Moxaid Sodium 500mg Powder For Solution For Injection
If you are given Moxaid Injection for a long time it can occasionally affect the amount of potassium, or sodium in your blood. Your doctor will probably take blood tests to check that this does not happen. You might also experience bone thinning or the risk of kidney stones with long-term therapy. High or low blood sugar levels may occasionally occur.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor 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 MOXAID INJECTION
Keep out of the sight and reach of children.
Do not use after the expiry date. This date is printed on your pack.
Do not store above 25°C
Any unused solution can be stored in a refrigerator for up to 24 hours but any solution not used within this time must be discarded.
For single use only.
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.
6. FURTHER INFORMATION
What Moxaid Injection Contains
The active substance is acetazolamide. Each vial contains 500mg acetazolamide.
The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.
What Moxaid Injection look like and contents of the pack
Moxaid Injection is a white powder, packed in glass vials with a rubber ring and aluminium seal. Before use, it is made into a solution, using at least 5ml water for injection.
Marketing Authorisation Holder and Manufacturer:
Mercury Pharmaceuticals Ltd,
No.1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK.
Moxaid is a trademark of Amdipharm International Limited.
This leaflet was last revised in September 2014.
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MercuryPharma
PATIENT INFORMATION LEAFLET
Moxaid™ Sodium 500mg Powder for Solution for Injection
(Acetazolamide)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Moxaid™ Sodium 500mg Powder for Solution for Injection. It will be referred to as Moxaid Injection for ease of use hereafter.
In this leaflet:
1. What Moxaid Injection is and what it is used for
2. Before you are given Moxaid Injection
3. How you are given Moxaid Injection
4. Possible side effects
5. How to store Moxaid Injection
6. Further information
1. WHAT MOXAID INJECTION IS AND WHAT IT IS USED FOR
Moxaid Injection contains the active substance Acetazolamide. This belongs to a group of medicines known as carbonic anhydrase inhibitors.
Moxaid Injection is used to treat:
• glaucoma (a condition of the eye), by reducing the pressure within the eye.
• Fluid retention
• Some forms of epilepsy (“fits”), in combination with other anti-epileptic drugs.
2. BEFORE YOU ARE GIVEN MOXAID INJECTION
You should NOT be given Moxaid Injection if:
• you know you are allergic to sulphonamides, sulphonamide derivatives including acetazolamide or to any of the ingredients in the medicine (listed in Section 6 at the end of this leaflet)
• you have or have ever had severe liver disease (problems)
• You have, or have ever had severe kidney problems
• you have a particular type of glaucoma known as chronic non congestive angle closure glaucoma (your doctor will be able to advise you)
• you have reduced function of the adrenal glands - glands above the kidneys - (also known as Addison's disease)
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Date of Approval: To be implemented by: |
PROOF 7 12/09/2014 |
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Product Description: |
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Moxaid Sodium 500mg Powder for Soln. for Inj. |
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• you have low blood levels of sodium and/or potassium or high blood levels of chlorine (your doctor will advise you)
Speak to your doctor if any of the above applies to you.
Take special care and speak to your doctor before taking Moxaid Injection if:
• you have or have ever had kidney problems such as kidney stones
• you have lung problems such as chronic bronchitis or emphysema, which causes difficulty in breathing
• you have diabetes or problems with your blood sugar level
• You are over the age of 65
A small number of people being treated with anti-epileptics such as Moxaid have had thoughts of harming or killing themselves, if at any time you have these thoughts, immediately contact your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effects of any of these medicines may change, particularly if you are taking, or using, any of the following:
• medicines for your heart such as cardiac glycosides (e.g. digoxin)
• medicines to reduce blood pressure
• medicines to thin your blood (e.g. warfarin)
• medicines to lower the sugar in your blood
• medicines for epilepsy or fits (in particular, phenytoin, primidone or carbamazepine or topiramate)
• Drugs which interfere with folic acid, eg methotrexate, pyrimethamine, or trimethoprim
• steroids such as prednisolone
• aspirin and related medicines, eg salicylic acid or choline salicylate for mouth ulcers
• other drugs in the group of medicines called carbonic anhydrase inhibitors
• amphetamines (a stimulant), quinidine (treats an irregular heart beat), methenamine (prevents urine infections) or lithium (treats severe mental problems)
• sodium bicarbonate therapy
• ciclosporin (used to suppress the immune system)
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicines.
Moxaid Injection SHOULD NOT be taken if you are pregnant, think you are pregnant or are planning to become pregnant. It may be taken when breast feeding but only on the advice of the doctor.
Driving and using machines
If Moxaid Injection makes you feel drowsy or confused you should not drive or operate machines. Moxaid Injection can occasionally cause short-sightedness; if this happens and you feel that you can no longer drive safely, you should stop driving and contact your doctor.
Important information about some of the ingredients of Moxaid Injection
This medicine contains less than 1 mmol sodium (23mg) per dose, i.e. essentially “sodium-free”.
3. HOW YOU ARE GIVEN MOXAID INJECTION
Moxaid Injection is a white powder which will be dissolved in water to make a solution for injection either into one of your veins (intravenous) or into one of your muscles (intramuscular).
The dose varies from person to person depending on their condition. Your doctor will decide on the most appropriate dose.
Before starting and during treatment your doctor will monitor your blood to check that treatment with Moxaid Injection is suitable for you.
If you are given more Moxaid Injection than you should:
As the injection will be administered by a doctor, it is unlikely that you will be given more than is necessary.
If you have any further questions on the use of this product ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Moxaid Injection can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
Extremely rarely, Moxaid Injection can affect the cells in your blood. This could mean that you are more likely to catch infections and that your blood may not clot properly. If you have a sore throat or fever or you notice bruises or tiny red or purple spots on your skin you should contact your doctor immediately. If your muscles feel weak or you have fits, you should see your doctor immediately. Common side effects include:
• headache
• diarrhoea
• feeling or being sick, loss of appetite, thirst, or a metallic taste in the mouth
• dizziness, loss of full control of arms or legs
• looking flushed
• a need to pass urine more often than normal
• tiredness or irritability
• feeling over-excited
• a tingling or numbness in the fingers or toes, or coldness in the extremities Other side effects include:
• depression
• drowsiness or confusion
• a loss of interest in sex
• ringing in the ears or difficulty in hearing
• temporary short-sightedness which subsides when the dosage is reduced or treatment is stopped.
Rare cases of skin rashes including an increased sensitivity to sunlight have been reported. If you experience any unusual skin rashes, inform your doctor. Very rarely, Moxaid Injection can affect the liver and kidneys. If you experience pain in your lower back, pain or burning when you pass urine, have difficulty in passing urine, or you stop passing urine, have blood in your urine, pale stools, or if your skin or eyes look slightly yellow, you should contact your doctor. You should also contact your doctor if your stools are black or tarry, or if you notice blood in your stools.
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continued overleaf
|
MercuryPharma |
Date of Approval: To be implemented by: |
PROOF 7 12/09/2014 |
|
Product Description: |
Originated by Date: |
Tech Approved Date: |
|
Moxaid Sodium 500mg Powder for Soln. for Inj. |
SMT 08/08/2013 |
No |
|
Component: |
Revised by |
Version: |
|
Leaflet |
PAT |
XXXXXX/LF/1 |
|
Manufacturer: |
File Name: |
CRF No.: |
|
BAG |
XXXXXXLF Moxaid PowInj v1_7 |
QA.CRF. 107.2013 |
|
Market: |
Software Package: |
Barcode: |
|
UK |
Quark Xpress 9 |
N/A |
|
Minimum Font Size & Typeface: |
Dimensions: |
Pharma Code: |
|
7.5pt Swiss 721BT |
220 x 180mm |
N/A |
|
Colours: 1 Black |
Key Line: |