Voltaren

Package leaflet: Information for the user

Voltaren 50 mg enteric-coated tablets
Diclofenacum natricum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Voltaren is and what it is used for
2. Important information before taking Voltaren
3. How to take Voltaren
4. Possible side effects
5. How to store Voltaren
6. Contents of the pack and other information

1. What Voltaren is and what it is used for
Voltaren 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 involves inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain and fever.
Voltaren is used in the treatment of:

• Inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, juvenile rheumatoid arthritis (Still's disease), ankylosing spondylitis, osteoarthritis, spinal arthritis, painful syndromes associated with spinal changes, and extra-articular rheumatism.
• Acute gout attacks.
• Pain caused by inflammatory and oedematous conditions following trauma or surgery, e.g., after dental or orthopaedic procedures.
• Painful and inflammatory conditions in gynaecology, e.g., primary dysmenorrhoea or salpingitis.
• As an adjunctive treatment in severe, painful infections of the ear, nose or throat, e.g., pharyngitis and tonsillitis, otitis. According to general therapeutic principles, causal treatment should be applied first in the above-mentioned conditions. Fever alone is not an indication for use.

Monitoring during Voltaren treatment
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 picture. 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 Voltaren treatment or adjust the dose.

2. Important information before taking Voltaren

When not to take Voltaren:

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if you have 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, facial swelling, swelling of lips, tongue, throat and/or limbs (symptoms of angioedema), breathing difficulties, chest pain or any other allergic-type reactions. If you think you may be allergic, you should consult your doctor,
• if you have active or a history of peptic ulcer disease of the stomach and/or duodenum, bleeding or perforation; if you have previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines,
• if you are in the last trimester of pregnancy,
• if you have liver failure,
• if you have kidney failure,
• if you have been diagnosed with heart disease and/or cerebrovascular disease, e.g., after myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or after revascularisation or bypass surgery,
• if you have current or previous circulatory disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren should not be used in individuals
in whom administration of acetylsalicylic acid or other prostaglandin synthesis inhibitors may
trigger asthma attacks, urticaria or acute rhinitis.
Inform your doctor if any of the above-mentioned diseases are present.
Warnings and precautions
Before taking Voltaren, discuss with your doctor:

• if you have diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if you are a smoker; if your doctor decides to prescribe Voltaren, 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 ulceration or in elderly patients. Diclofenac use may cause gastrointestinal bleeding, ulceration or perforation (with potentially fatal outcome). This effect may be particularly dangerous when high doses of diclofenac are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during Voltaren treatment, the medicine should be discontinued immediately and medical advice sought;
• if you have ulcerative colitis or Crohn's disease; diclofenac may exacerbate the course of the disease;
• if you suffer from asthma, allergic rhinitis, nasal mucosal oedema (e.g., due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, you 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 allergic to other substances (e.g., those with skin reactions, itching or urticaria). The medicine should be administered with particular caution (preferably under medical supervision);
• if you have liver function disorders; diclofenac may worsen the course of the disease. Strict adherence to your doctor's recommendations regarding regular liver function tests is essential;
• if you suffer from hepatic porphyria. Diclofenac may trigger an attack of porphyria.

Before taking diclofenac, inform your doctor

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

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
The risk of side effects can be reduced by using the lowest effective dose
and not for longer than necessary.
Use the lowest dose of Voltaren that relieves pain and/or inflammation,
and use it for the shortest possible duration to minimise the risk of side effects.
If at any time during Voltaren treatment you experience symptoms indicating heart or blood vessel problems, such as chest pain, shortness of breath,
weakness or slurred speech, contact your doctor or emergency department immediately.
Diclofenac use may, very rarely (especially at the beginning of treatment), cause 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 mucosal lesions, high fever and severe general condition). At the first signs of rash, mucosal changes or other symptoms of allergic reaction, the medicine should be discontinued and medical advice sought.
The medicine may mask symptoms of infection (e.g., headache, elevated body temperature) and may complicate accurate diagnosis. Inform your doctor about using this medicine during medical examinations.
Do not take Voltaren simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors.
Before taking the medicine, inform your doctor or pharmacist about any of the above-mentioned conditions.
Taking medicines such as Voltaren 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 duration 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, elevated cholesterol, smoking), discuss treatment options with your doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Before taking Voltaren, inform your doctor if you have recently undergone or are scheduled for stomach or gastrointestinal surgery, as Voltaren may sometimes impair intestinal wound healing after surgery.
Children and adolescents
This medicine should not be used in children and adolescents under 14 years of age.
Elderly patients (aged 65 years and over)
Elderly individuals may be more sensitive to the effects of the medicine than other adults. Follow the instructions in this leaflet, use the lowest effective doses as recommended by your doctor, and report any side effects occurring during treatment to your doctor.
Voltaren and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken or plan to take.
Inform your doctor especially 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 disease
• Diuretics – medicines that increase urine output
• Angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – a group of medicines used in the treatment of hypertension and heart failure
• Non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to relieve inflammation in body areas affected by inflammation)
• Anticoagulants and platelet function inhibitors
• Antidiabetic medicines, except insulin
• Methotrexate – a medicine used in the treatment of 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 with food and drink
Tablets should be swallowed whole, with water, preferably before a meal.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
you should consult your doctor before using this medicine.
During pregnancy, in the first two trimesters, Voltaren should not be used unless absolutely necessary.
As with other anti-inflammatory medicines, Voltaren use during the last 3 months of pregnancy is contraindicated, as it may seriously harm the unborn child or adversely affect delivery.
Voltaren should not be used in breastfeeding women, as it may have harmful effects on the infant.
Your doctor will discuss with you the potential risks of using Voltaren during pregnancy and breastfeeding.
Taking Voltaren may make it more difficult to become pregnant. If you are planning to become pregnant or have difficulty conceiving, you should inform your doctor.
Driving and operating machinery
The effect of Voltaren on the ability to drive, operate machinery or perform other tasks requiring special attention is unlikely.
Voltaren contains lactose
Voltaren in the form of enteric-coated tablets contains lactose. If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Voltaren

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Do not exceed the recommended doses. If you are using Voltaren enteric-coated tablets for longer
than a few weeks, regular medical check-ups are necessary to rule out any unnoticed adverse effects.
As a general rule, your doctor should individualize 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.
In milder cases and in chronic treatment, a daily dose of 75 mg to 100 mg is considered sufficient.
The total daily dose should be divided and administered in 2 to 3 doses. To relieve night-time pain and
morning stiffness, daytime tablet treatment may be supplemented with a suppository before bedtime
(provided the total maximum daily dose of 150 mg is not exceeded).
In primary dysmenorrhoea, the daily dose should be individually determined by the doctor.
It usually ranges from 50 mg to 150 mg. Initially, 50 mg to 100 mg should be administered, and if
necessary, the dose may be increased over several menstrual cycles up to a maximum daily dose of
200 mg. Treatment should be started at the onset of the first symptoms and continued for several days,
depending on symptom severity.
Other indications for use
Voltaren 50 mg enteric-coated tablets are not recommended for use in children and adolescents.
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 at doses ≤100 mg daily, if treatment
lasts longer than 4 weeks.
Renal function disorders
Voltaren is contraindicated in patients with renal failure.
Specific studies in patients with renal function impairment have not been conducted; therefore, no
specific dosage recommendations can be made. Caution is advised when administering Voltaren to
patients with mild to moderate renal impairment.
Hepatic function disorders
Voltaren is contraindicated in patients with hepatic failure.
Specific studies in patients with hepatic function impairment have not been conducted; therefore, no
specific dosage recommendations can be made. Caution is advised when administering Voltaren to
patients with mild to moderate hepatic impairment.
Method of administration
Tablets should be swallowed whole with water, preferably before meals. Do not divide or chew the
tablets.
How long to use Voltaren
Voltaren should always be used as directed by your doctor.
If you are using Voltaren long-term, regular contact with your doctor is recommended to ensure no
adverse effects have occurred.
If you are unsure how long to continue treatment, consult your doctor or pharmacist.
Use of a higher than recommended dose of Voltaren
Overdose with Voltaren does not produce characteristic symptoms, but the following may occur:
vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions.
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
If you miss a dose, take it as soon as you remember. However, if more than half of the interval between
doses has passed, do not take the missed dose; instead, 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The frequency of occurrence of adverse effects is estimated as follows:
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare
(≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (frequency cannot be determined from
available data).
The adverse effects listed below include those reported with Voltaren enteric-coated tablets as well as those observed during the use of other formulations 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.

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 dyspnoea),
• gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
• gastric and/or duodenal ulcer (with or without bleeding or perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• oedema.

Very rare

• thrombocytopenia (reduced platelet count), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of granulocytes, a type of white blood cell),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paraesthesia, memory disorders, 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 mucosal inflammation (including ulcerative stomatitis), glossitis, oesophageal disorders, pseudomembranous colitis, intestinal stricture, pancreatitis,
• fulminant hepatitis, hepatic necrosis, liver failure,
• bullous rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch purpura, 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 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse effects while taking Voltaren. 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 effects occur, stop taking Voltaren immediately and contact your doctor:

• stomach discomfort, heartburn or upper abdominal pain
• vomiting blood, blood in stool, blood in urine
• skin problems 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 abdominal cramps and tenderness beginning shortly after starting Voltaren, 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 1,000, 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, oedema of feet or legs (symptoms of heart failure)

If you take Voltaren for longer than a few weeks, you should regularly consult your doctor to ensure that no adverse effects have occurred.

Reporting of adverse effects
Reporting suspected 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 of Adverse Drug Reactions, 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
e-mail: [email protected]
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Voltaren

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
Store below 30°C.

6. Contents of the pack and other information

What Voltaren contains

• The active substance is sodium diclofenac. Each enteric-coated tablet of Voltaren contains 50 mg of sodium diclofenac.
• The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, povidone, sodium carboxymethyl starch.
  Coating ingredients: hypromellose, macrogol glycerol hydroxystearate, talc, copolymer of methacrylic acid and ethyl acrylate, macrogol 8000, anti-adherent emulsion, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Voltaren looks like and contents of the pack
One pack contains 2 blisters with 10 enteric-coated tablets each.
Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel. +48 22 37 54 888
Importer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw