Dolo-Spedifen Tabl 200 mg 20 pcs

What is Dolo-Spedifen 200 and when is it used?

Dolo-Spedifen 200 contains the active ingredient ibuprofen as ibuprofen arginate. This has analgesic, anti-inflammatory and antipyretic properties. The effect occurs after about 30 minutes and lasts about 6 hours. Dolo-Spedifen 200 is suitable for short-term treatment, i. for a maximum of 3 days treatment of: Pain in the area of ??joints and ligaments; back pain; headache; Toothache; Pain during menstrual bleeding; pain after injury; Fever associated with influenza.

When should Dolo-Spedifen 200 not be taken?

If you are allergic to any of the ingredients or after taking acetylsalicylic acid or other painkillers or rheumatism drugs, so-called non-steroidal anti-inflammatory drugs, shortness of breath or allergic-like skin reactions; if you are pregnant or breastfeeding (see also «Can Dolo-Spedifen 200 be taken during pregnancy or while breastfeeding?»); if you have active gastric and/or duodenal ulcers or gastrointestinal bleeding; if you have a history of gastrointestinal bleeding or perforation in connection with previous therapy with so-called non-steroidal anti-inflammatory drugs; in chronic intestinal inflammation (Crohn's disease, ulcerative colitis); in cerebral hemorrhages; if you have an increased tendency to bleed; if you have severe impairment of liver or kidney function; in severe heart failure; for the treatment of pain after coronary bypass surgery on the heart (or use of a heart-lung machine); in children under 12 years of age. Dolo-Spedifen 200 has not been studied for use in children under 12 years of age.

When is caution required when taking Dolo-Spedifen 200?

During treatment with Dolo-Spedifen 200, mucosal ulcers in the upper gastrointestinal tract, rarely bleeding or in individual cases perforations (stomach or intestinal perforations) occur. 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.

You may only take Dolo-Spedifen 200 with a doctor's prescription and under medical supervision in the following situations:

if you are currently being treated by a doctor for a serious illness; if you have previously suffered from a stomach or duodenal ulcer; if you have already had a heart attack, stroke or venous thrombosis, or if you have risk factors (such as high blood pressure, diabetes [diabetes], high blood fat levels, smoking); for certain painkillers with a similar effect, the so-called COX-2 inhibitors, an increased risk of heart attack and stroke has been found at high doses and/or long-term treatment. It is not known whether this increased risk also applies to Dolo-Spedifen 200; if you have heart disease or kidney disease, if you are taking medicines for high blood pressure (e.g. diuretics, ACE inhibitors) or if you lose more fluids, e.g. through excessive sweating; Taking Dolo-Spedifen 200 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 disease; if you are being treated with anticoagulants (blood thinners, anticoagulants) or have a blood clotting disorder; if you suffer from asthma; if you are taking medicines to treat diabetes, medicines to increase urine output (diuretics), medicines to treat infections (quinolone antibiotics), for AIDS (zidovudine), immunosuppressants (tacrolimus, cyclosporine), corticosteroids, antiplatelet agents such as acetylsalicylic acid , selective serotonin reuptake inhibitors (SSRIs), antifungals (voriconazole, fluconazole), or drugs containing any of the following: are taking lithium, digoxin, methotrexate, mifepristone, baclofen, phenytoin, probenecid, or sulfinpyrazone; if you have certain skin diseases (systemic lupus erythematosus (SLE) or mixed collagen disease); if you have an infection. Dolo-Spedifen 200 can mask signs of infection such as fever and pain. Therefore, Dolo-Spedifen 200 may delay adequate treatment of the infection, which may lead to an increased risk of complications. This has been seen in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and your infection symptoms persist or worsen, consult a doctor immediately. Serious skin reactions such as acute generalized pustular exanthema, scaly dermatitis or Stevens-Johnson syndrome have been reported in connection with treatment with medicines containing ibuprofen. The highest risk of such reactions appears to be at the beginning of therapy. If you develop a skin rash, lesions on the mucous membranes, blisters or other signs of allergy, you should stop using Dolo-Spedifen 200 and seek medical attention immediately, as these can be the first signs of a very serious skin reaction (see «Side effects Dolo-Spedifen have 200?»). Acetylsalicylic acid, other pain relievers or Cox-2 inhibitors should not be taken at the same time as ibuprofen as the risk of side effects may be increased. Patients who experience visual disturbances during Dolo-Spedife 200 therapy should discontinue treatment and consult a doctor immediately.

Excipients of particular interestDolo-Spedifen 200 granules sachets contain:

• Aspartame : 20 mg per sachet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare inherited disorder in which phenylalanine builds up because the body can't break it down properly.Sucrose: Please only take this medicine after consulting your doctor if you know that you suffer from an intolerance to sugar.Sodium: 30.05 mg sodium (main component of table salt /table salt) per sachet of 200 mg. This corresponds to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.Sulfite: Can in rare cases cause severe hypersensitivity reactions and bronchial spasms (bronchospasm).

Dolo-Spedifen 200 tabletscontain:

• Sodium: 41.33 mg sodium (main component of table salt / table salt) per tablet at 200 mg. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine may impair your ability to react, the ability to drive and the ability to use any tools or machines. Inform your doctor, pharmacist or druggist, or your doctor, pharmacist or druggist if you suffer from other illnesses, have allergies or are taking other medicines (even those you bought yourself!) or use them externally.

Can Dolo-Spedifen 200 be taken while pregnant or breastfeeding?Pregnancy

Should you be pregnant or are planning a pregnancy, you should only take Dolo-Spedifen 200 after consulting your doctor. Dolo-Spedifen 200 must not be taken in the last third of pregnancy.

