Dexamethasone hameln

Package leaflet: Information for the patient

Dexamethasone hameln, 4 mg/ml, solution for injection
Dexamethasoni phosphas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Dexamethasone hameln is and what it is used for
2. What you need to know before using Dexamethasone hameln
3. How to use Dexamethasone hameln
4. Possible side effects
5. How to store Dexamethasone hameln
6. Contents of the pack and other information

1. What Dexamethasone hameln is and what it is used for

Dexamethasone hameln is a synthetic glucocorticoid (a corticosteroid hormone) that affects metabolism, electrolyte balance, and tissue function.
Dexamethasone hameln is used in the treatment of diseases requiring glucocorticoid therapy. Depending on symptoms and severity, these include:

Systemic administration:

• Cerebral edema caused by brain tumor, neurosurgical intervention, brain abscess, or bacterial meningitis.
• Shock following severe trauma, for prophylactic treatment of post-traumatic acute respiratory distress syndrome (ARDS).
• Treatment of COVID-19 in adult and adolescent patients (aged 12 years and older, weighing at least 40 kg) who have difficulty breathing and require oxygen therapy.
• Severe acute asthma attack.
• Initial stage of treatment of extensive, acute skin diseases with severe course, such as erythroderma, pemphigus vulgaris, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases that may affect internal organs), such as systemic lupus erythematosus.
• Severe progressive course of active rheumatoid arthritis, e.g. rapidly progressing forms leading to joint and/or extra-articular tissue damage.
• Severe infectious diseases with sepsis-like symptoms: (tuberculosis, typhoid fever – only in combination with appropriate anti-infective therapy).
• Prevention and treatment of postoperative or cytostatic-induced vomiting.
• Palliative treatment of malignant tumors, when dexamethasone may sometimes be administered by injection or intravenous infusion or subcutaneously to relieve certain symptoms, including pain, fatigue, weight loss, and malaise.

Local administration

• Intra-articular injection: persistent inflammation of one or more joints following systemic treatment of chronic inflammatory joint diseases, activated osteoarthritis (in progressive phase), acute forms of shoulder pain syndrome.
• Tendon sheath injection (only when strictly indicated): non-bacterial tenosynovitis or bursitis, periarticular disorders, tendon disorders.

2. Information before using Dexamethasone hameln

When not to use Dexamethasone hameln

• If the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).

In individual cases, severe hypersensitivity reactions (anaphylactic reactions) have been observed during administration of Dexamethasone hameln, including circulatory collapse, cardiac arrest, cardiac arrhythmia, dyspnoea (bronchospasm), and/or decreased or increased arterial pressure.
Intra-articular injection is contraindicated in the following cases:

• Infections at or near the joint requiring treatment
• Septic arthritis
• Joint instability
• Bleeding tendency (spontaneous or drug-induced due to anticoagulants)
• Calcification around the joint
• Avascular necrosis of bone
• Tendon rupture
• Charcot joint

Intralesional administration should not be performed without additional causal treatment if there is an infection at the site of dexamethasone injection.
Do not discontinue any other steroid medications unless advised by a doctor.
Warnings and precautions

Before starting treatment with Dexamethasone hameln, discuss it with your doctor, pharmacist, or nurse.
If unusual physical stress occurs during treatment with Dexamethasone hameln (e.g. accident, surgery, childbirth, etc.), temporary dose increase may be necessary.
Dexamethasone hameln may mask symptoms of existing or developing infections, making diagnosis difficult. Dormant infections may reactivate.
General precautions regarding steroid use in specific diseases, masking of infections, concomitant medications, etc., should be followed according to current guidelines.
Treatment with Dexamethasone hameln should be considered only if absolutely necessary when other drugs acting on pathogens causing the following diseases are used concomitantly:

• Acute viral infections (hepatitis B virus, chickenpox, shingles, Herpes simplex infections, herpes virus-induced keratitis)
• Chronic active hepatitis with positive HBsAg test (infectious hepatitis)
• From approximately 8 weeks before until 2 weeks after vaccination with live vaccines
• Acute and chronic bacterial infections
• Systemic fungal infections
• Certain parasitic diseases (amebic or helminthic infestations). In case of infestation or suspected infestation with Strongyloides, Dexamethasone hameln may cause activation and massive proliferation of these parasites
• Poliomyelitis
• Lymph node disorders after BCG vaccination
• If the patient has had tuberculosis in the past

During treatment with Dexamethasone hameln, the following conditions should be carefully monitored and appropriate treatment initiated:

• Gastric or intestinal ulcers
• Bone mass loss (osteoporosis)
• Hypertension difficult to control
• Diabetes difficult to control
• Psychiatric disorders (including in the past), including suicidal tendencies. In such cases, supervision by a neurologist or psychiatrist is recommended.
• Increased intraocular pressure (closed-angle or open-angle glaucoma); ophthalmological monitoring and appropriate treatment are recommended.
• Corneal damage and ulceration; ophthalmological monitoring and appropriate treatment are recommended.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Pheochromocytoma crisis
Administration of this medicine may cause a pheochromocytoma crisis, which may be fatal. Pheochromocytoma is a rare adrenal gland tumour. A crisis may present as headache, excessive sweating, palpitations, and elevated blood pressure. If any of these symptoms occur, the patient should contact a doctor immediately.
Before starting treatment with Dexamethasone hameln, discuss with a doctor if there is suspicion of or a diagnosed pheochromocytoma (adrenal gland tumour).
Due to the risk of intestinal perforation, Dexamethasone hameln should be used only in urgent indications and under appropriate monitoring:

• In severe colitis (ulcerative colitis) with risk of perforation, with ulcerative or suppurative inflammation that may occur without peritoneal irritation
• In diverticulitis (inflammation of intestinal diverticula)
• After certain intestinal surgeries (intestinal anastomosis), immediately after surgery.

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients receiving high doses of glucocorticosteroids.
In patients with diabetes, blood glucose levels should be monitored regularly, and increased need for antidiabetic medications (insulin, oral antidiabetic drugs) should be considered.
Due to the risk of exacerbation of symptoms, patients with very high blood pressure and/or severe heart failure should remain under close observation.
During administration of high doses of the medicine, pulse rate may be lower than usual.
Severe anaphylactic reactions (immune system hypersensitivity) may occur.
The risk of tendon disease, tendonitis, and tendon rupture increases in patients treated concomitantly with fluoroquinolones (a type of antibiotic) and Dexamethasone hameln.
During treatment of a specific type of muscle paralysis (myasthenia gravis), symptoms may initially worsen.
Vaccination with vaccines containing killed pathogenic microorganisms (inactivated vaccines) is generally possible. However, it should be noted that after administration of high doses of corticosteroids, the immune response and thus vaccine efficacy may be weakened.
Particularly during long-term treatment with high doses of Dexamethasone hameln, attention should be paid to adequate potassium intake (e.g. vegetables, bananas). Salt intake should be limited and blood potassium levels monitored.
Viral diseases (e.g. measles, chickenpox) may have a particularly severe course in patients treated with Dexamethasone hameln. This especially applies to immunocompromised individuals who have not previously had measles or chickenpox. In case of exposure to measles or chickenpox during treatment with Dexamethasone hameln, immediate medical consultation is required, and preventive measures may be initiated if necessary.
Contact a doctor if the patient develops symptoms of tumour lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual disturbances or vision loss, and shallow breathing, especially if the patient has a haematological malignancy.
In case of intravenous administration, the injection should be given slowly over 2–3 minutes. If administered too rapidly, transient and generally harmless adverse effects such as unpleasant tingling or paraesthesia may occur, lasting up to 3 minutes.
Dexamethasone hameln is intended for short-term use. In case of inappropriate long-term use, additional warnings and precautions regarding long-term therapy with glucocorticosteroid-containing medicines should be considered.
After local administration, the possibility of adverse effects and interactions should be considered, as with systemic administration.
Intra-articular administration of glucocorticosteroids increases the risk of joint infections. Prolonged and repeated use of glucocorticosteroids in weight-bearing joints may lead to worsening of degenerative joint changes due to overuse of the affected joint after pain or other symptoms subside.
Children and adolescents
Dexamethasone should not be routinely used in premature infants with respiratory difficulties.
If dexamethasone is administered to a premature infant, cardiac function and structure must be monitored.
Dexamethasone hameln should be used in children only when necessary, due to the risk of growth retardation. During long-term treatment, the child's growth should be monitored regularly.
Dexamethasone hameln contains propylene glycol. Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Patients with impaired liver or kidney function
Dexamethasone hameln contains propylene glycol.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Elderly patients
Due to the increased risk of osteoporosis, the doctor will assess the benefit-risk ratio of using the medicine in elderly patients.
Effects after doping use
Administration of Dexamethasone hameln may result in positive doping test results.
Dexamethasone hameln and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including over-the-counter medicines, as well as any medicines you plan to take. This is particularly important for the following medicines, as they may affect the action of Dexamethasone hameln.
Medicines that may affect the action of Dexamethasone hameln:

