Document: leaflet MAH BRAND_PL 12580-0020 change

• leaflet MAH BRAND_PL 00116-5048R
• leaflet MAH BRAND_PL 03551-0067
• leaflet MAH BRAND_PL 12580-0020

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NTS085F 150X210 30/04/13 13:40 Pagel

PACKAGE LEAFLET: INFORMATION FOR THE USER GB J HARTMANN’S SOLUTION (Compound Sodium Lactate Intravenous Infusion B.P.)

Sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate 60%

Read all of this leaflet carefully before being given this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or nurse.

-    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Hartmann’s solution is and what it is used for

2.    What you need to know before you are given Hartmann’s solution

3.    How Hartmann’s solution is given

4.    Possible side effects

5.    How to store Hartmann’s solution

6.    Contents of the pack and other information

1. WHAT HARTMANN’S SOLUTION IS AND WHAT IT IS USED FOR

Hartmann’s solution is a clear solution of sodium chloride, potassium chloride, calcium chloride dihydrate and sodium lactate 60% in water. The solution is stored in a sealed plastic container.

Sodium, potassium, calcium and chloride ions are important for maintaining the correct balance of fluid in and around the body’s cells and tissues, and are involved in nerve signals and muscle contractions. Hartmann’s solution may be given for a variety of reasons:

-to help restore fluid levels and the normal salt balance

-to correct for low blood pressure or decreased blood volume

-to treat metabolic acidosis, a condition where there is increased acid in

the body.

The solution may be given alone but may be given with other medicines added.

You will be given Hartmann’s solution in hospital by a doctor or nurse.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HARTMANN’S SOLUTION

You MUST NOT be given this solution if you have:

•    increased levels of sodium, potassium, calcium or chloride in the blood. These conditions can be detected in blood tests

•    severe kidney disease and you are passing little or no urine

•    suffered heart failure

•    increased blood volume or fluid retention (water intoxication, or excess water content in the body)

•    severe metabolic acidosis or lactic acidosis, when you have increased acid in the body

•    metabolic alkalosis, when you have less acid in the body than normal

•    severe liver disease or cannot breakdown lactate

•    swelling caused by fluid retention

•    heart disease which is being treated with the medicine digitalis

•    a requirement to take additional medicines which may lead to increased potassium levels in the body, such as diuretics (water pills)

Warnings and precautions

Talk to your doctor or nurse before being given Hartmann’s solution if you:

•    have heart, kidney or liver disease, or swelling caused by fluid retention

•    have high blood pressure

•    have any condition which causes increased levels of Vitamin D

•    have or have had kidney stones

•    have any condition which may lead to increased potassium levels in the blood, such as extensive tissue destruction as occurs with severe burns, or acute dehydration

•    have pre-eclampsia of pregnancy

•    are very young or elderly.

Other medicines and Hartmann’s solution

Tell your doctor if you are taking or have recently taken any other medicines.

In particular, please tell your doctor if you are taking any of the following:

•    digitalis (for heart disease). You must not be given Hartmann’s solution if you are taking digitalis

•    the water tablets spironolactone, triamterene, amiloride, potassium canrenoate (diuretics used in congestive heart failure)

•    thiazide diuretics

•    medicines for treatment of high blood pressure (ACE inhibitors and angiotensine II inhibitor)

•    corticosteroids, used to treat inflammation

•    tacrolimus and ciclosporin (medicines used to prevent tissue rejection after transplantation)

•    Vitamin D

•    salicylates, barbiturates and lithium

•    adrenaline and the stimulants dexamphetamine sulphate, phenfluramine hydrochloride

•    biphosphonates (for the treatment of bone disorders, and menopausal symptoms)

•    the antibiotic tetracycline and some fluoroquinolones

•    carbenoxolone used to treat ulcers

•    pseudoephedrine used to treat sinus or nasal congestion from colds, hayfever, allergies

•    fluoride (used to prevent dental caries).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor for advice before being given this medicine.

The solution should be used with care during pregnancy and breastfeeding. Breastfeeding mothers should be aware that calcium will pass into breast-milk.

Driving and using machines

The solution has no effect on your ability to drive or use machines.

3. HOW HARTMANN’S SOLUTION IS GIVEN The solution will be given to you in hospital.

You will receive the solution by infusion into a vein, probably in your arm, administered by a doctor or nurse. The amount and rate at which the infusion is given depends on your requirements, such as your age, weight and clinical condition. Your doctor will decide on the correct volume for you to receive.

Your doctor will check your response to the treatment by the relief of your symptoms, and will probably take samples of blood and urine for laboratory testing.

If your levels of potassium could be raised, the level of this salt in your blood will be carefully checked.

Your doctor will monitor you carefully if you have heart or lung disease and you need to be given high volumes of the solution.

Levels of potassium in Hartmann's solution are not high enough to treat severely low blood potassium.

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