Thomapyrin - tablets

The active substances acetylsalicylic acid and paracetamol contained in Thomapyrin have a fast-acting, analgesic, antipyretic and anti-inflammatory effect.

Application

What is Thomapyrin and what is it used for?

The active substances acetylsalicylic acid and paracetamol contained in Thomapyrin have a fast-acting, analgesic, antipyretic and anti-inflammatory effect. The third active ingredient, caffeine, has been shown to enhance the analgesic effect of the combination of acetylsalicylic acid and paracetamol and to reduce fatigue and tiredness during colds.

Thomapyrin is used in adults and adolescents aged 12 to 18 years for the relief of
headaches (especially tension headaches) and migraine attacks with and without aura
mild to moderate pain, such as toothache; period pain; pain in the stomach; and pain in the face. e.g. toothache, period pain; as well as to relieve pain and reduce fever in colds and flu-like infections.

If you do not feel better or even worse after 3-4 days, consult your doctor.

How is it applied?

What is Thomapyrin and what is it used for?

The active substances acetylsalicylic acid and paracetamol contained in Thomapyrin have a fast-acting, analgesic, antipyretic and anti-inflammatory effect. The third active ingredient, caffeine, has been shown to enhance the analgesic effect of the combination of acetylsalicylic acid and paracetamol, and to relieve fatigue and tiredness associated with colds.
Thomapyrin is used in adults and adolescents aged 12 to 18 years for the relief of

• Headaches (especially tension headaches) and migraine attacks with and without aura
.
• Light to moderate pain, e.g. toothache, menstrual pain, as well as for the relief of pain and reduction of fever in colds and flu-like infections.

If you do not feel better or even worse after 3 to 4 days, contact your

What should you pay attention to before taking it?

Physician.2. What should you be aware of before taking Thomapyrin?
Thomapyrin must not be taken

.

• If you are allergic to acetylsalicylic acid, paracetamol, caffeine, other salicylates or any of the other ingredients of this medicine listed in section 6
.
• If you have already experienced signs of hypersensitivity after treatment with salicylates or other
  anti-inflammatory painkillers or rheumatism medicines (non-steroidal anti-inflammatory drugs = "NSAIDs"), e.g. breathing difficulties (asthma), nasal polyps, swelling of the skin and/or mucous membranes (especially in the
  face area, with involvement of the nose, larynx and tongue possibly with difficulty breathing and swallowing) or hives (itchy red spots on the skin)
.
• If you suffer from one of the following diseases:
• Ulcers, bleeding or perforations of the stomach or intestines
.
• Diseased increased bleeding tendency or blood coagulation disorder (e.g. haemophilia)
.
• Significant impairment of liver or kidney function
.
• severe cardiac insufficiency
• If you have ever had a gastrointestinal bleeding or rupture caused by anti-inflammatory painkillers or rheumatism medicines (NSAIDs)
.
• If you have previously had repeated (more than once) ulcers, bleeding or breakthroughs of the stomach or intestines
.
• If you experience heavy bleeding or an increased risk of bleeding (e.g. if an operation is planned for you - in this case, inform your doctor about taking Thomapyrin)
.
• If you have increased, prolonged or irregular menstrual bleeding
.
• If you are being treated with methotrexate (medicines with an inhibitory effect on the immune system or against cancer) at a dose of 15 mg per week or more (see "Taking Thomapyrin with other medicines")
.
• If you are using medicines to inhibit blood clotting (anticoagulants) and high doses of Thomapyrin at the same time (see "Taking Thomapyrin with other medicines")
.
• If you have a certain hereditary, very rare metabolic disorder (glucose-6-phospate dehydrogenase deficiency)
.
• If you drink alcohol regularly or in large quantities (see "Taking Thomapyrin with food, drink and alcohol")
.
• of pregnant women in the last trimester of pregnancy (see "Pregnancy and breast-feeding")
.
• of children or young people with chickenpox or flu-like illnesses because of the risk of developing "Reye's syndrome" - a very rare but possibly life-threatening condition (see "Warnings and precautions")
.
• of children under 12 years

