Pethidine 50 mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you must not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• 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.

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

1. What Pethidine Tablets are and what they are used for
2. What you need to know 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

• 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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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?”).

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.

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