Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.

Betnesol therapy should only be carried out with strict diagnostic criteria, and with additional targeted anti-infective therapy where appropriate for:
- HBsAg positive chronic active hepatitis
- Hardening of the lymph nodes (up to one year after a BCG vaccination specific histiocytosis should be excluded prior to starting therapy)
- Acute and chronic bacterial infections
- History of tuberculosis (caution: reactivation); Administration only with tuberculostatic protection
In addition Betnesol therapy should only be carried out with strict diagnostic criteria, and with additional targeted anti-infective therapy where appropriate for:

- Hypertension that is difficult to control
- Diabetes mellitus that is difficult to control
- Corneal ulcers and injuries
- Epilepsy
- Thrombophilia/thromboembolic processes
- Heart failure
- Renal failure
Because of the risk of intestinal perforation with peritonitis Betnesol may be used if there is a compelling indication and only under appropriate supervision for:
- Severe ulcerative colitis with impending perforation, abscess or purulent inflammation
- Diverticulitis
- Enteroanastomosis (immediately after surgery).

Glucocorticoids may only be used in severe infections in combination with casual therapy.
Before starting glucocorticoid therapy, a detailed investigation must be carried out; and in particular, gastric and intestinal ulcers should be excluded.
For the prevention of ulcers in the gastrointestinal tract, the administration of acid inhibitors and careful monitoring (including X-ray control/gastroscopy) is indicated in sensitive patients.
The signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoid.
Systemic glucocorticoid treatment can lead to a deterioration in carbohydrate metabolism, which can lead to the manifestation of latent diabetes or worsening of manifest diabetes.
In diabetics, the metabolic status must therefore be checked and if necessary antidiabetic treatment must be adjusted.
During treatment with Betnesol, regular blood pressure monitoring is required in patients with hypertension.
In the treatment of myasthenia gravis, the symptoms may worsen at the beginning, therefore glucocorticoid adjustment should be carried out in hospital. If irritation in the face and throat are particularly severe and respiration is impaired, treatment with Betnesol should be started gradually.
Treatment with Betnesol may mask the symptoms of existing or developing infection and thus complicate the diagnosis.
Treatment with glucocorticoids can lead to an increased risk of infection due to immunosuppression, in particular by opportunistic germs.
Immunisation with inactivated vaccines is generally possible. It should be noted however that the immune response and hence success of the vaccination could be impaired at higher corticosteroid doses.
At high doses, it is important to ensure an adequate intake of potassium and sodium restriction. Serum potassium levels should be monitored and adapted if necessary. This especially applies to simultaneous administration of medicines which are known to cause QT interval extension.
Certain viral diseases (chickenpox, measles, Herpes zoster) can be more severe in patients who are treated with glucocorticoids. Immunocompromised children and persons who have not been previously infected with chickenpox or measles are at risk. If these patients come in contact with infected persons during treatment with Betnesol, preventive therapy should be initiated if necessary.
Due to the growth-inhibiting effect of glucocorticoids, they should only be used in children if there are compelling medical reasons and height growth should be monitored regularly.
If physical stress (e.g. accident, surgery, birth) occurs during treatment with glucocorticoids a temporary dose increase may be necessary. Due to the possible danger in stressful situations, a corticosteroid identity card should be issued for patients on long-term treatment.
Depending on duration and dose of the treatment, a negative effect on calcium metabolism must be taken into account, and osteoporosis prevention recommended if necessary.
Prevention consists of adequate calcium and vitamin D intake and physical activity. For existing osteoporosis, additional medical treatment should be considered.
Relatively low doses may be sufficient for patients with hypothyroidism or liver cirrhosis and a general dose reduction may be necessary.
Betnesol is primarily intended for short-term use. If used for a longer period of time, warnings such as those described for glucocorticoid-containing drugs for long term use, must also be observed.
At the end or required discontinuation of long-term systemic treatment with glucocorticoids caution is advised to avoid acute adrenal insufficiency (especially under stress, such as infections, accidents, increased physical stress, and fever), withdrawal syndrome or a relapse of the disease.

Too rapid dose reduction after long-term treatment may lead to symptoms such as  muscle and joint pain.
Patients should be advised to inform subsequent physicians (e.g. surgery, travel, vaccinations) of the treatment with corticosteroids.
In long-term glucocorticoid therapy, independent of disease-related checks, and depending on the dosage and the individual condition of the patient, monitoring at reasonable intervals, for possible undesirable events may be necessary.

Visual disturbance
Visual disturbance can occur with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Athletes
Administration of Betnesol tablets can lead to a positive doping test result.

This medicine contains: less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free" - 6 mg sodium benzoate in each tablet. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in new-born babies (up to 4 weeks old).

Effects on Driving

4.7   Effects on ability to drive and use machines
No studies have been carried out on the effects of the ability to drive and to use machines.
However, based on the known pharmacodynamics and pharmacokinetic of the active ingredient it can be assumed that Betnesol has no direct influence on the ability to drive and the ability to operate machines. Some adverse events during cortisone therapy (eye disorders, nervous system disorders or myopathy) may reduce the ability to drive.