Dexametason Abcur

Document: Dexametason Abcur tablet PL ENG change

Package leaflet: Information for the patient

Dexametason Abcur 1 mg tablets

Dexametason Abcur 4 mg tablets

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 possible side effects not listed in this leaflet.

What is in this leaflet

1. What Dexametason Abcur is and what it is used for

2. What you need to know before you take Dexametason Abcur

3. How to take Dexametason Abcur

4. Possible side effects

5. How to store Dexametason Abcur

6. Contents of the pack and other information

What Dexametason Abcur is and what it is used for

The active substance in Dexametason Abcur is dexamethasone. Dexamethasone belongs to a group of medicines called corticosteroids.

Dexametason Abcur is mainly used for intensive care for treatment of inflammations and certain allergic reactions. Dexamethasone is also used in the treatment of for example inflammations in connection to cancer diseases and to prevent vomiting at treatment with cytostatic agents. Dexamethasone is used at brain oedema and swelling of the brain due to brain tumour.

Dexametason Abcur may also be used for controlling the function of the adrenal cortex and the pituitary.

What you need to know before you take Dexametason Abcur

Do not take Dexametason 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 the whole body

Warnings and precautions

Take special care with Dexametason Abcur if you have:

- diabetes,

- tuberculosis,

- osteoporosis,

- psychiatric disorders,

- gastric- and duodenal ulcer

- hypertension,

- migraine,

- heart failure,

- problems with the muscles in your heart after a recent heart attack,

- renal failure,

- eye diseases,

- an infection.

- If you will be vaccinated, you should inform the person who shall carry out the vaccination that you are using Dexametason Abcur.

- Contact you doctor if you have fever or feel stressed since these strains may require a change of the dose.

- Dexametason Abcur may affect the growth of children.

- Dexametason Abcur should not be given in conjuction with a head injury or stroke.

- Discontinuation of the dose should be done gradually.

Other medicines and Dexametason Abcur

The effect of the treatment may be affected if other medicinal products are taken concomitant with Dexametason Abcur. Your physician should be informed of such concomitant treatment.

Concomitant treatment with medicinal products for epilepsy (phenobarbital, phenytoin, carbamazepine, primidone), tuberculosis (rifampicin) and infections (itraconazole) may require dose adjustment.

Ask your doctor for advice before using products containing acetylsalicylic acid.

Tell your doctor or pharmacist if you are taking any other medicines.

Pregnancy and breast-feeding

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 the breastfeed baby will be affected. This medicine should only be used during breast-feeding if clearly necessary.

Fertility

If you are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Dexametason Abcur is not likely to affect you being able to drive or use any tools or machines.

Dexametason 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 medicinal product.

How to take Dexametason Abcur

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dose is decided by your doctor who adjusts it individually for you. A usual dose for anti‑inflammatory effect is 1-4 mg daily during the first week and thereafter 1-2 mg daily. It is important that you follow the advice from the doctor and do not change the dose or terminate the treatment.

Contact your doctor or pharmacist if you experience that the effect of Dexametason Abcur is too strong or too weak.

The tablet can be divided into equal doses.

If you take more Dexametason Abcur 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 Dexametason 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

When you take cortisone products in doses corresponding to the body's own production you don’t normally get any side effects. If you need higher doses for a longer period side effects can sometimes not be avoided.

Common (occurring in more than 1 out of 100 patients):

- Impaired resistance towards infections.

- Swelling of the face and skin redness in the face (Cushings syndrome).

- Growth retardation in children.

- Acne and growth of extra body hair in women.

- Muscle weakness.

- Thinning of the bones as a consequence of decalcification of the bone(osteoporosis).

- Decreased ability to take care of sugar which may worsen your diabetes and unknown diabetes becoming evident.

- Diabetes

- Low levels of nitrogen in the blood

Uncommon (occurring in less than 1 out of 100 patients):

- Hypersensitivity reactions such as oedema, rash and eczema.

- Swelling in the body as a result of problems with salts in your blood such as too much sodium or low potassium or calcium.

- Increased appetite and weight increase.

- High blood pressure, blood clots and heart failure.

- Gastrointestinal disorders such as nausea and gastric ulcer.

- Inflammation of the pancreas.

- Thin and fragile skin (bruises easily), impaired wound healing

- Changed mood and sleeping disturbance.

- Eye effects such as glaucoma, pop-eyedness and cataracts.

Rare (occurring in less than 1 out of 1 000 patients)

- Rupture of tendon

- Increased pressure inside the head.

- Decomposition of the tissue

Not known:

- Irregular or missing periods

- Cramps

- Headache, dizziness, feeling general unwell.

- Bone fractures

- Muscle disease in arms and legs

- Blocking of blood vessels

- Swelling in the body as a result of fluid retention.

- Low levels of potassium in the blood.

- Problems with the muscles in your heart after a recent heart attack

- Rash and skin redness.

- Gastric ulcers which may perforate and bleed, ulcers in the throat, swollen stomach.

If you get any side effects, talk to your doctor or pharmacist.This includes any side effects not listed in this leaflet.

5. How to store Dexametason Abcur

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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.

6. Contents of the pack and other information

What Dexametason Abcur contains

The active substance is dexamethasone.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.

What Dexametasone Abcur looks like and contents of the pack

Dexametason Abcur 1 mg is a round white tablet with a score line and embossed D1 on one side.

Dexametason Abcur 4 mg is a round white tablet with a score line and embossed D4 on one side.

Dexametason Abcur is available in:

Unit dose blister packs with 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1or 100x1 tablets

Blister packs with 20, 28, 30, 50, 56, 60, 98 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Abcur AB

P.O. Box 1452

251 14 Helsingborg

Sweden

This leaflet was last revised in 2015-03-06