What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL16973/0018.


Meptid Injections

PACKAGE LEAFLET: INFORMATION FOR THE USER

Meptid 100 mg/ml Solution for Injection

Meptazinol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or phamacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Meptid Injection is and what it is used for

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 doctor or pharmacist before using Meptid Injection.

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

The dose will be decided by your doctor.

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

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
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
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 June 2019