0.5 mg tablets
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.
– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
In this leaflet:
1. What Betamethasone Evolan is and what it is used for
2. What you need to know before you use Betamethasone Evolan
3. How to use Betamethasone Evolan
4. Possible side effects
5. How to store Betamethasone Evolan 6. Contents of the pack
and other information
What Betamethasone Evolan is and what it is used for
Betamethasone Evolan is potent cortisone that inhibits inflammation and allergic reactions. Betamethasone Evolan is mainly used in short-term treatment to relieve the symptoms of, for example, asthma, allergic conditions, snake bites, and more severe reactions to insect bites. Betamethasone Evolan also used for croup ( pseudo-croup ).
Betamethasone contained in Betamethasone Evolan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before using Betamethasone Evolan
Do not use Betamethasone Evolan
- If you are allergic to betamethasone or any of the other ingredients of this medicine (listed in section 6).
- If you have an infection (including a fungal infection) that affects your entire body if you are not already being treated for that infection.
Betamethasone Evolan may interfere with the effect of certain vaccinations. You should therefore avoid vaccinations during treatment with Betamethasone Evolan.
Do not take this medicine if any of these apply to you. Talk to your doctor or pharmacist before taking Betamethasone Evolan if you are not sure.
Warnings and cautions
Talk to your doctor before taking Betamethasone Evolan:
- if you have recently had a heart attack
- if you have a condition called chronic heart failure
- if you have suffered from a varicose vein or any other varicose vein infection
- if you have or have had stomach ulcers
- if you have kidney problems
- if you have liver problems
- if you have recently had a bowel operation (intestinal anastomosis)
- if you have ulcerative colitis and there is a risk of perforation of the intestine ( perforation )
- if you have intestinal pockets
- if you have the neuromuscular disease myasthenia gravis
- if you have muscle weakness ( myopathy ) caused by steroid treatment
- if you have high blood pressure
- if you have osteoporosis
- if you have diabetes
- if you have glaucoma ( glaucoma )
- if you have epilepsy
- if you have or have had tuberculosis
- if you have certain mental disorders (emotional instability or psychotic tendencies)
- if you have thyroid problems
Infection may worsen or occur during treatment with Betamethasone Evolan. If this happens, tell your doctor.
As long as you are taking Betamethasone Evolan, it is important that you avoid contact with people with chickenpox or measles. If you think you may have been infected with any of these diseases, contact your doctor immediately.
Doctors should be contacted in the event of stress such as fever or in stressful situations, as dose changes may be necessary.
Contact a doctor if you experience blurred vision or other visual disturbances.
Children and young people
Growth in children can be inhibited by long-term use. The doctor will regularly check the baby’s growth.
Children are at particular risk of increased intracranial pressure.
Other medicines and Betamethasone Evolan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some other medicines may affect or be affected by treatment with Betamethasone Evolan. The treating physician needs to be aware of such concomitant medication, as the dosage may need to be changed.
It is especially important that you talk to your doctor if you are taking any of the following medicines:
- Medicines that stop the build-up of extra water in your body ( diuretics such as thiazides and furosemide )
- Amphotericin B ( antibiotics for fungal infection)
- Theophylline (bronchodilator)
- Acetylsalicylic acid (used for fever and pain)
- Anti-inflammatory drugs ( NSAIDs, eg ibuprofen, diclofenac )
- Blood sugar lowering drugs (for diabetes ) and insulin
- Phenobarbital, phenytoin, carbamazepine (used in epilepsy )
- Ephedrine (tracheal dilatation and swelling of the mucous membranes)
- Rifampicin (used to treat tuberculosis )
- Anticoagulants (blood-thinning drugs), ie drugs that prevent the blood from being able to clot
- Some medicines for HIV: ritonavir, cobicistat
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.
There is a risk that the fetus is affected. Therefore, always consult a doctor before using Betamethasone Evolan during pregnancy.
Betamethasone passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Betamethasone Evolan during breast-feeding.
Driving and using machines
When using this medicine you may become dizzy or have eye effects (see section 4: Possible side effects ). It may affect your ability to drive. If this happens, do not drive or operate machinery.
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.
Betamethasone Evolan 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.
3. How to use Betamethasone Evolan
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you. The tablets should be dissolved in water. A small amount of liquid, such as a couple of tablespoons of water, is enough. The tablets dissolve into a white liquid within about 1-2 minutes. The tablets can also be chewed.
If you stop using Betamethasone Evolan
Prolonged treatment with Betamethasone Evolan should not be stopped too quickly, as the body’s own production of cortisol may have dropped and it may take some time before it starts properly again. It is therefore important that dose one is gradually reduced. The higher the dose one has been and the longer the treatment has been going on, the slower the dose one should be reduced. The doctor draws up a schedule for how the medication should be reduced.
If you have been treated with cortisone for a long time, the body’s own production of cortisol can be so subdued that it is unable to form the extra cortisol needed if you get a fever, any more serious infection, or injury. Then you may need to take extra cortisone preparations.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With short-term or one-time treatment, no side effects are normally seen, but in rare cases, allergic reactions can occur which can sometimes be severe and include cramps in the trachea. In the case of long-term treatment, however, side effects may occur:
Has been reported (occurs in an unknown number of users):
- The defense against infection can be inhibited and increase the risk of infection. There is also a risk that latent tuberculosis may be reactivated.
- Severe allergic reaction ( anaphylaxis ), swelling, and difficulty breathing. Contact your doctor immediately. Urticaria, eczema. Reduced response to skin tests.
- Reduced secretion of hormones from the adrenal glands. Cushing-like symptoms (moon face, fat deposits on the torso). Elevated blood sugar. Diabetes. Growth inhibition in children. Irregular menstruation.
- Psychotic disorder. Anxiety, irritability. Euphoria. Sleep disorders. Mood swings. Depression.
- Increased intracranial pressure. Visual impairment (swelling of the optic nerve ). Headache. Dizziness.
- Increased pressure in the eye ( glaucoma ). Cloudy eye lens. Dimsyn.
- Heart failure (in predisposed patients). High blood pressure. Increased risk of thrombosis.
- Disturbances in the electrolyte balance. Edema.
- Gastric ulcer. Holes in the intestine. Inflammation of the pancreas. Inflammation of the esophagus. Nausea.
- Thinning of skin with impaired wound healing. Acne, excessive hair growth, bruising, erythema (reddening of the skin), increased sweating.
- Osteoporosis. Muscle weakness. Bone fractures. Tendon rupture. Muscle aches, stiffness, joint pain, swelling, and fatigue.
- Weight gain, weight loss.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Betamethasone Evolan
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 expiration date is the last day of the specified month.
Do not store above 30 ° C.
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
The active substance is betamethasone sodium phosphate equivalent to 0.5 mg betamethasone.
The other ingredients are lactose monohydrate/corn starch (85:15), magnesium stearate.
What the medicine looks like and the contents of the pack
Betamethasone Evolan is white to off-white, round, flat tablets, 7 mm and with a notch on one side.
PVC / PVdC / Al blister with 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 105, 200, 300, 400, 500, 600, 700, 800, 900 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
182 12 Danderyd
68 “April Fool’s Day” Blvd.
7200 Razgrad, Bulgaria