4 mg / ml injection solution  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 or pharmacist.
  • 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 you will find information about: 
1. What Betapred is and what it is used for 
2. What you need to know before you receive Betapred 
3. How to use Betapred 
4. Possible side effects 
5. How to store Betapred 
6. Contents of the packaging and other information 

1. What Betapred is and what it is used for

Betapred is potent cortisone that inhibits inflammation and allergic reactions. Betapred is used in the intensive care of, for example, severe acute asthma attacks, allergic conditions, shock conditions, transfusion reactions, and in false croup ( pseudo-croup ).

Betamethasone contained in Betapred 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.

2. What you need to know before you receive Betapred

Do not use Betapred

  • 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.

Betapred may interfere with the effects of certain vaccinations. You should therefore avoid vaccinations during treatment with Betapred.

Warnings and cautions

Tell your doctor specifically before taking Betapred:

  • if you have recently had a heart attack
  • if you have heart failure
  • if you have had an abscess or any other acne 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 hypothyroidism
  • if you have had allergic reactions to corticosteroid s

Infection may worsen or occur during treatment with Betapred. If this happens, tell your doctor.

As long as you are receiving Betapred, 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 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.

Older

Elderly people may have a higher incidence of side effects. Your doctor will take this into account and evaluate which dosage of Betapred is best for you.

Other medicines and Betapred

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 Betapred. 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:

  • Potassium-lowering diuretics ( diuretics , eg thiazides and furosemide )
  • Some antibiotics for fungal infections (amphotericin B)
  • Tracheal dilators belonging to the group xanthines (eg theophylline)
  • Medicines for fever and pain (eg acetylsalicylic acid )
  • Anti-inflammatory drugs ( NSAIDs, eg ibuprofen, diclofenac )
  • Blood sugar lowering drugs (for diabetes ) and insulin
  • Some medicines used to treat epilepsy (phenobarbital, phenytoin, carbamazepine)
  • Medicines containing ephedrine (bronchodilators and expectorants on the mucous membranes)
  • Medicines for tuberculosis (rifampicin)
  • Some medicines for HIV (ritonavir, cobicistat)
  • Blood thinners ( anticoagulants, affect blood clotting ability)

Pregnancy and breastfeeding

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 Betapred during pregnancy.

Betamethasone passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Betapred 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.

Betapred contains sodium metabisulfite and sodium

Betapred contains sodium metabisulphite (E223), which in rare cases can cause severe hypersensitivity reactions and convulsions in the trachea.

This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.

3. How to use Betapred

Your doctor will decide which dose is right for you. The medicine is given to you as an injection into a vein (a blood vessel) or into a muscle. The drug can also be given as an infusion (drip).

If you stop taking Betapred

Prolonged treatment with Betapred should not be stopped abruptly, as the body’s own production of cortisol may have dropped and it may take some time before it starts up 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 medication.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Contact a doctor or healthcare professional immediately if you experience a severe allergic reaction ( anaphylactic reaction ) with symptoms such as fever, rash, swelling, and sometimes a drop in blood pressure (occurs in an unknown number of users).

The following side effects have also been reported (affects an unknown number of users):

  • Heart failure. High blood pressure. Edema.
  • Increased risk of blood clots.
  • The body’s infection defense can be inhibited and increase the risk of infection. There is also a risk that latent (dormant) tuberculosis can be reactivated.
  • Hives, eczema. Reduced response to skin tests.
  • Gastric ulcer. Holes in the intestine. Inflammation of the pancreas. Inflammation of the esophagus. Nausea.
  • Increased pressure in the skull. Swelling of the optic nerve. Headache. Dizziness.
  • Reduced secretion of hormones from the adrenal gland. Cushing-like symptoms (moon face, fat accumulation on the torso).
  • Diabetes. Exacerbation of diabetes.
  • Growth inhibition in children.
  • Osteoporosis. Muscle weakness. Fracture. Tendon rupture. Muscle aches, stiffness, joint pain, swelling, and fatigue.
  • Psychotic disorder. Anxiety. Irritability. Relapse in previous mental illness.
  • Skin thinning. Impaired wound healing. Acne, increased hair, bruising, reddening of the skin, increased sweating.
  • Irregular menstruation.
  • Elevated pressure in the eyes ( glaucoma ). Clouding of the eye lens. Dimsyn.
  • Increased appetite. Weight gain. Weight loss.
  • Disturbances in the salt balance, such as low levels of potassium or increased sodium in the blood.
  • Disturbances in the nitrogen balance.
  • Reduced amount of protein in the blood.
  • Hiccup

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 Betapred

The doctor and the pharmacy staff at the hospital are responsible for Betapred being stored, used, and destroyed correctly.

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. date. The expiration date is the last day of the specified month.

The break ampoules must be stored in the outer carton. Sensitive to light.

6. Contents of the packaging and other information

Content declaration

The active substance is betamethasone sodium phosphate. 1 ml solution for injection contains 5.3 mg betamethasone sodium phosphate equivalent to 4 mg betamethasone.

The other ingredients are sodium metabisulfite, disodium edetate, sodium chloride, sodium hydroxide or hydrochloric acid (for pH control), and water for injections.

What the medicine looks like and the contents of the pack

Betapred solution for injection is a clear solution in glass ampoules (type 1).

Pack sizes: 5×1 ml and 5 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Alfasigma SpA

Via Ragazzi del ´99, No. 5

40133 Bologna (BO), Italy

Manufacturer

Alfasigma SpA

Via Pontina Km 30,400,

00071 Pomezia (RM), Italy

Information is pfrovided by

Muhammad Nadeem

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