Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pethidine 50 mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Pethidine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Pethidine is an opioid analgesic with pain relieving properties. This medicine has been prescribed for you for the relief of moderate to severe pain including pain during labour and before and during operations. It contains the Pethidine Hydrochloride which belongs to a class of medicines called opioids, which are 'pain relievers'. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
What you need to know before you take it
e Pethidine Tablets You should not take Pethidine Tablets if:
- you are allergic to Pethidine or any of the other ingredients of this medicine (listed in section 6)
- you suffer from asthma, shallow breathing and other breathing difficulties
- you are taking or have taken within the last two weeks a type of drug used to treat severe depression known as monoamine oxidase inhibitors (MAOI's) (see 'Taking other medicines')
- you suffer from alcoholism
- you are suffering from severe headaches or have suffered a recent head injury (raised intracranial pressure)
- you have a tumour of the adrenal gland known as phaeochromocytoma
- you suffer from a convulsive disorder (fits) such as epilepsy
- you suffer from a problem that could cause paralysis of the small intestine (paralytic ileus)
- your kidneys or liver are not working properly
- you are suffering from a condition known as delirium tremens, caused by withdrawal from alcohol
- you suffer from diabetes Pethidine Tablets should not be given to you if you are unconscious. Warnings and precautions Talk to your doctor or pharmacist before being given Pethidine Tablets if
- your gall bladder is not working properly
- you have an underactive thyroid gland
- you think you may be in shock, as there is a risk of coma
- you have a rapid heartbeat
- you 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)
- you have any prostate problems
- you suffer from problems with your bowel
- you suffer from a muscle disorder known as myasthenia gravis
- you suffer from an irregular heartbeat
- you have been told you suffer from a severe heart problem known as cor pulmonale
- you suffer from low blood pressure
- you suffer from shallow breathing
- you are taking Selegiline, a medicine used to treat Parkinsons disease, or Ritonavir, a medicine used to treat HIV and AIDS.
- 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 Tablets 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. If you are elderly or ill you should take special care when taking Pethidine Tablets. Tolerance and dependence After prolonged use of Pethidine Tablets it is possible to develop tolerance and dependence on the medicine. If you feel that Pethidine Tablets are no longer providing adequate pain relief you should talk to your doctor. Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment. Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to
experience withdrawal symptoms. Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. Other medicines and Pethidine Tablets Tell your doctor, nurse or midwife if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. Pethidine Tablets must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them. These drugs are known as Monoamine Oxidase Inhibitors (MAOI's). Other medicines which may interact with Pethidine Tablets are:
- medicines for sleeping problems (sedatives) and anxiety, such as chloral, diazepam, and barbiturates
- 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.
- anaesthetics
- mood stabilisers (drugs used to treat mental disorders) e.g. chlorpromazine
- mexiletine, a drug used to treat an irregular heartbeat
- cimetidine, a drug used to treat stomach ulcers
- anticonvulsants (drugs used to stop fits), such as phenytoin.
- medicines used to treat feeling or being sick such as domperidone and metoclopramide
- cisapride, a drug used to treat gastric reflux
- alcohol
- antibiotics (medicines used to treat bacterial infections), such as ciprofloxacin
- duloxetine, a medicine used to treat depression
- medicines used to treat depression known as SSRIs, such as citalopram or paroxetine
- medicines used to treat depression known as tricyclic antidepressants, such as amitriptyline or clomipramine
- medicines used to treat anxiety known as anxiolytics, such as diazepam or lorazepam
- carbamazepine, a medicine used to treat epilepsy (fits) and bipolar disorder. Concomitant use of Pethidine Tablets 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. Pregnancy, breast-feeding and fertility Do not take Pethidine Tablets 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. Pethidine Tablets should not be taken in the first three months of pregnancy unless your doctor considers their use to be essential. If you use Pethidine Tablets during pregnancy, your baby
may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Do not take Pethidine tablets while you are breastfeeding as Pethidine Hydrochloride passes into breast milk and will affect your baby. Driving and using machines This medicine can affect your ability to drive and operate machinery. Do not drive or operate machinery if you feel drowsy or cannot think clearly. 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. Taking Pethidine Tablets with food, drink and alcohol You are advised not to drink alcohol during your treatment with Pethidine Tablets. Pethidine Tablets contain lactose and sucrose If you have been told by your doctor that you have an intolerance to some sugars (lactose, sucrose), contact your doctor before taking this medicinal product.
