Patient leaflet - Meptid injection 100 mg / ml
1. What Meptid Injection is and what it is used for
This medicine has been prescribed for you for the treatment of moderate to server pain, including post-operative pain, obstetric pain and the pain of renal colic. It contains meptazinol 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.
The name of this medicine is Meptid 100 mg/ml Solution for Injection but will be referred to as Meptid Injection throughout the remainder of the leaflet.
Meptid Injection belongs to a group of medicines known as opioid analgesics, which are used to relieve pain. It contains meptazinol as the active ingredient.
Meptid Injection is used to treat moderate to severe pain, including post-operative pain, pain during childbirth and the pain of renal colic.
2. What you need to know before you use Meptid Injection
Do not use Meptid Injection if you
- are allergic to Meptazinol or any of the other ingredients of this medicine (listed in Section 6)
- have any alcohol-related problems
- have or you are at risk of getting the condition known as paralytic ileus
- have a head injury, or build-up of pressure in the head (raised intracranial pressure)
- are having problems breathing
- are suffering from a tumour of the adrenal gland (phaeochromocytoma)
- are having an asthma attack
- are taking medicines known as monoamine-oxidase inhibitors(MAOIs) or have stopped taking MAOIs less than 14 days ago
Warnings and precautions
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 Meptid 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.
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.
Take special care with Meptid Injection if you
- have any liver or kidney problems
- have any severe breathing problems such as asthma (do not take this medicine during an asthma attack)
- have low blood pressure
- have an under-active thyroid gland (hypothyroidism)
- have an enlarged prostate gland
- suffer from fits or seizures (convulsive disorder)
- think your pain is due to a heart attack
If any of these apply to you, tell your doctor or pharmacist before you are given a Meptid Injection.
Other medicines and Meptid Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
If you are taking any medicines known as monoamine-oxidase inhibitors (MAOIs) including moclobemide to treat, for example, depression, or if you have taken this type of medicine during the past two weeks, you should also talk to your doctor.
In particular, tell your doctor if you are taking, or have recently taken, any of the following medicines which are known to interact with Meptid Injection:
- medicines for treatment of depression known as monoamine-oxidase inhibitors (MAOIs) including moclobemide, and those called tricyclic antidepressants such as amitriptyline or mirtazapine
- medicines for certain mental disorders, such as chlorpromazine
- ritonavir (for HIV infection)
- ciprofloxacin (for bacterial infections)
- domperidone and metoclopramide (for nausea and vomiting)
- cimetidine (for ulcers)
- anti-anxiety and sleeping medicines such as diazepam and nitrazepam
Meptid Injection with food and drink
Avoid taking alcohol with this medicine as it may make you feel especially dizzy and sleepy.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Meptid Injection is sometimes given to relieve pain during labour. However, you should not use Meptid Injection during pregnancy or while breast-feeding unless your doctor thinks that it is essential.
Driving and using machines
If this product makes you dizzy or drowsy, you should not drive or operate machinery.
3. How to use Meptid Injection
Your prescriber should have discussed with you, how long the course of Meptid will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
If you stop taking Meptid
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.
Pregnancy
Do not take Meptid 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 Meptid during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Meptid while you are breastfeeding as meptazinol passes into breast milk and will affect your baby.
The dose will be decided by your doctor.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Meptid 100 mg/ml Solution for Injection
Meptazinol
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Meptid 100 mg/ml Solution for Injection
Meptazinol
Refer to the Summary of Product Characteristics for the full prescribing information
Composition
Each 1 ml of solution contains 100 mg of meptazinol (as hydrochloride). In addition, each 1ml of solution contains 50 mg anhydrous glucose and 1 ml water for injection.
Uses
Meptid injection is indicated for the treatment of moderate to severe pain, including post-operative pain, obstetric pain and the pain of renal colic.
Dosage and administration
Adults
Intramuscular dosage: 75 to 100 mg meptazinol. The injection may be repeated 2 to 4 hourly as required. For obstetric pain a dose of 100 to 150 mg should be used according to weight. This dose should approximate 2 mg/kg.
Intravenous dosage: 50 to 100 mg meptazinol by slow intravenous injection. The injection may be repeated 2 to 4 hourly as required. If vomiting occurs, a suitable anti-emetic should be given.
Epidural/intrathecal use: This formulation is not suitable for these routes. Elderly
The adult dosage schedule can be used in the elderly.
Children
Meptid injection has not been evaluated for use in children.
Contra-indications
Patients with the following conditions:
- known hypersensitivity to the active ingredient or to any of the excipients
- acute alcoholism and where there is a risk of paralytic ileus
- raised intracranial pressure or head injury (in addition to interfering with respiration, affects papillary responses vital for neurological assessment)
- acute respiratory depression
- phaeochromocytoma (risk of pressor response to histamine release)
- during an asthma attack
patients on monoamine-oxidase inhibitors (MAOIs) and for 14 days after discontinuing an MAOI.
The recommended dose is:
Adults and elderly patients
Moderate to severe pain: 75 to 100 mg by injection into a muscle.
The injection may be repeated every two to four hours as required.
Pain during childbirth: 100 to 150 mg by injection into a muscle according to the weight.
If an injection is given into a vein, the usual dose is 50 to 100 mg. These injections may be repeated every two to four hours as required. If vomiting occurs, a suitable medication can be co-administered.
If you have the impression that the effect of Meptid Injection is too strong or too weak, talk to your doctor or pharmacist.
Long term use of Meptid Injection may cause dependence and tolerance. If you are worried about this, talk to your doctor or pharmacist. Meptid Injection is usually only used for short-term treatment of pain.
Use in children
Meptid Injection is not recommended for use in children.
If you receive more Meptid Injection than you should
Since this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if you are worried talk to the doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
At the correct dose Meptid Injection should not generally cause any problems. Talk to your doctor if you get any of the following side-effects:
Very common side effects (may affect more than 1 in 10 people)
- feeling or being sick
- constipation or diarrhoea
- stomach pains, indigestion
- dizziness and vertigo
- drowsiness and sleepiness
- sweating
- headache
- rash.
Uncommon side-effects (may affect up to 1 in 100 people)
- low blood pressure
- breathing problems.
Very rare side-effects (may affect up to 1 in 10,000 people)
- confusion
- hallucination
- depression
Unknown frequency: dependence and addiction (see section “How do I know if I am addicted?”).
Drug Withdrawal
When you stop taking Meptid, 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.
How do I know if I am addicted?
If you notice any of the following signs whilst taking Meptid, 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
Other side effects that have not been mentioned above, but are associated with medicines that act in the same way as Meptid Injection include:
- difficulty in passing urine
- dry mouth
- red face
- unusually fast or slow heart beat, palpitations
- feeling unusually cold
- mood changes
- reduction in pupil size
- depression or anxiety (dysphoria)
- abdominal pain as a result of spasms of the bile duct or ureter
- decreased sexual desire, erectile dysfunction
- hives, rash, itching.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance,
Website www.hpra.ie
5. How to store Meptid Injection
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule or carton after EXP. The expiry date refers to the last day of the month. Your doctor or nurse giving you this injection will have checked that this medicine is still before its expiry date.
Store below 25°C.
This medicine is for single use only. Discard any unused contents.
Do not throw away any medicines via wastewater or household waste. The doctor or pharmacist will dispose of any unused solution. These measures will help protect the environment. Your doctor or nurse giving you this injection will take care of proper disposal of this medicine.
6. Contents of the pack and other information
What Meptid Injection contains
- The active substance is meptazinol. Each 1 ml of solution contains 100 mg of meptazinol (as hydrochloride).
- The other ingredients are anhydrous glucose and water for injections.
What Meptid Injection looks like and contents of the pack
Meptid Injection is a clear and colourless solution and comes in glass ampoules filled with 1 ml of solution for injection. The ampoules are packed in cartons of 10.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almirall S.A.
Ronda General Mitre 151
08022 Barcelona, Spain
Manufacturer:
Kern Pharma SL
Poligono Ind. Colón II, Venus 72
E-08228, Terrassa, Spain
This leaflet was last revised in March 2020
Treatment of overdosage
Overdose with Meptid Injection has not been reported. Large doses, including seven times the recommended therapeutic dose, have been given in balanced and total intravenous anaesthesia without significant respiratory depressant effects.
In the event of cardiovascular and respiratory collapse, normal resuscitative procedures should be employed. Respiratory depression caused by overdosage with meptazinol may only be partially reversed with therapeutic doses of naloxone. Naloxone has a short duration of action in comparison with meptazinol. Repeated administration or administration by continuous intravenous infusion may be considered necessary.
Incompatibilities
Meptid Injection should not be mixed with other drugs in the same infusion solution or in the same syringe. Meptid Injection is an acidic solution of the hydrochloride salt of meptazinol and is therefore pharmaceutically incompatible with injection solutions known to be strongly basic (for example thiopentone) as precipitation of the meptazinol base may occur.
Pharmaceutical precautions
Do not store above 25ºC.
Legal Category POM
Package quantities 10 x 1 ml ampoules per pack or 1 x 1 ml ampoule per pack Product
Licence Number PL 16973/0018 PA 968/5/1
Almirall S.A.
Ronda General Mitre 151
08022 Barcelona, Spain
Manufactured by
Kern Pharma SL
Poligono Ind. Colón II, Venus 72
E-08228, Terrassa, Spain.
* Trade Mark Manufacturer’s Part No.
0000000-00