• Medicines that accelerate its metabolism in the liver, such as certain sleeping pills (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and some anti-tuberculosis drugs (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow corticosteroid metabolism in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain female sex hormones, e.g. contraceptives (oral contraceptives): the effect of Dexamethasone hameln may be increased.
• Ephedrine (a component, for example, of medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants in colds, and appetite suppressants): the effectiveness of Dexamethasone hameln may be reduced due to accelerated glucocorticoid metabolism.
• Medicines used to treat HIV: ritonavir, cobicistat may enhance the effect of Dexamethasone hameln; therefore, the doctor may wish to monitor the patient's condition.

Effect of Dexamethasone hameln on other medicines such as:

• Blood pressure-lowering medicines (ACE inhibitors). Concomitant use of Dexamethasone hameln may increase the risk of blood morphology changes.
• Dexamethasone hameln may enhance the effects of cardiac-stimulating medicines (cardiac glycosides) by causing potassium deficiency.
• Dexamethasone hameln may enhance potassium loss caused by diuretics (saluretics) or laxatives.
• Dexamethasone hameln may weaken the glucose-lowering effect of oral antidiabetic drugs and insulin.
• Medicines used to prevent blood clotting (oral anticoagulants, coumarins). Their effect may be weakened or enhanced by Dexamethasone hameln. The doctor will decide whether a dose adjustment of the anticoagulant is necessary.
• If Dexamethasone hameln is used concomitantly with anti-inflammatory and antirheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), there may be an increased risk of gastric ulcers and gastrointestinal bleeding.
• Dexamethasone hameln may prolong the muscle-relaxing effect of certain medicines (non-depolarizing muscle relaxants).
• Dexamethasone hameln may enhance the effect of medicines that increase intraocular pressure (atropine and other anticholinergics).
• Dexamethasone hameln may reduce the effectiveness of medicines used to treat worm infestations (praziquantel).
• When used concomitantly with medicines used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine), Dexamethasone hameln may increase the risk of muscle or heart disorders (myopathies and cardiomyopathies).
• Dexamethasone hameln may reduce the increase in thyrotropin (TSH) activity after administration of protirelin (TRH, a hormone produced by the hypothalamus).
• Concomitant use of Dexamethasone hameln with immunosuppressive medicines may increase susceptibility to infections and worsen the course of existing but not yet manifested infections.
• Cyclosporine (an immunosuppressive medicine) – concomitant use with Dexamethasone hameln may increase cyclosporine blood levels and thus the risk of seizures.
• Fluoroquinolones, a group of antibiotics: may increase the risk of tendon rupture.

Effect on diagnostic tests
Glucocorticosteroids may suppress skin reactions in allergy tests.
Due to interactions with these medicines, the doctor may need to adjust the dose of the medicine prescribed to the patient.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine. The doctor will then decide whether the medicine is suitable and may order additional tests during treatment.
Dexamethasone crosses the placenta. During pregnancy, especially in the first trimester, the medicine should be used only after careful assessment of benefit versus risk.
With prolonged use of dexamethasone during pregnancy, growth disturbances in the unborn child cannot be excluded. When glucocorticosteroids are used in late pregnancy, the newborn may develop adrenal insufficiency, which may require replacement therapy.
Newborns of mothers who received Dexamethasone hameln near the end of pregnancy may have low blood sugar levels after birth.
Glucocorticosteroids, including dexamethasone, pass into breast milk. No harmful effects on the infant have been reported, but if high doses are required, breastfeeding should be discontinued.
Driving and operating machinery
There is currently no evidence that Dexamethasone hameln affects the ability to drive or operate machinery or perform work under hazardous conditions.
Dexamethasone hameln contains propylene glycol
This medicine contains 20 mg of propylene glycol in 1 ml of solution.
Dexamethasone hameln contains sodium
This medicine contains up to 43 mg (1.9 mmol) of sodium (main component of table salt) in each maximum single dose (350 mg for a 70 kg person). This corresponds to 2.15% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Dexamethasone hameln

