Dolorflu acute 200 mg - 20 film-coated tablets

Dolorflu acute contains 2 active ingredients: ibuprofen and pseudoephedrine hydrochloride.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs alleviate the symptoms by relieving pain and reducing fever.
Pseudoephedrine hydrochloride belongs to a group of drugs called vasoconstrictors. They act on the blood vessels in the nose and thus lead to the swelling of the nasal mucosa.

Dolorflu acute is used for the symptomatic treatment of swelling of the nasal mucosa due to a cold with cold-related headaches and/or fever in adults and adolescents aged 15 and over.

Only take this combination medication if you have both a stuffy nose and a headache or fever. If you have only one of these symptoms, talk to your pharmacist or doctor about using either ibuprofen or pseudoephedrine alone.

If symptoms worsen or you need the medicine for more than 4-5 days, contact your doctor.

Contraindications

Dolorflu acute must not be taken

• if you are allergic to ibuprofen, pseudoephedrine hydrochloride or any of the other ingredients of this medicine listed in section 6
• if you are younger than 15 years
• if you are in the third trimester of pregnancy (pregnant for 7 months or more)
• if you are breastfeeding
• if you have had an allergic reaction or shortness of breath, asthma, skin rash, itchy, runny nose or facial swelling when you have previously taken acetylsalicylic acid or other NSAIDs
• if you currently have or have had a history of recurrent stomach or duodenal ulcers (peptic ulcers) or stomach or duodenal bleeding (at least two separate episodes of confirmed ulcers or bleeding)
• if you have had a previous gastrointestinal bleeding or breakthrough in connection with previous therapy with NSAIDs
• if you suffer from severe liver or kidney dysfunction
• if you suffer from severe heart failure
• if you have serious heart or circulatory problems (heart disease, high blood pressure, angina, fast heartbeat), hyperthyroidism, diabetes or pheochromocytoma (a tumor of the adrenal gland).
• if you have had a heart attack (myocardial infarction) in the past
• if you have had a stroke in the past or have been told that you are at risk of having a stroke
• if you have had seizures in the past
• if you have an unexplained blood disorder
• if you suffer from increased intraocular pressure (angle-closure glaucoma).
• if you have difficulty urinating due to prostate problems
• if you have been diagnosed with systemic lupus erythematosus (SLE), an immune system disorder that causes joint pain, skin changes and other problems
• if you take/use the following medicines:
  • other medicines to decongest the nasal mucosa (vasoconstrictors) that are taken or administered through the nose (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline)
  • Methylphenidate, a medicine used to treat attention deficit hyperactivity disorder (ADHD)
  • Medicines for depression, such as non-selective monoamine oxidase inhibitors (called MAOIs, e.g. iproniazid) or have taken them in the last 14 days

Interactions

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

Dolorflu acute may affect or be affected by some other medicines, e.g. b.

• Medicines that have an anticoagulant effect (i.e. thin the blood/prevent blood from clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Some other medicines may also acutely affect or be affected by treatment with Dolorflu. Therefore, always seek the advice of a doctor before taking Dolorflu acute together with other medicines.

Dolorflu acute must not be used together with the following medicines:

• other vasoconstrictors (vasoconstrictors) to reduce the swelling of the nasal mucosa, to be taken orally or applied through the nose (e.g. phenylpropanolamine, phenylephrine and ephedrine)
• a medicine used to treat attention deficit hyperactivity disorder (ADHD) called methylphenidate
• Medicines for depression (antidepressants) such as non-selective monoamine oxidase inhibitors (MAOIs such as iproniazid). Do not take this medicine even if you have taken the medicines mentioned in the past 14 days.

In particular, tell your doctor or pharmacist if you use the following products:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including high-dose acetylsalicylic acid and selective cyclooxygenase (COX-)2 inhibitors
• Medicines to treat cardiac arrhythmias (cardiac glycosides, e.g. digoxin)
• Medicines used to treat epilepsy (e.g. phenytoin)
• Glucocorticoids, which are used in numerous diseases, such as: E.g. pain, swelling, allergies, asthma, rheumatism and skin problems
• Heparin injections
• some medicines used to treat depression (e.g. lithium, selective serotonin reuptake inhibitors [SSRIs], monoamine oxidase A inhibitors [MAOIs])
• Medicines that temporarily suppress the immune system, e.g. B. methotrexate (used to treat arthritis, psoriasis and some forms of cancer), ciclosporin or tacrolimus (given after a transplant)
• Antidiabetika (Sulfonylharnstoffe)
• Medicines used to treat infections (e.g. quinolone antibiotics, trimethoprim)
• Medicines that promote urination (“water tablets”, e.g. potassium-sparing diuretics)
• Medicines used to treat gout (e.g. probenecid and sulfinpyrazone)
• any medicines for migraine (including medicines based on ergot alkaloids)
• Medicines used to treat HIV/AIDS (zidovudine)
• Preparations containing Ginkgo biloba

After taking pseudoephedrine, a sudden increase in blood pressure may occur during surgery. Stop treatment with Dolorflu acutely a few days before a surgical procedure and inform your anesthetist about this.

Taking Dolorflu acute together with alcohol
Avoid alcohol during treatment.

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.

