Ketesse 25 mg powder oral solution 10 sachets

This medicine is a pain-relieving medicine from the group of so-called non-steroidal anti-inflammatory drugs (NSAIDs, painkillers and anti-inflammatory drugs).
This medicine is used for the short-term symptomatic treatment of mild to moderate acute pain, e.g. B. acute pain of the musculoskeletal system, period pain (dysmenorrhea), toothache. This medicine is intended for use in adults.

If you don't feel better after 3-4 days or even feel worse, contact your doctor.

Contraindications

Ketsesse must not be taken

• if you are allergic to dexketoprofen or any of the other ingredients of this medicine listed in section 6,
• if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• if you suffer from asthma or asthma attacks after taking acetylsalicylic acid or other NSAIDs, acute allergic rhinitis (a short-term inflammation of the nasal mucosa), nasal polyps (allergy-related ulcers in the nose), hives (skin rash), angioedema (swelling of the face, eyes , on the lips or on the tongue or have suffered from shortness of breath) or wheezing,
• if you have ever suffered from photoallergic or phototoxic reactions (a certain form of redness/blistering of areas of skin exposed to sunlight) during treatment with ketoprofen (an NSAID) or fibrates (medicines used to lower blood fat levels),
• if you have a stomach/duodenal ulcer or gastrointestinal bleeding or if you have suffered from a gastrointestinal bleeding, a gastrointestinal ulcer or a gastrointestinal breakthrough (perforation) in the past,
• if you suffer from chronic digestive disorders (e.g. upset stomach, heartburn),
• if you have ever suffered from gastrointestinal bleeding or a gastrointestinal perforation due to previous use of non-steroidal pain and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs, NSAIDs),
• if you suffer from certain chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis),
• if you suffer from severe heart failure, moderate to severe kidney dysfunction or severe liver dysfunction,
• if you suffer from bleeding problems or a blood clotting disorder,
• if you are severely dehydrated (significant loss of fluid from the body), e.g. B. due to vomiting, diarrhea or insufficient fluid intake,
• if you are in the last three months of pregnancy or are breastfeeding.

Interactions

Taking Ketesse with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even if they are taken without a prescription. There are some medicines that should not be taken together or whose dosage may need to be adjusted if taken together.

Always tell your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to this medicine:

Combinations that are not recommended:

• Acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs
• Warfarin, heparin or other anticoagulant medicines
• Lithium: used to treat certain types of depression
• Methotrexate (anticancer medicine or immunosuppressant), used in high doses above 15 mg/week
• Hydantoin and phenytoin: used for epilepsy
• Sulfamethoxazole: used for bacterial infections

Combinations requiring careful use:

• ACE inhibitors, diuretics and angiotensin II receptor antagonists (used to lower blood pressure and for heart problems)
• Pentoxifylline and Oxpentifylline: are used for chronic venous ulcers
• Zidovudine: used to treat viral infections
• Aminoglycoside antibiotics: used for bacterial infections
• Sulfonylureas (e.g. chlorpropamide and glibenclamide), used to treat diabetes
• Methotrexate, used in low doses of less than 15 mg/week

Combinations that need to be carefully checked:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin): are used for bacterial infections
• Ciclosporin and tacrolimus: are used to treat immune diseases and in organ transplants
• Streptokinase and other thrombolytic or fibrinolytic medicines: are used against thrombosis (blood clots).
• probenecid: used for gout
• Digoxin: used to treat chronic heart failure
• Mifepristone: used as an abortifacient
• Antidepressants of the SSRI type (selective serotonin reuptake inhibitors)
• Platelet aggregation inhibitors: are used to prevent thrombosis (blood clots).
• Beta blockers, used to treat high blood pressure and heart problems
• Tenofovir, Deferasirox, Pemetrexed

If you have any doubts about taking other medicines with Ketesse, ask your doctor or pharmacist.

Taking Ketesse with food, drink and alcohol
It is recommended that Ketesse be taken with food to reduce the possibility of causing stomach upset (see section 3 “Method of administration”)
You must not drink alcohol while using this medicine . Some side effects, particularly those affecting the gastrointestinal tract or central nervous system, may occur more frequently when alcohol is taken at the same time.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine must not be taken in the last three months of pregnancy or while breastfeeding.
It can cause kidney and heart problems in your unborn baby. It can affect you and your baby's bleeding tendency and may cause labor to start later or take longer than expected.
You should not take Ketesse during the first 6 months of pregnancy unless absolutely necessary and recommended by your doctor. If you need treatment during this period or while you are trying to become pregnant, the dosage should be as low as possible and for as short a period of time as possible.
If you take Ketesse for more than a few days from the 20th week of your pregnancy, it may cause kidney problems in your unborn baby, which may lead to a reduced amount of amniotic fluid surrounding your baby (oligohydramnios) or it may cause a blood vessel to narrow (Ductus arteriosus) in your child's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

The use of this medicine is not recommended when trying to become pregnant or during infertility studies.
Regarding the possible effects on female fertility, see also Section 2. “Warnings and Precautions”.