How to take it
Pethidine Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your prescriber should have discussed with you, how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. This medicine is for oral use. Adults: 1-3 tablets (50-150mg) as a single dose. This may be repeated if the doctor decides this is needed but it should not be repeated more often than every four hours. Elderly and infirm patients: 1 tablet (50mg). This may be repeated if the doctor decides this is needed but it should not be repeated more often than every four hours. Your doctor may increase this to 2 or 3 tablets once your reaction to Pethidine is known. Children: A single dose of 0.5-2mg/kg body weight. This may be repeated if the doctor decides this is needed but it should not be repeated more often than every four hours. If you forget to take Pethidine Tablets If you have missed a dose take it as soon as you remember unless it is nearly time for your next dose. Then continue your normal dose times. Do not take a double dose. If you have taken more Pethidine Tablets than you should If you take too much of your medicine seek immediate medical advice from your doctor or your nearest hospital. Symptoms of an overdose include shaking, fits, and sudden or unexpected difficulty in breathing. Continued overleaf
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If you stop taking Pethidine Tablets 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.
Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them. Tolerance, addiction and withdrawal Repeated use of pethidine can result in tolerance and addiction. When you stop taking Pethidine Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. If you are worried about this possible side effect please talk to your doctor. If you have been given Pethidine Tablets during your pregnancy your baby may experience withdrawal symptoms shortly after birth. These symptoms include restlessness, jerking or shaking, sweating, fever, unusually fast breathing, poor feeding and projectile vomiting. If you are concerned about the possible side effects this medicine may have on your unborn child please talk to your doctor before being given this medicine. How do I know if I am addicted? If you notice any of the following signs whilst taking Pethidine Tablets, it could be a sign that you have become addicted.
- You need to take the medicine for longer than advised by your prescriber
- You feel you need to use more than the recommended dose
- You are using the medicine for reasons other than prescribed
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again If you notice any of these signs, it is important you talk to your prescriber. Serious side effects If any of the following symptoms occur tell your doctor or nurse immediately. These are symptoms of a serious allergic reaction. Not known (frequency cannot be estimated from the available data):
- 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: Not known (frequency cannot be estimated from the available data):
- feeling of intense happiness (euphoria)
- feeling sick (nausea)
- being sick (vomiting)
- breathing difficulties
- restlessness
- changes in mood
- low mood
- drowsiness
- a feeling of dizziness or spinning
- constipation
- facial flushing
- dry mouth
- difficulty in passing urine
- an itchy rash or redness
- headache
- feeling very cold
- pin-point pupils
- delay in blinking reflex when things are close to your eye
- spasms in the lower abdomen
- reduced blood pressure, the symptoms of which include feeling dizzy or light-headed, feeling weak and fainting
- a slow, rapid or irregular heartbeat
- sweating
- difficulty achieving or maintaining an erection
- loss of sexual appetite
- hallucinations (seeing or hearing things that aren't real)
- muscle stiffness
- dependence and addiction (see section "How do I know if I am addicted?"). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. 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.
This leaflet was last revised in: October 2024 D06059
How to store it
Pethidine Tablets Keep this medicine out of the sight and reach of children. Do not use this product after the expiry date which is on the carton and blister pack. The expiry date refers to the last day of that month. Store in the original packaging. Do not store above 25°C. 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.
