Diclac 50: detailed information

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Diclac 50 (Diclofenac Sandoz 50 mg), 50 mg, enteric-coated tablets
Diclofenacum natricum
Diclac 50 and Diclofenac Sandoz 50 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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
Important information 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 plays a key role in the pathogenesis of inflammation, pain and fever.

Diclac 50 is used for the treatment of:

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 attacks of gout;
Pain caused by inflammatory conditions and oedema following trauma or surgery, e.g. after dental or orthopaedic procedures;
Painful and inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis;
As an adjunct in severe, painful ear, nose or throat infections, such as pharyngitis and tonsillitis, or otitis media. According to general therapeutic principles, in the above-mentioned diseases, causal treatment should be initiated first. Fever alone, as the sole symptom, is not an indication for use.

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

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, 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 previously experienced stomach discomfort or heartburn after taking anti-inflammatory drugs;
if the patient is in the last trimester of pregnancy;
if the patient has hepatic insufficiency;
if the patient has renal insufficiency;
if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after 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 past circulatory disorders (peripheral vascular disease).

Patients should inform their doctor if any of these conditions apply.
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 should 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). These effects may be particularly dangerous 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 their doctor;
the patient has ulcerative colitis or Crohn's disease; diclofenac may worsen 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 infections, as they are at higher risk of 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 course of the disease. Strict adherence to the doctor's recommendations regarding periodic liver function tests is required;
the patient has hepatic porphyria, as diclofenac may trigger an acute porphyria attack.

Before taking diclofenac, inform the doctor:

if the patient smokes,
if the patient has diabetes,
if the patient suffers 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 for the shortest possible duration to minimize the risk of adverse effects.
If at any time during treatment with Diclac 50 the patient develops symptoms indicating 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 mucous membrane 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 their doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and may complicate accurate diagnosis. Inform the doctor about using this medicine during medical examinations.
Do not use Diclac 50 simultaneously with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Before using the medicine, inform the doctor or pharmacist if any of the above-mentioned conditions are present.
Taking 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 of the medicine. Do not use higher doses or longer treatment duration than recommended.
If the patient has heart problems, a history of stroke, or suspects they are at risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), they should discuss treatment options with their doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
Diclac 50 should 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 other adults. Follow the instructions in the leaflet, use the lowest effective dose as recommended by the doctor, and report all adverse effects occurring during treatment to the doctor.
Diclac 50 and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Especially inform the doctor if taking the following medicines:

lithium or antidepressants (selective serotonin reuptake inhibitors)
digoxin – a medicine used in the treatment of heart disease
diuretics – medicines that increase urine output
angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – a group of medicines used in the treatment of hypertension and heart failure
non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen, selective COX-2 inhibitors) and corticosteroids (a group of medicines used to relieve certain inflammatory conditions)
anticoagulants and medicines that inhibit platelet function
antidiabetic medicines, except insulin
methotrexate – a medicine used in the treatment of certain cancers or joint inflammation
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 Diclac 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 baby, she should consult her doctor before using this medicine.
Pregnancy
Do not take Diclac 50 if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac 50 may cause kidney and heart function disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor. Diclac 50 should not be used during the first 6 months of pregnancy 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 the 20th week of pregnancy, Diclac 50 may cause kidney function disorders in the unborn child if taken 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 is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Diclac 50 should 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 Diclac 50 during pregnancy and breastfeeding.
Fertility
Taking Diclac 50 may make it more difficult to become pregnant. If the patient is planning pregnancy or has difficulty becoming pregnant, she should inform her doctor.
Driving and operating machinery
The effect of Diclac 50 on the ability to drive, operate machinery, or perform other tasks requiring special attention is unlikely.
Diclac 50 contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine 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 any 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 should be individually determined 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, the dose may be increased over several menstrual cycles up to a maximum daily dose of 200 mg. Treatment should be started at the onset of the first symptoms and continued for several days, depending on their severity.

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

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

Hepatic function disorders
The use of Diclac 50 in patients with hepatic insufficiency is contraindicated.
No specific studies have been conducted in patients with hepatic function disorders; therefore, appropriate dosage recommendations cannot be established. 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 must not be divided or chewed.

Duration of treatment with 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, 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 of the interval between two 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 relate to diclofenac in enteric-coated tablet form and to diclofenac in other pharmaceutical forms, used for short- or long-term treatment.

Adverse effects

Common (may occur in fewer than 1 in 10 people taking the medicine):

headache, dizziness,
nausea, vomiting, diarrhoea, dyspepsia, 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 mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
peptic ulcer of the stomach and/or duodenum (with or without bleeding or 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 platelet count), leukopenia (reduced white blood cell count), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of granulocytes),
angioedema (including facial oedema),
disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke,
visual disturbances, blurred vision, double vision,
tinnitus, hearing disturbances,
hypertension, vasculitis,
pneumonia,
colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucosal inflammation (including oral ulceration), glossitis, oesophageal disorders, membranous stricture of the intestine, 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 disease, pruritus,
acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Frequency not known (frequency cannot be estimated from the available data):

simultaneous 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.
Other adverse effects may occur in some people during treatment with 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.

Immediately discontinue taking Diclac 50 and contact your doctor if any of the following occur:

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 fever,
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 not known – 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 a prolonged period:

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

If Diclac 50 is taken for longer than a few weeks, regular contact with a doctor is recommended 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 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 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.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help 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: tablet core: monohydrate lactose, maize starch, calcium hydrogen phosphate, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, anhydrous colloidal silicon dioxide; coating: Eudragit L 30 D, triethyl citrate, talc, titanium dioxide (E 171), iron oxide (E 172).

What Diclac 50 looks like and contents of the pack
The tablets are packed in blisters made of PP/Al foil in cardboard boxes.
Pack sizes contain either 30 or 50 enteric-coated tablets.
For more detailed information about this medicinal product, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, country of export:
Sandoz Farmacêutica, Lda.
Avenida Professor Doutor Cavaco Silva, n.º 10E
Taguspark
2740-255 Porto Salvo, Portugal
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
D-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
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorisation number in Portugal, country of export: 5762299
Parallel import authorisation number: 314/20