0.5 mg tablets 
betamethasone

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, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Betamethasone Alternova is and what it is used for 
2. What you need to know before you use Betamethasone Alternova 
3. How to use Betamethasone Alternova 
4. Possible side effects 
5. How to store Betamethasone Alternova
6. Contents of the packaging and other information 

1. What Betamethasone Alternova is and what it is used for

Betamethasone Alternova is potent cortisone that inhibits inflammation and allergic reactions. Betamethasone Alternova 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 Alternova also used for croup ( pseudo-croup ).

Betamethasone contained in Betamethasone Alternova may also be approved for the treatment of other conditions not mentioned in this product information. 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 Alternova

Do not use Betamethasone Alternova

  • 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 Alternova may interfere with the effect of certain vaccinations. You should therefore avoid vaccinations during treatment with Betamethasone Alternova.

Do not take this medicine if any of these apply to you. If you are not sure, talk to your doctor or pharmacist before taking Betamethasone Alternova.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Betamethasone Alternova for the following conditions:

  • 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 Alternova. If this happens, tell your doctor.

As long as you are taking Betamethasone Alternova, 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.

Contact your doctor in case of stress such as fever or in stressful situations as these conditions may require a dose change. 

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 pressure in the skull ( intracranial pressure).

Other medicines and Betamethasone Alternova

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 Alternova. 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 (eg 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.

Pregnancy

There is a risk that the fetus will be affected. Therefore always consult a doctor before using Betamethasone Alternova during pregnancy.

Breast-feeding

Betamethasone Alternova passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if you are taking Betamethasone Alternova more than temporarily 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 Alternova contains saccharin sodium and sodium benzoate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 

This medicine contains 5.5 mg benzoate per tablet. Benzoate may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).

3. How to use Betamethasone Alternova

Always use 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 tablets should be dissolved in water. A small amount of liquid is sufficient, e.g. a couple of tablespoons of water. The tablets dissolve within about 1-2 minutes. Alternatively, the tablets can be taken without water, but should then be chewed well.

The notch is not intended for splitting the tablet.

If you stop using Betamethasone Alternova

Prolonged treatment with Betamethasone Alternova 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 and the longer the treatment, the slower the dose 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, pharmacist, or nurse.

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 seen, unless you are allergic to any of the ingredients.

In the case of long-term treatment, however, the following 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 dormant ( latent ) tuberculosis may be reactivated.
  • Severe allergic reaction ( anaphylaxis ), swelling, and difficulty breathing. Contact your doctor immediately. Hives ( 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 pressure in the skull ( 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 blood clots ( 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, redness of the skin ( erythema ), increased sweating.
  • Osteoporosis ( 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 Alternova

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

Do not store above 30 ° C.

Store in the original package. Sensitive to light.


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 betamethasone; 1 tablet contains betamethasone sodium phosphate 0.66 mg equivalent to 0.5 mg betamethasone.
  • The other ingredients are sodium dihydrogen citrate, sodium bicarbonate, sodium benzoate (E211), saccharin sodium, and povidone.

What the medicine looks like and the contents of the pack

Appearance

Betamethasone Alternova is white, round, flat tablets with a scoreline on one side, 6 mm in diameter.

Pack sizes

Brown glass jars with desiccant (silica) break-sealed PE-LD screw cap.

Pack sizes: 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Alternova A / S

Lodshusvej 11

4230 Skælskør

Denmark

Manufacturer

Viminco A / S

Lodshusvej 11

4230 Skælskør

Denmark

Muhammad Nadeem

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