Aspirin + C forte 800 mg/480 mg effervescent tablets

Aspirin + C forte contains

• Acetylsalicylic acid, which relieves pain and reduces fever
.
• Ascorbic acid, also known as vitamin C
.

Aspirin + C forte is used

• For symptomatic relief of mild to moderate pain such as headache, toothache and period pain
.
• For symptomatic relief of pain and fever in colds and flu-like infections
.

Aspirin + C forte is used in adults and adolescents over 12 years of age.

Application

1. WHAT IS ASPIRIN + C FORTE AND WHAT IS IT USED FOR?

Aspirin + C forte contains
acetylsalicylic acid, which relieves pain and reduces fever
ascorbic acid.Ascorbic acid, also known as vitamin C

Aspirin + C forte is used
for the symptomatic relief of mild to moderate pain such as headache, toothache and fever.Ascorbic acid is used
for the symptomatic relief of mild to moderate pain such as headache, toothache and menstrual pain
for the symptomatic relief of pain and fever associated with colds and flu

Aspirin + C forte is used in adults and adolescents over 12 years of age

.

How is it applied?

WHAT IS ASPIRIN + C FORTE AND WHAT IS IT USED FOR?

Aspirin + C forte contains

• Acetylsalicylic acid, which relieves pain and reduces fever
.
• Ascorbic acid, also known as vitamin C
.

Aspirin + C forte is used

• For symptomatic relief of mild to moderate pain such as headache, toothache and period pain
.
• For symptomatic relief of pain and fever in colds and flu-like infections
.

Aspirin + C forte is used in adults and adolescents over 12 years of age.

What should you pay attention to before taking it?

WHAT SHOULD YOU BE AWARE OF BEFORE TAKING ASPIRIN + C FORTE?
Aspirin + C forte must not be taken,

.

• if you are allergic to
• Acetylsalicylic acid, ascorbic acid or any of the other ingredients of this medicine listed in section 6 or
.
• Other non-steroidal anti-inflammatory drugs (NSAIDS) which are used to treat pain, fever or inflammation
.
• If you have too many mast cells (existing mastocytosis). The use of acetylsalicylic acid can cause severe hypersensitivity reactions (including

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circulatory shock with flushing of the skin, low blood pressure, palpitations and vomiting).

• If you have had asthma attacks in the past caused by the use of acetylsalicylic acid or similar substances (especially NSAIDS)
.
• In the 3rd trimester of pregnancy (if you are more than 24 weeks pregnant).
• if you suffer from gastrointestinal ulcers.
• If you have bleeding or are at risk of bleeding
  (haemorrhagic diathesis),
.
• if you suffer from severe liver or kidney dysfunction,
.
• If you suffer from severe uncontrolled heart muscle weakness (heart failure),
.
• if you are being treated with methotrexate at doses of 15 mg per week or more.
• if you are taking medicines to "thin the blood" (oral anticoagulants) at the same time and you have a history of stomach or intestinal ulcers.

Warnings and precautions
Please talk to your doctor or pharmacist before you use Take aspirin + C forte,

• if you are using other medicines containing acetylsalicylic acid, to avoid the risk of overdose.
• If headaches occur during the intake of high doses of painkillers over a longer period of time. Do not take higher doses, ask your doctor or pharmacist for advice.
• If you regularly take painkillers, especially several painkillers in combination. This can lead to permanent kidney damage, with the risk of impaired kidney function.
• With a history of ulceration or bleeding in the stomach or intestines or inflammation of the stomach (gastritis)
.
• If you are also taking medicines to thin the blood or prevent a blood clot (anticoagulants)
.
• Stop taking Aspirin + C forte immediately and talk to your doctor if stomach or intestinal bleeding or ulcers occur.Signs include bleeding from the mouth, blood in or blackening of the stool.
• With reduced kidney function or problems with the heart and blood circulation, such as diseases of the kidney vessels, heart failure, major surgery or severe bleeding.
  Taking acetylsalicylic acid can further worsen kidney function, including acute kidney failure. Do not take Aspirin + C forte if the function of your kidneys or heart is severely restricted.
• When liver function is reduced
  Do not take Aspirin + C forte if the function of your liver is severely reduced.
.
• for heavy menstrual bleeding (the intensity and duration of the bleeding may increase).
• When surgery is about to take place
  Acetylsalicylic acid can increase the risk of bleeding, even at low doses or when taken a few days before. Tell your doctor, surgeon, anaesthetist or dentist if an operation, even a minor one (e.g. extraction of a tooth), is required.
.
• Acetylsalicylic acid inhibits the excretion of uric acid. This can cause gout if you already have low uric acid excretion.

