Ibufxal Acute 200, 50 pcs

Upute za korištenje Ibufxal Acute 200, 50 pcs

Important notes (compulsory information):

Ibufxal Acute 200 mg film-coated tablets. Active substance: Ibuprofen Applications: Easy to moderately strong pain, such as head, Dental, regulatory pain; Fever.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


Note of our pharmacists:
This medicine is not intended for continuous use. It should not be used for a long time or in higher doses without medical consultation. For this reason, we reserve the right, if necessary, the order quantity on the needs of a short-term symptomatic treatment (max 2 packs per person) Customize if there is no conflicting medical instructions.


Leaflet: Information for the User
Ibufxal acut 200 mg film-coated tablets
For use in children from 6 years, adolescents and adults
Active substance: ibuprofen

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you feel better or even worse after 4 days, contact your doctor.

What is in this leaflet

1. What is Ibufxal Acute 200 and what is it applied for?
2. What should you take before taking Ibufxal Acute 200 NOTE?
3. How to take ibufxal acute 200?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is iBuhxal Acute 200 to be kept?
6. Content of the pack and more information

1. What is Ibufxal Acute 200 and what is it applied for?

IBÜHEXAL Acute 200 is an anti-inflammatory and analgesic medicine (non-steroidal anti-inflammatory movie / anti-rheumatic matter).

IBÜFXAL Acute 200 is used at:

• light up to moderately strong pain, such as headaches, toothache, regulatory pain
• Fever

2. What should you take before taking Ibufxal Acute 200 NOTE?

IBÜFXAL Acute 200 must not be taken

• if you allergic against ibuprofen or one of the section 6 mentioned ingredients of this medicinal product are
• if you have responded in the past with respiratory distress, asthma, nasal mucosal swellings or skin reactions after taking acetylsalicylic acid or other non-steroidal antirheumatics / anti-phlogistics (NSAR
• if you have unexplained blood formation disorders
• in existing or past stomach / duodenal ulcer (peptic ulcer) or bleeding (at least two different episodes of proven ulcers or bleeding)
• in gastrointestinal bleeding or breakthrough (perforation) in the prehistory associated with a previous therapy with NSA
• if you have cerebral bleeding (cerebrovascular bleeding) or other active bleeding
• if you suffer from heavy liver or renal impairment
• while taking other NSARs, including selective cyclooxygenase-2 inhibitors, due to increased risks for side effects
• in the last 3 months of pregnancy (see section "Pregnancy, lactation and proclaimability")
• if you suffer from a disease of coronary heart disease (coronary heart disease) or a heavy heart muscle weakness (heart insuffi ciency
• if you are at a heavy Australoccupation (dehydration) suffer (caused by vomiting, diarrhea or insufficient fluid intake)
• for children under 20 kg body weight (6 years), as this dose thickness is not suitable due to the higher volume of active ingredients.

Warnings and Precautions
Please talk to your doctor or pharmacist before taking ibufxal acut 200.

• if they are in certain innate blood formation disorders (eg Acute intermittent porphyria suffering
• if you have specific autoimmune diseases (systemic lupus erythematosodes and mixing collagenosis
• if you have gastrointestinal disorders or chronic intelligence (colitis ulcerosa, crohn's disease
• if you suffer from redistributable kidney or liver function
• when dehydration (dehydration)
• if you are under high blood pressure and / or heart muscle weakness (Heart failure) suffer or ever suffered
• if you are at allergies (eg skin reactions on other medicines, asthma, hay fever), chronic mucosal throats or chronic, the respiratory respiratory diseases (such as asthma) suffer, as you then have increased risk for the occurrence of an overpraisi Nstandality reaction exists
• for blood coagulation disorders
• immediately after larger surgical procedures

Side effects can be reduced by applying the lowest effective dose to the shortest period required for symptom control. For prolonged use of IBÜFXAL Acute 200, a regular control of your liver values, renal function and blood image is required. Ibufxal acute 200 is part of a group of medicines (NSAR), which can affect the fertility of women. This effect is reversible (reversible) after discontinuation of the medicament).

Safety in the gastrointestinal tract
The simultaneous application of IBÜFXAL Acute 200 with other non-steroidal anti-rheumatics (NSAR) including so-called cyclooxygenase-2 inhibitors should be avoided.

Elderly
In older patients, frequent side effects after the application of NSAR, in particular bleeding and breakthroughs in the gastrointestinal tract, which can run deadly.

Bleeding, ulcers and breakthroughs (perforations) in the gastrointestinal tract
Bleeding, ulcers or perforations in the gastrointestinal tract that can be fatal were reported during treatment with all NSAs. They occurred with or without previous warning signs or Serious events in the gastrointestinal tract in the prehistory at any time of treatment.

The risk of bleeding, ulcers or perforations in the gastrointestinal tract is higher when the NSAR dose is rising if they used to already ulcer, especially when bleeding or breakthroughs occurred as complications and in older patients. You should start treatment with the lowest available dose. Please talk to your doctor, since a combination treatment with protective medicines (eg Misoprostol or proton pump inhibitor) could be considered.

This also applies if they occupy low-metered acetylsalicylic acid or other active ingredients at the same time, which probably increase the risk of gastrointestinal diseases.

If side effects in the gastrointestinal tract have occurred in the past, especially at a higher age, you should report all the unusual symptoms in the abdomen (especially bleeding in the gastrointestinal tract), especially at the beginning of the treatment to your doctor. Caution is advised if you apply medicines at the same time, which can increase the risk of ulcers or bleeding, such as: B. Corticosteroids for taking, blood cluttering drugs such as warfarin, selective serotonin recording inhibitors or platelet aggregation inhibitors such as acetylsalicylic acid.

If it comes during treatment with IBÜFXAL acute 200 for bleeding or ulcers in the gastrointestinal tract, the treatment must be terminated.

Effects on the blood vessels of heart and brain (cardiovascular and cerebrovascular effects)
Pharmaceuticals such as iBuhxal Acute 200 may be with a slightly increased risk of cardiac attacks ("heart attack") or Stroke associated. Any risk is more likely at high doses and longer lasting treatment. Do not exceed the recommended dose or duration of treatment. If you suffer from heart problems or have a stroke in the past or think that you could have a risk to these diseases (eg if you have high blood pressure, diabetes or high cholesterol levels or smokers are), you should treat your treatment with your Discuss doctor or pharmacist.

Skin reaction
Very rarely has been reported during treatment with NSAH about serious skin reactions with redness and blistering, 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 seems to be at the beginning of the treatment, as these reactions occurred in the majority of cases in the first treatment month. In the first occurrence of rash, mucous membranes or other signs of a hypersensitivity reaction, you must stop taking iBufroxal Acute 200 and check for your doctor immediately. During a windpox infection, it is advisable to acute the application of iBuhxal acute 200 to avoid.

additional Information
Blood clotting inhibitors (eg acetylsalicylic acid / Aspirin, warfarin, ticlopidine), drug against hypertension (ACE inhibitor, z. B. Captopril, Betarauceptor Blocker, Angiotensin II antagonists) and some other medicines can affect the treatment with ibuprofen or impaired by such a self. Therefore, you should always catch up with medical advice before using ibuprofen simultaneously with other medicines.

Heavy acute hypersensitivity reactions (eg Anaphylactic shock) were observed in very rare cases. For the first signs of a hypersensitivity reaction after taking iBuhxal Acute 200, the treatment must be aborted. The symptoms corresponding, medically necessary measures must be initiated by expert persons.

They should drink sufficient during treatment, especially in the case of fever, diarrhea or vomiting. There is a risk for renal function restrictions on dehydrated children and adolescents. For prolonged use of painkillers, headaches may occur, which must not be treated with increased doses of the medicine. Generally, the habitual intake of painkillers, especially when combining several analgesic active ingredients, for permanent kidney damage with the risk of renal failure (AnalgeTika Nephropathy) lead. NSAR like ibuprofen can disguise the signs of infections and fever.

Taking IBÜFXAL Acute 200 together with other medicines
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / use other medicines. The effect of the following medicines can be acute with simultaneous treatment with IBÜFXAL 200 will be influenced.

Reinforcement of the effect and / or side effects

• Digoxin (agents for the treatment of heart failure and cardiac arrhythmias), lithium (agents for the treatment of certain psychic disorders): possibly increased blood levels of these active ingredients. A control of the blood levels is usually not required when used (a maximum of 4 days.
• Blood clinical inhibitors like warfarin
• Methotrexate (means for the treatment of cancer and certain rheumatic diseases): side effects amplified.
• Acetylsalicylic acid and other anti-inflammatory pain means (non-steroidal anti-rheumatics) as well as glucocorticoids (Medicines containing cortisone or cortisone-like substances): There is an increased risk of ulcers and bleeding in the gastrointestinal tract.
• Blood plate aggregation inhibitors and selective serotonin reuptake inhibitors (medicinal products for the treatment of depression): There is an increased risk of bleeding in the gastrointestinal tract.
• Ginkgo Biloba can strengthen the risk of bleeding by NSARS.
• Drug against fungal diseases such. B. Voriconazole or fluconazole (CYP2C9 inhibitors): increased ibuprofen recording. Reducing the dose of ibuprofen should be considered, especially when a high dose of ibuprofen is administered.

Sounding of the effect

• dehydrating medicines (diuretics) and drugs for reducing blood pressure (antihypertonics). In addition, there may also be an increased risk for the kidneys.
• ACE inhibitor (medicines for the treatment of heart muscle weakness and high blood pressure). In addition, the risk for the occurrence of renal function malfunction is increased.
• Acetylsalicylic acid in low dosage: With simultaneous use with ibuprofen, the coagulation (antithrombotic) effect of low-metered acetylsalicylic acid may be impaired.
• Colestyramine, a medicinal product for lowering the cholesterol mirror. The simultaneous intake of ibuprofen and colestyramine can reduce the intake of ibuprofen in the gastrointestinal tract.
• Mifepriston, a medicine for medical pregnancy cancellation. NSArs should not be taken 8-12 days after taking Mifepriston, as NSArs can reduce the effect of Mifepriston.

Other possible interactions:

• Zidovudin (medicines for the treatment of HIV / AIDS): increased risk of bleeding in joints and bruises in HIV-positive bloods.
• Ciclosporin (medicines for suppressing the immune response): There are evidence of kidney damage.
• Tacrolimus: If both medicines are administered at the same time, a kidney damage / overdose may occur.
• Sulfonylureas (antidiabetics): Although interactions between ibuprofen and sulfonylureas, unlike other NSAR, has not previously been described, ahead of the blood sugar levels is recommended.
• SampleCid and Sulfi Npyrazon (medicine for treatment of gout): can delay the excretion of ibuprofen
• Potassium-efficient dewatering agent (certain diuretics): can lead to hypercalemia (too much potassium in the blood
• Quinolon Antibiotics: There may be an increased risk of convulsive accidents.
• Blood clotting inhibitors (eg acetylsalicylic acid, warfarin, ticlopidine), medicament for hypertension (ACE inhibitors, eg. B. Captopril; Beata receptor blocker; Angiotensin II antagonists; Aquatic tab Letten) and some other medicines can affect the treatment with ibuprofen or impaired by one self.

Therefore, you should always catch up with medical advice before using ibuprofen simultaneously with other medicines.

Taking IBÜFXAL Acute 200 together with food and beverages
During the use of iBuhxal Acute 200 you should not drink alcohol as possible.

Pregnancy, breastfeeding and procilability
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

pregnancy
If a pregnancy is detected while taking ibufxal acute 200, you should notify the doctor. In the first 6 months of pregnancy, you may only take ibuprofen after consultation with the doctor. In the last 3 Months of pregnancy may not be accepted in pregnancy 200 because of an increased risk of complications for mother and child.

