Voltaren Sr 75

Leaflet accompanying the packaging: patient information

Voltaren SR 75 75 mg prolonged-release tablets

Diclofenac sodium

Voltaren SR 100 100 mg prolonged-release tablets

Diclofenac sodium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Voltaren SR 75 and Voltaren SR 100 and what are they used for
• 2. Important information before taking Voltaren SR 75 and Voltaren SR 100
• 3. How to take Voltaren SR 75 and Voltaren SR 100
• 4. Possible side effects
• 5. How to store Voltaren SR 75 and Voltaren SR 100
• 6. Package contents and other information

1. What is Voltaren SR 75 and Voltaren SR 100 and what are they used for

Voltaren SR 75 and Voltaren SR 100 contain diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Voltaren SR 75 and Voltaren SR 100 involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of inflammation, pain, and fever.

Voltaren SR 75 and Voltaren SR 100 are used to treat:

• Inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, psoriatic arthritis, and other spondyloarthropathies.
• 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.

Control tests during treatment with Voltaren SR 75 and Voltaren SR 100

In patients with diagnosed heart disease or significant risk factors for heart disease, the doctor 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, regular blood tests should be performed in case of any liver function disorders, kidney function disorders, or blood count abnormalities.

Both liver function (transaminase levels), kidney function (creatinine levels), and blood count (white blood cell count, red blood cell count, and platelet count) should be monitored. The doctor will take into account the results of the blood tests when deciding whether to discontinue treatment with Voltaren SR 75 and Voltaren SR 100 or change the dose.

2. Important information before taking Voltaren SR 75 and Voltaren SR 100

When not to take Voltaren SR 75 and Voltaren SR 100:

• 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, facial swelling, lip, tongue, throat, and/or limb edema (symptoms of angioedema), difficulty breathing, chest pain, or any other allergic reactions. If the patient thinks they may be allergic, they should consult their doctor;
• If the patient has active or a history of stomach or duodenal ulcers, bleeding, or perforation; if the patient has 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 heart disease or cerebrovascular disease, e.g., after a heart attack, stroke, transient ischemic attack (TIA), or vascular surgery;
• If the patient has circulation disorders (peripheral arterial disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren SR 75 and Voltaren SR 100 should not be taken by people who may experience an asthma attack, hives, or acute rhinitis after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors.

The patient should inform their doctor about these conditions.

Warnings and precautions

Before taking Voltaren SR 75 and Voltaren SR 100, the patient should discuss the following with their doctor:

• If the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, elevated cholesterol or triglyceride levels, or if the patient is a smoker, and the doctor decides to prescribe Voltaren SR 75 and Voltaren SR 100, the dose should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• If the medicine is taken by people with a history of gastrointestinal ulcers or in the elderly. Taking diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (which can be fatal). This effect can be particularly dangerous when taking high doses of diclofenac. If any unusual abdominal symptoms occur during treatment with Voltaren SR 75 and Voltaren SR 100 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the doctor consulted;
• If the patient has ulcerative colitis or Crohn's disease; diclofenac may exacerbate the disease;
• If the patient has asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease (COPD), or chronic respiratory infections, 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 who experience skin reactions, itching, or urticaria). The medicine should be administered with caution (preferably under medical supervision);

Patients with liver function disorders should be cautious when taking diclofenac, as it may worsen the disease. The patient should strictly follow the doctor's recommendations for monitoring liver function;

• If the patient has porphyria, 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, thrombosis, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

The risk of side effects can be minimized by using the smallest effective dose for the shortest possible time.

The patient should take the smallest dose of Voltaren SR 75 and Voltaren SR 100 that provides relief from pain and/or inflammation and take it for the shortest possible time to minimize the risk of side effects.

If the patient experiences any symptoms of heart or blood vessel disorders, such as chest pain, shortness of breath, weakness, or slurred speech, they should immediately contact their doctor or go to the emergency room.

Taking diclofenac may temporarily inhibit platelet aggregation.

Before taking Voltaren, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Voltaren may sometimes cause delayed wound healing in the intestines after surgery.

Children and adolescents

The medicine is not recommended for children and adolescents due to the dose size.

Elderly patients (65 years and older)

Elderly patients may be more sensitive to the effects of the medicine than other adults.

Patients should follow the recommendations in this leaflet, take the smallest effective dose as recommended by their doctor, and report any side effects that occur during treatment to their doctor.

Voltaren SR 75 and Voltaren SR 100 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 especially inform their doctor about taking the following medicines

• Lithium or antidepressant medicines (selective serotonin reuptake inhibitors);
• Digoxin - a medicine used to treat heart conditions;
• Diuretics - medicines that increase urine production;
• Angiotensin-converting enzyme inhibitors, beta-blockers - groups of medicines used to treat high blood pressure and heart failure;
• Non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (groups of medicines used to alleviate inflammatory conditions);
• Anticoagulant medicines and platelet inhibitors;
• 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;
• Cholestyramine and colestipol - 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 Voltaren SR 75 and Voltaren SR 100 with food and drink

The tablets should be swallowed whole, with a glass of water, preferably during a meal.

Pregnancy, breastfeeding, and fertility

Pregnancy

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.

The patient should not take Voltaren SR 75 and Voltaren SR 100 if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Voltaren SR 75 and Voltaren SR 100 may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and the child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Voltaren SR 75 and Voltaren SR 100 should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Voltaren SR 75 and Voltaren SR 100 may cause kidney problems in the unborn child if taken for more than a few days (which can lead to a low level of amniotic fluid surrounding the child or narrowing of the fetal ductus arteriosus). If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Voltaren SR 75 and Voltaren SR 100 should not be taken by breastfeeding women, as it may harm the baby.

The doctor will discuss the potential risks of taking Voltaren SR 75 and Voltaren SR 100 during pregnancy and breastfeeding with the patient.

Fertility

Taking Voltaren SR 75 and Voltaren SR 100 may make it more difficult to conceive. If the patient plans to conceive or is having trouble conceiving, they should inform their doctor.

Driving and using machines

The effect of Voltaren SR 75 and Voltaren SR 100 on the ability to drive and use machines is unlikely.

Voltaren SR 75 and Voltaren SR 100 contain sucrose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Voltaren SR 75 and Voltaren SR 100 contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Voltaren SR 75 and Voltaren SR 100

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

The patient should not exceed the recommended dose. If the patient is taking Voltaren SR 75 and Voltaren SR 100 for more than a few weeks, they should have regular medical check-ups to rule out any unnoticed side effects. The general recommendation is for the doctor to adjust the dose individually for each patient and 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, taken as one Voltaren SR 100 tablet or two Voltaren SR 75 tablets.

In milder cases and for chronic treatment, one Voltaren SR 75 or Voltaren SR 100 tablet per day is usually sufficient.

If symptoms are most pronounced at night or in the morning, the patient should take Voltaren SR 75 or Voltaren SR 100 in the evening.

Use in children and adolescents

Due to the dose size, Voltaren SR 75 and Voltaren SR 100 are not recommended for children and adolescents under 18 years of age.

Elderly patients (65 years and older)

The medicine should be used with caution in elderly patients. For elderly patients and those with a low body mass, the smallest effective dose is recommended.

Diagnosed cardiovascular disease or significant cardiovascular risk factors

Patients with diagnosed cardiovascular disease or significant risk factors for cardiovascular events should be treated with diclofenac only after careful consideration and with doses not exceeding 100 mg per day if treatment lasts longer than 4 weeks.

Kidney function disorders

Voltaren SR 75 and Voltaren SR 100 are 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. Caution is advised when administering Voltaren SR 75 and Voltaren SR 100 to patients with mild to moderate kidney function disorders.

Liver function disorders

Voltaren SR 75 and Voltaren SR 100 are 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. Caution is advised when administering Voltaren SR 75 and Voltaren SR 100 to patients with mild to moderate liver function disorders.

Method of administration

If symptoms are most pronounced at night or in the morning, Voltaren SR 75 and Voltaren SR 100 should be taken in the evening. The tablets should be swallowed whole, with a glass of water, preferably during a meal. The tablets should not be divided or chewed.

How long to take Voltaren SR 75 and Voltaren SR 100

Voltaren SR 75 and Voltaren SR 100 should always be taken as directed by the doctor.

If the patient is taking Voltaren SR 75 and Voltaren SR 100 for a long time, they should regularly consult their doctor to ensure that no side effects have occurred.

