25 mg powder for solution for injection prednisolone
sodium succinate

WHAT PRECORTALON AQUOSUM IS AND WHAT IT IS USED FOR

Pharmaceutical group

Precortalon a quorum belongs to the group of hormones that are formed in the adrenal cortex ( corticosteroids ).

What is Precortalon a quorum used for?

System management

Conditions where intensive care is desirable, eg:

  • Shock treatment together with other treatment
  • Severe asthma attacks (status asthmaticus)
  • Severe hypersensitivity reaction
  • False croup
  • Severe reactions after insect and snake bites

Treatment in and around joints

  • Certain inflammatory conditions affecting the joints (such as rheumatoid arthritis, osteoarthritis, periarthritis, epicondylitis )

Rectal (in the rectum)

  • Certain gastrointestinal disorders, such as ulcerative colitis and proctosigmoiditis (inflammatory bowel disease)

BEFORE YOU USE PRECORTALON AQUOSUM

Do not use Precortalon aquosum

  • if you have a viral or bacterial infection at the site of your condition

Take special care with Precortalon a quorum

If you have or have had any of the following conditions, tell your doctor in advance, as further examinations may be necessary:

  • osteoporosis
  • newly inserted anastomosis (the surgical connection between organs/blood vessels)
  • gastric ulcer in the stomach or intestine
  • tuberculosis
  • diabetes
  • mental disorders ( psychosis )
  • heart failure
  • renal impairment
  • high blood pressure
  • migraine
  • infectious diseases
  • allergic reaction to Precortalon a quorum, medicines in general, or any previous allergy.

Precortalon a quorum should not be used in the treatment of complications after severe head injuries or strokes, this is because you probably have no benefit from the treatment and it can even be harmful.

If you suffer from fever or stress, the dose of Precortalon a quorum should be increased. Ask your doctor or pharmacist for more information.

During treatment with Precortalon a quorum in growing children, the doctor should monitor the growth and body development of the child.

Precortalon a quorum may interfere with certain vaccinations. You should preferably avoid vaccinations with a live vaccine during treatment with Precortalon a quorum.

During treatment with Precortalon a quorum, tell your doctor or nurse that you are receiving this medicine:

  • before you are vaccinated or undergo a skin test
  • before undergoing surgery
  • if you have a severe infection or ulcer

Use of other medicines

Please note: the following remarks may apply to medicines that you have been taking for a while or that you will be taking shortly. Tell your doctor or pharmacist if you are taking, will be taking, or have recently taken any other medicines, including medicines obtained without a prescription.

Contact your doctor if:

  • You also use:
    • drugs used in the treatment of epilepsy and as fast-acting anesthetics ( phenytoin, carbamazepine, and barbiturates as phenobarbital)
    • drugs for bacterial infection (rifampicin).

These medicines may reduce the effect of Precortalon a quorum.

  • salicylates (as acetylsalicylic acid )

If dose one of Precortalon a quorum is to be reduced, this should be done with caution to avoid salicylate poisoning.

Pregnancy and breastfeeding

Long-term treatment can lead to reduced weight in the placenta or baby and there is a risk of reduced activity in the newborn baby’s adrenal glands. Use Precortalon a quorum during pregnancy only if your doctor has told you to.

Prednisolone is excreted in small amounts in breast milk, but the risk of affecting the baby seems unlikely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No effect on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.

HOW TO USE PRECORTALON AQUOSUM

The injections must be given by a doctor or nurse.

Dosage

Dose one is determined by the severity of your medical condition, how you react to the treatment, and which injection site is chosen. The doctor will decide the appropriate dose and it may be necessary to change the dose during treatment, depending on your symptoms.

Systemic therapy: Usually 25 mg (1 ml) is given 1-4 times a day.

Treatment in or around joints: Usually 12.5–25 mg (0.5–1 ml) is given.

Rectal (in the rectum): 12.5–25 mg (0.5–1 ml) in 60–150 ml saline solution is given once a day or every other day in courses of 10–20 times.

Method of administration

How an injection is to be given depends on your disease state and where in the body it is located. The injection can, for example, be given directly into the blood, into muscle tissue, into the subcutaneous tissue, or a joint. The solution for injection can also be mixed with saline and given as an infusion or via the rectum ( enema ).

If you notice that you are either getting too strong or insufficient effect from Precortalon a quorum, talk to your doctor or pharmacist.

If you stop using Precortalon a quorum

After long-term treatment with Precortalon a quorum, the dose must be gradually reduced, as the symptoms you had before treatment may otherwise return. Complications can occur more quickly and the body’s production of adrenal cortex hormones may be reduced.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Precortalon a quorum can cause side effects, although not everybody gets them. Among other things, the side effects listed below may occur.

System management

Common (affects more than 1 user in 100)

  • Salt and fluid accumulation in the body
  • Too little potassium in the blood (hypokalemic alkalosis )
  • High blood pressure
  • Heart failure in heart patients
  • Growth inhibition in children
  • Insufficient amount of adrenal cortex hormone in the blood, especially in stressful situations (eg accident, surgery, or infection )
  • Decreased carbohydrate tolerance can lead to diabetes worsening or hidden diabetes occurring. The first signs are thirst, frequent urination, and weight loss.
  • Signs of Cushing’s disease (such as full moon face, overweight that settles on head and torso, red streaks on chest and abdomen)
  • Skin thinning with increased risk of bruising
  • Certain forms of bleeding under the skin ( petechiae and ecchymosis )
  • Reddening of the face
  • Acne and hair loss ( hirsutism )
  • Impaired wound healing
  • Impaired reaction in skin tests
  • Negative effect on the nitrogen balance
  • Irregular menstruation
  • Inhibition of the defense of infection

Uncommon (affects less than 1 user in 100)

  • Headache
  • Muscle weakness
  • Decreased muscle tissue (steroid myopathy)
  • Osteoporosis
  • Exhilaration
  • Restlessness
  • Depression
  • Difficulty sleeping
  • Rear cataracts
  • Eye problems (increased pressure in the eyeball with risk of glaucoma )

Rare (affects less than 1 user in 1,000)

  • Hypersensitivity
  • Dizziness
  • Increased pressure in the head with swelling of the optic nerve in the fundus, especially in children when treatment is stopped
  • Cramps
  • The infection defense can be inhibited and thus the susceptibility to infection increases. Infections can break out, such as tuberculosis.

Local treatment

Rare (affects less than 1 user in 1,000)

  • Irritation at the injection site
  • Painless degradation of joint tissue, especially after repeated administration

Occasional cases of allergic reaction have occurred.

Consult your doctor if you experience any of the mentioned side effects or if unusual signs appear during treatment or immediately after it has stopped.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE PRECORTALON AQUOSUM

Keep out of sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”. The expiration date is the last day of the specified month.

FURTHER INFORMATION

Content declaration

  • The active substance is prednisolone sodium succinate. One vial contains 25 mg of prednisolone sodium succinate.
  • No other ingredients are included

What the medicine looks like and the contents of the pack

Precortalon a quorum is a white to creamy white, dry cake or powder.

10 2 ml vials containing 25 mg powder for reconstitution of 1 ml solution for injection.

Marketing Authorization Holder and Manufacturer

ACE Pharmaceuticals BV

Schepenveld 41

3891 ZK Zeewolde

Netherlands

Information provided by:

Biocodex AB
Knarrarnäsgatan 7
164 40 Kista
Sverige
Tel: +46 8 615 2760

Muhammad Nadeem

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