Hydrocortisone Galepharm contains the active substance hydrocortisone, a corticosteroid. Hydrocortisone is produced in the body by the adrenal cortex. It influences vital processes in the body, such as fluid balance, mineral metabolism and the body’s adaptation to stressful situations. In addition, it inhibits inflammatory and allergic reactions.
Hydrocortisone Galepharm tablets are used on doctor’s prescription for the treatment of the following diseases:
- Allergies or severe allergic conditions that do not respond to usual medications: e.g. seasonal or chronic hay fever, bronchial asthma, allergic skin conditions, hypersensitivity reactions to drugs.
- Rheumatic disorders, as a short-term treatment during the acute phase or during worsening of the disease: eg rheumatoid arthritis, osteoarthritis, bursitis or tendosynovitis, epicondylitis.
- Dermatological disorders: eg psoriasis, severe rash or inflammation.
- Severe allergies or inflammations in the eyes.
- Certain congenital or acquired blood disorders: eg certain forms of deficiency of blood platelets and red blood cells, leukemia.
- Gastrointestinal disorders: during the critical stages of ulcerative colitis or regional enteritis (ulcerative destruction of the intestinal wall).
- Respiratory tract disorders.
- Fluid build-up in the tissues (edema).
- Hormonal disorders in disorders of the adrenal cortex or the thyroid.
- Tumors of the lymph nodes (lymphomas).
- Certain forms of pulmonary tuberculosis and tuberculous meningitis.
- Hypersensitivity reactions in trichinosis (parasitic disease caused by a worm).
- Bone destruction accompanied by increased calcium level in the blood as a result of tumor conditions.
As a rule, Hydrocortisone Galepharm is not used as a substitute but to supplement the treatment of the underlying disease.
Consideration of the following recommendations helps, during long-term treatment, to improve the tolerance of Hydrocortisone Galepharm:
- Restrict calorie intake to avoid weight gain.
- Limit the intake of salt and sugar.
- Ensure a diet as rich as possible in potassium (fruits and vegetables, especially apricots and bananas, orange juice).
- Consume enough calcium (milk, dairy products).
- Ensure a diet rich enough in protein.
In case of hypersensitivity to the active principle hydrocortisone or to any of the excipients.
Prolonged treatment with Hydrocortisone Galepharm is contraindicated in the following diseases and conditions: gastric and intestinal ulcers, general infections due to amoeba or fungi, viral diseases (herpes, shingles, chickenpox, infantile paralysis), severe reduction in blood bone mass (osteoporosis), intraocular hypertension (glaucoma), change in lymph nodes after vaccination against tuberculosis, psychiatric illnesses.
In emergency cases, however, your doctor may decide to prescribe the tablets for short-term treatment (a few days at most), even in the presence of these illnesses.
In the diseases below, Hydrocortisone Galepharm can only be used with special caution; please tell your doctor if you suffer from any of these conditions:
Tuberculosis, viral diseases (herpes, shingles and chickenpox; however no long-term treatment), amebiasis (no long-term treatment), diseases due to worms, abscesses or other purulent inflammations, high blood pressure, heart weakness, heart attack myocardium, ulcerative destruction of the intestine (ulcerative colitis) with risk of perforation, gastric or intestinal ulcer (no long-term treatment), diverticulitis, hepatic cirrhosis (chronic liver damage), renal dysfunction, thyroid failure, epilepsy, migraine, myasthenia gravis (a form of muscle weakness), tendency to blood clots, psychiatric illness (no long-term treatment).
Treatment with Hydrocortisone Galepharm requires special caution in women in menopause or postmenopause, as well as in elderly males, due to an increased tendency to decrease in bone mass.
Please tell your doctor if you have diabetes, as treatment with Hydrocortisone Galepharm may worsen carbohydrate metabolism. This is why the doctor will carry out more frequent blood sugar checks in patients with diabetes and in those with a familial predisposition. In addition, the patient may need to adjust the dosage of drugs for blood sugar that are too high. Hydrocortisone Galepharm should not be used for a long time in diabetics.
Since long-term use of corticosteroids can cause clouding of the lens (cataract) or increased pressure in the eye (glaucoma), your doctor may order regular ophthalmologist check-ups. Please contact your doctor if you experience symptoms such as blurred vision or other visual disturbances.
If you need to take high doses of Hydrocortisone Galepharm, you should not be given live vaccines; vaccines with killed viruses or viral fragments are allowed, however vaccine protection may decrease. If you take lower doses of Hydrocortisone Galepharm, the necessary vaccines may be given.
Please inform your doctor immediately if any infectious disease develops during treatment with Hydrocortisone Galepharm. This is especially important when a child contracts chickenpox or measles (in adults these diseases are rare), as chickenpox or measles can have a severe course under these circumstances.
If you are having a medical test, it is important to tell your doctor beforehand that you are taking Hydrocortisone Galepharm. This is because Hydrocortisone Galepharm can falsify test results.
Since corticosteroids inhibit the growth and development of children, the administration of Hydrocortisone Galepharm to children requires special caution. The doctor’s instructions should be strictly observed.
If hydrocortisone is used in premature infants, monitoring of cardiac function and structure may be necessary.
Many other medicines and Hydrocorisone Galepharm can interact when given at the same time, and thus may decrease or increase their effect. These include certain antibiotics (clarithromycin, erythromycin, rifampin), antifungals (ketoconazole), antimalarial drugs (chloroquine, hydroxychloroquine, mefloquine), anti-inflammatory / analgesic drugs, including acetylsalicylic acid (aspirin), drugs spasmolytics (atropine), drugs for the treatment of myasthenia gravis (neostigmine, pyridostigmine), antidiabetics and insulin (see above), antihypertensive drugs, anticoagulant drugs, antiepileptics (phenobarbital, primidone, phenytoin, carbamazepine ), diuretic drugs (furosemide), drugs used for weak heart (digoxin), drugs that suppress the immune system (methotrexate, ciclosporin), female sex hormones (estrogens), drugs for the treatment of anxiety and other mental illnesses, anti-asthma medicines (salbutamol), medicines for treating tumors (cyclophosphamide). Your doctor will decide how treatment with Hydrocortisone Galepharm and any of these medicines should be adjusted. asthma medicines (salbutamol), medicines for treating tumors (cyclophosphamide). Your doctor will decide how treatment with Hydrocortisone Galepharm and any of these medicines should be adjusted. asthma medicines (salbutamol), medicines for treating tumors (cyclophosphamide). Your doctor will decide how treatment with Hydrocortisone Galepharm and any of these medicines should be adjusted.
During treatment with Hydrocortisone Galepharm, changes in mood, vitality and ability to concentrate may occur, especially at high doses. Therefore, special care should be taken when driving a vehicle or using machines.
The use of Hydrocortisone Galepharm may lead to positive results in doping control. The use of Hydrocortisone Galepharm as a doping agent can have harmful consequences for your health.
Some medicines can make Hydrocortisone Galepharm work better and your doctor may monitor you closely if you are taking these medicines (including medicines for HIV, eg ritonavir, cobicistat).
Hydrocortisone Galepharm tablets contain lactose. If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. that it is essentially “sodium-free”.
Please inform your doctor or pharmacist if
- you suffer from another disease,
- you are allergic or
- you are already taking other medicines or are already using other medicines for external use (even self-medication!).
If you are pregnant, you should only use Hydrocortisone Galepharm on the express prescription of your doctor and only in an emergency. If you suspect pregnancy or if you are pregnant, you should definitely report it to your doctor as soon as possible.
If treatment with Hydrocortisone Galepharm is absolutely necessary during pregnancy, the doctor will check the newborn for signs that can be attributed to Hydrocortisone Galepharm and, if necessary, initiate appropriate treatment.
Hydrocortisone Galepharm passes into breast milk and may affect the development of your child. Therefore, you should not breast-feed your baby if you are taking Hydrocortisone Galepharm.
The dose needed varies from case to case. Your doctor will decide the dosage according to the nature and severity of your disease, your response to treatment; depending on the situation, it will gradually decrease or increase the dose. He will also decide whether further treatment or a switch to another medicine of the same type as Hydrocortisone Galepharm is necessary.
Hydrocortisone Galepharm is prescribed by the doctor and taken one to several times a day. Take Hydrocortisone Galepharm without chewing the tablets, with meals, with some liquid.
With regard to the treatment of children, the doctor will fix the dose mainly according to the severity of the disease, and less according to the age and body weight.
If you forget to take a dose once, catch up as soon as you think about it. If it is already time for the next dose, skip the missed dose and continue taking the tablets, just at the usual times, in the amount prescribed by the doctor. You should never double the dose. If you have taken considerably more tablets than prescribed at one time, you should tell your doctor immediately.
Since, during long-term treatment with corticosteroids, the body’s reaction to very trying situations (stress, severe infections, injuries or surgery) is disturbed, your doctor may temporarily increase the dose of Hydrocortisone Galepharm. or prescribe another medicine in addition. After long-term treatment, the reaction to stressful situations can possibly be disturbed for up to a year after stopping the treatment which requires, in stressful situations, a preventive intake of corticosteroids! Your doctor will decide how to proceed.
After abrupt discontinuation of long-term corticosteroid therapy, withdrawal symptoms such as fever, malaise, muscle or joint pain, which may cause severe or even dangerous disorders, may appear following discontinuation of the drug. the function of the adrenal gland. Long-term treatment should therefore not be interrupted abruptly. Hydrocortisone Galepharm should be stopped very slowly and gradually (over several weeks to months) under medical supervision.
After long-term treatment, it is necessary that you remain under medical supervision after stopping Hydrocortisone Galepharm, so that recurring problems can be detected and treated quickly.
Do not change the prescribed dosage on your own. Talk to your doctor or pharmacist if you think that the effectiveness of the drug is too weak or on the contrary too strong.
The side effects of Hydrocortisone Galepharm depend on the dose and duration of treatment, as well as the age, sex and disease of the patient. With short-term use, Hydrocortisone Galepharm is generally well tolerated. However, during administration of high doses or during prolonged treatment, the following side effects, typical of corticosteroids, may occur:
Fluid accumulation in tissue (edema, e.g. swelling of hands and feet), disturbances in electrolyte balance (e.g. potassium and calcium depletion), increased appetite, weight gain, disturbances in breakdown of fat (such as a full moon face and abdominal obesity), increased blood pressure, heart problems, muscle wasting, muscle pain, muscle weakness, increased bone fragility (osteoporosis), tendon rupture, nausea, new or recurrent gastrointestinal ulcers, inflammation of the esophagus or pancreas, gas, bone pain, slowed healing, skin changes (thin skin, acne, redness of the skin, papule formation, increased or decrease in pigmentation, stretch marks, petechiae,blood effusions, excessive sweating), cloudy lens (cataract), increased pressure in the eye (glaucoma), blurred vision, increased susceptibility to infections, blood clots in the blood vessels (thrombosis), changes in cells blood changes, mental changes (with changes in mood and personality, ranging from euphoria [increased sense of well-being] and depression to psychotic states), cramps, dizziness, headache, disorders of the release of ‘sex hormones (which can cause impotence and breast development in men and missed periods and increased body hair [hirsutism] in women), hypersensitivity reactions, malaise.
Growth delays can appear in children.
Increased heart muscle thickness (hypertrophic cardiomyopathy) in premature babies.
A worsening of carbohydrate metabolism may appear under treatment with corticosteroids (onset of diabetes, see above: “What precautions should be observed when taking / using Hydrocortisone Galepharm?”).
Most side effects go away gradually after stopping Hydrocortisone Galepharm.
In particular, when the following signs of the side effects mentioned above appear, you should notify your doctor or pharmacist: severe abdominal pain, significant increase in waist size or change in the color of the stool (gastrointestinal ulcer). bleeding), intense thirst or frequent urination (diabetes), rapid weight gain (more than 2 to 3 kg per week), increased tendency to bleed, eye pain (glaucoma), breathing problems or pain in the legs ( formation of clots).
If you notice any side effects, please inform your doctor or pharmacist. This applies in particular to side effects not mentioned in this package insert.