Ibucomp 200 mg/30 mg film-coated tablets

Ibucomp contains the active ingredients ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine hydrochloride, which causes the nasal mucosa to swell.

How is it used?

What is Ibucomp and what is it used for?

Ibucomp contains the active ingredients ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine hydrochloride, which causes the nasal mucosa to swell.

• Ibuprofen has analgesic, decongestant and antipyretic effects.
• Pseudoephedrine acts on the blood vessels in the nose to relieve nasal congestion.

Ibucomp is used for the symptomatic relief of nasal congestion accompanied by headache and/or fever in influenza infections.
Ibucomp is used in adults and adolescents aged 15 years and over.
Only use this combination medicine if you have both nasal congestion and pain or fever. If you only have one of these symptoms, do not use this medicine.
If you do not feel better or feel worse after 3 days with a fever or after 5 days with pain, contact your doctor.
If it is necessary to take this medicine for more than 3 days in adolescents aged 15 years and over or if your symptoms worsen, a doctor must be consulted.

What should you consider before taking it?

What should you consider before taking Ibucomp?

Ibucomp must not be taken,

• if you are allergic to ibuprofen, pseudoephedrine hydrochloride or any of the other ingredients listed in section 6 of this medicine.
• during the last 3 months of pregnancy and during breastfeeding.
• if you have previously had an allergic reaction such as wheezing, worsening asthma, itchy, runny nose, facial swelling or hives after taking acetylsalicylic acid (commonly known as aspirin) or other painkillers, fever reducers or anti-inflammatory
  medicines.
• if you have a stomach ulcer or have had a stomach ulcer in the past.
• if you have had gastrointestinal bleeding in connection with previous treatment with non-steroidal
  anti-inflammatory drugs (NSAIDs).
• if you have ever had a brain haemorrhage (cerebrovascular haemorrhage).
• in the case of severe liver or kidney disease.
• in severe heart failure.
• in the case of severe heart problems, high blood pressure, heart attack or
  circulation disorders (chest pain).
• in the case of an overactive thyroid gland.
• in the case of a phaeochromocytoma (a tumour of the adrenal gland).
• in the case of inadequately controlled high blood pressure.
• if you have had a stroke or if you have been found to have risk factors for a stroke in the past.
• if you suffer from narrow-angle glaucoma (increased intraocular pressure).
• in the case of unexplained blood disorders.
• if you have suffered from seizures in the past.
• if you are taking the following medicines:
• other decongestants such as phenylpropanolamine, phenylephrine or ephedrine
• methylphenidate (used to treat ADHD)
• non-selective monoamine oxidase inhibitors (known as MAO inhibitors, which are used to treat Parkinson's disease or depression) – or if you have taken them in the last 2 weeks.
• if you have difficulty urinating due to prostate problems.
• if you suffer from a specific autoimmune disease (lupus erythematosus).

Warnings and precautions
Talk to your doctor before taking Ibucomp,

• strong>– if you have asthma – taking this medicine can trigger an asthma attack.
• strong>– if you have been told by your doctor that you have a blood clotting disorder.
• strong>– if you are taking medicines to thin your blood, such as warfarin, low-dose acetylsalicylic acid (commonly known as aspirin).
• strong>– if you are taking medicines that increase the risk of stomach ulcers or bleeding, such as steroids, antidepressants from the class of selective serotonin-
  reuptake inhibitors (SSRIs) (e.g. fluoxetine or paroxetine) or NSAIDs including acetylsalicylic acid (commonly known as aspirin).
• strong>– if you have high blood pressure, heart problems or heart failure.
• strong>– if you have psychosis.
• strong>– if you have prostate problems.
• strong>– if you have diabetes.
• strong>– if you have neurological symptoms, such as seizures, hallucinations, behavioural disorders, restlessness and insomnia.
• strong>– if you have a history of gastrointestinal disease such as ulcerative colitis or Crohn's disease.
• strong>– if you have kidney or liver problems.
• strong>– if you are taking medicines for migraines.
• strong>– if you are elderly, as older people are more sensitive to NSAID-related side effects, especially stomach bleeding and perforation.
• strong>– if you have an infection – see below under "Infections".

