Diclac 50

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging 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 medicine.

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Diclac 50 and what is it used for
• 2. Important information before taking Diclac 50
• 3. How to take Diclac 50
• 4. Possible side effects
• 5. How to store Diclac 50
• 6. Contents of the pack and other information

1. What is Diclac 50 and what is it used for

Diclac 50 contains diclofenac sodium, which belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-rheumatic, anti-inflammatory, analgesic, and antipyretic effects. The mechanism of action of Diclac 50 involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of inflammation, pain, and fever.
Diclac 50 is used to treat:

• inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, juvenile rheumatoid arthritis (Still's disease), ankylosing spondylitis, osteoarthritis, psoriatic arthritis, spinal pain syndromes, and extra-articular rheumatism;
• acute attacks of gout;
• pain caused by post-traumatic and post-operative inflammatory conditions and swelling, e.g., after dental or orthopedic procedures;
• painful and inflammatory conditions in gynecology, e.g., primary dysmenorrhea or adnexitis;
• supportive treatment for severe, painful infections of the ear, nose, or throat, such as pharyngitis and tonsillitis. According to general therapeutic principles, in the case of the above-mentioned diseases, causal treatment should be applied first. Fever, as the only symptom, is not an indication for use.

Control Tests 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 their 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 levels), and blood cell count (white and red blood cell count and platelet count). Based on the test results, the physician will decide whether to discontinue treatment with Diclac 50 or change the dose of the medicine.

2. Important Information Before Taking Diclac 50

When Not to Take 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 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, facial swelling, lip swelling, tongue swelling, throat swelling, and (or) limb swelling (symptoms of angioedema). If the patient thinks they may be allergic, they should consult a doctor;
• if the patient has active or a history of stomach or duodenal ulcers, 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 third trimester of pregnancy;
• if the patient has liver failure;
• if the patient has kidney failure;
• if the patient has heart disease and (or) cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia (mini-stroke), occlusion of cardiac or cerebral vessels, or after a procedure to open or bypass blocked vessels;
• if the patient has or has had circulatory disorders (peripheral vascular disease).

The patient should inform their doctor about the presence of these diseases.

Warnings and Precautions

Before taking Diclac 50, the patient should discuss it with their doctor if:

• the patient has diagnosed cardiovascular disease (see above) or significant risk factors, such as high blood pressure, elevated lipid levels (cholesterol, triglycerides), or if the patient is a smoker, as in such cases, the dose of the medicine should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• the patient has had a gastrointestinal ulcer or is elderly. Taking diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (with possible fatal outcome). Such effects may be particularly dangerous in cases of high doses of the medicine;
• if any unusual abdominal symptoms occur during treatment with Diclac 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should consult a doctor;
• the patient has ulcerative colitis or Crohn's disease; diclofenac may exacerbate the disease;
• the patient has asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections, as they are more likely to experience an allergic reaction to diclofenac (exacerbation of asthma symptoms, angioedema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those with skin reactions, itching, or urticaria). The medicine should be taken with caution (preferably under medical supervision);
• the patient has liver function disorders; diclofenac may worsen the course of the disease. The patient should strictly follow the doctor's recommendations for regular liver function tests;
• the patient has porphyria, as diclofenac may trigger a porphyria attack.

Before taking diclofenac, the patient should inform their doctor:

• if they smoke,
• if they have diabetes,
• if they have angina pectoris, thrombosis, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

The patient should use the smallest effective dose of Diclac 50 that relieves pain and (or) inflammation and use it for the shortest possible time to minimize the risk of side effects.
If at any time during treatment with Diclac 50 the patient experiences symptoms indicating heart or blood vessel problems (such as chest pain, shortness of breath, weakness, or slurred speech), they should immediately contact their doctor or the emergency department.
Taking diclofenac may, in very rare cases (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, and toxic epidermal necrolysis with skin and mucous membrane changes, high fever, and severe general condition). After the first signs of rash, mucous membrane changes, or other symptoms of an allergic reaction, the medicine should be discontinued and the patient should consult a doctor.
The medicine may mask infection symptoms (e.g., headache, elevated body temperature) and make it difficult to diagnose properly. During medical examinations, the patient should inform their doctor about taking the medicine.
The patient should not take Diclac 50 at the same time as other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors.
Before taking the medicine, the patient should inform their doctor or pharmacist about the presence of the above-mentioned diseases.
Taking such medicines 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. The patient should not take higher doses or use the medicine for longer than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol levels, smoking), the patient should discuss their treatment with their doctor or pharmacist.
The medicine may temporarily inhibit platelet aggregation.

Children and Adolescents

The medicine should not be used in children and adolescents under the age of 14.

Elderly Patients (65 Years and Older)

Elderly patients may react more strongly to the medicine than other adults. The patient should follow the recommendations in the leaflet, take the smallest effective dose according to the doctor's recommendations, and report all side effects that occur during treatment to their doctor.

Diclac 50 and Other Medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The Patient Should Inform Their Doctor Especially About Taking the Following Medicines:

• lithium or antidepressant medicines (selective serotonin reuptake inhibitors)
• digoxin - a medicine used to treat heart diseases
• diuretics - medicines that increase urine production
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers - a group of medicines used to treat high blood pressure and heart failure
• non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid, ibuprofen, selective cyclooxygenase-2 inhibitors) and corticosteroids (a group of medicines used to alleviate certain inflammatory conditions)

and

• anticoagulant and antiplatelet medicines
• antidiabetic medicines (except insulin)
• methotrexate - a medicine used to treat certain cancers or arthritis
• cyclosporine and tacrolimus - medicines used in organ transplant patients
• trimethoprim - a medicine used to prevent and treat urinary tract infections
• quinolone antibacterials - medicines used to treat infections
• colestipol and cholestyramine - medicines that lower cholesterol levels in the blood
• voriconazole - a medicine used to treat fungal infections
• phenytoin - a medicine used to treat epileptic seizures

Taking Diclac 50 with Food and Drink

The tablets should be swallowed whole, with a glass of water, preferably before meals.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
The patient should not take Diclac 50 if they are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Diclac 50 may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, the patient should not take Diclac 50 unless their doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the patient should take the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, Diclac 50 may cause kidney problems in the unborn baby if taken for more 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 is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
The patient should not take Diclac 50 while breastfeeding, as it may harm the baby.
The doctor will discuss the potential risks of taking Diclac 50 during pregnancy and breastfeeding with the patient.
Fertility
Taking Diclac 50 may make it difficult to conceive. If the patient plans to conceive or has problems conceiving, they should inform their doctor.

Driving and Using Machines

The effect of Diclac 50 on the ability to drive and use machines is unlikely.

Diclac 50 Contains Lactose Monohydrate and Sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to Take Diclac 50

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should not exceed the recommended dose. If Diclac 50 is taken for more than a few weeks, the patient should regularly undergo medical check-ups to rule out any unnoticed side effects.
The dose of the medicine is determined by the doctor individually for each patient. The rule is to use the smallest effective dose for the shortest possible time.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Adults

The recommended initial daily dose is 100 mg to 150 mg.
In milder cases and for chronic treatment, a dose of up to 100 mg per day is considered sufficient.
The total daily dose should be taken in 2 to 3 divided doses. To alleviate nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented with a suppository before bedtime (without exceeding the maximum daily dose of 150 mg).
In primary dysmenorrhea, the daily dose is determined individually by the doctor 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 can be increased over several menstrual cycles to a maximum of 200 mg per day. Treatment should be started when the first symptoms appear and continued for several days, depending on their severity.

Other Indications for Use

Diclac 50 is not recommended for children and adolescents.

Diagnosed Cardiovascular Disease or Significant Cardiovascular Risk Factors

Patients with diagnosed cardiovascular disease or significant risk factors for cardiovascular events should take diclofenac only after their doctor has assessed their situation and only at a dose of ≤100 mg per day if treatment lasts longer than 4 weeks.

Kidney Function Disorders

Taking Diclac 50 is contraindicated in patients with kidney failure.
No special studies have been conducted in patients with kidney function disorders, so no specific dosage recommendations can be made. In patients with mild to moderate kidney function disorders, caution is advised.

Liver Function Disorders

Taking Diclac 50 is contraindicated in patients with liver failure.
No special studies have been conducted in patients with liver function disorders, so no specific dosage recommendations can be made. In patients with mild to moderate liver function disorders, caution is advised.

Method of Administration

The tablets should be swallowed whole, with a glass of water, preferably before meals. The tablets should not be divided or chewed.

How Long to Take Diclac 50

Diclac 50 should always be taken as directed by the doctor.
If the patient takes Diclac 50 for a long time, they should regularly consult their doctor to ensure that no side effects have occurred.
In case of doubts about how long to take the medicine, the patient should consult their doctor or pharmacist.

Taking a Higher Dose of Diclac 50 Than Recommended

Overdosing on Diclac 50 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In case of significant poisoning, acute kidney failure and liver damage may occur.
If the patient has accidentally taken more tablets than recommended, they should immediately consult their doctor, pharmacist, or go to the emergency department.

Missing a Dose of Diclac 50

If the patient misses a dose, they should take it as soon as they remember. However, if more than half of the time has passed between two doses, the patient should not take the missed dose but take the next tablet according to the previous dosage schedule. The patient should not take a double dose to make up for the missed dose.

4. Possible Side Effects

Like all medicines, Diclac 50 can cause side effects, although not everybody gets them.
The following side effects are related to diclofenac in the form of enteric-coated tablets and other pharmaceutical forms, used for short or long periods.

Side Effects

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

• headache, dizziness,
• nausea, vomiting, diarrhea, indigestion, abdominal pain, bloating, decreased appetite,
• increased aminotransferase activity,
• rash.

Uncommon(may occur in less than 1 in 100 people taking the medicine):

• myocardial infarction, heart failure, palpitations, chest pain.

Rare(may occur in less than 1 in 1000 people taking the medicine):

• hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including sudden drop in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, bloody vomiting, bloody diarrhea, melena,
• peptic ulcer of the stomach and (or) duodenum (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• edema.

Very Rare(may occur in less than 1 in 10,000 people taking the medicine):

• thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (decreased or absent granulocytes),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disorders, cerebrovascular accident,
• visual disturbances, blurred vision, double vision,
• tinnitus, hearing disorders,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including bloody colitis and exacerbation of ulcerative colitis and Crohn's disease), constipation, oral mucositis (including ulcerative stomatitis), glossitis, esophageal disorders, membranous intestinal stenosis, pancreatitis,
• fulminant hepatitis, liver necrosis, liver failure,
• bullous rash, erythema, erythema multiforme, Stevens-Johnson syndrome,
• toxic epidermal necrolysis, exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Henoch-Schönlein purpura, pruritus,
• acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Frequency Not Known(frequency cannot be estimated from the available data):

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

Taking such medicines as Diclac 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In some people, during treatment with Diclac 50, other side effects may occur.
If any side effects worsen or any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.
Some side effects can be serious.

In Case of Any of the Following Side Effects, the Patient Should Immediately Stop Taking Diclac 50 and Inform Their Doctor:

• discomfort in the stomach, heartburn, or abdominal pain
• bloody vomiting, blood in the stool, blood in the urine
• skin problems, such as rash or itching
• shortness of breath or difficulty breathing
• yellowing of the skin or whites of the eyes
• prolonged sore throat or high fever
• swelling of the face, feet, or ankles
• severe migraine
• chest pain accompanied by coughing
• mild painful abdominal cramps and tenderness, starting soon after taking Diclac 50, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from the available data).

Some Side Effects Can Be Serious

These uncommon side effects may occur in 1-10 patients in 1000, especially when taking high daily doses (150 mg) for a long time

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

If the patient takes Diclac 50 for more than a few weeks, they should regularly consult their doctor to ensure that no side effects have occurred.

Reporting Side Effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to Store Diclac 50

• Keep out of the sight and reach of children.
• Store in a temperature below 25°C. Store 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 month stated.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Diclac 50 Contains

• The active substance of the medicine is diclofenac sodium. One enteric-coated tablet contains 50 mg of diclofenac sodium.
• Other ingredients are: tablet core:lactose monohydrate, corn starch, calcium hydrogen phosphate, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, anhydrous colloidal silica; 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 packaged in PP/Al foil blisters in a cardboard box.
The packaging contains 30 or 50 enteric-coated tablets.
For more detailed information about the medicine, the patient should contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Portugal, the 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 by:

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
Portuguese Marketing Authorization Number:5762299
5670898
Parallel Import Authorization Number:314/20

Date of Leaflet Approval: 07.06.2023

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