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Contraneural Paracetamol / Codeine 500 mg / 30 mg
Dr. R.Pfleger Chemical Factory GmbH
Dr. R.Pfleger Chemical Factory GmbH
What is it and what is it used for?
Contraneural Paracetamol / Codeine is a pain reliever (analgesic) and is used to treat moderate to severe pain.
What do you need to consider before use?
Contraneural paracetamol / codeine must not be taken
- if you are allergic (hypersensitive) to paracetamol and / or codeine or any of the other ingredients of contraneural paracetamol / codeine
- if the metabolism of the liver cells is disrupted
- by children under 12 years of age
- if you are about to give birth
- if you have been diagnosed with a threatened premature birth
- if you have an asthma attack
- in the case of inflammation of the lungs (pneumonia)
- with disorders of the respiratory center and respiratory function.
Take special care when taking Contraneural Paracetamol / Codeine
Dependence on opioids (including strong painkillers and sedatives)
Conditions with increased intracranial pressure
- simultaneous use of monoamine oxidase (MAO) inhibitors (group of medicines used to treat depression)
Disordered ventilation of the lungs due to chronic bronchitis or asthma (bronchial).
You may only use Contraneural Paracetamol / Codeine in a lower dose or less often than indicated in the dosage instructions (dose reduction or extension of the dosage interval)
Liver dysfunction (for example due to persistent alcohol abuse or liver inflammation)
impaired liver function (inflammation of the liver, Gilbert syndrome)
Kidney dysfunction (even if dialysis is mandatory).
To avoid the risk of overdose, it should be ensured that other medicinal products used at the same time do not contain paracetamol.
Long-term, high-dose, improper use of painkillers can result in headaches that should not be treated with increased doses of the drug.
In general, the habitual use of painkillers, especially when combining several pain relievers, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
If you stop abruptly after prolonged, high-dose, improper use of painkillers, headaches as well as fatigue, muscle pain, nervousness and vegetative symptoms can occur. The withdrawal symptoms subside within a few days. Until then, you should not take painkillers again and you should not take them again without medical advice.
Depending on the individual's ability to break down codeine, a component of Contraneural Paracetamol / Codeine, signs of an overdose may also appear at doses of Contraneural Paracetamol / Codeine recommended by your doctor. If you experience symptoms such as blurred vision, drowsiness, tiredness, stomach pain or circulatory problems, please contact your doctor.
At the start of treatment, your doctor will check your individual reaction to contraneural paracetamol / codeine. This is especially true in elderly patients and patients with impaired kidney function or respiratory dysfunction.
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are very rarely observed.
The therapy must be discontinued at the first signs of a hypersensitivity reaction after ingestion / administration of Contraneural Paracetamol / Codeine. Medically necessary measures corresponding to the symptoms must be initiated by competent persons.
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, you should only take Contraneural Paracetamol / Codeine if your doctor has specifically prescribed it, as undesirable effects on the development of the unborn child cannot be ruled out.
If childbirth is approaching or premature birth is imminent, you must not use Contraneural Paracetamol / Codeine, as the active ingredient codeine contained in Contraneural Paracetamol / Codeine crosses the placental barrier and can lead to breathing disorders in newborns.
Long-term use of Contraneural Paracetamol / Codeine can lead to codeine dependence in the fetus. There have been reports of withdrawal symptoms in the newborn after repeated use of codeine in the last trimester of pregnancy.
Please contact your doctor immediately if you are planning a pregnancy or are already pregnant in order to discuss a continuation or a change of therapy together.
Paracetamol and codeine as well as its breakdown product morphine are excreted in breast milk. In general, a single dose of Contraneural Paracetamol / Codeine can breastfeed at the dose recommended by your doctor. If your child has difficulty drinking or appears unusually calm and sleepy, please contact your doctor immediately. If your doctor considers treatment necessary while breastfeeding, you should discontinue breastfeeding during treatment. Please talk to your doctor to discuss whether to continue or change the therapy.
Driving and using machines
Contraneural Paracetamol / Codeine, even when used as intended, can change the ability to react to such an extent that the ability to actively participate in road traffic or to operate machines, as well as to carry out dangerous activities, is impaired.
How is it used?
How to take Contraneural Paracetamol / Codeine?
Always take Contraneural Paracetamol / Codeine exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.
The dosage is based on the information in the table below. Adults and adolescents over 12 years of age take 1-2 tablets of Contraneural Paracetamol / Codeine each, if necessary up to 4 times a day. The maximum dose of 8 Contraneural Paracetamol / Codeine tablets per day must not be exceeded.
The respective dosage interval depends on the symptoms and the maximum total daily dose. It should not be less than 6 hours.
in number of tablets
|max. daily dose|
in number of tablets
|from 43 kg|
Adolescents (from 12 years) and adults
|1 - 2 tablets (equivalent to 500 - 1000 mg paracetamol and 30-60 mg codeine phosphate hemihydrate)||8 tablets (equivalent to 4000 mg paracetamol and 240 mg codeine phosphate hemihydrate)|
type of application
Swallow the tablets whole with sufficient liquid (preferably a glass of drinking water). Taking it after meals can delay the onset of action.
Duration of application
The duration of the usage will be decided by the medicating doctor.
Note: In the case of liver and kidney dysfunction, as well as congenital increased bilirubin levels in the blood (Gilbert syndrome or Meulengracht disease), the dose must be reduced or the interval between doses must be lengthened.
Please talk to your doctor or pharmacist if you have the impression that the effect of Contraneural Paracetamol / Codeine is too strong or too weak.
If you take more contraneural paracetamol / codeine than you should
Overdosing on paracetamol can cause severe liver damage.
Symptoms of overdose include vomiting, nausea, paleness, and abdominal pain.
Symptoms of codeine overdose include slow breathing to a coma.
Codeine in single doses over 60 mg can increase the tension in the muscle cells (muscle tone) in the smooth muscles.
If excessive amounts of Contraneural Paracetamol / Codeine are taken, a doctor should be consulted immediately and he will take appropriate measures.
If you forget to take Contraneural Paracetamol / Codeine
If you forget to take it, you can take it at any time, but you must allow at least 6 hours to take the next dose. Do not under any circumstances take double the amount.
If you stop taking contraneural paracetamol / codeine:
If Contraneural Paracetamol / Codeine is used as intended, no special precautionary measures need to be taken.
In the event of sudden termination of use (discontinuation) after prolonged, improper, high-dose use of painkillers, headaches as well as fatigue, muscle pain, nervousness and vegetative symptoms can occur. These consequences of discontinuation subside within a few days. Until then, no pain medication should be taken. Even after that, it should not be taken again without medical advice.
If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.
What are the possible side effects?
Taking Contraneural Paracetamol / Codeine with other medicinal products
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.
With simultaneous use of other central depressant drugs [for example sedatives and sleeping pills, antihypertensive drugs (agents for lowering blood pressure), but also other pain relievers, antihistamines (agents for treating allergies or colds, for example), psychotropic drugs (agents for treating mental and emotional Disorders)] as well as alcohol, the calming and breath-depressing effect can be intensified.
If you take drugs that accelerate the breakdown of drugs in the liver (enzyme induction), such as certain sleeping pills and anti-epileptics (including phenobarbital, phenytoin, carbamazepine) and rifampicin (a tuberculosis drug), otherwise harmless doses of paracetamol ( a component of Contraneural Paracetamol / Codeine) liver damage can be caused. The same applies to alcohol abuse.
Simultaneous use of agents that slow down gastric emptying can delay the absorption and onset of action of paracetamol.
With simultaneous use of agents that accelerate gastric emptying, such as metoclopramide, the absorption and onset of action of paracetamol may be accelerated.
If medicinal products containing paracetamol are used at the same time as zidovudine (AZT or Retrovir), the tendency to reduce white blood cells (neutropenia) is increased. This medicinal product should therefore only be used concomitantly with zidovudine on medical advice.
The dose of paracetamol should be reduced if drugs used to treat elevated uric acid levels, such as probenecid and contraneural paracetamol / codeine, are taken at the same time.
Colestyramine (a preparation used to lower high bile levels) reduces the absorption of paracetamol.
Alcohol should be avoided during treatment with Contraneural Paracetamol / Codeine, as movement and thought processes are significantly influenced.
Tricyclic antidepressants (medicines used to treat depressive disorders) can cause breathing disorders caused by codeine.
