Dolo-Spedifen forte Filmtabl 400 mg 10 pcs

Dolo-Spedifen forte Filmtabl 400 mg 10 Stk

Brand: ZAMBON SCHWEIZ AG
Product Code: 4760162
Availability: 1998
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Description

What is Dolo-Spedifen forte 400 and when is it used?

Dolo-Spedifen forte 400 contains the active ingredient ibuprofen in the form of ibuprofen arginate.

This has pain-relieving, anti-inflammatory and antipyretic properties. The effect occurs after about 30 minutes and lasts about 6 hours.

Dolo-Spedifen forte 400 is suitable for short-term treatment, i.e. 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 zen after injuries;

Fever with flu-like illnesses.

When should Dolo-Spedifen forte 400 not be taken?

If you are allergic to any of the ingredients or have had shortness of breath or allergy-like skin reactions after taking acetylsalicylic acid or other pain or rheumatism medicines, so-called non-steroidal anti-inflammatory drugs;

if you are pregnant or breastfeeding (see also «Can Dolo-Spedifen forte 400 be taken during pregnancy or while breastfeeding?»);

if you have active stomach and/or duodenal ulcers or gastrointestinal bleeding;

if you have a history of gastrointestinal bleeding or perforation (perforation) in connection with previous therapy with so-called non-steroidal anti-inflammatory drugs;

if you have chronic intestinal inflammation (Crohn's disease, ulcerative colitis);

in the case of cerebral hemorrhage;

in the case of an increased tendency to bleed;

in the case of severe impairment of liver or kidney function;

in the case of 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 under 12 years of age. Dolo-Spedifen forte 400 has not been tested for use in children under the age of 12.

When is caution required when taking Dolo-Spedifen forte 400?

During treatment with Dolo-Spedifen forte 400, mucosal ulcers in the upper gastrointestinal tract, rarely bleeding or, in isolated cases, perforations (perforations in the stomach or intestines) may 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.

Older people 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 forte 400 with a 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 a have had venous thrombosis, or if you have risk factors (such as high blood pressure, diabetes, high levels of fat in your blood, 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 forte 400;

if you have heart disease or kidney disease, if you are taking medicines for high blood pressure (e.g. diuretics, ACE inhibitors) or in the event of increased fluid loss, e.g. through heavy sweating; theTaking Dolo-Spedife forte 400 can impair the function of your kidneys, 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 medicines that inhibit blood clotting (blood thinners, anticoagulants) or have a blood clotting disorder;

if you suffer from asthma;

if you are taking medicines for Treatment of diabetes, medicines to increase urine output (water tablets), medicines to treat infections (quinolone antibiotics), for AIDS (zidovudine), immunosuppressants (tacrolimus, cyclosporine), corticosteroids, antiplatelet medicines such as acetylsalicylic acid, selective serotonin reuptake inhibitors (SSRIs), antifungal medicines (voriconazole, fluconazole), or medicines containing any of the following: lithium, digoxin, are taking methotrexate, mifepristone, baclofen, phenytoin, probenecid or sulfinpyrazone;

if you have certain skin diseases (systemic lupus erythematosus (SLE) or mixed collagenosis);

if you have an infection. Dolo-Spedifen forte 400 can mask signs of infection such as fever and pain. It is therefore possible that Dolo-Spedifen forte 400 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 skin inflammation 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 taking Dolo-Spedifen forte 400 and seek immediate medical attention, as these may be the first signs of a very serious skin reaction (see «What side effects can Dolo-Spedifen forte 400 have?»).

Acetylsalicylic acid, other painkillers 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-Spedifen forte 400 therapy should discontinue treatment and consult a doctor immediately.

Excipients of particular interest

Dolo-Spedifen forte 400 film-coated tablets contain:

  • Sucrose: Please take Do not use this medicine until you have consulted your doctor if you know that you have an intolerance to sugar.
  • Sodium: 83 mg sodium (main component of cooking/table salt) per 400 mg film-coated tablet. This corresponds to 4% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine may impair your ability to react, drive and use tools or machines.

Inform your doctor, pharmacist or druggist if you suffer from any other illnesses, have allergies or are taking or using other medicines (including those you have bought yourself)!

May do Thurs lo-Spedifen forte 400 taken during pregnancy or while breastfeeding?

Pregnancy

If you are pregnant or planning a pregnancy, you should only take Dolo-Spedifen forte 400 after consulting your doctor. In the last third of pregnancyDolo-Spedifen forte 400 must not be taken afterwards.

Breastfeeding

Dolo-Spedifen forte 400 should not be taken while breastfeeding unless your doctor has expressly permitted it.

