• The medicine contains:
  • Paracetamol, a proven pain and fever reliever.
  • Dextromethorphan hydrobromide, a cough suppressant that acts on the cough center. It dampens the urge to cough without suppressing the necessary expectoration.
  • Doxylamine succinate, an active ingredient that, among other things, reduces runny nose.
• The preparation is used for the symptomatic treatment of symptoms that occur together, such as headache, body aches or sore throat, fever, runny nose and dry cough as a result of a cold or a flu-like infection.

• Always take this medicine exactly as your doctor or pharmacist has told you.
• Check with your doctor or pharmacist if you are not sure.
• The recommended dose is
  • Adults and adolescents from the age of 12 take 30 ml once a day (according to the marking on the measuring cup) in the evening before going to bed.

• If you take more than you should
  • Exceeding the recommended dose can lead to very serious liver damage, especially if other medicinal products containing paracetamol are used at the same time.
  • A doctor should therefore be notified immediately if the following quantities of paracetamol are ingested:
    • More than 2.5 g with a body weight of 30 - 50 kg
    • More than 3.5 g with a body weight of 51 - 65 kg
    • More than 4.5 g for body weight over 65 kg

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

• 1 x daily 30 ml (according to the marking on the measuring cup) in the evening before going to bed.

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Not known (cannot be estimated from the available data)
• The following side effects have been reported very rarely (less than 1 in 1 million people treated) or not at all over a period of more than 30 years of use.
• Significant side effects or signs to look out for and actions to take if affected
• Immediate medical attention is required if one of the following significant side effects occurs, which occurs even with the first use and can be serious in individual cases. The medicine must no longer be taken.
• cardiovascular system
  • Accelerated or irregular heartbeat, drop or rise in blood pressure, worsening of an existing heart failure; ECG changes.
  • In the case of an adrenal gland tumor (pheochromocytoma), antihistamines (here: doxylamine) can release substances from the tumor that have a very strong effect on the cardiovascular system.
• blood, lymphatic system
  • Changes in the blood picture such as a reduced number of blood platelets (thrombocytopenia) or a severe reduction in the number of certain white blood cells (agranulocytosis), other blood cell damage.
• nervous system
  • Brain seizures, hallucinations, development of dependence if abused.
• Eyes
  • Increase in intraocular pressure.
• respiratory tract
  • Impaired respiratory function due to thickening of mucus and obstruction or narrowing of the bronchi (analgesic asthma).
• gastrointestinal tract
  • Life-threatening intestinal paralysis
• immune system
  • Allergic reactions up to a shock reaction. In the event of an allergic shock reaction, call the nearest available doctor for help.
• Liver bile
  • Liver dysfunction (cholestatic jaundice).
• Other possible side effects
  • Side effects on the vegetative nervous system such as dry mouth, constipation, nausea, vomiting, diarrhea, abdominal pain, gastrointestinal complaints, increased backflow of gastric acid into the esophagus, problems urinating, nasal congestion, blurred vision.
  • Concomitant effects on the central nervous system such as tiredness, drowsiness, fatigue, dizziness, drowsiness, restricted movement, difficulty concentrating, headaches, depression, muscle weakness, ringing in the ears. In addition, so-called "paradoxical" reactions can occur, such as restlessness, excitement, tension, insomnia, nightmares, confusion, tremors.
  • Disorders of body temperature regulation.
  • Allergic skin reactions (rash, nettle rash), skin sensitivity to light (avoid direct sunlight!).
  • Paracetamol: Cases of severe skin reactions have been reported very rarely.
  • Slight increase in certain liver enzymes (serum transaminases).
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

• Taking other medicines:
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
  • Enhancement of the effect up to an increased risk of side effects when taking at the same time:
    • other medicines with a depressant effect on the central nervous system (such as psychotropics, sleeping pills, painkillers, anesthetics, medicines to treat seizure disorders). This applies in particular to the simultaneous consumption of alcohol, which can alter or intensify these effects in an unforeseeable manner.
    • other substances with anticholinergic effects (e.g. biperidine, a medicine used to treat Parkinson's disease; tricyclic antidepressants). The anticholinergic effect can manifest itself through urinary retention, an acute increase in intraocular pressure or life-threatening intestinal paralysis. Pre-treatment with certain mood-enhancing drugs (antidepressants: MAO inhibitors or SSRIs) can also lead to muscle rigidity and increased functional impairment of the central nervous system such as states of excitement and confusion, high fever and changes in respiratory and circulatory functions (so-called serotonin syndrome). For these reasons, this preparation must not be used simultaneously with these substances for therapy.
  • Weakening of the effect with the simultaneous use of:
    • Neuroleptics (medicines used to treat certain mental illnesses).
    • cholestyramine (used to lower high levels of fat in the blood).
  • Other interactions are possible:
    • with drugs that increase gastric emptying (metoclopramide or domperidone).
    • with drugs that slow down gastric emptying.
    • with probenecid (remedy for gout). If taken at the same time, the dose of cold syrup must be reduced.
    • with drugs that inhibit the liver's cytochrome P450 2D6 enzyme (eg, amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenone, thioridazine, cimetidine, and ritonavir) or substances that are potentially liver-damaging (eg, phenobarbital ( sleeping pills), phenytoin or carbamazepine (anti-epileptic drugs), rifampicin (anti-tuberculosis drugs)). The same applies to alcohol abuse. The risk of paracetamol overdose is increased in these cases.
    • with agents to regulate blood coagulation (anticoagulants, e.g. warfarin or other coumarins) due to the paracetamol contained. This increases the bleeding tendency.
    • with expectorant cough medicine. Due to the restricted cough reflex, a dangerous build-up of secretion can occur.
    • with medicines for HIV infection (zidovudine). The tendency to reduce white blood cells (neutropenia) is increased. Therefore, only use concomitantly with zidovudine on medical advice.
    • with high blood pressure medicines that act on the central nervous system (such as guanabenz, clonidine, alpha-methyldopa). It can lead to increased tiredness and fatigue.
    • with epinephrine. Vascular dilatation, drop in blood pressure, accelerated heart rate may occur.
    • Taking paracetamol can affect laboratory tests such as uric acid and blood sugar levels.
    • Signs of incipient damage to the inner ear caused by other medicines may be reduced.
    • The result of skin tests can be falsified (false negative) under therapy with this preparation.
  • Consumed with alcohol
    • Large amounts of alcohol should be avoided while taking this medicine.

       

• The drug must not be taken
  • if you are allergic to paracetamol, dextromethorphan hydrobromide, doxylamine succinate or any of the other ingredients.
  • in asthma, chronic obstructive pulmonary disease, pneumonia, respiratory arrest (respiratory depression), insufficient breathing activity (respiratory insufficiency);
  • with glaucoma (increased intraocular pressure);
  • with pre-existing liver/kidney damage (also due to alcohol abuse), severe liver and kidney dysfunction, adrenal tumor (pheochromocytoma);
  • with enlargement of the prostate gland with residual urine and significant impairment in urination;
  • in seizure disorders (epilepsy), brain damage.
  • during pregnancy and lactation
  • if you are being treated with certain antidepressants (MAOIs or SSRIs) at the same time or within two weeks;
  • by children under the age of 12;
  • if not all of the active ingredients mentioned are needed for a cold or flu-like infection.

• 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.
• The drug should not be taken during pregnancy and breastfeeding.

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking this medicine if you suffer from any of the following diseases:
    • Gilbert Syndrome
    • insufficient closure of the entrance to the stomach with backflow of food into the esophagus (reflux)
    • Previous damage to the heart and high blood pressure
  • In the case of a cough with significant formation of mucus or a stubborn cough (e.g. due to smoking or pathological changes in the lungs), take it only in consultation with and on the instructions of your doctor, as suppressing the cough can be undesirable under these circumstances.
  • Please note that this medicine can lead to psychological and physical dependence. Patients who are prone to drug abuse or drug dependency should therefore be treated with this preparation for a short period of time and under the strictest medical supervision.
  • If your symptoms worsen or do not improve after 3 days, or if you have a high fever, you must see a doctor.
  • To prevent the risk of overdose, it should be ensured that other drugs used at the same time do not contain paracetamol.

• Driving and using machines
  • Even when used as directed, this medicine can cause tiredness and thereby change the ability to react to such an extent that the ability to drive or use machines is impaired. This applies to a greater extent in combination with alcohol or medication, which in turn can impair the ability to react.

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