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Suppository - rectal use
Non-steroidal antiphlogistic/antirheumatic
Active substance: diclofenac
Package leaflet: Information for the patient
Read all of this leaflet carefully before you start using this medicine because it contains important information
- Keep this leaflet. You may need to read it again.
-If you have any further questions, ask your doctor or
-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Diclo-Denk is and what it is used for
2. What you need to know before you use Diclo-Denk
3. How to use Diclo-Denk
4. Possible side effects
5. How to store Diclo-Denk
6. Contents of the pack and other information
1. What Diclo-Denk is and what it is used for Diclo-Denk is a pain-relieving and anti-inflammatory drug and belongs to the class of non-steroidal antiphlogistic/anti-rheumatic agents (NSAIDs).
Therapeutic indications
Symptomatic treatment of pain and inflammation in case of:
• acute joint inflammation (acute arthritides) including gout
• chronic joint inflammation (chronic arthritides), especially in case of rheumatoid arthritis (chronic polyarthritis)
• Bechterew's disease (ankylosing spondylitis) and other inflammatory rheumatoid disorders of the spine
• acute inflammatory condition of degenerative joint or spinal disorders (arthroses and spondylarthroses)
• inflammatory soft tissue rheumatisms
• painful swelling or inflammation after injuries.
2. What you need to know before you use
Do not use Diclo-Denk
• it you are allergic to diclotenac, acety salicylıc acıa, ibuproten, any other NSAID or to any of the other ingredients of this medicine (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face, lips, tongue, throat and/or limbs (angioedema), breathing problems, chest pain, swelling of the nasal mucous membranes, runny nose, skin rash or any other allergic type of reaction
• in case of unclarified impairment of blood cell formation
• in case of active or history of recurrent gastric or duodenal ulcers (peptic ulcers) or haemorrhage (2 or more distinct episodes of proven ulceration or bleeding)
in case of history of gastr intestinal bleeding or perforation, related to previous NSAID therapy, including Dido-Denk
• in case of brain haemorrhage (cerebrovascular bleeding) or other active haemorrhaging
• in case of severe liver or renal impairment
• in case of proctitis
• if you have established heart disease and/or cerebrovascular disease eg. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease)
• If you are a child or adolescent
• in the last three months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before using Diclo-Denk.
Make sure your doctor knows, before you are given diclofenac
• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before using Diclo-Denk, as Diclo-Denk can sometimes worsen wound healing in your gut after surgery.
Concurrent treatment with Diclo-Denk and other NSAIDs, including so-called COX-2 inhibitors (cyclooxygenase-2 inhib-itors), should be avoided due to the lack of evidence of any additional benefit and the fact that side effects may be enhanced Side effects may be minimised by using the lowest effective dose for the shortest duration necessary to improve symptoms.
Elderly patients
The elderly are at increased risk of adverse drug reactions to NSAIDs (including Diclo-Denk), especially gastrointestinal bleeding and perforation, which may be fatal. Close medical surveillance is therefore necessary in elderly patients. It is recommended that the lowest effective dose is used in elderly patients, who are frail or have a low body weight.
Gastrointestinal effects
Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs, including Diclo-Denk. They occurred at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section "Do not use Diclo-Denk"), and in the elderly. These patients should commence treatment on the lowest dose available.
Combination therapy with agents that protect the stomach lining (e.g. misoprostol or proton pump inhibitors) should be considered for these patients as well as for patients requiring concomitant low dose of acetylsalicylic acid or other drugs likely to increase the risk of gastrointestinal disturbances.
If you have a history of gastrointestinal adverse reactions, particularly if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to your doctor or pharmacist, notably in the initial stages of treatment.
Caution is advised if you are receiving concomitant treatment with medications which could increase the risk of ulceration or bleeding, such as oral and systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors that are used in the treatment of depression or antiplatelet agents such as acetylsalicylic acid see section "Other medicines and Diclo-Denk").
If you suffer from astrointestinal bleeding or ulceration, treatment with Diclo-Denk should be discontinued.
