ThomaDuo 400 mg/100 mg film-coated tablets

ThomaDuo contains two active ingredients: Ibuprofen and caffeine.

Application

ThomaDuo contains two active ingredients: Ibuprofen and caffeine. Ibuprofen belongs to a group of medicines called non-steroidal 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 sudden, moderately severe pain. ThomaDuo is only suitable for adults. When

How is it applied?

What is ThomaDuo and what is it used for?

ThomaDuo contains two active ingredients: Ibuprofen and caffeine.
Ibuprofen belongs to a group of medicines called non-steroidal 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 sudden onset moderate pain.

ThomaDuo is only suitable for adults.

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

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What should you pay attention to before taking it?

Physician.2. What should you be aware of before taking ThomaDuo?

ThomaDuo must not be taken,

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• If you are allergic to ibuprofen, caffeine or any of the other ingredients of this medicine listed in section 6,
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• If you have suffered from shortness of breath, asthma, a runny nose, swelling or hives in the past after taking/using
  acetylsalicylic acid or other similar painkillers (NSAIDs),
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• If you have a stomach ulcer or stomach bleeding (or this has happened to you two or more times before),
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• If you have previously had a gastrointestinal bleed or rupture associated with previous therapy with NSAIDs,
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• If you have severe liver, kidney or heart failure,
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• If you experience bleeding in the brain or other bleeding,
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• If you suffer from a blood formation disorder of unknown cause,
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• If you suffer from severe dehydration of the body caused by vomiting, diarrhoea or insufficient fluid intake,
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• If you are in the last trimester of pregnancy.

ThomaDuo must not be taken by children and young people under 18 years of age.

Warnings and precautions.

Please talk to your doctor or pharmacist before you use ThomaDuo take,

• If you suffer from asthma or an allergic disease or have been affected by it in the past, as it can cause shortness of breath,
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• For hay fever, nasal polyps or chronic obstructive
  respiratory diseases, as there is an increased risk of allergic reactions. The allergic reactions can manifest as asthma attacks (so-called analgesic asthma), allergic, painful swelling of the skin and mucous membranes, especially in the facial area (Quincke's oedema) or hives (urticaria).
• in the presence of liver disease,
• with impaired kidney function,
• If you are taking/using medicines that may interact with ThomaDuo , such as corticosteroids, medicines used to thin the blood (such as warfarin), selective serotonin reuptake inhibitors (medicines used to
  treat depression
  or medicines that affect blood clotting
  (such as acetylsalicylic acid) (see section "Taking ThomaDuo ").br>treatment of depression) or medicines that impair blood clotting
  (such as acetylsalicylic acid) (see section "Taking ThomaDuo with other medicines"),
• with an existing or previous inflammatory bowel disease (ulcerative colitis or Crohn's disease),
• for heart problems including heart failure, irregular heartbeat, chest pain (angina) or if you have had a heart attack,
  performed bypass surgery, peripheral arterial disease
  (poor circulation in legs or feet due to narrowed or
  obstructed arteries) or any form of stroke (including "mini-stroke" or transient ischaemic attack [TIA]),
• if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke,
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• If you have ever had high blood pressure and/or heart failure,
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• directly after major surgical interventions,
• for blood coagulation disorders,
• in a hereditary haematopoietic disorder (acute intermittent porphyria),
• for certain skin diseases (systemic lupus erythematosus [SLE] or mixed collagenosis),
• In the presence of severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Stop taking
  ThomaDuo immediately at the first appearance of a skin rash, mucous membrane damage or other signs of an allergic reaction.
• If you have chickenpox (varicella), it is recommended to avoid taking ThomaDuo .
• in cases of overactivity of the thyroid gland (hyperthyroidism), which can lead to increased appetite, weight loss or sweating (the risk of caffeine-related side effects could be increased),
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• If you take/use medicines containing ibuprofen for a long time
  (regular monitoring of your liver values, kidney function and blood count may be required).

Contact your doctor immediately if you notice any of the following:

• bright red stools, black stools (tarry stools), vomiting of blood or particles that look like coffee grounds,
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• severe pain in the upper abdomen

During the intake of ThomaDuo avoid excessive intake of products containing caffeine (e.g. coffee, tea, food, other medicines and drinks).

