Ketonal Active 50mg 10 Tablets na bol przeciwbolowy

CATEGORY: MEDICINES

1. What Ketonal is and what it is used for

The active substance of Ketone is ketoprofen, which belongs to the group of non-steroidal anti-inflammatory drugs. Ketonal relieves pain and has an anti-inflammatory and antipyretic (temperature-limiting) effect.

For symptomatic treatment of conditions associated with mild to moderate pain associated with cold and fever, headache, tooth decay, pain after dental surgery, muscle pain, joint pain, back pain, mild arthritis pain, menstrual pain;

For short-term treatment of pain conditions associated with osteoarthritis, ankylosing spondylitis, gouty arthritis, painful musculoskeletal conditions / post-traumatic pain (including, e.g., sports-related injuries), postoperative pain, back pain.

2. What you need to know before taking Ketonal

If you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);

If you have experienced difficulty in breathing, asthma attack, mucosal edema and nasal congestion or nasal discharge (rhinitis), skin reactions (swelling or itchy rash) after taking ketoprofen or similar active substances such as acetylsalicylic acid (aspirin) or other non-steroidal anti- or some kind of allergic reaction;

If you have active stomach or duodenal ulcer, or if you have had bleeding from the gastrointestinal tract, ulcer or perforation in the past;

If you suffer from severe liver and kidney disease;

If you suffer from severe heart failure;

If you have a tendency to bleeding;

If you are pregnant in the last trimester of pregnancy.

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before taking Ketonal.

If you have had gastrointestinal problems in the past. You should know that when using non-steroidal anti-inflammatory drugs (NSAIDs), sudden ulcer, hemorrhage or perforation of the stomach or intestine may occur, sometimes with a fatal outcome. These effects can occur at any time during treatment, whether there were previous symptoms or a history of serious gastrointestinal reactions in the past. The risk of bleeding from the gastrointestinal tract, onset or perforation increases with increasing NSAID doses in patients with a history of ulcer, especially if it has been complicated by haemorrhage or perforation (see section 2), as well as in patients in the elderly. Ketoprofen may be associated with a high risk of gastrointestinal toxicity, which is also common with some other NSAIDs, especially at high doses. Your doctor will prescribe the lowest possible dose in the shortest possible time. If these conditions occur with you, and if you need to treat yourself further with acetylsalicylic acid (ASA) or other medicines that may increase the risks associated with the gastrointestinal tract, your doctor may recommend treatment with a agents (such as misoprostol or proton pump inhibitors). Patients who have had problems with the gastrointestinal tract, especially when they are elderly, should report any unusual abdominal (especially bleeding) symptoms, especially during the initial stage of treatment. If ulcer or bleeding from the gastrointestinal tract occurs in patients taking Ketonal, the dose should be discontinued immediately.

If you are taking medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, some antidepressants (SSRIs) or platelet anti-aggregates such as acetylsalicylic acid (aspirin).

NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) due to possible exacerbation.

If you suffer from asthma, chronic rhinitis (stuffy nose and / or discharge of the nose), chronic sinusitis, polyps in the nose.

If you have or have had heart, liver or kidney disease in the past.

If you have or have had in the past VIS eye blood pressure (hypertension) and heart failure with edema, ischemic heart disease. Regular monitoring is required in patients with hypertension and / or mild to moderate congestive heart failure as fluid retention and edema have been reported during NSAID therapy. Medicinal products such as Ketonal may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and longer treatment. Do not prolong the recommended duration of treatment.

If you have a history of heart disease, stroke or think you have an increased risk of developing (for example, high blood pressure, diabetes, elevated cholesterol, or if you are a smoker) you should discuss your treatment with your doctor or pharmacist.

If you have peripheral or cerebrovascular disease.

Ketonal should be discontinued at the first symptoms of skin rash, mucosal disturbances or other signs of hypersensitivity. Cases of severe skin reactions with redness and blistering associated with the use of NSAIDs, sometimes fatal, have been reported very rarely (see also section 4). Patients are supposed to be at the highest risk of developing such conditions at the start of treatment. In most cases, the onset of these events is within the first month of treatment.

If you have an infectious disease.

In women of childbearing potential, the use of this drug may cause reversible suppression of fertility. In women who can not conceive or carry out sterility studies, ketamine should be discontinued.

If you are elderly. You should be carefully monitored for any unusual symptoms (especially for bleeding from the digestive tract), especially at the beginning of treatment. Your doctor will also monitor you more closely.

If you are being treated with other NSAIDs, including selective cyclooxygenase 2 inhibitors (COX-2 inhibitors).

If you have rare hereditary conditions of intolerance to some sugars, namely: hereditary galactose intolerance, lapa-lactase deficiency or glucose-galactose malabsorption. Ketonal capsules contain lactose monohydrate and such patients should not use them.

Ketonal may mask the symptoms of infection and fever.

Adverse reactions can be reduced using the lowest effective dose for the shortest possible treatment duration necessary to control the symptoms. Do not exceed the recommended dose or duration of treatment.

Children and adolescents

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

Other Ketonal Drugs

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Other painkillers such as NSAIDs (eg acetylsalicylic acid, diclofenac, naproxen) as well as selective cyclooxygenase 2 (COX-2) inhibitors.

