Label: Information for the Patient User

Sodium Chloride B. Braun 20% Concentrate for Infusion Solution

Sodium Chloride

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isSodium Chloride B. Braun 20%and how it is used

2. What you need to know before starting to useSodium Chloride B. Braun 20%

3. How to useSodium Chloride B. Braun 20%

4. Possible adverse effects

5. Storage ofSodium Chloride B. Braun 20%

6. Contents of the package and additional information

Sodium Chloride is a concentrated solution for infusion to treat sodium and chloride deficiency.It will be applied after being diluted in an infusion solution, through a cannula placed in a vein (intravenous drip).

It will be administered as a supplement of salts when:

• low levels of sodium or chloride are present

fluid retention with loss of salts is present

Do not use Sodium Chloride B. Braun:

• if you are allergic (hypersensitive) to sodium chlorideor to any of the other components of this medication (listed in section 6).
• if you have high levels of sodium or chloride in your blood

Warnings and Precautions

Consult your doctor or pharmacist before using Sodium Chloride B. Braun 20% if you have:

-low levels of potassium in your blood (hypokalemia)

-heart failure

-swelling of the extremities due to excess water in the body tissues (generalized edema)

-fluid in your lungs (pulmonary edema)

-high blood pressure (hypertension)

-eclampsia, a condition that occurs during pregnancy, with high blood pressure, muscle cramps, and edema

-severe kidney failure

-abnormally high levels of acidic substances in your blood (acidosis)

.

Be especially careful if you are receiving certain hormones, called corticosteroids or ACTH, as these substances may affect the balance of fluids and electrolytes. While you are receiving this medication, your doctor should monitor your serum electrolyte levels, fluid balance, and acid-base status regularly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Be especially careful if you suffer from eclampsia,a condition that occurs during pregnancy, with high blood pressure, muscle cramps, and edema.

Use of other medications

Inform your doctor or pharmacist if you are using, have used recently, or may use any other medication.

Corticosteroids and ACTH may lead to fluid and electrolyte retention, possibly causing edema and high blood pressure. Your doctor should know if you are using or receiving these medications.

Driving and operating machinery

The influence of Sodium Chloride B. Braun 20% on your ability to drive and operate machinery is none.

This medication will be administered by infusion, intravenously and diluted in the appropriate solution.

Your doctor will determine the most suitable dose for you. The concentration depends on your age, weight, and clinical status, particularly your sodium level and hydration status.

If your sodium levels have been chronically low, your doctor will administer Sodium Chloride B. Braun at a slower infusion rate to avoid brain damage (see also in the section “If you use more Sodium Chloride B. Braun 20% than you should”).

Follow exactly the usage instructions for Sodium Chloride Braun indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you use more Sodium Chloride B. Braun 20% than you should

Signs of overdose

If you are administered more Sodium Chloride than you should, it may cause an abnormal increase in your body water content, elevated sodium and chloride levels in your blood, and your blood may become much more concentrated than normal. Acidic substances may accumulate in your blood.

A rapid infusion may cause volume overload. It may cause fluid accumulation in your extremities or water in your lungs, as well as high blood pressure. You may also experience diarrhea and an increased urine flow due to an abnormally high concentration of salt in your blood.

Excessively rapid increases in sodium levels may affect your brain (chronic demyelination syndrome).

Actions to consider in case of overdose

In these cases, the infusion should be stopped immediately. Additionally, diuretics will be provided to increase your urine flow. Your sodium levels in the blood will be continuously monitored. Your doctor will prescribe other medications or recommend other measures to normalize your electrolyte levels, water balance, and acid-base balance.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Sodium Chloride B. Braun 20% may produce adverse effects, although not everyone may experience them.

Solutions with a high salt content may cause irritation or inflammation in the vein where the cannula for infusion has been placed.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Sodium Chloride B. Braun 20% after the expiration date shown on the packaging (after CAD). The expiration date is the last day of the month indicated.

Do not use this medication if the solution appears cloudy or discolored, if you find particles in the solution, or if the ampule and closure are damaged.

The contents of the ampules must be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition of Sodium Chloride B. Braun 20%

The active ingredient is sodium chloride.

1 ml of concentrated solution for infusion contains 200 mg of sodium chloride.

1 ml of concentrated infusion solution contains 3.4 moles of sodium and 3.4 moles of chloride.

Theother components are water for injectable preparations.

The theoretical osmolarity is 6,800 mOSmol/l and the pH is 4.5-7.0

Appearance of the product and content of the container

Sodium Chloride B. Braun 20% is an infusion solution that is presented in polyethylene ampoules (Miniplasco) of 10 ml. It is presented in containers containing 1 ampoule, 20 ampoules, and 100 ampoules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing:

This leaflet has been approved inJuly 2016

The detailed information of this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices.http//www.aemps.gob.es/

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This information is intended solelyfor doctors or healthcare professionals:

It should be taken into account the possibility of incompatibilities when mixed with other medications.

The doctor will decide on the use of mixed infusions with other solutions.