Simultaneous use of MAO inhibitors, such as tranylcypromine, can lead to an intensification of the central nervous effect and other side effects. Contraneural paracetamol / codeine may therefore only be used two weeks after the end of therapy with MAO inhibitors.
When used at the same time as painkillers such as buprenorphine or pentacozine, in contrast to other painkillers, the effect may be weakened.
Cimetidine and other drugs that affect liver metabolism can increase the effects of contraneural paracetamol / codeine.
Please note that this information can also apply to recently used drugs.
Taking Contraneural Paracetamol / Codeine with food and drink
During the use of Contraneural Paracetamol / Codeine, alcohol consumption should be avoided as far as possible (see section? Taking Contraneural Paracetamol / Codeine with other medicinal products?).
What side effects are possible?
Like all medicines, Contraneural Paracetamol / Codeine can cause side effects, although not every patient receives them.
When evaluating side effects, the following frequencies are used as a basis:
|Very common: affects more than 1 in 10 people|
|Common: affects 1 to 10 users in 100|
|Uncommon: affects 1 to 10 users in 1,000|
|Rare: affects 1 to 10 users in 10,000|
|Very rare: less than 1 user in 10,000|
|Not known: frequency cannot be estimated from the available data|
- Rare: increase in liver transaminases (enzymes in the liver)
Blood and lymphatic system disorders
- Rare: low blood platelets or white blood cells
- Very rare: decrease or lack of granulocytes, decrease in the number of cells in all blood-forming systems.
Nervous system disorders
- Very common: mild headache
- Common: mild drowsiness
When taking higher doses or in patients with increased intracranial pressure or head injuries, a deterioration in vision may occur.
Development of dependency is possible with prolonged use of higher doses!
Visual disturbances occurred when higher doses were taken.
Diseases of the ear and labyrinth
- Uncommon: ringing in the ears (tinnitus)
Respiratory, thoracic and mediastinal disorders
- Uncommon: shortness of breath
- Very rare: cramping of the muscles of the airways with shortness of breath (analgesic asthma)
Water retention in the lungs (pulmonary edema) has been observed when high doses are taken, especially in the case of pre-existing lung dysfunction.
When taking higher doses or in patients with increased intracranial pressure or head injuries, respiratory depression can occur.
- Very common: nausea, vomiting, constipation
- Uncommon: dry mouth
Skin and subcutaneous tissue disorders
- Uncommon: itching, reddening of the skin, hives
- Rare: severe allergic reaction (including Stevens-Johnson syndrome)
Heart, circulatory diseases
When higher doses are taken, cases of drop in blood pressure and fainting have been observed frequently.
General disorders and administration site conditions
Very common: tiredness
Immune system disorders
Very rare: Hypersensitivity reactions such as swelling of the face, shortness of breath, sweating, nausea, drop in blood pressure and even shock.
At the first signs of a hypersensitivity reaction, the drug should be discontinued and a doctor should be contacted immediately.
- Uncommon: sleep disorders
With higher doses or particularly sensitive patients, dependent euphoria can occur.
Please inform your doctor or pharmacist if you become seriously affected by any of the side effects listed, or if you notice any side effects not listed in this leaflet.
How should it be stored?
Do not use the medicine after the expiry date which is stated on the carton and container.
The expiry date refers to the last day of the month.
Do not store above 25 ° C.
Store in the original package in order to protect the tablets from light.
What a Contraneural Paracetamol / Codeine tablet contains
The active ingredients are: 500 mg paracetamol and 30 mg codeine phosphate hemihydrate.
The other ingredients are: sodium starch glycolate (type A) (Ph.Eur.), Microcrystalline cellulose, corn starch, povidone K25, highly dispersed silicon dioxide, stearic acid (Ph.Eur.), Pregelatinized starch (from corn).
What Contraneural Paracetamol / Codeine tablets look like and contents of the pack:
White, round, biplane tablet; Pack of 20 tablets.
Marketing Authorization Holder and Manufacturer
Dr. R. Pfleger Chemische Fabrik GmbH, D-96045 Bamberg, Telephone: 095043-0, Fax: 09504329.
This leaflet was last revised in May 2008.
We, from the Dr. R. Pfleger GmbH, wish you a speedy recovery.
Contraneural Paracetamol / Codeine 500 mg / 30 mg tablets
For the treatment of moderately severe to severe pain
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