This medicine should always be used exactly as directed by your doctor or nurse. Your doctor will determine the appropriate dose for you and how long you should use the medicine.
This medicine is an injection solution administered intravenously (i.v.), intramuscularly (i.m.), subcutaneously (s.c.), or into tissues.
Dexamethasone hameln should be administered slowly (over 2–3 minutes) by intravenous injection. Dexamethasone hameln may be given intramuscularly if there are difficulties with venous access or impaired blood circulation. Dexamethasone hameln may also be administered by subcutaneous injection or continuous subcutaneous infusion.
Dexamethasone hameln may also be administered intralesionally or injected directly into a joint.
Intra-articular injection must be performed under strictly aseptic conditions. A single intra-articular injection is usually sufficient to effectively relieve symptoms. If a subsequent injection is necessary, it should not be administered earlier than 3–4 weeks after the previous one. The number of injections into a single joint should be limited to 3–4. In particular, a medical evaluation of the joint is recommended after each subsequent injection.
Dexamethasone hameln may also be administered near the most painful site or tendon insertions, but not directly into the tendon itself. Repeated injections in close succession should be avoided, and strict aseptic precautions must be observed.
If high doses are required in a single administration, consider using dexamethasone medicinal products with higher strength/volume.

Systemic administration

• Cerebral edema: initially in acute conditions, depending on the cause and severity of the disease, the initial dose is 8 to 10 mg (up to 80 mg) intravenously, followed by 16 to 24 mg (up to 48 mg) per day, divided into 3–4 (up to 6) single doses, for 4–8 days.
• Cerebral edema due to bacterial meningitis: 0.15 mg/kg body weight every 6 hours for 4 days. Children: 0.4 mg/kg body weight every 12 hours for 2 days, starting before the first dose of antibiotic.
• Shock following severe trauma: initial dose of 40 to 100 mg (in children 40 mg) intravenously, repeated after 12 hours, or 16 to 40 mg every 6 hours for 2–3 days.
• Treatment of COVID-19: in adult patients, the recommended dose is 6 mg intravenously once daily for up to 10 days. In adolescents (aged 12 years or older), 6 mg intravenously once daily for up to 10 days is recommended.
• Severe acute asthma attack: adults 8 to 20 mg intravenously, administered as rapidly as possible; if needed, repeat 8 mg dose every 4 hours. Children: 0.15 to 0.3 mg/kg body weight or 1.2 mg/kg body weight intravenous bolus, followed by 0.3 mg/kg body weight every 4–6 hours.
• Acute skin diseases: depending on the type and extent of the disease, daily doses range from 8 to 40 mg intravenously, and in individual cases up to 100 mg. Subsequently, treatment should continue with oral tablets, gradually reducing the dose.
• Systemic lupus erythematosus: 6 to 16 mg/day.
• Severe, progressive rheumatoid arthritis, e.g. rapidly progressive forms leading to joint damage: 12 to 16 mg/day; in cases with extra-articular tissue involvement: 6 to 12 mg/day.
• Severe infectious diseases with symptoms resembling poisoning: 4 to 20 mg/day intravenously for several days, exclusively in combination with appropriate anti-infective therapy; in individual cases (e.g. typhoid fever), initially up to 200 mg intravenously, followed by gradually decreasing doses.
• Prevention and treatment of postoperative nausea and vomiting: single dose of 8 to 20 mg intravenously before the start of surgery; children over 2 years of age: 0.15 to 0.5 mg/kg body weight (maximum up to 16 mg).
• Adjunctive treatment of malignant tumors: initially 8 to 16 mg/day; 4 to 12 mg/day in long-term therapy.
• Prevention and treatment of vomiting induced by cytostatic agents as part of antiemetic therapy: 10 to 20 mg intravenously before the start of chemotherapy, and then, if necessary, 4 to 8 mg 2–3 times daily for 1–3 days (moderately emetogenic chemotherapy) or up to 6 days (highly emetogenic chemotherapy).
• In palliative care and for prevention and treatment of chemotherapy-induced nausea and vomiting (CINV), doses usually range from 4.8 mg to 19.3 mg subcutaneously over 24 hours, taking into account local clinical guidelines, and should be adjusted according to treatment response.