Pregnancy
Do not take Dolorflu acute if you are in the last 3 months of pregnancy as this could harm your unborn child or cause problems during birth. It can cause kidney and heart problems in your unborn baby. It can affect you and your baby's bleeding tendency and may cause labor to start later or take longer than expected. You should not take Dolorflu acute during the first 6 months of pregnancy unless absolutely necessary and recommended by your doctor. If you need treatment during this period or while you are trying to become pregnant, the dosage should be as low as possible and for as short a period of time as possible. If you take Dolorflu acute from the 20th week of pregnancy for more than a few days, it may cause kidney problems in your unborn child, which may lead to a reduced amount of the amniotic fluid surrounding your child (oligohydramnios) or it may cause narrowing a blood vessel (ductus arteriosus) in your child's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breast-feeding
Do not take this medicine if you are breast-feeding as it may harm your baby.

Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that can affect fertility in women. This effect disappears when the drug is discontinued.

Driving and using machines
Warning: This medicine may impair the ability to react and drive.

Dolorflu acute may cause dizziness, hallucinations, unusual headaches and problems with vision or hearing, which may temporarily limit your ability to drive and use machines. If you experience any of these symptoms, avoid driving or operating machines.

Application

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 unsure.
Do not use for long periods of time or in doses higher than recommended without a doctor's advice.

Duration of use
To relieve symptoms, take the lowest effective dose for the shortest possible period of time. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
If symptoms worsen or if you need the medicine for more than 4-5 days, contact your doctor.

Dosage
The recommended dosage applies to adults and adolescents aged 15 years and over:
1 film-coated tablet every 6 hours if necessary. If symptoms are more severe, take 2 film-coated tablets every 6 hours if necessary.
The maximum daily dose of 6 film-coated tablets (corresponding to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) must not be exceeded under any circumstances.

Method of administration
The film-coated tablets are intended to be taken orally. Take the film-coated tablets whole and without chewing with a large glass of water, preferably with meals.

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

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Dolorflu acute immediately and seek medical advice if you notice any of the following:

• Signs of stomach or intestinal bleeding such as bright red stools, black tarry stools, vomiting blood or black particles that look like coffee grounds
• Signs of a serious allergic reaction such as severe rashes, peeling, peeling or blistering of the skin, swelling of the face, unexplained wheezing, shortness of breath, tendency to bruise

If you notice any of the following side effects or if they worsen, contact your doctor. This also applies to side effects that are not listed in this leaflet.
Common (may affect up to 1 in 10 people)

• Digestive disorders, abdominal discomfort or pain, nausea, vomiting, flatulence, diarrhea, constipation, small blood loss in the gastrointestinal tract, which in rare cases leads to anemia

Uncommon (may affect up to 1 in 100 people)

• Hypersensitivity reactions with hives, itching and asthma attacks (along with a drop in blood pressure)
• Central nervous system disorders such as headaches, dizziness, sleep disorders, restlessness, irritability or tiredness
• Ulcers in the stomach/intestinal area, sometimes with bleeding and perforation, inflammation of the lining of the stomach (gastritis), inflammation of the lining of the mouth with ulcers (ulcerative stomatitis), exacerbation of colitis and Crohn's disease
• different skin rashes

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

• Tinnitus (ringing in the ears)
• Kidney tissue damage (papillary necrosis), increased uric acid concentration in the blood

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

• Worsening of infectious inflammation (e.g. necrotizing fasciitis), aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or disorientation) in patients with pre-existing autoimmune diseases (systemic lupus erythematosus [SLE], mixed connective tissue disease)
• impaired production of blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis); This can manifest itself in an increased tendency to bruises or susceptibility to infections
• severe allergic reactions
• psychotic reactions and depression
• High blood pressure, palpitations, heart failure, heart attack
• Inflammation of the esophagus (oesophagitis) or the pancreas (pancreatitis), diaphragm-like narrowings (strictures) in the intestine
• Liver dysfunction, liver damage, especially with long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• severe skin reactions including rash with redness and blistering (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell syndrome), hair loss (alopecia), severe skin infections and soft tissue complications of chickenpox (varicella zoster infection)
• increased serum creatinine, edema (especially in patients with arterial hypertension or renal impairment), nephrotic syndrome, interstitial nephritis, acute renal failure

Not known (frequency cannot be estimated from available data)

• abnormal behavior
• nervousness
• Hallucinations
• Angstgefuhl
• Stroke, seizures, headaches
• Palpitations, fast heartbeat (tachycardia), chest pain, abnormal heart rhythm (arrhythmia), myocardial infarction
• High blood pressure, increased transaminases
• Dry mouth, thirst, nausea, vomiting, inflammation of the colon due to insufficient blood supply (ischemic colitis)
• Rash, hives, itching, excessive sweating, severe skin reactions characterized by fever and numerous small, superficial blisters in large reddened areas. A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include rash, fever, swollen lymph nodes, and an increase in eosinophils (a form of white blood cells).
• Photosensitivity reactions
• Sudden onset of fever, skin redness, small pustules (possible signs of acute generalized exanthematous pustulosis - AGEP) may occur in the first 2 days of treatment (see section 2). Stop taking Dolorflu immediately if you notice any of these symptoms and contact a doctor or seek medical care immediately.
• Difficulty urinating
• Difficulty breathing (dyspnoea, asthma – acute episodes, bronchospasm; see section 2.)
• -Decreased blood supply to the optic nerve (ischemic optic neuropathy), visual disturbances
• Erectile dysfunction

Medicines such as Dolorflu acute may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

composition

The active ingredients are ibuprofen and pseudoephedrine hydrochloride.
Each film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride.

The other ingredients are:
microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, corn starch, highly disperse anhydrous silicon dioxide, magnesium stearate, hypromellose, macrogol 400, talc, titanium dioxide (E 171), yellow iron oxide (E 172)

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