When to use lethal doses of morphine

Morphine Ratiopharm 30 retard

Patient information for Morphine Ratiopharm 30 retard

1. What Morphine Ratiopharm 30 retard is and what it is used for

1.1 What are the properties of the medicinal product?

Morphine Ratiopharm 30 retard contains the active ingredient morphine, a drug from the group of so-called opioids.

Morphine is an alkaloid that is extracted from opium. It has, inter alia. strong pain reliever properties.

Morphine is usually used in salt form as morphine sulfate, morphine hydrochloride or morphine poly (styrene-co-divinylbenzene) sulfonate.

Morphine requires a prescription, is subject to the Narcotics Prescription Ordinance and may only be used on special medical prescription and instruction.

1.2 What strengths and dosage forms are there?

Morphine is usually available as

- drops / solution containing 5 mg or 20 mg of morphine hydrochloride in 1 ml,

- capsules containing 5 mg, 10 mg, 20 mg or 30 mg of morphine sulfate,

- film-coated tablets containing 10 mg or 20 mg morphine sulfate,

- drinking ampoules containing 10 mg or 30 mg or 100 mg of morphine sulphate in 5 ml,

- Effervescent tablet containing 20 mg of morphine sulfate,

- Retard capsules or tablets containing 10 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulfate,

- Retard granules containing 20 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulfate as morphine poly (styrene-co-divinylbenzene) sulfonate.

- Suppositories for introduction into the intestine containing 10 mg, 20 mg or 30 mg of morphine sulfate.

Your doctor will determine which strength and dosage form are suitable for your treatment.

1.3 Morphine is used for

severe and severe pain.

2. What should you know before you use Morphine Ratiopharm 30 retard?

2.1 Morphine Ratiopharm 30 retard must not be used

- if you are allergic (hypersensitive) to morphine or any of the other ingredients of Morphine Ratiopharm 30 retard,

- if the intestinal obstruction (ileus)

- in the case of unclear acute painful abdominal discomfort (acute abdomen).

2.2 Special care is required when using Morphine Ratiopharm 30 retard,

at:

- dependence on opioids,

- impaired consciousness,

- Disease states in which a disorder of the respiratory center and respiratory function is present or must be avoided,

- changed heart (cor pulmonale) as a result of chronic overload of the pulmonary circulation,

- conditions with increased intracranial pressure,

- low blood pressure associated with a low amount of blood circulating (hypotension in hypovolaemia),

- enlarged prostate gland (prostate hypertrophy) with residual urine formation (risk of bladder rupture [rupture of the urinary bladder] due to urinary retention),

- urinary tract narrowing or colic of the urinary tract,

- biliary tract diseases,

- obstructive (constricting) and inflammatory bowel diseases,

- tumor of the adrenal gland (pheochromocytoma),

Inflammation of the pancreas (pancreatitis)

- severe impairment of kidney function,

- underactive thyroid gland (hypothyroidism),

- epileptic seizures or an increased tendency to seizures.

Long-term use of Morphine Ratiopharm 30 retard can lead to habituation (tolerance) requiring higher doses to achieve the desired analgesic effect. The chronic use of Morphine Ratiopharm 30 retard can lead to physical (physical) dependence, and withdrawal syndrome can occur if the therapy is stopped abruptly. When therapy with morphine is no longer required, it may be advisable to gradually reduce the daily dose in order to avoid the symptoms of withdrawal syndrome.

The active ingredient morphine sulfate, like other highly effective opioids (strong pain relievers), has potential for abuse. The development of psychological addiction is possible. Therefore Morphine Ratiopharm 30 retard should be used with particular caution by patients with existing or past alcohol or drug abuse.

Morphine Ratiopharm 30 retard is not recommended before and within 24 hours after operations (increased risk of intestinal paralysis or respiratory depression).

Very rarely, especially in high doses, an increased sensitivity to pain (hyperalgesia) can occur that does not respond to a further increase in dose. Your doctor will decide if a dose reduction or a change in pain reliever (opioid) is necessary.

If you have a disease of the adrenal cortex (e.g. Addison's disease), your doctor will check the concentration of the adrenal cortex hormone in the blood (plasma cortisol concentration) and, if necessary, prescribe appropriate medication (corticoids).

Constipation is common with morphine treatment. Especially if you had problems with your bowel movements before you started taking it, you should take a laxative right from the start. Please speak to your doctor.

Men of childbearing potential and women of childbearing age: Because of the mutagenic properties of morphine, this active ingredient should only be administered to men of childbearing age or women of childbearing age if effective contraception is ensured.