NSAIDs, including Diclo-Denk, should be given with care to notients with a hictorv of nactreintestinal disease Ulcersti colitis, Crohn's disease) as these conditions may be exacerbated (see section 4).
Cardiovascular effects
Medicines such as Diclo-Denk are associated with an increased risk of heart attacks ("myocardial infarction" or strokes. Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment!
If you think that you could be at risk of heart problems or a stroke (e.g. if you have high blood pressure, diabetes or high cholesterol levels, or if you are a smoker), you should discuss your treatment with your doctor or pharmacist.
If you experience signs or symptoms of heart problems or problems with your blood vessels, such as chest pain, shortness of breath, weakness or speech disorders while using Diclo-Denk, contact your doctor immediately.
Skin reactions
Severe skin reactions with reddening and blistering, some of them fatal, are very rare in association with the use of NSAIDs, including Diclo-Denk (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell syndrome; see section 4). Patients appear to be at highest risk for these reactions early in the course of therapy, as the reactions occurred during the first month of treatment in the majority of cases.
Diclo-Denk should be withdrawn at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity, and a doctor should be consulted immediately.
Hepatic effects
Patients with impaired liver function require careful medical supervision, because their condition could deteriorate.
As with other medicines from the NSAID group, liver function may deteriorate during the use of Diclo-Denk. Regular measurement of liver function by your doctor is therefore indicated as a precautionary measure during prolonged treatment with Diclo-Denk.
Diclo-Denk should be discontinued if impairment of liver function persists or worsened or if certain signs of liver disease are noticed or other manifestations occur (e.g. so-called eosinophilia, skin rash). Hepatitis may occur without previous symptoms. Caution is indicated when using Diclo-Denk in patients with a specific blood formation disorder (so-called hepatic porphyria), because a deterioration may be triggered.
Other information
Diclo-Denk should only be used after careful consideration of the potential benefits and risks in case of
• certain congenital impairment of blood cell formation (e.g. acute intermittent porphyria)
• certain autoimmune diseases systemic lupus erythematosus and mixed connective tissue disease.
Close medical surveillance is required in the following cases:
• immediately after major surgery (if there is potentially an increased tendency to bleeding or a worsening of kidney function)
• if you suffer from allergies, skin reactions in response to other medicines, asthma, hay fever, chronic swelling of the nasal mucous membranes or chronic respiratory disease with airway obstruction, because you are at higher risk of allergic reactions. These may manifest as a hypersensitivity reaction, asthma attacks so called analgesic asthma), painful swelling of the skin and mucous membranes or urticaria.
• in case of impaired renal or liver function.
Since fluid retention and oedema have been reported in relation to NSAID treatment, including diclofenac, particular caution is required in patients with impaired heart and kidney function, patients, who already have or nave previously had high blood pressure, elderly patients and patients, who are also being treated with so-called diuretics and other medicines that can have a serious effect on kidney function. Furthermore, caution is required when treating patients with severe dehydration, (e.g. before or after major cruder (see section Do not use Dido Dants Carful after major surgery) see section "Do not use Dico-Denk " Careful monitoring of renal function is recommended in such patients.
After administration is discontinued, there is usually a return to the pre-treatment baseline.
Severe acute hypersensitivity reactions le. g, anaphylactic shock) have been observed in very rare cases with diclotenac. This may also occur even if you have not previously used any medicine from the NSAID group. At the first signs of a hypersensitivity reaction after administration, treatment with Dicto-Denk must be discontinued. The required symptomatic medical treatment must be carried out by a health care professional.
Diclofenac may temporarily inhibit platelet aggregation.
Patients with blood clotting disorders should therefore be monitored carefully.
If you are simultaneously taking medicine which inhibits blood clotting or which reduces blood sugar, the clotting status and/or blood sugar level should be monitored as a precaution.
Regular monitoring of renal function and blood count is required during long-term treatment with Diclo-Denk.
If using Diclo-Denk prior to surgery, the doctor or dentist should be consulted or informed.
Prolonged use of painkillers may cause headaches which must not be treated with higher doses of the medicinal product. Consult your doctor for advice if you suffer from frequent headaches despite using Diclo-Denk!
