VOLTAREN

VOLTAREN Dolo 25 mg coated tablets

Important information (mandatory information)

Voltaren Dolo 25 mg film-coated tablets. Active ingredient: Diclofenac-potassium. Areas of application: mild to moderately severe pain.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Voltaren Dolo 25 mg film-coated tablets for adults and adolescents aged 14 years and over
Active ingredient: Diclofenac-potassium

Read this entire leaflet carefully, as it contains important information for you. This medicine is available without prescription. However, to achieve the best possible treatment success, Voltaren Dolo 25 mg must be used correctly.

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 4 days, you must consult a doctor.
• If any of the listed side effects significantly affect you or if you notice side effects not listed in this leaflet, please inform your doctor or pharmacist.

This leaflet contains

1. WHAT IS VOLTAREN DOLO 25 MG AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLTAREN DOLO 25 MG?
3. HOW TO TAKE VOLTAREN DOLO 25 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VOLTAREN DOLO 25 MG?
6. FURTHER INFORMATION.

1. WHAT IS VOLTAREN DOLO 25 MG AND WHAT IS IT USED FOR?

Voltaren Dolo 25 mg is a pain-relieving and anti-inflammatory medicine from the group of so-called non-steroidal anti-inflammatory drugs/analgesics (anti-inflammatory and pain relievers). Areas of application: mild to moderately severe pain.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLTAREN DOLO 25 MG?

Voltaren Dolo 25 mg must not be taken:

• if you have been diagnosed with heart disease and/or cerebrovascular disease, e.g. if you have had a heart attack, stroke or mini-stroke (transient ischaemic attack, TIA) or if you have blockages in the arteries to the heart or brain or have had to undergo an operation to clear or bypass these blockages;
• if you have or have had problems with your blood circulation (peripheral arterial disease);
• if you are hypersensitive (allergic) to the active substance diclofenac or any of the other ingredients (see section 6) of Voltaren Dolo 25 mg;
• if you have ever had an allergic reaction to medicines for pain, inflammation or fever, such as diclofenac, ibuprofen or acetylsalicylic acid (also used to prevent blood clots). Allergic reactions may include: asthma, wheezing or whistling breath, skin rash, facial swelling, runny nose. Ask your doctor or pharmacist if you are unsure;
• in case of unexplained blood formation and blood clotting disorders;
• in case of existing or past stomach/duodenal ulcers (peptic ulcers);
• if you have noticed blood in your stool or black, tarry stools (symptoms of gastrointestinal bleeding);
• in case of severe kidney or liver disease;
• in the last three months of pregnancy.

Inform your doctor or pharmacist if any of the above points apply to you, as Voltaren Dolo 25 mg is not suitable for you in this case.

Special care is required when taking Voltaren Dolo 25 mg:

• in certain immune system diseases (systemic lupus erythematosus and mixed connective tissue diseases).
• if you have ever experienced gastrointestinal complaints such as stomach ulcers, bleeding or black, tarry stools.
• if you have previously suffered from stomach complaints or heartburn after taking pain or rheumatism medicines.
• in case of intestinal problems.
• when taking other pain or rheumatism medicines at the same time.
• in case of asthma, kidney or liver problems.
• if you have or have ever had heart problems.
• if your feet are swollen due to heart problems.
• if you dehydrate easily (e.g. due to illness, diarrhoea or after major surgical procedures).
• in case of bleeding disorders or other blood diseases including a rare liver disease called hepatic porphyria.
• if you suffer from allergies (e.g. skin reactions to other agents, asthma, hay fever), chronic mucosal swelling or chronic respiratory diseases that narrow the airways – your risk of hypersensitivity reactions is then increased.

Before you receive diclofenac, inform your doctor:

• if you smoke,
• if you are diabetic,
• if you have angina pectoris, blood clots, high blood pressure, elevated cholesterol or triglyceride levels.

Side effects can be minimised by using the lowest effective dose for the shortest necessary period. If any of these points apply to you, please ask your doctor or pharmacist before taking Voltaren Dolo 25 mg.

Other precautions

Medicines such as Voltaren Dolo 25 mg may be associated with a slightly increased risk of heart attacks ("myocardial infarction") or strokes. Any risk is more likely with high doses and longer treatment. Do not exceed the recommended dose (up to 3 film-coated tablets per day) or duration of treatment (for mild to moderately severe pain: 4 days). Concomitant use of Voltaren Dolo 25 mg with other NSAIDs, including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first sign of a hypersensitivity reaction after taking/administering Voltaren Dolo 25 mg, treatment must be discontinued. Medically necessary measures corresponding to the symptoms must be initiated by qualified personnel. Very rarely, severe skin reactions with redness and blistering, some with fatal outcome, have been reported under NSAID therapy (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome; see section 4). The highest risk for such reactions appears to exist at the beginning of therapy, as these reactions occurred in the majority of cases in the first month of treatment. At the first sign of skin rashes, mucosal lesions or other signs of a hypersensitivity reaction, Voltaren Dolo 25 mg should be discontinued and a doctor consulted immediately. When Voltaren Dolo 25 mg is administered concomitantly with lithium preparations (medicines for the treatment of mental-emotional disorders) or certain diuretics (potassium-sparing diuretics), monitoring of lithium and potassium concentrations in the blood is necessary (see "Interactions with other medicines").

Gastrointestinal bleeding, ulcers and perforations

Gastrointestinal bleeding, ulcers and perforations, sometimes with fatal outcome, have been reported with all NSAIDs. They occurred with or without previous warning symptoms or serious gastrointestinal events in the medical history at any time during therapy. The risk of gastrointestinal bleeding, ulcers and perforations is higher with increasing NSAID dose, in patients with a history of ulcers, especially with the complications of bleeding or perforation (see section 2 "Voltaren Dolo 25 mg must not be taken"), and in elderly patients. These patients should start treatment with the lowest available dose. For these patients, as well as for patients requiring concomitant therapy with low-dose acetylsalicylic acid (ASA) or other medicines that may increase the risk of gastrointestinal diseases, combination therapy with gastric mucosal protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered. If you, especially in old age, have a history of gastrointestinal side effects, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly at the beginning of therapy. Caution is advised if you are simultaneously receiving medicines that may increase the risk of ulcers or bleeding, e.g. oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, for the treatment of depressive moods, or platelet aggregation inhibitors such as ASA (see section 2 "When taking Voltaren Dolo 25 mg with other medicines"). If gastrointestinal bleeding or ulcers occur under Voltaren Dolo 25 mg, treatment should be discontinued. NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may worsen. If you have heart problems or a previous stroke, or think that you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol, or are a smoker), you should discuss your treatment with your doctor or pharmacist. In general, the habitual use of painkillers, especially when combining several pain-relieving active ingredients, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). With prolonged use, any type of headache medicine can lead to a worsening of the pain. Please ask your doctor for advice if you think this may be the case for you. Voltaren Dolo 25 mg can reduce the symptoms of an infection (e.g. headache, elevated temperature) and thus make diagnosis more difficult. If you feel unwell and need to see a doctor, please remember to inform him about taking Voltaren Dolo 25 mg. Side effects can be reduced by using the lowest effective dose for the shortest period necessary for symptom control.

Elderly patients

Elderly patients experience side effects more frequently after using NSAIDs, especially bleeding and perforations in the stomach and intestinal area, which can be life-threatening under certain circumstances. Therefore, particularly careful medical supervision is required in elderly patients.

Children and adolescents (under 14 years)

Children and adolescents under 14 years of age must not take Voltaren Dolo 25 mg, as there is insufficient experience.

When taking Voltaren Dolo 25 mg with other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines