IBSA FARMACEUTICI, Flectorgo 12.5 mg 20 IBSA FARMACEUTICI

“Composition
Active ingredients:
Each soft capsule contains diclofenac in the form of 15.38 mg diclofenac epolamine, equivalent to 12.5 mg diclofenac potassium.
Excipients:
Capsule contents: Macrogol 600 Anhydrous glycerol Purified water
Capsule: Gelatin Anhydrous glycerol Liquid sorbitol, partially dehydrated (E420) Purified water Hydroxypropyl betadex Sodium hydroxide

Directions
Flectorgo 12.5 mg is a medicinal product based on diclofenac epolamine, useful for the treatment of rheumatic and muscular pain, back pain, as well as pain of various origins and nature from mild to moderate (toothache, headache and menstrual pain).
Fast action on pain and inflammation.
Flectorgo soft capsules contain the active ingredient already in a liquid solution.
This ensures rapid absorption and rapid analgesic and anti-inflammatory action of the active ingredient against pain.
Flectorgo is also indicated for headaches.
It has a rapid effect against headaches.
Reduced capsule size
The exclusive reduced size of Flectorgo soft capsules makes them easier to take and especially comfortable for patients with swallowing difficulties.

Method of administration and dosage
Dosage
Adults and adolescents over 14 years of age should start with 1 or 2 soft capsules, then continue taking 1 or 2 soft capsules every 4 to 6 hours as needed.
In any case, do not take more than 6 soft capsules (equivalent to 75 mg diclofenac potassium) within 24 hours.

Flectorgo should be taken for a short period of time.
The duration of treatment should be 3 days.
If symptoms persist or worsen, consult a doctor.
Paediatric population.
Flectorgo is not recommended for use in children and adolescents under 14 years of age.
Elderly
No special dosage adjustment is required.
Given the potential side effect profile, especially careful monitoring of the elderly is required.
Renal impairment
Diclofenac is contraindicated in patients with severe renal impairment.
No dose reduction is required in patients with mild to moderate renal impairment.
Caution should be exercised when prescribing diclofenac to patients with mild to moderate renal impairment.
Hepatic impairment
Diclofenac is contraindicated in patients with severe hepatic impairment.
No dose reduction is required in patients with mild to moderate hepatic impairment.
Caution should be exercised when prescribing diclofenac to patients with mild to moderate hepatic impairment.
Directions for use:
Soft capsules should be swallowed whole with water.
The rate of absorption of diclofenac is reduced when Flectorgo is taken with food.
It is therefore not recommended to take soft capsules during or immediately after meals.

Contraindications
Hypersensitivity to the active substance or to any of the excipients;
Active gastric or intestinal ulcer, bleeding or perforation;
Hematopoietic changes of unknown origin;
History of gastrointestinal bleeding or perforation related to previous NSAID therapy;
History of recurrent peptic ulcer/bleeding (two or more separate episodes of ulcer or confirmed bleeding);
Overt congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
Last trimester of pregnancy;
Severe liver, kidney or heart failure;
Like other nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom acetylsalicylic acid or other NSAIDs cause attacks of bronchospasm, asthma, urticaria or acute rhinitis.”

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