In general, habitual intake of painkillers, especially when several types of painkillers are combined, can result in permanent kidney damage with the risk of renal failure (analgesic nephropathy).
As with other NSAIDs, diclofenac may mask the signs and symptoms of an infection. If signs of an infection (e.g. reddening, swelling, hyperthermia, pain, fever) occur or worsen during treatment with Diclo-Denk, a doctor should be consulted immediately.
As with other drugs that inhibit prostaglandin synthesis, Diclo-Denk may make it more difficult for you to become pregnant.
You should inform your doctor if you are planning or finding it difficult to become pregnant.
Children and adolescents
Use in children and adolescents is not recommended, as the active ingredient content is too high.
Other medicines and Diclo-Denk
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant administration of Diclo-Denk and digoxin (medici-nal product which strengthens the cardiac function, phenytoin (medicinal product for treating seizures) or lithium (medicinal product for treating mental and psychological disturbances) can increase plasma concentrations of these drugs. Monitoring of lithium levels in the blood is necessary. Monitoring of digoxin and phenytoin levels in the blood is recommended.
Diclo-Denk may diminish the effect of diuretics and blood pressure reducing agents (anti-hypertensives).
Diclo-Denk may reduce the efficacy of ACE inhibitors and angio-tensin-ll antagonists (medicinal products for treating cardia insufficiency and reducing high blood pressure. Concomitant administration may also increase the risk of kidney function impairment, primarily in elderly patients, in whom blood pressure should be regularly monitored. Always drink sufficient fluid. You doctor will test your kidney levels regularly.
Concomitant treatment of Diclo-Denk and potassium-sprain diuretic, ciclosporin, tacrolimus (primarily used after transplants) or trimethoprim (antibiotic used to treat urinary tract infections) may be associated with increased potassium levi in the sedum. Regular monitoring of your potassium levels the blood is therefore recommended.
Concomitant administration of Diclo-Denk and other NSAIDS glucocorticids increases the risk of gastrointestinal side effer e.g. gastrointestinal ulceration or bleeding.
Antiparet agents such as acetylsalicylic acid and certain a incressaths selective serotonin-reuptake inhibitors SI. increase the risk of gastrointestinal side effects, such as gar, intestinal bleeding. Therefore, the simultaneous administration of Diclo-Denk with other so-called NSAID is not recommended.
If Dico-Denk is used within 24 hours before or after the administration of methotrexate, the concentration of methotrexate in the blood and its undesirable effects may increase.
NSAIDs such as diclofenac) may potentiate the kidney toxicity of closporin and tacrolimus (medicinal product used to prevent transplant rejection but also used in the treatment of rheumatism). For this reason, medicines containing diclofenac should be used at lower doses than in patients not receiving ciclosporin or tacrolimus.
Medicines which contain probenecid can delay the excretion of diclofenac. This may result in increased concentrations of ticlofenac in the body and an increase in its undesirable effects Simultaneous use of Dico-Denk and certain enzyme inhibitors, so-called CYP2C9 inhibitors, e.g. voriconazole la medicine for the treatment of fungal diseases), may result in diclofenac being accumulated in the body and in a strengthening of its side effects.
Simultaneous use of diclofenac and certain enzyme activators know as Cinders, such as rifampicin (a medicine used to treat bacterial infections), can lead to a reduction of diclofenac in the body and its effect.
NSAIDS, including Diclo-Denk, may enhance the effect of anticoagulants such as warfarin. Furthermore, the risk of bleeding may be increased during simultaneous administration with medicines that inhibit blood clotting.
Clinical studies have shown that diclofenac can be used together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycemic and hyperglycemic effects necessitating changes in the dosage of the antidiabetic agents during the treatment with diclofenac. Precautionary monitoring of blood glucose values is therefore recommended during simultaneous treatment.
In isolated cases, the side effects (central nervous system (cerebral seizures) of quinolone antibiotics are increased or strengthened.
Diclo-Denk with alcohol
Alcohol should be avoided if possible, during treatment with Diclo-Denk, since any side effects may be more severe, especially those that affect the gastrointestinal tract or central nervous system.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If a patient becomes pregnant during treatment with Diclo-Denk a doctor should be consulted.
Do not take Diclo-Denk if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labor to be later or longer than expected. You should not take Diclo-Denk during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should e used. If taken for more than a few days from 20 weeks of pregnancy onward, Diclo-Denk can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
Breast-feeding
The active ingredient diclofenac and its metabolites pass in small quantities into breast milk. Since no adverse effects on infants have been made known to date, short-term use of the medicinal product should in general not require discontinuation of breast-feeding. However, if high doses are prescribed or if the medicine is to be taken over a prolonged period of time, early weaning should be considered.
Driving and using machines
Since the use of Diclo-Denk, especially at higher doses, can result end central nervous side effects such as tiredness, problems with eyesight and dizziness, the ability to react, to drive a vehicle or to operate machines may be impaired in individual cases. This applies in particular in combination with alcohol. In such instances you may not be able to react promptly and deliberately to unexpected and sudden events. In such cases do not drive a car or other vehicle yourself! Do not use tools or operate machines!
Do not work without a secure hold!
3. How to use Diclo-Denk
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
For treatment of rheumatic diseases
The dose of diclofenac depends on the severity of the illness. The recommended daily dose for adults is between 50 and 150 mg of diclofenac sodium.
Adults are given 1 suppository of Diclo-Denk 100 Rectal daily (equivalent to 100 mg of diclofenac sodium).
Method and duration of application
Insert Diclo-Denk deep into the anus, if possible, after a bowel movement.
The suppositories are designed for rectal use. Never take them by mouth.
Your doctor will decide about the duration of treatment.
Long-term treatment with Diclo-Denk may be required for patients with rheumatic disease.
If you use more Diclo-Denk than you should use Diclo-Denk as instructed by the doctor or according to the dose instructions in the package leaflet. If you think that the pain relief is insufficient, do not increase the dose independently, but ask your doctor.
Signs of an overdose may be central nervous symptoms such as headache, dizziness, light-headedness, ringing in the ears (tin-nitus), seizures and unconsciousness (myoclonic seizures may occur in children) as well as stomachache, nausea, vomiting and diarrhoea. Gastrointestinal bleeding and liver and renal impairment may also occur. There may also be a fall in blood pressure, shallow breathing (respiratory depression) and bluish discoloration of the skin and mucous membranes (cyanosis).
In very severe cases of poisoning, sudden kidney failure and liver damage may occur.
There is no specific antidote.
If you think you might have overdosed with Diclo-Denk, please inform your doctor who can then decide what medical treatment is required depending on the severity of the intoxication.
If you forget to use Diclo-Denk
Do not use a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of adverse drug reactions is classified as follows:
Very common:
may affect more than 1 in 10 people
Common:
may affect up to 1 in 10 people
Uncommon:
may affect up to 1 in 100 people
Rare:
may affect up to 1 in 1,000 people
Very rare:
may affect up to 1 in 10,000 people
Not known:
frequency cannot be estimated from the available data
Possible side effects
The following side effects include those reported with diclofenac suppositories and/or other pharmaceutical forms of diclofenac during both short-term and long-term use.
Please note that the following adverse drug reactions are mostly dose-dependent and may differ from individual to individual.
The most common adverse drug reactions affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2). Nausea, vomiting, diarrhea, flat-ulcers, constipation, indigestion, abdominal pain, melaena, vomiting of blood, ulcerative inflammation of the oral mucous membranes (ulcerative stomatitis), exacerbation of colitis and Crohn's disease (see section 2) have been reported after use.
Gastritis is less common.
Fluid retention (oedema), high blood pressure and heart failure have been reported in association with NSAID therapy, include Medicinal products such as Diclo-Denkare associated with an increased risk of heart attacks ("myocardial infarction" or strokes, above all at high doses and during prolonged treatment.
Tell your doctor immediately if you notice any of the following:
Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome,
Cardiac disorders
These side effects may occur in uncommon cases, especially if diclofenac is used for prolonged periods at high doses (150 mg/day heart attack, weakness of heart muscles (heart failure), palpi-tations, chest pain.
Very rare
Fluid retention (oedema).