How do you use Dolo-Spedifen forte 400?

Adults and adolescents from the age of 12

D olo-Spedifen forte 400: Take 1 film-coated tablet with plenty of liquid.

Before taking the next dose, wait 4 to 6 hours.

In the case of pain during menstrual bleeding, it is recommended to start treatment with 1 film-coated tablet of Dolo-Spedifen forte 400 at the first sign of symptoms.

Maximum daily dose

Do not take more than 3 film-coated tablets of Dolo- Spedifen forte 400 within 24 hours, unless prescribed by a doctor.

Do not use Dolo-Spedifen forte 400 for more than 3 days and only to treat the symptoms listed above.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms.

If the symptoms increase despite taking Dolo-Spedifen forte 400 or if the pain is painful en 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 be careful when taking Dolo-Spedifen forte 400?»).

If you have taken more Dolo-Spedifen forte 400 than you should, or if children have accidentally taken the medicine, always consult a doctor to get an assessment of the risk and advice on further treatment.

Symptoms may 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 forte 400 must not be used in children under the age of 12. The use and safety of Dolo-Spedifen forte 400 in children under the age of 12 has not yet been systematically tested.

Stick to the dosage given in the package insert or prescribed by the 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 forte 400 have?

The following side effects can occur when taking Dolo-Spedifen forte 400, which may require medical treatment.

Please tell your doctor or your doctor immediately if you experience one or more of the following symptoms and stop taking Dolo-Spedifen forte 400:

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

  • Stomach and intestine problems such as indigestion, diarrhea

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

  • Gastro-intestinal complaints such as nausea, feeling of fullness, heartburn, pain in the upper abdomen, anorexia, constipation, flatulence, vomiting, erosive inflammation of the gastric mucosa, blood stool
  • Central nervous side effects wie Impaired reactions (especially when combined with alcohol), drowsiness, headache and dizziness
  • Depression, anxiety, confusion
  • Visual disturbances (the visual disturbances are usually reversible if treatment is stopped)
  • Ringing in the ears, hearing loss
  • Acute skin rash

Occasional side effects, occurring in more than 1 in 1,000 cases but less than 1 in 100 cases

  • Allergic reactions, swelling of the face
  • Asthma, spasm of the muscles of the airways and shortness of breath
  • Stomach ulcer, gastrointestinal bleeding, tarry stools, gastritis

Rare side effects, occurring in more than 1 in 10,000 cases but less than 1 in 1,000 cases

  • Changes in the blood count
  • Symptoms of lupus erythematosus (butterfly plexus), aseptic meningitis (meningitis) in patients suffering from an autoimmune disease
  • "Tingling" of the skin
  • Irreversible visual disturbance or visual impairment
  • Patients with heart failure are at risk of acute pulmonary edema (water lung)
  • Perforation in the stomach and intestines, vomiting blood, ulcers in the oral mucosa, worsening of colitis or Crohn's disease
  • Liver failure, liver dysfunction
  • Blood in the urine
  • Various kidney diseases such as kidney toxicity, kidney dysfunction with fluid retention in the tissue

Very rare side effects occurring in less than 1 in 10'00 0 cases

  • Psychotic states
  • Severe allergic skin reactions with formation of blisters and/or extensive detachment of the skin, photosensitivity reactions, worsening of skin reactions
  • Acute kidney failure

Side effects with unknown frequency:

  • Anemia
  • Anaphyl acute shock
  • Heart failure
  • Arterial thrombosis, blood pressure disorders
  • Throat irritation
  • Hepatitis, jaundice, liver injury
  • General swelling
  • 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 forte 400 if you develop these symptoms and seek medical treatment immediately (see also «When should you be careful when taking Dolo-Spedifen forte 400?»).

If you notice any side effects, contact 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 taken into account?

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

Storage instructions

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

Further information

Your doctor or pharmacist can provide you with further information or druggist or your doctor, pharmacist or druggist. These people have the executiveHonest professional information.

What does Dolo-Spedifen forte 400 contain?

Active ingredients

1 film-coated tablet contains 400 mg ibuprofen as ibuprofen arginate.

Excipients

Arginine, sodium bicarbonate, crospovidone, magnesium stearate, film coating: hypromellose, sucrose, titanium dioxide (E1 71), Macrogol 4000.

Authorization number

56720 (Swissmedic).

Where can you get Dolo-Spedifen forte 400? Which packs are available?

in pharmacies and drugstores, without medical prescription.

packs of 10 film -coated tablets for 400 mg.

registration owner

Zambon Switzerland AG

6814 Cadempino

This package insert was last in August 2020 checked (Swissmedic).