Dicloratio retard 100

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! The leaflet should be kept. 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 medicine.

You should read the contents of the leaflet before taking 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Dicloratio retard 100 and what is it used for
• 2. Important information before taking Dicloratio retard 100
• 3. How to take Dicloratio retard 100
• 4. Possible side effects
• 5. How to store Dicloratio retard 100
• 6. Contents of the pack and other information

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

Dicloratio retard 100 belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammatory conditions.
Dicloratio retard 100 relieves the symptoms of inflammatory conditions, such as swelling and pain. It does not affect the causes of inflammatory conditions and fever.
Dicloratio retard 100 can be used to treat pain and inflammatory conditions, in cases of:

• acute inflammatory joint diseases,
• chronic inflammatory joint diseases, in particular rheumatoid arthritis (chronic joint inflammation),
• ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine,
• disorders resulting from degenerative joint disease and spinal inflammation,
• rheumatic inflammatory soft tissue conditions,
• painful swelling or inflammation after injury.

In case of doubts about the action or reasons for prescribing Dicloratio retard 100, you should consult a doctor.

2. Important information before taking Dicloratio retard 100

You should follow all the instructions given by your doctor or pharmacist carefully, even if they differ from the general information contained in this leaflet.

When not to take Dicloratio retard 100:

• if the patient is allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6),
• if the patient has or has had stomach or duodenal ulcer, gastrointestinal bleeding, symptoms related to the presence of blood in the stool, black stools, or perforation of the stomach,
• if the patient has had bleeding or perforation of the intestines or stomach associated with the use of NSAIDs in the past,
• in the last three months of pregnancy (see "Pregnancy, breastfeeding, and fertility"),
• if the patient has severe liver, kidney, or heart failure,
• if the patient has ever had an allergic reaction after taking an anti-inflammatory or pain-relieving medicine (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). In the above case, asthma, rhinitis, chest pain, skin rash, or facial swelling may occur. If the patient suspects an allergy, they should consult a doctor,
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia, or occlusion of coronary vessels, or after a procedure to clear or bypass blocked vessels,
• if the patient has or has had circulatory disorders (peripheral vascular disease).

If any of the above symptoms occur in the patient, they should inform their doctor and not take Dicloratio retard 100 until the doctor determines that the medicine is suitable for the patient.

Children and adolescents

Dicloratio retard 100 should not be taken by children and adolescents.

Warnings and precautions

Before starting to take Dicloratio retard 100, the patient should discuss it with their doctor, pharmacist, or nurse.
The patient should inform their doctor if:

• they are taking Dicloratio retard 100 at the same time as other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" medicines, or certain antidepressants (see also "Dicloratio retard 100 and other medicines"),
• they have asthma or allergies,
• they have had gastrointestinal disorders in the past, such as stomach ulcers, bleeding, or black stools, or have experienced stomach discomfort or heartburn after taking NSAIDs in the past,
• they have inflammatory bowel disease (ulcerative colitis) or gastrointestinal disease (Crohn's disease),
• they have or have had heart problems or high blood pressure (see "Other special warnings" below),
• they have kidney or liver problems,
• they have foot swelling,
• they have bleeding disorders or other blood diseases, including a rare liver disease called porphyria.

Before taking diclofenac, the patient should inform their doctor

• if they smoke,
• if they have diabetes,
• if they have angina, thrombosis, high blood pressure, high cholesterol, or high triglycerides.

Before taking Dicloratio retard 100, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Dicloratio retard 100 may sometimes cause weakening of the intestinal wound healing process after surgery.
The occurrence of side effects can be limited by taking the medicine in the smallest effective dose and for no longer than necessary.
If any of the above warnings apply to the patient, they should inform their doctor before taking Dicloratio retard 100.
Other special warnings
Dicloratio retard 100 should not be taken at the same time as other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors.
Taking medicines like Dicloratio retard 100 may be associated with a small increased risk of heart attack or stroke. Any risk is more likely after taking high doses and long-term treatment. The recommended dose or treatment duration should not be exceeded.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, or smoking), the patient should discuss the treatment with their doctor or pharmacist.
Dicloratio retard 100 may reduce the symptoms of infection (e.g., headache, high temperature), making it more difficult to diagnose and treat the infection effectively. If the patient feels unwell and needs to see a doctor, they should inform the doctor that they are taking Dicloratio retard 100.
In very rare cases, Dicloratio retard 100, like other anti-inflammatory medicines, may cause severe allergic skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, and toxic epidermal necrolysis with skin and mucous membrane lesions, high fever, and severe general condition). Therefore, the patient should inform their 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 taken before.
Elderly patients
Elderly patients may be more sensitive to the effects of Dicloratio retard 100. Therefore, they should follow their doctor's instructions carefully and take the minimum effective dose for the shortest necessary period to relieve symptoms. It is particularly important for patients to report any side effects to their doctor immediately.

Dicloratio retard 100 and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or plan to take.
It is particularly 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 to treat heart diseases,
• Diuretics (medicines that increase urine production),
• 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),
• Anticoagulant medicines (medicines that prevent blood clotting),
• Antidiabetic medicines, except insulin,
• Methotrexate (a medicine used to treat certain cancers or arthritis),
• Cyclosporin (a medicine used in organ transplant patients),
• Quinolone antibacterials (medicines used to treat infections),
• Phenytoin (an antiepileptic medicine),
• Colestyramine and colestipol (a medicine used to treat high cholesterol),
• Sulfinpyrazone (a medicine used to treat gout),
• Voriconazole (a medicine used to treat fungal infections),
• Mifepristone (a medicine used in gynecology),
• Diclofenac resinates.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Dicloratio retard 100 should not be taken during the first and second trimesters of pregnancy, unless it is necessary. When diclofenac is taken by women planning to become pregnant or during the first and second trimesters of pregnancy, the lowest possible dose and shortest duration of treatment should be used.
Dicloratio retard 100 should not be taken during the last three months of pregnancy, as it may harm the baby or cause delayed or accelerated labor.

Breastfeeding

The patient should not breastfeed if they are taking Dicloratio retard 100, as the medicine may have a harmful effect on the baby.

Fertility

Diclofenac may make it more difficult to become pregnant. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

The patient should not drive or operate any tools or machines if they experience side effects while taking Dicloratio retard 100, such as vision disturbances, dizziness, drowsiness, or other central nervous system disorders.

The medicine contains lactose and sodium

Lactose
If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release capsule, which means the medicine is considered "sodium-free".

3. How to take Dicloratio retard 100

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will tell the patient exactly how to take Dicloratio retard 100. Depending on the individual patient's response to treatment, the doctor may recommend a higher or lower dose of the medicine.

Dosage

The patient should not exceed the recommended dose. It is important to take the smallest effective dose for the shortest necessary period to control symptoms and not to take Dicloratio retard 100 for longer than necessary.
The doctor will tell the patient exactly how to take Dicloratio retard 100. Depending on the individual patient's response to treatment, the doctor 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 diclofenac sodium), unless the doctor recommends otherwise.
If necessary, therapy may be combined with a dose of 25 mg or 50 mg in the form of tablets or suppositories to a maximum dose of 150 mg of diclofenac sodium per day.
Patients with renal and hepatic impairment
In patients with mild and moderate renal or hepatic impairment, there is no need to adjust the dose.
Elderly patients
When taking Dicloratio retard 100 in elderly patients, special caution should be exercised, and the smallest effective dose should be used for the shortest necessary period to relieve symptoms. The possibility of gastrointestinal bleeding should be regularly monitored.
Children and adolescents
Dicloratio retard 100 should not be taken by children and adolescents.

When and for how long to take Dicloratio retard 100

The capsules should be swallowed whole before meals, without chewing, and washed down with a glass of water.
The patient should not exceed the recommended dose.

How long to take Dicloratio retard 100

The patient should strictly follow their doctor's instructions.

Taking a higher dose of Dicloratio retard 100 than recommended

If the patient has accidentally taken a higher dose of Dicloratio retard 100 than recommended, they should inform their doctor or pharmacist or go to the hospital emergency department immediately. Medical attention may be necessary.

Missing a dose of Dicloratio retard 100

If the patient misses a dose, they should take it as soon as they remember. If it is almost time for the next dose, the patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Dicloratio retard 100

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dicloratio retard 100 can cause side effects, although not everybody gets them.
Some side effects can be serious.

The patient should stop taking Dicloratio retard 100 and contact their doctor immediately if they notice:

• Mild, painful abdominal cramps and tenderness starting soon after taking Dicloratio retard 100, followed by rectal bleeding or black bloody stools, usually within 24 hours of abdominal pain onset (frequency unknown - cannot be estimated from available data).

Chest pain - chest pain that may be a sign of a potentially serious allergic reaction called Kounis syndrome.

• Chest pain - chest pain that may be a sign of a potentially serious allergic reaction called Kounis syndrome.

During treatment with Dicloratio retard 100, the following side effects have occurred with the following frequency:
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 unknown (frequency cannot be estimated from available data).

Some rare or very rare side effects can be serious:

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

If the patient experiences any of the above symptoms, they should inform their doctor immediately.
Common:occurs in 1 to 10 in 100 patients

• Headache,
• Dizziness,
• Nausea,
• Vomiting,
• Diarrhea,
• Indigestion,
• Abdominal pain,
• Bloating,
• Loss of appetite,
• Liver function disorders (e.g., increased aminotransferase activity),
• Skin rash.

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

• Drowsiness,
• Hives,
• Swelling.

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

• Disorientation,
• Depression,
• Sleep disturbances,
• Nightmares,
• Irritability,
• Psychotic disorders,
• Numbness or tingling of hands or feet,
• Memory disorders,
• Anxiety,
• Tremors,
• Taste disorders,
• Visual or hearing disorders,
• Pneumonia,
• Mouth ulcers,
• Constipation,
• Esophageal 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),
• Anemia (anemia).

Medicines like diclofenac may slightly increase the risk of heart attack or stroke. The risk of this is more likely after taking high doses and long-term treatment. The patient should not exceed the recommended dose or treatment duration.
The patient should inform their doctor if they experience any of the above side effects.
If the patient experiences any side effects, including any side effects not listed in the leaflet, they should consult their doctor, pharmacist, or nurse.
If Dicloratio retard 100 is taken for more than a few weeks, the patient should have regular check-ups with their doctor to ensure that no unnoticed side effects have occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dicloratio retard 100

The medicine should be stored 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 month stated.

Translation of some abbreviations on the immediate packaging:

Ch.-B. und Verw. bis siehe Prägung - batch number and expiry date: see imprint
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dicloratio retard 100 contains

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

What Dicloratio retard 100 looks like and contents of the pack

Prolonged-release capsules, 100 mg.
Capsule: orange, matte with imprint "Diclo. ret.", transparent with imprint "Diclo. ret.".
Contents of the capsule: white to light yellow pellets.

Packaging

PVC/Al blisters in a cardboard box.
20, 50, 100 prolonged-release capsules.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
License number in Germany, the country of export: 4369.00.03

Parallel import license number: 764/12 Date of leaflet approval: 10.11.2022

[Information about the trademark]