Ascorbisal - tablets

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The active ingredient acetylsalicylic acid has pain-relieving, anti-inflammatory and fever-reducing effects.

Application

1. What is Ascorbisal and what is it used for?

The active ingredient acetylsalicylic acid has pain-relieving, anti-inflammatory and fever-reducing effects.
The active ingredient vitamin C covers the increased need for vitamin C in the case of colds.

If you do not feel better or even worse after 3 days, contact your doctor.

Ascorbisal is used
- to relieve mild to moderate pain (e.g. headaches, toothaches, menstrual pain).
- to relieve pain and reduce fever in colds and flu-like infections.

Ascorbisal must not be used for pain in the gastrointestinal tract.

How is it used?

What is Ascorbisal and what is it used for?

The active ingredient acetylsalicylic acid has pain-relieving, anti-inflammatory and fever-reducing effects.
The active ingredient vitamin C covers the increased need for vitamin C in the case of colds.

If you do not feel better or even worse after 3 days, contact your doctor.

Ascorbisal is used
- to relieve mild to moderate pain (e.g. headaches, toothaches, menstrual pain).
- to relieve pain and reduce fever in colds and flu-like infections.
Ascorbisal must not be used for pain in the gastrointestinal tract.

What should you consider before taking it?

What should you consider before taking Ascorbisal?

Ascorbisal must not be taken,
- if you are allergic to acetylsalicylic acid or other salicylates, vitamin C or any of the other ingredients listed in section 6 of this medicine.
- if you have suffered from asthma in the past that was triggered by acetylsalicylic acid or similar pain-relieving medicines, so-called non-steroidal anti-inflammatory drugs (NSAIDs).
- during the last third of pregnancy.
- if you suffer from a gastrointestinal ulcer, gastrointestinal bleeding or a gastrointestinal perforation.
- if you have suffered from a gastrointestinal ulcer, gastrointestinal bleeding or a gastrointestinal perforation more than once in the past.
- in the case of a pathologically increased bleeding tendency or a blood clotting disorder.
- in the case of heavy bleeding or an increased risk of bleeding (e.g. before or immediately after surgery).
- in the case of severe heart failure.
- in the case of severe liver dysfunction.
- in the case of severe kidney dysfunction.
- together with methotrexate (a medicine to suppress tumour growth and immune reactions) in higher doses (15 mg per week and more).
- together with anticoagulant medicines.
- in the case of hyperoxaluria (a certain condition with a tendency to form kidney stones).
- in the case of chickenpox or flu, if they occur in children.
- if you weigh less than 30 kg.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Ascorbisal.

Special care must be taken when taking Ascorbisal

- if you are allergic to other anti-inflammatory medicines or have other allergies.
- if you have ever had an ulcer or bleeding in the gastrointestinal tract or gastritis (inflammation of the gastric mucosa).
- in the case of heart failure, liver or kidney dysfunction.
- if you suffer from severe kidney dysfunction and are a dialysis patient: You should not take more than 50 to 100 mg of vitamin C per day, as otherwise high oxalate concentrations in the blood (hyperoxalemia) and consequently the formation of oxalate crystals in the kidneys (kidney stones) can occur. In this case, Ascorbisal is not suitable for you.
- if you are prone to kidney or urinary stones: If you have had kidney stones several times in the past, you should not take more than 100 to 200 mg of vitamin C per day.
- if you suffer from asthma, as the risk of a hypersensitivity reaction is increased. - in the case of pathologically prolonged or increased menstrual bleeding.

If one or more of the above points apply to you, you may only take Ascorbisal after consulting your doctor and under strict medical supervision.

Gastrointestinal tract
Pay attention to signs of a gastrointestinal disorder while taking Ascorbisal, as bleeding and/or ulcers as well as perforations can occur during treatment, even without previous complaints or a corresponding history. The relative risk is higher in elderly patients, people with low body weight and in patients treated with anticoagulant medicines.

Warnings for such conditions can be: abdominal pain, vomiting blood, coffee-ground vomiting, blackening of the stool. In these cases, please stop taking Ascorbisal immediately and talk to a doctor without delay.

Operations
The active ingredient acetylsalicylic acid inhibits the adhesion of platelets, which is why there is an increased risk of bleeding during operations (even minor ones, such as dental procedures). Please inform your doctor before any operations if you are taking or have recently taken Ascorbisal.

Uric acid
The active ingredient acetylsalicylic acid changes the uric acid level in the blood.

Contraception with the coil
If you are using an intrauterine device ("coil") for contraception, please note that the active ingredient acetylsalicylic acid can weaken the effect of an intrauterine device

Enzyme defects
In certain cases of severe so-called glucose-6-phosphate dehydrogenase deficiency (a congenital metabolic disorder), high doses of acetylsalicylic acid triggered a breakdown of red blood cells. The administration of acetylsalicylic acid and higher doses of vitamin C in the case of glucose-6-phosphate dehydrogenase deficiency may therefore only be carried out under medical supervision.

Headaches caused by painkillers
Taking higher doses of painkillers on a regular basis can lead to headaches, which must not be treated with this painkiller. In such a case, contact your doctor.

Kidney damage caused by painkillers
Taking painkillers on a regular basis for a long period of time can lead to kidney damage, which can progress to kidney failure.

Fever treatment in children and adolescents
There is a possible connection between acetylsalicylic acid and the life-threatening Reye's syndrome when acetylsalicylic acid is administered to children with fever, especially in the case of fever treatments for flu or chickenpox. Reye's syndrome is a non-contagious disease of the brain (encephalopathy) with simultaneous liver failure. It typically occurs after the first signs of a feverish illness (especially chickenpox and flu) have subsided. Warning signs are long-lasting, severe vomiting, headaches and impaired consciousness. Contact a doctor immediately if these symptoms occur and also inform them about the medicine you are taking.

Acetylsalicylic acid-containing medicines may therefore only be administered to children under 12 years of age on doctor's orders.

Further information
If you suffer from kidney stones, iron storage disease or gastritis (inflammation of the gastric mucosa), ask your doctor whether you may take Ascorbisal.

If you have recurrent kidney stones, you should not take more than 100 to
200 mg of vitamin C per day.

Taking Ascorbisal 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.


Please note that some other medicines may also contain acetylsalicylic acid (e.g. "flu remedies") and that taking them together could lead to an overdose.

Ascorbisal should not be taken at the same time as similar pain-relieving medicines, so-called non-steroidal anti-inflammatory drugs (NSAIDs).

Caution is advised when taking at the same time as
- anticoagulant medicines (e.g. coumarin derivatives, heparin, dipyridamole and sulfinpyrazone),
- certain medicines for treating depression (selective serotonin reuptake inhibitors, lithium),
- cortisone,
- certain medicines for heart failure (cardiac glycosides),
- medicines for treating rheumatism (non-steroidal anti-inflammatory drugs),
- blood sugar-lowering medicines (sulfonylureas),
- methotrexate (a medicine for inhibiting tumour growth or immune reactions),
- pentoxifylline (a certain medicine for improving blood circulation),
- valproic acid (a certain medicine for treating epilepsy),
- diuretics (e.g. spironolactone, furosemide),
- medicines for high blood pressure or heart failure (ACE inhibitors, antihypertensives),
- medicines for treating gout (uricosurics, e.g. probenecid, sulfinpyrazone),
- locally effective gastrointestinal medicines (e.g. magnesium, aluminium and potassium salts),
- iron-containing medicines,
- certain medicines for too much stomach acid (aluminium-containing antacids).

Since acetylsalicylic acid and vitamin C can change the results of
certain laboratory tests in higher doses, inform your doctor that you are taking Ascorbisal.

Taking Ascorbisal together with alcohol
Please avoid drinking alcohol during treatment with Ascorbisal, as certain side effects can be intensified (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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
First and second trimester:
You should not take Ascorbisal during the first 6 months of pregnancy. If you are still considering taking it, be sure to talk to your doctor first.

Third trimester:
Ascorbisal must not be taken in the last 3 months of pregnancy.

Breastfeeding
Ascorbisal may only be taken during breastfeeding on the orders of your doctor. In such a case, you should either stop breastfeeding or pump off the milk and throw it away.


Fertility
Ascorbisal belongs to a group of medicines (so-called non-steroidal anti-inflammatory drugs, "NSAIDs") that can impair fertility in women. This effect is reversible after discontinuing the medicine (see also "Contraception with the coil" in the section "Special care must be taken when taking Ascorbisal").

Driving and operating machinery
Ascorbisal has no or a negligible influence on the ability to drive
and operate machinery.

How should the medicine be taken?

How should Ascorbisal be taken?

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

Use the lowest possible dosage if this is sufficient.

The recommended dose is:

Adults and adolescents weighing over 50 kg (from about 15 years of age) Single dose: 1 to 2 tablets per dose. The single dose can be taken up to 3 times a day. The minimum interval between doses should be 4 hours.
The maximum daily dose of 6 tablets must not be exceeded.

Adolescents weighing between 30 and 50 kg (from 12 to 15 years of age) Single dose: 1 tablet per dose. The maximum daily dose of 4 tablets must not be exceeded.
The minimum interval between doses should be 6 hours.

Children and adolescents under 12 years of age
Ascorbisal is not suitable for children under 12 years of age.
Medicines containing acetylsalicylic acid may only be given to children under 12 years of age on doctor's orders.
A children's dosage is not possible with this medicine.

Elderly people (over 65 years of age)
Single dose: 1 tablet per dose, in the case of more severe pain and higher fever, 2 tablets can also be taken at once. The minimum interval between doses should be 4 hours.
The maximum daily dose of 4 tablets must not be exceeded.

Patients with liver and/or kidney dysfunction
Please talk to your doctor before taking Ascorbisal, as you may need a different dosage.

Method of administration
Dissolve the tablet in a glass of water. Take with meals. Drink plenty of fluids afterwards.


The tablet can be divided into equal doses.

Duration of use
Do not take the medicine for longer than necessary.
Ascorbisal must not be taken for more than 3 days in a row without medical advice.

If you have taken more Ascorbisal than you should If you suspect an overdose of Ascorbisal, contact a doctor immediately.

Overdoses can be dangerous, especially for elderly patients and especially young children.

The following symptoms may occur in the case of a slight overdose:
Tinnitus, hearing disorders, visual disturbances, headaches, dizziness and confusion.
Irritations in the gastrointestinal tract, such as nausea, vomiting and stomach pain (due to ulcers in the gastrointestinal tract), kidney damage, water retention in the tissue and severe bleeding must be expected.

The following symptoms may occur in the case of a severe overdose: Fever, increased respiration, metabolic disorders (e.g. acidosis, severe hypoglycaemia), cardiovascular failure, impaired lung function and unconsciousness.

Note for the doctor:
Information on the treatment of poisoning with Ascorbisal tablets can be found at the end of this package leaflet.

If you forget to take Ascorbisal
Do not take twice the amount if you have forgotten to take the previous dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What side effects are possible?

How should Ascorbisal be stored?

Do not store above 25° C.
Keep this medicine out of the reach of children.
You must not use the medicine after the expiry date which is stated on the blister pack and the folding box after "use by" or "usable until". The expiry date refers to
the last day of the specified month.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment.

Special storage instructions

5. How should Ascorbisal be stored?

Do not store above 25° C.

Keep this medicine out of the reach of children.

You must not use the medicine after the expiry date which is stated on the blister pack and the folding box after ,,use.bis" or ,,usable until" respectively. The expiry date refers to the last day of the specified month.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment.

Special information on the content

Contents of the pack and further information

What Ascorbisal contains

- The active ingredients are: Acetylsalicylic acid and ascorbic acid (vitamin C). 1 tablet contains 500 mg acetylsalicylic acid and 20 mg ascorbic acid.
- The other ingredients are: Potato starch, glycerol monostearate, silica.

What Ascorbisal looks like and contents of the pack
Ascorbisal tablets are white to brownish-white, round and biconvex
Tablets with a break notch on one side.
Ascorbisal is available in blister packs of 20 and 60 pieces.