Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Diclac 150 Duo (Diclac ID 150 mg)
150 mg, prolonged-release tablets
Diclofenacum natricum
Diclac 150 Duo and Diclac ID 150 mg are different trade names for the same medicinal product.
Please read the 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 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, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What Diclac 150 Duo is and what it is used for
Important information before taking Diclac 150 Duo
How to take Diclac 150 Duo
Possible side effects
How to store Diclac 150 Duo
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 for the treatment of:

inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spinal arthritis, painful conditions associated with spinal changes, extra-articular rheumatism;
pain caused by traumatic and postoperative inflammatory conditions and oedema, e.g. after dental or orthopaedic procedures;
painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis.

Monitoring during treatment with Diclac 150 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 response to the medicine, especially if treatment lasts longer than 4 weeks.
During treatment, the physician 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 physician will decide whether to discontinue treatment with Diclac 150 Duo or adjust the dose.

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 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 you think you may be allergic, consult your doctor.
if you have active or a history of peptic ulcer 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 liver failure,
if you have kidney failure,
if you have been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA), or vascular embolism in the heart or brain, or after a procedure to open blocked vessels or bypass surgery,
if you have current or previous circulatory disorders (peripheral vascular disease).

You should inform your doctor if you have any of the above conditions.
Warnings and precautions
Talk to your doctor before starting to take Diclac 150 Duo 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 dose of the medicine should not exceed 100 mg per day if treatment lasts longer than 4 weeks;
you have a history of gastrointestinal ulceration or are elderly. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation (which may be fatal). Such effects may be particularly dangerous when high doses of the medicine 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 oedema (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 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);
you have liver function disorders, as diclofenac may worsen the course of the disease. Strictly follow your doctor's recommendations regarding regular liver function tests;
you suffer from hepatic porphyria, as diclofenac may trigger an attack of porphyria;
you have previously experienced severe skin rash, skin peeling, blistering and/or oral ulceration after taking Diclac 150 Duo or other analgesic medicines.

Before taking diclofenac, inform your doctor if:

you smoke,
you have diabetes,
you suffer from 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 minimise the risk of adverse effects.
If at any time during treatment with Diclac 150 Duo you experience symptoms indicating heart or blood vessel problems, such as chest pain, shortness of breath, weakness or slurred speech, contact your doctor or emergency department immediately.
The use of diclofenac 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, mucous membrane changes or other symptoms of allergic reaction, discontinue the medicine and contact your doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and make correct diagnosis more difficult. Inform your doctor during medical examinations that you are taking this medicine.
Do not take Diclac 150 Duo together with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Before taking the medicine, inform your doctor or pharmacist if you have 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 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, elevated cholesterol, smoking), discuss treatment options 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 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 smallest effective dose as recommended by your doctor, and report all adverse effects occurring during treatment to your doctor.
Diclac 150 Duo with other medicines
Inform 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 in the treatment of 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 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
Tablets should be swallowed 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, you should consult your doctor before taking this medicine.
Pregnancy
Do not take Diclac 150 Duo if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac 150 Duo may cause kidney and heart function disorders in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour. Do not use Diclac 150 Duo during the first 6 months of pregnancy unless your 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 duration.
From the 20th week of pregnancy, Diclac 150 Duo 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 the blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Do not use Diclac 150 Duo in breastfeeding women, as it may harm the infant.
Your doctor will discuss with you the potential risks of using Diclac 150 Duo during pregnancy and breastfeeding.
Fertility
Taking Diclac 150 Duo may make it more difficult to become pregnant. If you are planning a pregnancy 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 lactose monohydrate and sodium
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this 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 150 Duo

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician 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 physician will determine the dosage individually 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 the physician.

Adults
1 Diclac 150 Duo tablet (150 mg of sodium diclofenac) once daily. Do not use a daily dose exceeding 150 mg.

Use in children and adolescents
Due to the dose size, 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 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 of ≤100 mg per day if treatment lasts longer than 4 weeks.

Renal function disorders
The use of Diclac 150 Duo in patients with renal insufficiency is contraindicated.
No specific studies have been conducted in patients with renal function disorders; therefore, appropriate dose adjustment recommendations cannot be provided. Caution is advised in patients with mild to moderate renal impairment.

Hepatic function disorders
The use of Diclac 150 Duo in patients with hepatic insufficiency is contraindicated.
No specific studies have been conducted in patients with hepatic function disorders; therefore, appropriate dose 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 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
Diclal 150 Duo should always be used as directed by the physician.
If Diclac 150 Duo is used long-term, regular contact with the physician is recommended to ensure no adverse effects have occurred.
In case of doubt regarding the duration of treatment, consult the physician or pharmacist.

Overdose of Diclac 150 Duo
Overdose of 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.
In case of accidental ingestion of more tablets than recommended, contact a physician, 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 of the interval between doses has passed, the missed dose should not be taken; instead, the next tablet should be taken according to the original 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 the form of prolonged-release tablets and diclofenac in other pharmaceutical forms, used short-term or long-term.
Adverse effects
Common ( may affect up to 1 in 10 patients ):

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

Uncommon ( may affect up to 1 in 100 patients ):

myocardial infarction, heart failure, palpitations, chest pain.

Rare ( may affect up to 1 in 1,000 patients ):

hypersensitivity, anaphylactic and pseudoallergic reactions (including sudden drop in blood pressure and shock),
somnolence,
asthma (including breathlessness),
gastric mucosal inflammation, gastrointestinal bleeding, blood in vomit, bloody diarrhoea, tarry stools,
gastric and (or) duodenal ulcer disease (with or without bleeding and perforation),
hepatitis, jaundice, liver function disorders,
urticaria,
oedema.

Very rare ( may affect up to 1 in 10,000 patients ):

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 white blood cells - neutrophil 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 oral ulcerative stomatitis), glossitis, oesophageal disorders, membranous intestinal stricture, pancreatitis,
fulminant hepatitis, hepatic necrosis, liver failure,
blistering rash, eczema, erythema, erythema multiforme, 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 effects with unknown frequency ( frequency cannot be estimated from the available data ):

simultaneous occurrence of chest pain and allergic reaction (symptoms of Kounis syndrome),
allergic skin reaction, which may present as round or oval redness and swelling of the skin, blisters and itching (fixed erythema). The skin in affected areas may also appear darker, which may persist after healing. Upon re-administration of the drug, fixed erythema usually reappears in the same locations.

Taking medicines such as Diclac 150 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 150 Duo. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
You must stop taking Diclac 150 Duo and seek immediate medical advice if any of the following adverse effects occur – you may require urgent treatment:

stomach discomfort, heartburn or upper abdominal pain,
vomiting blood, blood in stool, blood in urine,
skin reactions such as rash or itching,
severe allergic skin reaction, which may present as extensive red and (or) dark patches, skin swelling, blisters and itching (generalized fixed bullous drug eruption),
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 150 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 up to 1 in 100 patients, especially when high daily doses (150 mg) are used for a prolonged period:

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 150 Duo for longer than a few weeks, you should regularly consult your doctor to ensure that no adverse effects have occurred.
Reporting 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 150 Duo

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
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 how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diclac 150 Duo contains

The active substance is sodium diclofenac. One prolonged-release tablet contains 150 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 150 Duo looks like and contents of the pack
Diclac 150 Duo tablets consist of two layers: pink and white.
The tablets are packed in PP/Aluminium blisters in a cardboard box.
The packs contain 10 or 20 prolonged-release tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany
LEK S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Latvia, country of export: 99-0828
Parallel Import Authorisation number: 106/21