Local administration
Local infiltration and local injection therapy usually require a dose of 4 to 8 mg; for injection into small joints, a dose of 2 mg is sufficient.
Whenever possible, the entire daily dose should be administered in the morning as a single dose. However, in diseases requiring high-dose treatment, splitting the daily dose into several administrations may provide better therapeutic outcomes.
The duration of treatment depends on the type and course of the disease. Your doctor will determine the treatment plan, which must be strictly followed. As soon as a satisfactory treatment response is achieved, the dose will be gradually reduced to a maintenance dose or treatment will be discontinued.
Abrupt discontinuation of treatment after approximately 10 days may lead to acute adrenal insufficiency; therefore, if treatment needs to be stopped, the dose should be tapered gradually.
In cases of adrenal insufficiency or hepatic cirrhosis, relatively low doses may be sufficient, or dose reduction may be necessary.

Use of a higher than recommended dose of Dexamethasone hameln or missing a dose
This medicine will be administered by a doctor or nurse, so it is unlikely that a patient will receive too high or too low a dose. If in doubt, consult your doctor or nurse.
Generally, Dexamethasone hameln is well tolerated even at high doses, even during short-term use, and no special precautions are required. If you experience more severe or unusual side effects, consult your doctor.
A missed dose can be taken later the same day, and the next prescribed dose should be taken the following day as usual. If multiple doses are missed, symptoms of the disease may recur or worsen. In such cases, contact your doctor, who will assess and possibly adjust your treatment.
Do not use a double dose to make up for a missed dose.

Stopping treatment with Dexamethasone hameln
You must strictly follow your doctor's dosing instructions. Never discontinue Dexamethasone hameln on your own, especially since long-term use of the medicine may suppress the body's own production of glucocorticosteroids (adrenal insufficiency). Under conditions of physical stress, insufficient glucocorticosteroid levels could then pose a life-threatening risk.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