Effects of misuse for doping purposes: The use of Morphine Ratiopharm 30 retard can lead to positive results in doping controls.

Notes on other ingredients:

- Oral medicines can contain different types of sugar. Therefore, please only take this after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

- A possible component of the effervescent tablets, aspartame as a source of phenylalanine, can be harmful if you have phenylketonuria. Effervescent tablets usually contain potassium and sodium. If you have impaired kidney function, are on a controlled potassium diet (diet with low potassium content), or are on a restricted sodium diet, this should be taken into account.

- If suppositories and latex condoms are used at the same time, the hard fat component may reduce the tear resistance and thus impair the safety of condoms.

2.2.a) Children

In children under 1 year of age, morphine should only be used with particular caution, as there is an increased sensitivity to the impairing effect on the respiratory function.

Oral solutions are available for children under 12 years of age, and 5 mg capsules for oral use and 10 mg suppositories are also available from 6 years of age.

2.2.b) Elderly patients

In the elderly, particular care should be taken to dose morphine.

2.2.c) Pregnancy

Ask your doctor or pharmacist for advice before taking / using any medicine.

Since there are indications of harm to the offspring of morphine-treated mothers from animal studies, you must not use Morphine Ratiopharm 30 retard during pregnancy unless your doctor considers this to be absolutely necessary and estimates the benefit for you to be significantly higher than the risk for the child. Because of the mutagenic properties of morphine, this active ingredient should only be administered to men and women of fertile and childbearing age if effective contraception is ensured.

Withdrawal symptoms after prolonged use of morphine during pregnancy have been described in newborns.

2.2.d) Breastfeeding

Morphine is excreted in breast milk and can reach effective concentrations in the infant. Breastfeeding is therefore not recommended.

2.2.e) Ability to drive and use machines

Morphine can impair alertness and the ability to react. You will then no longer be able to react quickly enough and in a targeted manner to unexpected and sudden events.

Discuss with your doctor whether and under what conditions you can e.g. drive a car (see below). Increased impairment is to be expected, especially when starting treatment, increasing the dose and changing preparations, as well as in combination with alcohol or the use of sedatives. Then do not drive a car or other vehicles! Do not then operate any electrical tools or machines! Do not then work without a secure hold!

2.3 Which interactions with other medicinal products have to be considered?

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

The simultaneous use of morphine and other drugs that have a central, ie depressant effect on the brain function (such as drugs against anxiety disorders (tranquilizers), against depression (antidepressants), against mental disorders (neuroleptics), for anesthesia (anesthetics), against sleep disorders (hypnotics, Sedatives, barbiturates), against allergies or motion sickness (antihistamines / antiemetics) or other highly effective pain relievers (opioids) or alcohol can lead to an intensification of the side effects of morphine, in particular impaired respiratory function.

Medicines with an anticholinergic effect (e.g. psychotropic drugs, drugs against allergies, vomiting or Parkinson's disease) can increase the anticholinergic side effects of opioids (e.g. constipation, dry mouth or urination disorders).

Cimetidine (used to treat gastric ulcers) and other drugs that put a strain on the liver metabolism can cause increased concentrations of morphine in the blood by inhibiting the breakdown.

Morphine Ratiopharm 30 retard should not be administered at the same time as MAO inhibitors (medicines that work against depression). When MAO inhibitors were administered within the last 14 days before administration of another opioid (pethidine), life-threatening interactions that affected the brain (central nervous system) as well as respiratory and circulatory function have been observed. The same interactions with MAO inhibitors cannot be ruled out with Morphine Ratiopharm 30 retard.

Morphine can increase the effect of drugs that relax muscles (muscle relaxants).

If rifampicin (an anti-tuberculosis drug) is used at the same time, the effects of morphine may be weakened.

2.4 What should be considered when using Morphine Ratiopharm 30 retard together with food, luxury foods and beverages?

The use of alcohol during treatment with Morphine Ratiopharm 30 retard can lead to increased sleepiness or the risk of serious side effects, such as shallow breathing with the risk of respiratory failure and loss of consciousness. It is recommended not to drink alcohol while using Morphine Ratiopharm 30 retard.

3. How should Morphine Ratiopharm 30 retard be used?

Always take Morphine Ratiopharm 30 retard exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

The solution is swallowed with sufficient liquid. It can be taken independently of meals.

The film-coated tablets / hard capsules / capsules are to be swallowed whole with sufficient liquid, regardless of meals.

The effervescent tablets are dissolved in a glass of water before taking. It can be taken independently of meals.

If possible, the suppositories are inserted deep into the anus after a bowel movement. To improve the lubricity, the suppositories can be warmed in the hand or briefly dipped in hot water.

The prolonged-release tablets / capsules are to be swallowed whole, not crushed and undivided with sufficient liquid, regardless of meals, taking in the morning and evening is recommended.

Granules: The contents of a sachet can be stirred into water and drunk, sprinkled over soft food, e.g. yoghurt, or administered through a feeding tube, whereby it is recommended to take it in the morning and in the evening.

Morphine Ratiopharm 30 retard should under no circumstances be used longer than absolutely necessary. If long-term pain treatment with Morphine Ratiopharm 30 retard appears to be necessary depending on the type and severity of the disease, a careful and regular check should be carried out at short intervals to determine whether and to what extent a medical requirement persists. It may be necessary to switch to more suitable forms of administration.

In the treatment of chronic pain, preference should be given to dosing according to a fixed schedule.

Your doctor will decide on the duration of the treatment depending on the pain symptoms.

Please talk to your doctor if you have the impression that the effect of Morphine Ratiopharm 30 retard is too strong or too weak.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

The dosage must be adjusted according to the severity of the pain and the individual sensitivity of the patient.

Initially, treatment is started with a non-retarded morphine (e.g. tablet / solution / effervescent tablet) in order to determine the dose with which adequate pain control is achieved. The patient is then switched to the corresponding daily dose of morphine. Persistent pain (breakthrough pain) should be treated with a non-delayed dosage form of morphine.

For a readjustment of the dose, dosage forms with a lower active ingredient content may be used, possibly in addition to an existing therapy with prolonged-release tablets.

In principle, a sufficiently high dose should be given and, at the same time, the smallest effective pain-relieving dose should be aimed for. Should you undergo any other additional pain treatment (e.g. surgery, plexus blockade), the dose will have to be reset after the procedure. If necessary, this will be done by your doctor.

The dosage depends on the severity of the pain as well as the age of the patient and his previous analgesic needs.

As a rule, adults take 1 retarded drug (e.g. prolonged-release capsules / tablets / granules) once a day. If a higher dose is required, the intake interval must not be less than 12 hours.

The following dosage recommendations apply on the basis of a single dose of 0.2 to 0.3 mg morphine sulfate / kg or 0.2 to 0.3 mg morphine hydrochloride 3H2O / kg body weight:

The single doses can be repeated after 4 to 6 hours if the effect diminishes. The maximum daily doses should not exceed 4 to 6 times the individual doses!

3.2.a) Children from 6 and adults (for non-retarded dosage forms)

3.2.a.1.Adults and young people over 16 years of age

Single dose: 10 to 60 mg of morphine sulfate.

The single dose can be repeated after 4 to 6 hours if the effect diminishes.

Total daily dose: up to 360 mg morphine sulfate.

3.2.a.2.Adolescents 12 to 16 years (40 to 50 kg body weight)

Single dose: 10 to 20 mg of morphine sulfate.

The single dose can be repeated after 4 to 6 hours if the effect diminishes.

Total daily dose: up to 60 to 120 mg of morphine sulfate.

3.2.a.3.Children 6 to 12 years (20 to 40 kg body weight)

Single dose: 5 to 10 mg of morphine sulfate.

The single dose can be repeated after 4 to 6 hours if the effect diminishes.

Total daily dose: up to 30 to 60 mg of morphine sulfate.

3.2.b) Children under 6 years of age (for oral solutions 5 mg / ml or 20 mg / ml, not retarded)

3.2.b.1.Children up to 2 years (up to 12.5 kg)

Single dose: up to 2.5 mg morphine hydrochloride 3H2O (equivalent to e.g. 0.5 ml oral solution 5 mg / ml).

The single dose can be repeated after 4 to 6 hours if the effect diminishes.

Total daily dose: up to 22.5 mg morphine hydrochloride 3H2O (equivalent to e.g. 4.5 ml oral solution 5 mg / ml).

Note: Medicines containing morphine may only be used with particular caution in children under 1 year of age!

3.2.b.2.Children 2 to 6 years

Single dose: 2.5 to 5 mg morphine hydrochloride 3H2O or morphine sulfate (corresponding to 0.5 ml to 1 ml solution 5 mg / ml or 0.125 to 0.25 ml solution 20 mg / ml).

The single dose can be repeated after 4 to 6 hours if the effect diminishes.

Total daily dose: up to 15 to 30 mg of morphine hydrochloride 3H2O or morphine sulfate (corresponding to 3 to 6 ml of 5 mg / ml solution or 0.75 to 1.5 ml of 20 mg / ml solution).

3.2.c) Liver or kidney dysfunction

In patients with liver or kidney dysfunction or if delayed gastrointestinal passage is suspected, morphine should be dosed with particular care.

