Papaveretum And Hyoscine Injection 15.4mg & 400mcg In 1ml
PACKAGE LEAFLET: INFORMATION FOR THE USER C*****
Papaveretum and Hyoscine Hydrobromide
Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Papaveretum and Hyoscine Injection is and what it is used for
2. Before you are given Papaveretum and Hyoscine Injection
3. How Paravereum and Hyoscine Injection will be given
4. Possible side effects
5. How to store Papaveretum and Hyoscine Injection
6. Further information
1. What Papaveretum and Hyoscine Injection is and what it is used for
This medicine is a mixture of four active ingredients. Two of the active ingredients of this medicine; Morphine Hydrochloride and Codeine Hydrochloride, are powerful substances with pain relieving properties. The active ingredient Papaverine Hydrochloride is a muscle relaxant. Hyoscine Hydrobromide is used to prevent feeling and being sick, and to reduce bodily secretions during operations.
Papaveretum and Hyoscine Injection is used to stop you from feeling pain before, during and after an operation.
2. Before you are given Papaveretum and Hyoscine Injection
You should not be given Papaveretum and Hyoscine
Injection if you:
• are allergic (hypersensitive) to Morphine,
Codeine, Papaverine or Hyoscine, or to any of the ingredients listed in section 6 of this leaflet
• are currently suffering from breathing difficulties or you usually suffer from breathing problems such as asthma
• are currently having an asthma attack
• are suffering from severe stomach pains
• have suffered a head injury or are experiencing severe and undiagnosed headaches
• suffer from heart problems
• suffer from a tumour of the adrenal gland known as phaeochromocytoma
• are unable to open your bowels due to a blockage in your intestines (paralytic ileus)
• are in a coma
• suffer from alcoholism
• suffer from a blood disorder known as porphyria
• have been told you are suffering from a condition known as delayed gastric emptying, the symptoms of which include heartburn, feeling sick or being sick and feeling full quickly whilst eating
• suffer from a convulsive disorder (fits) such as epilepsy
• are suffering from severe heart and lung problems
Take special care with Papaveretum and Hyoscine Injection
Tell your doctor if you:
• are in labour
• are elderly or ill
• suffer from problems related to your adrenal gland (the organ responsible for stress levels), including Addisons disease (an illness caused by a lack of the hormone cortisol which controls stress levels)
• have low blood pressure
• suffer from thyroid problems
• suffer from problems with your prostate
• have liver or kidney problems
• are in shock, the symptoms of which include sweating, a fast pulse and cold, clammy skin
• have an unusually fast heartbeat
• suffer from problems with your pancreas
• suffer from a muscle disorder known as myasthenia gravis
• are suffering from gall stones
• are having problems passing urine
• suffer from heart disease
• have been told you are at risk of developing a condition known as glaucoma which causes raised pressure in the eye.
• have any lung problems, in particular emphysema (enlarged and damaged lungs)
• have had an operation in the last 24 hours
• are extremely overweight
• suffer from spine problems
• suffer from an irregular heartbeat
• have been told you suffer from a severe heart problem known as cor pulmonale
• suffer from bowel problems
If any of the above apply to you or your child please tell your doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking, or have recently taken, any other medicine including medicines obtained without prescription.
Medicines which may interact with Papaveretum and Hyoscine Injection include:
• medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs) such as phenelzine or moclobemide. Tell your doctor even if you have stopped taking them within the last two weeks
• medicines used to reduce anxiety (anxiolytics) such as diazepam or lorazepam
• medicines used to help you to sleep (hypnotics) such as temazepam or phenobarbital
• CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, anti-histamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic.
• medicines used to treat mental disorders (antipsychotics) such as haloperidol or chlorpromazine
• medicines used to treat allergies (antihistamines) such as desloratadine or promethazine
• medicines that cause the drying up of bodily fluids (antimuscarinics) such as atropine or glycopyrronium
• ciprofloxacin, a medicine used to treat bacterial infections
• medicines designed to be placed under the tongue e.g. nitrates
If you are in any doubt please tell your doctor of any medication you are taking.
