Nozinan 25mg/Ml Solution For Injection Or Infusion
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UKPILdated November 2013
Ormation Leaflet MOCK
By alik at 12:30 pm, Oct 23, 2014 X
Nozinan® 20/my/mi Solution for Injection or Infusion
(levomepromazine hydrochloride)
Read all of this leaflet carefully before you start receiving this medicine.
• Please keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you suffer from any side effects that get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Your medicine is available in the above name, but will be referred to as Nozinan Injection throughout the remainder of the leaflet.
In this leaflet:
1. What Nozinan Injection is and what it is used for
2. Before Nozinan Injection is given
3. How Nozinan Injection is given
4. Possible side effects
5. How to store Nozinan Injection
6. Further information
1. What Nozinan Injection is and what it is used for
Nozinan Injection belongs to a group of medicines called phenothiazines. It is used for the relief of severe pain and as a sedative to relieve anxiety and distress associated with severe pain, particularly in terminally ill patients.
This medicine is given by a healthcare professional either by injection into a muscle or vein, or slowly via a needle under the skin.
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Food and drink with Nozinan Injection
Avoid alcohol while you are having these injections.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breastfeeding, ask your doctor or pharmacist before taking any medicine. The following symptoms may occur in newborn babies, of mothers that have used Nozinan Injection in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Driving and using machines
Do not drive or operate machinery whilst receiving Nozinan Injections as it may make you feel drowsy, confused, dizzy or lightheaded.
Important information about some of the ingredients of Nozinan Injection
Sodium - this medicinal product is essentially 'sodium-free' as it contains less than 1mmol sodium (23mg) per millilitre.
3. How Nozinan Injection is given
Your doctor will prescribe the appropriate dosage for your condition. The medicine will be given to you by a healthcare professional, either by injection into a muscle or vein or slowly via a needle under your skin.
2. Before Nozinan Injection is given
You MUST NOT be given Nozinan Injection if you have:
• an allergy (hypersensitivity) to levomepromazine hydrochloride or any of the other ingredients in the product (see Section 6 and end of Section 2)
Take special care with Nozinan Injection
Consult your doctor if you:
• have liver problems
• are elderly, frail or have heart disease as you may feel faint or light-headed when you are given the injection. (if you receive a large initial dose, you will have to stay in bed)
• suffer from slow or irregular heartbeats/palpitations (Torsades de Pointes) or have a family history of heart problems
• or someone else in your family have a history of blood clots, as medicines like these have been associated with formation of blood clots
• are diabetic or have been told that you have an increased risk of diabetes
• already know you have low levels of potassium, calcium or magnesium in your blood
• find it difficult, or are unable, to eat
• are an alcoholic
• have epilepsy
Additional tests will be done by your doctor at the start of treatment, if you are being given Nozinan Injection for a long period of time, or if you are taking other medicines at the same time such as heart drugs, anti-depressants or drugs for mental health disorders. These tests might include an ECG (electrocardiogram) to check your heart is working normally and/or blood tests.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may change the way Nozinan Injection works.
These include:
• medicines for the treatment of irregular heartbeats
• antidepressants and drugs for other mental health disorders (i.e. antipsychotics)
Adults, including the elderly
• The usual dose is half to one vial by injection, although up to two vials may be used. This dose may be repeated every 6 to 8 hours if required
Alternatively a dose of up to 8 vials diluted with saline may be infused over 24 hours. Nozinan Tablets 25mg may be given instead of Nozinan Injection if oral therapy is more convenient.
Children
• If the injection is given to children, the dose will be calculated according to their weight; usually 0.35mg -3.0mg/kg/day
If you are given more Nozinan Injection than you should
As this product will be given to you under medical supervision, it is unlikely that you will be given too much.
However, speak to your doctor or nurse if you are worried. Symptoms of overdose include: drowsiness or loss of consciousness, convulsions, low blood pressure, irregular heartbeats and hypothermia (abnormally low body temperature).
If a Nozinan Injection is missed
Contact your doctor or nurse as soon as you remember to arrange another appointment for your next injection. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nozinan Injection can cause side effects, although not everybody gets them.
Allergic reaction - if following your injection you experience symptoms such as skin rash, swelling or breathing difficulties, inform your doctor immediately.
This may be an indication that you are sensitive to the medicine and should not be given a repeat dose.
Frequent side effects include: sleepiness, weakness and dry mouth.
POM
Tell your doctor IMMEDIATELY if you experience any of the following:
• dizziness, feeling faint or loss of alertness
• fever, ulceration of the mouth or throat, or sore throat
• stiffness, shaking (tremor) or slow movement
• low blood pressure, especially in elderly patients
• heart palpitations (usually rapid or irregular heartbeats)
• blood abnormalities
• jaundice (yellowing of the skin and eyes)
• constipation, which may become severe and stop food moving through the bowel
• heat stroke
• high temperature, sweating, pale complexion, difficulty in
passing urine
• colicky abdominal pain with bloody diarrhoea
• skin irritation or burning due to sensitivity to sunlight
• unwanted and persistent erections
• Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
• an illness where the removal of bile from the liver is blocked (cholestasis). Signs include jaundice, rash or fever, and the colour of your water (urine) becomes darker
• you have discolouration of the skin or eyes, pain in the abdomen (stomach) or a
bloated feeling, severe itching, pale or bloody stools, extreme weakness, nausea
or loss of appetite. This could be caused by an infection or injury to the liver
• you have a fit (seizure)
• tired, weak, confused, have muscles that ache, are still or do not work well.
This may be due to low sodium levels in your blood
• feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be something called a syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Other side effects include:
• high blood sugar (hyperglycaemia)
• Feeling confused
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
In elderly people with dementia, a small increase in the number of deaths has
been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
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 Nozinan Injection is stored
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package. Protect from light.
Do not use Nozinan Injection after the expiry date which is stated on the pack.
Medicines should not be disposed of via wastewater or household waste. Your hospital pharmacist will dispose of any medicine no longer required. These measures will help to protect the environment.
6. Further Information
Nozinan injections contain the active ingredient levomepromazine hydrochloride (25mg/ml) per vial.
Each 1ml of solution contains 25mg levomepromazine hydrochloride.
Also contains other ingredients ascorbic acid, sodium sulphite anhydrous, sodium chloride and water for injections (see end of Section 2 for further, important information on Sodium).
Nozinan Injection is a clear, colourless solution for injection. It is supplied in packs of 10 colourless glass vials.
Manufactured by: Gruppo Lepetit Srl, Localita Valcanello 03012 Anagni, Italy. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA.
PL 20774/1393 Nozinan 25/mg/ml Solution for Injection or Infusion
Date of issue: 23rd October 2014
Nozinan is a registered trade mark of May and Baker Limited UK.
PP1/1393/V4