Voltaren Sr 100

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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 crucial role in the pathogenesis of inflammation, pain, and fever. Voltaren SR 75 and Voltaren SR 100 are used in the treatment of:

• 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 surgery.
• 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 cardiovascular 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 blood tests when deciding 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:

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren SR 75 and Voltaren SR 100 should not be taken by people who may experience asthma attacks, hives, or nasal polyps after taking acetylsalicylic acid or other medicines that inhibit prostaglandin synthesis. Inform your doctor about these conditions.

Warnings and precautions

Before taking Voltaren SR 75 and Voltaren SR 100, discuss with your doctor:

if you have liver function disorders, diclofenac may worsen the course of the disease. Follow your doctor's recommendations for regular liver function tests;

Before taking diclofenac, inform your doctor:

The risk of side effects can be minimized by using the smallest effective dose and for the shortest duration necessary. Use the smallest dose of Voltaren SR 75 and Voltaren SR 100 that provides relief from pain and/or inflammation and use it for the shortest time necessary to minimize the risk of side effects. If you experience any symptoms that may indicate heart or blood vessel disorders, such as chest pain, shortness of breath, weakness, or slurred speech, consult your doctor or hospital emergency department immediately. Taking diclofenac may temporarily inhibit platelet aggregation. Before taking Voltaren, tell your doctor if you 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. Follow the recommendations in this leaflet, take the medicine as directed by your doctor, and report any side effects that occur during treatment to your doctor.

Voltaren SR 75 and Voltaren SR 100 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.

Inform your doctor especially 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 relieve inflammation in areas of the body affected by inflammation);
• Anticoagulants and antiplatelet agents;
• Oral 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;
• Colestyramine 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

Swallow the tablets whole with water, preferably during a meal.

Pregnancy, breastfeeding, and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine.
Do not take Voltaren SR 75 and Voltaren SR 100 if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Voltaren SR 75 and Voltaren SR 100 may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, do not take Voltaren SR 75 and Voltaren SR 100 unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest effective dose 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 baby if taken for more than a few days (which may lead to low amniotic fluid levels around the baby or narrowing of the ductus arteriosus in the baby's heart). If treatment is required for a longer period, your doctor may recommend additional monitoring.
Breastfeeding
Do not take Voltaren SR 75 and Voltaren SR 100 while breastfeeding, as it may harm the baby.
Your doctor will discuss the potential risks of taking Voltaren SR 75 and Voltaren SR 100 during pregnancy and breastfeeding with you.
Fertility
Taking Voltaren SR 75 and Voltaren SR 100 may make it more difficult to conceive. If you plan to conceive or are having trouble conceiving, inform your 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 you have been diagnosed with intolerance to some sugars, consult your 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

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Do not exceed the recommended dose. If you are taking Voltaren SR 75 and Voltaren SR 100 prolonged-release tablets for more than a few weeks, regular medical check-ups should be performed to rule out any unnoticed side effects. The general recommendation is for your doctor to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible time.
If you feel that the effect of the medicine is too strong or too weak, consult your 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, 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 low body weight, the recommended dose is the smallest effective dose.

Diagnosed cardiovascular disease or significant cardiovascular risk factors

Patients with diagnosed cardiovascular disease or significant cardiovascular risk factors should be treated with diclofenac only after careful consideration and only with doses ≤ 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 recommended 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 recommended 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, take Voltaren SR 75 or Voltaren SR 100 in the evening. Swallow the tablets whole with water, preferably during a meal. Do not divide or chew the tablets.

How long to take Voltaren SR 75 and Voltaren SR 100

Always take Voltaren SR 75 and Voltaren SR 100 exactly as your doctor has told you.
If you are taking Voltaren SR 75 and Voltaren SR 100 for a long time, regularly consult your doctor to ensure that no side effects have occurred.
If you are unsure how long to take the medicine, consult your 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 case of significant poisoning, acute kidney failure and liver damage may occur.
If you have taken more tablets than recommended, consult your doctor, pharmacist, or hospital emergency department immediately.

Missing a dose of Voltaren SR 75 and Voltaren SR 100

If you miss a dose, take it as soon as you remember. However, if more than half of the time has passed between two doses, do not take the missed dose and take the next dose according to the previous dosing schedule. Do 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 listed, which have been reported with Voltaren SR 75 and Voltaren SR 100 prolonged-release tablets, as well as with other diclofenac formulations, used for short or long periods.

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 pseudoanaphylactic reactions (including sudden drop in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, bloody vomiting, bloody diarrhea, melena,
• stomach or duodenal ulcers (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• hives,
• 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, stroke,
• 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 available data)

• concomitant occurrence of chest pain and allergic reactions (Kounis syndrome symptoms),
• 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, while taking Voltaren SR 75 and Voltaren SR 100, other side effects may occur. If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

If you experience any of the following side effects, stop taking Voltaren SR 75 and Voltaren SR 100 and consult your doctor immediately:

• discomfort in the stomach, heartburn, or abdominal pain,
• bloody vomiting, blood in stool, blood in urine,
• skin reactions 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 legs,
• 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 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 no more 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 while lying down, swelling of the feet or legs (symptoms of heart failure).

If you are taking Voltaren SR 75 and Voltaren SR 100 for more than a few weeks, regularly consult your doctor to ensure that no side effects have occurred.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

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

Keep the medicine out of the 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.
• Other ingredients are: sucrose, cetyl alcohol, colloidal anhydrous silica, povidone K 30, magnesium stearate. The coating contains: hypromellose, polysorbate 80, titanium dioxide (E 171), red iron oxide (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.
• Other ingredients are: cetyl alcohol, colloidal anhydrous silica, magnesium stearate, povidone K 30, sucrose. The coating contains: red iron oxide (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