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Coolmetec Side Effects submitted to FDA

Total Coolmetec reports: 3.
Coolmetec FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Coolmetec Side Effects: pallor, nausea, myalgia, hyperhidrosis, dizziness,
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Coolmetec Side Effects Report #5678759-5
Consumer or non-health professional from FRANCE reported COOLMETEC problem on Mar 10, 2008. Female patient was diagnosed with hypertension and was treated with COOLMETEC. After drug was administered, patient experienced the following problems/side effects: dry mouth, hypertension, hyponatraemia. COOLMETEC dosage: 20/12.5 MG (1 IN 1 D), ORAL. During the same period patient was treated with FUROSEMIDE, SOLUPRED. Patient was hospitalized. Patient recovered.



Coolmetec Side Effects Report #5679732-3
COOLMETEC problem was reported by a Consumer or non-health professional from FRANCE on Mar 10, 2008. Female patient was diagnosed with hypertension and was treated with COOLMETEC. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dry mouth, hypertension, hyponatraemia. COOLMETEC dosage: 20/12/5 MG (1 IN 1 D), ORAL. During the same period patient was treated with FUROSEMIDE, SOLUPRED. Patient was hospitalized. Patient recovered.



Coolmetec Side Effects Report #5729018-3
Health Professional from FRANCE reported COOLMETEC problem on Apr 16, 2008. Male patient, 80 years of age, was treated with COOLMETEC. After drug was administered, patient experienced the following problems/side effects: bradycardia, renal failure, renal hypoplasia. COOLMETEC dosage: unknown. During the same period patient was treated with LYRICA, TARKA, LOPRESSOR LP, TENSTATEN, AMLODIPINE BESYLATE, KARDEGIC, PANTOPRAZOLE. Patient was hospitalized. Patient recovered.




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, Coolmetec was diagnosed with hypertension and Coolmetec was diagnosed with hypertension and Coolmetec