ratioDolor Ibuprofen 400 mg Film-coated tablets

ratioDolor Ibuprofen 400 mg is an analgesic and antipyretic medicine (non-steroidal anti-inflammatory drug, also called non-steroidal anti-inflammatory drug [NSAID]).

Application

What is ratioDolor akut 400 mg and what is it used for?

ratioDolor akut 400 mg is an analgesic and antipyretic medicine (non-steroidal anti-inflammatory drug, also called non-steroidal anti-inflammatory drug [NSAID]).

ratioDolor akut 400 mg is used for the short-term symptomatic treatment of:
- mild to moderately severe pain such as headache, toothache, period pain and fever and pain associated with a cold
- acute migraine headache with or without aurane headaches with or without aura

ratioDolor akut 400 mg is used in children weighing 20 kg or more (6 years and older), adolescents and adults.

How is it applied?

What is ratioDolor Ibuprofen 400 mg and what is it used for?

ratioDolor Ibuprofen 400 mg is an analgesic and antipyretic medicine (non-steroidal anti-inflammatory drug, also called non-steroidal anti-inflammatory drug [NSAID]).

ratioDolor Ibuprofen 400 mg is used for the short-term symptomatic treatment of:
- mild to moderately severe pain such as headache, toothache, period pain and fever and pain associated with a cold
- acute migraine headache with or without aurane headache with or without aura

ratioDolor Ibuprofen 400 mg is used in children weighing 20 kg or more (6 years and older), adolescents and adults.

What should you pay attention to before taking it?

What precautions should you take before using ratioDolor Ibuprofen 400 mg?

ratioDolor Ibuprofen 400 mg must not be taken
- if you are allergic to ibuprofen or any of the other ingredients listed in section 6. If you have a history of breathlessness, asthma, rhinitis, swelling (angioedema) or hives after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, do not take this medicine.If you have had a reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past
- if you have unexplained blood formation disorders
- if you have ulcers (peptides) in your stomach or intestines
- .nnd intestine (peptic ulcers) or bleeding or have had ulcers or bleeding in the past (at least two distinct episodes of proven ulceration or bleeding)
- .if you have a history of bleeding or perforation in the gastrointestinal tract related to previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
- if you have bleeding in the brain (cerebrovascular haemorrhage) or other active bleeding
- if you have severe liver or kidney dysfunction
.- during the last 3 months of pregnancy
- if you have severe heart muscle weakness (heart failure)
- if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
- in children under 20 kg body weight or under 6 years of age, as this dose level is not recommended due to the higher amount of active substance.
Warnings and precautions
Please talk to your doctor or pharmacist before taking ratioDolor Ibuprofen 400 mg Film-Coated Tablets.
- if you have congenital haematopoietic disorders (e.g. acute intermittent porphyria)
- if you have certain autoimmune diseases (systemic lupus erythematosus and mixed collagenoses)
- if you have certain autoimmune diseases (systemic lupus erythematosus and mixed collagenoses).br>- if you have gastrointestinal complaints or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease)
- if you have impaired kidney or liver function
- if you suffer from dehydration
- if you ever suffer or have suffered from high blood pressure and/or heart muscle weakness (heart failure)
- if you have allergies (e.g. B. skin reactions to other agents, asthma, hay fever), chronic swelling of the mucous membranes or chronic respiratory diseases that narrow the airways, as you are then at increased risk of developing a hypersensitivity reaction
.- in blood clotting disorders
- immediately after major surgery

The side effects are lowest when the smallest effective amount is taken for the shortest possible time. If you use ratioDolor Ibuprofen 400 mg for a long time, your liver values, kidney function and blood count must be checked regularly.

Gastrointestinal safety
The concomitant use of ratioDolor Ibuprofen 400 mg with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called cyclooxygenase-2 inhibitors, should be avoided.

Elderly patients:
Elderly patients are more likely to experience side effects following the use of NSAIDs, particularly bleeding and perforation in the gastrointestinal tract, which can be fatal.