Side effects can be minimised by taking the lowest effective dose for the shortest possible period of time. There is an increased risk of side effects in older people.

The concomitant use/administration of non-steroidal anti-inflammatory drugs (NSAIDs), including cyclo-oxygenase-2-specific inhibitors, increases the risk of adverse reactions (see section "Taking ThomaDuo with other medicinal products") and should be avoided.

Anti-inflammatory/painkilling medicines such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration (3 days).
Taking/using any type of painkiller for a headache for a long period of time can make it worse. If this situation exists or is suspected, seek medical advice and discontinue treatment.
Taking ThomaDuo together with other medicinal products.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

ThomaDuo may affect or be affected by the effects of certain other medicines. For example:
- Anticoagulant medicines (i.e. blood thinners/anticoagulants such as Aspirin®, acetylsalicylic acid [ASA], warfarin, ticlopidine).
- Medicines 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 have an effect on treatment with ThomaDuo or be influenced by it. You must therefore always consult your doctor or
Consult your pharmacist for advice before you Take ThomaDuo with other medicines.

In particular, tell your doctor or pharmacist if you are taking/using the following other medicines:
Acetylsalicylic acid or other NSAIDs
The risk of ulcers in the stomach-(anti-inflammatory and
intestinal tract or bleeding may increase pain-relieving medicines).
become. . . tract. . . . .

Digoxin (for the treatment of heart failure)	The effect of digoxin may be increased
become.
Glucocorticoids (medicines containing cortisone
The risk of ulcers in the
or contain cortisone-like substances)
Gastrointestinal tract or
Blood flow may be increased.
Anticoagulant medicines	The risk of bleeding in the gastrointestinal
Tract can be increased.
Acetylsalicylic acid (in low dosage)	The blood-thinning effect may be reduced
become.
Medicines for thinning the blood (such as
Ibuprofen can reduce the effects of these
Warfarin)
Reinforce medicines.
Phenytoin (for the treatment of epilepsy)	The effect of phenytoin can
be strengthened.
selective serotonin reuptake inhibitors
These can increase the risk of bleeding in the
(Medicinal products for the treatment of
Increase gastrointestinal tract.
Depression)
Lithium (a medicine used to treat
The effect of lithium may be increased
manic-depressive disorders and
become.
Depression)
Probenecid and sulfinpyrazone (medicinal products
The excretion of ibuprofen can
for the treatment of gout)
delayed.
Medicines for high blood pressure and
Ibuprofen	can
Water tablets

Reduce medicines there may be an increased risk to the kidneys.
Potassium-sparing diuretics Hyperkalaemia (high potassium levels in the blood) may occur.
Methotrexate (a medicinal product for the
The effect of methotrexate may be treatment of cancer or rheumatism).
be strengthened.
Tacrolimus and ciclosporin (medicinal products which
Kidney damage may occur.
suppress the immune system)
Zidovudine (a medicine for the treatment of
The intake of ThomaDuo can be used at
of HIV/AIDS)
HIV-positive haemophiliacs increase the risk of bleeding in joints or swelling due to haemorrhage.

Sulfonylureas (medicinal products for the
Changes in blood glucose levels Treatment of diabetes)
are possible.

Chinolone antibiotics	The risk of seizures can
should be increased. The effect of
Caffeine can also be increased
become.
CYP2C9 inhibitors:	The simultaneous use of
Ibuprofen with CYP2C9 inhibitors
can reduce exposure to
Ibuprofen (CYP2C9 substrate)
increase. A reduction in
Ibuprofen dose should be considered
shall be drawn, especially if
High-dose ibuprofen with
Voriconazole or Fluconazole
is administered.
Mifepristone:	Ibuprofen can reduce the effect of
Attenuate mifepristone.

Barbiturates, antihistamines and others
Caffeine can reduce the sedative effect of medicines with a sedative effect.
reduce.
(calming or anxiety-relieving effect)
Barbiturates and smoking These can reduce the effects of caffeine.
Sympathomimetics, thyroxine and others
Since the simultaneous
Medicinal products with a heartbeat
Intake/application that has the accelerating effect (medicines, with
Heartbeat accelerating effect
which include, for example, low blood pressure and
this medicine may increase.thyroid disorders are treated).
Oral contraceptives, cimetidine,
These can counteract the caffeine effects of fluvoxamine and disulfiram (medicines for the
amplify.
Conception, inhibition of the
Gastric acid production, for the treatment of
Depression and chronic alcohol addiction)
Theophylline (a medicinal product for the
The effect of theophylline may be increased treatment of
become.
Respiratory diseases)
Analgesics (painkillers) The likelihood of becoming dependent on painkillers taken/used at the same time is not increased.

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

Taking ThomaDuo Taken with food, drink and alcohol.

Patients with a sensitive stomach are recommended, ThomaDuo to be taken with meals. Will ThomaDuo taken shortly after a meal, the effect may be delayed. If this is the case, no more ThomaDuo must not be taken as described in the section "How to use ThomaDuo". ThomaDuo to take?" (see below), or until the appropriate time interval between two doses has elapsed. The occurrence of some side effects, such as those affecting the gastrointestinal tract and the central nervous system, is more likely when alcohol is taken together with ThomaDuo is taken.
Pregnancy, lactation and reproductive capacity.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Inform your doctor if, while taking ThomaDuo get pregnant. Do not take this medicine during the last 3 months of pregnancy. Avoid taking this medicine for the first few days.
6 months of pregnancy, unless otherwise prescribed by your doctor.

The active substances ibuprofen and caffeine and their breakdown products pass into breast milk. Irritability and poor sleep behaviour have been reported in breastfed infants. ThomaDuo must only be taken by breast-feeding mothers if absolutely necessary.

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

Driving ability and ability to operate machinery.
When taken for a short time and in normal doses, this medicine has no or negligible effect on the ability to drive and use machinery. People who nevertheless experience side effects such as dizziness, tiredness or visual disturbances should not participate in traffic or operate machinery. This is especially true in combination with alcohol.

How should the medicine be taken?

How to take ThomaDuo?

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:
Initial 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 dose of three film-coated tablets (1,200 mg ibuprofen and 300 mg caffeine) within
24 hours. 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 expected.

To take.
Swallow the film-coated tablets whole with a glass of water.

Treatment duration must not exceed 3 days.
ThomaDuo is not recommended for mild pain or treatment duration of more than 3 days. Consult your doctor or pharmacist if the pain persists.

If you have taken more ThomaDuo than you should
If you have taken more ThomaDuo than you should, or if children have taken the medicine by
accident, always contact a doctor or hospital near you for an assessment of the risk and possible side effects.br>by mistake, always contact a doctor or hospital near you for an assessment of the risk and advice on further treatment.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, ringing in the ears, confusion and eye tremor. At high
doses, drowsiness, chest pain, palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, freezing and
breathing problems have been reported. Other symptoms of an overdose may include: Blue colouration of skin and mucous membranes (cyanosis), kidney and liver dysfunction, low blood pressure, decreased breathing (respiratory depression), restlessness, tremors and gastrointestinal bleeding.

Severe intoxication may cause impaired consciousness, seizures and irregular heartbeat.

If you forget to take ThomaDuo forget
Do not take double the amount if you have forgotten to take it before.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store ThomaDuo?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP" and on the blister pack after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required for this medicinal product.

Do not dispose of the medicinal product in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month indicated. No special storage conditions are required for this medicinal product. Do not dispose of the medicine in sewage or household waste. Ask your pharmacist how to dispose of the medicine

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Special notes on the content

Contents of the pack and other information
What ThomaDuo contains
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, highly dispersed silicon dioxide, magnesium stearate

tablet coating
hypromellose, hyprolose, macrogol 6000, talc, titanium dioxide (E 171)

What ThomaDuo looks like and contents of the pack
ThomaDuo is a white, oval film-coated tablet measuring 17.8 mm x 8.6 mm.Packs of 6, 12, 15, 18, 20 and 24 film-coated tablets

Not all pack sizes may be marketed.

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