FIZAMOL 500 mg effervescent tablets, 12 pcs

Instructions for use for FIZAMOL 500 mg effervescent tablets, 12 pcs

Application notes

Children from 11-12 years with 33-43 kg body weight	1 Effervescent tablet	1-4 times a day	at least 6 hours, regardless of the meal
Young people aged 12 and over and adults from 43 kg body weight	1-2 Effervescent tablets	1-4 times a day	at least 6 hours, regardless of the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient has a pain relieving and fever -lowering. It also has low anti -inflammatory properties. He blocks the formation of certain messenger substances in the body, so -called prostaglandins. These are significantly involved in the development of pain, fever and inflammation.

Composition

Contradictions

What speaks against an application?

Always:
- Hypersensitivity to the ingredients

Under certain circumstances - speak to your doctor or pharmacist:
- Restricted liver function (e.g. B. by chronic alcohol abuse or inflammation of the liver)
- Limited kidney function
- Gilbert syndrome (Meulengracht disease)
- Alcohol abuse
- Hereditary enzyme disorder (glucose-6-phosphate dehydrogenase deficiency)
- Anemicamure by faster reducing red blood cells (hemolytic anemia)
- Glutathione deficiency
- Lack of fluid
- Malnutrition

Which age group must be observed?
- Children under the age of 11: The drug should generally not be used in this group. There are preparations that from the active ingredient strength and/or daringgsform are more suitable.

What about pregnancy and lactation?
- Pregnancy: Contact your doctor. Different considerations play a role in whether and how the medicine can be used during pregnancy.
- Breastfeeding: According to current knowledge, there is no evidence that the drug must not be applied during breastfeeding.

If the medicine has been prescribed to you despite a counter -notification, speak to your doctor or pharmacist. The therapeutic benefit can be higher than the risk of using a counter -notification.

Side effects

What adverse effects may occur?

Only side effects are described for the medicine, which have so far only occurred in exceptional cases.

If you notice a disruption or change during treatment, contact your doctor or pharmacist.

For information at this point, side effects are taken into account that occurs in at least one of 1,000 patients treated.

Hints

What should you consider?
- Do not apply longer for pain or fever without medical advice than specified in the package insert!
- If painkillers are used permanently, headaches can occur caused by the painkillers. Talk to your doctor to prevent your headache from becoming chronic.
- The habitual use of painkillers can lead to permanent kidney damage. If several pain relievers are combined, or if there are several active ingredients in a pain reliever, the risk increases.
- Attention: With regular or high alcohol enjoyment, existing liver damage can lead to life -threatening conditions if the drug is also used.
- Beware of allergy to painkillers!
- Be careful with allergy against the sweetener saccharin (E 954)!
- Beware of an intolerance to fructose (fructose). If you have to adhere to a diabetes diet, you should take the sugar content into account.
- There can be medicines that occur with which interactions occur. Therefore, you should generally provide the doctor or pharmacist before treatment with a new medicine. This also applies to medicines that you buy yourself, only apply occasionally or that the application has been available for some time.

Detailed instructions for FIZAMOL 500 mg effervescent tablets, 12 pcs

Field of use

• This preparation is a pain relieving and fever -lowering drug (analgesic and antipyretics).
• It is used for symptomatic treatment of light to moderately severe pain, such as headache, toothache and regulation pain and/or fever.
• If you don't feel better or worse after 3 days or if you have a high fever, contact your doctor.

Active ingredients / ingredients / ingredients

500 mg paracetamol
Citronic acid, water -free auxiliary material (+)
Macrogol 6000 Hedge Terms (+)
Natrium carbonate auxiliary substance (+)
Sodium hydrogen carbonate auxiliary substance (+)
Povidon K25 Hedge material (+)
Saccharin, sodium salt auxiliary material (+)
Simeticon Hedge substance (+)
100 mg sorbitol auxiliary material (+)
418.5 mg total sodium ion hedge material (+)
Lemon aroma hedge material (+)
Maltodextrin auxiliary substance (+)
Arab rubber auxiliary substance (+)
alpha-tocopherol auxiliary material (+)
Aroma fabrics, natural and natural identical auxiliary substances (+)

Contradictions

• This medicine must not be taken
  • if you are allergic to paracetamol or one of the other components of this drug.

dosage

• Always take this medicine exactly as described or after instruction from your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.
• According to the information, the dosage is directed in the following table. Paracetamol is dosed depending on body weight (kg) and age, usually with 10 to 15 mg/kg kg as a single dose, up to a maximum of 60 mg/kg kg as a total daily dose.
• The respective dosage interval depends on the type of symptoms and the maximum total daily dose. It should not fall below 6 hours. This means that you can take the medicine at most 4 times a day.
• In the event of complaints that last for more than 3 days, a doctor should be consulted.
• Body weight or age: 33 kg - 43 kg; Children: 11 - 12 years
  • Single dose in the number of effervescent tablets: 1 effervescent tablet (corresponding to 500 mg paracetamol)
  • max. Daily dose (24 hours) in number of effervescent tablets: 4 effervescent tablets (corresponding to 2000 mg paracetamol)
• Body weight or age: from 43 kg: young people from 12 years and adults
  • Single dose in the number of effervescent tablets: 1 - 2 effervescent tablets (corresponding to 500 - 1000 mg paracetamol)
  • max. Daily dose (24 hours) in number of effervescent tablets: 8 effervescent tablets (corresponding to 4000 mg paracetamol)
• Special patient groups
  • Liver dysfunction
    • In patients with liver dysfunction and Gilbert syndrome, the dose must be reduced or the distance between the individual doses must be extended.
    • A daily total dose of 2 g must not be exceeded in adults without medical instruction.
  • Renal failure
    • Unless otherwise prescribed, dose reduction is recommended in patients with renal failure.
    • The distance between the individual doses must be at least 6 hours, see table below.
    • In the case of severe kidney function disorder (creatinine clearance < 10 ml/min), the distance between the individual doses must be at least 8 hours.
    • A daily total dose of 2 g must not be exceeded in adults without medical instruction.
    • Adult:
      • Glomerular filtration rate: 10 - 50 ml/min
        • Dose: 500 mg every 6 hours
      • Glomerular filtration rate: < 10 ml/min
        • Dose: 500 mg every 8 hours
  • Chronic alcoholism
    • Chronic alcohol consumption can reduce the threshold, caused by paracetamol damage. In these patients, the time between two income should be at least 8 hours. Do not take more than 2 g paracetamol per day.
  • Older patients
    • Experience has shown that no special dose adjustment is required.
    • However, a reduction in the dose or extension of the dosage interval may be necessary for weakened, immobilized older patients with impaired liver or kidney function.
    • Without medical instruction, the maximum daily dose of 60 mg/kg body weight (up to a maximum of 2 g/day in adults) should not be exceeded at:
      • Body weight below 50 kg
      • chronic alcoholism
      • Water deprivation
      • chronic malnutrition
  • Children and adolescents with low body weight
    • Using paracetamol in children under 11 years of age or below 33 kg body weight is not recommended, since the dose strength is not suitable for this patient group. However, suitable dose strengths or dosage forms are available for this patient group.

 

• If you have taken a larger amount than you should
  • The total dose of paracetamol is allowed to exceed 4,000 mg paracetamol (corresponding to 8 effervescent tablets) daily for adults and adolescents from the age of 12 or from 43 kg body weight and 60 mg/kg/day for children.
  • In the event of an overdose, complaints generally occur within 24 hours that include nausea, vomiting, loss of appetite, pale and abdominal pain. The first signs of liver damage occur after a few days.
  • The consequences of an overdose can be very serious and, in rare cases, even lead to death.
  • If a larger amount of this medicine has been taken as recommended, call a doctor to help as soon as possible!

 

• If you have forgotten taking it
  • Do not take the double dose if you have the previous onehave forgotten.

 

• If you have any further questions about the application of the drug, ask your doctor or pharmacist.

Taking

• To take.
• Disconnect the effervescent tablets in a glass with water before taking it.

Patient information

• Warnings and Precautions
  • Please speak to your doctor or pharmacist before taking the preparation,
    • if you are chronically alcoholic,
    • if you suffer from the impairment of liver function (liver inflammation, Gilbert syndrome),
    • with pre -damaged kidney.
    • if medication is taken at the same time, which affect the liver function.
    • in the event of an inherited lack of the enzyme glucose-6-phosphate dehydrogenase, which can lead to severe anemia, also called favism.
    • for hemolytic anemia (anemia due to a decay of the red blood cells).
    • in the event of a lack of the protein glutathione involved in the liver metabolism (e.g. in the event of malnutrition, alcohol abuse).
    • in the event of a lack of liquid in the body (dehydration), e.g. B. due to small amount of drinking, diarrhea or vomiting.
    • in chronic malnutrition.
    • with a body weight of less than 50 kg.
    • with higher age.
  • In patients with reduced glutathione reserve (caused by malnutrition, pregnancy, liver disease, blood poisoning/infection, kidney disease, alcohol abuse), taking paracetamol can increase the risk of liver damage, which can also lead to acidification of blood.
  • Do not use paracetamol if you are alcohol -dependent unless your doctor has prescribed it. In patients with alcohol abuse, the dose must be reduced.
  • If you also take other painkillers that contain paracetamol, you may only take the preparation after consultation with your doctor or pharmacist.
  • Never take a larger amount than recommended. A higher dose does not cause severe pain relief, but instead can lead to serious liver damage.
  • In the case of long -dosed, non -intended use of pain relievers, headaches can occur that may not be treated by increased doses of the drug.
  • In general, the habitual intake of pain relievers, especially when combining several pain relieving active ingredients, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
  • If there is a long -dosed, non -determined use of pain relievers, headaches and fatigue, muscle pain, nervousness and vegetative symptoms can occur after a long time. The deductible symptoms subside within a few days. Until then, painkillers will be reinforced and re -taking it again should take place without medical advice.
  • Do not take paracetamol for more than 3 days or in higher doses without medical or dental advice.
  • Taking the total daily dose once can lead to severe liver damage; In such a case, medical help should be consulted immediately.

 

• Wateriness and operating machines
  • This medicine has no or a negligible influence on the traffic and the ability to use machines.

Pregnancy

• Pregnancy
  • If necessary, paracetamol can be taken during pregnancy.
  • You should take the lowest possible dose with which your pain and/or fever are alleviated, and you should take the medicine for the shortest possible period. Contact your doctor if the pain and/or the fever are not alleviated or you have to take the drug more often.
• Breastfeeding
  • Paracetamol passes into breast milk in small quantities. Since adverse consequences for the infant have not yet become known, paracetamol can be taken during breastfeeding.

Hints

Do not apply longer for pain or fever without medical advice than specified in the package insert!

Manufacturer:  Accord Healthcare GmbH, Hansastraße 32, 80686 Munich