500 mg hard
sodium chloride capsules
What Sodium Chloride Evolan is and what it is used for
Sodium chloride Evolan contains the salt sodium chloride (common table salt), a substance that is important for fluid balance. Sodium chloride Evolan is used to treat sodium deficiency caused by, for example, having a shortened bowel ( stoma ) or suffering from a disease called SIADH (overproduction of ADH, antidiuretic hormone, which leads to too low a concentration of sodium in the blood).
Sodium Chloride contained in Sodium Chloride Evolan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Sodium Chloride Evolan
Do not use Sodium Chloride Evolan
– if you are allergic to sodium chloride or any of the other ingredients of this medicine (listed in section 6).
– if you have severe renal impairment
– if you have symptoms of heart failure despite treatment
– if you have fluid retention in your body ( edema )
– if you have severe hepatic impairment ( liver cirrhosis )
– if you have preeclampsia
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Sodium Chloride Evolan if any of the following apply to you:
– if you have heart failure
– if you have impaired kidney or liver function
– if you have high blood pressure
– if you are taking medicines containing cortisone
Other medicines and Sodium Chloride Evolan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Sodium chloride Evolan may affect or be affected if you use any of the following:
– antihypertensive drugs
medicines containing lithium
Pregnancy, breastfeeding and fertility
No known risks at the recommended dose.
Driving and using machines
No effects on the ability to drive and use machines have been demonstrated.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Sodium Chloride Evolan
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by the doctor, who adjusts it individually for you.
Adults:
Individual dosing, however, no more than 20 capsules per day divided into several dosing occasions.
The capsules should be swallowed whole with water.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you use more Evolan sodium chloride than you should
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you take too much Sodium Chloride Evolan you may experience the following: thirst, decreased saliva, swollen tongue, palpitations, drop in blood pressure, fluid accumulation in the brain or body, headache, restlessness, dizziness, stomach cramps, vomiting, and diarrhea. Coma and respiratory arrest may occur in severe cases.
If you forget to use Sodium Chloride Evolan
Do not take a double dose to make up for a forgotten capsule.
If you stop using Sodium Chloride Evolan
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported (affects unknown users):
Nausea, vomiting
How to store Sodium Chloride Evolan
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the outer carton after EXP. and on the blister after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is sodium chloride 500 mg.
– Other excipients are magnesium stearate and colloidal anhydrous silica.
What the medicine looks like and contents of the pack
Pack sizes: 20, 40, 60, 80, 100, 105, 200, 300, 400, 500 and 1000 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer
SC Laropharm SRL,
145 A Alexandriei street,
Bragadiru, Ilfov, 077025,
Romania