Contents of the pack and other information
What Pethidine Tablets contain: Active substance: Pethidine Hydrochloride 50mg per tablet. Other ingredients: maize starch, lactose monohydrate, sucrose, purified talc, magnesium stearate and acacia. What Pethidine Tablets look like and contents of the pack: The tablets are white, round and flat with bevelled edges. The have M50 marked on one face and a break line on the other. They are supplied in cartons of 2 blister packs each containing 25 tablets. Marketing Authorisation Holder: Martindale Pharma Bampton Road Harold Hill Romford Essex RM3 8UG Manufacturer: Custom Pharmaceuticals Limited Conway Street, Hove, BN3 3LW, United Kingdom Product licence number: PL 00156/0031
D06059
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Frequently asked questions about Pethidine 50 mg Tablets
How do I take Pethidine 50 mg Tablets?
Pethidine 50 mg Tablets comes as tablet containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Pethidine 50 mg Tablets?
The active substance in Pethidine 50 mg Tablets is pethidine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pethidine 50 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Pethidine 50 mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: pethidine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
1. Obstetric analgesia.
2. Moderate to severe pain.
3. Premedication and analgesia during anaesthesia.
4.2. Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with pethidine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4)
Posology
Adults:
The normal single dose, usually not to be repeated more often than four hourly, is as follows: Orally: 50 - 150 mg.
Elderly and debilitated patients
The initial dose should not exceed 50 mg orally as such patients are likely to be particularly sensitive to the central depressant effects of the drug.
Paediatric population:
A single dose of 0.5 - 2 mg / kg body weight orally. This dose may be repeated if clinically necessary but it should not be repeated more often than four hourly.
(As the tablet may not be cut, a child requiring 2mg/kg will need to weigh 25kg, and any child requiring a lower dose will need to be given Pethidine Solution for Injection.)
Method of administration
For oral administration
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Not to be given to comatose patients or to patients with respiratory depression, obstructive airways disease or acute asthma. It should not be given to patients who are receiving monoamine oxidase inhibitors or moclobemide, or within two weeks of their withdrawal. For full list of interactions with other medicinal products, see section 4.5. Not to be given to patients with a history of hypersensitivity or idiosyncratic response to the drug or any of its constituents.
Pethidine should be avoided in patients exhibiting acute alcoholism, delirium tremens or convulsive disorders, and paralytic ileus. Pethidine depresses respiratory function and should be avoided in patients with respiratory insufficiency and in patients with head injuries, raised intracranial pressure severe hepatic or renal impairment. Patients with phaechromocytoma should not be treated with pethidine
Use of pethidine should be avoided in patients with diabetic acidosis where there is a danger of coma.
4.4. Special warnings and precautions for use
Pethidine should only be given with caution, and in reduced dosage, to neonates and premature infants, elderly or debilitated patients, hypotension, decreased respiratory reserve, biliary tract disorders, hypothyroidism, adrenal cortical insufficiency, shock, prostatic hypertrophy, and supraventricular tachycardia. Use of cough suppressants containing opioid analgesics is not generally recommended in children and should be avoided altogether in those under at least 1 year.
Repeated administration may induce tolerance to the drug, with a tendency to psychological dependence of the morphine type, with withdrawal symptoms after abrupt cessation of therapy. Cross tolerance between narcotic analgesics can occur. In the case of severe continuing pain it may be advisable to try other treatments. A reduction in dose is advisable in cases of renal disease and chronic hepatic disease.
Pethidine hydrochloride tablets contain lactose and sucrose.
Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:
Concomitant use of Pethidine tablets and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe methadone concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Drug dependence, tolerance and potential for abuse
For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression).
Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.
A comprehensive patient history should be taken to document concomitant medications, including over- the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance.The risks of developing tolerance should be explained to the patient.
Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly.
Drug withdrawal syndrome
Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with pethidine.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Hyperalgesia
Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.
4.5. Interaction with other medicinal products and other forms of interaction
Alcohol: Enhanced sedative and hypotensive effects.
Antidepressants, SSRI and Tricyclic: The use of pethidine should be avoided in patients receiving monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal. Increased risk of CNS toxicity. Pethidine may increase potential for both selective serotonin re-uptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) to cause convulsions.
Anxiolytics and Hypnotics: Sedative effects may be enhanced by simultaneous use of pethidine.
Antipsychotics: Increased risk of convulsions with pethidine
Carbamazepine: Reduces the effects of Pethidine.
Coumarins: Pethidine enhances anticoagulant effects of coumarins.
Digoxin: Risk of digoxin toxicity increased.
Duloxetine: Possible increased serotonergic effects when administered with pethidine.
Selegiline: Caution with pethidine advised by manufacturer of selegiline.
Ciprofloxacin: The manufacturer of ciprofloxacin advises that, if it is used for surgical prophylaxis, opiates should not be used for premedication as this may reduce the plasma concentration of ciprofloxacin.
Cimetidine: The metabolism of pethidine is inhibited (plasma concentrations of pethidine are increased).
Domperidone and metoclopramide: Pethidine antagonises the gastro-intestinal activity of these drugs.
Mexilitine: Pethidine delays the absorption of mexilitine.
Ritonavir: Plasma concentration of pethidine may be increased by ritonavir.
Sedative medicines such as benzodiazepines or related drugs:
The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
There is inadequate evidence of safety of pethidine in human pregnancy, but the drug has been widely used for many years without apparent ill-consequence, and animal studies have not shown any hazard. Nevertheless the established medical practice of prescribing medicaments in early pregnancy should be observed.
Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.
Breast feeding
Administration to nursing women is not recommended as pethidine may be secreted in breast milk and may cause respiratory depression in the infant.
Fertility
There are insufficient fertility data available to indicate whether pethidine hydrochloride has any effect on fertility.
4.7. Effects on ability to drive and use machines
Pethidine may modify the patient's reactions to a varying extent, depending on dosage, administration and individual susceptibility. If affected or if you are in any doubt that you may be affected do not drive or operate machinery until any effects have worn off.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely
4.8. Undesirable effects
The table below presents adverse drug reactions by System Organ Class. Within each System Organ Class, the adverse drug reactions are presented by incidence, using the following convention:
Not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse Event
Psychiatric disorders
Unknown
Euphoria, hallucinations, dysphoria, mood changes, drug dependence (see section 4.4)
Nervous system disorders
Unknown
Central Nervous System excitation, dizziness, vertigo, drowsiness, headache
Eye disorders
Unknown
Obtund or abolish the corneal reflex, miosis (pupillary constriction)
Cardiac disorders
Unknown
Bradycardia, tachycardia, palpitations
Vascular disorders
Unknown
Hypotension, facial flushing,
Respiratory, thoracic and mediastinal disorders
Unknown
Respiratory depression
Gastrointestinal disorders
Unknown
Nausea,vomiting, constipation, dry mouth
Hepatobiliary disorders
Unknown
Biliary spasm
Skin and subcutaneous tissue disorders
Unknown
Rashes, urticaria, pruritis
Musculoskeletal and connective tissue disorders
Unknown
Muscle rigidity
Renal and urinary disorders
Unknown
Difficulty in micturition, ureteral spasm
Reproductive system and breast disorders
Unknown
Decreased libido or potency
General disorders and administration site conditions
Unknown
Uncommon
Sweating, hypothermia,
drug withdrawal syndrome
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.
Symptoms
In acute overdose the signs may be incoordination, tremors and convulsions followed by respiratory depression and coma.
Management
Gastric lavage should be performed soon after ingestion, and intensive supportive therapy carried out. Naloxone is the preferred antidote. The urinary excretion can be increased by rendering the urine acid by the administration of ammonium chloride. Patients exhibiting symptoms of CNS toxicity should be treated by immediate discontinuation of pethidine, substituting an alternative narcotic for pain, supporting respiratory function and administering an anticonvulsant if seizures occur.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- MIALGIN 100 mg/2 ml prescriptionPETHIDINUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
💬 Ask about this leaflet
Ask anything about Pethidine 50 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.