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Morfin Abcur

Document: Morfin Abcur solution for injection ENG PL change

Package leaflet: Information for the user


Morfin Abcur 10 mg/ml, solution for injection


morphine hydrochloride


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


What is in this leaflet

1. What Morfin Abcur is and what it is used for

2. What you need to know before you use Morfin Abcur

3. How to use Morfin Abcur

4. Possible side effects

How to store Morfin Abcur

6. Contents of the pack and other information


What Morfin Abcur is and what it is used for


Morfin Abcur is a medicine used to relieve severe pain, and it belongs to a group of medicines called natural opium alkaloids.


What you need to know before you use Morfin Abcur


Do not use Morfin Abcur:

- if you are allergic to morphine hydrochloride or any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions

There is a risk of habituation with Morfin Abcur.

Talk to your doctor , pharmacist or nurse before using Morfin Abcur if you have:


In treatment of elderly a lower dose of Morfin Abcur is recommended.


Other medicines and Morfin Abcur

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


If Morfin Abcur is taken simultaneously with certain other medicines, the effect of treatment may be affected.


Morfin Abcur may cause impaired respiratory function during concomitant use with:

tranquilizers and sleeping pills (methohexital, pentothal, phenobarbital, meprobamate)

medicines to treat depression (MAO inhibitors) (moclobemide, selegiline)


Morfin Abcur may cause impaired respiratory function during concomitant use with alcohol.


The effect of Morfin Abcur is enhanced by:

- tranquilizers and sleeping pills (methohexital, pentothal, phenobarbital, meprobamate)

- medicines to treat depression (clomipramine, amitriptyline)

- MAO inhibitors (moclobemide, selegiline)


The effect of Morfin Abcur decreases when co-administered with some other analgesics (buprenorphine, nalbuphine, pentazocine).


During concomitant therapy with rifampicin, the dose of Morfin Abcur may need to be increased.


Morfin Abcur with food, drink and alcohol

Combination with alcohol should be avoided since the respiratory function may be impaired.


Pregnancy, breast-feeding and fertility

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 taking this medicine.


If Morfin Abcur is used for a long time during pregnancy the newborn baby may get withdrawal symptoms. The use of morphine during labour may cause reduced respiratory function in the newborn baby.

Morphine is excreted into breast milk. Morphine Abcur should not be used during breast-feeding.


Driving and using machines


Treatment with Morfin Abcur may impair the ability to react. This should be considered when alertness is required, eg when driving or operating machinery.

How to use Morfin Abcur


Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Dosage is individual and determined by the doctor.

Adults:
The usual dose is 1- 1.5 ml solution for injection given subcutaneously or intramuscularly 1-3 times daily. In urgent cases, morphine can be given slowly intravenously.

Elderly:
A lower dose is recommended in elderly patients.


If you use more Morfin Abcur than you should

If you have taken more medicinal product than you should or if for example a child has taken the medicine by mistake, you should seek medical advice. Symptoms of overdose include: pin-point pupils, impaired respiratory function, low blood pressure. Circulatory disorders and coma may occur in severe cases.


If you forget to use Morfin Abcur

Do not take a double dose to make up for a forgotten dose.


If you stop using Morfin Abcur

Withdrawal symptoms may occur if you suddenly stop using Morfin Abcur or if you use certain other strong pain killers.


If you have any further questions on the use of this medicine, ask your doctor, pharnacist or nurse.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Common (affects up to 1 in 10 people): drowsiness, pupil reduction, nausea, vomiting, obstipation, problems passing urine.


Uncommon (affectup to 1 in 100 people):depressed mood, reduced respiratory function, spasm in the airways, spasm in ureter or bile duct, itching, lightheadedness.


Rare (affect up to 1 in 1,000 people):dizziness when rapidly rising up.


Reporting of side effects

If you get any side effects, talk to your doctor 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.

[To be completed nationally]


5. How to store Morfin Abcur


Keep this medicine out of the sight and reach of children.


Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.


Keep the ampoule in the outer carton, in order to protect from light.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Morfin Abcur contains



What Morfin Abucr looks like and contents of the pack


1 ml in glass ampoules (typ I) in packages of 5 or 10 ampoules.

5 ml in glass ampoules (typ I) in packages of 10 ampoules.


Marketing Authorisation Holder


<[To be completed nationally]>


Manufacturer

L Molteni & Dei F .LLI Alitti Societa di Esercizio SpA

Strada Statale 67

Fraz Granatieri

50018 Scandicci Firenze

Italy


This leaflet was last revised in 10 December 2013 .


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