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• If you have glucose-6-phosphate dehydrogenase (G6DP) deficiency: a congenital condition that affects red blood cells. The administration of acetylsalicylic acid must be carried out under medical supervision.
• with increased excretion of oxalate through the urine (hyperoxaluria), a tendency to calcium oxalate kidney stones or recurrent kidney stones.
• for iron overload or iron storage diseases (thalassaemia,
  haemochromatosis, sideroblastic anaemia).
• If you have asthma
  Do not take this medicine if the third point of section 2 "Aspirin + C forte must not be taken" applies to you. Acetylsalicylic acid may cause spasms of the bronchial muscles and asthma attacks or other
  hypersensitivity reactions. Risk factors are:
  - history of asthma,
  - hay fever,
  - nasal polyps or long-lasting (chronic) respiratory diseases or - allergic reactions, such as on the skin (e.g. itching or urticaria).
• The use of this medicinal product is not recommended during breast-feeding.

Children and adolescents:

In children and adolescents with viral diseases (especially influenza or chickenpox), Reye's syndrome, a very rare life-threatening condition with neurological and liver damage, has been observed during treatment with acetylsalicylic acid. Therefore:

Acetylsalicylic acidmay only be administered to children and adolescents with this condition on a doctor's prescription and only if other measures do not work.
Ifdizziness or fainting, abnormal behaviour or vomiting occurs, you must stop the treatment immediately and inform the doctor.

After the varicella vaccination, it is also recommended to refrain from taking medicines containing acetylsalicylic acid for 6 weeks.

Taking Aspirin + C forte. together with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Take Aspirin + C forte. do not use if you are being treated with the following medicines become:

• Methotrexate in doses of 15 mg/week or more: a medicine used to treat serious rheumatic diseases, cancers and the skin disease psoriasis.
  The toxicity of methotrexate is increased.
• Drugs to inhibit blood clotting ("blood thinners", oral anticoagulants) if you have a history of stomach or intestinal ulcers.
  The risk of bleeding is increased.

Talk to your doctor or pharmacist before taking Aspirin + C forte. take,
if you use the following medicines:

Not recommended combinations:

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• Drugs to inhibit blood clotting (oral anticoagulants) if you do not have a history of stomach or intestinal ulcers.
  The risk of bleeding is increased.
• Clopidogrel (except for the authorised indication for this
  combination)and Ticlopidine: Medicinal products which inhibit blood clotting. The risk of bleeding is increased.
• Medicines for pain, fever and inflammation that belong to the group of so-called non-steroidal anti-inflammatory drugs.
  The risk of stomach or intestinal ulcers and bleeding is increased.
• Heparin in doses used for treatment (e.g. of blood clots in a vessel) or in patients over 65 years of age regardless of the heparin dose. The risk of bleeding is increased. Another painkiller or antipyretic should be used.
• Benzbromarone, probenecid: Medicines used to increase uric acid excretion for the treatment of gout.
  The effect of these medicines is reduced.

Combinations that require special care:

• Methotrexate in doses below 15 mg/week: Increased toxicity of methotrexate. Close monitoring of patients with renal impairment and in elderly patients over 65 years of age is required. See also the first point under "Taking Aspirin + C forte together with other medicines".
• Drugs that have a dehydrating effect (diuretics) and drugs that treat high blood pressure and other heart diseases,whose names end in "pril" or "sartan" (angiotensin-converting (ACE) enzyme inhibitors, angiotensin II receptor antagonists):
  In dehydrated patients, rapid loss of renal function may occur. In addition, there may be a blood pressure-lowering effect.
• Clopidogrel (within the authorised field of use for this combination): a medicinal product used to inhibit blood clotting:
  the risk of bleeding is increased.
• Medicines that act locally in the stomach or intestines, medicines that neutralise or bind stomach acid (antacids) or activated charcoal, a medicine used to treat diarrhoea and acute poisoning:
  Take these medicines at least 2 hours apart from Aspirin + C forte.
• Heparin at doses for prevention (e.g. against blood clots) in patients under 65 years of age:
  The risk of bleeding is increased.
• Drugs that dissolve blood clots (thrombolytics), such as streptokinase: the risk of bleeding is increased.
• Medicines containing cortisone or cortisone-like substances (glucocorticoids), with the exception of hydrocortisone replacement therapy:
  the risk of bleeding is increased.
• Selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline),drugs used to treat depression:
  The risk of bleeding is increased.
• Digoxin: A medicine used to treat heart failure and irregular heartbeat.
  The concentration of digoxin in the blood is increased. A check of the amount of digoxin in the blood by the doctor and, if necessary, dose adjustment is recommended.

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• Medicines to lower blood sugar (antidiabetics), e.g. insulin, sulphonylureas:
  Monitoring of blood sugar levels is recommended.
• Valproic acid:a medicine for the treatment of epilepsy.
  The toxicity of valproic acid is increased.

Combinations that should be considered:

• Deferasirox, deferoxamine: Medicines that remove excess iron from the body:
  Deferasirox: the risk of stomach or intestinal bleeding or ulcers is increased. Taking deferoxamine and ascorbic acid can increase the toxicity of iron to the tissues, especially in the heart.
• Iron and aluminium: The administration of ascorbic acid leads to increased absorption by the stomach and intestines. This is particularly important in the case of impaired kidney function, iron replacement and the administration of aluminium-containing antacids (medicines that bind or neutralise gastric acid).
• Lab tests:
  Both acetylsalicylic acid and ascorbic acid in high doses can affect various laboratory tests such as detection of hidden blood in stool,
  liver function tests. Inform your doctor that you are taking Aspirin + C forte .

Taking Aspirin + C forte. together with alcohol.
Avoid drinking alcohol during the treatment period with Aspirin + C forte.

Pregnancy, breast-feeding and childbearing.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
Do not take this medicine in the third trimester (after 24
weeks) of your pregnancy, as it can cause serious harm to you and your unborn child.
During the first six months of pregnancy, you must not Take Aspirin + C forte only after consulting your doctor.
If you have taken this medicine during pregnancy, please inform your doctor immediately.

Breastfeeding time:
During the application of Aspirin + C forte breastfeeding is not recommended because it passes into breast milk.

Bearability:
This medicine belongs to a group of medicines (NSAIDs) that can affect fertility in women. This effect is reversible after discontinuation of the medicinal product.

Driving ability and ability to operate machinery.
This medicine may occasionally cause headaches and dizziness. You should not drive vehicles or operate machinery if you are affected.

Aspirin + C forte contains sodium
This medicine contains 20.61 mmol (or 473.72 mg) of sodium per dose. If you have to follow a low-salt diet, you should take this into account.

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How should the medicine be taken?

HOW TO TAKE ASPIRIN + C FORTE?

Always take this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage
To take. Completely dissolve one effervescent tablet in a glass of water and drink. Do not take on an empty stomach to prevent stomach irritation.
The recommended dose is:
Adults:

.

• Single dose: 1 effervescent tablet
  The single dose can be repeated at intervals of 4 - 8 hours if necessary.
• Maximum daily dose: 3 effervescent tablets

Application in children and adolescents:
Youth: 12 years and older
The lowest effective dose should be used.
The dosage depends on the body weight of the young person. This medicine should only be used in young people over 53 kg body weight. The age given is for information only.
The recommended single dose is one effervescent tablet (800 mg acetylsalicylic acid / 480 mg ascorbic acid) if this dosage is suitable. The maximum daily dose must not exceed 3 effervescent tablets.
The strength of Aspirin + C forte (800 mg acetylsalicylic acid / 480 mg ascorbic acid) may be unsuitable for the treatment of adolescents.
Other products with less acetylsalicylic acid are available for this age group.

Use in children under 12 years:
Aspirin + C forte must not be used in children under 12 years of age. In case of accidental administration, see section "What you should do before taking Aspirin + C forte observe?" and "If you use a large amount of Aspirin + C forte than you should have taken".

Older persons (from 65 years) and underweight persons:
Due to the possibility of other diseases, the lowest effective dose should be used.
Dose to be used. See also section 2 " Aspirin + C forte must not be taken" and "Warnings and precautions".

Patients with liver or kidney dysfunction or circulatory diseases:
The dose must be reduced or the time interval between two doses must be increased if you suffer from

• slight or moderate impairment of liver or kidney function
.
• Suffer from circulatory problems such as heart failure or severe bleeding.

Take Do not take Aspirin + C forte if you have severe kidney or kidney disease.
Have liver dysfunction or severe uncontrolled heart problems. See section 2 " Aspirin + C forte must not be taken".

Duration of use

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Do not take this medicine for more than 3 days in case of fever and for more than 3 - 4 days in case of pain without doctor's orders.

If you take a large amount of Aspirin + C forte. take more than you shouldStop treatment and seek medical attention immediately if an overdose is suspected.

Signs of an overdose may be:

• Noise in the ears, hearing disorders
.
• Sweating
• Nausea, vomiting, diarrhoea
.
• Headache
• Fake
• Rapid loss of kidney function
.

In children, even a dose of 100 mg/kg acetylsalicylic acid in a single dose can be fatal.

If you forget to take Aspirin + C forte.
Do not take double the amount if you have forgotten to take it before.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

What are the possible side effects?

HOW TO STORE ASPIRIN + C FORTE?

Keep this medicine out of the reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton/film after "EXP" or "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required for this medicinal product.

Do not dispose of medicinal products in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. HOW TO STORE ASPIRIN + C FORTE?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton/film after "EXP" or "EXP". The expiry date refers to the last day of the month stated.

No special storage conditions are required for this medicinal product.

Do not dispose of medicinal products in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. In this way, they contribute to the protection of the environment.

Special notes on the content

PACKAGE CONTENTS AND FURTHER INFORMATION

.What Aspirin + C fortecontains

• Die Wirkstoffe sind Acetylsalicylsäure und Ascorbinsäure.
  Jede Brausetablette enthält:
   800 mg Acetylsalicylsäure und
   480 mg Ascorbinsäure
• The other ingredients are:
  Sodium hydrogen carbonate (modified), citric acid, povidone, highly dispersed silicon dioxide
.

Like Aspirin + C forte. Looks like and contents of the pack.
Aspirin + C forte are white to cream-coloured, round effervescent tablets. The tablets are embossed with the "Bayer Cross" in a circle.

Aspirin + C forte is available in aluminium/paper strips in carton packs of 10 or 20.

Not all pack sizes may be marketed.