Dexamethasone hameln

Leaflet accompanying the packaging: patient information

Dexamethasone hameln, 4 mg/ml, solution for injection

Dexamethasone phosphate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Dexamethasone hameln is a synthetic glucocorticosteroid (adrenal cortex hormone) affecting metabolism, electrolyte balance, and tissue function. Dexamethasone hameln is used to treat diseases that require the use of glucocorticosteroids. Depending on the symptoms and severity, these include:

Systemic administration:

• Brain edema caused by brain tumors, neurosurgical interventions, brain abscesses, bacterial meningitis.
• Shock after severe injuries, for preventive treatment of post-traumatic acute respiratory distress syndrome (ARDS).
• Use in the treatment of COVID-19 in adult patients and adolescents (aged 12 and older, weighing at least 40 kg), with breathing difficulties and requiring oxygen therapy.
• Severe acute asthma attack.
• Initial stage of treatment of extensive, acute skin diseases with a severe course, such as erythroderma, bullous pemphigoid, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases that can affect internal organs), such as systemic lupus erythematosus.
• Severe progressive rheumatoid arthritis, e.g., rapidly progressive forms of the disease leading to joint damage and/or damage to tissues outside the joint.
• Severe infectious diseases with symptoms resembling sepsis: (tuberculosis, typhoid fever only in combination with appropriate anti-infective therapy).
• Prevention and treatment of postoperative or chemotherapy-induced vomiting.
• Supportive treatment of malignant tumors, when dexamethasone may be administered as an injection or infusion into a vein or under the skin (subcutaneously) to alleviate some symptoms, including pain, fatigue, weight loss, and malaise.

Local administration

• Intra-articular injection: persistent inflammation of one or more joints after systemic treatment of chronic inflammatory joint diseases, activated degenerative joint disease (in the progressive phase), acute forms of shoulder pain syndrome.
• Soft tissue injection (only if strictly indicated): non-bacterial tendon or bursa inflammation, periarticular inflammation, tendon disorders.

2. Important 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, during the use of Dexamethasone hameln, severe hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest, arrhythmia, dyspnea (bronchospasm), and/or decreased or increased blood pressure have been observed.
Intra-articular injection is contraindicated in the presence of infections in or near the joint, requiring treatment

• Bacterial arthritis
• Joint instability
• Bleeding tendency (spontaneous or caused by anticoagulant medications)
• Calcifications in the joint area
• Avascular necrosis of bone
• Tendon rupture
• Charcot's joint

Do not administer locally without additional causal treatment in the presence of infections at the injection site of dexamethasone.
Do not stop taking any other steroid medications unless a doctor has advised it.

Warnings and precautions

Before starting treatment with Dexamethasone hameln, discuss it with a doctor, pharmacist, or nurse.
If special physical stress situations occur during treatment with Dexamethasone hameln (accident, surgery, childbirth, etc.), it may be necessary to temporarily increase the dose.
Dexamethasone hameln may mask the symptoms of an existing or developing infection, making diagnosis difficult. Latent infections may recur.
General precautions for the use of steroids in certain diseases, masking of infections, concomitant medications, etc. in accordance with current recommendations.
Treatment with Dexamethasone hameln should only be considered when absolutely necessary in patients taking other medications that affect the pathogens causing the following diseases:

• Acute viral infections (hepatitis B virus, chickenpox, shingles, Herpes simplex infections, Herpes virus keratitis)
• Chronic active hepatitis with a positive HBsAg test result (infectious hepatitis)
• Approximately 8 weeks before and up to 2 weeks after vaccinations with live vaccines
• Acute and chronic bacterial infections
• Systemic fungal infections
• Certain parasitic diseases (amoeba or worm infections). In the case of infection or suspected infection with threadworms (Strongyloides), Dexamethasone hameln may lead to activation and massive multiplication of these parasites
• Poliomyelitis
• Lymph node disorders after BCG vaccination
• If the patient has had tuberculosis in the past

During treatment with Dexamethasone hameln, carefully monitor the course of the following diseases and apply appropriate treatment:

• Stomach or intestinal ulcers
• Bone density loss (osteoporosis)
• Difficult-to-treat high blood pressure
• Difficult-to-treat diabetes
• Mental disorders (also in the past), including suicidal tendencies. In such cases, neurological or psychiatric supervision is recommended.
• Increased intraocular pressure (glaucoma with closed or open angle); ophthalmological supervision and appropriate treatment are recommended.
• Corneal damage and ulcers; ophthalmological supervision and appropriate treatment are recommended.

If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.

Crisis in the course of pheochromocytoma

The use of this medicine may cause a crisis in the course of pheochromocytoma, which can be life-threatening. Pheochromocytoma is a rare tumor of the adrenal gland. A crisis in its course may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If these symptoms occur, the patient should immediately contact a doctor.
Before starting treatment with Dexamethasone hameln, discuss it with a doctor if there is a suspicion or diagnosis of pheochromocytoma (adrenal gland tumor).
Due to the risk of intestinal perforation, Dexamethasone hameln should only be used in emergency situations and under appropriate control:

• in severe colitis (ulcerative colitis) with a risk of perforation, with ulcerative or abscessing inflammation that may occur without peritoneal irritation
• in diverticulitis (inflammation of the intestinal wall pouches)
• after certain intestinal surgeries (intestinal anastomosis), immediately after surgery.

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients receiving large doses of glucocorticosteroids.
In diabetic patients, it is necessary to regularly monitor blood glucose levels and consider increased insulin requirements or oral hypoglycemic agents.
Due to the risk of worsening the disease, patients with very high blood pressure and/or severe heart failure should be closely monitored.
During the use of large doses of the medicine, the pulse may be lower than usual.
Severe anaphylactic reactions (hypersensitivity of the immune system) may occur.
The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated concurrently with fluoroquinolones (a type of antibiotic) and Dexamethasone hameln.
During the treatment of a certain type of muscle paralysis (myasthenia gravis), there may be an initial worsening of symptoms.
Vaccination with vaccines containing killed pathogens (inactivated vaccines) is generally possible. However, it should be noted that after administration of large doses of corticosteroids, there may be a weakening of the immune response, and thus the effectiveness of the vaccine.
Vaccination with live vaccines should be avoided due to the risk of infection.
Particularly during long-term treatment with large 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 should be monitored.
In patients treated with Dexamethasone hameln, viral diseases (e.g., measles, chickenpox) may have a particularly severe course. Especially in individuals with impaired immunity who have not previously had measles or chickenpox. If these individuals come into contact with people with measles or chickenpox while taking Dexamethasone hameln, they should immediately consult a doctor, who may take preventive measures if necessary.
If the patient experiences symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, visual disturbances, or loss of vision, and shortness of breath, in the case of a hematological malignancy, they should consult a doctor.
When administered intravenously, the injection should be given slowly, over 2-3 minutes. After too rapid administration, short-term and generally harmless side effects may occur, such as unpleasant tingling or paresthesia, lasting up to 3 minutes.
Dexamethasone hameln is intended for short-term use. In case of improper use of the medicine for a long time, it is necessary to familiarize yourself with additional warnings and precautions regarding long-term therapy with glucocorticosteroid-containing medications.
After local administration, the possibility of side 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 stressed joints may lead to worsening of degenerative joint changes due to overloading of the affected joint after pain or other symptoms have subsided.

Children and adolescents

Dexamethasone should not be routinely used in premature infants who have breathing difficulties.
If dexamethasone is administered to a prematurely born infant, it is necessary to monitor heart function and structure.
In children, Dexamethasone hameln can only be used when necessary, due to the risk of growth retardation/suppression. During long-term treatment, the child's growth should be regularly monitored.
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 medications containing propylene glycol or alcohol.

Patients with liver and kidney function disorders

Dexamethasone hameln contains propylene glycol.
Patients with liver or kidney function disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on 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.

Doping effects

Taking 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, recently taken, or plan to take, including those available without a prescription. This is especially 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 breakdown in the liver, such as certain sleeping pills (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and some anti-tuberculosis medicines (rifampicin), may weaken the effect of corticosteroids.
• Medicines that slow down the metabolism of corticosteroids in the liver, such as certain antifungal medicines (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain female sex hormones, e.g., contraceptives (pills): the effect of Dexamethasone hameln may be increased.
• Ephedrine (is a component, e.g., of medicines used to treat low blood pressure, chronic bronchitis, asthma attacks, decongestant nasal sprays, and appetite suppressants): the effectiveness of Dexamethasone hameln may be reduced due to accelerated metabolism of glucocorticosteroids.
• HIV treatment medicines: ritonavir, cobicistat may enhance the effect of Dexamethasone hameln, so the doctor will want to monitor the patient's condition.

Effect of Dexamethasone hameln on the action of other medicines:

• Blood pressure-lowering medicines (ACE inhibitors). Concomitant use of Dexamethasone hameln may increase the risk of changes in blood morphology.
• Dexamethasone hameln may enhance the effects of heart-strengthening medicines (cardiac glycosides) by causing potassium deficiency.
• Dexamethasone hameln may enhance the potassium loss caused by diuretic medicines (saluretics) or laxatives.
• Dexamethasone hameln may weaken the effect of oral hypoglycemic agents and insulin.
• Blood clotting inhibitors (oral anticoagulants, coumarins). Their effect may be weakened or enhanced by Dexamethasone hameln. The doctor will decide whether it is necessary to change the dose of the anticoagulant medicine.
• If Dexamethasone hameln is used concomitantly with anti-inflammatory and anti-rheumatic medicines (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), there may be an increased risk of stomach ulcers and gastrointestinal bleeding.
• Dexamethasone hameln may prolong the action of some muscle relaxants (non-depolarizing muscle relaxants).
• Dexamethasone hameln may enhance the effect of medicines that increase intraocular pressure (atropine and other anticholinergic medicines).
• Dexamethasone hameln may reduce the effectiveness of medicines used to treat worm infections (praziquantel).
• During concomitant use with medicines used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine), Dexamethasone hameln may increase the risk of muscle or heart diseases (myopathy and cardiomyopathy).
• Dexamethasone hameln may weaken the increase in thyrotropin (TSH) levels after administration of protirelin (TRH, a hormone produced by the hypothalamus).
• Concomitant use of Dexamethasone hameln with immunosuppressive medicines may increase the susceptibility to infections and enhance the course of existing infections that have not yet manifested.
• Cyclosporin (an immunosuppressive medicine) - concomitant use with Dexamethasone hameln may increase the blood cyclosporin level 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 administered to the patient.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will then decide whether the medicine is suitable for the patient and may order additional tests during treatment.
Dexamethasone crosses the placenta. During pregnancy, especially in the first three months, the medicine should only be used after careful assessment of the benefit-risk ratio.
In case of long-term use of dexamethasone during pregnancy, it is not possible to exclude the occurrence of growth disorders in the unborn child. In case of glucocorticosteroid use in the late stage of pregnancy, the newborn may experience adrenal insufficiency, which may require replacement therapy in the newborn.
In newborns of mothers who received Dexamethasone hameln at the end of pregnancy, low blood sugar may occur after birth.
Glucocorticosteroids, including dexamethasone, pass into breast milk. No harmful effects on the infant have been reported, but in case of necessity to use high doses, breastfeeding should be discontinued.
During pregnancy and after delivery, the doctor will closely monitor the patient's condition and the development of the fetus or newborn.

Driving and using machines

So far, there is no evidence that Dexamethasone hameln affects the ability to drive or operate machinery, or perform work in 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 (the main component of common salt/table salt) in each maximum single dose (350 mg for a person weighing 70 kg). This corresponds to 2.15% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Dexamethasone hameln

This medicine should always be used as directed by a nurse or doctor. The doctor will determine the dose of the medicine suitable for the patient and how long the patient should use it.
This medicine is a solution for injection 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 administered into a muscle if there are difficulties with venous access and blood circulation is impaired. Dexamethasone hameln can also be administered by injection or continuous infusion under the skin (subcutaneously).
Dexamethasone hameln can also be administered locally or into a joint.
Intra-articular injection should be performed under strictly aseptic conditions. A single intra-articular injection is usually sufficient to effectively alleviate symptoms. If a repeat injection is necessary, it should be performed no earlier than 3-4 weeks later. The number of injections into one joint should be limited to 3-4. In particular, after each subsequent injection, medical supervision of the joint is recommended.
Dexamethasone hameln can also be administered around the most painful area or tendon attachments, but not directly into the tendon itself. Injections should be avoided at short intervals, and rigorous aseptic precautions should be ensured.
If large doses are required in a single administration, the use of dexamethasone products with higher potency/volume should be considered.

Systemic administration

• Brain 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, then 16 to 24 mg (up to 48 mg) per day, divided into 3-4 (up to 6) single doses, for 4-8 days.
• Brain edema caused by 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 administration of the first dose of antibiotics.
• Shock after severe injury: initial dose 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 a day, for up to 10 days. In adolescents (aged 12 and older), the recommended dose is 6 mg intravenously once a day, for up to 10 days.
• Severe acute asthma attack: adults 8 to 20 mg intravenously, administered as quickly as possible, if necessary, the dose of 8 mg may be repeated every 4 hours. Children: 0.15 to 0.3 mg/kg body weight or 1.2 mg/kg body weight intravenously in a bolus, then 0.3 mg/kg body weight every 4-6 hours.
• Acute skin diseases: depending on the type and extent of the disease, daily doses ranging from 8 to 40 mg intravenously, and in individual cases up to 100 mg. Subsequent treatment with tablets in gradually decreasing doses may be used.
• Systemic lupus erythematosus: 6 to 16 mg/day.
• Rheumatoid arthritis with severe, progressive course, e.g., rapidly progressive forms of the disease leading to joint damage and/or damage to tissues outside the joint: 12 to 16 mg/day, in case of damage to tissues outside the joint: 6 to 12 mg/day.
• Severe infectious diseases with symptoms resembling sepsis: 4 to 20 mg/day intravenously, for several days, only in combination with appropriate anti-infective therapy; in individual cases (e.g., typhoid fever) initially up to 200 mg intravenously, then gradually decreasing doses.
• Prevention and treatment of postoperative vomiting: single dose 8 to 20 mg intravenously before the start of surgery; children over 2 years: 0.15 to 0.5 mg/kg body weight (up to 16 mg).
• Supportive treatment of malignant tumors: initially 8 to 16 mg/day; 4 to 12 mg/day in case of long-term therapy.
• Prevention and treatment of chemotherapy-induced vomiting: 10 to 20 mg intravenously before the start of chemotherapy, and if necessary, 4 to 8 mg up to 2-3 times a day for 1-3 days (moderately emetogenic chemotherapy) or up to 6 days (highly emetogenic chemotherapy).
• In palliative care and as prophylaxis and treatment of nausea and vomiting induced by chemotherapy (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 administered according to the response to treatment.

Local administration

Treatment by local injection usually requires a dose of 4 to 8 mg; in the case of injection into small joints, a dose of 2 mg is sufficient.
If possible, the entire daily dose should be administered in the morning as a single dose. However, in cases of diseases that require treatment with large doses, dividing the daily dose into several doses may give a better treatment result.
The duration of treatment depends on the type of disease and its course. The doctor will determine the treatment plan, which should be strictly followed. Once a satisfactory treatment result is achieved, the dose will be reduced to a maintenance dose or treatment will be discontinued.
Sudden discontinuation of treatment after approximately 10 days may cause acute adrenal insufficiency, so if treatment is to be discontinued, the dose should be gradually reduced.

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 the patient will receive too much or too little of the medicine. In case of doubts, consult a doctor or nurse.
Generally, Dexamethasone hameln is well-tolerated in large doses without complications, even during short-term use. No special precautions are necessary. If more severe or unusual side effects are observed, consult a doctor.
A missed dose can be taken later on the same day, and the next prescribed dose should be taken the next day as usual. If several doses are missed, the disease may recur or worsen. In such cases, consult a doctor, who will check and correct the treatment if necessary.
Do not take a double dose to make up for a missed dose.

Discontinuation of Dexamethasone hameln

Follow the doctor's instructions regarding dosing. Never stop taking Dexamethasone hameln on your own, especially since long-term use of the medicine may lead to suppression of the body's own glucocorticosteroid production (adrenal insufficiency). Severe stress on the body without sufficient glucocorticosteroids could be life-threatening.
In case of further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

During short-term treatment with dexamethasone, the risk of side effects is low. The only exception is parenteral treatment with large doses, which may lead to changes in electrolytes, edema, possible increased blood pressure, cardiac arrest, arrhythmia, or seizures; clinical symptoms of infections may also be observed, even during short-term use.
Attention should be paid to the possibility of stomach and duodenal ulcers, often associated with stress, as corticosteroid treatment may mask their symptoms, as well as a decrease in glucose tolerance.
Dexamethasone hameln may cause allergic reactions, including anaphylactic shock in very rare cases.
Generally, after administration of large doses over a long period, regular occurrence of side effects of varying severity can be expected.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (cannot be estimated from the available data)

Infections and infestations:

Masking of infection symptoms, occurrence or worsening of viral, fungal, bacterial, parasitic, or opportunistic infections, activation of threadworm infection.

Blood and lymphatic system disorders:

Changes in blood cell count (increased white blood cell count or all types of blood cells, decreased count of certain white blood cells).

Immune system disorders:

Hypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as arrhythmia, bronchospasm (smooth muscle spasm in the bronchi), too high or too low blood pressure, circulatory collapse, cardiac arrest, immune system suppression.

Endocrine disorders:

Cushing's syndrome (typical symptoms: moon face, central obesity, facial flushing), adrenal insufficiency or atrophy.

Metabolic and nutritional disorders:

Weight gain, increased blood sugar levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium levels with tissue edema (edema), potassium deficiency due to increased excretion (may lead to 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, occurrence of previously unrecognized epilepsy symptoms, increased frequency of seizures in recognized epilepsy.

Eye disorders:

Increased intraocular pressure (glaucoma), cataract (lens opacity), worsening of corneal ulcers, increased frequency or worsening of infections caused by viruses, bacteria, or fungi; worsening of bacterial corneal ulcers, ptosis (drooping eyelid), mydriasis (pupil dilation), conjunctival edema, corneal perforation (perforation of the white part of the eye), visual disturbances, loss of vision.
In rare cases, transient exophthalmos (bulging eyes) occurred.

Cardiac disorders:

Thickening of the heart muscle (hypertrophic cardiomyopathy) in prematurely born infants, which usually returns to normal after treatment is discontinued.

Vascular disorders:

High blood pressure, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased fragility of blood vessels.

Gastrointestinal disorders:

Stomach and intestinal ulcers, gastrointestinal bleeding, pancreatitis, discomfort in the stomach.

Skin and subcutaneous tissue disorders:

Stretch marks on the skin, thinning of the skin ("parchment-like" skin), dilation of skin blood vessels, tendency to bruise, pinpoint or widespread bleeding of the skin, increased hair growth, acne, facial inflammation, especially around the mouth, nose, and eyes, skin pigmentation changes.

Musculoskeletal and connective tissue disorders:

Muscle diseases, muscle weakness and atrophy, bone density loss (osteoporosis) dependent on dose and duration of treatment, and possible even after short-term therapy, other forms of bone tissue death (bone necrosis), tendon diseases, tendonitis, tendon rupture, fat deposits in the spine (epidural lipomatosis), growth retardation in children.
If the dose of the medicine is reduced too quickly after long-term treatment, complications such as withdrawal syndrome may occur, which may manifest as muscle and joint pain.

Reproductive system and breast disorders:

Disorders of sex hormone secretion (manifested as irregular or absent menstrual periods, hirsutism in women), impotence.
General disorders and administration site conditions:delayed wound healing.

Local administration:

Possible occurrence of irritation and hypersensitivity reactions (burning sensation, persistent pain). In case of incorrect intra-articular administration (outside the joint cavity), it is not possible to exclude the occurrence of atrophy (shrinkage) of the skin and subcutaneous tissue at the injection site.
If the patient experiences any of the following, they should immediately consult a doctor:

• gastrointestinal symptoms,
• back, shoulder, or hip pain,
• mood changes,
• significant fluctuations in blood sugar levels in patients with diabetes.

It is very important to remember not to stop taking this medicine abruptly (even in case of side effects), unless a doctor advises otherwise (see sections 2 and 3).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the
Department of Adverse Reaction Monitoring of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dexamethasone hameln

Store at a temperature below 25°C. Do not freeze.
Store the ampoule in the outer packaging to protect it from light.
The medicine should be stored 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 specified month.
For single use only. Any unused solution should be discarded.
Do not use this medicine if visible solid particles are observed in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dexamethasone hameln contains

• The active substance of the medicine is dexamethasone phosphate. Each 1 ml ampoule contains 4 mg of dexamethasone phosphate (in the form of dexamethasone sodium phosphate).

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

What Dexamethasone hameln looks like and contents of the pack

Dexamethasone hameln, 4 mg/ml, solution for injection (injectable solution) is a clear, colorless solution without solid 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 authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 08.02.2024