InfluASS tablets

The active ingredients acetylsalicylic acid (ASA) and paracetamol in InfluASS® tablets have a rapid onset of analgesic, fever-reducing and anti-inflammatory effects.
The caffeine it also contains is said to alleviate exhaustion and tiredness, which are common side effects of colds.

InfluASS® tablets are suitable for the treatment of
fever and pain associated with colds or flu-like infections and acute mild to moderate pain in adults and adolescents over the age of 12.

Contraindications

InfluASS® tablets must not be taken

• if you are hypersensitive (allergic) to the active substances acetylsalicylic acid (ASA), paracetamol and caffeine or salicylates and to any of the other ingredients of InfluASS® tablets
• by people who, after using salicylates or other anti-inflammatory painkillers (non-steroidal anti-inflammatory drugs [NSAIDs]), have symptoms such as asthma, runny nose, sudden swelling, especially in the face area, if the nose, larynx and tongue are involved, possibly with shortness of breath and developed difficulty swallowing or hives (itchy red patches on the skin).
• if you have an existing gastric or duodenal ulcer
• if you have an increased tendency to bleed or have blood clotting disorders
• in case of heavy bleeding or risk of bleeding (e.g. in the course of an operation, see section “Take special care when taking InfluASS® tablets”)
• with high blood pressure
• in case of severe cardiac arrhythmia, coronary artery disease, myocardial insufficiency
• with severe hepatic impairment
• in case of excessive or chronic alcohol consumption
• in severe renal dysfunction
• if you are being treated with methotrexate (medicines that suppress the immune system or anticancer) at a dose of 15 mg per week or more
• if you have a glucose-6-phosphate dehydrogenase deficiency (rare, hereditary metabolic disease; see this section under “Take special care when taking InfluASS® tablets”)
• pregnant women in the last trimester of pregnancy (see this section under “Pregnancy and breast-feeding”)
• of children or adolescents with chickenpox or flu (influenza) because of the risk of developing the so-called "Reye syndrome" through the ASA contained in InfluASS® tablets - a very rare but potentially life-threatening disease (see also this section under "Special Caution is required when taking InfluASS® tablets")
• by children under the age of 12

Particular care is required when taking InfluASS® tablets

• chronic or recurring stomach or duodenal problems
• History of ulcer, bleeding or perforation of an ulcer in the gastrointestinal tract
• Bronchial asthma, allergic rhinitis and chronic swelling of the nasal mucosa (nasal polyps)
• Hypersensitivity to anti-inflammatory painkillers and rheumatism drugs (NSAIDs)
• concomitant use of anticoagulant medicines (e.g. coumarin derivatives, heparin), medicines to prevent blood clot formation, or medicines that dissolve blood clots
• impaired liver function
• impaired renal function
• Dehydrated patients
• low blood pressure
• hyperthyroidism
• diabetes
• Tendency to determine kidney stones (oxalate stones)
• Gilbert-Meulengracht syndrome (rare, hereditary metabolic disease) 

interactions

If InfluASS® tablets are used at the same time as other medicines, they can influence each other's effects.

Acetylsalicylic acid (ASA):
Combination of ASA with: Possible reactions:

• Anti-inflammatory pain and rheumatism drugs (NSAIDs) Mutual reduction in effectiveness with an increased risk of gastrointestinal damage (combination is not recommended)
• "Digitalis" (cardiac drugs) Dangerous increase in their effectiveness - appropriate control by the doctor is required
• Certain medicines against infections (antibiotics such as sulfonamides, co-trimoxazole) increase the effect or side effects
• Certain medicines used to treat infections (the antibiotic "tetracycline") disruption of absorption into the body when taken at the same time (taking them 1-3 hours apart is recommended)
• "Cortisone" increasing the risk of stomach ulcers or bleeding
• Thyroid hormones potentiation
• Drugs that inhibit blood clotting ASA can increase the effect of anticoagulant drugs; Increased risk of bleeding possible (control of coagulation values ​​is recommended) Increased risk of gastrointestinal bleeding
• Valproic acid (medicine to treat epilepsy) ASA can lead to an increase in blood levels of valproic acid and as a result the (side) effects of this substance can be increased
• Medicines used to treat depression (“SSRIs”) increase the risk of gastrointestinal bleeding
• Lithium (medicine for the treatment of mental illnesses) Increase in lithium blood levels - monitoring and, if necessary, dose adjustment is recommended
• Uric acid-lowering drugs Reduced effectiveness
• diuretics to reduce their antihypertensive effect (blood pressure checks are recommended)
• Antihypertensive drugs, reduction in their antihypertensive effect (blood pressure monitoring is recommended)
• Methotrexate (medicine with an inhibitory effect on the immune system or anticancer) ASA can lead to an increase in the blood levels of methotrexate and as a result increase the damaging effect of this substance (a combination should be avoided - alternatively, strict monitoring of the blood count, liver and renal function recommended)
• Blood sugar lowering medicines to be taken by mouth Blood sugar fluctuations are possible (increased blood sugar monitoring is recommended)
• Alcohol Increased risk of occurrence and worsening of gastrointestinal bleeding (combination should be avoided)

Paracetamol: combination of paracetamol
Possible reactions: with:

• Medicines that affect liver enzymes, such as glutethimide (sleeping pills and tranquilizers), phenytoin, phenobarbital (both medicines used to treat epilepsy), carbamazepine (medicines used to treat depression), rifampicin (medicines used to treat tuberculosis) increase the liver-damaging effect from paracetamol; Liver damage is possible from otherwise harmless doses
• Chloramphenicol (antibiotic) Increased damaging effects of chloramphenicol due to significantly delayed excretion
• Anticoagulant drugs Long-term use of paracetamol can increase the effect of anticoagulant drugs; increased risk of bleeding possible (checking of blood coagulation values ​​is recommended)
• zidovudine (medicine used to treat AIDS) increased tendency to changes in blood counts (combination should only be done on medical advice)
• Probenecid (uric acid lowering drug) and salicylamide (anti-inflammatory painkiller) Increased damaging effect of paracetamol due to delayed excretion
• Metoclopramide (medicine against vomiting and nausea) Increase in the intake of paracetamol
• Alcohol Increased risk of liver damage

Caffeine: Combination of caffeine with:
Possible reactions:

• Sedative Reduction of the depressant effect
• Thyroid hormones Enhancement of the heartbeat-accelerating effect

Interference with laboratory tests
ASA can affect various laboratory results in higher doses. Paracetamol can interfere with the determination of uric acid levels and blood sugar levels using certain laboratory tests. Before laboratory tests, please inform the doctor that you are taking InfluASS® tablets.

Taking InfluASS® tablets with food and drink
Combining InfluASS® tablets with alcoholic beverages increases the risk of bleeding in the gastrointestinal tract and should therefore be avoided. When consuming caffeine-containing beverages, it should be taken into account that caffeine overdose could occur.

Pregnancy and breast-feeding
Ask your doctor for advice before taking/using any medicine.

Pregnancy:

First and second trimester of pregnancy:
Like other medicines with an inhibiting effect on the formation of certain tissue hormones (prostaglandins), InfluASS® tablets can adversely affect pregnancy and/or the development of the unborn child.
Unless absolutely necessary, InfluASS® tablets should therefore not be used during the first and second trimester of pregnancy. When using InfluASS® tablets in women who wish to become pregnant or during the first and second trimester of pregnancy, the dose should be kept as low and the duration of treatment as short as possible.

Last trimester of pregnancy:
InfluASS® tablets must not be taken during the last trimester of pregnancy, as there is an increased risk of complications for the mother and child (maldevelopments in the circulatory system and/or kidney dysfunction in the child, increased risk of bleeding in the mother and child during birth, birth delay due to interfering with labour)

Long-term intake of high doses of caffeine can lead to miscarriage and premature birth in pregnant women.

Breast-feeding
The active ingredients pass into breast milk. ASA can disrupt blood clotting in infants. The infant's general well-being and behavior can be adversely affected by caffeine ingested with breast milk.
You should therefore not breastfeed while taking InfluASS® tablets.

Fertility
ASA inhibits the formation of certain tissue hormones (prostaglandins) and can therefore impair female fertility and is therefore not recommended for women who want to become pregnant. 

application

The tablets have a cross-break groove and can therefore be divided.

Possible undesirable effects can be kept low by taking the smallest effective dose for the shortest necessary time.

Unless otherwise prescribed by the doctor, the usual dose is at

Adults and adolescents from the age of 12:
1-1 ½ tablets up to 3 times a day (usually at intervals of 4-8 hours).

Special patient groups: 

Renal impairment:
There are no specific dosing recommendations; it is recommended to extend the dosing interval. If you suffer from kidney problems, please ask your doctor for advice before taking this medicine.
InfluASS® tablets should not be taken in the case of severe kidney dysfunction

Hepatic impairment: There are no specific dosing recommendations; it is recommended to extend the dosing interval. If you suffer from liver dysfunction, please ask your doctor for advice before taking this medicine.
InfluASS® tablets should not be taken in the case of severe liver dysfunction

Elderly people (from 65 years of age): Elderly people
should be particularly careful because of possible concomitant illnesses (see section 2. WHAT YOU MUST CONSIDER BEFORE TAKES InfluASS® tablets?) or being underweight (see section 2 under “Particular caution with the Taking InfluASS® tablets is required"). It is recommended that the elderly and underweight, in particular, take the lowest effective dose.

Children under the age of 12:
There is insufficient knowledge about the use of the fixed combination in InfluASS® tablets in children. For this reason and because of the caffeine content, InfluASS® tablets must not be given to children under the age of 12.

Type of application:
Take InfluASS® tablets with plenty of liquid or let the tablets disintegrate and then drink plenty of liquid.

Duration of use:
InfluASS® tablets should not be used for more than 3-4 days in a row and not in higher doses without medical advice.

side effects

In (very) rare cases, one of the active ingredients in InfluASS® tablets can cause a side effect that requires discontinuation of the tablets and immediate medical attention. Alarm signals for such a potentially dangerous side effect are:

• Vomiting blood, coffee grounds like vomiting, abdominal pain, or tarry stools
• Disorder of the general condition with shortness of breath, skin reddening or itching, possibly with reduced blood pressure and swelling in the head area
• Skin rashes with blistering or bleeding, possibly with mouth ulcers
• Pallor with exhaustion, fever, increased tendency to bleed (skin bleeding, nosebleeds!), sore throat, mouth sores
• Headache and loss of consciousness, possibly with cramps or vomiting or changes in behavior
• Severe exhaustion with pronounced loss of appetite or reduced urine output

In all these cases, please contact a doctor immediately.

The following side effects can occur during treatment with InfluASS® tablets:

Due to the acetylsalicylic acid content:
The list of side effects of ASA also extends to observations of patients with rheumatic complaints who have been treated with high doses over a long period of time.

ASA can cause upper abdominal discomfort, gastrointestinal ulcers and gastric mucosal inflammation with mucosal defects (erosive gastritis), which can lead to serious gastrointestinal bleeding. These side effects are more likely to occur with higher doses, although they can also occur with lower doses. If ASA is used over a longer period of time, gastrointestinal bleeding can lead to anemia due to iron deficiency.

Blood and lymphatic system disorders
Uncommon: increased risk of bleeding (e.g. nosebleeds, bleeding gums, bleeding from mucous membranes) possibly with prolonged bleeding time due to the anticoagulant effect, which persists for a few days (up to 8 days) after stopping treatment.

Rare to very rare: severe bleeding such as cerebral haemorrhage has been reported, particularly in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants. This can potentially be life-threatening. 

Very rare: reduction in blood platelets, white blood cells or all blood cells, anemia due to reduced production of red blood cells in the bone marrow

Nervous system disorders
Undetermined: headache, dizziness, drowsiness, confusion, restlessness, nervousness

Eye disorders
Undetermined: visual disturbances

Ear and inner ear disorders
Undetermined: hearing impairment, ringing in the ears ("ringing in the ears")

Respiratory, thoracic and thoracic cavity disorders
Uncommon: spasm of the muscles of the bronchi (with shortness of breath)

Gastrointestinal disorders
Common: Gastrointestinal disorders such as heartburn, nausea, vomiting, diarrhoea, abdominal pain
Rare: Gastrointestinal ulcers and bleeding
Very rare: Perforation of gastrointestinal ulcers

Renal and urinary disorders
Rare: impairment of renal function
Very rare: acute renal failure

Skin and subcutaneous tissue disorders
Uncommon: skin reactions
Rare: serious inflammatory skin disorders with blistering and skin peeling, skin bleeding, allergic vasculitis

Musculoskeletal and connective tissue disorders
Very rare: Inflammation of the connective tissue with tissue damage - has been reported in temporal association with the use of anti-inflammatory analgesics (NSAIDs).

Metabolism and nutritional disorders
Very rare: blood sugar deficiency, disturbance of the acid-base balance

General disorders and administration site conditions
Very rare: Reye's syndrome (rare but life-threatening disease that occurs in children and adolescents with feverish illnesses - especially chickenpox and flu-like illnesses - occurs (see also section 2 under "InfluASS® tablets must not be taken be" and "Particular caution is required when taking InfluASS® tablets")

Immune system disorders
Uncommon: skin reactions (e.g. nettle rash)
Rare: hypersensitivity reactions, including drop in blood pressure, shortness of breath, sudden swelling, especially in the face area (if the larynx and tongue are involved, possibly with shortness of breath), difficulty swallowing and circulatory failure

Hepatobiliary disorders
Very rare: increase in certain liver values, impairment of liver function

Due to the paracetamol content:
Blood and lymphatic system disorders
Very rare: Changes in the blood picture including reduction in blood platelets, white blood cells or all blood cells

Nervous system disorders
Common: nervousness, restlessness, headache

Respiratory, thoracic and thoracic cavity disorders
Very rare: spasm of the muscles of the bronchi (more common in people with allergy to anti-inflammatory painkillers and rheumatism drugs [NSAIDs])

Renal and urinary disorders
Rare: impairment of renal function
Very rare: acute renal failure

Skin and subcutaneous tissue disorders
Rare: skin rash Very rare: serious skin reactions

Metabolism and nutritional disorders
Very rare: Blood sugar deficiency

Immune system disorders
Very rare: Hypersensitivity reactions including reddening of the skin, rise in temperature (“drug fever”), nettle rash, nausea, sudden swelling, especially in the facial area, if the larynx and tongue are involved, sometimes with difficulty breathing and swallowing, sweating, shortness of breath and circulatory failure

Hepatobiliary disorders
Uncommon: bile stasis
Rare: increase in certain liver values

Due to the caffeine content:
Caffeine can cause restlessness, insomnia, tremors, indigestion and a faster heart rate.

There is no evidence that, when used as intended, the scope and type of side effects of the individual substances are increased or broadened by the fixed combination. 

composition

The active ingredients are: acetylsalicylic acid (ASA), paracetamol and caffeine.
1 tablet contains: acetylsalicylic acid (ASA) 250 mg paracetamol 200 mg caffeine, anhydrous 50 mg

The other ingredients are: Pregelatinised starch, maize starch, lactose monohydrate (milk sugar), stearic acid, talc.