3.2.d) Elderly patients

Elderly patients (usually from 75 years of age) and patients with a poor general physical condition can react more sensitively to morphine. Care should therefore be taken to set the dose more carefully and / or to select longer dose intervals. If necessary, it is necessary to switch to lower active ingredient strengths.

3.3 If you use more Morphine Ratiopharm 30 retard than you should

you should inform the nearest available doctor immediately.

In particular, the following can occur: narrow pupils, impaired breathing up to respiratory arrest, impaired consciousness up to coma, drop in blood pressure up to shock, increase in heart rate, seizures and muscle damage up to muscle breakdown (possibly resulting in kidney failure). Overdosing on strong opioids can be fatal.

Under no circumstances should you put yourself in situations that require increased attention, e.g. driving a car.

The following measures in the event of an overdose make sense until a doctor arrives: keeping awake, giving breathing orders, breathing aid.

3.4 If you forget to use Morphine Ratiopharm 30 retard

If you use a lower dose of Morphine Ratiopharm 30 retard than intended or if you forget to use it completely, this will lead to inadequate or no pain relief. Under no circumstances should you use a double single dose!

3.5 Effects if treatment with Morphine Ratiopharm 30 retard is discontinued

If you want to interrupt or end the treatment, you should definitely talk to your doctor about the reasons for the interruption and the further treatment.

If Morphine Ratiopharm 30 retard is used for a long time, physical dependence can develop. Sudden discontinuation of treatment will therefore be accompanied by withdrawal symptoms. These can be headaches, muscle aches, anxiety, tension, agitation, confusion, irritability, recurring insomnia, mood swings, hallucinations, and seizures.

Since the risk of withdrawal symptoms is greater if treatment is stopped suddenly, the dose should be reduced gradually when treatment is discontinued.

4. What are the possible side effects?

Like all medicines, Morphine Ratiopharm 30 retard can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

Morphine shows a variety of psychological side effects, which can appear individually in terms of strength and type (depending on personality and duration of treatment). Such side effects are listed below. Significant side effects or signs to look out for and actions to be taken if they are affected

If you experience any of the following significant side effects, call a doctor immediately.

Flattening and slowing of breathing (respiratory depression) are the most significant hazards of opioid overdose and are most likely to occur in elderly or debilitated patients.

Other possible side effects

4.1.a) Very common

Mood changes, mostly elevated (euphoric) mood, but also disgruntled mood, constriction of the pupils, constipation (with long-term treatment).

4.1.b) Often

Vomiting (especially at the beginning of treatment), digestive disorders, allergic reactions (hypersensitivity reactions), decreased appetite up to loss of appetite, changes in activation (mostly reduced activity, but also increased activity or over-excitability), insomnia, thought disorders, perception disorders (e.g. hallucinations), states of confusion, Headache, dizziness, taste disturbances, sweating, wheals or nettle-like skin rash (urticaria), itching, urinary retention.

4.1.c) Occasionally

Accelerated pulse, slower pulse, drop in blood pressure, increase in blood pressure, malaise.

4.1.d) Rarely

Physical dependence with withdrawal symptoms, spasms of the airways muscles, increase in pancreatic enzymes, inflammation of the pancreas (pancreatitis), biliary colic, renal colic.

4.1.e) Very rare

Psychological dependence, decreased libido, epileptic seizures, muscle tremors, involuntary muscle twitching; increased sensitivity to pain, shortness of breath, intestinal obstruction, abdominal pain; Dental diseases, although a causal connection to the morphine treatment cannot be established. Syndrome of inadequate release of a hormone that controls water flushing (SIADH), blurred vision, double vision and eye tremors, increased liver values, other skin rashes (e.g. exanthema), muscle cramps, increased muscle tension, erectile dysfunction, missed menstrual period, feeling weak, chills, water retention in the tissue .

4.1.f) Not known

Acute general allergic reactions such as sudden breathing problems, swelling of the skin and / or drop in blood pressure (anaphylactic reactions), drowsiness, sedation (-dosependent); Fainting, abnormal sensations, vertigo, palpitations, heart failure, feeling hot, decreased coughing, flattening and slowing of breathing (respiratory depression - a dose-dependent side effect); Water retention in the lungs (after a rapid increase in dose), nausea, dry mouth (both dose-dependent), fatigue, development of tolerance.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert.

5. How should Morphine Ratiopharm 30 retard be stored?

Store the medicine at normal room temperature and keep the medicine in the original packaging, protected from light and moisture, unless the manufacturer says otherwise.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; January 2013 (4)