Dismenol N film-coated tablets, 20 pcs

Instructions for use for Dismenol N film-coated tablets, 20 pcs

Important notes (compulsory information):

Dismenol N. active ingredient: ibuprofen. In light to moderately strong pain, such as headaches, toothache, regulatory pain; Fever.

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


Instructions for use: Information for users

Dismenol N 200 mg film tablet
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 Dismenol N and what is it used for?
2. What do you need to consider before taking Dismenol N?
3. How is Dismenol N taking?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Dismenol N?
6. Content of the pack and further information

1. What is Dismenol N and what is it used for?

Dismenol N is an anti-inflammatory and analgesic medicine (non-steroidal anti-phlogistikum / analgesic)

Dismenol N is applied to

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

2. What do you need to consider before taking Dismenol N?

Dismenol N must not be taken,

• if you allergic against ibuprofen or one of the section 6. stated other ingredients of this medicinal product are;
• when they reacted in the past with asthma attacks, nasal mucosal swellings or skin reactions after ingestion of acetylsalicylic acid or other non-steroidal anti-steroids.
• with unexplained blood formation disorders;
• in 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;
• for heavy liver or renal impairment
• for heavy heart failure (heart failure)
• In the last third of pregnancy.
• for children under 20 kg (6 years), as this dose thickness is usually not suitable due to the active ingredient content.

Warnings and Precautions:
Please talk to your doctor or pharmacist before taking Dismenol N.

Safety in the gastrointestinal tract:
Simultaneous use of dismenol N with other non-steroidal anti-inflammatory inhibitors, including so-called COX 2 inhibitors (cycloxigenase-2 inhibitors), should be avoided.

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 ulcations in prehistory, in particular with the complications of bleeding or breakthrough (see section 2: "Dismenol N must not be taken "), and in older patients. These patients should start treatment with the lowest available dose. For these patients and patients who require accompanying therapy with low-metered acetylsalicylic acid (ASS) or other medicines that can increase the risk of gastrointestinal diseases, a combination therapy with gastric mucosal protective medicinal products (eg misoprostol or Proton pump inhibitor) are considered. If you have a history of side effects on the gastrointestinal tract, especially at a higher age, you should have any unusual symptoms in the abdomen (especially gastrointestinal bleeding) Report in particular 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: 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 (see section 2: "Taking Dismenol N along with other medicines"). If it comes to stomach intestinal bleeding or ulceration for you during treatment with Dismenol N, the treatment must be deducted. NSAR should be in patients with a gastrointestinal disease in the prehistory (Colitis ulcerosa, Crohn's disease) To be careful, as your condition can deteriorate (see section 4.).

Effects at the cardiovascular system:
Anti-inflammatory agent / painkillers such as ibuprofen can be accompanied by a slightly increased risk of cardiac array or stroke, especially for high doses applications. Do not exceed the recommended dose or duration of treatment. You should discuss your treatment before the breaking of Dismenol N with your doctor or pharmacist if

• You have a heart disease, including heart failure (Heart failure) and angina (chest pain), have or a heart attack, a bypass operation, a peripheral arterial sealing disease (circulation disorders in the legs or feet due to narrowed or sealed arteries) or any kind of stroke (including mini-stroke or transitory ischemic attack , "TIA.
• Hypertension, diabetes, or high cholesterol levels or have heart disease or strokes in their family history or when they are smokers.

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 a hypersensitivity reaction, Dismenol N should be discontinued and the doctor should be consulted immediately. During a windpox infection (varicella infection), a use of dismenol n should be avoided.

Other notes:
Dismenol N should only be applied under strict balance of the benefit risk ratio:

• in certain innate blood formation disorders (eg acute intermittent porphyria);
• in certain autoimmune diseases (systemic lupus erythematosities and mixing collagenosis);

A particularly careful medicale Monitor is required:

• with impaired kidney or liver function.
• immediately after larger surgical procedures;
• in allergies (eg skin reactions on other medicines, asthma, hay fever), chronic nasal mucosa swellings or chronic, the respiratory respiratory respiratory diseases

Heavy acute hypersensitivity reactions (eg Anaphylactic shock) are very rarely observed. At first signs of a heavy hypersensitivity reaction after taking Dismenol N, the therapy must be aborted. The symptoms corresponding, medically necessary measures must be initiated by expert persons. Ibuprofen, the active ingredient of dismenol N, can temporarily inhibit the platelet function (thrombocyte aggregation). Patients with blood clotting disorders should therefore be carefully monitored.

For longer permanent administration of Dismenol N, a regular control of liver values, renal function and blood image is required. When taking Dismenol N before operational interventions, the doctor or dentist should be consulted or informed.

For prolonged use of painkillers, headaches can not be treated by increased doses of the medicine. Ask your doctor about advice if you often suffer from headaches despite taking Dismenol N! 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). Dismenol N 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: "Dismenol N must not be taken".

Taking Dismenol N along with other medicines:
Inform your doctor or pharmacist if you take / use other medicines or recently taken / applied or intend to take / use / use other medicines, even if it is non-prescription medicines. The simultaneous application of Dismenol N and digoxin (means for strengthening heart force), phenytoin (agents for the treatment of convulsive accidents) or lithium (agent for the treatment of spiritual 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. Drugs that act at tempering tempering (d. H. Dilute blood or prevent blood clotting, e.g. As acetylsalicylic acid, warfarin, ticlopidine) as well as drugs lowering high blood pressure (ACE inhibitors such as captopril, beta blocker such. B. Atenolol-containing medicines, angiotensinii, receptor blockers such. B. Losartan) can also affect the treatment with Dismenol N or be affected by such a self. Therefore, before using Dismenol N, together with other medicines, you should always catch up with the advice of your doctor or pharmacist. Dismenol N can attenuate the effect of dewatering and blood pressure-lowering medicines (diuretics and antihypertensives). Dismenol N 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 dismenol N and potassium-efficient dewatering agents (certain diuretics) can lead to an increase in the potassium mirror in the blood. Simultaneous administration of Dismenol N with other inflammatory and pain-resources from the group of non-steroidal anti-inflammatory or glucocorticoids increases the risk of gastrointestinal ulcers or bleeding. Thrombocyte aggregation inhibitors and certain antidepressants (selective serotonin recording inhibitors / SSRI) can increase the risk of gastrointestinal bleeding. The administration of Dismenol N within 24 hours before or after Habe of methotrexate can lead to an increased concentration of methotrexate and an increase in undesirable effects. The risk of a kidney-damaging effect by Ciclosporin (means used to prevent graft fusions, but also in rheumatic treatment) is increased by the simultaneous administration of certain non-steroidal anti-phlogistics. This effect can also be excluded for a combination of Ciclosporin with Dismenol N. Medicines containing sampleecide or sulfinpyrazone (agent for treatment of gout) can delay the excretion of ibuprofen. This can lead to an enrichment of Dismenol N 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. Zidovudine: 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 Dismenol N along with food and beverages:
During the use of dismenol n, you should not drink alcohol as possible.

Pregnancy and breast feeding period:
Ask your doctor or pharmacist for advice before taking / application of all medicines. If a pregnancy is detected during the use of Dismenol N, 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, Dismenol N may not be applied because of an increased risk of complications for mother and child. 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. If a longer application or taking of higher doses is prescribed, but an early deselectric should be considered. For the influence of dismenol on fertility see under 2 (other instructions).

Driving and ability to operate machines:
Since in the application of Dismenol N higher dosage, 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 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!

3. What is Dismenol N taking?

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 Dismenol N without medical or dental advice no longer than 4 days.

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

Body weight (age)	Single dose	Maximum daily dose
20-29 kg (6-9 years)	1 Film tablet (corresponding to 200 mg ibuprofen)	3 Film-coated tablets (corresponding to 600 mg ibuprofen)
30-39 kg (10-12 years)	1 Film tablet (corresponding to 200 mg ibuprofen)	4 Film-coated tablets (corresponding to 800 mg ibuprofen)
> 40 kg (children and adolescents from 12 years, adults)	1 - 2 Film-coated tablets (corresponding 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 for children and adolescents:
According to the table above. The intake depends on the body weight or age and due to the dose thickness of the tablets from a body weight of 20 kg.

Dosage in older people:
No special dose adjustment is required.
Side effects can be reduced by applying the lowest effective dose to the shortest time required for symptom control.

Type of application:
Please take the film-coated tablets 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 advisable to take Dismenol N during meals. Please talk to your doctor or pharmacist if you have the impression that the effect of Dismensol N is too strong or too weak.

If you take a greater amount of dismenol n than you should:
Assume Dismenol N according to the doctor's instructions or according to the dosing 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, blood pressure drop, reduced breathing (respiratory depression) and the blorus dyeing of skin and mucous membranes (cyanosis) can occur. There is no specific antidote (antidote). If you suspect an overdose with Dismenol N, please notify your doctor. This may decide according to the severity of poisoning over the necessary measures.

