Voltaren sr 100

Package leaflet: Information for the user

Warning! Keep this leaflet, information on the immediate packaging in a foreign language.
Voltaren SR 100 (Voltaren)
100 mg, prolonged-release tablets
Diclofenacum natricum
Voltaren SR 100 and Voltaren are different trade names for the same medicinal product.
Please read this leaflet carefully before using this 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Voltaren SR 100 is and what it is used for
2. What you need to know 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 pack and other information

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

Voltaren SR 100 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 Voltaren SR 100 involves inhibition of prostaglandin biosynthesis, which play a key 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, spinal arthritis, painful syndromes associated with spinal changes, and extra-articular rheumatism.
• Pain caused by inflammatory conditions and oedema following trauma or surgery, e.g. after dental or orthopaedic procedures.
• Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or salpingitis.

Monitoring during treatment with Voltaren SR 100
In patients with diagnosed heart disease or significant cardiovascular risk factors, the treating physician should periodically assess the patient's need for symptomatic treatment and response to the medicine, especially if treatment lasts longer than 4 weeks.
Regular blood tests should be performed during treatment if there are any signs of liver dysfunction, kidney dysfunction or blood abnormalities.
Liver function (transaminase levels), kidney function (creatinine levels) and blood cell counts (white and red blood cells and platelets) should be monitored. The treating physician will take into account the results of blood tests when deciding whether to discontinue treatment with Voltaren SR 100 or adjust the dosage.
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2. Important information before using Voltaren SR 100

When not to use 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 pain-relieving medicines (e.g. acetylsalicylic acid, diclofenac or ibuprofen). Reactions may include asthma, rhinitis, skin rash, swelling of the face, lips, tongue, throat and/or limbs (symptoms of angioedema), breathing difficulties, chest pain or any other allergic-type reactions. If the patient thinks they may be allergic, they should consult their doctor for advice,
• if the patient has active or a history of peptic ulceration of the stomach and/or duodenum, 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 last trimester of pregnancy,
• if the patient has liver failure,
• if the patient has kidney failure,
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after a heart attack, stroke, mini-stroke (transient ischaemic attack), or arterial blockage or procedure to open blocked vessels (angioplasty or bypass surgery),
• if the patient has current or previous circulatory disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren SR 100 should not be used in patients in whom administration of acetylsalicylic acid or other drugs inhibiting prostaglandin synthesis may trigger an asthma attack, urticaria or acute rhinitis.

Patients should inform their doctor if any of the above conditions are present.

Warnings and precautions

Before using Voltaren SR 100, discuss with your doctor:

• if the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if the patient is a smoker. If the doctor decides to prescribe Voltaren SR 100, the dose must not exceed 100 mg per day if treatment lasts longer than 4 weeks;
• if the medicine is to be used in patients with a history of gastrointestinal ulceration or in elderly patients. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation (which may be life-threatening). This effect may be particularly dangerous when high doses of diclofenac are used. If any unusual abdominal symptoms occur during treatment with Voltaren SR 100 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should contact their doctor;
• if the patient has ulcerative colitis or Crohn’s disease; diclofenac may worsen the course of the disease;
• if the patient suffers from asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory infections, they are more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, Quincke’s edema 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 administered with particular caution (preferably under medical supervision);
• if the patient has impaired liver function; diclofenac may worsen the course of the disease. Strict adherence to the doctor’s recommendations regarding regular liver function tests is required;
• if the patient has hepatic porphyria. Diclofenac may trigger an attack of porphyria.

Before taking diclofenac, the patient should inform their doctor:

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

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

The risk of adverse effects can be reduced by using the medicine at the lowest effective dose and for the shortest duration necessary.

The lowest effective dose of Voltaren SR 100 should be used to relieve pain and/or swelling, and it should be taken for the shortest possible time to minimise the risk of adverse effects.

If at any time during treatment with Voltaren SR 100 the patient experiences symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness or slurred speech, they should contact their doctor or go to a hospital emergency department immediately.

Diclofenac may very rarely (especially at the beginning of treatment) cause serious, life-threatening skin reactions (such as 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, mucosal changes or other symptoms of an allergic reaction, the medicine should be discontinued and the patient should contact their doctor.

The medicine may mask signs of infection (e.g. headache, increased body temperature) and may complicate accurate diagnosis. Patients should inform their doctor about using this medicine during medical examinations.

Do not use Voltaren SR 100 simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors.

Before using the medicine, inform your doctor or pharmacist if you have any of the above-mentioned conditions.

Taking medicines 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. Do not use higher doses or longer treatment durations than recommended.

If you have heart problems, a history of stroke, or suspect you are at risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment approach with your doctor or pharmacist.

The medicine may transiently inhibit platelet aggregation.

Before taking Voltaren SR 100, tell your doctor if the patient has recently undergone or is scheduled for stomach or gastrointestinal surgery, as Voltaren SR 100 may occasionally impair intestinal wound healing after surgical procedures.

Children and adolescents

This medicine is not recommended for use in children and adolescents due to the dosage size.

Elderly patients (aged 65 years and over)

Elderly patients may be more sensitive to the effects of the medicine than other adults. Follow the instructions in the leaflet, use the lowest effective dose as recommended by the doctor, and report any adverse effects occurring during treatment to the doctor.

Voltaren SR 100 and other medicines

Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Especially inform your doctor if you are taking the following medicines:

• Lithium or medicines belonging to the group of antidepressants (Selective Serotonin Reuptake Inhibitors)
• Digoxin – a medicine used in the treatment of heart conditions
• Diuretics – medicines that increase the amount of urine produced
• Angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – groups of medicines used in the treatment of high blood pressure and heart failure
• Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (medicines used to relieve inflammation in affected body areas)
• Anticoagulants and platelet inhibitors
• Antidiabetic medicines, except insulin
• Methotrexate – a medicine used in the treatment of certain cancers or joint inflammation
• Cyclosporine and tacrolimus – medicines used in organ transplant recipients
• Trimethoprim – a medicine used to prevent and treat urinary tract infections
• Quinolone antibiotics – 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 Voltaren SR 100 with food and drink

Tablets should be swallowed whole with water, preferably during a meal.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.

During pregnancy, Voltaren SR 100 should not be used during the first two trimesters unless absolutely necessary.

As with other anti-inflammatory medicines, use of Voltaren SR 100 during the last three months of pregnancy is contraindicated, as it may seriously harm the unborn child or adversely affect labour.

Do not use Voltaren SR 100 in breastfeeding women, as it may cause harm to the infant.

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

Taking Voltaren SR 100 may make it more difficult to become pregnant. If the patient plans to become pregnant or has difficulty becoming pregnant, she should inform her doctor.

Driving and operating machinery

The effect of Voltaren SR 100 on the ability to drive, operate machinery or perform other tasks requiring special attention 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 certain sugars, they should consult their doctor before taking this medicine.

3. How to use Voltaren SR 100

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Available on the market are: Voltaren SR 75 (75 mg) and Voltaren SR 100 (100 mg).
Do not exceed the recommended doses. When using prolonged-release tablets of Voltaren SR 100 for longer than several weeks, regular medical check-ups should be performed to rule out any unnoticed adverse effects. As a general rule, the doctor should individually adjust the dose for each patient and use the lowest effective dose for the shortest possible duration.
If you feel 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, administered as one tablet of Voltaren SR 100 or two tablets of Voltaren SR 75.
In milder cases and for chronic treatment, one tablet of Voltaren SR 75 or Voltaren SR 100 per day is usually sufficient.
If symptoms worsen at night or in the morning, it is recommended to take Voltaren SR 75 or Voltaren SR 100 in the evening.

Use in children and adolescents
Due to the dose strength, Voltaren SR 100 is not recommended for use in children and adolescents under 18 years of age.

Elderly patients (aged 65 years and above)
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.

Established cardiovascular disease or significant cardiovascular risk factors
Patients with established cardiovascular disease or significant cardiovascular risk factors should only be treated with diclofenac after careful assessment and only at doses ≤100 mg daily, if treatment lasts longer than 4 weeks.

Renal function impairment
Voltaren SR 100 is contraindicated in patients with renal failure.
Specific studies in patients with renal function impairment have not been conducted; therefore, appropriate dose adjustment recommendations cannot be provided. Caution is advised when administering Voltaren SR 100 to patients with mild to moderate renal function impairment.

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Hepatic function impairment
Voltaren SR 100 is contraindicated in patients with hepatic failure.
Specific studies in patients with hepatic function impairment have not been conducted; therefore, appropriate dose adjustment recommendations cannot be provided. Caution is advised when administering Voltaren SR 100 to patients with mild to moderate hepatic function impairment.

Method of administration
If symptoms are most pronounced at night or in the early morning, Voltaren SR 100 should be taken in the evening. Tablets should be swallowed whole with water, preferably with food. Do not divide or chew the tablet.

How long to use Voltaren SR 100
Voltaren SR 100 should always be used as directed by your doctor.
If Voltaren SR 100 is used long-term, regular contact with your doctor is necessary to ensure no adverse effects have occurred.
If in doubt about how long to use the medicine, consult your doctor or pharmacist.

Use of a higher than recommended dose of Voltaren SR 100
Overdose with Voltaren SR 100 does not typically 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.
If an overdose is accidentally taken, contact your doctor, pharmacist, or go immediately to the nearest hospital emergency department.

Missed dose of Voltaren SR 100
If a dose is missed, take it as soon as you remember. However, if more than half of the time interval between doses has passed, do not take the missed dose and take the next dose according to the regular 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 frequency of adverse effects is estimated as follows:
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100);
rare (≥1/10 000 to <1/1000); very rare (<1/10 000); unknown (frequency cannot be determined from the available data).
The adverse effects listed below include those observed with Voltaren SR 100 prolonged-release tablets, as well as those observed during the use of other forms of diclofenac, administered either short-term or long-term.

Adverse effects:
Common

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

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Uncommon

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

Rare

• hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
• somnolence,
• asthma (including shortness of breath),
• gastric mucosal inflammation, gastrointestinal bleeding, vomiting of blood, bloody diarrhoea, black tarry stools,
• peptic ulcer of the stomach and/or duodenum (with or without bleeding or perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• oedema.

Very rare

• thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of 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 ulcerative stomatitis), glossitis, oesophageal disorders, membranous intestinal stricture, pancreatitis,
• fulminant hepatitis, hepatic necrosis, liver failure,
• bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, 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.

Unknown

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

Taking medicines such as Voltaren SR 100 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Other adverse effects may occur in some individuals during treatment with Voltaren SR 100. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
If any of the following adverse effects occur, stop taking Voltaren SR 100 immediately and contact your doctor:

• stomach discomfort, heartburn or upper abdominal pain, Page 7 of 9
• vomiting blood, blood in stool, blood in urine,
• skin reactions such as rash or itching,
• 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 cramps and abdominal tenderness beginning shortly after starting Voltaren SR 100, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency unknown – cannot be determined from available data),
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Some adverse effects may be serious
These uncommon adverse effects may occur in 1–10 patients per 1000, especially when high daily doses (150 mg) are used for a prolonged period

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

If Voltaren SR 100 is taken for longer than a few weeks, regular contact with a doctor is recommended to ensure that no adverse effects have occurred.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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 adverse effects helps to provide more information on the safety of the medicine.

5. How to store Voltaren SR 100

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Voltaren SR 100 contains

• The active substance is sodium diclofenac. One prolonged-release tablet of Voltaren SR 100 contains 100 mg of sodium diclofenac. Page 8 of 9
• Other ingredients: cetyl alcohol, anhydrous colloidal silicon dioxide, magnesium stearate, povidone, sucrose.
  Coating composition: hypromellose (E 464), iron oxide red, talc (E 553b), polysorbate 80, titanium dioxide (E 171), macrogol 8000, sucrose.

What Voltaren SR 100 looks like and contents of the pack
One package contains 2 blisters with 10 prolonged-release tablets each.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Greece, 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Greece, country of export: 26179/24-04-2013
8546/6-2-2007

Parallel Import Authorisation Number: 16/22
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