Ability to drive and use machines

Caution: This medicine can impair your ability to react and drive.

This medicine may have a slight influence on the ability to drive and use machines, as dizziness, drowsiness and visual disturbances may occur after taking it. If you experience these side effects, do not drive or use machines until the symptoms have subsided. Ask your doctor for advice.

Application

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.

The lowest effective dose should be taken for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

Adults over 18 years of age
The generally recommended dose is 1 sachet (25 mg dexketoprofen) every 8 hours, up to a maximum of 3 sachets daily (75 mg dexketoprofen).

If there is no improvement after 3-4 days or your condition worsens, contact your doctor. Your doctor will tell you how many sachets you need to take each day and for how long. The dose you need depends on the type, severity and duration of your pain.

If you are elderly or have kidney or liver problems, start treatment with a total daily dose of 2 sachets (50 mg of dexketoprofen).
In elderly patients, if dexketoprofen is well tolerated, this initial dose may later be increased to the generally recommended dose (75 mg).

Use in children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.

Method of administration
The oral solution can be taken directly from the sachet or after stirring the entire contents of the sachet into a glass of water. After opening the sachet, the entire contents must be taken immediately. Take the contents of the sachet with food as this helps to reduce the risk of gastrointestinal side effects (see also section 2 of this leaflet). If your pain is severe and you need quicker relief, take the sachet contents on an empty stomach, at least 15 minutes before eating, as the medicine will then work slightly faster.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Possible side effects are listed according to the likelihood of them occurring. Since the peak plasma levels of dexketoprofen for the oral solution are higher than those reported for the tablets, a potential increased risk of adverse (gastrointestinal) effects cannot be excluded.

Common side effects (may affect up to 1 in 10 people)
nausea and/or vomiting, abdominal pain predominantly in the upper quadrants, diarrhea and indigestion (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):
vertigo, dizziness/lightheadedness, sleepiness, difficulty sleeping, nervousness, headache, palpitations, flushing, inflammation of the stomach lining (gastritis), constipation, dry mouth, flatulence, rash, fatigue, Pain, chills and feeling feverish, general malaise.

Rare side effects (may affect up to 1 in 1,000 people)
peptic ulcer, bleeding or perforation in the gastrointestinal area (recognizable as vomiting blood or tarry stools), fainting, high blood pressure, slow breathing, fluid retention in the tissues and peripheral swelling (e.g . swollen ankles), swelling of the larynx, loss of appetite (anorexia), abnormal sensations, hives (itchy rash), acne, increased sweating, back pain, increased urination, menstrual disorders, prostate problems, abnormal values ​​in liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure .

Very rare side effects (may affect up to 1 in 10,000 people)
Anaphylactic reaction (hypersensitivity reaction that can lead to collapse), open sores on the skin, mouth, eyes and intimate areas (Stevens-Johnson and Lyell syndromes). ), facial swelling or swelling of the lips and throat (angioedema), shortness of breath due to narrowed airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, hypersensitivity to light, itching, kidney problems, reduced number of white blood cells (neutropenia), reduced number of blood platelets (thrombocytopenia).

Tell your doctor immediately if you notice any gastrointestinal side effects (e.g. stomach pain, heartburn or bleeding) at the start of treatment or if you have previously suffered from any of these side effects as a result of long-term treatment with anti-inflammatory drugs, especially if you are older.

Stop taking this medicine immediately if you notice a rash or sores in the mouth or genital area, or other signs of allergy.

Fluid retention and swelling (especially of the ankles and legs), increased high blood pressure and heart failure have been reported during treatment with NSAIDs.

The use of medicines such as Ketesse may be associated with a slightly increased risk of having a heart attack or stroke.

In patients with certain immune disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache, or stiff neck.

The most frequently observed side effects involve the digestive tract. Stomach or duodenal ulcers (peptic ulcers), perforation (perforations) or bleeding, sometimes fatal, may occur, especially in older patients. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, hematemesis, ulcer-like inflammation of the oral mucosa, worsening of colon inflammation or Crohn's disease have been reported after use. Inflammation of the stomach lining (gastritis) has been observed less frequently.

As with other NSAIDs, aseptic meningitis (which can occur particularly in patients with systemic lupus erythematosus or mixed connective tissue disease), hematological reactions (small patches of bleeding in the skin, subcutaneous tissue or mucous membranes, anemia due to the reduction of the blood-forming bone marrow or the breakdown of red blood cells [aplastic or hemolytic anemia] and rarely severe reduction in white blood cells [agranulocytosis] or reduction in bone marrow [medullary hypoplasia]).

composition

The active ingredient is dexketoprofen (as dexketoprofen trometamol).
Each oral solution sachet contains 25 mg of dexketoprofen (as dexketoprofen-trometamol).

The other ingredients are ammonium glycyrrhizinate, neohesperidine dihydrochalcone, methyl 4-hydroxybenzoate (E 218), saccharin sodium, sucrose, macrogol 400, lemon flavor, povidone K-90, disodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, purified water (see section 2. “Ketesse contains Sucrose").

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