Package leaflet: Information for the patient

Voltaren SR 75 75 mg prolonged-release tablets
Diclofenacum natricum
Voltaren SR 100 100 mg prolonged-release tablets
Diclofenacum natricum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are similar.
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

What Voltaren SR 75 and Voltaren SR 100 are and what they are used for
Important information before taking Voltaren SR 75 and Voltaren SR 100
How to take Voltaren SR 75 and Voltaren SR 100
Possible side effects
How to store Voltaren SR 75 and Voltaren SR 100
Contents of the pack and other information

1. What Voltaren SR 75 and Voltaren SR 100 are and what they are used for
Voltaren SR 75 and Voltaren SR 100 contain 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 75 and Voltaren SR 100 involves inhibition of prostaglandin biosynthesis, which plays a key 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, spinal arthritis, painful syndromes associated with spinal changes, and extra-articular rheumatism.
Pain due to inflammatory and oedematous post-traumatic and postoperative conditions, e.g. following dental or orthopaedic procedures.
Painful and inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or salpingitis.

Monitoring during treatment with Voltaren SR 75 and Voltaren SR 100
If the patient has diagnosed heart disease or significant risk factors for heart disease, the treating physician will periodically assess the need for symptomatic treatment and the patient's response to the medicine, especially if treatment lasts longer than 4 weeks.
During treatment, regular blood tests should be performed if there are any disturbances in liver function, kidney function or blood parameters. 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 consider blood test results when deciding whether to discontinue treatment with Voltaren SR 75 and Voltaren SR 100 or adjust the dosage.

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

When not to use 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 experienced 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, lip, tongue or throat swelling and/or limb oedema (symptoms of angioedema), breathing difficulties, chest pain or any other allergic-type reactions. If the patient suspects allergy, they should consult a doctor;
if the patient has active or a history of peptic ulcer disease of the stomach and/or duodenum, bleeding or perforation; if the patient has previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines;
if the patient is in the third trimester of pregnancy;
if the patient has hepatic insufficiency;
if the patient has renal insufficiency;
if the patient has diagnosed heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA) or arterial embolism of the heart or brain, or after revascularisation 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 75 and Voltaren SR 100 should not be used in patients in whom administration of acetylsalicylic acid or other prostaglandin synthesis inhibitors may trigger an asthma attack, urticaria or acute rhinitis.
The patient should inform the doctor if any of the above conditions are present.

Warnings and precautions
Before taking Voltaren SR 75 and 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 75 and Voltaren SR 100, the dose must not exceed 100 mg per day if treatment lasts longer than 4 weeks;
if the medicine is used in patients with a history of gastrointestinal ulcers or in elderly patients. Diclofenac use may cause gastrointestinal bleeding, ulceration or perforation (which may be fatal). These effects may be particularly dangerous when high doses of diclofenac are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Voltaren SR 75 and Voltaren SR 100, 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 exacerbate the disease;
if the patient has asthma, allergic rhinitis, nasal mucosal oedema (e.g. due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, they are more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, Quincke's oedema or urticaria). This warning also applies to patients

who are 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 disease. The patient must strictly follow the doctor's recommendations regarding regular liver function tests;
if the patient has hepatic porphyria, diclofenac may trigger an attack of porphyria;
if the patient has previously experienced severe skin rash, skin peeling, blistering or/or oral mucosal ulcers after taking Voltaren SR or other analgesic medicines.

Before taking diclofenac, inform the doctor:

if the patient smokes,
if the patient has diabetes,
if the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol or elevated triglycerides.

The risk of adverse effects can be reduced by using the lowest effective dose for the shortest necessary duration.
The lowest effective dose of Voltaren SR 75 and Voltaren SR 100 that relieves pain and/or swelling should be used, and treatment should be as short as possible to minimise the risk of adverse effects.
If at any time during treatment with Voltaren SR 75 and Voltaren SR 100 the patient experiences symptoms suggesting cardiovascular disorders, such as chest pain, dyspnoea, weakness or slurred speech, they should contact their doctor or go to the nearest emergency department immediately.
Diklofenac may, very rarely (especially at the beginning of treatment), cause life-threatening skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever and severe general condition).
At the first signs of rash, mucosal changes or other allergic reactions, the medicine should be discontinued and the patient should contact their doctor.
The medicine may mask signs of infection (e.g. headache, elevated body temperature) and complicate accurate diagnosis. Inform the doctor about taking this medicine during medical examinations.
Do not use Voltaren SR 75 and Voltaren SR 100 concurrently with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
Before taking the medicine, inform the doctor or pharmacist about any of the above-mentioned diseases.
Taking medicines such as Voltaren SR 75 and 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 the patient has heart problems, has had a stroke, or suspects they are at risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), they should discuss treatment options with their doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Before taking Voltaren, inform the doctor if the patient has recently undergone or is scheduled for stomach or gastrointestinal surgery, as Voltaren may occasionally impair intestinal wound healing after surgical procedures.

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

Elderly patients (aged 65 years and above)
Elderly patients may be more sensitive to the effects of the medicine than younger adults. Follow the recommendations in this leaflet, use the lowest effective dose as advised by the doctor, and report any adverse effects to the doctor.

Voltaren SR 75 and Voltaren SR 100 with other medicines
Inform the doctor about all medicines currently taken, recently taken or planned for use.

Especially inform the doctor about taking the following medicines:

Lithium or antidepressants (selective serotonin reuptake inhibitors);
Digoxin – a medicine used in heart disease treatment;
Diuretics – medicines that increase urine output;
Angiotensin-converting enzyme inhibitors, beta-blockers – groups of medicines used in treating hypertension and heart failure;
Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (medicines used to reduce inflammation in affected body areas);
Anticoagulants and platelet inhibitors;
Antidiabetic medicines, except insulin;
Methotrexate – a medicine used in treating certain cancers or arthritis;
Cyclosporine and tacrolimus – medicines used in organ transplant recipients;
Trimethoprim – a medicine used to prevent and treat urinary tract infections;
Antibacterial quinolones – 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 75 and Voltaren SR 100 with food and drink
Tablets should be swallowed whole with water, preferably during a meal.

Pregnancy, breastfeeding and effects on fertility

Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to become pregnant, she should consult her doctor before taking this medicine.
Do not take Voltaren SR 75 and Voltaren SR 100 during the last 3 months of pregnancy, as it may harm the unborn child or cause delivery complications. Voltaren SR 75 and Voltaren SR 100 may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Voltaren SR 75 and Voltaren SR 100 should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible 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 used for longer than a few days (this may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios)), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Do not use Voltaren SR 75 and Voltaren SR 100 in breastfeeding women, as it may have harmful effects on the infant.
The doctor will discuss with the patient the potential risks of using Voltaren SR 75 and Voltaren SR 100 during pregnancy and breastfeeding.

Fertility
Taking Voltaren SR 75 and Voltaren SR 100 may impair fertility. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
The effect of Voltaren SR 75 and Voltaren SR 100 on the ability to drive, operate machinery or perform other tasks requiring special attention is unlikely.

Voltaren SR 75 and Voltaren SR 100 contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

Voltaren SR 75 and Voltaren SR 100 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

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

This medicine should always be used as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Do not exceed the recommended doses. When taking the prolonged-release tablets Voltaren SR 75 and
Voltaren SR 100 for longer than a few weeks, regular medical check-ups are necessary to rule out
unnoticed adverse effects. As a general principle, the doctor should individually adjust the dose for
each patient and use the lowest effective dose for the shortest possible duration.
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, administered as one tablet of Voltaren SR 100
or two tablets of Voltaren SR 75.
In milder cases and in 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 75 and Voltaren SR 100 are 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 in patients with
low body weight, the lowest effective dose is recommended.
Established cardiovascular disease or significant cardiovascular risk factors
Patients with diagnosed cardiovascular disease or significant risk factors for cardiovascular events
should only be treated with diclofenac after careful consideration and only at doses ≤ 100 mg per day
if treatment lasts longer than 4 weeks.
Renal function disorders
Voltaren SR 75 and Voltaren SR 100 are contraindicated in patients with renal impairment.
Specific studies have not been conducted in patients with renal function disorders; therefore, 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 renal impairment.
Hepatic function disorders
Voltaren SR 75 and Voltaren SR 100 are contraindicated in patients with hepatic impairment.
Specific studies have not been conducted in patients with hepatic function disorders; therefore, 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 hepatic impairment.
Method of administration
If symptoms are most pronounced at night or in the early morning, Voltaren SR 75 and 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 tablets.
How long to use Voltaren SR 75 and Voltaren SR 100
Voltaren SR 75 and Voltaren SR 100 should always be used as directed by your doctor.
If you are using Voltaren SR 75 and Voltaren SR 100 for a prolonged period, you should regularly consult
your doctor to ensure that no adverse effects have occurred.
If you have any doubts about how long to use the medicine, consult your doctor or pharmacist.
Taking more than the recommended dose of Voltaren SR 75 and Voltaren SR 100
Overdose with Voltaren SR 75 and Voltaren SR 100 does not produce characteristic symptoms, but the
following may occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or seizures. In
cases of severe poisoning, acute renal failure and liver damage may occur.
If you accidentally take more tablets than recommended, contact your doctor, pharmacist, or go to
the nearest hospital emergency department immediately.
Missed 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 between
doses has passed, do not take the missed dose and take the next dose according to your regular
schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below include those observed with
Voltaren SR 75 and Voltaren SR 100, prolonged-release tablets, as well as those observed
during the use of other formulations of diclofenac, administered either short-term or long-term.
Adverse reactions:
Common (may occur in up to 1 in 10 people)

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

Uncommon (may occur in up to 1 in 100 people)

myocardial infarction, heart failure, palpitations, chest pain.

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

hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
somnolence,
asthma (including dyspnoea),
gastric mucositis, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
peptic ulcer of the stomach and/or duodenum (with or without bleeding and perforation),
hepatitis, jaundice, liver function disorders,
urticaria,
oedema.

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

thrombocytopenia (reduced platelet count), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis
(deficiency of white blood cells - neutrophil granulocytes),
angioedema (including facial oedema),
disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke,
visual disturbances, blurred vision, diplopia,
tinnitus, hearing disturbances,
hypertension, vasculitis,
pneumonia,
colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucositis (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.

Frequency not known (frequency cannot be estimated from available data)

concurrent occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome),
ischaemic colitis,
allergic skin reaction which may present as circular or oval redness and swelling of the skin, blisters and itching (erythema multiforme). The skin in affected areas may also appear darker, which may persist after healing of the lesions. Upon re-exposure to the drug, erythema multiforme usually recurs in the same locations.

Taking medicines such as Voltaren SR 75 and Voltaren SR 100 may be associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse reactions while taking Voltaren SR 75 and Voltaren SR 100. If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
If any of the following adverse reactions occur, stop taking Voltaren SR 75 and Voltaren SR 100 immediately and contact your doctor:

stomach discomfort, heartburn or upper abdominal pain,
vomiting blood, blood in stool, blood in urine,
skin reactions such as rash or itching,
severe allergic skin reaction which may present as widespread red and/or dark patches, skin swelling, blisters and itching (generalised fixed bullous drug eruption),
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 occurring soon after starting Voltaren SR 75 and Voltaren SR 100, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency not known - frequency cannot be estimated from available data),
chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Some adverse reactions may be serious
These uncommon adverse reactions may occur in up to 1 in 100 people, especially
when high daily doses (150 mg) are used for prolonged periods

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

If Voltaren SR 75 and Voltaren SR 100 are taken for longer than a few weeks,
regular contact with a doctor is recommended to ensure that no adverse reactions have occurred.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the 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 cardboard package.
Voltaren SR 75
Store below 30°C.
Keep in the original packaging to protect from moisture.
Voltaren SR 100
Store below 30°C.

6. Contents of the pack and other information

What Voltaren SR 75 contains

The active substance is sodium diclofenac. One prolonged-release tablet of Voltaren SR 75 contains 75 mg of sodium diclofenac.
Other ingredients are: sucrose, cetyl alcohol, anhydrous colloidal silica, povidone K 30, magnesium stearate.
Coating ingredients: 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 sodium diclofenac. One prolonged-release tablet of Voltaren SR 100 contains 100 mg of sodium diclofenac.
Other ingredients are: cetyl alcohol, anhydrous colloidal silica, magnesium stearate, povidone K 30, sucrose.
Coating ingredients: iron oxide red (E 172), polysorbate 80, talc, titanium dioxide (E 171), hypromellose 2910, macrogol 8000, sucrose.

What Voltaren SR 75 looks like and contents of the pack
Voltaren SR 75 is light pink, round, slightly biconvex coated tablets with bevelled edges, embossed with the code "ID" on one side and "CG" on the other.
One pack contains 2 or 3 blisters of 10 prolonged-release tablets each.

What Voltaren SR 100 looks like and contents of the pack
Voltaren SR 100 is pink, round, biconvex coated tablets with bevelled edges, embossed with the code "CGC" on one side and "CG" on the other.
One pack contains 2 blisters of 10 prolonged-release tablets each.

Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warszawa
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 und Obere Turnstrasse 8-10
90429 Nürnberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain