Aktren Special soft capsules, 20 pcs

Instructions for use for Aktren Special soft capsules, 20 pcs

Important notes (compulsory information):

Aktren Special. Active ingredient: ibuprofen. Application areas: Easy to moderately strong pain such as headaches, toothache, regulating pain; Fever. Acute headache at migraine with and without aura.

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


LEAFLET: INFORMATION FOR THE USER

Aktren Special
Soft capsule with 400 mg ibuprofen

Read the entire leaflet carefully before you start taking / application of this medicine. This medicine is also available without prescription. In order to achieve the best possible treatment success, Aktren Specifically, however, they are used properly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms aggravate or get no improvement after 4 days, you will definitely see a doctor.
• If one of the side effects you significantly affect or notice side effects that are not specified in this information information, inform your doctor or pharmacist.

This leaflet contains:

1. What is Aktren Special, and what is it applied for?
2. What do you need to know before taking / application of Aktren special?
3. How to take / use Aktren Special?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Aktren special?
6. ADDITIONAL INFORMATION

1. What is Aktren Special, and what is it used for?

Aktren Special is an anti-inflammatory and analgesic medicine (non-steroidal anti-phlogistikum / analgesic). Applications of Aktren Special

Aktren Special is used

• for light to moderately strong pain such as headaches, toothache, regulating pain;
• with fever;
• to treat the acute headache phase with migraine with and without aura.

2. What do you need to pay special attention before taking / application of Aktren special?

Aktren Special must not be taken / applied:

• in known hypersensitivity to the active substance ibuprofen or any of the other ingredients of the medicament;
• if they have reacted in the past with asthma attacks, nasal mucosal swellings or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory inhibitors;
• with unexplained blood formation disorders;
• with existing or past stomach / duodenal ulcer (peptic ulcer) or bleeding (at least 2 different episodes of proven ulcers or bleeding);
• in gastrointestinal bleeding or breakthrough (perforation) in the history associated with a previous therapy with non-steroidal antirheumatics / anti-phlogistika (NSAR);
• in brain bleeding (cerebrovascular bleeding) or other active bleeding;
• in severe liver or renal impairment;
• in severe heart failure (heart failure);
• in the last third of pregnancy;
• for children under 12 years, since this dose thickness is not suitable due to the higher active ingredient content.

Special care when taking Aktren Special is required:
Safety in the gastrointestinal tract a simultaneous application of Aktren Special with other non-steroidal inflammatory inhibitors, including so-called COX-2 inhibitors (cyclooxygenase 2-inhibitors) should be avoided. Side effects can be reduced by the lowest effective dose over the shortest, for the symptom konnTrolle required period is applied.

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 for the occurrence of gastrointestinal bleeding, ulcers and breakages is higher with increasing NSAR dose, in patients with ulcers in prehistory, in particular with the complications of bleeding or breakthrough (see Section 2: "Aktren Special must not be taken / applied "), 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: "When taking / using Aktren Special with other medicines"). If it comes with you during treatment Aktren Special to stomach intestinal bleeding or ulcers is the treatment. NSAR should be used in patients with a gastrointestinal disease in the prehistory (colitis ulcerosa, crohn's disease), as their condition can deteriorate (see section 4).

Effects at the cardiovascular system:
Medicines like Aktren Special may be associated with a slightly increased risk of cardiac attacks ("heart attack") or strokes. Any risk is more likely with high doses and longer lasting treatment. Do not exceed the recommended dose or treatment time (maximum 4 days)! If you have heart problems or a preceding stroke or think that you could have a risk to these diseases (e.g., if you have high blood pressure, diabetes or high cholesterol levels or smokers), you should discuss your treatment with your doctor or pharmacist.

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. The first sign of rashes, mucosal defects or other signs of a hypersensitivity reaction should Aktren Special issued and the doctor will be consulted immediately. During a windpox infection (varicella infection) should be an application of Aktren be avoided.

Other notes:
Aktren Special should only be used under strict weighing the benefit risk ratio:

• in certain innate blood formation disorders (e.g., acute intermittent porphyria);
• for certain autoimmune diseases (Systemischer lupus erythematosodes and mixing collagenosis).

A particularly careful medical monitoring is required:

• with impaired kidney or liver function;
• immediately after larger surgical procedures;
• in allergies (e.g., skin reactions on other medicines, asthma, hay fever), chronic nasal mucosal thriplets or chronic respiratory respiratory respiratory diseases.

Heavy acute hypersensitivity reactions (e.g., anaphylactic shock) are very rarely observed. For first signs of a heavy hypersensitivity reaction after taking / administration of Aktren Special the therapy must be canceled. The symptoms corresponding, medically necessary measures must be initiated by expert persons.
Ibuprofen, the active ingredient of Aktren Special, can temporarily inhibit the platelet function (thrombocyte aggregation). Patients with blood clotting disorders should therefore be carefully monitored. With simultaneous use of ibuprofen-containing medicines, the coagulation inhibiting effect of low-metered acetylsalicylic acid (prevention of the formation of blood clots) be impaired. In this case, you should not apply ibuprofen-containing medicines without your doctor's explicit instruction.

If you simultaneously take medicinal products for inhibiting blood clotting or reducing blood sugar, precautionary controls of blood clotting or blood sugar levels should take place. For longer permanent administration of Aktren Special is required a regular control of liver values, renal function as well as the blood count.

When taking Aktren Special prior to operational interventions is the doctor or dentist questioning or informing.
For prolonged use of painkillers, headaches can not be treated by increased doses of the medicine. Ask your doctor about advice if you have, despite taking Aktren Special often suffer from headaches! Generally, the habitual intake of painkillers, especially when combining several analgesic agents, for permanent kidney damage with the risk of renal failure (analgesics nephropathy) to lead.

Aktren Special belongs 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: "Aktren Special can not be taken / applied".

When taking Aktren Special with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines.
The simultaneous application of Aktren Special and digoxin (means for strengthening heart power), phenytoin (medium for the treatment of convulsions) or lithium (agent for the treatment of spiritual-mental illnesses) can increase the concentration of these medicines in the blood. Control of serum digoxin mirrors, serum phenytoin mirrors and serum lithium levels is usually not required when used (a maximum of 4 days.

Aktren Special can be the effect of dewatering and blood pressure medicines (diuretics and antihypertensives) To weaken.
Aktren Special 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 Aktren Special and potassium-saving dewatering agents (certain diuretics) can lead to an increase in the potassium mirror in the blood.
Simultaneous administration of Aktren Special co-primary inflammatory and pain-resource agents from the group of non-steroidal anti-inflammatory or glucocorticoids increases the risk of gastrointestinal ulcers or bleeding. Thrombocytenaggregation inhibitors such as acetylsalicylic acid and certain antidepressants (selective serotonin reuptake inhibitors / SSRI) Can increase the risk of gastrointestinal bleeding. With simultaneous use of ibuprofen, the thrombocyte aggregation-inhibiting effect of low-dose acetylsalicylic acid may be impaired (see Section 2: "Special care when taking Aktren Special is required").

The gift of Aktren Special within 24 hours before or after administration of methotrexate can lead to increased concentration of methotrexate and an increase in its unwanted effects.

The risk of kidney-damaging effects by Ciclosporin (Means used to prevent graft exercises, 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 sampleecide or sulfinpyrazone (agent for treatment of gout) can delay the excretion of ibuprofen. This can cause an enrichment of Aktren Special in the body with reinforcement of its unwanted effects come. There are individual case reports on interactions between ibuprofen and blood clotting resources. 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 medicines 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.

When taking Aktren Special together with food and beverages:
During the application of Aktren Special should not drink alcohol as possible.

Pregnancy:
Becomes during an application of Aktren Special a pregnancy detected, so 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 may Aktren Special because of an increased risk of complications for mother and child not be used.

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.

Driveion and use of machines:
Because in the application of Aktren Special in higher dosing Central nervous side effects such as fatigue and dizziness can occur, the reaction assets can be changed in individual cases and the ability to actively participate in road traffic and servicing machines can be impaired. 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!

Important information about certain ingredients of Aktren Special:
Macrogolglycerol hydroxystearate can cause gastric failure and diarrhea.

3. How to take / use Aktren Special?

Unless otherwise prescribed by the doctor, the following dosing guidelines apply:
Take Aktren Always exactly as statement in this leaflet. Please ask your doctor or pharmacist if you are not sure. Take Aktren Special without medical or dental advice no longer than 4 Days.

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

Body weight (age)	Single dose in number of soft capsules	max. Daily dose in number of soft capsules
> 40 kg (children and adolescents from 12 years and adults)	1 Soft capsule	3 Soft capsules

If you have taken / applied the maximum single dose, wait at least 6 hours to the next intake / application.

Dosage in older people:
No special dose adjustment is required.

Type of application:
Please take the soft capsules with abundant fluid (eg a glass of water) during or after a meal. For patients who have a sensitive stomach, it is recommended Aktren To take special during meals. Please talk to your doctor or pharmacist if you have the impression that the effect of Aktren Special too strong or too weak.

If you have a larger amount of Aktren Specialceed / applied as you should:
Take / use Aktren Special according to the instructions of the doctor or according to the dosing instructions specified in the package leaflet on / at. 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).

With suspected overdose with Aktren Special Notify your doctor. This may decide according to the severity of poisoning over the necessary measures.

If you are taking / application of Aktren Forgot special forgotten:
If you have forgotten the ingestion / application once, take / use / contact the next gift more than the usual recommended amount.

4. Which side effects are possible?

Like all medicines can also Aktren Have special side effects. If you are watching the following side effects, please discuss this with your doctor who determines how to proceed.

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 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 does not estimate.

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 for oral dosage forms (= 3 soft capsules Aktren Special). The following undesirable pharmaceutical effects must be taken into account that they are predominantly dose-dependent and patient to patient. The most frequently observed side effects involve 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, bloating, constipation, digestive complaints, abdominal pain, teery chair, blebering, ulcerative stomatitis, mixing 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. Medicines like Aktren Special may be associated with a slightly increased risk of cardiac attacks ("heart attack") or strokes.

Heart diseases:
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:
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 ulcerosa or a crohn disease, gastric mucosal inflammation (gastritis).
Very rare: inflammation of the esophagus (esophagitis) and the pancreas (pancreatitis).
Very rare: training of membrane-like constrictions in thin and colon (intestinal, diaphragmic strictures).
Should stronger pain in the upper abdomen, bruising, blood in the chair and / or a black staining of the chair occur, so you need Aktren Setting up special and inform the doctor immediately.

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 occur or worse, so you need Aktren Setting up special and contact your doctor immediately.

Diseases of the skin and subcutaneous tissue:
Very rare: heavy skin reactions like rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis / 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 movie; It also includes Aktren special), a deterioration of infection-related inflammation (e.g., developing a necrotizing fasciitis) has been described.
Very rare was under the application from ibuprofen the symptoms of a mereglitis (aseptic meningitis) such as strong headaches, nausea, vomiting, fever, neck stiffness or consciousness. 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 Aktren Special signs of an infection (e.g., redness, swelling, overheating, pain, fever) Recommendation or worsen, the doctor should therefore 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 is to be informed immediately, and Aktren Special 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.

5. How to keep Aktren special?

Store drug out of reach of children. You may not use the medicinal product after the expiry date specified on the outbox / container. Storage conditions: Do not store over 30 ° C!

6. Further information

What contains Aktren Special:
The active ingredient is ibuprofen.
1 soft capsule contains 400 mg ibuprofen.

The other ingredients are:
Poloxamer 124, propylene glycol, Macrogolglycerolhydroxystearate (Ph.eur.), Gelatin, Glycerol 85%, purified water, titanium dioxide (E171).

Like Aktren Special looks and content of the pack:
Aktren Special is a white soft capsule and is in packs with 10 or 20 soft capsules available.

Pharmaceutic entrepreneur
Bayer Vital GmbH,
51368 Leverkusen,
Germany

Manufacturer
Dolorgiet GmbH & Co. KG,
Otto-von-Guericke-Str. 1,
53754 pcs. Augustin,
Germany

This information information was last revised in March 2011

Source: Information of the leaflet
Status: 03/2015