Diclac 75 duo

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging 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, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Diclac 75 Duo is and what it is used for
2. Important information before taking Diclac 75 Duo
3. How to take Diclac 75 Duo
4. Possible side effects
5. How to store Diclac 75 Duo
6. Contents of the pack and other information

1. What Diclac 75 Duo is and what it is used for
Diclac 75 Duo contains diclofenac sodium, 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 involves the inhibition of prostaglandin biosynthesis, which plays 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 inflammatory and oedematous post-traumatic and postoperative conditions, e.g. after dental or orthopaedic procedures;
• painful and (or) inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis.

Control examinations during treatment with Diclac 75 Duo
In patients with diagnosed heart disease or 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 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 dose.
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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 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 has previously experienced discomfort in the stomach area 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 ischaemic attack (TIA) or arterial embolism in the heart or brain, or after a revascularization or bypass procedure,
• if the patient has current or past circulatory disorders (peripheral vascular disease).

Inform your doctor about any of the above conditions.
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 increased blood lipid levels (cholesterol, triglycerides), or if the patient is a smoker, as 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 ulceration or is elderly. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation (potentially fatal). This effect may be particularly dangerous when high doses of the medicine are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Diclac 75 Duo, the medicine should be discontinued immediately and the patient should contact their doctor;
• the patient has ulcerative colitis or Crohn's disease, as diclofenac may exacerbate the disease;
• the patient has asthma, allergic rhinitis, mucosal oedema of the nose (e.g. due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory infections, as they are more susceptible to allergic reactions to diclofenac (worsening of asthma symptoms, Quincke's oedema 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 course of the disease. Strictly follow the doctor's recommendations regarding regular liver function tests;
• the patient has hepatic porphyria, as diclofenac may trigger an attack of porphyria.

Before taking diclofenac, inform your doctor if:

• the patient smokes tobacco,

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• the patient has diabetes,
• the patient has angina pectoris, thrombosis, hypertension, increased cholesterol or increased triglyceride levels.

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 lesions on the skin and mucous membranes, high fever and severe general condition). At the first signs of rash, mucosal changes or other symptoms of allergic reaction, discontinue the medicine and contact a doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and complicate correct diagnosis. Inform your doctor about taking this medicine during medical examinations.
Do not take Diclac 75 Duo simultaneously with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.
Before taking the medicine, inform your doctor or pharmacist about any of the above conditions.
Taking medicines such as Diclac 75 Duo may be associated with a small increased risk of myocardial infarction or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended.
If you have heart problems, have had a stroke, or suspect you are at risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment approach with your doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
Diclac 75 Duo should not be used in children and adolescents due to the dose size.
Elderly patients (aged 65 years and older)
Elderly individuals may react 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 your doctor.
Diclac 75 Duo and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken or plan to take.
Especially inform your doctor if you are 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

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• 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-inhibiting medicines
• antidiabetic medicines except insulin
• methotrexate – a medicine used in the treatment of 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 her doctor before using this medicine.
Pregnancy
Do not take Diclac 75 Duo if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac 75 Duo may cause kidney and heart dysfunction in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. 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, the lowest possible dose should be used for the shortest possible time.
From week 20 of pregnancy, Diclac 75 Duo may cause kidney dysfunction 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
Do not use Diclac 75 Duo in breastfeeding women, as it may harm the infant.
Your doctor will discuss with you 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 you are planning to conceive or have difficulty conceiving, inform your 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 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 75 Duo

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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 75 Duo is used for longer than several
weeks, regular medical check-ups should be performed to rule out any 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 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 doctor 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 individuals and those 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 risk factors for cardiovascular events should only take diclofenac after careful assessment by a physician and only at a dose of ≤100 mg per day if treatment lasts longer than 4 weeks.

Renal function disorders
The use of Diclac 75 Duo is contraindicated in patients with renal insufficiency.
Specific studies have not been conducted in patients with renal function disorders; therefore, appropriate dosage adjustment recommendations cannot be provided. Caution is advised in patients with mild to moderate renal impairment.

Hepatic function disorders
The use of Diclac 75 Duo is contraindicated in patients with hepatic insufficiency.
Specific studies have not been conducted in patients with hepatic function disorders; therefore, appropriate dosage adjustment recommendations cannot be provided. 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.

Duration of treatment with 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 necessary 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 of Diclac 75 Duo does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions. In cases of severe poisoning, acute renal failure and liver damage may occur.
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In case of accidental ingestion of more tablets than recommended, contact a doctor, pharmacist, or go immediately to the nearest hospital emergency department.

Missed dose of Diclac 75 Duo
If a dose is missed, it should be taken as soon as remembered.
However, if more than half of 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 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, dyspepsia, abdominal pain, flatulence, 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 ulcer disease (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 blood 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 disturbances, 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, membranous stricture of the intestine, pancreatitis,

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• fulminant hepatitis, hepatic necrosis, liver failure,
• bullous rash, eczema, erythema, erythema multiforme, 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 with unknown frequency ( 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 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 inform 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 during long-term use of high daily doses (150 mg)

• sudden, pressing 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 contact your doctor regularly to ensure that no adverse effects have occurred.
Reporting suspected adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 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 75 Duo

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• Keep this medicine out of sight and reach of children.
• No special storage instructions required.
• Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

Translation of some blister pack markings:
Ch.-B./verwendbar bis: siehe Prägung – Batch number and expiry date: see embossing

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging 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: lactose monohydrate, 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 more detailed information, please contact the responsible party or parallel importer.
Responsible party in Germany, 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:
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: 48728.00.00
Parallel import licence number: 140/23
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