require dose adjustment.
Do not use medicines containing acetylsalicylic acid without first consulting your doctor.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is a risk that the fetus will be affected. This medicine should only be used during pregnancy if clearly necessary.
Breast-feeding
There is a risk that children who are breastfed may be affected. This medicine should only be used during breastfeeding if necessary.
Fertility
If you are planning to have a baby, consult your doctor before taking this medicine.
Driving and using machines
Dexamethasone Abcur is unlikely to affect your ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Dexamethasone Abcur contains lactose monohydrate
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Dexamethasone Abcur
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by your doctor who adjusts it individually for you. The usual dose for treating inflammation is 1-4 mg daily for the first week and then 1-2 mg daily. It is important that you follow your doctor’s instructions and do not change the dose or stop treatment.
If you have the impression that the effect of Dexamethasone Abcur is too strong or too weak, talk to your doctor or pharmacist.
The tablet can be divided into two equal doses.
If you take more Dexamethasone Abcur then you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Dexamethasone Abcur
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you take cortisone preparations in doses that correspond to the body’s own production, you generally do not get any side effects. If you need higher doses for a long time, side effects can sometimes not be avoided.
Common (may affect up to 1 in 10 people):
- decreased resistance to infection.
- swelling of the face and reddening of the face (Cushing’s syndrome)
- growth retardation in children
- acne and increased hair in women
- muscle weakness
- osteoporosis due to calcification of the skeleton ( osteoporosis )
- reduced ability to take care of sugar that can lead to your diabetes deteriorating and hidden diabetes can be detected
- diabetes
- low levels of nitrogen in the blood.
Uncommon ( may affect up to 1 in 100 people):
- hypersensitivity reactions such as edema, rash, and eczema
- swelling in the body due to imbalance of salts in the blood eg too much sodium or too little potassium and calcium
- increased appetite and weight gain
- high blood pressure, blood clots, and heart failure
- gastrointestinal disorders such as nausea and stomach ulcers
- inflammation of the pancreas
- thin and brittle skin (easy to get bruises), impaired wound healing
- altered mood and difficulty sleeping
- effects on the eye such as glaucoma, glaucoma, and lens blurring.
Rare ( may affect up to 1 in 1,000 people):
- tendon rupture (rupture of a tendon)
- increased pressure in the skull
- degradation of bone tissue.
Has been reported (occurs in an unknown number of users):
- irregular or absent while
- cramps
- headache, dizziness, general malaise
- fracture
- muscle disease in arms and legs
- blockage of blood vessels
- swelling in the body due to fluid retention
- low levels of potassium in the blood
- heart muscle problems after a recent heart attack
- skin rash and redness
- stomach ulcers that can rupture and bleed, ulcers in the esophagus, swollen stomach.
- Visual disturbances, vision loss
- Dimsyn
5. How to store Dexamethasone Abcur
Do not store above 30 ° C. Store in the original package. Sensitive to light.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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. Contents of the packaging and other information
Content declaration
- The active substance is dexamethasone.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
What the medicine looks like the contents of the pack
Dexamethasone Abcur 1 mg is a round, flat, white to off-white tablet with beveled edges and a scoreline, imprinted with “D 1”.
Dexamethasone Abcur 4 mg is a round, flat, white to off-white tablet with beveled edges and a scoreline, imprinted with “D 4”.
Dexamethasone Abcur is available in:
Perforated PVC / PVDC / Al single-dose blisters with 20×1, 28×1, 30×1, 50×1, 56×1, 60×1, 98×1 or 100×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Abcur AB
Box 1452
251 14 Helsingborg
Manufacturer
Formula Pharmazeutische und chemische Entwicklungs GmbH
Goerzallee 305 b, DE-14167 Berlin
Germany