Warnings and precautions.
Please talk to your doctor before taking Thomapyrin,

• If you suffer from chronic or recurrent stomach or duodenal problems
.
• If you suffer from bronchial asthma, allergic rhinitis, chronic
  nasal mucous membrane swelling (nasal polyps), chronic respiratory diseases or allergies (e.g. with skin reactions, itching, hives). In some patients, the occurrence of asthma attacks may be due to an allergy to acetylsalicylic acid or other NSAIDs, in which case Thomapyrin must not be taken (see "Thomapyrin must not be taken")
.
• If you are hypersensitive (allergic) to anti-inflammatory painkillers and
  rheumatic drugs (non-steroidal anti-inflammatory drugs = "NSAIDs", e.g. acetlysalicylic acid - see "Thomapyrin must not be taken")
.
• If you are taking medicines to inhibit blood clotting (anticoagulants), medicines to prevent or dissolve a blood clot
  at the same time.(platelet aggregation inhibitors, heparin, thrombolytics) or certain medicines for the treatment of depression (so-called selective serotonin reuptake inhibitors = "SSRI") are used (see "Taking Thomapyrin with other medicines")
.
• If you have heart muscle weakness and/or high blood pressure - fluid retention and swelling have been reported in association with the use of one of the active ingredients in Thomapyrin (acetylsalicylic acid)
.
• if you have chronically low blood pressure
.
• If your liver function is slightly to moderately impaired (e.g. after
  liver inflammation)
.
• If your kidney function is slightly to moderately impaired or there is kidney damage due to previous
  diseases
.
• If you have Gilbert's syndrome (a rare inherited metabolic disorder)
.
• If you have diabetes mellitus
.
• If you have malnutrition or dehydration (e.g. if you do not drink enough)
.
• if you are chronically alcoholic, even if you have recently started withdrawal
.
• If you are scheduled to have an operation - including "tooth extraction" (in this case, inform your doctor about taking Thomapyrin)
.

