SPALT Forte soft capsules, 50 pcs

Instructions for use for SPALT Forte soft capsules, 50 pcs

Detailed instructions for SPALT Forte soft capsules, 50 pcs

Field of use

• The preparation is an anti-inflammatory and pain relieving drug (non-steroidal anti-inflammatory/anti-rheumatic).
• The medicine is used at
  • easy to moderately severe pain such as headache, toothache, regulation pain
  • Fever

Active ingredients / ingredients / ingredients

400 mg ibuprofen
Iron (III) oxid auxiliary material (+)
Gelatine auxiliary substance (+)
Potassium hydroxide Hilfuel (+)
Macrogol auxiliary substance (+)
Polyvinyl acetate phthalate Hedge substance (+)
Propylen glycol auxiliary substance (+)
Sorbitol solution, partially dehydrated auxiliary substance (+)
Water, cleaned, sterile auxiliary substance (+)

Contradictions

• The medicine must not be taken
  • if you are hypersensitive (allergic) against ibuprofen or one of the other components of the preparation;
  • if you have reacted in the past with asthma attacks, nasal mucus swelling or skin reactions after taking acetylsalicylic acid or other non-steroidal inflammatory inhibitors;
  • in the case of unexplained blood formation disorders;
  • in the event of existing or repeated stomach/duodenum ulcers (peptic ulcers) or bleeding (at least 2 different episodes of proven ulcers or bleeding);
  • in the case of gastrointestinal bleeding or breakthrough (perforation) in the history in connection with previous therapy with non-steroidal anti-rheumatics/anti-inflammatory drugs (NSAID);
  • for brain bleeding (cerebrovascular bleeding) or other active bleeding;
  • in severe liver or kidney dysfunction;
  • with severe heart failure (heart failure);
  • In the last third of the pregnancy;
  • in children under the age of 12, since this dose strength is not suitable due to the higher active ingredient content.

dosage

• Always take the medicine exactly according to instructions. Please ask your doctor or pharmacist if you are not quite sure.
• Do not take the preparation without a medical or dental advice for more than 4 days.
• If this medicine is required for more than 3 days in children and adolescents or the symptoms worsen, medical advice should be obtained.
• Unless otherwise prescribed by the doctor, the usual dose is:
  • Body weight > 40 kg (children and adolescents from 12 years and adults)
    • Single dose: 1 soft capsule (corresponding to 400 mg ibuprofen)
    • max. Daily dose: 3 soft capsules (corresponding to 1200 mg ibuprofen)
  • If you have taken the maximum single dose, wait at least 6 hours until the next income.
• Dosage in older people:
  • No special dose adjustment is required.
• Please speak to your doctor or pharmacist if you have the impression that the effect of the drug is too strong or too weak.

 

• If you have taken a larger amount than you should:
  • Take the medicine according to the doctor's instructions or after the dosage instructions specified in the package insert. If you have the feeling that you do not feel sufficient pain relief, then do not increase the dosage independently, but ask your doctor.
  • Central nervous disorders such as headaches, dizziness, dunging and unconsciousness (in children also seizures) as well as abdominal pain, nausea and vomiting can occur as symptoms of overdose. Furthermore, bleeding in the gastrointestinal tract and functional disorders of the liver and kidneys are possible. Furthermore, blood pressure drop, reduced breathing (respiratory depression) and the blue -red color of the skin and mucous membranes (cyanosis) can occur.
  • There is no specific antidote (antidot).
  • If you suspect an overdose with the preparation, please notify your doctor. According to the severity of poisoning, this can decide on the measures necessary.

 

• If you forgot to take it:
  • If you have forgotten the intake, the next time you give you the usual recommended amount.

 

• If you have any further questions about the application of the drug, ask your doctor or pharmacist.

Taking

• Please take the capsules with plenty of liquid (e.g. a glass of water) during or after a meal.
• For patients who have one have sensitive stomach, it is advisable to take the preparation during meals.

Patient information

• Particular caution when taking the drug is required
  • Security in the gastrointestinal tract
    • A simultaneous use of the preparation with other non-steroidal inflammatory inhibitors, including so-called COX-2 inhibitors (cyclooxigenase-2-inhibitors), should be avoided.
    • Side effects can be reduced by using the lowest effective dose via the shortest period required for symptom control.
    • Older patients:
      • In older patients, side effects occur more frequently after using NSAR, in particular bleeding and breakthroughs in the stomach and intestinal area, which may be life-threatening. Therefore, particularly careful medical monitoring is required in older patients.
    • Bleeding of the gastrointestinal tract, ulcers and breakthroughs (perforations):
      • Bleeding of the gastrointestinal tract, ulcers and perforations, also with a fatal outcome, were reported during treatment with all NSAIDs.
      • They occurred with or without prior warning symptoms or serious events in the gastrointestinal tract in the prehistory at any time of therapy.
      • The risk of the occurrence of gastrointestinal bleeding, ulcers and breakthroughs is higher with increasing NSAR dose, in patients with ulcers in the history, especially with the complications bleeding or breakthrough and in older patients. These patients should begin treatment with the lowest available dose.
      • For these patients as well as for patients who need accompanying therapy with low-dose acetylsalicylic acid (ASA) or other medicines that can increase the risk of gastrointestinal diseases, a combination therapy with gastric mucosa protecting drugs (e.g. Misoprostol or proton pump inhibitor).
      • If you have a history of side effects on the gastrointestinal tract, especially at older age, you should report any unusual symptoms in the abdomen (especially gastrointestinal bleeding), especially at the beginning of the therapy.
      • Caution is advisable if you get medicines that can increase the risk of ulcers or bleeding, such as: B. Oral corticosteroids, anti-blood clotting drugs such as warfarin, selective serotonin reuptake inhibitors that are used, among other things, to treat depressive moods, or thrombocyte aggregation inhibitors such as ASA.
      • If you have gastrointestinal bleeding or ulcers during treatment with the preparation, the treatment must be discontinued.
    • In patients with a gastrointestinal disease in the prehistory (Colitis Ulzerosa, Crohn's disease), caution should be used because their condition can deteriorate.
  • Effects on the cardiovascular system
    • Anti -inflammatory agents/painkillers such as ibuprofen can go hand in hand with a slightly increased risk of heart attack or stroke, especially when using in high doses. Do not exceed the recommended dose or duration of treatment.
    • You should take your treatment with your doctor or
      Discuss pharmacists when they
      • having heart disease, including heart failure (heart failure) and angina (chest pain), or a heart attack, a bypass operation, peripheral arterial disease (circulatory disorders in the legs or feet due to the narrowed or closed arteries) or any kind of stroke (including mini Had stroke or transitory ischemic attack, "tia");
      • Heavy prints, diabetes or high cholesterol levels or heart diseases or strokes occur in their family history or when they are smokers.
  • Skin reactions
    • Under NSAR therapy, serious skin reactions with redness and bladder formation, some with a fatal outcome, were reported (exfediative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/lyell syndrome). The highest risk of such Reactions seem to exist at the beginning of the therapy, since these reactions appeared in the majority of cases in the first month of treatment. At the first sign of rashes, mucosal defects or other signs of a hypersensitivity reaction, the preparation should be stopped and the doctor should be consulted immediately.
    • Use of the drug should be avoided during a chickenpox infection (varicella infection).
  • Other information
    • The preparation should only be used with the strict weighing of the benefit-risk ratio:
      • for certain innate blood formation disorders (e.g. acute intermittent porphyria);
      • for certain autoimmune diseases (systemic lupus erythematosus and mixed collagenosis);
    • A particularly careful medical monitoring is required:
      • with limited kidney or liver function;
      • directly after larger surgical interventions;
      • in allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic nasal mucosal swelling or chronic, respiratory respiratory diseases.
    • Severe acute hypersensitivity reactions (for example anaphylactic shock) are very rarely observed. At the first sign of a severe hypersensitivity reaction after taking/administration of the preparation, the therapy must be canceled. The symptoms corresponding, medically required measures must be initiated by expert persons.
    • Ibuprofen, the active ingredient of the preparation, can temporarily inhibit the platelet function (thrombocyte aggregation). Patients with blood clotting disorders should therefore be carefully monitored.
    • If the drug is permanently durable, regular control of the liver values, the kidney function and the blood count is required.
    • When taking the preparation before surgical interventions, the doctor or dentist must be questioned or informed.
    • The longer use of all kinds of painkillers against headaches can make them worse. If this is the case or if this is suspected, medical advice should be obtained and treatment can be broken off. The diagnosis of headache in medication overuse (Medication Overuse Headache, MOH) should be assumed in patients who suffer from frequent or daily headaches, although (or precisely because) they regularly take medicines for headaches.
    • In general, the habitual intake of pain relievers, especially when combining several pain relieving active ingredients, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
    • The preparation belongs to a group of medicinal products (non-steroidal anti-rheumatics) that can affect the fertility of women. This effect is reversible after stopping the drug (reversible).
  • Children and adolescents
    • There is a risk of kidney dysfunction in dehydrated children and adolescents. Therefore, before using this medicine in children and adolescents, ask your doctor if the patient has difficulty taking liquids or suffered a loss of fluid due to persistent or diarrhea.
    • Please note the information under category "Contraindication".

 

• Wateriness and operating machines
  • Since when using the drug in higher dosage, central nervous side effects such as tiredness and dizziness can occur, the reaction capacity can be changed in individual cases and the ability to actively participate in road traffic and to operate machines can be impaired. This applies even more in combination with alcohol. You can then no longer react quickly and specifically to unexpected and sudden events. Do not drive a car or other vehicles in this case! Do not operate any tools or machines! Do not work without a safe grip!

Pregnancy

• Ask your doctor or pharmacist for advice before taking/using all drugs.
• Pregnancy
  • Is being used during the application of the drug Efound in pregnancy, the doctor must be notified. You can only use ibuprofen in the first and second thirds of pregnancy after consultation with your doctor. In the last third of pregnancy, the preparation must not be used due to an increased risk of complications for mother and child.
• Breastfeeding
  • The active ingredient ibuprofen and its dismantling products only pass into breast milk in small quantities. Since disadvantageous consequences for the infant have not yet become known, breastfeeding will generally not be necessary for short -term use. If a longer use or intake of higher doses is prescribed, however, an early wing should be considered.

Hints

Do not apply longer for pain or fever without medical advice than specified in the package insert!

Miscellaneous

- No longer take ibuprofen in the event of severe pain in the upper abdomen and see a doctor immediately
- Inform the doctor immediately for visual disturbances and no longer take the medicine
- If signs of an infection appear or worsen while taking it, see the doctor immediately
- Since side effects such as tiredness and dizziness can occur when taking ibuprofen in larger quantities, the ability to drive a motor vehicle or to use machines can be restricted in individual cases. This is particularly true in interaction with alcohol.
- No special precautionary notices are required when taking ibuprofen as pain relievers.
- If Ibuprofen is taken for a long time, regular control of the liver values, the kidney function and the blood count by the doctor is required.
- The habitual intake of painkillers can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy), especially when several pain relieving medication is taken.

Manufacturer:  PharmaSGP GmbH, Am Haag 14, 82166 Gräfelfing