Patient Leaflet Updated 07-Jan-2021 | Martindale Pharma, an Ethypharm Group Company
Pethidine 50 mg Tablets
Pethidine 50mg Tablets
Pethidine Hydrochloride
1. What Pethidine Tablets are and what they are used for
2. Before you take Pethidine Tablets
3. How to take Pethidine Tablets
4. Possible side effects
5. How to store Pethidine Tablets
6. Contents of the pack and other information
Pethidine is an opioid analgesic with pain relieving properties. This medicine is used for the relief of moderate to severe pain including pain during labour and before and during operations.
Pethidine Tablets should not be given to you if you are unconscious.
Talk to your doctor or pharmacist before being given Pethidine Tablets if
If you are elderly or ill you should take special care when taking Pethidine Tablets.
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.
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:
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.
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.
Pethidine Tablets should not be taken in the first three months of pregnancy unless your doctor considers their use to be essential.
Pethidine can pass into your baby either through your blood (during pregnancy and labour) or through your breast milk. This can cause breathing problems in newborn babies. Your doctor will be aware of this and will correct the problem and discuss feeding with you.
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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
You are advised not to drink alcohol during your treatment with Pethidine Tablets.
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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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 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 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.
You should not stop taking Pethidine Tablets until advised to do so by your doctor. If you stop treatment too suddenly you may experience symptoms of withdrawal such as stomach pains, feeling sick and feeling anxious. Your doctor will advise you how to stop your treatment with Pethidine Tablets.
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. Prolonged use of this medicine can result in mental and physical dependence on pethidine which may result in withdrawal symptoms if your treatment is stopped too quickly. The withdrawal symptoms of Pethidine Tablets include sweating, anxiety, difficulty sleeping, loss of appetite, pain, stomach cramps and diarrhoea. 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.
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):
Other side effects that may occur include:
Not known (frequency cannot be estimated from the available data):
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.
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.
Active substance: Pethidine Hydrochloride 50mg per tablet.
Other ingredients: starch, lactose, sucrose, talc, magnesium stearate and acacia.
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 5 blister packs each containing 10 tablets.
Marketing Authorisation Holder:
Manufacturer:
Product licence number: PL 00156/0031
This leaflet was last revised in:
December 2020
D05458
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