Gastrointestinal bleeding, ulcers and perforations:
Gastrointestinal bleeding, ulcers or perforations, which can be fatal, have been reported during treatment with all NSAIDs. They occurred with and without prior warning signs or serious gastrointestinal events in the medical history at any time during treatment.

The risk of bleeding, ulceration or perforation in the gastrointestinal tract is higher with increasing doses of NSAIDs if you have had an ulcer before, especially if bleeding or perforation occurred as a complication, and in elderly patients. You should start
treatment with the lowest dose available. Please talk to your doctor as a combination treatment with protective medicines (e.g. misoprostol or proton pump inhibitors) could be considered. This also applies if you are simultaneously taking low-dose acetylsalicylic acid or other agents that are likely to increase the risk of gastrointestinal disorders.

If you have a history of gastrointestinal side effects, especially at an older age, you should report any unusual abdominal discomfort (especially bleeding in the gastrointestinal tract) to your doctor
especially at the start of treatment. Caution is advised if you are using medicines at the same time that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or platelet aggregation inhibitors such as acetylsalicylic acid.

If bleeding or ulcers occur in the gastrointestinal tract during treatment with ratioDolor Ibuprofen 400 mg, stop the treatment and consult a doctor.

Effects on the blood vessels of the heart and brain (cardiovascular and cerebrovascular effects)
Inflammatory agents/painkillers.Anti-inflammatory agents/painkillers 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 duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking ratioDolor Ibuprofen 400 mg if you
- have a heart condition, including heart weakness (heart failure) and angina (chest pain).heart failure and angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (problems with blood flow in the legs or feet due to narrowed or blocked arteries) or any type of stroke (including mini-stroke or transient ischaemic attack, "TIA").
- Have high blood pressure, diabetes or high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

Skin reactions
Very rarely, serious skin reactions with redness and blistering have been reported during treatment with NSAIDs, some of which were fatal (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/lyell syndrome, see section 4). The highest risk for such reactions appears to be at the beginning of treatment, as these reactions occurred in the majority of cases in the first month of treatment. At the first appearance of a skin rash, mucous membrane sores or other signs of a hypersensitivity reaction, you must stop taking ratioDolor Ibuprofen 400 mg and consult your doctor immediately.

During a chickenpox infection (varicella) it is advisable to avoid using ratioDolor Ibuprofen 400 mg.

More information
Serious acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed in very rare cases. At the first sign of a hypersensitivity reaction after taking ratioDolor Ibuprofen 400 mg, the treatment must be discontinued. Medically necessary measures corresponding to the symptoms must be initiated by competent persons.

You should drink enough during treatment, especially if fever, diarrhoea or vomiting occur.
The prolonged use of any type of painkiller for headaches can make them worse. If this is the case or is suspected, you should seek medical advice and stop the treatment. The diagnosis of medication overuse headache (MOH) should be suspected in patients who suffer from frequent or daily headaches despite (or because of) regularly taking medication for headaches.

In general, habitual use of analgesics, especially when several analgesic agents are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).

NSAIDs such as ibuprofen can mask the signs of infection and fever.

Children and adolescents
Children and adolescents with fluid deficiency are at risk of kidney dysfunction.

Take ratioDolor Ibuprofen 400 mg with other medicines
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

ratioDolor Ibuprofen 400 mg may interfere with or be affected by other medicines. For example:

- Medicines that have an anticoagulant effect (i.e. thin the blood/prevent blood clotting, e.g. aspirin/acetlysalicylic acid, warfarin, ticlopidine.
- Drugs that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers, etc.).(ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

Some other medicines may also interfere with treatment with ratioDolor Ibuprofen 400 mg or may themselves be interfered with by such treatment. You should therefore always seek the advice of your doctor or pharmacist before using ratioDolor Ibuprofen 400 mg with other medicines.
Increase in effect and/or side effects:
- Digoxin (active substance for the treatment of heart failure and cardiac arrhythmias), phenytoin (active substance for the treatment of epilepsy or neuropathic pain), lithium (active substance for the treatment of certain mental disorders): possibly increased blood levels of these active substances. Blood levels do not usually need to be monitored when used as directed (for a maximum of 3 days in the case of migraine headaches or fever in children and adolescents and for 4 days in adults for the treatment of pain).
- Anticoagulants such as warfarin.
- Methotrexate (medicine used to treat cancer and certain rheumatic diseases): Side effects increased.
- Acetylsalicylic acid and other anti-inflammatory painkillers (non-steroidal anti-inflammatory drugs) and glucocorticoids (medicines containing cortisone or substances similar to cortisone): There is an increased risk of ulcers and bleeding in the gastrointestinal tract.
- Blood platelet aggregation inhibitors and selective serotonin reuptake inhibitors (medicines used to treat depression): There is an increased risk of bleeding in the gastrointestinal tract.

Attenuation of effect:
- Drainage medicines (diuretics) and medicines to lower blood pressure (antihypertensives). There may also be an increased risk to the kidneys.
- ACE inhibitors (medicines used to treat heart muscle weakness and high blood pressure). In addition, the risk for the occurrence of renal dysfunction is increased.
- Low-dose acetylsalicylic acid: When used concomitantly with ibuprofen, the anticoagulant (antithrombotic) effect of low-dose acetylsalicylic acid may be impaired.

Other possible interactions:
- Zidovudine (medicinal product for the treatment of HIV infection/AIDS): increased risk of bleeding into joints and haematomas in HIV-positive haemophiliacs.
- Ciclosporin (medicine to suppress immune response): there is evidence of kidney damage.
- Tacrolimus: If both drugs are administered at the same time, kidney poisoning/overdose may occur.
- Sulfonylureas (antidiabetics): Although interactions between ibuprofen and sulfonylureas, in contrast to other NSAIDs, have not been described so far, as a precaution, it is recommended to check blood glucose levels when taking them simultaneously.
- Probenecid and sulfinpyrazone (medicinal products for the treatment of gout): May delay the excretion of ibuprofen.
- Potassium-sparing drainage agents (diuretics): May cause hyperkalaemia (too much potassium in the blood).
- Chinolone antibiotics: There may be an increased risk of seizures.
- CYP2C9 inhibitors: concomitant use of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), exposure to S(+) - ibuprofen was found to be increased by 80 to 100 %. A reduction in the dose of ibuprofen should be considered with concomitant administration of potent CYP2C9 inhibitors, especially when high doses of ibuprofen are co-administered with either voriconazole or fluconazole.

Taking ratioDolor Ibuprofen 400 mg with alcohol
Do not drink alcohol if possible during treatment with ratioDolor Ibuprofen 400 mg. Simultaneous intake of alcohol may increase some side effects affecting the gastrointestinal tract or on the central nervous system.

Pregnancy, breast-feeding and fertility

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.

Pregnancy
If you become pregnant while using ratioDolor Ibuprofen 400 mg, you should inform your doctor. In the first 6 months of pregnancy, you may only take ibuprofen after consulting your doctor. In the last 3 months of pregnancy, ratioDolor Ibuprofen 400 mg must not be taken because of an increased risk of
complications for mother and child.

Lactation
The active substance ibuprofen and its breakdown products pass into breast milk only in small quantities. As adverse effects on the infant have not been reported so far, interruption of breast-feeding is not usually necessary with short-term use of the recommended dose.

Fertility
ratioDolor Ibuprofen 400 mg belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible after stopping the medicine.

Be sure to ask your doctor or pharmacist for advice before taking/using any medicine.
Driving and ability to use machines
! Caution: This medicinal product may impair the ability to react and drive.

Since side effects such as tiredness, dizziness and visual disturbances may occur with the use of ratioDolor Ibuprofen 400 mg, this medicine may not be suitable for use in individual cases.In individual cases, the ability to react and to actively participate in road traffic and to operate machinery may be impaired. This applies to a greater extent in combination with alcohol.

How should the medicine be taken?

How should ratioDolor Ibuprofen 400 mg be taken?

Always take ratioDolor Ibuprofen 400 mg 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 usual dose is:

Adults
Initial dose: take 200 mg or 400 mg of ibuprofen (½ or 1 tablet ratioDolor Ibuprofen 400 mg).
If necessary, take an additional 200 mg or 400 mg of ibuprofen (½ or 1 tablet), but do not exceed the total dose of 1200 mg of ibuprofen (3 tablets) within
24 hours. The interval between doses should not be less than 6 hours.

Children weighing 20 kg or more (6 years and over) and adolescents
ratioDolor Ibuprofen 400 mg should only be used in children weighing 20 kg or more. The maximum total daily dose of ibuprofen is 30 mg per kg body weight, divided into 3 to 4 single doses. The interval between doses should not be less than 6 hours. Do not exceed the recommended maximum daily dose.

The following dosing guidelines apply to ratioDolor Ibuprofen 400 mg in children and adolescents:

Body weight Single dose
Maximum daily dose
.mg Ibuprofen
mg Ibuprofen
(tablets)
(tablets)
.20-29 kg 200 mg
600 mg
(½ tablet)
(1 ½ tablets)
30-39 kg 200 mg
800 mg
(½ tablet)
(2 tablets)
40 kg and over 200-400 mg
1200 mg
(½-1 tablet)
(3 tablets)

Must not be given to children under 12 years of age unless prescribed by a doctor.

Please talk to your doctor or pharmacist if you have the impression that the effect of ratioDolor Ibuprofen 400 mg is too strong or too weak.
Type of use
For oral use. Swallow the film-coated tablets with water.
For patients with a sensitive stomach, it is recommended to take ratioDolor Ibuprofen 400 mg during meals.
The tablet can be divided into equal doses.

Duration of use
For short-term use only.
The smallest effective amount should be used for the shortest time necessary to control symptoms.
If adults need to take ratioDolor Ibuprofen 400 mg for the treatment of migraine headache or fever for more than 3 days or for the treatment of pain for more than 4 days, or if symptoms get worse, consult a doctor.
If the use of this medicine in children and adolescents is necessary for more than 3 days or if the symptoms worsen, consult a doctor.

If you have taken more ratioDolor Ibuprofen 400 mg than you should
.If you have taken more ratioDolor Ibuprofen 400 mg than you should have, or if children have accidentally taken the medicine, 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 tremors. 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.
Discomfort after overdose with ibuprofen may also include:
abdominal pain, bleeding in the gastrointestinal tract, liver and kidney dysfunction, drop in blood pressure, decreased breathing (respiratory depression) and blue colouring of the skin.

If you forget to take ratioDolor Ibuprofen 400 mg
Do not take twice the amount if you have forgotten to take it before.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store ratioDolor Ibuprofen 400 mg ?

Keep this medicine out of the reach of children.

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

Do not store above 25 °C.

Do not dispose of medicinal products 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

How to store ratioDolor akut 400 mg?

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the outer carton and blister packs after ,,Expiry date". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Do not dispose of medicinal products 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 notes on the content

Contents of the pack and other information
What ratioDolor Ibuprofen 400 mg contains
The active substance is ibuprofen-DL-lysine.
Each film-coated tablet contains 684 mg of ibuprofen-DL-lysine, corresponding to 400 mg of ibuprofen.

The other ingredients are:
Tablet core
Microcrystalline cellulose, croscarmellose sodium, talc, highly dispersed silicon dioxide, anhydrous, magnesium stearate.
Film coating
Hypromellose, macrogol 6000, glycerol 85 %.

What ratioDolor Ibuprofen 400 mg looks like and contents of the pack
White to greyish-white, plain to dark speckled, oval film-coated tablets.

ratioDolor Ibuprofen 400 mg is available in packs of 6, 10, 12, 14, 16, 20, 24, 30, 40, 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

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