Blood and lymphatic system disorders
Very rare
Impaired haemopoiesis (anaemia, leukopenia, thrombocyto-penia, pancytopenia, agranulocytosis. Initial symptoms may be fever, sore throat, superficial lesions in the mouth influenza like complaints, severe lassitude, nose bleeding and dermatorrhagia. In such cases this medication is to be discontinued immediately, and a doctor has to be consulted. Patients should not self-medicate with analgesics or antipyretics. The blood count should be monitored regularly during long-term therapy.
Very rare
Haemolytic anaemia (anaemia resulting from accelerated degradation of red blood cells) or aplastic anaemia (anaemia due to impaired blood production) may occur.
Nervous system disorders
Common
Central nervous symptoms such as headache, vertigo, light-headedness, state of excitement, irritability or fatigue.
Very rare
Sensory disturbances, distortion of taste, impaired memory, disorientation, seizures, tremor, stroke.
Eye disorders
Very rare
Impaired vision (blurred and double vision).
Ear and labyrinth disorders
Common
Dizziness.
Very rare
Ringing in the ears (tinnitus), transitory impaired hearing.
Gastrointestinal disorders
Very common
Gastrointestinal complaints, such as nausea, vomiting and diar-rhoea and minor gastrointestinal bleeding, which in individual cases may cause anaemia.
Common
indigestion dyspepsia), flatulence, abdominal pain, abdominal cramps, loss of appetite as well as gastric or intestinal ulcers (sometimes with bleeding and perforation).
Uncommon
Vomiting of blood (hematemesis), bloody stool or bloody diarrhea, melaena.
Rare
Proctitis, gastritis.
Very rare
Inflammation of the oral mucosa (including mouth ulcers), glos-sitis, oesophagus lesions, constipation as well as lower abdominal complaints such as inflammation of the colon (colitis), haemor-rhaging inflammation of the colon (haemorrhagic colitis), exacerbation of Crohn's disease or ulcerative colitis (specific inflammation of the colon associated with ulcers), haemorrhoids, inflammation of the pancreas (pancreatitis, membranous narrowing of the intestine (intestinal strictures).
In cases of severe upper abdominal pain, black discolouration or the stool or blood in stool, you must stop using Diclo-Denk and intorm your doctor immediately.
Stop using Diclo-Denk and tell your doctor straight away if you notice mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Diclo-Denk and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
General disorders and administration site conditions
Suppositories may often cause local signs of irritation, bloody mucous secretion or painful defecation.
Renal and urinary disorders
Uncommon
Development of odema (fluid retention in the body) especially in patients with high blood pressure or impaired kidney function.
Very rare
Renal tissue damage (interstitial nephritis, papillary necrosis) that may be associated with acute renal dysfunction (renal insufficiency), protein in urine (proteinuria) and/or blood in urine (haematuria); nephrotic syndrome (fluid retention in the body loedemal and excretion of large amounts of protein in urine), acute renal failure.
Reduced urinary output, accumulation of water in the body (oedema) as well as general malaise may be symptoms of kidney disease ranging to kidney failure.
If the mentioned symptoms occur or worsen, you must stop using Diclo-Denk and consult your doctor immediately.
Skin and subcutaneous tissue disorders
Common
Inflammatory skin lesions.
Uncommon
Alopecia.
Very rare
Skin rashes associated with reddening (eczema, erythema, exan-thema), hypersensitivity to light, purpura, severe skin reactions such as rash with blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell syndrome), inflammatory skin disease with redness, formation of large scales, swelling, itch-ing, feeling of tension and shivering (exfoliative dermatitis), ammatory reddening (erythroderma).
Infections and parasitic diseases
In very rare cases associated with the use of special anti-inflammatory drugs (NSAIDs to which Diclo-Denk also belongs) an exacerbation of infective inflammations (e.g. development of necrotic fascits) has been reported.
If signs of an infection (e.g. reddening, swelling, hyperthermia, pain, fever) occur or worsen during treatment with Dilo-Denk, a doctor should be consulted immediately.
In very rare cases, the use of diclofenac has been associated with the symptoms of non-infectious inflammation of the meninges (aseptic meningitis) such as severe headache, nausea, vomiting, tever, stiff neck or clouding of consciousness. Patients already suffering from certain autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disorder, appear to be at increased risk.
Vascular disorders
Very rare
High blood pressure (hypertension), inflammation of blood vessels.
Immune system disorders
Common
Hypersensitivity reactions such as skin rash and itching.
Uncommon
Hives (urticaria).
Rare
Hypersensitivity reactions (including low blood pressure and shock).
Very rare
Severe general hypersensitivity reactions that may be manifested by: angioedema including swelling of the face, tongue and internal swelling of the larynx with constriction of the respiratory tract, laboured breathing, palpitations, drop in blood pressure and eventually life-threatening shock.
If any of these symptoms occur, and this is possible following the first application, immediate medical attention is required.
In such cases, the medicine is to be discontinued immediately and a doctor has to be consulted.
In very rare cases, allergic inflammation of the blood vessels (vasculitis) and lungs (pneumonitis) was observed.
Hepatobiliary disorders
Common
An increase in blood liver enzymes.
Uncommon
Liver damage, especially during long-term therapy, acute hepatitis with or without icterus (in individual cases very severe [fulminant] course, sometimes without prodromal symptoms).
Very rare
Liver failure, liver disease accompanied by destruction of liver cells (liver cell necrosis.
Regular monitoring of liver parameters is therefore necessary during long-term therapy.
Psychiatric disorders
Psychotic reactions, depression, feeling of anxiety, nightmares,
Respiratory disorders
Rare
Asthma (including breathlessness).
Very rare
Interstitial lung inflammation (pneumonitis).
Follow the instructions listed above if adverse drug reactions occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Diclo-Denk
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister strips after "Exp.". The expiry date refers to the last day of that month.
Shelf-life: 3 years.
Store below 25 °C. Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
Pharmacodynamic properties
Pharmacotherapeutic group: Antinflammatory and anti-rheumatic products; acetic acid derivatives and related sub-stances; ATC Code: MO1AB05
Diclofenac is a non-steroidal antiphlogistic/antirheumaticagent which proved to be effective in standard animal experiments on inflammation by inhibiting prostaglandin synthesis. In humans diclofenac reduces inflammatory pain, swelling and fever.
Diclofenac also inhibits ADP- and collagen-induced platelet aggregation.
Pharmacokinetic properties
Absorption and distribution
After oral application of the standard enteric coated pharmaceutical form, diclofenac is completely absorbed distally from the stomach. Maximum plasma levels are reached within 1-16 hours depending on how long passage through the stomach takes and are reached on average within 2-3 hours. Maximum plasma levels are reached within 10-20 minutes after IM administration and approx. 30 minutes after rectal administration. The plasma protein binding is approx. 99%.
Metabolism and elimination
Orally administered diclofenac is clearly subject to a first pass effect; only 35-70% of the absorbed active ingredient reaches post-hepatic circulation in unchanged form. Approximately 30% of the active ingredient is metabolised and excreted in the faeces. Approximately 70% is eliminated renally after hepatic metabolisation (hydroxylisation and conjugation) in the form of pharmacologically inactive metabolites. Largely independent of hepatic and renal function, the elimination half-life is approximately 2 hours.
What Diclo-Denk 100 Rectal contains
• The active substance is diclofenac. Each suppository contains 100 mg diclofenac sodium.
• The other ingredient is hard fat.
General classification for supply
Medicinal product subject to medical prescription.
What Diclo-Denk 100 Rectal looks like and contents of the pack
Diclo-Denk 100 Rectal are ivory coloured, homogenous sup-positories.
Diclo-Denk 100 Rectal is available in PVC/PVC/PE blisters.
Pack size: 10 suppositories.
Marketing Authorization Holder
DENK PHARMA GmbH & Co. KG
Prinzregentenstr. 79
81675 München
Germany
Manufacturer of bulk, packaging and batch release
Haupt Pharma Wülfing GmbH
Bethelner Landstr. 18
31028 Gronau/Leine, Germany
This leaflet was last revised in 09/2022.