Description
PSOCAPS
Food supplement based on fumaric acid salts.Ingredients
Active ingredients: salified fumaric acid (120 mg of fumarates per 1 capsule).
Other Components cellulose; calcium carbonate; magnesium chelate; potassium carbonate; anti-caking agent (silicon dioxide; magnesium stearate; zinc oxide; vitamin B6; coating agent (shellac, castor oil).
How to use
Gradual dosing is recommended in order to achieve an optimal combination of efficacy and tolerability. The maximum dose of 3 times 2 gastro-resistant tablets of the product should NOT be exceeded. In many cases, however, administration of the maximum daily dose is not necessary. The first therapeutic effects are generally visible after the fourth week of treatment.
After the skin reactions improve, we try to slowly reduce the daily intake until reaching the maintenance dose necessary on a case-by-case basis.
Gastro-resistant capsules should be swallowed unchewed with a good amount of liquid during or immediately after meals. In general, a sufficient amount of liquid (1-2 liters) should be consumed throughout the day.
The duration of treatment is determined by the attending physician. There is sufficient experience with a treatment duration of 4 months. Although there are data for treatments lasting up to 36 months, it is recommended not to extend the treatment beyond 6 months.
Contraindications
The product should not be used in case of serious gastrointestinal diseases such as gastric ulcer and duodenal ulcer, and in case of serious liver and kidney diseases; do not administer to patients under 12 years of age.
Although there is no evidence of a teratogenic action based on experimental data in laboratory animals, the product should not be used during pregnancy and breastfeeding, as there is no experience with pregnant patients and it is not known whether the substances pass into breast milk.
Warnings
Do not exceed the recommended daily dose.
Keep out of reach of children under three years of age.
Supplements are not intended as a substitute for a varied diet.
Side effects
At the beginning of treatment, facial redness and hot flashes (flush) are common, and very rarely gastralgia and diarrhea. During the course of treatment, these disorders generally decrease. However, if they are very pronounced, they may lead to an interruption of treatment.
Other digestive disorders such as heaviness in the stomach, epigastric pain and flatulence are also rare.
Nausea, drowsiness, dizziness and headache have been reported rarely. These side effects usually disappear during treatment. In most cases, a dose reduction is sufficient to relieve the symptoms. However, if these side effects do not decrease, the attending physician should decide whether to continue the therapy. During therapy with PSOCAPS, as with any product containing fumaric acid derivatives, blood count changes such as leukopenia, lymphopenia and eosinophilia of mild severity are often observed.
Precautions
Before starting and at the end of a treatment cycle with the product, a complete blood count (with white blood cell count and platelet count) is recommended. If, on medical advice, the recommended dosage is exceeded, periodic blood count checks (white blood cell count and platelet count) should be performed during treatment.
Likewise, SGOT, SGPT, gamma-GT activity, plasma creatinine concentration, protein and urine sediment should be analyzed before the start and at the end of treatment in order to control possible hypersensitivity effects.
Interactions with other preparations
Methotrexate, retinoids, psoralen, ciclosporins, immunosuppressants, cytostatics and medicinal products known to have a negative effect on renal function should not be administered concomitantly with the product.
Conservation
Keep away from light sources and in places inaccessible to children. Store in a cool, dry place. The expiry date refers to the product in its intact package stored correctly.
Format
60 gastro-resistant capsules.