Breastfeeding

Dolo-Spedifen 200 should not be taken while breastfeeding unless your doctor has given you express permission to do so.

How do you use Dolo-Spedifen 200?Adults and adolescents over 12 years

Dolo- Spedifen 200 tablets: Take 1-2 tablets with plenty of liquid. Dolo-Spedifen 200 granules, sachet: Dissolve 1-2 sachets of granules in a glass of water. A gap of 4 to 6 hours should be observed before the next dose. In the case of pain during the menstrual period, it is recommended to start the treatment at the first sign of the symptoms with 2 tablets of Dolo-Spedifen 200 or 2 sachets of Dolo-Spedifen 200 granules.

Maximum daily dose

Do not take more than 6 tablets of Dolo-Spedifen 200 or 6 sachets of Dolo-Spedifen 200 granules in a 24-hour period, unless prescribed by a doctor. Do not use Dolo-Spedifen 200 for more than 3 days and only to treat the conditions listed above. The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If symptoms increase despite taking Dolo-Spedifen 200 or if the painful area becomes red or swollen, consult your doctor. A serious illness can be the cause. Even if the symptoms do not improve within 3 days at the latest, you should consult your doctor so that the reason can be clarified. If you have an infection, consult a doctor immediately if the symptoms (e.g. fever and pain) persist or worsen (see «When should you take Dolo-Spedifen 200 with caution?»). . If you have taken more Dolo-Spedifen 200 than you should, or if children have accidentally taken the medicine, always contact a doctor for an assessment of the risk and advice on further treatment . Symptoms can include nausea, stomach pain, vomiting (possibly with blood), headache, ringing in the ears, confusion and eye tremors. At high doses, drowsiness, chest pain, palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems have been reported.

Children under the age of 12

Dolo-Spedifen 200 must not be used in children under the age of 12. The use and safety of Dolo-Spedifen 200 in children under 12 years of age has not been systematically tested. Follow the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Dolo-Spedifen 200 have?

The following side effects can occur when taking Dolo-Spedifen 200, which may require medical treatment. Please tell your doctor immediately if you get any of the following symptoms and stop taking Dolo-Spedifen 200:

Very common side effects, which may affect more than 1 in 10 cases

• Stomach and intestine problems such as indigestion, diarrhea

Common side effects, which may occur in more than 1 in 100 cases but less than 1 in 10 cases

• Stomach and intestine problems such as nausea, feeling of fullness , heartburn, pain in the upper abdomen, anorexia, constipation, flatulence, vomiting, erosive inflammation of the gastric mucosa, blood stoolCentral nervous side effects such as restricted reaction capacity (especially in combination with alcohol), drowsiness, headache and dizzinessDepression, anxiety, confusional stateVisual disturbances (the visual disturbances are usually reversible when treatment is stopped)Ringing in the ears, hearing lossAcute skin rash

Uncommon side effects, which may occur in more than 1 in 1,000 but less than 1 in 100 cases

• Allergic reactions, Swelling of the faceAsthma, spasm of the muscles of the airways and shortness of breathStomach ulcer, gastrointestinal bleeding, tarry stools, gastritis

Rare side effects , which can occur in more than 1 in 10,000 but less than 1 in 1,000 cases

• Changes in blood countSymptoms of lupus erythematosus (butterfly plexus), aseptic meningitis (inflammation of the meninges) in patients suffering from an autoimmune disease"Tingling" of the skinIrreversible visual disturbance or visual impairmentIn patients with heart failure, there is a risk of acute pulmonary edema (water lung)Perforation in the stomach and intestines, vomiting blood, mouth ulcers, worsening of colitis or Crohn's diseaseLiver failure, liver dysfunction
• Blood in the urineVarious kidney diseases such as kidney toxicity, renal dysfunction with accumulation of water in the tissue

Very rare side effects that occur in less than 1 in 10' 000 cases

• Psychotic statesSevere allergic skin reactions with formation of blisters and/or extensive detachment of the skin, photosensitivity reactions, worsening of skin reactionsAcute renal failure

Side effects with unknown frequency:

• AnemiaAnaphylactic ShockHeart failureArterial thrombosis, blood pressure disordersThroat irritationHepatitis, jaundice, liver injuryGeneral swelling li>Severe skin reaction: Known as DRESS syndrome. Symptoms of DRESS include a rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell). Known as acute generalized pustular exanthema (AGEP); at the start of treatment there is a red, scaly, widespread rash with bumps under the skin and blisters accompanied by fever, primarily on the skin folds, trunk and upper extremities. Discontinue use of Dolo-Spedifen 200 if you develop these symptoms and seek medical attention immediately (see also «When should you take Dolo-Spedifen 200 with caution?»).

If you notice any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage Instructions

Keep at room temperature (15-25°C) and out of the reach of children.

Further information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Dolo-Spedifen 200 contain?Active ingredients

1 tablet contains 200 mg ibuprofen as ibuprofen arginate. 1 sachet of granules contains 200 mg ibuprofen as ibuprofen arginate.

Excipients

Tablets: arginine, sodium bicarbonate, crospovidone, magnesium stearate. Granulate: arginine, aspartame (E951), saccharin (E954), sucrose, peppermint flavor (contains sodium and sulphites) and sodium bicarbonate.

Approval number

53616, 54878 (Swissmedic).

Where can you get Dolo-Spedifen 200? What packs are available?

In pharmacies and drugstores, without a doctor's prescription. The following packs are available: 20 tablets of 200 mg. 20 sachets of 200 mg granules.

Authorization holder

Zambon Schweiz AG 6814 CadempinoThis leaflet was last checked by the drug authority (Swissmedic) in August 2020.