pROFF Scheigndragon, 20 pcs

Upute za korištenje pROFF Scheigndragon, 20 pcs

Important notes (compulsory information):

pROFF® Pain Display. Active ingredient: ibuprofen. Applications: For slight to moderately strong pain; For 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 5 packs per person) Customize if there is no conflicting medical instructions.


Instructions for use: Information for users

PROFF® pain dragging, 200 mg plated tablets
Active substance: ibuprofen
For application in adults, adolescents and children from 6 Years

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, pharmacist or medical personnel.
- 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, pharmacist or medical personnel. This also applies to side effects that are not indicated in this leaflet. See section 4.
- If you do not feel better or even worse after 4 days, contact your doctor.

What is in this leaflet
1. What are PROFF® analgesis and what are you used for?
2. What should you consider before taking PROFF® analgesis?
3. How are PROFF® pain to take pain?
4. Which side effects are possible?
5. How are PROFF® pain to be kept?
6. Content of the pack and further information

1. What are PROFF® analgesis and what are you used for?

PROFF® analgesites are anti-inflammatory and analgesic medicines (non-steroidal - Antiphlogistikum / Antirheumaticsum).

Application areas of PROFF pain code:
PROFF® pain dragging are applied to
- slight to moderate pain
- Fever
If you feel better or even worse after 4 days, contact your doctor.

2. What should you consider before taking PROFF® analgesis?

PROFF® pain code must not be taken,
- If you allergic against ibuprofen or one of the in section 6. mentioned other ingredients of this medicinal product are.
- If you have reacted in the past with asthma attacks, nasal mucosal swellings or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-steroidal anti-steroids.
- with unclear blood formation disorders.
- stomach / duodenal ulcer (peptic ulcer) occurred in existing or in the past (peptic ulcer) or bleeding (at least 2 different episodes of proven ulcers or bleeding).
- in gastrointestinal bleeding or breakthrough (perforation) in the prehistory associated with a previous therapy with non-steroidal anti-inflammatory / anti-phlogistika (NSAR).
- For cerebral bleeding (cerebrovascular bleeding) or other active bleeding.
- For heavy liver or renal impairment.
- in heavy heart failure (heart failure).
- in the last third of pregnancy.
- in children under 20 kg (6 years), since this dose thickness is usually not suitable due to the active ingredient content.

Warnings and Precautions:
Please talk to your doctor, pharmacist or medical personnel before you take PROFF® analgesis.

Safety in the Maqen Darm Tract:
A simultaneous application of PROFF® analgesis with other non-steroidal inflammatory inhibitors, including so-called COX-2 inhibitors (cycloxigenase-2 inhibitors), should be avoided Wearth. Side effects can be reduced by applying the lowest effective dose to the shortest time required for symptom control.

Elderly patients:
In the case of elderly patients, adverse effects after the application of NSAR, in particular bleeding and breakthroughs in the stomach and intestinal sector, which may may be life-threatening. Therefore, in older patients, a particularly careful medical monitoring is required.

Bleeding of the gastrointestinal tract, ulcers and breakthroughs (Perforations):
Bleeding of the gastrointestinal tract, ulcers and perforations, even with fatal output, were reported during treatment with all NSAs. They occurred with or without prior warning symptoms or Serious events in the gastrointestinal tract in the prehistory at any time of therapy. The risk of the occurrence of gastrointestinal bleeding, ulcers and breakages is higher with increasing NSAR dose, in patients with ulcers in the history, in particular with the complications of bleeding or breakthrough (see Section 2: "PROFF® pain code must not be taken "), and in older patients. These patients should start treatment with the lowest available dose. For these patients as well as patients receiving accompanying therapy with low-metered acetylsalicylic acid (ASS) or other medicines that may increase the risk of gastrointestinal diseases require a combination therapy with gastric mucosa protective medicines (eg misoprostol or proton pump inhibitors) are considered. If you have a history of side effects on the gastrointestinal tract, especially at higher age, you should report any unusual symptoms in the abdomen (especially gastrointestinal bleeding), especially at the beginning of the therapy. Caution is advised if you at the same time receive medicines that can increase the risk of ulcers or bleeding, such as: As oral corticosteroids, blood cluttering drugs such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, for the treatment of depressive moods, or thrombocyte aggregation inhibitors such as ass (s. SECTION 2: "Taking / use of PROFF8 pain dragging together with other medicines"). When it comes to gastrointestinal bleeding or ulceration during treatment with PROFF® analgesis, the treatment must be deducted. NSAR should be used in patients with a gastrointestinal disease in the prehistory (Colitis ulcer, Crohn's disease), as their condition can deteriorate (s. Section 4).