Thomapyrin may only be taken in these cases according to a doctor's orders and under medical supervision. Therefore, please consult your doctor if any of the above points apply to you.
Thomapyrin must not be taken for more than 3 to 4 days for pain and for more than 3 days for fever without a doctor's order. If pain or fever persists or even worsens, or if new symptoms occur (e.g. redness or swelling or a deterioration in general condition), please consult a doctor immediately, as these may be signs of a serious illness.
The anti-inflammatory agents in Thomapyrin can mask the signs (symptoms) of an infection. If there are any signs of infection, such as redness, swelling or persistent
of complaints such as pain or fever for more than three days, medical advice must be sought.
Severe acute hypersensitivity reactions (up to failure of the cardiovascular system = anaphylactic shock) may occur. Discontinue treatment at the first sign of a hypersensitivity reaction.
Serious skin reactions, often with blistering or mucosal damage, have been reported in association with paracetamol. This may indicate the life-threatening skin reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Stop the treatment immediately and contact your doctor immediately if you notice any skin reactions.
Risk of bleeding during operations.
Since the acetylsalicylic acid contained in Thomapyrin is already available in very low dosages and
inhibits blood clotting for several days, haemostasis after operations may be impaired. Before an operation - even minor surgical procedures (e.g. "pulling teeth") - you must therefore please inform the attending doctor or dentist about taking Thomapyrin.
Situations with increased risk of side effects
During treatment, bleeding, ulcers or a rupture of ulcers in the gastrointestinal tract, even with a fatal outcome, can occur at any time - even without previous complaints or corresponding gastrointestinal diseases in the history. If you are older, have a low body weight or are being treated with an anticoagulant drug (anticoagulants such as warfarin or antiplatelet drugs), there is an increased risk (see also "Taking Thomapyrin with other medicines").
Caution is also required if you are receiving medicines at the same time that increase the risk of stomach damage or bleeding, such as other painkillers or rheumatism medicines (NSAIDs), medicines containing cortisone (corticosteroids), or certain medicines for depression (selective serotonin reuptake inhibitors = SSRIs) (see also "Taking Thomapyrin with other medicines").
The risk of bleeding, ulceration or rupture of ulcers in the gastrointestinal tract increases with increasing dose, in the case of a history of ulcers, especially in association with the complications of bleeding or rupture (see "Thomapyrin must not be taken") and for elderly patients. If you belong to these patient groups, you should start treatment with the lowest possible dose and talk to your doctor about treatment together with stomach-protecting medicines (e.g. misoprostol or proton pump inhibitors).
If you notice any signs of an adverse reaction in the gastrointestinal tract (e.g. vomiting blood, coffee-like vomiting, stomach pain, abdominal pain, tar-like stools), please stop taking Thomapyrin immediately and seek medical advice without delay.
Patients with increased risk of side effects
In certain cases of severe glucose-6-phosphate dehydrogenase deficiency (a hereditary, very rare metabolic disorder), higher doses of acetylsalicylic acid may cause anaemia due to the breakdown of red blood cells (see "Thomapyrin must not be taken"). One of the active ingredients in Thomapyrin (acetylsalicylic acid) can reduce the excretion of uric acid and trigger a gout attack in susceptible patients.
Young people with febrile illnesses may only take medicines containing acetylsalicylic acid on a doctor's instructions - and only if other measures have no effect.
show - are given. Especially in young patients, there is a risk of the rare but life-threatening Reye's syndrome (see "Thomapyrin must not be taken"), which requires immediate intensive medical treatment. However, there have also been cases in adults. Reye's syndrome is a non-contagious disease of the
Disease of the brain (encephalopathy) with simultaneous liver failure. Typically, the first signs of a febrile illness (especially chickenpox and flu-like illnesses) appear after it has subsided. Alarm signals are prolonged, violent vomiting, headache and clouding of consciousness. Stop treatment with Thomapyrin immediately and consult a doctor immediately if these symptoms occur.
For this reason, as a precaution, no medicine containing acetylsalicylic acid should be taken for 6 weeks after a vaccination against chickenpox.
Thomapyrin is not suitable for people weighing less than 30 kg.
Consequences of prolonged use of painkillers
With prolonged use of painkillers - especially in high doses - the following can occur
Headaches occur which may not be treated by increased doses of the same medicine. If you think you have such headaches, please consult your doctor.
Sudden discontinuation of painkillers after prolonged use in high doses can cause withdrawal symptoms (e.g. headache, tiredness, muscle aches or nervousness) that usually subside within a few days. Painkillers may only be taken again after the doctor has given the appropriate instructions and the withdrawal symptoms have subsided.Habitual long-term use of painkillers can lead to permanent kidney damage with the risk of kidney failure.
More warnings
Thomapyrin, or NSAIDs in general, can weaken the effect of an intrauterine device (" the IUD"), an effect that is thought to be due to their anti-inflammatory effect.
Thomapyrin in higher doses may affect various clinical chemistry determinations or their results (see "Taking Thomapyrin with other medicines").
Taking NSAIDs might be associated with a slightly increased risk of having a heart attack or stroke. There are too few data to rule out this risk for Thomapyrin or acetylsalicylic acid at a daily dose of no more than 3 g. Taking Thomapyrin with other medicines.
To avoid the risk of an overdose, you should not take any other medicines containing paracetamol together with Thomapyrin. Please also note the possible content of acetylsalicylic acid or caffeine in other medicines you use. The liver-damaging effect of paracetamol can already occur after taking therapeutic doses or after short-term use and in patients without previous liver disease (see also "If you have taken more Thomapyrin than you should").
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.
If Thomapyrin is used at the same time as other medicines, the individual active substances may affect each other as shown in the table below:
Acetylsalicylic acid:

Combination of
Possible reactions:
Acetylsalicylic acid with:
Anti-inflammatory painkillers.
Reciprocal reduction of effectiveness in the case of
and rheumatism medicines (NSAIDs)
increased risk of gastrointestinal damage - this combination is not recommended. If your doctor considers a combination to be necessary, the directions for use of the NSAID used must be followed carefully.
"Digitalis" (heart-strengthening
Increase in their blood level and effect - a medicinal product).
Appropriate control and, if necessary, dose adjustment by the doctor is required.
Certain medicines for
Amplification of the effect or side effectsInfections (sulphonamides) . . .

"Cortisone" (corticosteroids)	Increase the risk of gastrointestinal ulcer or
a -bleed
Thyroid hormones	Acetylsalicylic acid can reduce the absorption of
Thyroid hormones are inhibited

Medicines to prevent a
Increased risk of bleeding in the gastrointestinal tract (see also Blood clots
"Warnings and precautions" and "What side effects may occur?") - your doctor may check your blood clotting levelsBlood clotting inhibitors
Acetylsalicylic acid can reduce the effect of
Medicine
increase blood-clotting medication, increased risk of bleeding (see also "Warnings and precautions" and "What are the possible side effects?") - your doctor may check your blood-clotting values.
Anti-coagulant medicines must not be
be used together with high doses of Thomapyrin (acetylsalicylic acid) (see "Thomapyrin must not be taken").
Medicinal product for the dissolution of
Increased risk of bleeding (see also "Warnings and blood clots
Precautions" and "What side effects are possible?").
Valproic acid (medicinal product for the
Acetylsalicylic acid may cause an increase in blood levels of Treatment of epilepsy).
Valproic acid and subsequently increase the effect or side effects of this substance.
Certain medicinal products for
Increase the risk of gastrointestinal bleeding (see also Treatment of depression.
"Warnings and precautions" and "Which (so-called selective serotonin-
Side effects are possible?")
Reuptake inhibitor =
"SSRI")
Lithium (medicines for
Increase in lithium blood levels - appropriate treatment of psychiatric
Control and, if necessary, dose adjustment by the doctor Diseases)
is required
Pentoxifylline (medicinal product for the
Increased risk of bleeding - medical monitoring with treatment of
Frequent controls of bleeding time are recommendedBlood circulation disorders).
Certain medicines for
If acetylsalicylic acid is taken at the same time as bacterial infections (antibiotics), you should not take acetylsalicylic acid.
Tetracyclines may result in the formation of compounds
of the tetracycline type)
come that the body cannot absorb. Therefore, a period of at least 1 to 3 hours should elapse between the use of Thomapyrin and tetracycline antibiotics

Uric acid-lowering medicines

Effect reduction

. . . . . . . . . . . . . type). .

Dewatering medicines	Attenuation of their antihypertensive effect -
Blood pressure checks are recommended
Certain draining
Effect reduction
(potassium-saving) medicines -
so-called aldosterone antagonists
(z. B. spironolactone)
Hypertensive medicines	Attenuation of their antihypertensive effect -
Blood pressure checks are recommended
Methotrexate (medicinal product with
Acetylsalicylic acid may cause an increase in the blood levels of
inhibiting effect on best.
Methotrexate lead and subsequently the harmful effect
Immune reactions or against
reinforce this substance - this combination should be avoided
Cancer)
shall, if nevertheless necessary, be strictly controlled by
Blood count, liver and kidney function by doctor required. At
a dosage of methotrexate of 15 mg or more per
Week Thomapyrin must not be used at the same time
(see also "Thomapyrin must not be taken")
Drugs that lower blood sugar
Swings in blood sugar are possible
For ingestion
- Increased blood glucose checks are recommended
Certain antihypertensive
Diminished renal excretion, watch out for a
Drugs (of the ACE-
Enough fluid intake
Inhibitors)
Locally effective gastrointestinal
Increased excretion of salicylates through the urine
Preparations (magnesium,
Aluminium and calcium salts, -
oxides and hydroxides)

Paracetamol:
Combination of paracetamol with: Possible reactions:
Medicines that impair the liver function
influence, e.g. phenobarbital,
Topiramate and phenytoin
(Medicinal products for the treatment of
Increase from the liver-damaging effect of
Epilepsy), gluthethimide (sleeping
Paracetamol, liver damage already caused by otherwise non-toxic
and sedatives),
Cans possible
Carbamazepine (medicinal product for the
Treatment of depressive
diseases). Rifampicin
(antibiotic) and alcohol
Chloramphenicol (determined
Increased harmful effect of chloramphenicol due to antibiotic = drug against
delayed excretion
Infections )
Increase in the risk of bleeding in patients treated with warfarin Warfarin and other vitamin K-
and other vitamin K antagonists. Antagonists
Patients who are taking a vitamin K antagonist and an anticoagulant at the same time.
Paracetamol should be given in sufficient quantity.)
Blood clotting and bleeding should be monitored.
Increased risk of a reduction in certain white zidovudine (medicine used in HIV-
Blood cells (neutropenia) - this combination should only infection).
be done on medical advice

Probenecid (uric acid-lowering
increased harmful effect of paracetamol by drugs) and salicylamide.
delayed excretion, with simultaneous ingestion of (anti-inflammatory
Probenecid the paracetamol dose should be reducedPainkillers).
Colestyramine (determined
Medicinal products for
reduced absorption of paracetamol
Cholesterol reduction)
Medicinal products that have the
Accelerate gastric emptying
Increase in the absorption of paracetamol, thereby
(z. B. Metoclopramide or
accelerated onset of action
Domperidone [against vomiting and
Nausea])
Medicinal products that have the
Reduce absorption of paracetamol, thereby slowing stomach emptying.
delayed onset of action.
Increased risk of metabolic acidification of flucloxacillin (antibiotic).
Blood and the body,
Caffeine:
. . . . . . .

Combination of caffeine with:	Possible reactions:
Tranquillisers	Reduction of the calming effect
Certain medicines for
Asthma (sympathomimetics) or
Enhancing the heartbeat accelerating effect
Thyroid hormones (thyroxine)
Theophylline (certain
Delay in the excretion of theophylline (the effect
Medicinal products for the treatment of
of theophylline lasts longer)
Breathing difficulties)
Chinolone (certain
Delaying the excretion of caffeine (the effect of
Antibiotics = drugs against
Caffeine lasts longer)
Infections)
Ingestible contraceptives
(oral contraceptives = "the pill"),
Cimetidine (medicine against
too much stomach acid), fluvoxamine
Delay of caffeine metabolism in the liver (the
(Medicinal product for depression)
Effect of caffeine lasts longer)
or disulfiram (medicines for
Support of the
Alcohol withdrawal)
Nicotine (smoking or
nicotine replacement therapy) or
Increase in caffeine breakdown in the liver (The effect
certain depressant medicines
of caffeine wears off more quickly)
(Barbiturates)

There is no evidence that the possible dependence potential of painkillers is increased when used together with caffeine.
Influencing laboratory tests
Acetylsalicylic acid in higher doses can influence the results of various laboratory tests. Paracetamol may interfere with certain laboratory tests to determine uric acid levels and blood sugar levels.
Please therefore inform the doctor about the intake of Thomapyrin before laboratory tests. Taking Thomapyrin with food, drink and alcoholDrinking alcohol at the same time increases the risk of side effects, especially in the gastrointestinal tract (e.g. bleeding), in the central nervous system and the risk of liver damage.
at normally harmless doses of paracetamol and should therefore be avoided! This is especially true for alcohol abuse.
Please note the possible content of caffeine in stimulants (e.g. coffee or tea) to avoid the risk of overdose. Smoking increases caffeine metabolism in the liver. Pregnancy, lactation and reproductive capacity.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
for advice.
Pregnancy
First and second trimester
Thomapyrin should only be taken during the first 6 months of pregnancy on the express instructions of a doctor. The dose must be kept as low as possible and the duration of treatment as short as possible.
Last trimester
Do not take Thomapyrin in the last trimester of pregnancy, as there is an increased risk of complications for mother and child (maldevelopment of the circulatory system and/or kidney dysfunction in the unborn child, increased risk of bleeding in mother and child during birth, delay in birth due to impaired contractions).
A prolonged intake of high doses of caffeine can lead to miscarriages and premature births in pregnant women.
Breastfeeding
The active substances pass into the mother's milk. A disturbance of blood clotting in the infant cannot be ruled out. Caffeine can affect the general condition and behaviour of the infant. Short-term use of Thomapyrin in the recommended dosage does not usually require interruption of breastfeeding. Thomapyrin must not be taken for a longer period of time or in higher doses during breast-feeding.
During breast-feeding, Thomapyrin should only be used under medical supervision.
Driving ability and ability to operate machinery.
No studies have been carried out on the effects on the ability to drive and operate machinery. Some of the possible side effects may impair attention or reaction (e.g. dizziness, spinning dizziness). If you notice these side effects, you must not drive a vehicle or operate dangerous machinery or tools until the symptoms subside.
Thomapyrin contains lactose.
Please only take Thomapyrin - Tablets after consulting your doctor if you are known to suffer from a sugar intolerance.
One Thomapyrin tablet contains 16 mg of lactose monohydrate (milk sugar), which corresponds to 96 mg of lactose monohydrate when 6 tablets are taken. Thomapyrin tablets are suitable for diabetics (1 tablet contains 0.094 g carbohydrates corresponding to 0.008 bread units [BE]).

How should the medicine be taken?

How to take Thomapyrin?

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.
The recommended dose is:
Adults and adolescents 15 years and over:
1 to 2 tablets up to 3 times daily, a daily dose of 6 tablets (corresponding to 1.5 g acetylsalicylic acid, 1.2 g paracetamol and 300 mg caffeine) should not be exceeded.Adolescents from 12 to 14 years and 30 kg bw:
½ to 1 tablet up to 3 times daily, a daily dose of 3 tablets (corresponding to 750 mg acetylsalicylic acid, 600 mg paracetamol and 150 mg caffeine) should not be exceeded.
The interval between the individual egg