Document: leaflet MAH GENERIC_PL 01502-0038 change

• leaflet MAH GENERIC_PL 01502-0038
• leaflet MAH GENERIC_PL 02848-5914R

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Patient Information Leaflet    w hameln

Calcium Gluconate Injection 10%

What is in this leaflet

1.    What Calcium Gluconate Injection 10% is and what it is used for

2.    What you need to know before you use Calcium Gluconate Injection 10%

3.    How to use Calcium Gluconate Injection 10%

4.    Possible side effects

5.    How to store Calcium Gluconate Injection 10%

6.    Contents of the pack and other information

1.    What Calcium Gluconate Injection 10% is and what it is used for

Calcium is found naturally in the body and is necessary for the normal function of muscles and nerves. It is needed to make the heart work properly and for blood to clot. Calcium Gluconate Injection 10% is used:

•    to replace low levels of calcium in the body

•    in the treatment of heart attacks

•    in neonatal tetany (a condition affecting the muscles of newly born babies and young infants)

•    in the treatment of lead and fluoride poisoning

•    to prevent low calcium levels from blood transfusions

2.    What you need to know before you use Calcium Gluconate Injection 10%

Do NOT use Calcium Gluconate Injection 10%:

•    if you are allergic to Calcium Gluconate Injection 10% or any of the other ingredients in this injection (listed in section 6)

•    if you have high levels of calcium in your urine

•    if you have high levels of calcium in your blood (for example as a result of hyperparathyroidism (overactivity of the parathyroid gland), excessive levels of vitamin D, a tumour, impaired kidney function, osteoporosis due to a lack of mobility, sarcoidosis or so-called milk-alkali syndrome)

•    if you have severe kidney disease

•    if you have kidney disease and require repeated or prolonged treatment

•    if you are receiving treatment with digitalis medicines unless you have an extremely low blood calcium level with life-threatening symptoms, which can only be treated by an immediate injection of calcium

•    if you are a child (less than 18 years of age) and require repeated or prolonged treatment

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before using Calcium Gluconate Injection 10%:

•    if you suffer from deposition of calcium in the kidneys (nephrocalcinosis)

•    if you have sarcoidosis

•    if you have kidney disease

•    if you have heart disease

•    if you have excessive levels of calcium in the urine

•    if you are receiving adrenaline (epinephrine)

•    if you are elderly

Children and Adolescents:

Children and adolescents (under the age of 18) should not be routinely administered Calcium Gluconate Injection 10%.

Other medicines and Calcium Gluconate Injection 10%:

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Calcium Gluconate Injection 10%:

¹ digoxin (a heart medicine)

¹ diuretics (water tablets)

¹ ceftriaxone (an antibiotic)

¹ adrenaline (epinephrine)

¹ magnesium

¹ calcium channel blockers

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Calcium Gluconate Injection 10%.

3. How to use Calcium Gluconate Injection 10%

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given. During treatment, your blood calcium levels will be monitored closely.

If you use more Calcium Gluconate Injection 10% than you should Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too

much. If you think you have been given too much, you feel sick, are sick, are constipated, have stomach pain, suffer muscle weakness, feel thirsty, are passing a lot of urine, feel confused or have bone pain you must tell the person giving you the injection immediately.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects on the heart, circulation or other body functions may appear as symptoms of an excessively high blood calcium level after overdosing or too rapid injection into a vein.

The presence and frequency of such symptoms depend directly on the speed of injection and the dose administered.

The following side effects may be serious If any of the following side effects occur tell your doctor immediately:

Rare: may affect up to 1 in 1,000 people

•    Severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged <28 days) who had been treated with intravenous ceftriaxone and calcium. Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem.

Not known: frequency cannot be estimated from the available data

•    slow or irregular heartbeat

•    drop in blood pressure (hypotension)

•    circulatory collapse (possibly fatal)

Other side effects

Not known: frequency cannot be estimated from the available data

•    widening of blood vessels

•    hot flushes, mainly after the injection has been administered too rapidly

•    feeling sick or being sick (vomiting)

•    sensation of heat

•    sweating

Side effects when Calcium Gluconate Injection 10% is used incorrectly

•    It has been reported that following leaking of the solution from a vein into the surrounding tissue (extravasation), calcium deposition in the soft tissue may occur. It may be followed by peeling and destruction of the skin.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Calcium Gluconate Injection 10%

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after “Exp. date”. The expiry date refers to the last day of that month.

Your injection will be stored at less than 25°C and protected from light.

6. Contents of the pack and other information

What Calcium Gluconate Injection 10% contains

The active substance is calcium gluconate. Each 1 ml of solution contains 95 mg calcium gluconate in a sterile solution for injection.

The other ingredients are Calcium D Saccharate USP and Sterile Water for Injections EP.

What Calcium Gluconate Injection 10% looks like and contents of the pack

Calcium Gluconate Injection 10% is supplied in 10 ml clear glass ampoules. 10 ampoules supplied in each carton.

The marketing authorisation number of this medicine is: PL 01502/0038.

Marketing Authorisation Holder

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer

hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

hameln rds a.s.

Horna 36 900 01 Modra Slovak Republic

HBM Pharma s.r.o.

Sklabinska 30 03680 Martin Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in February 2016.

43888/06/16