Voltaren Sr 100

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Voltaren SR 100 (Voltaren)

100 mg, prolonged-release tablets

Diclofenac sodium
Voltaren SR 100 and Voltaren are different trade names for the same medicine.

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should 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 adverse reactions, including any adverse reactions 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 100 and what is it used for
• 2. Important information before taking Voltaren SR 100
• 3. How to take Voltaren SR 100
• 4. Possible side effects
• 5. How to store Voltaren SR 100
• 6. Contents of the packaging and other information

1. What is Voltaren SR 100 and what is it used for

Voltaren SR 100 contains diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-rheumatic, anti-inflammatory, analgesic, and antipyretic effects. The mechanism of action of Voltaren SR 100 involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of inflammation, pain, and fever.
Voltaren SR 100 is used to treat:

• Inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, psoriatic arthritis, spinal arthritis, pain syndromes associated with spinal changes, extra-articular rheumatism.
• Pain caused by post-traumatic and post-operative inflammatory conditions and swelling, e.g. after dental or orthopedic procedures.
• Painful and/or inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis.

Control tests during treatment with Voltaren SR 100

In the case of 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 the event of any liver function disorders, kidney function disorders, and blood count disorders.
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 100 or change the dose of the medicine.

2. Important information before taking Voltaren SR 100

When not to take Voltaren SR 100:

Like other non-steroidal anti-inflammatory drugs (NSAIDs), 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 the above-mentioned diseases.

Warnings and precautions

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

The medicine should be administered with caution (preferably under medical supervision);

Before taking diclofenac, the patient should inform their doctor

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".
Taking this type of medicine, such as Voltaren SR 100, 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 the event of heart problems, a history of stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, high 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 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. The patient should follow the recommendations in the leaflet, take the smallest effective dose as recommended by the doctor, and report any side effects that occur during treatment to their doctor.

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 and antiplatelet medicines
• Antidiabetic medicines (except insulin)
• Methotrexate - a medicine used to treat certain cancers or arthritis
• Cyclosporine and tacrolimus - medicines used in organ transplantation
• 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 100 with food and drink

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

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.
During pregnancy, during the first two trimesters, if it is not absolutely necessary, Voltaren SR 100 should not be taken.
As with other anti-inflammatory drugs, taking Voltaren SR 100 in the last 3 months of pregnancy is contraindicated, as it may seriously harm the fetus or have an adverse effect on labor.
Voltaren SR 100 should not be taken by breastfeeding women, as it may have adverse effects on the infant.
The doctor will discuss the potential risks of taking Voltaren SR 100 during pregnancy and breastfeeding with the patient.
Taking Voltaren SR 100 may make it more difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

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

Voltaren SR 100 contains sucrose

Voltaren SR 100 in the form of prolonged-release tablets contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Voltaren SR 100

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Voltaren SR 75 (75 mg) and Voltaren SR 100 (100 mg) are available on the market.
The recommended dose should not be exceeded. If the patient is taking Voltaren SR 100 prolonged-release tablets 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 period.
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, given as one Voltaren SR 100 tablet or two Voltaren SR 75 tablets.
In milder cases and in chronic treatment, one Voltaren SR 75 or Voltaren SR 100 tablet per day is usually sufficient.
If the 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 100 is 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. In elderly patients and those with low body weight, 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 100 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. Caution is recommended when administering Voltaren SR 100 to patients with mild to moderate kidney function disorders.

Liver function disorders

Voltaren SR 100 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. Caution is recommended when administering Voltaren SR 100 to patients with mild to moderate liver function disorders.

Method of administration

If the symptoms are most pronounced at night or in the morning, 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 100

Voltaren SR 100 should always be taken as directed by the doctor.
If the patient is taking Voltaren SR 100 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 Voltaren SR 100 than recommended

Overdosing on Voltaren SR 100 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In the case of significant poisoning, acute kidney failure and liver damage may occur.
In the event of accidental ingestion of a larger amount of tablets than recommended, the patient should immediately consult a doctor, pharmacist, or go to the emergency department.

Missing a dose of Voltaren SR 100

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

4. Possible side effects

Like all medicines, Voltaren SR 100 can cause side effects, although not everybody gets them.
The frequency of side effects is estimated as follows:
very common (≥1/10); common (≥1/100 to <1>rare (≥1/10 000 to <1>The following side effects include those reported with Voltaren SR 100, as well as those observed with other forms of diclofenac, used for short or long periods.

Side effects:

Common

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

Uncommon

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

Rare

• hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including sudden drop in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, hematemesis, melena,
• peptic ulcer disease (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• hives,
• edema.

Very rare

• 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 hemorrhagic colitis and exacerbation of ulcerative colitis, 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.

Unknown

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

Taking medicines like 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 100, other side effects may occur. If any of the side effects worsen or if any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.

If any of the following side effects occur, the patient should stop taking Voltaren SR 100 and inform their doctor:

• discomfort in the stomach, heartburn, or pain in the upper abdomen,
• hematemesis, melena, or hematuria,
• skin disorders such as rash or pruritus,
• shortness of breath or wheezing,
• jaundice or yellowing of the eyes,
• prolonged sore throat or high fever,
• facial edema, swelling of the feet or ankles,
• severe migraine,
• chest pain accompanied by coughing,
• mild painful abdominal cramps and tenderness, starting soon after taking Voltaren SR 100, followed by rectal bleeding or melena, usually within 24 hours of abdominal pain onset (frequency unknown - cannot be estimated from the available data),
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Some side effects can be serious

These uncommon side effects may occur in 1-10 patients out of 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 while lying down, swelling of the feet or ankles (symptoms of heart failure).

If the patient is taking 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 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 Adverse Reaction Monitoring 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 side effects will help gather more information on the safety of the medicine.

5. How to store Voltaren SR 100

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 packaging and other information

What Voltaren SR 100 contains

• The active substance of the medicine is diclofenac sodium. One prolonged-release tablet of Voltaren SR 100 contains 100 mg of diclofenac sodium.
• Other ingredients are: cetyl alcohol, anhydrous colloidal silica, magnesium stearate, povidone, sucrose. The ingredients of the coating are: hypromellose (E 464), red iron oxide, talc (E 553b), polysorbate 80, titanium dioxide (E 171), macrogol 8000, sucrose.

What Voltaren SR 100 looks like and contents of the pack

One pack of Voltaren SR 100 contains 2 blisters of 10 prolonged-release tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Novartis (Hellas) Α.Ε.Β.Ε.
12 km Ethniki Oldos Athinon-Lamias
144 51 Metamorfosi
Greece

Manufacturer:

Novartis Farma SpA, Torre Annunziata, Italy
Novartis (Hellas) A.E.B.E., Metamorfosi, Greece

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
Marketing authorization number in Greece, the country of export:26179/24-04-2013
8546/6-2-2007

Parallel import authorization number: 16/22 Date of leaflet approval: 05.01.2022

[Information about the trademark]