Diclac 150 duo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Diclac 150 Duo (Diclac ID 150 mg)
150 mg, modified-release tablets
Diclofenacum natricum
Diclac 150 Duo and Diclac ID 150 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking 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 give it 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 or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Diclac 150 Duo is and what it is used for
2. Important information before taking Diclac 150 Duo
3. How to take Diclac 150 Duo
4. Possible side effects
5. How to store Diclac 150 Duo
6. Contents of the pack and other information

1. What Diclac 150 Duo is and what it is used for
Diclac 150 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 150 Duo involves inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain, and fever.
Diclac 150 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, and 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 adnexitis.

Controlled examinations during treatment with Diclac 150 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 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 150 Duo or adjust the dosage.

2. Important information before taking Diclac 150 Duo

When not to take Diclac 150 Duo

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had 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, or swelling of the face, lips, tongue, throat, and (or) limbs (symptoms of angioedema). If you think you may be allergic, consult your doctor.
• If you have active or a history of peptic ulcer disease of the stomach and (or) duodenum, gastrointestinal bleeding or perforation; if you have previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines,
• if you are in the last trimester of pregnancy,
• if you have hepatic insufficiency,
• if you have renal insufficiency,
• if you have been diagnosed with heart disease and (or) cerebrovascular disease, e.g. after myocardial infarction, stroke, mini-stroke (transient ischemic attack), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass obstructed vessels,
• if you have current or past circulatory disorders (peripheral vascular disease).

You should inform your doctor if you have any of the above conditions.
Warnings and precautions
Before taking Diclac 150 Duo, discuss with your doctor if:

• you have diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if you are a smoker, as in such cases the daily dose should not exceed 100 mg if treatment lasts longer than 4 weeks;
• you have a history of gastrointestinal ulceration or are elderly. Diclofenac use may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). Such effects may be particularly dangerous when high doses are used;
• if you experience any unusual abdominal symptoms (especially gastrointestinal bleeding) during treatment with Diclac 150 Duo, stop taking the medicine immediately and contact your doctor;
• you have ulcerative colitis or Crohn's disease, as diclofenac may worsen the course of the disease;
• you have asthma, allergic rhinitis, nasal mucosal edema (e.g. due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections, as you may be more susceptible to allergic reactions to diclofenac (worsening of asthma, 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);
• you have liver function disorders, as diclofenac may worsen the disease. Strictly follow your doctor's recommendations regarding regular liver function tests;
• you have hepatic porphyria, as diclofenac may trigger an attack of porphyria.

Before taking diclofenac, inform your doctor if:

• you smoke,
• you have diabetes,
• you have angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

Use the lowest effective dose of Diclac 150 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 150 Duo you experience symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness, or slurred speech, contact your doctor or emergency department immediately.
Diclofenac use may, in very rare cases (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). If early signs of rash, mucosal changes, or other allergic reactions occur, discontinue the medicine and contact your doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and complicate accurate diagnosis. Inform your doctor during medical examinations that you are taking this medicine.
Do not take Diclac 150 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 150 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 you have heart problems, have had a stroke, or suspect you are at risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss the treatment approach with your 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 strength.
Elderly patients (aged 65 years and older)
Elderly individuals may react more strongly to the medicine than other adults. Follow the instructions in this leaflet, use the lowest effective dose as recommended by your doctor, and report all adverse effects occurring during treatment to your doctor.
Diclac 150 Duo and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you 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 to treat hypertension and heart failure
• non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to reduce inflammatory conditions)
• anticoagulants and antiplatelet agents
• 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 150 Duo with food and drink
Swallow the tablets whole with water, preferably during a meal.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
Diclac 150 Duo should not be used during the first two trimesters unless absolutely necessary.
As with other anti-inflammatory medicines, Diclac 150 Duo should not be used during the last three months of pregnancy, as it may seriously harm the unborn child or adversely affect delivery.
Do not use Diclac 150 Duo if you are breastfeeding, as it may harm the infant.
Your doctor will discuss with you the potential risks of using Diclac 150 Duo during pregnancy and breastfeeding.
Taking Diclac 150 Duo may make it more difficult to become pregnant. If you are planning to become pregnant or have difficulty conceiving, inform your doctor.
Driving and operating machinery
The effect of Diclac 150 Duo on the ability to drive, operate machinery, or perform other tasks requiring special attention is unlikely.
Diclac 150 Duo contains monohydrate lactose and sodium
If you have previously been diagnosed with intolerance to certain sugars, consult your 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 150 Duo

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Do not exceed the recommended doses. If Diclac 150 Duo is used for longer than a few 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 the effect of the medicine seems too strong or too weak, consult a doctor.

Adults
1 Diclac 150 Duo tablet (150 mg of sodium diclofenac) once daily. The daily dose should not exceed 150 mg.

Use in children and adolescents
Due to the dosage strength, Diclac 150 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 those with low body weight, the lowest effective dose is recommended.

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

Renal function disorders
The use of Diclac 150 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 function impairment.

Hepatic function disorders
The use of Diclac 150 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 function impairment.

Method of administration
If symptoms are most pronounced at night or in the early morning, Diclac 150 Duo should be taken in the evening hours. Tablets should be swallowed whole with water, preferably during a meal. Do not divide or chew the tablets.

Duration of treatment with Diclac 150 Duo
Diclac 150 Duo should always be used as directed by a physician.
If Diclac 150 Duo is used long-term, regular contact with a physician is recommended to ensure no adverse effects have occurred.
If in doubt about how long to use the medicine, consult a doctor or pharmacist.

Overdose of Diclac 150 Duo
Overdose with Diclac 150 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.
If an excessive amount of tablets is taken by accident, contact a doctor, pharmacist, or go to a hospital emergency department immediately.

Missed dose of Diclac 150 Duo
If a patient misses a dose, it should be taken as soon as remembered. However, if more than half the time 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below relate to diclofenac in modified-release tablets and to diclofenac in other pharmaceutical forms, used either short-term or long-term.

Adverse reactions
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 1000 people taking the medicine):

• hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
• somnolence,
• asthma (including shortness of breath),
• gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, 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 platelet count), leukopenia (reduced white blood cell count), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of neutrophil granulocytes),
• angioedema (including facial oedema),
• 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 mucosal inflammation (including oral ulcerative stomatitis), glossitis, oesophageal disorders, membranous 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 disease, pruritus,
• acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

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

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

Taking medicines such as Diclac 150 Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Other adverse reactions may occur in some people during treatment with Diclac 150 Duo. If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

If any of the following adverse reactions occur, stop taking Diclac 150 Duo immediately and inform your doctor:

• stomach discomfort, heartburn or upper abdominal pain
• vomiting blood, blood in stools, 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 starting shortly after beginning treatment with Diclac 150 Duo, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency unknown).

Some adverse reactions may be serious
These uncommon adverse reactions may occur in 1 to 10 out of 1000 patients, especially during long-term use of high daily doses (150 mg):

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

If the patient is taking Diclac 150 Duo for longer than a few weeks, they should have regular contact with their doctor to ensure that no adverse reactions have occurred.

Reporting suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 reactions helps provide more information on the safety of the medicine.

5. How to store Diclac 150 Duo

Keep the medicine out of the sight and reach of children.
No special storage instructions are required.
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. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Diclac 150 Duo contains

• The active substance is sodium diclofenac. One modified-release tablet contains 150 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 150 Duo looks like and contents of the pack
Diclac 150 Duo tablets are two-layered, pink and white.
They are packed in PP/Al or PVC/Al blisters, placed in a cardboard box. The packs contain 10 or 20 modified-release tablets.
For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Lithuania, the country of export:
Sandoz d.d.
Verovškova 57
1000 Ljubljana
Slovenia
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
LEK S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Poland
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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation numbers in Lithuania, the country of export: LT/1/97/0010/013
LT/1/97/0010/014
Parallel import authorisation number: 50/22