Infections
Ibucomp can mask signs of infections such as fever and pain. Therefore, it is possible that Ibucomp may delay appropriate treatment of the infection, which could lead to an increased risk of complications. This has been seen in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an infection and your symptoms of infection persist or worsen, consult a doctor immediately.

Skin reactions
Serious skin reactions have been reported in connection with treatment with Ibucomp. If you develop a skin rash, lesions of the mucous membranes, blisters or other signs of an allergy, stop taking Ibucomp and
seek medical attention immediately, as these may be the first signs of a very serious skin reaction (see section 4).
There is a risk of impaired renal function in dehydrated adolescents. In the event of dehydration, e.g. if you are not drinking enough fluids or if you are suffering from severe diarrhoea or vomiting, talk to your doctor before taking this medicine.
Anti-inflammatory drugs/painkillers such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Talk to your doctor or pharmacist before treatment if you

• strong>– have heart disease including heart failure (heart insufficiency) and angina
  (chest pain) or have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries) or any kind of stroke (including mini-stroke or transient ischaemic attack, "TIA").
• strong>– have high blood pressure, diabetes or high cholesterol or have a family history of heart disease or stroke or if you are a smoker.

If you get a feverish generalised skin rash with pustules, stop taking Ibucomp and see a doctor immediately. See section 4.
Stop taking Ibucomp if you get high blood pressure, a fast or pounding heartbeat, heart rhythm disturbances, nausea or neurological signs such as worsening headaches.
Sudden abdominal pain or bleeding from the back passage can occur during treatment with Ibucomp as a result of inflammation of the large intestine (ischaemic colitis). Stop taking Ibucomp and seek medical advice or seek medical attention immediately if you experience these gastrointestinal symptoms. See section 4.
If you experience visual disturbances during your treatment, contact your doctor. Your doctor will decide whether you should be examined by an eye specialist.
Reduced blood supply to the optic nerve may occur when using Ibucomp. If you experience a sudden loss of vision, stop taking Ibucomp and seek medical advice or seek medical attention immediately. See section 4.
Always take the lowest possible dose for the shortest period necessary to relieve your symptoms to reduce the risk of side effects. In general, doses higher than recommended may carry risks. This also means that combining several NSAID products at the same time should be avoided.

Contact a doctor if your symptoms persist or worsen.

Children and adolescents
Ibucomp must not be used in children and adolescents under 15 years of age.



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

Ibucomp must not be taken if you are using the following medicines:

• monoamine oxidase inhibitors (so-called MAO inhibitors, which are used to treat Parkinson's disease or depression), or if these have been taken in the last 2 weeks
• vasoconstrictors used to treat nasal congestion (e.g. phenylpropanolamine, phenylephrine or ephedrine taken by mouth or directly into the nose)
• methylphenidate (for the treatment of ADHD)

