PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Diclac 75 Duo (Diclo 75 SL - 1 A Pharma)
75 mg, prolonged-release tablets
Diclofenacum natricum
Diclac 75 Duo and Diclo 75 SL - 1 A Pharma are different trade names for the same medicine.
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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Diclac 75 Duo is and what it is used for
Important information before taking Diclac 75 Duo
How to take Diclac 75 Duo
Possible side effects
How to store Diclac 75 Duo
Contents of the pack and other information

1. What Diclac 75 Duo is and what it is used for
Diclac 75 Duo 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 75 Duo primarily involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain, and fever.
Diclac 75 Duo is used in the treatment of:

inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spinal arthritis, painful syndromes associated with spinal changes, extra-articular rheumatism;
pain caused by post-traumatic and postoperative inflammatory conditions and swelling, e.g., after dental or orthopedic procedures;
painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhea or salpingitis.

Monitoring during treatment with Diclac 75 Duo
In patients diagnosed with heart disease or significant risk factors for heart 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 doctor will 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 doctor will decide whether to discontinue treatment with Diclac 75 Duo or adjust the dosage.

2. Important information before taking Diclac 75 Duo

When not to take Diclac 75 Duo

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 analgesic 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 an allergy, they should consult a doctor.
if the patient has active or a history of peptic ulcer disease of the stomach and/or duodenum, bleeding, or perforation; if the patient previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines,
if the patient is in the last trimester of pregnancy,
if the patient has liver failure,
if the patient has kidney failure,
if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g., after myocardial infarction, stroke, transient ischemic attack (TIA), or arterial embolism in the heart or brain, or after a procedure to open blocked vessels or bypass surgery,
if the patient has or has had circulatory disorders (peripheral vascular disease).

Inform the doctor if any of these conditions are present.
Warnings and precautions
Before taking Diclac 75 Duo, discuss with your 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, as in such cases the dose 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 (potentially fatal). This effect may be particularly dangerous when high doses are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Diclac 75 Duo, discontinue the medicine immediately and contact a doctor;
the patient has ulcerative colitis or Crohn's disease, as diclofenac may exacerbate the disease;
the patient has asthma, allergic rhinitis, mucosal swelling of the nose (e.g., due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory infections, as they may be more susceptible 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 liver function disorders, as diclofenac may worsen the disease. Strictly follow the doctor's recommendations regarding liver function monitoring tests;
the patient has hepatic porphyria, as diclofenac may trigger a porphyria attack.

Before taking diclofenac, inform the doctor if:

the patient smokes,
the patient has diabetes,
the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

Use the lowest effective dose of Diclac 75 Duo that relieves pain and/or swelling, and use it for the shortest possible duration to minimize the risk of adverse effects.
If at any time during treatment with Diclac 75 Duo the patient experiences symptoms indicating heart or blood vessel problems, such as chest pain, shortness of breath, weakness, or slurred speech, contact a doctor or emergency department immediately.
Diclofenac use may, very rarely (especially at the beginning of treatment), cause life-threatening skin 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). At the first signs of rash, mucosal changes, or other allergic reaction symptoms, discontinue the medicine and contact a doctor.
The medicine may mask signs of infection (e.g., headache, elevated body temperature) and complicate accurate diagnosis. Inform the doctor about medicine use during medical examinations.
Do not take Diclac 75 Duo simultaneously with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Inform the doctor or pharmacist about any of the above-mentioned conditions.
Taking medicines such as Diclac 75 Duo may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment durations than recommended.
If the patient has heart problems, has had a stroke, or suspects risk of these conditions (e.g., high blood pressure, diabetes, elevated cholesterol, smoking), discuss the treatment approach with a doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
This medicine should not be used in children and adolescents due to the dosage size.
Elderly patients (aged 65 years and older)
Elderly individuals may respond more strongly to 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 75 Duo 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 heart disease treatment
diuretics – medicines that increase urine output
angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – a group of medicines used in treating hypertension and heart failure
non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to relieve inflammatory conditions)
anticoagulants and platelet inhibitors
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 Diclac 75 Duo with food and drink
Tablets should be swallowed whole with water, preferably during 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
Do not take Diclac 75 Duo if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Diclac 75 Duo 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. During the first 6 months of pregnancy, Diclac 75 Duo should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Diclac 75 Duo may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Do not use Diclac 75 Duo in breastfeeding women, as it may harm the infant.
The doctor will discuss with the patient the potential risks of using Diclac 75 Duo during pregnancy and breastfeeding.
Fertility
Taking Diclac 75 Duo may make it more difficult to become pregnant. If the patient plans to become pregnant or has difficulty conceiving, she should inform the doctor.
Driving and operating machinery
The effect of Diclac 75 Duo on the ability to drive, operate machinery, or perform other tasks requiring special attention is unlikely.
Diclac 75 Duo contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a 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 75 Duo

This medicine should always be used as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Do not exceed the recommended doses. If Diclac 75 Duo is used for longer than a few weeks, regular medical check-ups should be performed to rule out undetected adverse effects.
The dosage is determined individually by the physician for each patient. The general principle is to use the lowest effective dose for the shortest possible duration.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Adults
1 tablet of Diclac 75 Duo (75 mg of sodium diclofenac) once daily. If necessary, the physician may increase the dose to 2 tablets of Diclac 75 Duo (150 mg per day). Do not use a daily dose higher than 150 mg.

Use in children and adolescents
Due to the dosage strength, Diclac 75 Duo should not be used in children and adolescents under 18 years of age.

Elderly patients (aged 65 years and older)
This medicine should be used with caution in elderly patients. In elderly patients and in patients with low body weight, the lowest effective dose should be used.

Diagnosed cardiovascular disease or significant cardiovascular risk factors
Patients with diagnosed cardiovascular disease or significant cardiovascular risk factors should take diclofenac only after a physician has assessed their condition and only at a dose ≤100 mg per day, if treatment lasts longer than 4 weeks.

Renal function impairment
Use of Diclac 75 Duo is contraindicated in patients with renal insufficiency. Specific studies have not been conducted in patients with impaired renal function, therefore appropriate dosage recommendations cannot be established. Caution is advised in patients with mild to moderate renal impairment.

Hepatic function impairment
Use of Diclac 75 Duo is contraindicated in patients with hepatic insufficiency. Specific studies have not been conducted in patients with impaired liver function, therefore appropriate dosage recommendations cannot be established. Caution is advised in patients with mild to moderate hepatic impairment.

Method of administration
If symptoms are most pronounced at night or in the early morning, Diclac 75 Duo should be taken in the evening. Tablets should be swallowed whole with water, preferably during a meal. Tablets must not be divided or chewed.

How long to use Diclac 75 Duo
Diclac 75 Duo should always be used as directed by the physician.
If Diclac 75 Duo is used long-term, regular contact with the physician is recommended to ensure that no adverse effects have occurred.
In case of doubt about how long to use the medicine, consult your doctor or pharmacist.

Overdose of Diclac 75 Duo
Overdose with Diclac 75 Duo does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In cases of severe poisoning, acute renal failure and liver damage may occur.
If an overdose is accidentally taken, contact a doctor, pharmacist, or go to the nearest hospital emergency department immediately.

Missed dose of Diclac 75 Duo
If a dose is missed, 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 relate to diclofenac in modified-release tablets and to diclofenac in other pharmaceutical forms, used short- 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 mucosal inflammation, gastrointestinal bleeding, vomiting of blood, bloody diarrhoea, melaena,
gastric and (or) duodenal ulceration (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 (decreased number of blood platelets), leukopenia (decreased number of white blood cells), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (decreased number or absence of granulocytes),
angioedema (including facial swelling),
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 ulcerative stomatitis), glossitis, oesophageal disorders, intestinal stricture, pancreatitis,
fulminant hepatitis, hepatic necrosis, liver failure,
bullous rash, eczema, 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 75 Duo 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 75 Duo. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
If any of the following adverse effects occur, stop taking Diclac 75 Duo immediately and contact your doctor:

stomach discomfort, heartburn or upper abdominal pain
vomiting blood, blood in stool, blood in urine
skin reactions 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 75 Duo, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency unknown).

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

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

If you are taking Diclac 75 Duo for longer than a few weeks, you should regularly consult your doctor to ensure that no adverse effects have occurred.
Reporting suspected adverse effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 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 75 Duo

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use after the expiry date stated on the cardboard carton following EXP. The expiry date refers to the last day of the stated month.
The batch number on the cardboard carton is marked with "Lot".
Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint.
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 75 Duo contains

The active substance is sodium diclofenac. One prolonged-release tablet contains 75 mg of sodium diclofenac.
Other ingredients are: monohydrate lactose, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A), colloidal anhydrous silica, corn starch, iron oxide red (E 172); hypromellose.

What Diclac 75 Duo looks like and contents of the pack
Diclac 75 Duo tablets consist of two layers: pink and white.
They are packed in PP/Aluminium or PVC/PVDC/Aluminium blisters in a cardboard box.
Pack sizes contain 10 or 20 prolonged-release tablets.
For further detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
German Marketing Authorisation Number (country of export): 48728.00.00
Parallel Import Licence Number: 200/23