Dicloberl 100 mg

Leaflet accompanying the packaging: patient information

Dicloberl 100 mg

100 mg, suppositories
Diclofenac sodium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should 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 100 mg and what is it used for
• 2. Important information before taking Dicloberl 100 mg
• 3. How to take Dicloberl 100 mg
• 4. Possible side effects
• 5. How to store Dicloberl 100 mg
• 6. Package contents and other information

1. What is Dicloberl 100 mg and what is it used for

Dicloberl 100 mg is an anti-inflammatory and analgesic medicine (non-steroidal anti-inflammatory drug, NSAID).
Symptomatic treatment of pain and inflammation in:

• acute joint inflammation, including gout;
• chronic joint inflammation, especially rheumatoid arthritis (chronic polyarthritis);
• Bechterew's disease (ankylosing spondylitis) and other rheumatic inflammatory conditions of the spine;
• exacerbations of degenerative joint disease of the peripheral joints and degenerative disease of the spine;
• soft tissue inflammation in the course of rheumatic disorders;
• painful swelling or inflammation after injuries.

Dicloberl 100 mg is intended for use in adults.
If there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Dicloberl 100 mg

When not to take Dicloberl 100 mg

• 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 other non-steroidal anti-inflammatory drugs;
• if the patient has non-specific blood disorders;
• if the patient currently has stomach or intestinal ulcers, bleeding, or perforations (which may include bloody vomiting, bleeding during bowel movements, fresh blood in the stool, or black stools);
• if the patient has a history of 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 occlusion of the heart or brain, or after a procedure to clear blocked vessels;
• if the patient has circulatory disorders (peripheral vascular disease);
• within the last three months of pregnancy;
• if the patient has proctitis or anal proctitis;
• in children and adolescents under 18 years of age due to the high content of the active substance.

Warnings and precautions

The following cases are situations in which special caution should be exercised when taking Dicloberl 100 mg and it should only be used in a specific way (e.g., maintaining longer intervals between doses or using smaller doses of the medicine under medical supervision). You should ask your doctor about this. This also applies to situations that have occurred in the past.
Before starting treatment with Dicloberl 100 mg, you should discuss it with your doctor or pharmacist.
General information
You should avoid taking Dicloberl 100 mg 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 serious side effects.
Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects (see section 3 "How to take Dicloberl 100 mg").
Gastrointestinal bleeding, ulcers, and perforation
There have been reports of gastrointestinal bleeding, gastric and duodenal ulcers, and perforations with fatal outcomes in patients taking all NSAIDs, occurring at various times during treatment, with and without warning signs and with or without previously severe adverse reactions affecting the gastrointestinal tract.
The risk of gastrointestinal bleeding, gastric and duodenal ulcers, and perforation increases with increasing doses of NSAIDs and is higher in patients with a history of peptic ulcers, especially if complicated by bleeding or perforation, as well as in the elderly. In such patients, treatment should be started and continued with the lowest available dose.
In such patients, as well as in patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, consideration should be given to concomitant administration of drugs 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 beginning of treatment.
Before using Dicloberl 100 mg, you should tell your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Dicloberl 100 mg may sometimes cause impaired wound healing in the intestines after surgery.
Effect on the cardiovascular system
Taking such medicines as Dicloberl 100 mg may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
Before taking Dicloberl 100 mg, you should inform your doctor

• if you smoke
• if you have diabetes
• if you have angina pectoris, thrombosis, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects.
In case of heart problems or a history of stroke, you should discuss the treatment with your doctor or pharmacist.
Skin reactions
Very rarely, severe skin reactions with redness and blisters have been reported in association with the use of NSAIDs, some of which were fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis/Lyell's syndrome (see section 4 "Possible side effects"). It seems that the greatest risk of these reactions occurs at the beginning 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 skin rash, mucosal lesions (oral and nasal), or other symptoms of hypersensitivity, you should discontinue Dicloberl 100 mg and contact your doctor immediately.
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 worsening 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 100 mg should be discontinued immediately in case of symptoms of liver function disorders.
During the use of diclofenac, hepatitis without preceding warning signs may occur.
Caution should be exercised when using Dicloberl 100 mg in patients with hepatic 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 receiving diuretics or drugs 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 the use of diclofenac, it is recommended as a precautionary measure to monitor renal function.
Discontinuation of treatment usually results in a return to the pre-treatment state.
Other
Dicloberl 100 mg can be used only 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 100 mg 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.

Rarely, severe, acute hypersensitivity reactions (e.g., anaphylactic shock) may occur. After the onset of the first symptoms of a hypersensitivity reaction after taking Dicloberl 100 mg, the medicine should be discontinued. Medical personnel will initiate appropriate symptomatic treatment.
Diclofenac may periodically inhibit platelet aggregation. Therefore, patients with coagulation disorders should be closely monitored.
Like other NSAIDs, diclofenac may mask symptoms of infection. If symptoms of infection (e.g., redness, swelling, overheating, pain, fever) occur or worsen during treatment with Dicloberl 100 mg, the patient should contact their doctor immediately.
If the patient is taking medicines that inhibit blood clotting or lower blood sugar levels, it is recommended as a precautionary measure to monitor coagulation or blood sugar levels.
During long-term administration of Dicloberl 100 mg, regular monitoring of liver function parameters, renal function, and blood morphology is required.
You should inform your doctor or dentist about taking Dicloberl 100 mg before surgical procedures.
During long-term administration of painkillers, headaches may occur, which should not be treated by increasing the dose of these medicines. You should consult your doctor if you experience frequent headaches despite taking Dicloberl 100 mg.
Generally, 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

Dicloberl 100 mg should not be used in children and adolescents under 18 years of age (see section 2 "When not to take Dicloberl 100 mg").

Elderly

Due to the possibility of side effects in elderly patients, they should be monitored particularly 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 serious consequences in the elderly and can lead to death.

Dicloberl 100 mg and other medicines

You should 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 corticosteroids
Concomitant administration of Dicloberl 100 mg with other anti-inflammatory and analgesic medicines from the NSAID group or glucocorticosteroids (anti-inflammatory medicines or used in hormone replacement therapy) increases the risk of gastric and duodenal ulcers and gastrointestinal bleeding. You should not take diclofenac with other NSAIDs.
Digoxin, phenytoin, and lithium
Concomitant administration of Dicloberl 100 mg with digoxin (a medicine used to treat heart rhythm disorders), phenytoin (a medicine used to treat epileptic 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 100 mg may reduce the effect of diuretics and blood pressure-lowering medicines (e.g., beta-adrenergic blockers, ACE inhibitors, and angiotensin II antagonists). Therefore, blood pressure should be monitored periodically.
Dicloberl 100 mg may reduce the effect of ACE inhibitors and angiotensin II antagonists (medicines used to treat heart diseases and blood pressure-lowering medicines). Concomitant administration of these medicines with Dicloberl 100 mg may increase the risk of renal function disorders. Patients should be properly hydrated, and renal function should be monitored periodically after starting treatment and at appropriate intervals thereafter.
Concomitant administration of Dicloberl 100 mg with diuretics that spare potassium (certain diuretics) may lead to an increase in 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 gastrointestinal bleeding and ulcers.
Methotrexate
Taking Dicloberl 100 mg within 24 hours before or after methotrexate administration (a medicine used to treat inflammatory diseases and certain types of cancer) may increase methotrexate levels in the blood and increase side effects.
Cyclosporin
Non-steroidal anti-inflammatory drugs (including diclofenac) may increase the toxic effect of cyclosporin on the kidneys (a medicine used to prevent transplant rejection and treat rheumatic diseases). The patient should use a lower dose of diclofenac.
Anticoagulant and antiplatelet medicines
Non-steroidal anti-inflammatory drugs may increase the effect of antiplatelet and anticoagulant medicines (used to prevent blood clotting), such as warfarin. Regular medical check-ups are recommended.
Probenecid
Medicines containing probenecid (medicines used to treat gout) may slow down the elimination of diclofenac. This may lead to an increase in side effects.
Antidiabetic medicines
During the use of medicines that lower blood sugar levels (antidiabetic medicines), there have been reports of the effect of diclofenac on blood sugar levels, which required adjustment of the dose of antidiabetic medicines. Therefore, as a precautionary measure, it is recommended to monitor blood sugar levels when using these medicines concomitantly.
Quinolone antibacterials
Quinolones (a type of antibiotic) may cause seizures when used concomitantly with NSAIDs.
Cholestyramine and colestipol
These medicines (used to lower cholesterol levels in the blood) may induce prolonged or reduced absorption of diclofenac. Therefore, it is recommended to take diclofenac at least one hour before or 4 to 6 hours after taking cholestyramine or colestipol.
Potent CYP2C9 inhibitors
Voriconazole (a medicine used to treat severe fungal infections) and sulfinpyrazone (a medicine used to treat gout) may increase diclofenac levels in the blood when used concomitantly. This may lead to accumulation of diclofenac in the body and increase its side effects.
Tenofovir
Taking tenofovir (a medicine used to treat viral hepatitis B and to prevent and treat HIV/AIDS) at the same time as NSAIDs (such as diclofenac) may increase the levels of urea and creatinine (kidney function parameters) in the blood. Therefore, kidney function should be monitored to check for possible increases in these parameters.
Deferasirox
Taking deferasirox (a medicine used in patients undergoing multiple blood transfusions due to various types of anemia) at the same time as NSAIDs (such as diclofenac) may increase the risk of side effects affecting the stomach and intestines. Therefore, the doctor should closely monitor patients taking deferasirox with NSAIDs.
Mifepristone
Used to terminate pregnancy. NSAIDs should not be taken for 8-12 days after mifepristone administration due to the theoretical risk that prostaglandin synthesis inhibitors may alter the effectiveness of mifepristone.
Pemetrexed
Concomitant administration of pemetrexed and NSAIDs may enhance the effect of pemetrexed, so special caution should be exercised when administering high doses of NSAIDs.

Dicloberl 100 mg and alcohol

You should not consume alcohol during treatment with Dicloberl 100 mg.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should inform your doctor if you become pregnant during treatment with Dicloberl 100 mg. Dicloberl 100 mg may be used in the first and second trimester of pregnancy only after consulting a doctor.
You should not take Dicloberl 100 mg if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Dicloberl 100 mg may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first six months of pregnancy, Dicloberl 100 mg 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 possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Dicloberl 100 mg, if taken for more than a few days, may cause kidney disorders in the unborn child - this may 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 necessary 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 100 mg may make it more difficult to conceive. If you plan to conceive or have problems conceiving, you should inform your doctor.

Driving and using machines

When taking high doses of Dicloberl 100 mg, side effects affecting the central nervous system, such as fatigue and dizziness, may occur, which may limit the ability to drive vehicles and operate machinery. This applies especially to situations where the medicine is taken concomitantly with alcohol. The patient may have limited ability to react quickly and appropriately to unexpected and sudden events. If the above-mentioned symptoms occur, you should not drive vehicles or operate machinery! Do not use tools and do not operate machinery! Do not work without proper foot support!

3. How to take Dicloberl 100 mg

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Dosage

If your doctor has not prescribed otherwise, you should take the medicine as follows:

Diclofenac is dosed according to the severity of the disorder. Diclofenac in the form of suppositories allows for an alternative route of administration in patients who cannot take oral administration. The recommended daily dose for adults is 50 to 150 mg of diclofenac sodium.
Adults: 1 suppository of Dicloberl 100 mg per day (corresponding to 100 mg of diclofenac sodium).

Method of administration

To remove the suppository from the packaging, you should repeatedly bend the perforation and tear off one suppository from the blister or cut the suppository along the perforation line using scissors.
Then, holding the free ends of the foil at the top of the suppository between your index fingers and thumbs, you should carefully tear it until you can remove the suppository (see diagram).
The suppository should be inserted deeply into the rectum, preferably after bowel movements.
To improve the sliding properties, the suppository can be warmed in the hand or briefly immersed in hot water.

Duration of treatment

The duration of treatment will be decided by your doctor.
In rheumatic diseases, long-term use of Dicloberl 100 mg may be necessary.
Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects (see section 2 "Warnings and precautions").
If you feel that the effect of Dicloberl 100 mg is too strong or too weak, you should consult your doctor.

Taking a higher dose of Dicloberl 100 mg than recommended

You should take Dicloberl 100 mg as directed by your doctor or according to the dosage instructions in the leaflet. If you feel that the analgesic effect of the medicine is insufficient, you should not increase the dose of the medicine but consult your doctor.
There are no characteristic clinical symptoms resulting from diclofenac overdose.
Symptoms of overdose may include central nervous system disorders, such as headaches, dizziness, feeling of fainting, and loss of consciousness (in children, myoclonic seizures as well), as well as

abdominal pain, nausea, vomiting, and gastrointestinal bleeding. Additionally, a sudden decrease in blood pressure, breathing difficulties (respiratory depression), and blue discoloration of the skin and mucous membranes (cyanosis) may occur.
There is no specific antidote.
In case of suspected overdose, you should inform your doctor.
Depending on the severity of the poisoning, the doctor will decide on the appropriate treatment.

Missing a dose of Dicloberl 100 mg

You should not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dicloberl 100 mg can cause side effects, although not everybody gets them.
Some side effects can be serious. If you experience any side effects, you should 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 most common side effects are gastrointestinal disorders. Gastric and duodenal ulcers (peptic ulcers), perforation, or gastrointestinal bleeding may occur, sometimes leading to death, especially in the elderly (see section 2 "Warnings and precautions"). Nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, and gastrointestinal inflammation have been reported, as well as exacerbation of ulcerative colitis and Crohn's disease (see section 2 "Warnings and precautions"). Rarely, gastric mucosal inflammation has been observed. The risk of gastrointestinal bleeding is particularly dependent on the dose of NSAIDs and the duration of treatment.

You should discontinue Dicloberl 100 mg and contact your doctor immediately if you experience:

• mild painful abdominal cramps and tenderness, starting soon after taking Dicloberl 100 mg, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency unknown - cannot be estimated from available data).

You should tell your doctor immediately if you experience any of the following symptoms:

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reports have been made of fluid retention (edema), high blood pressure, and heart failure associated with NSAID treatment.
Taking such medicines as Dicloberl 100 mg may be associated with an increased risk of arterial thrombotic events, e.g., heart attack (myocardial infarction) or stroke (see section 2 "When not to take Dicloberl 100 mg" 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 cause anemia (a decrease in red blood cells);
• allergic reactions, such as skin rash and itching;
• central nervous system disorders, such as headache, dizziness, feeling of fainting, and loss of consciousness;
• digestive disorders (indigestion), bloating, constipation, indigestion, abdominal pain, as well as gastric and duodenal ulcers (with a risk of bleeding or perforation);
• increased liver enzyme activity in the blood;
• vertigo of labyrinthine origin;
• local signs of irritation, discharge of blood with mucus, or painful defecation may frequently occur after suppository administration.

Uncommon:may affect up to 1 in 100 patients

• urticaria. In such a case, you should discontinue the medicine and contact your doctor;
• bloody vomiting, blood in the stool, or bloody diarrhea;
• liver damage (especially during long-term therapy), hepatitis with or without jaundice (having a stormy course in individual cases, 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 (may manifest as bronchospasm, dyspnea, tachycardia, hypotension, and shock);
• gastric mucosal inflammation, gastrointestinal bleeding;
• liver function disorders;
• asthma, including breathing difficulties (dyspnea).

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 100 mg) In case of symptoms of infection (e.g., redness, swelling, overheating, pain, fever) or their worsening during treatment with Dicloberl 100 mg, the patient should contact their doctor immediately. The doctor will decide whether there are indications for treatment with antibiotics;
• symptoms of meningitis (aseptic meningitis), such as headache, nausea, vomiting, fever, stiff neck, or changes in consciousness occurred during the use of diclofenac. It seems that patients with concomitant autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more likely to experience the above-mentioned side effects;
• blood disorders [anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, hemolytic anemia, and aplastic anemia]. 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, you should discontinue the medicine and contact your doctor immediately. You should not take painkillers or antipyretics on your own. During long-term treatment, it is recommended to regularly monitor blood morphology;

In such cases, you should discontinue the medicine and contact your doctor immediately. You should not take painkillers or antipyretics on your own.
Unknown frequency:frequency cannot be estimated from available data

• ischemic colitis.

You should follow the instructions provided above for some of the side effects!

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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, you can help provide more information on the safety of this medicine.

5. How to store Dicloberl 100 mg

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after the abbreviation "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Dicloberl 100 mg contains

• The active substance of the medicine is diclofenac sodium. One suppository contains 100 mg of diclofenac sodium.
• The other ingredients are: solid fat.

What Dicloberl 100 mg looks like and what the package contains

Suppositories are ivory-colored, torpedo-shaped, and have a longitudinal shape, in a soft blister pack made of non-transparent PVC/PE foil with the batch number printed.
A cardboard box contains 5 or 10 suppositories.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

Date of last revision of the leaflet: