Thomapyrin pain killer

Thomapyrin is used in adults and adolescents aged 12 to 18 to relieve

• Headaches (particularly tension headaches) and migraine attacks with and without aura
• mild to moderate pain such as B. Toothache, menstrual pain; as well as for relieving pain and lowering fever in colds and flu-like infections.

Contraindications

Thomapyrin must not be taken

• if you are allergic to acetylsalicylic acid, paracetamol, caffeine or salicylates or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from a rare inherited metabolic disease leading to intolerance to any of the components of the medicine (see "Thomapyrin contains lactose")
• if you have ever experienced hypersensitivity symptoms, such as B. Difficulty breathing (asthma), nasal polyps, swelling of the skin and/or mucous membranes (especially in the facial area, if the nose, larynx and tongue are involved, sometimes with shortness of breath and difficulty swallowing) or nettle rash (itchy red spots on the skin)
• if you suffer from any of the following diseases:

- Ulcers, bleeding or perforation of the stomach or intestines
- Pathologically increased tendency to bleed or blood clotting disorder
- Significant impairment of liver or kidney function
- Severe heart muscle weakness

• if you have ever had gastrointestinal bleeding or perforation caused by anti-inflammatory painkillers or anti-rheumatic drugs (NSAIDs).
• if you have previously had repeated (more than once) ulcers, bleeding or perforation of the stomach or intestines
• if you have heavy bleeding or are at increased risk of bleeding (e.g. if you are going to have an operation - in this case tell your doctor that you are taking Thomapyrin)
• 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 (see “Other medicines and Thomapyrin”)
• if you are taking medicines to prevent blood clotting (anticoagulants) and high doses of Thomapyrin at the same time (see “Other medicines and Thomapyrin”)
• if you have a certain hereditary, very rare metabolic disease (deficiency of glucose-6-phosphate dehydrogenase).
• if you drink alcohol regularly or in large quantities (see “Thomapyrin with food, drink and alcohol”)
• of pregnant women in the last trimester of pregnancy (see “Pregnancy and lactation”)
• of children or adolescents with chickenpox or flu-like illnesses because of the risk of developing “Reye’s syndrome” – a very rare but potentially life-threatening disease (see “Warning and precautions”)
• by children under the age of 12

interactions

Acetylsalicylic Acid:

• Anti-inflammatory painkillers and rheumatism drugs (NSAIDs): Mutual reduction in effectiveness with an increased risk of gastrointestinal damage - this combination is not recommended, if your doctor considers it necessary, you must carefully follow the instructions for use of the NSAIDs used
• "Digitalis" (heart-strengthening drugs): increase in their blood levels and effect - appropriate monitoring and, if necessary, dose adjustment by the doctor is required
• Certain medicines used to treat infections (sulfonamides): increased effect or side effects
• "Cortisone" (corticosteroids): increase the risk of stomach ulcers or bleeding
• Thyroid hormones: acetylsalicylic acid can inhibit the absorption of thyroid hormones
• Medicines to prevent a blood clot: increased risk of bleeding in the gastrointestinal tract (see also “Warning and precautions” and “Possible side effects”) – your doctor may check your blood clotting values
• Anticoagulants: acetylsalicylic acid can increase the effect of anticoagulants; increased risk of bleeding (see also “Warnings and precautions” and “Possible side effects”) – your doctor may check your blood clotting values. Anticoagulant medicines must not be used together with high doses of Thomapyrin (acetylsalicylic acid) (see “Do not take Thomapyrin”)
• Medicines used to dissolve blood clots: increased risk of bleeding (see also "Warnings and precautions" and "Possible side effects?")
• Valproic acid (medicine used to treat epilepsy): Acetylsalicylic acid can lead to an increase in blood levels of valproic acid and as a result increase the effects or side effects of this substance
• Certain medicines used to treat depression (so-called selective serotonin reuptake inhibitors = "SSRIs"): increase the risk of gastrointestinal bleeding (see also "Warnings and precautions" and "Possible side effects?")
• Lithium (medicine for the treatment of mental illnesses): Increase in the lithium blood level - appropriate monitoring and, if necessary, dose adjustment by the doctor is required
• Pentoxifylline (medicine to treat circulatory disorders): Increased risk of bleeding - medical supervision with more frequent checks of bleeding time is recommended
• Certain medicines for bacterial infections (antibiotics of the tetracycline type): Taking acetylsalicylic acid and tetracyclines at the same time can lead to the formation of compounds that the body cannot absorb. Therefore, a period of at least 1 to 3 hours should elapse between the administration of Thomapyrin and tetracycline antibiotics
• Uric acid-lowering drugs: reduced effectiveness
• Dehydrating medicines: weakening of their antihypertensive effect - blood pressure checks are recommended
• Certain diuretic (potassium-sparing) drugs - so-called aldosterone antagonists (e.g. spironolactone): reduced effectiveness
• Antihypertensive drugs: Reduction of their antihypertensive effect - blood pressure checks are recommended
• Methotrexate (medicine with an inhibitory effect on certain immune reactions or against cancer): acetylsalicylic acid can lead to an increase in blood levels of methotrexate and as a result increase the harmful effects of this substance - this combination should be avoided; if it is necessary, a strict blood count, liver and kidney function check by the doctor is necessary. If the dose of methotrexate is 15 mg or more per week, Thomapyrin must not be used concomitantly (see also “Do not take Thomapyrin”)
• Oral blood sugar lowering medicines: blood sugar fluctuations are possible; increased blood glucose controls are recommended
• Certain antihypertensive drugs (of the ACE inhibitor type): decreased renal excretion, make sure you drink enough fluids
• Locally effective gastrointestinal preparations (magnesium, aluminum and calcium salts, oxides and hydroxides): increased urinary excretion of salicylates

Paracetamol:

• Medicines that affect liver function such as B. gluthethimide (sleeping pills and sedatives), phenytoin (medicines to treat epilepsy), barbiturates (anesthetics), carbamazepine (medicines to treat depression), rifampicin (medicines to treat infections) and other liver-damaging agents: increase of the liver-damaging effect from paracetamol; Liver damage is possible even from otherwise non-toxic doses
• Chloramphenicol (specific antibiotic = drug against infections): increased damaging effect of chloramphenicol due to delayed excretion
• Warfarin and coumarin: The significance of interactions between paracetamol and warfarin or coumarin is still unclear. Prolonged use of paracetamol (over a period of 7 days or more) together with warfarin or coumarin should only take place under medical supervision
• Zidovudine: increased risk of low levels of certain white blood cells (neutropenia) - this combination should only be used on medical advice
• Probenecid (uric acid-lowering drug) and salicylamide (anti-inflammatory painkiller): increased damaging effect of paracetamol due to delayed excretion, if probenecid is taken at the same time, the paracetamol dose should be reduced
• Cholestyramine (certain medicine used to lower cholesterol): reduced absorption of paracetamol
• Drugs that accelerate gastric emptying (e.g. metoclopramide [for vomiting and nausea]): Increased absorption of paracetamol, thereby accelerating the onset of action
• Drugs that slow down gastric emptying: Reduction in the absorption of paracetamol, thereby delaying the onset of action

caffeine:

• Sedatives: Reduction of the sedative effect
• Certain medicines for asthma (sympathomimetics) or thyroid hormones (thyroxine): increase in the heartbeat-accelerating effect
• Theophylline (certain medicines used to treat breathing problems): Delay in the elimination of theophylline (theophylline effects last longer)
• Quinolones (certain antibiotics = medicines against infections): Delay in the elimination of caffeine (the effect of caffeine lasts longer)
• oral contraceptives (oral contraceptives = “the pill”), cimetidine (medicine against too much stomach acid); Fluvoxamine (medicines for depression) or disulfiram (medicines to help alcohol withdrawal): slowing down the metabolism of caffeine in the liver (the effect of caffeine lasts longer)
• Nicotine (smoking or nicotine replacement therapy) or certain depressant drugs (barbiturates): increase in the breakdown of caffeine in the liver (the effect of caffeine wears off more quickly)

There is no evidence that the possible dependence potential of painkillers is increased when caffeine is used together.

Interference with laboratory tests
High doses of acetylsalicylic acid can influence the results of various laboratory tests. Acetaminophen can interfere with certain laboratory tests that measure uric acid levels and blood sugar levels.

application

The recommended dose is:

Adults and adolescents from the age of 15:
1-2 tablets up to 3 times a day, a daily dose of 6 tablets (equivalent to 1.5 g acetylsalicylic acid, 1.2 g paracetamol and 300 mg caffeine) should not be exceeded.

Adolescents from 12 to 14 years:
1⁄2-1 tablet up to 3 times a day, a daily dose of 3 tablets (equivalent to 750 mg acetylsalicylic acid, 600 mg paracetamol and 150 mg caffeine) should not be exceeded.

The interval between the individual intakes should be at least 4 hours.

Possible undesirable effects can be minimized by administering the smallest effective dose for the shortest necessary duration.

Special patient groups

Elderly people (over 65 years of age) Elderly people
should be particularly cautious because they may have concomitant diseases or are underweight (see "Do not take Thomapyrin" and "Warnings and precautions"). Older and underweight people should therefore only ever use the lowest effective dose.

Children under 12 years of age
Thomapyrin must not be given to children under 12 years of age (see “Do not take Thomapyrin”).

Patients with kidney problems
If you suffer from kidney problems, please ask your doctor for advice before taking this medicine. He may recommend that you extend the dosing interval (the interval between 2 doses). If you have severe kidney problems, Thomapyrin must not be taken (see “Thomapyrin must not be taken”).

Patients with liver problems
If you suffer from liver problems, please ask your doctor for advice before taking this medicine. He may recommend that you extend the dosing interval (the interval between 2 doses). If you have severe liver dysfunction, Thomapyrin must not be taken (see “Do not take Thomapyrin”).

Method of
administration For oral use.

Swallow the tablets with plenty of liquid or allow the tablets to disintegrate in liquid and then drink plenty of liquid.

The tablet can be divided into equal doses.

Duration of
administration Thomapyrin should not be taken for longer than 3-4 days (maximum 10 days) for pain and for no longer than 3 days for fever without medical advice (see "Warnings and precautions").

side effects

Side effects requiring immediate medical attention
In (very) rare cases, one of the active ingredients in Thomapyrin can cause a side effect that requires discontinuation and immediate medical attention. Signs of 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
• low blood pressure and swelling in the head area
• Skin rashes with blisters or bleeding, possibly with mouth ulcers
• Pallor with exhaustion, fever, increased tendency to bleed (skin bleeding, nosebleeds!), sore throat, mouth sores
• Headache and decreased level of consciousness, possibly with convulsions, vomiting or behavioral changes
• Severe exhaustion with pronounced loss of appetite or reduced urine output

Adverse reactions observed when testing Thomapyrin in a limited number of patients

Common (affects 1 to 10 users in 100)

• nervousness
• dizziness
• stomach pain
• indigestion
• nausea

Uncommon (affects 1 to 10 users in 1,000)

• Skin disorders (see also the information in the following section “Side effects observed with the use of acetylsalicylic acid or paracetamol”)
• palpitations
• Vomit

Rare (affects 1 to 10 users in 10,000)

• accelerated heart rate
• inflammation of the esophagus
• Diarrhea
• restlessness
• fatigue
• Tremble
• Sweat
• rotary vertigo

Side effects observed with the use of acetylsalicylic acid or paracetamol

The list of side effects also includes observations made in the treatment of rheumatic complaints with high doses of acetylsalicylic acid over a long period of time.

Common (affects 1 to 10 users in 100)

• heartburn

Uncommon (affects 1 to 10 users in 1,000)

• skin reactions (e.g. hives)
• drug eruption
• bile stasis

Rare (affects 1 to 10 users in 10,000)

• Hypersensitivity reactions (including drop in blood pressure, shortness of breath, cramping of the bronchial muscles and sudden swelling of the skin and/or mucous membranes - especially in the facial area, with involvement of the nose, larynx and tongue [angioedema], sometimes with shortness of breath and difficulty swallowing; reddening of the skin, nausea and sweating with failure of the cardiovascular system [anaphylactic shock])
• Gastrointestinal ulcers and bleeding (if used for a long time, anemia due to iron deficiency [iron deficiency anemia] may occur as a result of gastrointestinal bleeding)
• Elevation of certain liver values
• Skin reactions (including serious inflammatory skin conditions with blistering and peeling skin)
• skin bleeding
• inflammation of the blood vessels
• impairment of renal function

Very rare (affects less than 1 in 10,000 people)

• Changes in blood counts such as a reduction in the number of blood platelets (thrombocytopenia), white blood cells (leukocytopenia or agranulocytosis) or total blood cells (pancytopenia); Anemia due to reduced formation of red blood cells in the bone marrow (aplastic anaemia)
• Low blood sugar (low blood sugar, hypoglycemia)
• Gastrointestinal breakthroughs
• Hepatic impairment – ​​liver function tests should be performed in patients with juvenile arthritis (joint pain in adolescents), rheumatic fever, systemic lupus erythematosus and a history of liver damage
• Reye's syndrome (rare but life-threatening condition - see also Do not take Thomapyrin and Warnings and precautions)
• Bronchospasm (more common in people allergic to NSAIDs)
• acute renal failure
• Serious skin reactions (such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP))

Not known (cannot be estimated from the available data)

• severe bleeding, e.g. B. Bleeding in the brain, which can also be life-threatening in individual cases, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants (see also “Warning and precautions” and “Thomapyrin with food, drink and alcohol”)
• bleeding, e.g. nosebleeds, bleeding gums (the risk of bleeding may be increased because of the anticoagulant effect, which lasts for a few days (up to 8 days) after stopping treatment)
• Inflammation of the gastric mucosa
• visual disturbances
• Hearing impairment
• ringing in the ears ("ringing in the ears")
• headache
• dizziness
• sleepiness
• confusion
• nervousness
• restlessness
• disorientation
• upper abdominal complaints
• Swelling, high blood pressure and heart failure have been reported with NSAID treatment

The use of acetylsalicylic acid can cause gastrointestinal symptoms that can lead to serious gastrointestinal bleeding (see above). These side effects are more likely to occur with higher doses, although they can also occur with lower doses.

Taking NSAIDs may be associated with a small increased risk of blockage of arterial blood vessels - which can lead to a heart attack or stroke - particularly in patients who are taking higher doses or who are on long-term treatment.

Side effects that can occur from caffeine

The side effects of caffeine are dose-dependent and vary from person to person. They depend on the individual's sensitivity to caffeine and daily consumption of caffeinated beverages.

If the recommended dosage is adhered to, side effects are rare, but taking it in the evening hours can lead to problems falling asleep. With additional caffeine consumption (e.g. from drinks), increased side effects from caffeine are possible; the caffeine content of a Thomapyrin tablet corresponds approximately to half a cup of filter coffee.

Caffeine stimulates the central nervous system and, in higher doses, can cause restlessness, irritability, insomnia, tiredness, muscle tremors, dizziness, anxiety, visual disturbances, hearing disturbances, gastrointestinal complaints (dry mouth, increased thirst, loss of appetite, cravings, stomach pains, diarrhea, nausea, heartburn ), increase in systolic blood pressure, increased heart rate, increased urine flow, hives, muscle pain and changes in potassium and blood sugar levels.

There is no evidence that when used as intended, the fixed combination of the 3 active ingredients increases the scope and type of side effects of the individual substances or expands their type.

composition

What Thomapyrin tablets contain

• The active ingredients are: 1 tablet contains 250 mg acetylsalicylic acid, 200 mg paracetamol and 50 mg caffeine
• The other ingredients are: milk sugar (lactose monohydrate), maize starch, stearic acid