Lactation
The drug ibuprofen and its degradation products only go into the breast milk in small amounts. Since adverse consequences for the infant have not yet become known, short-term use of the recommended dose is not required to interrupt the breastfeeding.

Cancellability
This medicine belongs to a group of medicines (NSARS) that can affect the fertility of women. This effect is reversible by termination of taking the medicine.

Verility and the use of machines
Since using iBufroxal AKuT 200 side effects such as fatigue, dizziness and visual disturbances can occur, in individual cases, the reactivity and the ability to actively participate in road traffic and to operate machines may be impaired. This applies in reinforced dimensions in combination with alcohol.

3. How to take ibufxal acute 200?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. Do not take Ibufxal Acute 200 without medical or dental advice no longer than 4 days. If in children from 20 kg body weight (6 Years) and adolescents the application of this medicine is required for more than 3 days or if the symptoms worsen, medical advice should be obtained.

Unless otherwise prescribed by the doctor, the usual dose is:

Age of the child	Body weight	Single dose	Maximum daily dose
6 - 9 Years	20 - 29 kg	1 Film tablet (corresponding to 200 mg ibuprofen)	3 Film-coated tablets (corresponding to 600 mg ibuprofen)
10 - 12 Years	30 - 39 kg	1 Film tablet (corresponding to 200 mg ibuprofen)	4 Film-coated tablets (corresponding to 800 mg ibuprofen)
Children and adolescents from 12 years and adults	over 40 kg	1-2 Film-coated tablets (according to 200-400 mg ibuprofen)	6 Film-coated tablets (corresponding to 1200 mg ibuprofen)

If you take the maximum single dose, wait at least 6 hours to the next intake.

Dosage in older people
No special dose adjustment is required.

type of application
Take Ibufxal Acute 200 so far with plenty of fluid (eg a glass of water) during or after a meal. For patients who have a sensitive stomach, it is recommended that IBÜFXAL Acute 200 during the
Take meals.

Please talk to your doctor or pharmacist if you have the impression that the effect of iBufroxal acute 200 is too strong or too weak.

If you take a greater amount of IBÜFXAL ACUT 200 as you should
Find a doctor immediately.
The symptoms after overdose with ibuprofen can include:
Headache, dizziness, dizziness, unconsciousness (in children also myoclonic convulsions), abdominal pain, nausea, vomiting, bleeding in the gastrointestinal tract, functional disorders of liver and kidneys, blood pressure drop, reduced breathing (Respiratory depression) and blue coloring of the skin

If you forget to take ibufxal acut 200
Do not take the double dose if you forget the previous ingestion. If you have further questions about taking this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

The following abutment of undesirable effects comprises all side effects known in connection with ibuprofen treatment, including those under high-dose long-term treatment in rheuma capacity. The frequency indications that go beyond very rare messages refer to the short-term use of daily doses of a maximum of 1200 mg ibuprofen for dosage forms for taking and maximum 1800 mg for suppositories.

If you get one of the following severe side effects, you can not continue to take Ibufroxal Acute 200 and immediately inform your doctor:

• Rash and itching
• Asthma attack
• heavy hypersensitivity reactions. These can be characterized by swelling of face, tongue and larynx with narrowing of airways, respiratory distress, heart hunt and blood pressure drop to life-threatening shock.
• Blood education disorders. First signs canbeing: Fever, sore throat, surface-like wounds in the mouth, flu-like complaints, strong pollution, nosebleeds and skin bleeding. Any self-treatment with analgesic or fever-cut medicines should be omitted.
• Deterioration Infection-related inflammation: When using IBÜFXAL acute 200 characters of an infection occur or deteriorate
• Vision
• stronger upper abdominal pain, bleeding, blood in the chair or black staining of the chair (Teerstuhl)
• reduced urinary excretion and water collection in the body (Edema)

Other possible side effects
The following side effects must be taken into account that they are predominantly dose-dependent and different from patient to patient. The most frequently observed side effects involve the digestive tract. Ulcers in stomach and duodenum (peptic ulcer), breakthroughs or bleeding in the gastrointestinal tract, sometimes fatal, can occur, especially in older patients (see section 2. "Warnings and Precautions"). Nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, teist chair, bleeding, ulcerative stomatitis (Inflammation of the oral mucosa with ulcer formation), Boring of bowel diseases Colitis ulcerosa and Crohn's disease (see section 2. "Warnings and Precautions") have been reported according to application. Less often an inflammation of the gastric mucosa (gastritis) was observed. Pharmaceuticals such as IBÜFXAL Acute 200 may be associated with a slightly increased risk of cardiac attacks ("heart attack") or strokes.

Frequently (at 1 to 10 treated from 100)

• Complaints in the gastrointestinal area such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation and light gastrointestinal bleeding, which can lead to anemia (anemia) in exceptional cases

Occasionally (at 1 to 10 treated from 1,000)

• Headache, dizziness, sleeping osity, excitement, irritability or fatigue
• Hypersensitivity reactions with rash and itching as well as asthma attacks (possibly with blood pressure drop)
• Vision
• Ulcers in the gastrointestinal tract, in some cases with bleeding and breakthrough
• ulcerative stomatitis, aggravation of colitis and crohn's disease, gastric mucosalitis (gastritis)

Rarely (at 1 to 10 treated from 10,000)

• Ohr noises (tinnitus)
• Kidney taste damage (papilla necrosis), especially for long-term treatment
• increased urinary acid concentration in the blood

Very rare (less than 1 out of 10,000 treated)

• reduced urinary excretion and accumulation of water in the body (edema). This can be signs of renal disease, sometimes including renal failure.
• nephrotic syndrome (accumulation of fluid in the body edema and strong protein excretion in urine), inflammatory kidney disease (interstitial nephritis), which may be accompanied by an acute renal impairment disorder
• Liver function disorders, liver damage, especially for long-term treatment, liver failure, acute lifetitis (Hepatitis)
• Hyemeral disorders, agranulocytosis (signs: an infection with symptoms such as fever and strong deterioration of the general condition or fever with localized signs of infection such as inflammation of neck / throat / mouth or urinary tract)
• heavy skin reactions like rash with redness and blistering (eg Stevens-Johnson syndrome and toxic epidermal necrolysis / Lyell syndrome), hair loss (alopecia)
• in individual cases, heavy skin infections can occur with soft tissue complications during a windpox infection
• Signs of a meregnitis based on infection (aseptic meningitis) such as strong headache, nausea, vomiting, fever, neck stiffness or consciousness. An increased risk seems Ffor patients to exist, already in certain diseases of the immune system (Systemic lupus erythematosodes and mixing collagenosis) To suffer.
• heavy hypersensitivity reactions
• Deterioration infection-related inflammation
• psychotic reactions, depression
• Heartock, heart muscle weakness (heart failure), Heart attack
• high blood pressure
• Inflammation of the esophagus and the pancreas
• Training of membrane-like constrictions in the intestine

Message of side effects
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de, ads. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep iBufroxal Acute 200?

Keep this medicine inaccessible to children.
You may not use this medicine after the expiration date specified on the outer carton and the container (blister) according to "until". The expiration date refers to the last day of the specified month.

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Ibufxal Acute 200 contains
The active ingredient is: ibuprofen
1 film tablet contains 200 mg ibuprofen.

The other ingredients are:
Microcrystalline cellulose, croscarmello sodium, hypromellose, macrogol 400, magnesium stearate (pH. EUR.), Hochdiserses silica, talc, titanium dioxide (E 171)

How iBuhxal Acute 200 looks like and content of the pack
Ibufxal Acute 200 are white, round, double-sided film-coated tablets.
Ibufxal Acute 200 is available in packs of 10, 20 and 50 film-coated tablets.

Pharmaceutic entrepreneur
Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: [email protected]

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Bar life

This leaflet was last revised in March 2014.

Source: Information of the leaflet
Status: 07/2014