Thomapyrin ThomaDuo 400 mg 24 tablets

ThomaDuo contains two active ingredients: ibuprofen and caffeine.

Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs help by changing the way the body responds to pain and fever. Caffeine belongs to a group of medicines called stimulants.

ThomaDuo is used for the short-term treatment of moderately severe pain that occurs suddenly.

ThomaDuo is only suitable for adults.

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

Contraindications

ThomaDuo must not be taken

• if you are allergic to ibuprofen, caffeine or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had shortness of breath, asthma, runny nose, swelling or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs),
• if you have (or have had two or more times) a stomach ulcer or bleeding
• if you have previously had gastrointestinal bleeding or perforation related to previous NSAID therapy,
• if you suffer from severe liver, kidney or heart failure,
• if you have bleeding in the brain or other bleeding,
• if you suffer from blood disorders of unknown cause,
• if you suffer from severe dehydration of the body caused by vomiting, diarrhea or not drinking enough fluids,
• if you are in the last trimester of pregnancy.

ThomaDuo must not be taken by children and adolescents under the age of 18.

interactions

Taking ThomaDuo together with other medicines Tell
your doctor or pharmacist if you are taking/using other medicines, have recently taken/used other medicines or intend to take/use other medicines.

ThomaDuo can affect or be affected by certain other medicines. For example:

• anticoagulant medicines (ie blood thinners/anticoagulants such as Aspirin®, acetylsalicylic acid [ASA], warfarin, ticlopidine)
• Medicines used to lower blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Some other medicines can also affect or be affected by treatment with ThomaDuo. You must therefore always first ask your doctor or pharmacist for advice before taking ThomaDuo together with other medicines.

In particular, tell your doctor or pharmacist if you are taking/using the following other medicines:

• acetylsalicylic acid or other NSAIDs (anti-inflammatory and pain-relieving medicines)
  • The risk of gastrointestinal ulcers or bleeding may be increased.
• digoxin (used to treat heart failure)
  • The effect of digoxin can be increased.
• glucocorticoids (medicines containing cortisone or cortisone-like substances)
  • The risk of gastrointestinal ulcers or bleeding may be increased.
• anticoagulant drugs
  • The risk of bleeding in the gastrointestinal tract may be increased.
• Acetylsalicylic acid (low dose)
  • The blood-thinning effect can be reduced.
• medicines to thin the blood (such as warfarin)
  • Ibuprofen can increase the effects of these medicines.
• phenytoin (used to treat epilepsy)
  • The effects of phenytoin can be increased.
• selective serotonin reuptake inhibitors (medicines used to treat depression)
  • These can increase the risk of bleeding in the gastrointestinal tract.
• lithium (a medicine used to treat manic-depressive illness and depression)
  • The effect of lithium can be increased.
• probenecid and sulfinpyrazone (medicines used to treat gout)
  • Elimination of ibuprofen can be delayed.
• Medicines for high blood pressure and water tablets
  • Ibuprofen can reduce the effects of these medicines and there may be an increased risk for the kidneys.
• Potassium-sparing diuretics
  • Hyperkalemia (high levels of potassium in the blood) may occur.
• methotrexate (a medicine used to treat cancer or rheumatism)
  • The effect of methotrexate can be increased.
• tacrolimus and ciclosporin (medicines that suppress the immune system)
  • Kidney damage can occur.
• zidovudine (a medicine used to treat HIV/AIDS)
  • Taking ThomaDuo can increase the risk of bleeding in joints or swelling due to bleeding in HIV-positive hemophiliacs.
• sulfonylureas (medicines used to treat diabetes)
  • Changes in blood sugar levels are possible.
• quinolone antibiotics
  • The risk of seizures may be increased. The effects of caffeine can also be increased.
• CYP2C9 Inhibitors:
  • Concomitant use of ibuprofen with CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). Reduction of the ibuprofen dose should be considered, particularly when high-dose ibuprofen is co-administered with voriconazole or fluconazole.
• Mifepristone:
  • Ibuprofen can reduce the effects of mifepristone.
• Barbiturates, antihistamines and other drugs with sedative effects (calming or anti-anxiety effects)
  • Caffeine can reduce the sedative effect.
• barbiturates and smoking
  • These can reduce the effects of caffeine.
• Sympathomimetics, thyroxine and other medicines that increase the heart rate (medicines used to treat e.g. low blood pressure and thyroid disorders)
  • Since concomitant use may increase the heart rate-accelerating effect of these medicines.
• Oral contraceptives, cimetidine, fluvoxamine and disulfiram (medicines used to prevent pregnancy, stop stomach acid production, treat depression and chronic alcoholism)
  • These can increase the effects of caffeine.
• theophylline (a medicine used to treat respiratory diseases)
  • The effect of theophylline can be increased.
• Analgesics (painkillers)
  • The likelihood of becoming dependent on painkillers taken/used at the same time is not increased.

A higher effect produced by an interaction can cause side effects.

Taking ThomaDuo with food, drink and alcohol
Patients with a sensitive stomach are advised to take ThomaDuo with meals. If ThomaDuo is taken shortly after a meal, the effect can be delayed. If this is the case, you should not take more ThomaDuo than recommended in the section "How to take ThomaDuo?" (see below) or until the appropriate time interval between two doses has passed. Some side effects, such as those affecting the gastrointestinal tract and the central nervous system, are more likely to occur when alcohol is taken with ThomaDuo.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Tell your doctor if you become pregnant while taking ThomaDuo. Do not take this medicine during the last 3 months of pregnancy. Avoid taking this medicine during the first 6 months of pregnancy unless otherwise directed by your doctor.

The active ingredients ibuprofen and caffeine and their breakdown products pass into breast milk. Irritability and poor sleep patterns have been reported in breastfed infants. ThomaDuo may only be taken by breastfeeding mothers if this is absolutely necessary.

This medicine belongs to a group of medicines (NSAIDs) that can impair fertility in women. This effect reverses when the drug is stopped.

application

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:

For adults:
Starting dose: Take one film-coated tablet (400 mg ibuprofen and 100 mg caffeine). If necessary, take another dose (one film-coated tablet), but do not exceed a total of three film-coated tablets (1,200 mg ibuprofen and 300 mg caffeine) in a 24-hour period. The time interval between two intakes must be at least 6 hours.

Contact your doctor or pharmacist if you feel that the effect of this medicine is stronger or weaker than you think.

To take.

Swallow the film-coated tablets whole with a glass of water.
The duration of treatment must not exceed 3 days.
ThomaDuo is not recommended for mild pain or treatment lasting more than 3 days. Consult your doctor or pharmacist if the pain persists.

side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may experience some of the known side effects of NSAIDs (see below). If this applies to you or you have concerns, stop taking this medicine and contact your doctor as soon as possible. Elderly people taking this medicine are at an increased risk of developing problems related to the side effects.

STOP TAKING ThomaDuo immediately and contact a doctor if you notice any of the following, which could be signs of serious unwanted side effects:

• severe stomach problems, heartburn or abdominal pain,
• vomiting blood or particles that look like coffee grounds
• black tarry stools or blood in the urine,
• skin reactions such as itchy rash,
• Difficulty breathing and/or swelling of the face or neck
• fatigue associated with loss of appetite,
• sore throat associated with mouth ulcers, weakness and fever,
• nosebleeds and skin bleeding,
• unusual tiredness associated with decreased urination,
• swelling of the face, feet or legs,
• chest pain

Common (may affect up to 1 in 10 people)

• heartburn, abdominal pain, nausea and indigestion, vomiting, wind (flatulence), diarrhoea, constipation and slight blood loss in the stomach and/or intestines, which in exceptional cases can lead to anemia,
• Dizziness, insomnia, headache

Uncommon (may affect up to 1 in 100 people)

• Ulcers in the stomach or intestines, sometimes with bleeding and perforation, inflammation of the lining of the mouth causing ulcers (ulcerative stomatitis), inflammation of the stomach (gastritis), black tarry stools, vomiting with particles that look like coffee grounds, worsening of inflammation of the large intestine (ulcerative colitis). ) and Crohn's disease,
• restlessness, noticeable heartbeat, irritability or tiredness,
• visual disturbances, psychotic reactions,
• allergic reactions such as skin rashes, itching and asthma attacks. You must stop taking ThomaDuo and consult a doctor immediately.

Rare (may affect up to 1 in 1,000 people)

• ringing in the ears (tinnitus),
• Kidney damage (papillary necrosis) and increased uric acid concentrations in the blood.

Very rare (may affect up to 1 in 10,000 people)

• Swelling (oedema), high blood pressure (hypertension) and heart failure have been reported in association with NSAID treatment.
• Inflammation of the esophagus or pancreas, formation of membrane-like narrowings in the small and large intestine (diaphragm-like strictures in the intestine),
• Passing less urine than usual and swelling (especially in patients with high blood pressure or reduced kidney function), swelling (oedema) and cloudy urine (nephrotic syndrome), inflammatory disease of the kidneys (interstitial nephritis) with possible sudden kidney failure. If you experience any of the above symptoms or if you feel very bad in general, stop taking ThomaDuo and contact your doctor immediately, as these may be the first signs of kidney damage or kidney failure.
• problems with blood cell production; The first signs are: fever, sore throat, superficial wounds in the mouth, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In these cases, you must stop the therapy immediately and consult a doctor. You must not start taking painkillers or medicines to reduce fever (antipyretics) yourself without first consulting a doctor.
• Depressions,
• Worsening of infection-related inflammation (e.g. necrotizing fasciitis) with the concomitant use of certain analgesic drugs (NSAIDs) has been reported. If signs of an infection appear or worsen while taking ThomaDuo, you must consult a doctor immediately. It must be investigated whether anti-infective/antibiotic therapy is required.
• high blood pressure, heart failure, heart attack, vasculitis,
• Liver dysfunction (first signs may be discoloration of the skin), liver damage, especially with long-term treatment, liver failure, sudden inflammation of the liver (acute hepatitis),
• Symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or depressed level of consciousness have been observed with ibuprofen. Patients with autoimmune diseases (SLE, mixed collagenosis) seem to be more susceptible. If you experience these symptoms, contact a doctor immediately.
• severe skin reactions such as rash with reddening and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia), severe skin infections and soft tissue complications during chickenpox infection (varicella infection),
• severe general hypersensitivity reactions (signs may be a serious allergic reaction with swelling of the face or throat, difficulty breathing, rapid heartbeat, drop in blood pressure, anaphylactic shock [severe allergic reaction that causes difficulty in breathing or dizziness]).

Not known (cannot be estimated from the available data)

• At the start of treatment a red, scaly, widespread rash with bumps under the skin and blisters accompanied by fever, primarily on the skin folds, trunk and upper extremities (acute generalized pustular rash). Stop using ThomaDuo if you develop these symptoms and seek medical attention immediately. See also Section 2.
• Tremble,
• accelerated heartbeat,
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include a rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell).
• increased sun sensitivity of the skin

Medicines such as ThomaDuo can slightly increase the risk of a heart attack (“myocardial infarction”) or stroke.

In a clinical study of (pain after) tooth extraction, some patients (2.8%) experienced inflammation of the tooth cavity (resulting tooth gap) of the extracted tooth and some patients (1.4%) experienced gingivitis.

composition

The active ingredients are: ibuprofen and caffeine.
Each film-coated tablet contains 400 mg ibuprofen and 100 mg caffeine.

The other ingredients are:
Tablet core:
microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate

Tablet coating:
hypromellose, hyprolose, macrogol 6000, talc, titanium dioxide (E171)