Skin reactions:
Among NSAR therapy has been very rarely reported on serious skin reactions with redness and blistering, some with fatal exit (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis / Lyell syndrome; see section 4). The highest risk of such reactions seems to be at the beginning of therapy, as these reactions occurred in the majority of cases in the first treatment month. In the first sign of skin rashes, mucosal defects or other signs of hypersensitivity reaction, PROFF should be discovered and consulted and immediately consulted the doctor. During a windpox infection (varicella infection), an application of PROFF "analgesis should be avoided.

Other notes:
PROFF® pain code should only be applied under strict balance of benefit risk ratio:
- in certain innate blood formation disorders (eg acute intermittent porphyria);
- For certain autoimmune diseases (systemic lupus erythematosodes and mixed collagenosis).

A particularly careful medical monitoring is required:
- with impaired kidney or liver function;
- directly after larger surgical procedures;
- For allergies (eg skin reactions on other medicines, asthma, hay fever), chronic nasal mucosa thresholds or chronic respiratory respiratory respiratory diseases.
Heavy acute hypersensitivity reactions (for example, anaphylactic shock) are very rarely observed. For first signs of a heavy hypersensitivity reaction after taking / administration of PROFF® pain codes must be stopped the therapy. The symptoms corresponding, medically necessary measures must be initiated by expert persons. Ibuprofen, the active ingredient of PROFF® Pain dispute, can temporarily the platelet function (Thrombocyte aggregation) inhibit. Patients with blood clotting disorders should therefore be carefully monitored. For longer permanent administration of PROFF® pain throat, a regular control of liver values, renal function and blood image is required. When taking PROFF® analgesis before operational interventions, the doctor or dentist should be consulted or to inform. The longer application of any kind of painkillers against headaches can aggravate these. If this is the case or this is suspected, medical advice should be obtained and treatment can be broken off. The diagnosis of headache in drug use (Medication Overuse Headache, MOH) should be suspected in patients who suffer from frequent or daily headaches, though (or just because) they regularly occupy medicines against headaches. Generally, the habitual intake of painkillers, especially when combining multiple analgesic agents, can lead to permanent kidney damage with the risk of renal failure (analgesics nephropathy). PROFF® analgesis belong to a group of medicines (non-steroidal anti-rheumatics) that can affect the fertility of women. This effect is reversible (reversible) after discontinuation of the medicament).

Children and adolescents:
Please note the instructions under Section 2: "PROFF analgesis may not be taken / applied".




Intake / application of PROFF pain dragging together with other medicines:
Inform your doctor or pharmacist if you take / apply other medicines, recently taken / applied / applied or intend to take / use other medicines. The simultaneous application of PROFF® Paindresses and digoxin (means for strengthening heart power), Phenytoin (means for the treatment of convulsions) or lithium (Means for the treatment of spiritual-emotional diseases) can increase the concentration of these medicines in the blood. A control of serum lithium mirrors, the serum digoxin and serum phenytoin mirror is when used as intended (Maximum over 4 days) usually not required.
PROFF® analgesis can affect or impair other medicines. For example:
- Drugs that act cluttering (d. H. Dilute blood / prevent blood clotting, eg acetylsalicylic acid, warfarin, ticlopidine).
- Drugs that reduce high blood pressure (ACE inhibitors such as B. Captopril, beta blocker such. As aesolol-containing medicines, angiotensin IL receptor antagonists such. B. Losartan).

Some other medicines can treat the treatment with PROFF® Analysis of pain also affect or impaired by such a self. Therefore, before using PROFF® analgesis, together with other medicines, you should always catch up with the advice of your doctor or pharmacist. PROFF® Paindresses can the effect of dewatering and blood-pressure medicines (diuretics and antihypertensives) To weaken. PROFF® analgesis can attenuate the effect of ACE inhibitors (medium for the treatment of heart failure and high blood pressure). With simultaneous use, the risk for the occurrence of a kidney function malfunction may continue to increase. The simultaneous administration of PROFF® analgesis and potassium-saving drainage means (certain diuretics) can lead to an increase in the potassium mirror in the blood. Simultaneous administration of PROFF® pain code with other inflammation and pain-resource agents from the group of non-steroidal antiphlo gypistics or glucocorticoids increases the risk of gastrointestinal ulcers or bleeding. Thrombocyte aggregation inhibitors and certain antidepressants (selective serotonin resumption inhibitors / SSRI) can increase the risk of gastrointestinal bleeding. The administration of PROFF® analgesis within 24 hours before or after administration of methotrexate can lead to an increased concentration of methotrexate and an increase in its undesirable effects. The risko a kidney-damaging effect by ciclosporin (agent used to prevent graft fusions, but also in rheumatic treatment) is increased by the simultaneous administration of certain non-steroidal anti-phlogistika. This effect can not be excluded for a combination of Ciclosporin with ibuprofen. Medicines containing sampling or sulfinpyrazon (agent for treatment of gout) can delay the excretion of ibuprofen. This can lead to an enrichment of PROFF® analgesis in the body with reinforcement of its unwanted effects. Nsar may enhance the effect of blood clotting inhibiting medicines such as warfarin. With simultaneous treatment, a control of coagulation status is recommended. Clinical studies have shown interactions between NSA and sulfonylureas (means for lowering blood sugar). Although interactions between ibuprofen and sulfonylureas are previously not described, a check of blood sugar levels is recommended with simultaneous use.
Tacrolimus: The risk of kidney damage is increased when both drugs are administered simultaneously.
Zidovudin: There are evidence of increased risk of bleeding in joints (hemarthroses) and hematomas in HIV-positive hemophilia patients ("blood"), which simultaneously occupy zidovudine and ibuprofen.

Taking PROFF® pain dragging together with foods, drinks and alcohol:
During the use of PROFF® analgesis, 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 / application of this medicine.

> Pregnancy:
If a pregnancy is detected during the use of PROFF® analgesis, the doctor is notified. You may only use ibuprofen in the first and second pregnancy a third party after consultation with your doctor. In the last third of pregnancy, PROFF® analgesis may not be used because of an increased risk of complications for mother and child.

> Latving:
The drug ibuprofen and its degradation products only go into the breast milk in small amounts. Since disadvantageous consequences for the infant have not become known so far, a short-term application is not required to interrupt the breastfeeding. Will be a longer application or However, taking higher doses prescribed, but should be considered an early desele.

Driving and ability to operate machines:
Since the use of PROFF® analgesis in higher dosage centrally nervous side effects such as fatigue and dizziness can occur, the reactivity can be changed in individual cases and the ability to actively participate in road traffic and servicing machines can be affected. This applies even more in combination with alcohol. You can then no longer respond to unexpected and sudden events quickly and specifically enough. Do not drive in this case car or other vehicles! Do not operate any tools or machines! Do not work without a safe grip!

PROFF Paindraye contain sucrose:
This medicine contains sucrose. Please take Proff® Paindresses only after consulting with your doctor if you are known to suffer from any intolerance to certain sugars.

3. How are PROFF® pain to take pain?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor, pharmacist or medical personnel. Ask your doctor, pharmacist or medical personnel if you are not sure.
Do not take PROFF analgesis without medical or dental advice no longer than 4 days.

The recommended dose is:
Body weight (age)	Azeldosis max.	Daily dose
20 kg - 29 kg (6-9 years )	1 coated tablet (corresponding to 200 mg ibuprofen)	3 plated tablets (corresponding to up to 600 mg ibuprofen)
30 kg - 39 kg (10-12 years)	1 coated tablet (corresponding to 200 mg ibuprofen)	4 plated tablets (corresponding to 800 mg ibuprofen)
> 40 kg (children and adolescents from 12 years and adults)	1-2 plated tablet N (corresponding to 200 mg-400 mg ibuprofen)	6 plated 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
Please take PROFF® analgesis in question with plenty of fluid (eg a glass of water) during or after a meal. For patients who have a sensitive stomach, it is advisable to take PROFF® analgesis during meals. Please talk to your doctor or pharmacist if you have the impression that the effect of PROFF * pain dragging is too strong or too weak.

If you take a greater amount of PROFF® analgesic as you should:
Take Proff® pain code according to the doctor's instructions or according to the dosage instructions specified in the package leaflet. If you feel, do not feel sufficient pain relief, then do not even increase the dosage independently, but ask your doctor. As symptoms of overdose, central nervous disturbances such as headaches, dizziness, dizziness and unconsciousness (in children also cause convulsions) as well as abdominal pain, nausea and vomiting. Furthermore, bleeding in the gastrointestinal tract and functional disorders of liver and kidneys are possible. Furthermore, it can cause blood pressure drop, reduced breathing (Respiratory depression) and to the blorus coloring of skin and mucous membranes (cyanosis) come. There is no specific antidote (antidote). If there is suspected overdose with PROFF® analgesis, please notify your doctor. This may decide according to the severity of poisoning over the necessary measures.

If you forget to take Proff® pain code:
Do not take the double amount when you forget the previous taking.

If you have further questions about the application of this medicine, ask your doctor, pharmacist or medical personnel.

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 assessment of side effects is based on the following frequency information:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated by 1,000
Rarely:	1 to 10 treated from 10,000
Very rare:	less than 1 treated from 10,000
Not known:	Frequency on the basis of the available data not estimable

Possible side effects:
The enumeration of the following undesirable effects includes all known side effects under treatment with ibuprofen, including those under high-dose long-term therapy for rheumatist. The frequency information that goes beyond very rare messages relate to the short-term application up to daily doses of a maximum of 1200 mg ibuprofen (= 6 PROFF® Pain dispute). The following undesirable pharmaceutical effects must be taken into account that they are predominantly dose-dependent and patient to patient. The most commonaccounted side effects relate to the digestive tract. Stomach / duodenum ulcers (Peptic ulcer), perforations (breakthroughs) or bleeding, sometimes fatal, can occur, especially in older patients (see section 2) nausea, vomiting, diarrhea, flatulence, constipation, digestive complaints, abdominal pain, teery chair, bleeding, ulcerative stomatitis, aggravation of colitis and crohn's disease (see section 2) have been reported according to application. Less frequently gastritis has been observed. In particular, the risk of the occurrence of gastrointestinal bleeding depends on the dose range and the application time. Edema, hypertension and heart failure were reported in connection with NSAR treatment. Pharmaceuticals such as PROFF® pain code may be associated with a slightly increased risk of cardiac attacks ("heart attack") or strokes.

> Heart disease
Very rare: palpitations (palpitations), heart muscle weakness (Heart insufficiency), heart attack.

> Diseases of the blood and the lymphatic system:
Very rare: disorders of blood formation (anemia, leukopenia, thrombocytopenia, tank topsia, agranulocytosis).
First signs may be: fever, sore throat, superficial wounds in the mouth, influenza-like complaints, strong shock, nosebleed and skin bleeding. In these cases, the medicine must be stopped immediately and seek the doctor. Any self-treatment with pain or fever-lowering medicines should be omitted.

> Diseases of the nervous system:
Occasionally: Central nervous disturbances such as headaches, dizziness, insomnia, excitement, irritability or fatigue.

> Eye diseases:
Occasionally: visual disturbances.

> Diseases of the ear and the labyrinth:
Rare: Earritis (Tinnitus).

> Diseases of the gastrointestinal tract:
Frequently: gastrointestinal discomfort such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation and minor gastrointestinal blood losses that can cause anemia (anemia) in exceptional cases.
Occasionally: gastric / duodenum ulcers (peptic ulcer), Under certain circumstances with bleeding and breakthrough, oral mucosal inflammation with ulcerator (ulcerative stomatitis), reinforcement of a colitis ulcers or a crohn disease. Stomach mucosalitis (gastritis)
Very rare: inflammation of the esophagus (esophagitis) and the pancreas (pancreatitis). If there are stronger pain in the upper abdominal, bruising, blood in the chair and / or a black staining of the chair, so you need PROFF® Setting a pain code and inform the doctor immediately.
Very rare: training of membrane-like constrictions in thin and colon (intestinal, diaphragmic strictures).

> Diseases of kidneys and urinary tract:
Very rare: increased water storage in the tissue (edema), especially in patients with hypertension or renal function; Nephrotic syndrome (water collection in the body (Edema) and strong protein excretion in the urine); Flammable kidney disease (interstitial nephritis) that can be accompanied by acute renal impairment. There can also be kidney taste damage (papilla nephroes) and increased urinary acid concentrations in the blood. Reduction of urinary excretion, accumulation of water in the body (edema) and general malaise can be expression of kidney disease to renal failure. If the symptoms mentioned appear or aggravate, they must have PROFF® Setting the analgesis and contact your doctor immediately.

> Classifications of the skin and subcutaneous tissue:
Very rare: heavy skin reactions like rash with redness and blistering (eg Stevens-Johnson syndrome, toxic epidermal necrolye / Lyell syndrome), hair loss (alopecia). In exceptional cases, there may be an occurrence of heavy skin infections and soft tissue complications during a chickenpox disease (varicella infection) (see also "Infections and parasitic diseases").

> Infections and parasitic diseases:
Very rare is in the temporal connection with the use of certain anti-inflammatory medicinal products (non-steroidal anti-inflammatory disease; These are also PROFF® pain code), an encryptionseniorization of infectious inflammation (eg Development of a necrotizing fasciitis) has been described.
Very rarely, under the use of ibuprofen, the symptoms of a mereglitis based on infection was not based on infection (Aseptic Meningitis) How strong headaches, nausea, vomiting, fever, neck stiffness or consciousness true is observed. An increased risk seems to be for patients who already suffer from certain autoimmune diseases (systemic lupus erythematoses, mixing collagenosis). If, during the application of PROFF pain, characters of an infection (eg Redness, swelling, overheating, pain, fever) occur or worsen, therefore, should the doctor be consulted immediately.

> Vascular diseases:
Very rare, hypertension (arterial hypertension).

> Diseases of the immune system:
Occasionally: Hypersensitivity reactions with rashes and skinchilden as well as asthma attacks (if necessary with blood pressure drop). In this case, the doctor must be informed immediately and PROFF® Pain deposit must no longer be taken / applied.
Very rare: severe general hypersensitivity reactions. They can express themselves as: facial edema, tongue swelling, internal laryngeal swelling with narrowing of airways, air not, heart hunt, blood pressure drop to the threatening shock. If one of these phenomena, which can already occur in first-time use, immediate medical assistance is required.

> Liver and bile diseases:
Very rare: liver dysfunctions, liver damage, especially in long-term therapy, liver failure, acute lifetitis (Hepatitis). For longer permanent administration, the liver values should be checked regularly.

> Psychiatric diseases:
Very rare: psychotic reactions, depression.

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

5. How are PROFF to keep an analgesic?

Keep this medicine inaccessible to children. You may not use the medicinal product after the expiry date specified on the outboard and blister after the expiry date. The expiry 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

As for PROFF® analgesis:

The active ingredient is: ibuprofen
1 coated tablet contains 200 mg ibuprofen

The other ingredients are:
High-disperses silica, corn starch, copovidone, microcrystalline cellulose, alginic acid, magnesium stearate (pH. EUR.), Sucrose, Talc, Carnauba Wax, Povidone, Carmelosis sodium, dye: titanium dioxide (E 171).

How PROFF® pain deposit look and content of the pack:
PROFF® analgesis are white, round, bikonvexic coated tablets in PVC / aluminum blister packs. Pack of 10 Plated tablets pack with 20 plated tablets

Pharmaceutical entrepreneur and manufacturer:
Dolorgiet GmbH & Co. Kg
Otto-von-Guericke-Strasse 1,
53757 Saint Augustin
Telephone: 02241 / 317-0,
Fax: 02241/317 390,
E-Mail: [email protected]

This leaflet was recently revised in August 2015

Source: Information of the leaflet
Status: 10/2015