Pregnancy and breast-feeding:
If you are pregnant, trying for a baby or breast-feeding you should ask your doctor for advice before you are given this medicine.
Effects on the ability to drive and use machinery:
This medicine may cause drowsiness. If you are affected do not drive or use machines.
Having Papaveretum and Hyoscine Injection with food and drink
You are advised not to drink alcohol during your treatment with this medicine.
Important information about some of the ingredients:
This medicine contains sodium metabisulphite which may cause allergic (hypersensitive) type reactions in some people and can lead to breathing difficulties or collapse. People with a history of asthma or allergies are most likely to experience these problems.
3. How Papaveretum and Hyoscine Injection will be given
Your doctor will give Papaveretum and Hyoscine Injection to you as an injection under the skin (subcutaneously) or into a muscle (intramuscularly).
Your doctor will determine how much of Papaveretum and Hyoscine Injection you need.
Adults:
The usual dose is a single dose of 0.5ml-1ml Elderly and infirm patients:
It is recommended that a reduced dose be used. The usual initial dose is up to a maximum of 0.5ml.
Children:
Under 1 month of age: 0.0075ml per kilogram of bodyweight 1 month to 1 year of age: 0.01ml per kilogram of bodyweight 1 year to 5 years of age: 0.125ml-0.25ml as the maximum single dose
6 years to 12 years: 0.25ml-0.5ml as the maximum single
dose
If you are given more Papaveretum and Hyoscine Injection than you should be:
This medicine will be given to you in hospital so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose.
If you feel unwell after being given this medicine, or are at all concerned you have been given too much, tell your doctor or nurse.
• tingling, pricking or numbness of the skin ('pins and needles')
• seizures (fits)
• fainting
• feeling weak
• a feeling of being unwell
• feeling disoriented, confused or having problems concentrating
• feeling excited
• lack of menstruation (period)
• twitching muscles
• pain, tenderness, swelling or weakness of the muscles (rhabdomyolysis)
• blurred vision
• raised pressure in the front of the eye (angle-closure glaucoma)
If any of these side effects get serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or nurse.
5. How to Store Papaveretum and Hyoscine Injection
Keep all medicines out of the reach and sight of children.
You should not be given Papaveretum and Hyoscine Injection after the expiry date on the ampoule and carton label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.
Protect from light.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible Side Effects
Like all medicines Papaveretum and Hyoscine Injection can cause side effects, although not everybody gets them.
Repeated use of papaveretum can result in tolerance and addiction
What Papaveretum and Hyoscine Injection contains:
Active ingredients: Papaveretum 15.4mg and Hyoscine Hydrobromide 0.4mg in 1ml.
Other ingredients: Glycerol, Sodium Metabisulphite and Water for Injections. Hydrochloric Acid may be added to adjust the pH.
What Papaveretum and Hyoscine Injection looks like and contents of the pack:
The clear colourless solution is supplied in 1ml clear glass ampoules. Each pack contains 10 ampoules.
If any of the following symptoms occur tell your doctor or nurse immediately. These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
Other side effects that may occur include:
• hallucinations (seeing or hearing things that aren't real)
• confusion
• mood changes
• feeling sad, restless or worried
• headache
• a feeling of spinning (vertigo)
• dizziness
• drowsiness
• sweating
• feeling faint on standing up from a seated position
• pinpoint pupils
• a faster or slower heartbeat than usual
• facial flushing
• slowed breathing or difficulty breathing
• constipation
• feeling or being sick
• dry mouth
• spasms in the lower abdomen
• itching or a rash
• reduced sex drive
• difficulty achieving or maintaining an erection
• difficulty passing urine
• hypothermia, the symptoms of which include shivering, drowsiness and feeling weak
• stomach pain
• loss of appetite
• indigestion
• worsening of a condition that affects the pancreas known as pancreatitis. The symptoms of this include stomach pain and feeling or being sick.
• changes in the way things taste
• high blood pressure
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals Ltd., Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom.
Product Licence Number:
PL 01883/6182R
This leaflet was last approved in: 09/2008
MARTINDALE
Pharmaceuticals
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom