Diclac 50: detailed information

Patient Information Leaflet

Keep this leaflet! The information on the immediate packaging is in a foreign language.
Diclac 50, 50 mg, enteric-coated tablets
Diclofenacum natricum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Diclac 50 is and what it is used for
What you need to know before taking Diclac 50
How to take Diclac 50
Possible side effects
How to store Diclac 50
Contents of the pack and other information

1. What Diclac 50 is and what it is used for

Diclac 50 contains sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Diclac 50 involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain, and fever.

Diclac 50 is used to treat:

Inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, juvenile rheumatoid arthritis (Still's disease), ankylosing spondylitis, osteoarthritis, spinal arthritis, painful syndromes associated with spinal changes, and extra-articular rheumatism;
Acute gout attacks;
Pain caused by inflammatory conditions and edema following trauma or surgery, e.g. after dental or orthopedic procedures;
Painful and inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis;
As an adjunct in severe, painful infections of the ear, nose, or throat, such as pharyngitis and tonsillitis. According to general therapeutic principles, causal treatment should be initiated first in the above-mentioned conditions. Fever alone, as a single symptom, is not an indication for use.

Monitoring during treatment with Diclac 50
In patients diagnosed with heart disease or with significant risk factors for heart disease, the treating physician will periodically assess the patient's need for symptomatic treatment and their response to the medicine, especially if treatment lasts longer than 4 weeks.
During treatment, the doctor will order regular blood tests to monitor liver function (aminotransferase activity), kidney function (creatinine levels), and blood cell counts (white blood cells, red blood cells, and platelets). Based on the test results, the doctor will decide whether treatment with Diclac 50 should be discontinued or whether a dose adjustment is necessary.

2. Important Information Before Using Diclac 50

When not to use Diclac 50:

if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
if the patient has ever experienced an allergic reaction after taking anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, or swelling of the face, lips, tongue, throat, and/or limbs (symptoms of angioedema). If the patient suspects they may be allergic, they should consult a doctor;
if the patient has active or a history of peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, or perforation; if the patient has previously experienced stomach discomfort or heartburn after taking anti-inflammatory drugs;
if the patient is in the third trimester of pregnancy;
if the patient has liver failure;
if the patient has renal failure;
if the patient has heart disease and/or cerebrovascular disease, e.g. following myocardial infarction, stroke, transient ischemic attack (TIA), arterial embolism in the heart or brain, or procedures to unblock or bypass obstructed blood vessels;
if the patient has current or a history of circulatory disorders (peripheral vascular disease).

Patients should inform their doctor if any of these conditions are present.
Warnings and precautions
Before using Diclac 50, discuss with a doctor if:

the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if the patient is a smoker, because in such cases the dose of the medicine must not exceed 100 mg per day if treatment lasts longer than 4 weeks;
the patient has a history of gastrointestinal ulcers or is elderly. Use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). This risk may be particularly serious when high doses of the medicine are used;
if any unusual symptoms occur in the abdominal area during treatment with Diclac 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should contact a doctor;
the patient has ulcerative colitis or Crohn’s disease; diclofenac may worsen the course of the disease;
the patient suffers from asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease (COPD), or chronic respiratory tract infections, as they may be more prone to allergic reactions to diclofenac (worsening of asthma symptoms, Quincke’s edema, or urticaria). This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching, or urticaria). The medicine should be taken with particular caution (preferably under medical supervision);
the patient has impaired liver function; diclofenac may worsen the disease. Strict adherence to the doctor’s recommendations regarding regular liver function tests is required;
the patient has hepatic porphyria, as diclofenac may trigger an attack of porphyria.

Before taking diclofenac, the patient should inform the doctor:

if they smoke,
if they have diabetes,
if they suffer from angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

The lowest effective dose of Diclac 50 that relieves pain and/or swelling should be used, and only for the shortest possible duration to minimize the risk of adverse effects.
If at any time during treatment with Diclac 50 the patient experiences symptoms suggesting heart or blood vessel problems (such as chest pain, shortness of breath, weakness, or slurred speech), they should contact a doctor or emergency department immediately.
Diclofenac may, very rarely (especially at the beginning of treatment), cause life-threatening skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever, and severe general condition). At the first signs of rash, mucosal changes, or other symptoms of allergic reaction, the medicine should be discontinued and the patient should contact a doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and hinder accurate diagnosis. Patients should inform their doctor about using this medicine during medical examinations.
Diclax 50 must not be used simultaneously with other systemic nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Before using the medicine, patients should inform their doctor or pharmacist about any of the above-mentioned conditions.
Use of medicines such as Diclac 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Doses higher than recommended or treatment longer than advised should not be used.
In case of heart problems, history of stroke, or suspected risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), the treatment approach should be discussed with a doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
Diclax 50 must not be used in children and adolescents under 14 years of age.
Elderly patients (aged 65 years and above)
Elderly individuals may be more sensitive to the effects of the medicine than younger adults. Patients should follow the instructions in the leaflet, use the lowest effective dose as recommended by the doctor, and report any adverse effects occurring during treatment to their doctor.
Diclax 50 and other medicines
Patients should inform their doctor about all medicines currently or recently taken, as well as any medicines they plan to take.
Patients should especially inform their doctor about taking the following medicines:

lithium or antidepressants (selective serotonin reuptake inhibitors)
digoxin – a medicine used in heart disease treatment
diuretics – medicines that increase urine output
angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – groups of medicines used in treating hypertension and heart failure
nonsteroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen, selective cyclooxygenase-2 inhibitors) and corticosteroids (medicines used to relieve certain inflammatory conditions)
anticoagulants and medicines that inhibit platelet function
antidiabetic medicines, except insulin
methotrexate – a medicine used in treating certain cancers or arthritis
cyclosporine and tacrolimus – medicines used in organ transplant recipients
trimethoprim – a medicine used to prevent and treat urinary tract infections
antibacterial quinolones – medicines used to treat infections
colestipol and cholestyramine – medicines that lower blood cholesterol levels
voriconazole – a medicine used to treat fungal infections
phenytoin – a medicine used to treat epileptic seizures

Taking Diclax 50 with food and drink
Tablets should be swallowed whole with water, preferably before a meal.
Pregnancy, breastfeeding, and fertility
If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Pregnancy
Diclax 50 must not be taken during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclax 50 may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor. During the first 6 months of pregnancy, Diclax 50 should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Diclax 50 may cause kidney problems in the unborn child if used for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Diclax 50 must not be used in breastfeeding women, as it may have harmful effects on the infant.
The doctor will discuss with the patient the potential risks of using Diclax 50 during pregnancy and breastfeeding.
Fertility
Taking Diclax 50 may make it more difficult to become pregnant. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
The effect of Diclax 50 on the ability to drive, operate machinery, or perform other tasks requiring special attention is unlikely.
Diclax 50 contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Diclac 50

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
Do not exceed the recommended doses. If Diclac 50 is used for longer than a few weeks, regular medical check-ups are necessary to rule out undetected adverse effects.
The dosage is determined individually by the physician for each patient. The principle is to use the lowest effective dose for the shortest possible duration.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Adults
The recommended initial daily dose is 100 mg to 150 mg.
In milder cases and in chronic treatment, a daily dose of up to 100 mg is considered sufficient.
The total daily dose should be divided into 2 to 3 doses. To relieve nocturnal pain and morning stiffness, daytime tablet treatment may be supplemented with a suppository before bedtime (without exceeding the maximum total daily dose of 150 mg).
In primary dysmenorrhoea, the daily dose is determined individually by the physician for each patient. It usually ranges from 50 mg to 150 mg. Initially, 50 mg to 100 mg should be administered, and if necessary, this dose may be increased over several menstrual cycles up to a maximum daily dose of 200 mg. Treatment should begin at the onset of the first symptoms and continued for several days, depending on symptom severity.

Other indications for use
Diclac 50 is not recommended for use in children and adolescents.

Diagnosed cardiovascular disease or significant cardiovascular risk factors
Patients with diagnosed cardiovascular disease or significant risk factors for cardiovascular events should take diclofenac only after a physician's assessment and only at a dose ≤100 mg daily, if treatment lasts longer than 4 weeks.

Renal function disorders
Use of Diclac 50 is contraindicated in patients with renal impairment.
No specific studies have been conducted in patients with renal function disorders; therefore, appropriate dosage recommendations cannot be provided. Caution is advised in patients with mild to moderate renal impairment.

Hepatic function disorders
Use of Diclac 50 is contraindicated in patients with hepatic impairment.
No specific studies have been conducted in patients with hepatic function disorders; therefore, appropriate dosage recommendations cannot be provided. Caution is advised in patients with mild to moderate hepatic impairment.

Method of administration
Tablets should be swallowed whole with water, preferably before meals. Tablets should not be divided or chewed.

How long to use Diclac 50
Diclac 50 should always be used as directed by the physician.
If Diclac 50 is used long-term, regular contact with the physician is necessary to ensure no adverse effects have occurred.
If in doubt about how long to use the medicine, consult your doctor or pharmacist.

Use of a higher than recommended dose of Diclac 50
Overdose with Diclac 50 does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions. In cases of severe poisoning, acute renal failure and liver damage may occur.
If an excessive amount of tablets is accidentally ingested, seek immediate medical advice from a doctor or pharmacist, or go to a hospital emergency department.

Missed dose of Diclac 50
If a patient misses a dose, it should be taken as soon as remembered.
However, if more than half the interval between doses has passed, the missed dose should not be taken; instead, the next tablet should be taken according to the previous dosing schedule.
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects listed below apply to diclofenac in enteric-coated tablet form and to diclofenac in other pharmaceutical forms, used either short-term or long-term.
Adverse effects
Common (may occur in fewer than 1 in 10 people taking the medicine):

headache, dizziness,
nausea, vomiting, diarrhoea, indigestion, abdominal pain, bloating, decreased appetite,
increased aminotransferase activity,
rash.

Uncommon (may occur in fewer than 1 in 100 people taking the medicine):

myocardial infarction, heart failure, palpitations, chest pain.

Rare (may occur in fewer than 1 in 1 000 people taking the medicine):

hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
somnolence,
asthma (including breathlessness),
gastric mucositis, gastrointestinal bleeding, vomiting blood, bloody diarrhoea, melaena,
peptic ulcer of the stomach and/or duodenum (with or without bleeding and perforation),
hepatitis, jaundice, liver function disorders,
urticaria,
oedema.

Very rare (may occur in fewer than 1 in 10 000 people taking the medicine):

thrombocytopenia (reduced number of platelets), leukopenia (reduced number of white blood cells), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of granulocytes),
angioedema (including facial swelling),
disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
paraesthesia, memory disorders, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke,
visual disturbances, blurred vision, double vision,
tinnitus, hearing disorders,
hypertension, vasculitis,
pneumonia,
colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucositis (including ulcerative stomatitis), glossitis, oesophageal disorders, membranous stricture of the intestines, pancreatitis,
fulminant hepatitis, hepatic necrosis, liver failure,
bullous rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome,
toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch purpura, pruritus,
acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Adverse effects occurring with unknown frequency (frequency cannot be estimated from available data):

concurrent occurrence of chest pain and allergic reaction (symptoms of Kounis syndrome).

Taking medicines such as Diclac 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse effects while taking Diclac 50.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Some adverse effects may be serious.
If any of the following effects occur, stop taking Diclac 50 immediately and inform your doctor:

stomach discomfort, heartburn or upper abdominal pain
vomiting blood, blood in stools, blood in urine
skin problems such as rash or itching
wheezing or shortness of breath
yellowing of the skin or whites of the eyes
persistent sore throat or high body temperature
swelling of the face, feet or legs
severe migraine
chest pain associated with cough
mild painful abdominal cramps and tenderness, beginning shortly after starting Diclac 50, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency unknown – cannot be estimated from available data).

Some adverse effects may be serious
These uncommon adverse effects may occur in 1-10 patients per 1 000, especially when high daily doses (150 mg) are used for prolonged periods:

sudden, pressing chest pain (symptoms of myocardial infarction or heart attack).
breathlessness, difficulty breathing when lying down, swelling of ankles or legs (symptoms of heart failure).

If you are taking Diclac 50 for longer than a few weeks, you should regularly consult your doctor to ensure that no adverse effects have occurred.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products, 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diclac 50

Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung - batch number/expiry date - see imprint.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Diclac 50 contains

The active substance is sodium diclofenac. Each enteric-coated tablet contains 50 mg of sodium diclofenac.
Other ingredients are: lactose monohydrate, maize starch, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate, colloidal anhydrous silica, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Diclac 50 looks like and contents of the pack
The tablets are packed in blisters within a cardboard box.
Pack sizes contain 30 or 50 enteric-coated tablets.
For more detailed information about the medicine, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Germany, country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorisation number in Germany, country of export: 6360.01.03
Parallel import authorisation number: 74/23