During short-term treatment with dexamethasone, the risk of adverse effects is low. The only exception is parenteral administration of high doses, which may lead to electrolyte disturbances, development of oedema, possible increase in blood pressure, cardiac arrest, cardiac arrhythmias or seizures; clinical signs of infection may also be observed, even during short-term use.
One should be aware of the possibility of gastric and duodenal ulcers, often associated with stress, as corticosteroid therapy may mask their symptoms, as well as reduced glucose tolerance.
The medicinal product Dexamethasone hameln may cause allergic reactions, including, in very rare cases, anaphylactic shock.
Generally, following long-term administration of high doses, adverse effects of varying severity may be expected to occur regularly.
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequency unknown (cannot be estimated from available data)
Infections and infestations:
Masking of signs of infection, occurrence or exacerbation of viral, fungal, bacterial, parasitic or opportunistic infections, activation of helminthic infestation.
Blood and lymphatic system disorders:
Changes in blood cell count (increased white blood cell count or increased count of all types of blood cells, decreased number of certain white blood cells).
Immune system disorders:
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmias, bronchospasm (constriction of smooth muscles of bronchi), excessively high or low blood pressure, circulatory collapse, cardiac arrest, immunosuppression.
Endocrine disorders:
Cushing's syndrome (typical symptoms: moon face, central obesity, facial redness), adrenal insufficiency or adrenal atrophy.
Metabolism and nutrition disorders:
Weight gain, increased blood glucose concentration, diabetes mellitus, increased blood lipid levels (cholesterol and triglycerides), increased sodium concentration with tissue swelling (oedema), potassium deficiency caused by increased potassium excretion (this may lead to cardiac arrhythmias), increased appetite.
Psychiatric disorders:
Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, anxiety, sleep disturbances, suicidal tendencies.
Nervous system disorders:
Increased intracranial pressure, emergence of symptoms of previously unrecognized epilepsy, increased frequency of seizures in diagnosed epilepsy.
Eye disorders:
Increased intraocular pressure (glaucoma), lens opacity (cataract), worsening of corneal ulcers, increased frequency or severity of infections caused by viruses, bacteria or fungi; worsening of bacterial keratitis, ptosis (drooping eyelid), pupil dilation, conjunctival oedema, scleral perforation (of the white part of the eyeball), visual disturbances, loss of vision.
In rare cases, transient exophthalmos (protrusion of the eye) has occurred.
Cardiac disorders:
Myocardial hypertrophy (hypertrophic cardiomyopathy) in premature infants, which usually resolves after discontinuation of treatment.
Vascular disorders:
High blood pressure, increased risk of atherosclerosis and thrombosis, vasculitis (also as withdrawal syndrome after long-term treatment), increased fragility of capillaries.
Gastrointestinal disorders:
Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, gastric discomfort.
Skin and subcutaneous tissue disorders:
Skin striae, decreased skin thickness ("parchment skin"), skin capillary dilation, tendency to bruising, petechial or extensive skin haemorrhages, hirsutism, acne, inflammatory skin lesions of the face, particularly around the mouth, nose and eyes, skin pigmentation changes.
Musculoskeletal and connective tissue disorders:
Muscle disorders, muscle weakness and atrophy, loss of bone mass (osteoporosis) dose-dependent and possible even after short-term therapy, other forms of bone tissue necrosis (avascular necrosis), tendon disorders, tendonitis, tendon rupture, fat deposition in the spine (epidural lipomatosis), growth suppression in children.
If the dose of the medicine is reduced too quickly after long-term treatment, complications may occur, such as withdrawal syndrome, which may manifest as muscle and joint pain.
Reproductive system and breast disorders:
Disturbances in sex hormone secretion (manifesting as irregular menstruation or absence of menstruation (amenorrhoea), male-pattern hair growth in women (hirsutism), impotence).
General disorders and administration site conditions: slower wound healing.
Local administration:
Possible occurrence of irritant and hypersensitivity reactions (burning sensation, persistent pain). In case of improper intra-articular administration (outside the joint cavity), atrophy (wasting) of the skin and subcutaneous tissue at the injection site cannot be excluded.
If any of the following symptoms occur in a patient, immediate medical advice must be sought:

• gastrointestinal symptoms,
• back, shoulder or hip pain,
• mood disturbances,
• significant fluctuations in blood glucose levels in diabetic patients.

It is very important to remember not to abruptly discontinue treatment with this medicine (even if adverse effects occur), unless otherwise advised by a physician (see section 2 and 3).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dexamethasone hameln

Store below 25°C. Do not freeze.
Keep the ampoule in the outer packaging to protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule label and carton
after: EXP. The expiry date refers to the last day of the stated month.
For single use only. Any unused solution should be discarded.
Do not use this medicine if you notice visible solid particles in the solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Dexamethasone hameln contains

• The active substance is dexamethasone sodium phosphate. Each 1 ml ampoule contains 4 mg of dexamethasone sodium phosphate (as dexamethasone sodium phosphate).

Each 2 ml ampoule contains 8 mg of dexamethasone sodium phosphate (as dexamethasone sodium phosphate).
The other ingredients are propylene glycol, disodium edetate, sodium hydroxide (for pH adjustment), and water for injections.

What Dexamethasone hameln looks like and contents of the pack

Dexamethasone hameln 4 mg/ml, solution for injection (injection solution) is a clear, colourless solution free from particles.

Dexamethasone hameln is available in packs of 5 or 10 ampoules, each ampoule containing 1 ml or 2 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
hameln pharma gmbh
Inselstraße 1
Hameln, 31787
Germany

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
Hameln, 31789
Germany
HBM Pharma s.r.o.
Sklabinska 30
Martin, 036 01
Slovakia
hameln rds s.r.o.
Horna 36
Modra, 900 01
Slovakia

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: