Dicloberl 75 mg/3 ml

Leaflet accompanying the packaging: patient information

Dicloberl 75 mg/3 ml

75 mg/3ml, solution for injection Diclofenac sodium

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dicloberl 75 mg/3 ml and what is it used for
• 2. Important information before using Dicloberl 75 mg/3 ml
• 3. How to use Dicloberl 75 mg/3 ml
• 4. Possible side effects
• 5. How to store Dicloberl 75 mg/3 ml
• 6. Contents of the packaging and other information

1. What is Dicloberl 75 mg/3 ml and what is it used for

Dicloberl 75 mg/3 ml is an anti-inflammatory and analgesic medicine (non-steroidal anti-inflammatory drug, NSAID).
Symptomatic treatment of acute pain in:

• acute joint inflammation, including gout attacks;
• chronic joint inflammation, especially rheumatoid arthritis (chronic polyarthritis);
• ankylosing spondylitis (Bechterew's disease) and other rheumatic inflammatory conditions of the spine;
• exacerbations of peripheral osteoarthritis and spinal osteoarthritis;
• soft tissue inflammation in rheumatic disorders;
• post-traumatic painful swelling and inflammation.

Dicloberl 75 mg/3 ml is intended for use in adults.
Note:
The use of the solution for injection is indicated only when a very rapid onset of action is necessary or when oral or suppository administration is not possible.
In such cases, treatment with a single injection should only initiate therapy.
If there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before using Dicloberl 75 mg/3 ml

When not to use Dicloberl 75 mg/3 ml:

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a history of breathing problems (bronchospasm), asthma attacks, chest pain, swelling of the nasal mucosa, or skin reactions after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug;
• if the patient has non-specific blood disorders;
• if the patient currently has stomach or intestinal ulcers, bleeding, or perforations (which may be accompanied by bloody vomiting, bleeding during bowel movements, fresh blood in the stool, or black stools);
• if the patient has active or recurrent peptic ulcer disease or bleeding (two or more separate cases of confirmed ulcers or bleeding);
• if the patient has a history of gastrointestinal bleeding or perforation related to previous use of NSAIDs;
• if the patient has cerebral bleeding or any other active bleeding;
• if the patient has severe renal or hepatic impairment;
• if the patient has heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient ischemic attack (temporary cerebral ischemia), or vascular surgery or angioplasty;
• if the patient has circulatory disorders (peripheral vascular disease);
• during the last three months of pregnancy;
• in children and adolescents under 18 years of age due to the high content of the active substance.

Warnings and precautions

The following cases require special caution when taking Dicloberl 75 mg/3 ml. The medicine should only be used in a specific way (e.g., with longer intervals between administrations or with smaller doses under medical supervision). Consult a doctor.
This also applies to situations that have occurred in the past.
Before starting treatment with Dicloberl 75 mg/3 ml, discuss it with your doctor or pharmacist.
General
Taking the medicine in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of side effects (see section 3 "How to use Dicloberl 75 mg/3 ml").
Avoid concurrent use of Dicloberl 75 mg/3 ml with other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), due to the lack of data confirming better efficacy and the possibility of more frequent and severe side effects.
Gastrointestinal bleeding, ulcers, and perforation:
There have been reports of gastrointestinal bleeding, ulcers, and perforations with fatal outcomes in patients taking all NSAIDs, occurring at various times during treatment, with or without warning signs and with or without previous severe adverse reactions affecting the gastrointestinal tract.
The risk of gastrointestinal bleeding, ulcers, and perforation increases with increasing NSAID doses and is higher in patients with a history of ulcers, especially if complicated by bleeding or perforation, as well as in the elderly. In such patients, treatment should be initiated and continued with the smallest doses.
In such patients, as well as in patients requiring concurrent administration of low-dose acetylsalicylic acid or other medications that may increase the risk of gastrointestinal disorders, the doctor will consider concurrent administration of medications with a protective effect on the gastric mucosa (e.g., misoprostol or proton pump inhibitors).
Patients who have experienced gastrointestinal side effects, especially the elderly, should report all abnormal abdominal symptoms (especially gastrointestinal bleeding), particularly at the start of treatment.
Caution is advised when using the medicine in patients taking medications that may increase the risk of ulcers or bleeding, such as systemic corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (used to treat depression) or antiplatelet agents (e.g., acetylsalicylic acid) (see section 2: Dicloberl 75 mg/3 ml and other medicines).
In case of gastrointestinal bleeding or ulcers in a patient taking Dicloberl 75 mg/3 ml, the medicine should be discontinued.
Use of Dicloberl 75 mg/3 ml should be stopped and medical attention sought immediately if the patient experiences severe abdominal pain, black stools, or bloody vomiting (see section 4 "Possible side effects").
NSAIDs should be used with caution and under close medical supervision in patients with symptoms indicating gastrointestinal disorders, patients with a history of ulcers, bleeding, or perforation, or with gastrointestinal diseases (ulcerative colitis, Crohn's disease), as they may experience exacerbation of the disease (see section 4 "Possible side effects").
Before using Dicloberl 75 mg/3 ml, inform your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as the medicine may sometimes cause impaired wound healing in the intestines after surgery.
Effect on the cardiovascular system
Taking such medicines as Dicloberl 75 mg/3 ml may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
Before taking Dicloberl 75 mg/3 ml, inform your doctor:

• if you smoke
• if you have diabetes
• if you have: angina pectoris, reduced heart function, a disease characterized by reduced blood flow to the heart, conditions that affect blood flow to the brain, narrowing of arteries other than those supplying blood to the heart or brain, blood clots, high blood pressure, elevated cholesterol or elevated triglycerides.

The occurrence of side effects can be limited by using the medicine in the smallest effective dose and for no longer than necessary.
In case of heart problems or a stroke, discuss the treatment with your doctor or pharmacist.
Skin reactions
Very rare cases of severe skin reactions with redness and blisters, some with fatal outcomes, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell's syndrome) (see section 4 "Possible side effects"), have been reported in association with the use of NSAIDs. It appears that the greatest risk of these reactions occurs at the start of treatment: in most cases, the onset of such a reaction occurs during the first month of treatment. In case of the first signs of a skin rash, mucosal lesions (oral and nasal), or other symptoms of hypersensitivity, discontinue Dicloberl 75 mg/3 ml and consult a doctor.
Effect on the liver
Before deciding to start treatment with diclofenac in patients with liver function disorders, caution should be exercised (consult a doctor or pharmacist), as they may experience exacerbation of the disease. During the use of NSAIDs, including diclofenac, an increase in the activity of one or more liver enzymes may occur. If diclofenac is to be used for a long time or repeatedly, it is recommended as a precautionary measure to regularly monitor liver function parameters. Dicloberl 75 mg/3 ml should be discontinued immediately in case of symptoms of liver function disorders.
Hepatitis may occur without warning signs.
Caution should be exercised when using Dicloberl 75 mg/3 ml in patients with porphyria (a blood disorder), as it may exacerbate the disease.
Effect on the kidneys
Since cases of fluid retention and edema have been reported in association with NSAID treatment, including diclofenac, special caution should be exercised in patients with impaired renal function, a history of hypertension, the elderly, patients taking diuretics or medications that significantly reduce renal function, and patients with significantly reduced extracellular fluid volume for any reason (e.g., before or after major surgery). In such cases, during diclofenac use, it is recommended as a precautionary measure to monitor renal function.
Discontinuation of treatment usually leads to a return to the pre-treatment state.
Other
Dicloberl 75 mg/3 ml can only be used after careful consideration of the benefit-risk ratio:

• in certain congenital blood disorders (e.g., acute intermittent porphyria),
• in certain autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease).

Dicloberl 75 mg/3 ml can only be used under close medical supervision:

• in patients with allergies (e.g., skin reactions to other medicines, asthma, hay fever), chronic nasal mucosa swelling, or chronic respiratory diseases with bronchial obstruction or chronic respiratory infections, as these patients are at increased risk of allergic reactions.

When using diclofenac parenterally, special caution is advised in patients with asthma, as symptoms may worsen.
Do not inject Dicloberl 75 mg/3 ml into an area with inflammation or infection.
Rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) may occur. After the first symptoms of a hypersensitivity reaction to Dicloberl 75 mg/3 ml, discontinue the medicine. Medical personnel will provide appropriate symptomatic treatment.
Diclofenac may periodically inhibit platelet aggregation. Therefore, the doctor will closely monitor patients with coagulation disorders.
Like other NSAIDs, diclofenac may mask signs of infection. If signs of infection (e.g., redness, swelling, overheating, pain, fever) occur or worsen while taking Dicloberl 75 mg/3 ml, the patient should contact their doctor immediately.
If the patient is taking medications that affect blood clotting or lower blood sugar levels, it is recommended to monitor coagulation or blood sugar levels as a precautionary measure.
During long-term administration of Dicloberl 75 mg/3 ml, regular monitoring of liver function parameters, renal function, and blood morphology is required.
Inform your doctor or dentist about taking Dicloberl 75 mg/3 ml before surgical procedures.
During long-term use of painkillers, headaches may occur, which should not be treated by increasing the dose of these medicines. Consult a doctor if you frequently experience headaches while taking Dicloberl 75 mg/3 ml.
Habitual use of painkillers, especially combinations of several active substances with analgesic effects, may cause irreversible kidney damage, associated with the risk of kidney failure (analgesic nephropathy).

Children and adolescents

Do not use Dicloberl 75 mg/3 ml in children and adolescents under 18 years of age (see section 2 "When not to use Dicloberl 75 mg/3 ml").

Elderly

Due to the possibility of side effects, elderly patients should be monitored closely. Caution is advised in elderly patients with concomitant diseases.
In particular, in frail elderly patients or those with low body weight, the use of the smallest effective dose is recommended. The frequency of side effects during NSAID treatment, especially gastrointestinal bleeding, ulcers, and perforation, is higher in the elderly. These gastrointestinal reactions usually have more severe consequences in the elderly and can lead to death.

Dicloberl 75 mg/3 ml and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Other NSAIDs (including acetylsalicylic acid) and glucocorticosteroids
Concurrent administration of Dicloberl 75 mg/3 ml with other anti-inflammatory and analgesic medicines from the NSAID group or glucocorticosteroids (anti-inflammatory or hormone replacement therapy medicines) increases the risk of ulcers and gastrointestinal bleeding. Do not take diclofenac with other NSAIDs.
Digoxin, phenytoin, lithium
Concurrent use of Dicloberl 75 mg/3 ml with digoxin (a medicine used to treat heart rhythm disorders), phenytoin (a medicine used to treat seizures), or lithium (a medicine used to treat mental disorders) may increase the levels of these medicines in the blood. Monitoring of lithium levels in the blood is necessary. Monitoring of digoxin and phenytoin levels in serum is recommended.
Diuretics, beta-adrenergic blockers, ACE inhibitors, and angiotensin II antagonists
Dicloberl 75 mg/3 ml may reduce the effect of diuretics and antihypertensive medicines (e.g., beta-adrenergic blockers, ACE inhibitors, and angiotensin II antagonists). Therefore, blood pressure should be monitored periodically.
Dicloberl 75 mg/3 ml may reduce the effect of ACE inhibitors and angiotensin II antagonists (medicines used to treat heart diseases and lower blood pressure). Concurrent use of these medicines with Dicloberl 75 mg/3 ml may increase the risk of renal function disorders. Patients should be properly hydrated, and renal function should be monitored periodically.
Concurrent use of Dicloberl 75 mg/3 ml with potassium-sparing diuretics (e.g., spironolactone) or other medicines such as tacrolimus or trimethoprim may lead to increased potassium levels in the blood. Therefore, regular monitoring of potassium levels is recommended.
Selective serotonin reuptake inhibitors (SSRIs)
Certain antidepressants (selective serotonin reuptake inhibitors [SSRIs]) may increase the risk of ulcers or gastrointestinal bleeding.

...

Use of Dicloberl 75 mg/3 ml with alcohol

Do not consume alcohol while being treated with Dicloberl 75 mg/3 ml.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you become pregnant during treatment with Dicloberl 75 mg/3 ml. Dicloberl 75 mg/3 ml may be used in the first and second trimester of pregnancy after consulting a doctor.
Do not use Dicloberl 75 mg/3 ml if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Dicloberl 75 mg/3 ml may cause renal and cardiac disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and cause prolongation or prolongation of labor. During the first six months of pregnancy, Dicloberl 75 mg/3 ml should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time.
From the 20th week of pregnancy, Dicloberl 75 mg/3 ml, if used for more than a few days, may cause renal disorders in the unborn child, which can lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Like other NSAIDs, diclofenac passes into breast milk in small amounts. To avoid side effects in the infant, diclofenac should not be used during breastfeeding.
Fertility
Like other prostaglandin synthesis inhibitors, Dicloberl 75 mg/3 ml may make it more difficult to conceive. If you are planning to conceive or are having trouble conceiving, inform your doctor.

Driving and using machines

When using high doses of Dicloberl 75 mg/3 ml, side effects related to the central nervous system, such as fatigue and dizziness, may occur, which can limit the ability to drive vehicles and operate machinery. This is especially true when the medicine is taken in combination with alcohol. The patient may have limited ability to react quickly and appropriately to unexpected and sudden events.
If the above-mentioned symptoms occur, do not drive vehicles or operate machinery.
Note:
The propylene glycol contained in Dicloberl 75 mg/3 ml may cause symptoms similar to those after alcohol consumption.

Dicloberl 75 mg/3 ml contains benzyl alcohol, propylene glycol, and sodium

Benzyl alcohol

This medicine contains 105 mg of benzyl alcohol in each ampoule. Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Propylene glycol

This medicine contains 600 mg of propylene glycol in each ampoule.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium in each ampoule, which means the medicine is considered "sodium-free".

3. How to use Dicloberl 75 mg/3 ml

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Recommended dose is

Adults
Treatment with Dicloberl 75 mg/3 ml should be in the form of a single injection.
In severe cases, the medicine may be administered in a volume of 2 ampoules per day.
Parenteral administration of the medicine should be limited to 2 days. The duration of treatment will be decided by the attending physician.
If further treatment is necessary, it should be continued with oral or suppository forms. Do not exceed the total daily dose of 150 mg, even on the day of injection.

Method of administration

Dicloberl 75 mg/3 ml should be injected deeply into the gluteal muscle. Due to the possibility of anaphylactic reactions (severe allergic reactions), the patient should be observed for at least 1 hour.
In case of a feeling that the effect of Dicloberl 75 mg/3 ml is too strong or too weak, consult a doctor.
After opening the ampoule, the medicine should be used immediately.

Note: Handling of one-point-cut (OPC) ampoules

No need to score the ampoule!

Hold the ampoule so that the colored point is facing upwards

Break off the neck from the lower
part of the ampoule.

Use of a higher dose of Dicloberl 75 mg/3 ml than recommended

There are no characteristic clinical symptoms resulting from an overdose of the medicine. Symptoms of overdose from the central nervous system may include, for example, headaches, dizziness, drowsiness, and loss of consciousness (in children, also seizures), as well as abdominal pain, nausea, vomiting. Additionally, gastrointestinal bleeding and liver or kidney function disorders may occur. Sudden decreased blood pressure, breathing difficulties (respiratory failure), and blue discoloration of the skin and mucous membranes (cyanosis) may also occur.
There is no specific antidote.
In case of suspected overdose, inform a doctor.
Depending on the severity of the poisoning, the doctor will decide on the appropriate treatment.

Hold the ampoule so that the colored point is facing upwards

Tap or shake the ampoule to cause
the entire solution in the upper part
of the ampoule to move to the lower part.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Dicloberl 75 mg/3 ml can cause side effects, although not everybody gets them.
Some side effects can be serious. If you experience any side effects, tell your doctor, who will decide on further action.
The occurrence of the following side effects of the medicine depends mainly on the dose used and varies individually.
The side effects presented below also include side effects reported during the use of other forms of diclofenac, used for a short or long period.
There have been reports of side effects affecting the stomach and intestines. Nausea, vomiting, diarrhea, bloating, indigestion, and abdominal pain after taking the medicine (see section 2 "Warnings and precautions") have been reported. Bleeding, ulcers, or perforation of the stomach or intestines may occur, sometimes leading to death, especially in the elderly (see section 2 "Warnings and precautions"). The risk of gastrointestinal bleeding depends on the size of the dose used and the duration of treatment.
After taking the medicine, constipation, gastric mucosa inflammation, oral ulceration, worsening of ulcerative colitis or Crohn's disease symptoms (see also section 2 "Warnings and precautions") have also been reported.

Stop using Dicloberl 75 mg/3 ml and consult a doctor immediately if you experience:

• mild painful abdominal cramps and tenderness, starting soon after starting Dicloberl 75 mg/3 ml, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from available data).

Inform your doctor immediately if you experience symptoms such as:

• injection site reactions, including pain, redness, swelling, hardening, ulceration, and bruising. This can lead to blackening and necrosis of the skin and surrounding tissues, healing with scarring, known as Nicolau's syndrome;
• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome.

There have been reports of fluid retention (edema), high blood pressure, and heart failure associated with NSAID treatment.
Taking such medicines as Dicloberl 75 mg/3 ml may be associated with an increased risk of arterial thrombotic events, such as heart attack (myocardial infarction) or stroke (see section 2 "When not to use Dicloberl 75 mg/3 ml" and "Warnings and precautions").
Frequent:may affect up to 1 in 10 patients

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, as well as minor gastrointestinal bleeding, which may rarely cause anemia (anemia);
• allergic reactions, such as skin rash and itching;
• central nervous system disorders, such as headache, dizziness, drowsiness, and restlessness (agitation), irritability;
• digestive disorders (indigestion), bloating, stomach cramps (abdominal pain), loss of appetite, as well as stomach or duodenal ulcers (with a risk of bleeding or perforation);
• increased liver enzyme activity in the blood;
• vertigo of labyrinthine origin;
• injection site reactions, pain, and hardening at the injection site;

Uncommon:may affect up to 1 in 100 patients

• hives; In this case, discontinue the medicine and consult a doctor;
• bloody vomiting, blood in the stool, or bloody diarrhea;
• liver damage (especially during long-term treatment), hepatitis with or without jaundice (in rare cases, rapidly progressing, even without preceding symptoms);
• hair loss;
• edema (fluid retention), especially in patients with high blood pressure or renal impairment;

Rare:may affect up to 1 in 1,000 patients

• hypersensitivity, anaphylactic, and pseudoanaphylactic reactions (which may manifest as bronchospasm, dyspnea [respiratory failure], tachycardia, hypotension, and shock);
• gastritis, gastrointestinal bleeding;
• liver function disorders;
• asthma, including breathing difficulties (dyspnea);
• allergic reactions to benzyl alcohol;
• edema at the injection site;

Very rare:may affect up to 1 in 10,000 patients

• worsening of infections (e.g., development of necrotizing fasciitis) associated with the use of anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, including Dicloberl 75 mg/3 ml); in case of infection symptoms (e.g., redness, swelling, overheating, pain, fever) or their worsening while taking Dicloberl 75 mg/3 ml, the patient should immediately consult a doctor. The doctor will decide on the use of antibiotics or other medicines;
• symptoms of meningitis (e.g., headache, nausea, vomiting, fever, stiff neck, or impaired consciousness), which have occurred during diclofenac use. It appears that patients with concomitant autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease) are more likely to experience these side effects;
• blood disorders [anemia (anemia), leukopenia (reduced white blood cell count), thrombocytopenia (reduced platelet count), pancytopenia (reduced red and white blood cell and platelet count), agranulocytosis (a serious, life-threatening decrease in neutrophil count), hemolytic anemia, and aplastic anemia (lack of red blood cells due to their rapid breakdown)]. The first symptoms of these disorders may be fever, sore throat, mouth ulcers, flu-like symptoms, significant fatigue, nosebleeds, and skin bleeding. In such cases, discontinue the medicine and consult a doctor immediately. Do not take painkillers or antipyretics on your own. During long-term use of the medicine, regularly monitor blood morphology parameters;
• angioedema (angioedema); in case of one of these symptoms, which can occur even after a single use of the medicine, discontinue diclofenac and seek medical attention immediately;
• allergic vasculitis and pneumonia;
• psychotic disorders, depression, anxiety, insomnia, nightmares;
• sensory disturbances, taste disturbances, memory disturbances, disorientation, seizures, tremors;
• visual disturbances (blurred or double vision);
• tinnitus, transient hearing impairment;
• palpitations, chest pain, heart failure, myocardial infarction;
• hypertension (high blood pressure);

Frequency not known(frequency cannot be estimated from available data)

• tissue damage at the injection site
• ischemic colitis

Follow the instructions above for some of the side effects!

5. How to store Dicloberl 75 mg/3 ml

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the ampoule and outer packaging after: "EXP". The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Store the ampoules in the outer packaging to protect from light.
Do not store in the refrigerator or freeze.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dicloberl 75 mg/3 ml contains

The active substance is sodium diclofenac.
One 3 ml ampoule with solution for injection contains 75 mg of sodium diclofenac.
1 ml of solution for injection contains 25 mg of sodium diclofenac.
The other ingredients are:
propylene glycol (600 mg/3 ml), benzyl alcohol (105 mg/3 ml), acetylcysteine, mannitol, sodium hydroxide (1 N solution), water for injections.
Dicloberl 75 mg/3 ml has a pH: 8.0-9.0.

What Dicloberl 75 mg/3 ml looks like and what the pack contains

A clear, colorless solution in 3 ml ampoules made of colorless glass type I, in a cardboard box.
Pack size: 1 or 5 ampoules.
Hospital pack size: 30, 150, 300, 600, 1200 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
Manufacturer

• A. Menarini Manufacturing Logistics and Services S.r.l. Via Sette Santi, 3 50131 Florence, Italy

Alfasigma S.p.A.
Via Enrico Fermi, 1
65020 Alanno (Pescara)
Italy
To obtain more detailed information on this medicinal product, please contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel. + 48 22 566 21 00
Fax: + 48 22 566 21 01

Date of last update of the leaflet: