Morfin Kalceks

Document: Morfin Kalceks solution for injection ENG PL change

Package leaflet: Information for the user

Morfin Kalceks 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.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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.

What is in this leaflet

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

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

3. How to use Morfin Kalceks

4. Possible side effects

How to store Morfin Kalceks

6. Contents of the pack and other information

What Morfin Kalceks is and what it is used for

Morfin Kalceks contains the active substamce morphine and belongs to a group of medicines called natural opium alkaloids. This medicine is used to relieve severe pain, when other pain relieving medicines do not have sufficient effect.

What you need to know before you use Morfin Kalceks

Do not use Morfin Kalceks:

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

- in conditions with a lot of mucus in the airways

- in impaired breathing function

- in acute liver disease

- in anxiety conditions in patients affected by alcohol or sleeping medicines

Warnings and precautions

There is a risk of being addicted to Morfin Kalceks.

Talk to your doctor, pharmacist or nurse before using Morfin Kalceks:

- if you are addicted to other pain-relieving medicines (opioids)

- if you receive peritoneal dialysis

- if you have asthma

- if you have airway cramps

- if you have skull injuries

- if you have low blood pressure with reduced blood volume

- if you have impaired thyroid function

- if you have impaired liver or kidney function

- if you have inflammatory bowel disease

- if you have inflammation of pancreas

- if you have bile or urinary tract cramps

if you have enlarged prostate gland
if you have muscular weakness called myasthenia gravis

- if you have concomitant treatment with MAO inhibitors (medicine to treat depression)

In the treatment of elderly patients a lower dose of Morfin Kalceks is recommended.

This medicine should not be used in the pain treatment of unknown origin or in pain connected with mental disorders.

This medicine should not be administered alone during biliary or kidney colic attacks as it may increase the cramp. In these cases Morfin Kalceks should be given in a combination with spasms relieving medicine (spasmolytic).

The effects of this medicine can be enhanced after encephalitis (inflammation of the brain).

Other medicines and Morfin Kalceks

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

The effect of the treatment can be affected if Morfin Kalceks is taken concomitantly with certain other medicines.

Combinations that should be avoided with Morfin Kalceks:

- tranquilizers and sleeping pills containing barbiturates (methohexital, penthotal, phenobarbital);

- medicines to treat depression or Parkinson’s disease (MAO inhibitors) (moclobemide, selegiline).

These medicines can decrease breathing function if used in combination with Morfin Kalceks.

Medicines that may require dose adjustment:

- medicines to treat epilepsy (gabapentin);

- medicines to treat tuberculosis (rifampicin);

- medicines to treat depression (clomipramine, amitripyline, nortriptyline);

- some other pain relieving medicines (buprenorphine, nalbuphine, pentazocine).

Other medicines that can affect or be affected by Morfin Kalceks:

- antispasmodic medicines (baclofen);

- tranquilizers containing benzodiazepines (nitrazepam, flunitrazepam, tirazolam, midazolam);

- tranquilizers that reduces itching (hydroxizine);

- medicines stimulating the central nervous system (methylphenidate);

- medicines against brain membrane bleeding (nimodipine);

- medicines to treat HIV (ritonavir).

Morfin Kalceks with food, drink and alcohol

The combination with alcohol should be avoided since the breathing function can deteriorate.

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.

When studied in animals, this medicine has shown adverse effects on animal fertility and may cause damage to the developing foetus. Therefore, women of childbearing potential, and men, should use effective contraceptive measures. Please discuss this with your doctor.

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

Morphine passes into the breast milk. Morfin Kalceks should therefore not be used during breast‑feeding.

Driving and using machines

During treatment with Morfin Kalceks the ability to react can be reduced. This should be considered when special attention is needed such as when driving or using machines.

How to use Morfin Kalceks

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

The dose is individual and is determined by your doctor. It depends on your age, weight, pain severity and previous medication and pains. If you are elderly or have impaired liver or kidney function a lower dose will be prescribed.

If you use more Morfin Kalceks than you should

If you have received too much medicine or for instance if a child took the medicine by mistake, you should seek medical advice. Symptoms of overdose are: pinpoint pupils, impaired breathing function, low blood pressure. Circulatory disorders and coma can occur in serious cases.

If you forget to use Morfin Kalceks

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

If you stop using Morfin Kalceks

Withdrawal symptoms can occur if you suddenly stop using Morfin Kalceks or if you use certain other strong pain relieving medicines.

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

4. Possible side effects

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

Impaired breathing function is a serious, uncommon side effect with morphine, which may affect up to 1 of 100 people. If you have trouble breathing, immediately contact a doctor for treatment of the impaired breathing function.

Common (may affect up to 1 in 10 people): drowsiness, dizziness, narrowed pupils, nausea, vomiting, constipation, difficulties in urinating, increase in ADHD (a hormone) release.

Uncommon (may affect up to 1 in 100 people): depressed mood, confusion, spasm in the airways, spasm in the urinary or bile duct, itching, light-headedness.

Rare (may affect up to 1 in 1000 people): palpitations, rapid heartbeat (tachycardia), fainting, dizziness when rapidly standing up, high blood pressure, low blood pressure, swollen feet and legs.

Not known (frequency cannot be estimated from the available data): euphoria (sense of happiness), sleep, memory and concentration disturbances, spasm, dry mouth, nettle rash, involuntary muscle twitches (myoclonus),.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via (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 Kalceks

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.

Store in the original package 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 Kalceks contains

The active substance is morphine hydrochloride.

Morfin Kalceks contains 10 mg/ml morphine hydrochloride equivalent to 7.6 mg/ml morphine.

The other ingredients are hydrochloric acid (for pH adjustment), water for injections.

What Morfin Kalceks looks like and contents of the pack

1 ml in glass ampoules (type I) in packages of 10 ampoules.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Morfin Kalceks,10 mg/ml, injektionsvätska, lösning

The Netherlands: Morfine Kalceks 10 mg/ml oplossing voor injectie

Poland: Morphine Kalceks

This leaflet was last revised in 21 September 2016