If the patient has any doubts about how long to take the medicine, they should consult their doctor or pharmacist.

Taking a higher dose of Voltaren SR 75 and Voltaren SR 100 than recommended

Overdose of Voltaren SR 75 and Voltaren SR 100 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In cases of significant overdose, acute kidney failure and liver damage may occur.

If the patient has taken more tablets than recommended, they should immediately consult their doctor, pharmacist, or go to the emergency room.

Missing a dose of Voltaren SR 75 and Voltaren SR 100

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 the missed dose and the next scheduled dose, the patient should not take the missed dose and should take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Voltaren SR 75 and Voltaren SR 100 can cause side effects, although not everybody gets them.

The following side effects are described in the leaflet:

Side effects:

Common (may affect up to 1 in 10 people)

• Headache, dizziness,
• Nausea, vomiting, diarrhea, indigestion, abdominal pain, bloating, decreased appetite,
• Increased transaminase activity,
• Rash.

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

• 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,
• Peptic ulcer disease (with or without bleeding and perforation),
• Hepatitis, jaundice, liver function disorders,
• Urticaria,
• Edema.

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

• Thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (decreased granulocyte count),
• Angioedema (including facial edema),
• 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, intestinal stricture, pancreatitis,
• Fulminant hepatitis, liver necrosis, liver failure,
• Bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), 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)

• Concurrent occurrence of chest pain and allergic reactions (Kounis syndrome),
• Ischemic colitis.

Taking medicines like Voltaren SR 75 and Voltaren SR 100 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

In some people, taking Voltaren SR 75 and Voltaren SR 100 may cause other side effects not listed in this leaflet. If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

If the patient experiences any of the following side effects, they should stop taking Voltaren SR 75 and Voltaren SR 100 and consult their doctor:

• Discomfort in the stomach, heartburn, or abdominal pain,
• Bloody vomiting, blood in the stool, blood in the urine,
• Skin disorders such as rash or itching,
• Shortness of breath or difficulty breathing,
• Yellowing of the skin or whites of the eyes,
• Persistent 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 Voltaren SR 75 and Voltaren SR 100, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency not known - frequency cannot be estimated from the available data),
• Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Some side effects can be serious

These uncommon side effects may occur in fewer than 1 in 100 people, 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 is taking Voltaren SR 75 and Voltaren SR 100 for more than a few weeks, they should regularly consult their doctor to ensure that no side effects have occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they 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 181, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Voltaren SR 75 and Voltaren SR 100

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton.

Voltaren SR 75

Store below 30°C.

Store in the original packaging to protect from moisture.

Voltaren SR 100

Store below 30°C.

6. Package contents and other information

What Voltaren SR 75 contains

• The active substance is diclofenac sodium. One prolonged-release tablet of Voltaren SR 75 contains 75 mg of diclofenac sodium.
• The other ingredients are: sucrose, cetyl alcohol, colloidal anhydrous silica, povidone K 30, magnesium stearate. The coating contains: hypromellose, polysorbate 80, titanium dioxide (E 171), iron oxide red (E 172), talc, macrogol 8000, sucrose.

What Voltaren SR 100 contains

• The active substance is diclofenac sodium. One prolonged-release tablet of Voltaren SR 100 contains 100 mg of diclofenac sodium.
• The other ingredients are: cetyl alcohol, colloidal anhydrous silica, magnesium stearate, povidone K 30, sucrose. The coating contains: iron oxide red (E 172), polysorbate 80, talc, titanium dioxide (E 171), hypromellose 2910, macrogol 8000, sucrose.

What Voltaren SR 75 and Voltaren SR 100 look like and contents of the pack

One package contains 2 or 3 blisters of 10 prolonged-release tablets.

What Voltaren SR 100 looks like and contents of the pack

One package contains 2 blisters of 10 prolonged-release tablets.

Marketing authorization holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, tel. +48 22 37 54 888

Manufacturer/Importer

Novartis Farma S.p.A., Via Provinciale Schito, 131, 80058 Torre Annunziata (NA), Italy; Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg und Obere Turnstrasse 8-10, Germany; Novartis Farmacéutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain

Date of last revision of the leaflet: 05/2025