If you forget to take Dismenol N:
If you have forgotten taking once, take more than the usual recommended amount at the next gift. 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 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 1,200 mg ibuprofen (= 6 film-coated tablets dismenol n) for oral dosage forms and a maximum of 1,800 mg for suppositories.

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. Pharmaceuticals such as Dismenol N may be associated with a slightly increased risk of cardiac attacks ("heart attack") or strokes.

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.

Frequently:

• Gastrointestinal complaints such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation and minor gastrointestinal blood losses that can cause anemia (anemia) in exceptional cases.

Occasionally:

• Central nervous disturbances such as headaches, dizziness, insomnia, excitement, irritability or fatigue.
• Visual disorders.
• Stomach / duodenal ulcer (peptic ulcer), under certain circumstances with bleeding and breakthrough, oral mucosal inflammation with ulcerator (ulcerative stomatitis), reinforcement of a colitis or a crohn disease. Gastric mucosal inflammation (Gastritis).
• Hypersensitivity reactions with rashes and skinchilden as well as asthma attacks (possibly with blood pressure drop). In this case, the doctor must be informed immediately, and Dismenol N may no longer be taken.

Rarely:

• Earritis (tinnitus).

Very rare:

• Palpitations (palpitations), heart muscle weakness (Heart insufficiency), heart attack.
• Disruptions of blood formation (anemia, leukopenia, thrombocytopenia, tank tops, 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-cut medicines should be omitted. For long-term treatment, the blood picture should be checked regularly.
• 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 must discontinue Dismenol N and immediately inform the doctor.
• Training of membrane-like constrictions in thin and colon (Intestinal, diaphragmatic strictures).
• Increased water storage in the tissue (edema), especially in patients with hypertension or impaired renal function; Nephrotic syndrome (water collection in the body (edema) and strong protein excretion in urine); Inflammatory kidney disease (Interstitial nephritis) that can be accompanied by an 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, you must discontinue Dismenol N and contact your doctor immediately. Kidney function should be regularly controlled by the doctor.
• Heavy skin reactions such as rash with redness and blistering (eg 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 windpox disease (Varicelle infection) come (see also section "Infections and Parasitic Diseases").
• Hypertension (arterial hypertension).
• Heavy general hypersensitivity reactionen. You can express yourself as: facial edema, tongue swelling, internal laryngeal swelling with constraints of airways, air not, heart hunt, blood pressure drop up to the life-threatening shock. If one of these phenomena, which can already occur in first-time use, immediate medical assistance is required.
• Liver function disorders, liver damage, especially in long-term therapy, liver failure, acute lifetitis (hepatitis). For longer permanent administration, the liver values should be checked regularly.
• Psychotic reactions, depression.

Infections and parasitic diseases:
Very rare is in the temporal connection with the application of certain anti-inflammatory drugs (non-steroidal anti-inflammatory movie; which is also part of Dismenol N), a deterioration 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 an infection was (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 a sign of an infection (eg redness, swelling, overheating, pain, fever) occurs during the application of Dismenol N, it is recommended to visit the doctor immediately.

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 have side effects directly through the
Federal Institute for Pharmaceuticals and Medical Products
Dept. Pharmacovigilance
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn
Website: http://www.bfarm.de
Show. By reporting side effects, you can help to provide more information about the security of this medicine.

5. What is Dismenol N keeping?

Keep this medicine inaccessible to children. You may follow this medicine after the on the outer carton / container "Usable until" stated expiry date no longer use.

6. Content of the pack and further information

As for Dismenol N
The active ingredient is:
1 film tablet contains 200 mg ibuprofen

The other ingredients are:
Corn starch, pre-ordered corn starch, carboxymethyl starch (type A), talc, magnesium stearate, hypromellosis, dye E 171, Macrogol 400.

Like Dismenol N looks and content of the pack:
Dismenol N are white, round, rolled outwards on both sides (Bikonvexe) film-coated tablets.
Dismenol N are available in a pack size with 20 film-coated tablets.

Pharmaceutic entrepreneur:
Georg Simons GmbH
Eckenheimer Landstraße 100
60318 Frankfurt / Main
Telephone: 069 / 1503-1
Fax: 069 / 1503-200
Georg Simons GmbH is a company of the Merz Group.

Manufacturer:
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstraße 100
60318 Frankfurt / Main

This leaflet was recently revised in August 2015.

Source: Information of the leaflet
Status: 09/2015