Aspirin + C effervescent tablets

Aspirin+C effervescent tablets contain the active ingredient acetylsalicylic acid (ASA).

Application

1. WHAT ARE ASPIRIN+C EFFUSION TABLETS AND WHAT ARE THEY USED FOR?

Aspirin+C Effervescent Tablets contain the active substance acetylsalicylic acid (ASA). This has a pain-relieving, antipyretic and anti-inflammatory effect. The addition of vitamin C in the effervescent tablets helps to meet the increased need for this vitamin in febrile colds and flu-like infections.

When are Aspirin+C effervescent tablets used?
Symptomatic treatment of mild to moderate pain such as headache, toothache and period pain.
To relieve pain and fever in colds and flu-like infections.

If you do not feel better or even worse after 3-4 days in the case of pain and after 3 days in the case of fever, if new complaints occur (e.g. redness or swelling).

If you do not feel better or even worse after 3-4 days and fever after 3 days, if new symptoms occur (e.g. redness or swelling), it is essential to consult a doctor, as these may be signs of a serious illness.

Please note the information for children (see section 2).

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How is it applied?

WHAT ARE ASPIRIN+C BREWING TABLETS AND WHAT ARE THEY USED FOR?

Aspirin+C effervescent tablets contain the active substance acetylsalicylic acid (ASA). This has an analgesic, antipyretic and anti-inflammatory effect. The addition of vitamin C in the effervescent tablets helps to cover the increased need for this vitamin in febrile colds and flu-like infections.

When are Aspirin+C effervescent tablets used?
Symptomatic treatment of mild to moderate pain such as headaches, toothaches and period pains.
For the relief of pain and fever in colds and flu-like infections.

If you do not feel better or even worse after 3-4 days with pain and after 3 days with fever, if new symptoms appear (e.g. redness or swelling), it is essential to consult a doctor, as these may be signs of a serious illness.

Please note the information for children (see section 2).

What should you pay attention to before taking it?

What SHOULD YOU TAKE INTO ACCOUNT BEFORE TAKING ASPIRIN+C Effervescent Tablets?

Aspirin+C Effervescent Tablets must not be taken,

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• If you are allergic to the active substances acetylsalicylic acid and ascorbic acid, other salicylates or to any of the other ingredients of this medicine listed in section 6,
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• If you have reacted in the past to certain pain-relieving medicines - acetylsalicylic acid or substances with a similar mechanism of action (non-steroidal anti-inflammatory drugs) - with asthma attacks or in another way hypersensitivity,
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• If you suffer from acute gastrointestinal ulcers,
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• If you have a history of gastrointestinal bleeding, ulceration or rupture due to previous therapy with NSAIDs
  (non-steroidal anti-inflammatory drugs),
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• If you have active gastrointestinal ulcers/bleeding or a history of bleeding, ulcers or a breakthrough in the gastrointestinal area,
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• If you suffer from a pathologically increased tendency to bleed (haemorrhagic diathesis)
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• If you suffer from severe liver dysfunction,
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• if you suffer from severe kidney dysfunction,
• If you suffer from severe heart muscle weakness (cardiac insufficiency)
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• If you are taking 15 mg per week or more of methotrexate (medicine used to treat cancer or certain rheumatic diseases) at the same time,
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• If you are taking anticoagulants (medicines to "thin the blood") at the same time, if salicylates are used in high doses,
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• in the last 3 months of pregnancy,
• if you suffer from hyperoxaluria (certain condition with a tendency to form kidney stones)
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Aspirin+C Effervescent Tablets must not be given to children under one year of age.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Aspirin+C Effervescent Tablets.

Particular caution is required when taking Aspirin+C Effervescent Tablets in

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• Hypersensitivity to painkillers, certain medicines for
  inflammation or rheumatism, or in the presence of other allergies.
• High blood pressure and/or cardiac insufficiency in the medical history. Fluid retention and swelling have been reported in association with acetylsalicylic acid treatment.
• simultaneous treatment with anticoagulant medicines.
• Known gastrointestinal ulcers, including chronic or recurrent gastrointestinal ulcers, or a history of gastrointestinal bleeding.
• Patients with reduced kidney function or patients with reduced cardiovascular function (e.g. in the case of renal vascular disease, cardiac muscle weakness, loss of volume, major surgery, blood poisoning or major
  bleeding events).bleeding events), as acetylsalicylic acid, one of the active ingredients of Aspirin+C Effervescent Tablets, may further increase the risk of renal dysfunction and acute renal failure.
• limited liver function.
• pending operations (also minor operations such as dental procedures): there may be an increased tendency to bleed. Please inform your doctor before all operations if you have taken Aspirin+C Effervescent Tablets
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• Patients with a so-called "glucose-6-phosphate dehydrogenase deficiency" (a congenital metabolic disorder): Aspirin+C Effervescent Tablets may cause a breakdown of the red blood cells or anaemia due to a breakdown of the red blood cells. The administration of Aspirin+C Effervescent Tablets in glucose-6-phosphate dehydrogenase deficiency must therefore be carried out under medical
  supervision.

Aspirin+C Effervescent Tablets must not be used for more than 3-4 days in the case of pain and for more than 3 days in a row in the case of fever without a doctor's orders.
Possible side effects can be reduced by using the lowest dose that is sufficiently effective for the shortest period of time necessary to control the symptoms.

What else do you need to look out for?
Before you start treatment, you must inform your doctor

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• If you are pregnant or think you are pregnant or intend to become pregnant,
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• If you are breastfeeding,
• If you are taking other medicines, especially medicines that contain acetylsalicylic acid or medicines for pain and rheumatism,
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• if you suffer from other diseases or allergies.

A tendency to bleed:
Acetylsalicylic acid (the active ingredient in Aspirin+C Effervescent Tablets) inhibits (even at very low doses) platelets from sticking together. There is therefore an increased risk of bleeding both during and after surgery (including minor procedures such as tooth extraction), which may continue for several days after the patient stops taking the medicine.

Rarely to very rarely, serious bleeding such as cerebral haemorrhage has also been reported, especially in patients with uncontrolled high blood pressure and/or concurrent treatment with anticoagulants. In individual cases, these can be potentially life-threatening.

Gastrointestinal disorders:
During treatment, serious - even life-threatening - bleeding, ulcers and/or breakthroughs may occur at any time, even without previous complaints or corresponding gastrointestinal diseases in the history. Therefore, look out for signs of illness in the gastrointestinal tract while taking Aspirin+C Effervescent Tablets.

The risk increases with increasing dose, in the elderly, in people with a history of stomach ulcers (especially complications such as bleeding and perforation), in people with low body weight and in patients who are being treated with medicines that may increase the risk of ulcers or bleeding.

The risk increases with increasing dose in the elderly (especially if there is a history of complications such as bleeding or rupture), in people of low body weight and in patients receiving concomitant treatment with medicines that may increase the risk of ulcers or bleeding, such as cortisone, blood clots, or other medicines. These include cortisone, anticoagulants (such as aspirin in small doses for the treatment of cardiovascular diseases), certain medicines for the treatment of depression (selective serotonin reuptake inhibitors).
These patients should receive the lowest possible dose and report any unusual gastrointestinal complaints (especially bleeding), especially at the start of treatment.
Treatment with Aspirin+C Effervescent Tablets in combination with stomach medicine should be considered in these cases.

If you experience bleeding or ulcers in the gastrointestinal tract, treatment with Aspirin+C Effervescent Tablets must be stopped.

Signs of gastrointestinal side effects may include: abdominal pain, vomiting of blood, coffee-like vomiting, blackening of the stools.
In these cases, please stop taking Aspirin+C Effervescent Tablets immediately and seek medical advice without delay.

Hypersensitivity reactions:
Aspirin+C Effervescent Tablets may cause spasms of the bronchial muscles (bronchospasm), asthma attacks or other hypersensitivity reactions. Risk factors include pre-existing asthma, hay fever, nasal polyps or chronic respiratory diseases.
The same applies to patients who are also allergic to other substances (e.g. with skin reactions, itching, hives).

Gout attack:
Aspirin+C effervescent tablets increase the uric acid level in the blood by inhibiting the excretion of uric acid. In patients who are already prone to low uric acid excretion, this can possibly trigger a gout attack.

Treatment of fever in children and adolescents:
Very rarely, a severe life-threatening disease of the brain and liver (so-called "Reye's syndrome"), possibly related to acetylsalicylic acid, has been observed in children and adolescents - especially during fever treatment of influenza or chickenpox - during treatment with acetylsalicylic acid (active ingredient of
Aspirin+C Effervescent Tablets). It also occurs in young adults.

Acetylsalicylic acid-containing medicines such as Aspirin+C Effervescent Tablets may therefore only be administered to children under 12 years of age and adolescents with febrile illnesses on a doctor's
prescription and only if other measures are not effective.
If prolonged vomiting, clouding of consciousness and/or abnormal behaviour (even after initial improvement of the general condition) occur as a result of the treatment,
the intake of Aspirin+C Effervescent Tablets must be discontinued immediately and medical help sought without delay.

Also after the chickenpox vaccination, it is recommended to refrain from taking Aspirin+C effervescent tablets for 6 weeks to be on the safe side.

Children:
Acetylsalicylic acid-containing medicines, such as Aspirin+C Effervescent Tablets, should only be given to children under 12 years of age on a doctor's prescription.
With this ASA dosage form, children's dosages are not possible.
Always keep this medicine out of the sight and reach of children.

Headaches caused by painkillers:
Prolonged use of painkillers may cause headaches which must not be treated by increased doses of the medicine.
Consult your doctor if you often suffer from headaches despite taking Aspirin+C Effervescent Tablets!

Kidney damage from painkillers:
The habitual use of painkillers can lead to permanent kidney damage (nephropathy), which can progress to kidney failure. This risk is particularly high if you take several different painkillers in combination.

Lab controls:
If Aspirin+C Effervescent Tablets are taken for a long time, checks (e.g. liver function, kidney function, blood count, blood clotting) are indicated.

Vascular disease:
The use of medicines such as Aspirin+C Effervescent Tablets may be associated with a
slightly increased risk of having a heart attack or stroke. Any risk increases with the level of dosage and duration of use. Therefore, do not increase the recommended dosage and treatment duration of 3-4 days.

If you have heart problems, have already had a stroke or think you may be at increased risk of these conditions (such as: High blood pressure, diabetes, elevated cholesterol or if you are a smoker), talk to your doctor about this treatment.

Stopping the discomfort:
The analgesic effect may mask the discomfort of a concomitant disease. In case of high fever, signs of a new infection (e.g. redness, swelling) or persistence of the symptoms (such as pain or fever) for more than three days, medical advice must be sought.

Fertility
Aspirin+C Effervescent Tablets may affect fertility in women (see section "Pregnancy, lactation and fertility").

Aspirin+C Effervescent Tablets must only be used with caution in cases of kidney stones, urinary stones and iron storage disease because of the vitamin C component.
If there is a tendency to form kidney stones, there is a risk of calcium oxalate stones forming if high amounts of vitamin C are taken. Patients with recurrent kidney stone formation are advised not to exceed a daily vitamin C amount of 100 to 200 mg.

Taking Aspirin+C Effervescent Tablets with other medicines Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

The effect of the following medicinal products or groups of medicinal products may be influenced by simultaneous treatment with Aspirin+C Effervescent Tablets.

Contraindicated combinations
If you are taking methotrexate (medicine used to treat cancer or certain rheumatic diseases) in doses of 15 mg/week or more, you must not take Aspirin+C Effervescent Tablets.
If you are taking anticoagulants (medicines to "thin the blood"), you must not take Aspirin+C Effervescent Tablets in high doses.

Combinations that require special care:

• Methotrexate in doses below 15 mg/week (medicinal products for the treatment of cancer or certain rheumatic diseases) - there is a risk of increased (side) effects of methotrexate
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• Anticoagulant medicines, medicines that dissolve blood clots/other medicines that inhibit platelets from sticking together and clumping (antiplatelet medicines)/ medicines that inhibit haemostasis (haemostasis inhibitors) - bleeding may occur due to an increase in effect. Aspirin+C Effervescent Tablets may increase the risk of bleeding if taken before a treatment intended to dissolve blood clots. Therefore, you must pay close attention to signs of external or internal bleeding (e.g. bruising) if you are to undergo such treatment. A medical check-up is absolutely necessary.
• Other painkilling and anti-inflammatory medicines (non-steroidal anti-inflammatory drugs/anti-inflammatory drugs) at high doses of acetylsalicylic acid: increased risk of ulcers and bleeding in the gastrointestinal tract, overdose is also possible.
• Certain medicines for the treatment of depression (selective serotonin reuptake inhibitors): the risk of bleeding in the gastrointestinal tract increases.
• Certain medicinal products for the treatment of cardiac insufficiency and for the treatment of certain cardiac arrhythmias (digoxin): intensification of the effect up to increased risk of side effects. Appropriate monitoring and, if necessary, dose adjustment by the doctor is recommended.
• Certain medicines for gout (e.g. probenecid, benzbromarone).
  Possible weakening of the effect of gout medicines. It is recommended to use another painkiller.
• Drugs for diabetes (e.g. insulin, sulphonylureas): hypoglycaemia may occur due to an increase in effect. More frequent blood glucose self-monitoring is recommended.
• Certain medicines for dehydration and lowering blood pressure (diuretics): there is a risk of severe kidney dysfunction. If taken at the same time, make sure to drink enough fluids. With certain dehydrating agents (e.g. furosemide), the
  blood pressure-lowering effect may be weakened, therefore blood pressure controls are recommended.
• Medicines containing cortisone or substances similar to cortisone (with the exception of products applied to the skin or hydrocortisone in cortisone replacement therapy for Addison's disease): increased risk of side effects (bleeding or ulcers) in the gastrointestinal tract.
• Certain medicines for high blood pressure (antihypertensives) and/or cardiac insufficiency ("ACE inhibitors", aldosterone antagonists): there is a risk of severe kidney dysfunction; in addition, the blood pressure-lowering effect may be reduced. If taken at the same time, make sure to drink enough fluids. Blood pressure checks are recommended.
• Certain medicines against epilepsy (valproic acid): There is a risk of increased (side) effects of valproic acid.
• The intake of Aspirin+C effervescent tablets leads to increased absorption of iron and aluminium from the gastrointestinal tract due to the vitamin C component. This is particularly important in cases of renal dysfunction, iron replacement therapy and the intake of aluminium-containing medicines to neutralise gastric acid (antacids).
• Certain medicines for the treatment of iron or aluminium overload: Taking Aspirin+C at the same time may lead to increased cellular damage from iron, especially to the heart, and to a deterioration in heart function due to the vitamin C component.
• Locally active gastrointestinal preparations: magnesium, aluminium and calcium salts, oxides and hydroxides.

Please also note that:
Aspirin+C Effervescent Tablets in higher doses may alter the results of laboratory tests, so inform your doctor about taking Aspirin+C Effervescent Tablets.

Taking Aspirin+C Effervescent Tablets with alcohol
Please avoid drinking alcohol during the treatment period with Aspirin+C Effervescent Tablets.Please avoid drinking alcohol during treatment with Aspirin+C Effervescent Tablets, as this could increase the side effects of the medicine (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your
doctor for advice before taking this medicine.
Pregnancy:
First and second trimesters:
During the first six months of pregnancy and if you wish to have a child, you should only take Aspirin+C Effervescent Tablets after consulting your doctor. The dose should be kept low and the treatment as short as possible.

Third trimester:
Do not take Aspirin+C Effervescent Tablets during the last three months of pregnancy because of an increased risk of complications for mother and baby.
Due to the acetylsalicylic acid component, there is a risk of developmental disorders in the unborn child (maldevelopment of the circulatory system and/or kidney dysfunction up to kidney failure).
During birth, there may be increased bleeding in the mother and child and a delay/prolongation of the birth process.

Lactation:
The active substance acetylsalicylic acid and its degradation products pass into breast milk in small amounts. Vitamin C also passes into the mother's milk. With short-term use of Aspirin+C Effervescent Tablets and low dose, interruption of breastfeeding will not be necessary. However, you should stop breastfeeding if you use the medicine for a long time or take high doses.

Pregnancy/fertility:
Aspirin+C Effervescent Tablets belong to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible after discontinuation of the medicinal product.

Driving ability and ability to operate machines
Aspirin+C Effervescent Tablets have no or negligible effect on driving ability and ability to operate machines.

Nevertheless, do not drive vehicles or use dangerous tools or machines if your attention is impaired - such as by possible
side effects like drowsiness, headache, dizziness or confusion.

Aspirin+C Effervescent tablets contain sodium
1 Aspirin+C Effervescent tablet contains 446 mg of sodium. If you have to follow a low-salt diet, you should take this into account.

How should the medicine be taken?

HOW TO TAKE ASPIRIN+C BREWING TABLETS?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is:

Adults and adolescents aged 12 years and over:
Single dose: 1 - 2 effervescent tablets (corresponding to 400 mg - 800 mg acetylsalicylic acid and
240 mg - 480 mg ascorbic acid).
Daily dose: 3 - maximum 7 effervescent tablets (corresponding to 1200 - 2800 mg acetylsalicylic acid and 720 mg - 1680 mg ascorbic acid). The maximum daily dose of 7 effervescent tablets (corresponding to 2800 mg acetylsalicylic acid) must not be exceeded.

Use in children under 12 years of age:
Medicines containing ASA (such as Aspirin+C Effervescent Tablets) must only be given to children under 12
years of age on a doctor's prescription.
Aspirin+C effervescent tablets are not suitable for children, as this dosage form does not allow children to be dosed.

Type of application
For ingestion after dissolving.
Dissolve one effervescent tablet completely in a glass of water and drink. Do not take on an empty stomach.

Duration of use
The single dose can be taken at intervals of 4 - 8 hours up to 3 times a day, if necessary. However, the total daily dose of a maximum of 7 effervescent tablets must not be exceeded.
Since the tablets are sensitive to moisture, the airtight film should only be torn open immediately before using the tablet.

Aspirin+C effervescent tablets must not be taken for more than 3 - 4 days for pain and for more than 3 days for fever without a doctor's prescription. If pain or fever persist during this time or even get worse, if new symptoms appear (e.g. redness or swelling), you must consult your doctor as these may be signs of a serious illness.

Special patient groups:

Older persons (65 years and over) and underweight persons:
In elderly patients, special caution is indicated due to possible concomitant diseases or underweight (see sections "Aspirin+C Effervescent Tablets must not be taken" and "Warnings and precautions"). In particular, it is recommended to use the lowest effective dose in elderly and underweight people.

Patients with liver dysfunction:
If you suffer from liver dysfunction, the dose must be reduced or the interval between two doses must be increased. Do not take Aspirin+C Effervescent Tablets if you have severe liver dysfunction.

Patients with renal dysfunction:
If you suffer from renal dysfunction, the dose must be reduced or the interval between two doses must be increased. You must not take Aspirin+C Effervescent Tablets if you have severe kidney dysfunction.

If you have taken a larger amount of Aspirin+C Effervescent Tablets than
You should
Overdoses can be a danger, especially for elderly patients and especially young children.
Overdoses can be dangerous, particularly for elderly patients and especially for young children (overdoses in the course of treatment or accidental poisoning can be fatal).

Discomfort in moderate poisoning:
Noise in ears, hearing disturbances, sweating, nausea, vomiting, headache and dizziness Discomfort in severe poisoning:
Fever, accelerated breathing, unconsciousness (coma), life-threatening shock, respiratory failure, severe drop in blood sugar.

Furthermore, an overdose with Aspirin+C Effervescent Tablets can lead to the following complaints due to the vitamin C component:
Diarrhoea, gastrointestinal complaints (such as nausea, gastritis), breakdown
of red blood cells (especially in patients with glucose-6-phosphate dehydrogenase deficiency), kidney stone formation and kidney dysfunction up to and including kidney failure.

If you suspect an overdose with Aspirin+C Effervescent Tablets, please notify a doctor immediately. The doctor can decide on the necessary measures according to the severity of the overdose / poisoning. Poisoning with Aspirin+C Effervescent Tablets can be life-threatening.

For more information for healthcare professionals, see the relevant section at the end of the leaflet.

If you have forgotten to take Aspirin+C Effervescent Tablets
Do not take twice 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.

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What are the possible side effects?

HOW TO STORE ASPIRIN+C BREWING TABLETS?

Do not store above 25 °C. Store in the original packaging to protect the contents from moisture.
Tear the foil only immediately before taking the tablets.


Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton/film after "Use by". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines 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 BREWING TABLETS?

Do not store above 25 °C. Keep in the original packaging to protect the contents from moisture.
Tear the foil just before taking the tablets.

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". The expiry date refers to the last day of the month indicated.
Do not dispose of medicines 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

Contents of the pack and other information
What Aspirin+C Effervescent Tablets contain

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• The active ingredients are acetylsalicylic acid and ascorbic acid.
  One effervescent tablet contains 400 mg acetylsalicylic acid (ASA), 240 mg ascorbic acid (vitamin C)
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• The other ingredients are sodium citrate, sodium bicarbonate, sodium carbonate anhydrous, citric acid anhydrous.

What Aspirin+C Effervescent Tablets look like and contents of the pack
Aspirin+C - Effervescent Tablets are white, round effervescent tablets with a "Bayer cross" on one side and are available in packs of 10, 20 and 40.