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Inflamac Dolo 25 mg contains the active ingredient diclofenac sodium. This belongs to the group of non-steroidal anti-inflammatory drugs (prostaglandin synthesis inhibitors) and has an analgesic, fever-reducing and anti-inflammatory effect. The effect occurs within 30-60 minutes and lasts about 4-6 hours.
Inflamac Dolo 25 mg is suitable for short-term treatment, ie for a maximum of 3 days of treatment of: headaches, toothaches, menstrual pains, pain in the area of joints and ligaments, back pain, pain from injuries and to reduce fever in flu-like illnesses.
• if you are allergic to diclofenac or one of the excipients or have had shortness of breath or allergy-like skin reactions, e.g. swelling of the face, lips, tongue, throat and/or on the extremities (signs of angioedema);
• if you are pregnant or breastfeeding (see also the chapter "Can Inflamac Dolo 25 mg be taken during pregnancy or while breastfeeding?");
• if you have an active stomach and/or duodenal ulcer or gastrointestinal bleeding or perforation (this may be manifested by blackening of the stool, blood in the stool or vomiting of coffee grounds-like material);
• with chronic intestinal inflammation (Crohn's disease or ulcerative colitis);
• if you have severe impairment of liver or kidney function;
• if you have severe heart failure;
• for the treatment of pain after a coronary bypass operation on the heart (or use of a heart-lung machine);
• in children and adolescents under 14 years of age. Inflamac Dolo 25 mg has not been studied for use in children and adolescents under 14 years of age. For this reason, Inflamac Dolo 25 mg must not be used in children and adolescents under 14 years of age.
During treatment with Inflamac Dolo 25 mg, mucosal ulcers, rarely bleeding or, in isolated cases, perforations (perforations in the stomach or intestines) can occur in the upper gastrointestinal tract. These complications can occur at any time during treatment, even without warning symptoms. To reduce this risk, the smallest effective dose should be used over the shortest possible duration of therapy. Contact your doctor if you have stomach pain and suspect it is related to taking the medicine.
Elderly patients may be more sensitive to the medicine than younger adults. It is particularly important that elderly patients report any side effects to their doctor immediately.
In the following situations, you may only take Inflamac Dolo 25 mg if prescribed by a doctor and under medical supervision:
•if you are currently receiving medical treatment for a serious illness;
• if you have previously suffered from a stomach or duodenal ulcer;
• if you have a heart or blood vessel disease (known as cardiovascular disease, including uncontrolled high blood pressure, heart failure, existing ischemic heart disease or peripheral arterial disease), have ever had a heart attack, stroke or venous thrombosis, or if you have risk factors (such as high blood pressure, Diabetes [diabetes], high levels of fats in the blood [cholesterol, triglycerides], smoking). Inflamac Dolo mg 25 is not usually recommended in these situations. For certain painkillers with a similar effect, the so-called COX-2 inhibitors, an increased risk of heart attack and stroke has been found with high doses and/or long-term treatment. It is not known whether this increased risk also applies to Inflamac Dolo 25 mg. It is important,
• if you have kidney problems, if you are taking medicines for high blood pressure (eg diuretics, ACE inhibitors) or if you lose more fluids, eg through heavy sweating or diarrhea; taking Inflamac Dolo 25 mg can affect the way your kidneys work, which can lead to an increase in blood pressure and/or fluid retention (oedema);
• if you have liver problems;
• if you are being treated with anticoagulants (blood thinners, anticoagulants) or have a blood clotting disorder or any other blood disease, including the rare disease hepatic porphyria;
• if you suffer from asthma;
• if you are taking anti-rheumatic medicines or other painkillers (eg acetylsalicylic acid, aspirin, ibuprofen) or other anti-inflammatory drugs (corticosteroids);
• if you are taking the following medicines: lithium or specific serotonin reuptake inhibitors (SSRI's, medicines to treat depression), digoxin (medicine for heart problems), diuretics (medicines to increase urine output), medicines (eg metformin) to treat diabetes with the exception of insulin, methotrexate (used to treat arthritis and cancer), ciclosporin or tacrolimus (used for organ transplantation), trimethoprim (used for urinary tract infections), quinolone antibiotics (used to treat infections), voriconazole (used to treat fungal infections), phenytoin (used to treat treatment of epileptic seizures) or sulfinpyrazone (gout medicine);
• If you get signs or symptoms while taking Inflamac Dolo 25 mg that indicate problems with your heart or blood vessels, such as chest pain, shortness of breath, weakness or slurred speech, contact your doctor immediately.
In very rare cases, anti-inflammatories (including Inflamac Dolo) can cause serious skin reactions (eg rash). At the first sign of a skin reaction, treatment with Inflamac Dolo 25 mg should be discontinued and medical attention sought immediately.
Inflamac Dolo 25 mg can reduce the symptoms of an infection (eg high fever) and thus make it more difficult to diagnose the infection.
Information about the excipients
Sucrose:
Inflamac Dolo 25 mg contains sucrose. Please only take Inflamac Dolo 25 mg after consulting your doctor if you know that you suffer from a sugar intolerance.
Sodium:
This medicinal product contains less than 1 mmol sodium (23 mg) per 1 capsule, ie essentially 'sodium-free'.
This medicine can affect your ability to react, drive and use tools or machines. You should refrain from driving or using machines, especially if you experience dizziness or visual disturbances.
Tell your doctor, pharmacist or druggist if you
• suffer from other diseases,
•have allergies or
• Use other medicines (including those you bought yourself).
If you are pregnant or planning to become pregnant, you should only take Inflamac Dolo 25 mg after consulting your doctor. Inflamac Dolo 25 mg should not be taken during the last third of pregnancy.
lactation
Inflamac Dolo 25 mg should not be taken while breast-feeding unless your doctor has given you permission to do so.
Like other anti-inflammatory drugs, Inflamac Dolo 25 mg can make it difficult to get pregnant. After stopping the drug, this effect ends. If you are planning to become pregnant or are having trouble conceiving, talk to your doctor.
How much Inflamac Dolo 25 mg to take?
The recommended dosage must not be exceeded.
The lowest effective dose should always be taken for the shortest possible time.
Adults and young people aged 14 and over:
Swallow 1 capsule up to 3 times daily with plenty of water, preferably with or after meals.
A gap of at least 4 to 6 hours should be observed before the next intake.
Maximum Daily Dose : Do not take more than 3 capsules (75 mg) in any 24 hour period, unless prescribed by a doctor.
How long should Inflamac Dolo 25 mg be taken?
Do not take Inflamac Dolo 25 mg for more than 3 days and only to treat the conditions listed above.
If the symptoms persist or worsen, consult your doctor so that the reason can be clarified. A serious illness can be the cause.
If you take more Inflamac Dolo 25 mg than you should?
If you accidentally take more capsules, contact your doctor immediately.
Children and young people under the age of 14:
Inflamac Dolo 25 mg must not be used in children and adolescents under 14 years of age. The use and safety of Inflamac Dolo 25 mg in children and adolescents under 14 years of age has not yet been tested.
Elderly patients:
Elderly patients may be more sensitive to the medicine than younger adults. It is particularly important that elderly patients report any side effects to their doctor immediately.
Follow the dosage given in the package leaflet or prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.
After taking Inflamac Dolo 25 mg, the following side effects may occur:
Common side effects (affects 1 to 10 users in 100):
•stomach pain, stomach pain, diarrhea, nausea, vomiting, gas, indigestion, decreased appetite;
•headache, drowsiness;
•Skin rash;
•Dizziness;
• Increase in liver enzymes.
Uncommon side effects (affects 1 to 10 patients in 1,000):
•palpitations, sudden and oppressive chest pain (signs of heart attack and heart attack)*;
• Shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)*.
Rarely occurring side effects (affects 1 to 10 patients in 10,000):
• unusual tiredness;
• itchy rash;
• Ulcers in the gastrointestinal tract, blood in the stools or black stools, vomiting blood, bloody diarrhoea;
• Allergic reaction including difficulty breathing or swallowing, swelling of the face, mouth, tongue or throat often with rash, collapse;
• wheezing or shortness of breath, feeling suffocated (signs of asthma);
• swelling of the arms, legs and feet (oedema);
• Yellowing of the skin or eyes (signs of liver inflammation or liver failure).
Very rare side effects (less than 1 in 10,000 patients):
• bleeding or unusual bruising;
• low white blood cells (which can lead to high fever or persistent sore throat, frequent infections), low red blood cells;
•Constipation, inflammation of the mouth, inflammation and redness of the tongue, taste disturbances, epigastric cramps;
• itching and redness of the skin, hair loss;
• tingling or rigidity of the hands or feet, tremors;
• Blurred vision, ringing in the ears, hearing problems;
• mood swings, trouble sleeping, confusion;
• skin rash with blisters, peeling skin, purplish skin, blistering of the eyes and mouth, skin inflammation with scaling;
• discolored urine (may be caused by blood or proteins in the urine) or change in the amount of urine passed;
•Increased skin sensitivity to the sun;
• seizures;
•Sudden and severe headache, difficulty speaking, stiff neck.
If you notice side effects, contact your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.
* This frequency may occur when taking a high daily dose (150 mg) for a long period of time.
The medicinal product may only be used up to the date marked “EXP” on the container.
Storage Notice
Store at room temperature (15-25°C).
Keep out of the reach of children.
More information
Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.
1 capsule contains
active ingredients
25 mg diclofenac sodium
excipients
Sugar-starch pellets (contain sucrose, glucose and corn starch), methacrylic copolymer dispersion 30%, Povidone K30, talc, nicotinamide, diethyl phthalate, macrogol 400, silicone antifoam emulsion.
Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), erythrosine (E127).
57457 (Swissmedic)
In pharmacies and drugstores, without medical prescription.
Pack of 10 capsules.
Spirig Healthcare AG, 4622 Egerkingen