Diclofenac retard 100 mg: detailed information

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Dicloratio retard 100 (Diclofenac-ratiopharm), 100 mg, prolonged-release capsules
Diclofenacum natricum
Dicloratio retard 100 and Diclofenac-ratiopharm are different trade names for the same medicinal product.
Read the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

What Dicloratio retard 100 is and what it is used for
Important information before taking Dicloratio retard 100
How to take Dicloratio retard 100
Possible side effects
How to store Dicloratio retard 100
Contents of the pack and other information

1. What Dicloratio retard 100 is and what it is used for

Dicloratio retard 100 belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used in the treatment of pain and inflammatory conditions.
Dicloratio retard 100 relieves symptoms of inflammatory conditions such as swelling and pain. It does not affect the underlying causes of inflammation or fever.
Dicloratio retard 100 may be used in the treatment of pain and inflammatory conditions in:

acute joint inflammation,
chronic joint inflammation, particularly rheumatoid arthritis (chronic joint inflammation),
ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic spinal disorders,
disorders arising from degenerative joint disease and spinal joint inflammation,
rheumatic inflammatory conditions of soft tissues,
painful swelling or inflammation following injury.

If you have any doubts regarding the action or reasons for prescribing Dicloratio retard 100, consult your doctor.

2. Important information before using Dicloratio retard 100

Carefully follow all instructions provided by your doctor or pharmacist, even if they differ from the general information contained in this leaflet.
When not to use Dicloratio retard 100:

if the patient is allergic to sodium diclofenac or any of the other ingredients of this medicine (listed in section 6),
if the patient has or has had peptic ulcer disease of the stomach and (or) duodenum, gastrointestinal bleeding, symptoms related to blood in the stool, black stools, or gastric perforation,
if the patient has previously experienced intestinal or gastric bleeding or perforation associated with the use of NSAIDs,
during the last three months of pregnancy (see section "Pregnancy, breastfeeding and effects on fertility"),
if the patient has severe liver, kidney, or heart failure,
if the patient has ever experienced an allergic reaction after taking an anti-inflammatory or pain-relieving medicine (e.g. acetylsalicylic acid, diclofenac, or ibuprofen). In such cases, asthma, rhinitis, chest pain, skin rash, or facial swelling may occur. If the patient suspects an allergy, consult a doctor for advice,
if the patient has been diagnosed with heart disease and (or) cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack, or arterial embolism in the heart or brain, or after a procedure to unblock or bypass blocked blood vessels,
if the patient has or has had circulatory disorders (peripheral vascular disease).

If any of the above conditions apply to the patient, inform the doctor and do not take Dicloratio retard 100 until the doctor confirms that this medicine is suitable for the patient.
Children and adolescents
Dicloratio retard 100 must not be used in children and adolescents.
Warnings and precautions
Before starting treatment with Dicloratio retard 100, discuss this with your doctor, pharmacist, or nurse.
Inform your doctor if:

the patient is taking Dicloratio retard 100 together with other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" medicines, or certain antidepressants (see also "Dicloratio retard 100 and other medicines"),
the patient has asthma or allergies,
the patient has previously experienced gastrointestinal disorders, e.g. gastric ulcers, bleeding, or black stools, or has had stomach discomfort or heartburn after taking NSAIDs in the past,
the patient has inflammatory bowel disease (ulcerative colitis) or gastrointestinal inflammation (Crohn's disease),
the patient has or has ever had heart problems or high blood pressure (see "Other special warnings" below),
the patient has kidney or liver problems,
the patient has swelling of the feet,
the patient has bleeding disorders or other blood diseases, including the rare liver disease called porphyria.

Before taking diclofenac, inform your doctor

if the patient smokes,
if the patient has diabetes,
if the patient has angina, thrombosis, hypertension, increased cholesterol levels, or increased triglyceride levels.

Before taking Dicloratio retard 100, inform your doctor if the patient has recently undergone or is scheduled for surgery on the stomach or gastrointestinal tract, as Dicloratio retard 100 may sometimes impair wound healing in the intestines after surgery.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.
If any of the above warnings apply to the patient, inform the doctor before using Dicloratio retard 100.
Other special warnings
Do not take Dicloratio retard 100 together with other systemic non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors.
The use of medicines such as Dicloratio retard 100 may be associated with a small increased risk of heart attack or stroke. The risk is greater with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If the patient has heart problems, has had a stroke, or is at risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking), discuss the treatment approach with a doctor or pharmacist.
Dicloratio retard 100 may reduce signs of infection (e.g. headache, fever), making infection harder to diagnose and treat effectively. If the patient feels unwell and needs to see a doctor, inform them about the use of Dicloratio retard 100.
In very rare cases, Dicloratio retard 100, like other anti-inflammatory medicines, may cause severe skin allergic reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, or toxic epidermal necrolysis with skin and mucous membrane lesions, high fever, and severe general condition). Therefore, inform your doctor if such reactions occur. In rare cases, Dicloratio retard 100, like other anti-inflammatory medicines, may cause allergic reactions, including severe allergic reactions, even if the medicine has not been used before.
Elderly patients
Elderly patients may be more sensitive to the effects of Dicloratio retard 100. Therefore, they should follow the doctor's instructions particularly carefully and take the lowest effective dose that relieves symptoms. It is especially important that elderly patients report any adverse effects to their doctor immediately.
Dicloratio retard 100 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor about taking any of the following medicines:

Lithium or selective serotonin reuptake inhibitors (medicines used to treat certain types of depression),
Cardiac glycosides (e.g. digoxin), used in the treatment of heart disease,
Diuretics (medicines that increase urine output),
Angiotensin-converting enzyme inhibitors or beta-blockers (a group of medicines used to treat high blood pressure and heart failure),
Other anti-inflammatory medicines (such as acetylsalicylic acid/aspirin or ibuprofen),
Corticosteroids (medicines used to relieve inflammatory conditions),
Anticoagulants (medicines that prevent blood clotting),
Antidiabetic medicines, except insulin,
Methotrexate (a medicine used in the treatment of certain cancers or arthritis),
Cyclosporine (a medicine used in organ transplant recipients),
Quinolone antibiotics (medicines used to treat infections),
Phenytoin (an anticonvulsant medicine),
Colestipol and cholestyramine (anti-atherosclerotic medicines),
Sulfinpyrazone (a medicine used in the treatment of gout),
Voriconazole (a medicine used to treat fungal infections),
Mifepristone (a medicine used in gynaecology),
Diclofenac resinate.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Dicloratio retard 100 during the first and second trimesters of pregnancy unless clearly necessary. When using diclofenac in women planning pregnancy or during the first and second trimesters of pregnancy, the lowest possible dose for the shortest possible duration should be used.
Do not use Dicloratio retard 100 during the last three months of pregnancy, as it may harm the unborn child or delay or accelerate labour.
Breastfeeding
Do not breastfeed while taking Dicloratio retard 100, as this medicine may have harmful effects on the infant.
Fertility
Diclofenac may impair fertility. Inform your doctor if the patient is planning pregnancy or has difficulty becoming pregnant.
Driving and operating machinery
Do not drive or operate any tools or machinery if adverse effects such as visual disturbances, dizziness, drowsiness, or other central nervous system disorders occur during treatment with Dicloratio retard 100.
The medicine contains lactose and sodium
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release capsule, meaning the medicine is considered "sodium-free".

3. How to use Dicloratio retard 100

This medicine should always be used as directed by the physician. If in doubt, consult a
physician or pharmacist.
The physician will advise exactly how to use Dicloratio retard 100. Depending on the individual
patient's response to treatment, the physician may recommend a higher or lower dose of the medicine.
Dosage
Do not exceed the recommended dose. It is important to use the lowest effective dose for the
shortest duration necessary to control symptoms, and not to use Dicloratio retard 100 longer than
necessary.
The physician will advise exactly how to use Dicloratio retard 100. Depending on the individual
patient's response to treatment, the physician may recommend a higher or lower dose of the medicine.
Adults
The recommended initial daily dose is 100 mg to 150 mg.
The recommended dose for adults is 1 capsule per day (100 mg of active substance sodium diclofenac),
unless otherwise directed by the physician.
If necessary, therapy may be supplemented with 25 mg or 50 mg tablets or rectal capsules, up to a
maximum daily dose of 150 mg of active substance sodium diclofenac.
Patients with renal or hepatic impairment
Dosage adjustment is not necessary in patients with mild to moderate renal or hepatic impairment.
Elderly patients
Particular caution should be exercised when using Dicloratio retard 100 in elderly patients, and the
lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
Potential gastrointestinal bleeding should be monitored regularly.
Children and adolescents
Do not use Dicloratio retard 100 in children and adolescents.
When and how long to use Dicloratio retard 100
Capsules should be swallowed whole before meals, without chewing, with a glass of water.
Do not exceed the recommended dose.
How long to use Dicloratio retard 100
Strictly follow the physician's instructions.
Use of a higher than recommended dose of Dicloratio retard 100
If a higher than recommended dose of Dicloratio retard 100 has been taken by accident, inform the
physician or pharmacist immediately or go to the nearest hospital emergency department. Medical
assistance may be required.
Missed dose of Dicloratio retard 100
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the
missed dose and take the next dose at the regular time. Do not take a double dose to make up for a
missed dose.
Stopping treatment with Dicloratio retard 100
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious.
You should stop taking Dicloratio retard 100 and contact your doctor immediately if you notice:

Mild, painful abdominal cramps and tenderness beginning soon after starting treatment with Dicloratio retard 100, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – cannot be estimated from available data).
Chest pain – chest pain which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

The following adverse reactions have occurred during treatment with Dicloratio retard 100, with the frequencies listed below:
Very common: 1 in 10 patients; common: 1 to 10 in 100 patients; uncommon: 1 to 10 in 1,000 patients; rare: 1 to 10 in 10,000 patients; very rare: less than 1 in 10,000 patients; frequency not known (frequency cannot be estimated from available data).
Some of the rare or very rare adverse reactions may be serious:

Bruising or purpura,
High fever or persistent sore throat,
Allergic reaction with swelling of the face, lips, mouth, tongue or throat, often associated with rash and itching, which may cause difficulty in swallowing, hypotension (low blood pressure), fainting,
Wheezing and feeling of tightness in the chest, shortness of breath (symptoms of asthma),
Chest pain (symptoms of heart attack),
Sudden and severe headache, nausea, dizziness, numbness, inability or difficulty speaking, paralysis (symptoms of stroke),
Neck stiffness (symptoms of meningitis),
Seizures,
High blood pressure (hypertension),
Red or purple skin (possible symptoms of vasculitis), blistering rash, formation of blisters on lips, eyes and mouth, skin inflammation with peeling or erosion of the epidermis,
Severe stomach pain, bloody or black stools, vomiting blood, gastric or (and) duodenal ulcer,
Yellowing of the skin or eyes (symptoms of hepatitis),
Blood in urine, excess protein in urine, significantly reduced urine output (symptoms of kidney dysfunction),
Decreased platelet count (thrombocytopenia),
Decreased white blood cell count (leukopenia),
Decreased neutrophil count (agranulocytosis).

If any of the above symptoms occur, you should inform your doctor immediately.
Common: occur in 1 to 10 in 100 patients

Headache,
Dizziness,
Nausea,
Vomiting,
Diarrhoea,
Dyspepsia,
Abdominal pain,
Flatulence,
Loss of appetite,
Liver function abnormalities (e.g. increased aminotransferase activity),
Skin rash.

Rare: occur in 1 to 10 in 10,000 patients

Drowsiness,
Urticaria,
Oedema.

Very rare: occur in less than 1 in 10,000 patients

Disorientation,
Depression,
Difficulty falling asleep,
Nightmares,
Irritability,
Psychotic disorders,
Tingling or numbness in hands or feet,
Memory disturbances,
Restlessness,
Tremor,
Taste disturbances,
Vision or hearing disturbances,
Lung inflammation,
Oral mucosal ulcers,
Constipation,
Oesophageal ulcers (upper part of the digestive tract leading food to the stomach),
Palpitations,
Hair loss,
Redness, swelling and blistering of the skin (due to increased sensitivity to sunlight),
Anaemia.

Medicines such as diclofenac may slightly increase the risk of heart attack or stroke. The risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment.
You should inform your doctor if any of the above adverse reactions occur.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor, pharmacist or nurse.
If Dicloratio retard 100 is used for longer than a few weeks, regular check-up visits with your doctor should be arranged to ensure that no undetected adverse reactions have occurred.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dicloratio retard 100

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B. und Verw. bis siehe Prägung - batch number and expiry date: see imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Dicloratio retard 100 contains

The active substance is sodium diclofenac. Each capsule contains 100 mg of sodium diclofenac.
Other ingredients are: lactose, microcrystalline cellulose, microcrystalline cellulose and sodium carmellose, glycerol trimyristate, ammonio methacrylate copolymer (type B), triethyl citrate, colloidal anhydrous silica, titanium dioxide (E 171); Capsule shell: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171); Printing ink: shellac, iron oxide black, propylene glycol, potassium hydroxide, ammonium hydroxide.

What Dicloratio retard 100 looks like and contents of the pack
Extended-release capsules, 100 mg.
Capsule: upper part orange, matte, printed with "Diclo. ret.", lower part colourless, transparent, printed with "Diclo. ret."
Contents of capsule: white to pale yellow pellets.
Packaging
PVC/Al blisters in a cardboard box.
20, 50, or 100 extended-release capsules.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Germany, country of export:
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Manufacturer:
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German marketing authorisation number, country of export: 4369.00.03
Parallel import authorisation number: 764/12