Cefalotin Sodium injection
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Cefalotin Sandoz.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Cefalotin Sandoz against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT CEFALOTIN SANDOZ IS USED FOR
The name of your medicine is Cefalotin Sandoz. It contains the active ingredient Cefalotin sodium.
Cefalotin Sandoz is an antibiotic used to treat infections in different parts of the body caused by bacteria.
Cefalotin Sandoz is also used to prevent infections before, during and after surgery.
Cefalotin Sandoz belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.
Your doctor may have prescribed Cefalotin Sandoz for another reason. Ask your doctor if you have any questions about why Cefalotin Sandoz has been prescribed for you.
Cefalotin Sandoz is available only with a doctor’s prescription.
Cefalotin Sandoz is not addictive.
BEFORE YOU ARE GIVEN CEFALOTIN SANDOZ
When you must not be given it
Do not use Cefalotin Sandoz if:
- you have an allergy to Cefalotin, or any other cephalosporins
Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; skin rash, itching or hives. - you have had a serious allergic reaction to any penicillins
You may be more likely to have an allergic reaction to Cefalotin Sandoz if you are allergic to penicillin medicines.
Do not use Cefalotin Sandoz if the packaging is torn or shows signs of tampering.
Do not use Cefalotin Sandoz after the expiry date on the pack has passed.
If you are not sure whether you should be given Cefalotin Sandoz, talk to your doctor or nurse.
Before you are given it
Tell your doctor if:
- you have had any type of allergic reaction to any cephalosporin or penicillin medicines
You may have an increased chance of being allergic to Cefalotin Sandoz if you are allergic to any cephalosporins or penicillins. - you have any allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes
- you are pregnant, or intend to become pregnant.
Your doctor will discuss the risks and benefits of using Cefalotin Sandoz during pregnancy. - you are breast-feeding or intend to breast-feed.
Cefalotin Sandoz passes into breast milk. Your doctor will discuss the risks and benefits of using it when breast-feeding. - if you have or have had any medical conditions, including:
- kidney problems
- severe stomach or bowel conditions/disease
If you have not told your doctor about any of the above, tell them before you are given Cefalotin Sandoz.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Cefalotin Sandoz. These include:
- aminoglycoside antibiotics, medicines used to treat certain bacterial infections; e.g. gentamicin or tobramycin
- anticoagulants, medicines used to prevent blood clots; e.g. warfain
- colistin sulfomethate sodium, a medicine used to treat certain bacterial infections
- ethacrynic acid or frusemide, fluid tablets which cause a loss of fluid
- methotrexate, medicines used to treat cancer, rheumatoid arthritis or psoriasis
- non-steroidal anti-inflammatory drug (NSAIDs), salicylates or sulfinpyrazone
- probenecid, a medicine used to treat gout or prolongs the action of certain antibiotics
- theophylline, a medicine used to treat asthma
These medicines may be affected by Cefalotin Sandoz, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.
Talk to your doctor about the need for an additional method of contraception while using Cefalotin Sandoz. Some antibiotics may decrease the effectiveness of some birth control pills.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Cefalotin Sandoz.
HOW CEFALOTIN SANDOZ IS GIVEN
Cefalotin Sandoz must only be given by a doctor or nurse.
Cefalotin Sandoz can be given in two ways:
- as a slow injection into a vein
- as a deep injection into a large muscle
Your doctor will decide what dose and how long you will receive Cefalotin Sandoz. This depends on factors such as your weight, your condition and whether you are using any other medicines. For most infections, Cefalotin Sandoz is usually given in divided doses throughout the day.
If you are given too much (overdose)
As Cefalotin Sandoz is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.
However, if you experience severe side effects after being given Cefalotin Sandoz, immediately tell your doctor, or the Poisons Information Centre (telephone 13 11 26) or go to the Accident and Emergency department of your nearest hospital.
You may need urgent medical attention.
Symptoms of a Cefalotin overdose may include fits or convulsions.
WHILE YOU ARE USING CEFALOTIN SANDOZ
Things you must do
If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Cefalotin Sandoz has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
If you get a sore white mouth or tongue while using or soon after stopping Cefalotin Sandoz, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
This may mean you have a fungal infection called thrush. Sometimes the use of Cefalotin Sandoz allows fungi to grow and the above symptoms to occur. Cefalotin Sandoz does not work against fungi.
If you become pregnant while you are being treated with Cefalotin Sandoz tell your doctor immediately.
If you are about to start using any new medicine, tell your doctor and pharmacist that you are being treated with Cefalotin Sandoz.
If you have to have any blood or urine tests tell your doctor you are being given Cefalotin Sandoz. Cefalotin Sandoz may affect the results of some blood and urine tests.
Tell all the doctors, dentists and pharmacists who are treating you that you are using Cefalotin Sandoz.
Things to be careful of
Be careful driving or operating machinery until you know how Cefalotin Sandoz affects you. Cefalotin Sandoz may cause dizziness in some people. Make sure you know how you react to Cefalotin Sandoz before you drive a car, operate machinery or do anything else that may be dangerous if you are affected.
SIDE EFFECTS
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are being given Cefalotin Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
While being given Cefalotin Sandoz
Tell your doctor if you notice any of the following and they worry you:
- oral thrush – white, furry, sore tongue and mouth
- vaginal thrush – sore and itchy vagina sometimes with a white discharge
- pain or swelling at the injection site
- diarrhoea
- nausea (feeling sick) or vomiting
These side effects are usually mild.
Tell your doctor immediately if you notice any of the following:
- skin rash, itching or hives
- bleeding or bruising more easily than normal
- flaking of the skin
- passing more or less urine than normal
- worsening of your infection, with symptoms such as fever, severe chills
These may be serious side effects of Cefalotin Sandoz. You may need urgent medical attention.
If any of the following happen, stop taking Cefalotin Sandoz and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- symptoms of a hypersensitivity reaction such as swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
- allergic reactions which may cause shortness of breath or difficulties breathing
- fits or seizures
- fast or irregular heartbeat
- severe abdominal cramps or stomach cramps
- watery and severe diarrhoea which may also bloody
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are rare.
After finishing Cefalotin Sandoz
Tell your doctor immediately if you notice any of the following side effects, even if they occur several weeks after stopping treatment with Cefalotin Sandoz:
- severe abdominal cramps or stomach cramps
- watery and severe diarrhoea, which may also be bloody
- fever, in combination with one or both of the above
These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention. However, this side effect is rare.
Do not take any diarrhoea medicine without first checking with your doctor.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STORAGE
Cefalotin Sandoz will be stored in the pharmacy or on the ward.
The powder for injection is kept in a cool dry place where the temperature stays below 25°C.
The reconstituted solution must be used immediately and any unused solution should be discarded.
PRODUCT DESCRIPTION
What it looks like
Cefalotin Sandoz is a white to off-white crystalline powder. It is reconstituted before being injected.
Cefalotin Sandoz is available in packs containing 10 vials.
Ingredients
Each vial contains 1.0 g Cefalotin as the sodium salt.
It also contains sodium bicarbonate.
Cefalotin Sandoz does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Sponsor
Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris Street
Pyrmont NSW 2009
Australia
Tel: 1800 634 500
Australian Registration Number
AUST R 116692
Date of preparation
October 2011
Published by MIMS September 2012