THOMAPYRIN CLASSIC

THOMAPYRIN CLASSIC pain tablets

Important notes (mandatory information)

Thomapyrin Classic Pain Tablets. Areas of application: for acute mild to moderate pain.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Thomapyrin Classic 250 mg/200 mg/50 mg per tablet, pain tablets for adults and adolescents aged 12 and over
Active ingredients: acetylsalicylic acid (Ph. Eur.), paracetamol, caffeine

Read the entire package leaflet carefully as it contains important information for you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 3-4 days, you must see a doctor.
• If any of the side effects listed become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of this leaflet

1. WHAT ARE THOMAPYRIN CLASSIC PAIN TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING THOMAPYRIN CLASSIC PAIN TABLETS?
3. HOW TO TAKE THOMAPYRIN CLASSIC PAIN TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE THOMAPYRIN CLASSIC PAIN TABLETS?
6. FURTHER INFORMATION

1. WHAT ARE THOMAPYRIN CLASSIC PAIN TABLETS AND WHAT ARE THEY USED FOR?

Thomapyrin Classic Pain Tablets are an analgesic, antipyretic and anti-inflammatory drug (non-steroidal anti-inflammatory drug/analgesic). Thomapyrin Classic Pain Tablets are used for adults and adolescents aged 12 and over for: acute mild to moderate pain.

2. WHAT YOU NEED TO KNOW BEFORE TAKING THOMAPYRIN CLASSIC PAIN TABLETS?

Thomapyrin Classic Pain Tablets must not be taken:

• if you are allergic (hypersensitive) to salicylates, paracetamol or any of the other ingredients of Thomapyrin Classic Pain Tablets.
• if you have reacted to the use of salicylates or other non-steroidal anti-inflammatory drugs (certain medicines for pain, fever or inflammation) in the past with asthma attacks, nasal swelling (nasal polyps), swelling of the face, tongue, larynx (angioedema) or rash.
• with stomach and intestinal ulcers.
• with liver and kidney failure.
• with severe, non-drug-adjustable heart muscle weakness (heart failure).
• with abnormally increased bleeding tendency.
• if you are taking 15 mg or more of methotrexate per week at the same time.
• in the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility").
• by children and adolescents under 12 years of age.
• by children and adolescents with chickenpox or flu-like illnesses, as there is a risk of developing Reye's syndrome.
• In cases of rare congenital intolerance to one of the excipients, Thomapyrin Classic Pain Tablets should not be used. Excessive intake of caffeine (e.g. in coffee, tea, food and other medicines and drinks) should be avoided while taking Thomapyrin Classic Pain Tablets (see section "If you have taken more Thomapyrin Classic Pain Tablets than you should").

Special care is required when taking Thomapyrin Classic Pain Tablets:

• with concomitant therapy with anticoagulants (e.g. coumarin derivatives, heparin), thrombolytics or certain antidepressants (selective serotonin reuptake inhibitors, SSRIs).
• with bronchial asthma, hay fever or nasal swelling (nasal polyps).
• with a hypersensitivity (e.g. skin reactions) to other anti-inflammatories/antirheumatics (so-called analgesic intolerance/analgesic asthma).
• with chronic or recurrent stomach or intestinal problems.
• with a history of stomach or intestinal ulcers, gastrointestinal bleeding or perforation.
• with impaired kidney function or pre-damaged kidney.
• with impaired liver function (e.g. due to chronic alcohol abuse or liver inflammation).
• with glucose-6-phosphate dehydrogenase deficiency.
• with Gilbert's syndrome (Meulengracht's disease).
• before operations.
• with hyperthyroidism (hyperthyroidism).

If the recommended dose is exceeded, liver damage may result. To prevent the risk of overdose, it should be ensured that other medicines used at the same time do not contain paracetamol. Long-term, non-prescription use of high doses of painkillers can increase the risk of kidney disease progression in patients with pre-existing kidney damage. Prolonged high-dose, non-prescription use of painkillers can cause headaches that should not be treated with increased doses of the drug. In such cases, no further painkillers should be taken without medical advice. If you stop taking the painkiller abruptly after prolonged high-dose, non-prescription use, you may experience headaches, fatigue, vegetative symptoms, muscle pain and nervousness. These withdrawal symptoms subside within a few days. Until then, the painkiller should not be taken again and should not be taken again without medical advice. At the first signs of a hypersensitivity reaction after taking Thomapyrin Classic Pain Tablets, therapy must be discontinued. Acetylsalicylic acid reduces uric acid excretion in low doses. In predisposed patients, this can occasionally trigger a gout attack. Thomapyrin Classic Pain Tablets can mask the signs of an infection. Therefore, if signs of an infection (e.g. redness, swelling, overheating, pain, fever) appear or worsen during use, a doctor should be consulted immediately. Patients, especially the elderly, should report any unusual abdominal symptoms, especially at the beginning of therapy, as bleeding, ulceration and perforation in the gastrointestinal tract have been reported in connection with the use of non-steroidal anti-rheumatic drugs, which can be life-threatening. If bleeding or ulcers occur in the gastrointestinal tract, Thomapyrin Classic Pain Tablets must be discontinued.

Children

Thomapyrin Classic Pain Tablets should only be used on medical advice and only if other measures do not work in children and adolescents with febrile illnesses, e.g. chickenpox, because of the acetylsalicylic acid content. If persistent vomiting, headaches or impaired consciousness occur during these illnesses, this may be a sign of Reye's syndrome, a very rare but potentially life-threatening disease that requires immediate medical attention.

Taking Thomapyrin Classic Pain Tablets with other medicines

Acetylsalicylic acid

The acetylsalicylic acid content can increase the effects and side effects of the following active ingredients:

• anticoagulants (e.g. coumarin derivatives and heparin), thrombolytics, certain antidepressants (SSRIs): increased risk of bleeding.
• platelet aggregation inhibitors (medicines that inhibit the aggregation and clumping of platelets), e.g. ticlopidine.
• certain painkillers (so-called non-steroidal anti-rheumatic drugs, NSAIDs), corticosteroids or concomitant alcohol consumption: increased risk of gastrointestinal problems (e.g. gastrointestinal bleeding).
• blood sugar lowering medicines.
• valproic acid, methotrexate, digoxin, lithium.

The acetylsalicylic acid content can reduce the effects of the following active ingredients:

• medicines for increased urine output (diuretics).
• medicines for increased uric acid excretion (certain gout medicines).
• medicines for lowering blood pressure (antihypertensives).

Paracetamol

Concomitant use of medicines that accelerate the breakdown of paracetamol in the liver, such as barbiturate-containing sleeping pills, antiepileptics and rifampicin, can cause liver damage even with otherwise harmless doses of paracetamol. The same applies to other medicines that may damage the liver and to alcohol abuse. With concomitant use of agents that slow gastric emptying, the absorption and onset of action of paracetamol may be delayed. With concomitant use of agents that accelerate gastric emptying, such as metoclopramide, the absorption and onset of action of paracetamol may be accelerated. With concomitant use of paracetamol and zidovudine, the tendency to reduce white blood cells (neutropenia) is increased. This medicine should therefore only be used concomitantly with zidovudine on medical advice.

Other known effects:

• Probenecid: reduced excretion of paracetamol, increased risk of side effects.
• Cholestyramine: reduced absorption of paracetamol.

If anticoagulants and paracetamol are taken together for a long period of time, medical supervision should be carried out. Taking paracetamol can affect the determination of uric acid and sugar levels in the blood.

Caffeine

Caffeine reduces the sedative effects of numerous substances, such as barbiturates, antihistamines, etc. Caffeine increases the heart-accelerating effects of e.g. sympathomimetics, thyroxine etc. Oral contraceptives (so-called "pill"), cimetidine, fluvoxamine and disulfiram reduce the breakdown of caffeine in the liver, barbiturates and smoking accelerate it. The excretion of theophylline is reduced by caffeine. Caffeine increases the dependence potential of substances of the ephedrine type. Concomitant administration of quinolone carboxylic acid type gyrase inhibitors may delay the excretion of caffeine and its degradation product paraxanthine.

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Taking Thomapyrin Classic Pain Tablets with food and drink

You should avoid drinking alcohol while taking Thomapyrin Classic Pain Tablets.

Pregnancy, breastfeeding and

Fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Thomapyrin Classic Pain Tablets should not be taken during pregnancy as the pregnancy and/or the development of the unborn child may be affected. You should therefore only take Thomapyrin Classic Pain Tablets during the first and second trimesters of pregnancy after consulting your doctor or dentist and only at the lowest effective dose and for the shortest possible time, as there is evidence of an increased risk of miscarriage and malformations. The same applies to women who are trying to conceive. Thomapyrin Classic Pain Tablets must not be used in the last three months of pregnancy or during childbirth, as there is an increased risk of complications for mother and child. Note: If pregnancy is discovered while taking the preparation, the doctor must be informed.

Breastfeeding

The active ingredients pass into breast milk. The infant's condition and behaviour may be affected by caffeine taken in with breast milk. With short-term use of the recommended dose, it is usually not necessary to interrupt breastfeeding. In case of prolonged use or intake of higher doses, breastfeeding should be discontinued.

Fertility

Acetylsalicylic acid belongs to a group of medicines (non-steroidal anti-rheumatic drugs) that can impair female fertility. This effect is reversible after discontinuation of the drug.

Driving and operating machinery

There are no known effects on the ability to drive or operate machinery as a result of taking Thomapyrin Classic Pain Tablets. If you experience side effects such as drowsiness, blurred vision, dizziness or balance problems, you should not drive or operate machinery.

Important information about certain other ingredients of Thomapyrin Classic Pain Tablets

This medicine contains lactose. Therefore, please only take Thomapyrin Classic Pain Tablets after consulting your doctor if you know that you are intolerant to certain sugars.

3. HOW TO TAKE THOMAPYRIN CLASSIC PAIN TABLETS?

Always take Thomapyrin Classic Pain Tablets exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

Age Single dose Maximum dose per day (24 hours)
Adults and adolescents aged 12 and over 1 - 2 tablets (equivalent to 250 - 500 mg acetylsalicylic acid, 200 - 400 mg paracetamol and 50 - 100 mg caffeine) 6 tablets (equivalent to 1,500 mg acetylsalicylic acid, 1,200 mg paracetamol and 300 mg caffeine)

The maximum dose per day (24 hours) should not be exceeded and the time interval until the next tablet is taken should be 4 - 8 hours. Thomapyrin Classic Pain Tablets should not be used for more than 4 days or in higher doses without medical or dental advice. Take the tablets either dissolved in a little liquid or unchewed with plenty of liquid. Taking after meals can delay the onset of action. Please talk to your doctor or pharmacist if you have the impression that the effect of Thomapyrin Classic Pain Tablets is too strong or too weak.

If you have taken more Thomapyrin Classic Pain Tablets than you should

In case of overdose, nausea, vomiting, loss of appetite, pallor and abdominal pain may initially occur (1st day), but also dizziness and ringing in the ears. Despite an improvement in general well-being on the 2nd day, progressive liver damage can occur up to liver coma on the 3rd day. Overdosage or long-term, chronic use can lead to severe liver damage, CNS disorders such as headache, dizziness, vomiting, tinnitus, visual or auditory disturbances, as well as iron deficiency anaemia, acid-base balance disorders and kidney damage. Early symptoms of acute caffeine poisoning are usually tremors and restlessness. Symptoms of caffeine poisoning (nausea, vomiting, decreased potassium blood levels, increased blood sugar levels, central nervous system symptoms, cardiovascular reactions up to myocardial damage) may also occur if large amounts are ingested in a short period of time. Other possible symptoms of acute poisoning may include hypoglycaemia (hypoglycaemia), skin rash, gastrointestinal bleeding, hyperventilation and confusion. In severe poisoning, delirium, tremors, convulsions, respiratory distress, sweating, fluid loss, increased body temperature and coma may occur. An increased risk of poisoning, up to and including death, exists for elderly patients, children, patients with liver disease, chronic alcohol consumption or chronic malnutrition, and patients who are taking medicines that can lead to liver damage at the same time. If you suspect an overdose, contact a doctor immediately - even if the symptoms subside temporarily - and stop taking any further medication.

If you forget to take Thomapyrin Classic Pain Tablets

Do not take a double dose to make up for a forgotten dose.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Thomapyrin Classic Pain Tablets can have side effects, although not everybody gets them. The following list of undesirable effects includes all known side effects under treatment with acetylsalicylic acid and paracetamol, including those under high-dose long-term therapy.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Blood and lymphatic system disorders:

• Very rare: blood count changes (e.g. reduction in the number of blood cells)
• Rare to very rare: severe bleeding, e.g. cerebral haemorrhage, which can be life-threatening in individual cases, especially in patients with untreated high blood pressure and/or concomitant treatment with anticoagulant medication (see Chap. 2)
• Not known: bleeding such as nosebleeds, gum bleeding or skin bleeding with a possible prolongation of bleeding time. This effect can persist for 4-8 days after ingestion.

Immune system disorders:

• Rare: hypersensitivity reactions (including anaphylactic shock, swelling of the face, tongue and larynx (angioedema), narrowing of the bronchi, drop in blood pressure, shortness of breath)
• Uncommon: hypersensitivity reactions such as skin reactions (e.g. skin redness, hives)

Respiratory disorders:

• Very rare: bronchial spasm in patients allergic to NSAIDs

Endocrine disorders:

• Very rare: decreased blood sugar levels

Nervous