Pethidine Injection BP 50mg/ml

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Pethidine Hydrochloride 50mg/ml Solution for Injection but will be referred to as “Pethidine Injection” throughout the remainder of this leaflet.

1. What Pethidine Injection is and what it is used for
2. What you need to know before you are given Pethidine Injection
3. How Pethidine Injection is given to you
4. Possible side effects
5. How to store Pethidine Injection
6. Contents of the pack and other information

This medicine contains pethidine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

• if you are allergic to Pethidine Hydrochloride or any of the other ingredients of this medicine (listed in section 6), or to other strong pain relievers, such as morphine
• if you have any problems that affect your breathing including chronic bronchitis or asthma, shallow breathing or other breathing difficulties
• if you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs (eg. moclobemide, phenelzine or isocarboxazid, selegiline and rasagiline) are medicines used to treat depression. (see ‘Other medicines and Pethidine Injection’)
• if you are taking ritonavir used for treatment of HIV infection and isoniazid for tuberculosis
• if you are suffering from severe headaches or you have recently suffered a head injury,
• if you have any conditions associated with raised pressure in the brain or a tumour of the adrenal gland (pheochromocytoma).
• if you have any liver or kidney problems
• if you suffer from alcoholism
• if you suffer from a convulsive disorder (fits) such as epilepsy
• if you are suffering from a condition known as delirium tremens, caused by withdrawal from alcohol
• if your heartbeat is faster than usual
• if you suffer from diabetes.

Patients in a coma should not be given this medicine.

Speak to your doctor if one of these applies to you before you are given this medicine.

Tolerance, dependence and addiction

This medicine contains pethidine, which is an opioid. It can cause dependence and/or addiction.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of pethidine can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to pethidine if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking pethidine, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Pethidine).

Talk to your doctor or pharmacist before being given Pethidine Injection

• if you are in shock, the symptoms of which include sweating, a fast pulse and cold, clammy skin
• if you have an underactive thyroid gland (which may cause tiredness, intolerance to cold, constipation, and puffiness of the face)
• if you have underactive adrenal glands (Addison’s disease) or suffer from problems related to your adrenal gland (the organ responsible for stress levels), including adrenocortical insufficiency (a lack of the hormones produced by the adrenal gland)
• if you have a condition that makes you have fits, eg. epilepsy
• if you have problems with your heart causing an increased heart rate
• if you have a problem with your bowel, liver, kidneys or gall bladder
• if you are in a collapsed state from loss of blood or fluid
• if you are feeling weak and run-down
• if you are complaining of headache and vomiting
• if you suffer from sickle cell anaemia
• if you are elderly and in a poor state of health
• if you have an enlarged prostate gland causing difficulty passing water (men only)
• if you have low blood pressure
• if you have weak muscular movement
• if you have diseases of the stomach or intestine
• if you have lung problems
• if you have been drinking alcohol within the previous 24 hours.
• if you are taking any medicine from the group of medicines known as benzodiazepines. Taking these medicines with Pethidine may result in sedation, difficulties in breathing (respiratory depression), coma and may be fatal. Even if benzodiazepines are prescribed, your doctor may need to change the dose, the duration of treatment or monitor you regularly.

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating when you have stopped taking alcohol or drugs
• feel you need to take more of Pethidine Injection to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Talk to your doctor or pharmacist or nurse if you experience any of the following symptoms while using pethidine

• You experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.
• Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.

Sleep-related breathing disorders

Pethidine can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

If you are elderly or ill, or your baby or child is being given Pethidine Injection, special care will be taken. This medicine may cause difficulty in breathing (respiratory depression) in neonates and young infants.

If any of the above apply to you or your child, please tell your doctor before being given Pethidine Injection.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pethidine Injection must not be used with drugs used to treat severe depression, such as rasagiline or moclobemide, or if you are within 2 weeks of discontinuing them.

A large number of drugs can interact with Pethidine Injection which can significantly alter their effects. These drugs include:

• gabapentin or pregabalin (medicines used to treat epilepsy, nerve pain or anxiety).
• medicines to treat depression (eg. tricyclic antidepressants such as amitriptyline)
• medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics);
• medicines to treat psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines to treat Parkinson’s disease (e.g selegiline)
• medicines for anxiety (anxiolytics) (eg. benzodiazepines such as diazepam)
• medicines used to help you to sleep (hypnotics)
• medicines for schizophrenia or other serious mental illness, such as phenothiazines (which may be present in various medicines including some for treating allergic disorders, nausea (feeling sick) and vomiting (being sick)
• CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, antihistamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders.
• sedatives, sleeping tablets or barbiturates (eg. phenobarbitone for epilepsy)
• cimetidine (for heart burn or stomach ulcers)
• duloxetin (used to treat depression)
• domperidone and metoclopramide (used for disorders of the gastrointestinal tract)
• monoamine oxidase inhibitor A and B (used to treat depression)
• ritanovir (antiviral), a medicine used to treat HIV
• pain relievers and other opioid medicines
• anticholinergic drugs (eg. for a tummy or intestine problem, or for a “weak” bladder or as an inhaler for a breathing problem)
• phenytoin, a medicine used to treat fits (antiepileptic medicine)
• isoniazid (used to treat tuberculosis)
• ciprofloxacin, an antibiotic used to treat a number of bacterial infections
• mexiletine, a medicine used to treat seriously irregular heartbeats
• concomitant use of Pethidine and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Pethidine together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

If you are already taking one of these medicines, speak to your doctor before you receive Pethidine Injection.

You must avoid drinking alcohol whilst being given Pethidine Injection as it may increase the risk of developing breathing problems and low blood pressure.

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 using this medicine.

Pregnancy

Do not take Pethidine Injection if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Pethidine Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Pethidine Injection may cause breathing problems in newborns.

Breast-feeding

Do not take Pethidine Injection while you are breastfeeding as pethidine passes into breast milk and will affect your baby.

Pethidine Injection can cause drowsiness and clouding of consciousness which could interfere with your ability to use machines. Do not operate machinery whilst you are taking this medicine. When your Pethidine Injection treatment has stopped, ask your doctor when it will be safe for you to use machines.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.

A single dose of between 25 - 100mg may be injected into a muscle or into the tissue just beneath the skin. For injection into a vein, a single dose of between 25 - 50mg may be given slowly. These single doses should not usually be repeated more frequently than every 4 hours if required.

The initial dose should not exceed 25mg, because elderly patients or those in a weakened condition are more sensitive to the unwanted effects of pethidine.

The usual single dose is 0.5 to 2.0mg per kilogram of body weight by injection into a muscle. If necessary, this dose may be repeated, allowing at least 4 hours between doses.

To ensure that the correct dose is given, use of a special syringe with fine markings is recommended for administration in children. Alternatively, the solution may be diluted in Water for Injections to make it easier to measure the dose accurately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

The symptoms and signs of taking too much of this medicine include shallow breathing, drowsiness, incoordination, coma, seizures, blue skin and lips, eye closure (miosis), shaking, cold, clammy skin, drop in body temperature, slow heartbeat and low blood pressure.

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 immediately.

Tell your doctor, nurse immediately.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is pethidine hydrochloride.
• The other ingredients are sodium hydroxide or dilute hydrochloric acid in water for injections BP.

Pethidine Injection is a clear, colourless, sterile solution. Each 1ml of solution contains 50mg of pethidine hydrochloride.

The solution is presented in clear glass ampoules (bottles), containing either 1ml or 2ml. The ampoules are then packed in cardboard cartons with 10 ampoules per box.