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

• other non-steroidal anti-inflammatory drugs (NSAIDs) including
  acetylsalicylic acid (commonly known as aspirin)
• other painkillers or fever-reducing medicines and selective COX-2 inhibitors (such as ibuprofen, naproxen and diclofenac)
• cardiac glycosides for the treatment of heart rhythm disorders (e.g. digoxin)
• steroids, which are used to treat pain, swelling, allergies, asthma, rheumatism and skin problems
• certain medicines for the treatment of depression (e.g. lithium, imipramine, amitriptyline and mianserin, SSRIs such as fluoxetine, paroxetine), monoamine oxidase A inhibitors (MAOIs) (e.g. isocarboxazid, moclobemide)
• methylene blue (dye)
• medicines that have an anticoagulant effect (i.e. thin the blood/prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• medicines for the treatment of high blood pressure (e.g. ACE inhibitors such as captopril, beta-receptor blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• medicines for the temporary suppression of your immune system such as methotrexate (for arthritis, psoriasis and certain cancers), ciclosporin or tacrolimus
• medicines for heart rhythm disorders, angina, heart failure (e.g. digoxin or quinidine)
• phenytoin (for epilepsy)
• appetite suppressants
• probenecid or sulfinpyrazone (for the treatment of gout)
• sulphonylureas (antidiabetic)
• medicines that promote urination (diuretics/water tablets, e.g. potassium-sparing diuretics)
• medicines for migraines (such as ergotamine and triptans)
• zidovudine (for the treatment of HIV/AIDS)
• heparins (blood thinners)
• trimethoprim, linezolid (antibiotics)
• colestiramine (used to lower cholesterol, for itchy skin and diarrhoea), it should be taken at a time interval of 2 hours from ibuprofen, as the effect of ibuprofen is reduced by colestyramine.
• voriconazole and fluconazole (for fungal infections)
• pemetrexed (for the treatment of cancer)
• tenofovir (for the treatment of HIV infections and hepatitis B)
• deferasirox (used to remove excess iron from the body)

Pseudoephedrine hydrochloride can cause a sudden increase in blood pressure during an operation. Therefore, stop taking Ibucomp a few days before a planned surgical procedure and inform your anaesthetist (anaesthetist)

or dentist about it.
Some other medicines may also affect or be affected by treatment with Ibucomp. You should therefore always seek the advice of your doctor or pharmacist before using Ibucomp
together with other medicines.

Taking Ibucomp with food, drink and alcohol
You can take Ibucomp with food and drink.
Avoid alcohol consumption during treatment.

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:
Avoid using this medicine during the first 6 months of pregnancy unless otherwise directed by your doctor. Do not take Ibucomp during the third trimester of pregnancy.

Breastfeeding:
Do not take this medicine if you are breastfeeding as it may harm your child.

Fertility:
Ibucomp contains ibuprofen, which belongs to a group of medicines (NSAIDs) that can impair fertility in women. This effect is reversible (reversible) after discontinuation of the medicine. Ibucomp is not recommended for women who wish to become pregnant.

Athletes
The use of the medicinal product Ibucomp 200 mg/30 mg film-coated tablets can lead to positive results in doping controls.

Driving and using machines
Ibucomp has a minor influence on the ability to drive and use machines. Please note that in individual cases side effects such as dizziness or hallucinations may occur.

How should the medicine be taken?

How should Ibucomp be taken?

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Ibucomp is for oral use only.
The recommended dose is:
Adults and adolescents aged 15 years and over: 1 film-coated tablet, if necessary every 4–6 hours. For more severe symptoms, take 2 film-coated tablets, if necessary every 6–8 hours.
Do not exceed the maximum daily dose of 6 film-coated tablets.
Swallow the film-coated tablets with water.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Use in patients with impaired liver function is not recommended.
Use in patients with impaired renal function is not recommended.



Use in children and adolescents
Ibucomp must not be used in children and adolescents under 15 years of age.

Duration of use
This medicine is intended for short-term use only. Take the lowest dose necessary for the shortest possible time to relieve your symptoms. Adults
Do not take this medicine for more than 5 days.
Adolescents (15 to 17 years)
Do not take this medicine for more than 3 days.
If your symptoms persist or worsen, see a doctor.

If you have taken more Ibucomp than you should
If you have taken more Ibucomp than you should, or if children have accidentally taken the medicine, always contact a doctor or the nearest hospital for an assessment of the risk and advice on further treatment.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion and eye twitching. At high doses, drowsiness, chest pain, palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, chills and breathing problems have been reported.

If you forget to take Ibucomp
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What side effects are possible?

How should Ibucomp be stored?

Keep this medicine out of the reach of children.
Do not store above 30 ºC.
Do not use this medicine after the expiry date which is stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the specified month.
Do not dispose of the medicine in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This will