Medicines that are anticoagulants and break down blood clots (ie suppress / prevent clotting such as acetylsalicylic acid, clopidogrel, ticlopidine, heparin or warfarin)

Lithium (for the treatment of mania and depression): due to the risk of rising lithium levels in the blood, which may sometimes reach toxic values. When necessary, the level of lithium in the blood should be closely monitored and adjusted during and after ketone therapy.

Methotrexate (for treatment of malignancies) at doses higher than 15 mg weekly: due to an increased risk of haematological toxicity of methotrexate.

Medicines that can affect or be affected by concomitant use with Ketonal. You should consult your doctor or pharmacist before using Ketonal with other medicines such as:

Urinary excretion and / or urinary excretion (diuretics or so-called „drainage pill”): patients, especially dehydrated patients taking diuretics, are at an increased risk of developing renal insufficiency. Such patients should be rehydrated before commencement of concomitant administration, such as renal function should be re-controlled upon initiation of treatment. Diuretics increase the risk of nephrotoxicity of NSAIDs. Ketone reduces the effect of diuretics.

High doses of ACE inhibitors (ACE inhibitors, diuretics and angiotensin II antagonists such as losartan): in patients with impaired renal function (eg dehydrated or elderly patients), concomitant use of Ketonal with these medicines may further aggravate renal function and even cause acute renal failure.

Methotrexate at doses lower than 15 mg weekly: during the first weeks of concomitant administration, the full blood count should be monitored weekly. If there is a change in renal function or if the patient is elderly, control should be performed more frequently.

Corticosteroids (used in many conditions such as pain, edema, allergies, asthma, rheumatism and skin problems): due to an increased risk of gastrointestinal ulcer or bleeding.

Pentoxifylline (a medicine used against muscle pain due to peripheral vascular disease, reduces blood density and is prescribed for various diseases of the arteries and veins): due to an increased risk of bleeding. More frequent clinical monitoring and control of bleeding time is required.

Medicines for which concomitant use with ketone requires caution:

Antihypertensive agents (medicines prescribed for the treatment of high blood pressure – beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Ketone reduces the effects of antihypertensive agents.

Thrombolytics (medicines that „dissolve” the clots that are formed: due to an increased risk of bleeding).

Selective serotonin reuptake inhibitors (SSRIs) (prescribed for depression): due to an increased risk of gastrointestinal bleeding.

Probenecid (a medicine prescribed for gout and hyperuricaemia): Concomitant use can significantly enhance the effect of Ketonal.

Medicinal products to be considered when used concomitantly with Ketonal:

Ciclosporin and tacrolimus (medicines prescribed to suppress the immune response): there is an increased risk of kidney damage, especially in the elderly.

Ketonal with food and drink

It is recommended to avoid drinking alcohol during treatment with Ketonal.

Pregnancy, breast-feeding and fertility

Ketonal should not be taken during the first and second trimesters of pregnancy unless clearly necessary, according to your doctor.

If Ketone is prescribed to a woman trying to get pregnant or during the first and second trimesters of her pregnancy, the dose should be as low as possible and the duration of the dose as short as possible.

Ketonal is contraindicated during the third trimester of pregnancy.

Driving and using machines

Non-steroidal anti-inflammatory drugs may cause dizziness, vertigo, seizures, blurred vision, and drowsiness. If you experience such reactions, do not drive or operate machinery during treatment.

Ketonal contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ketonal.

Take the capsule with at least 100 ml of water or milk during or after a meal. You may also take antacids (medicines to suppress gastric secretion) at the same time to reduce the likelihood of adverse reactions of ketoprofen on the digestive tract.

Do not break or chew the capsule.

If you take more Ketonal than you should

If you have taken more than the prescribed Ketonal dose, talk to your doctor straight away or go to the Emergency Department immediately. Carry the medicine with you so the doctor knows what you have taken.

High doses of the medicine can cause nausea, vomiting, stomach pain, vomiting of blood, black stools, consciousness, drowsiness, respiratory depression, convulsions, decreased kidney function and renal failure.

In case of suspected massive overdose, gastric lavage with active carbon and symptomatic and supportive treatment is recommended to compensate for dehydration. If renal insufficiency is present, hemodialysis may be helpful in eliminating the circulating medicinal product. Treatment is symptomatic.

There is no specific antidote for overdose with ketoprofen.

If you forget to take Ketonal

Take the dose as soon as you remember. If it is time for the next dose, wait and take the next dose at the appointed time. Do not take a double dose to compensate for the missed dose.

very common (affects 1 or more in 10 patients);

common (affects 1 or more in every 100 but less than 1 in every 10 patients);

uncommon (affects 1 or more in every 1,000 but less than 1 in every 100 patients);

rare (affects 1 or more in 10,000 but less than 1 in every 1,000 patients);

very rare (affects less than 1 in 10,000 patients);

unknown (frequency can not be estimated from the available data).

The following side effects have been reported with the use of Ketonal in adults:

Uncommon: anemia (decreased red blood cell count and hemoglobin), haemolysis (destruction of red blood cells), purpura (multiple small bleeding in the skin), thrombocytopenia (decreased blood platelets), agranulocytosis (severe reduction to complete lack of the granulocytes that are part of the white blood cells). High doses of Ketone may prolong bleeding time and cause bleeding from the nose and easily bruise.

Rare: haemorrhagic anemia (decreased red blood cell count due to haemorrhage).

Not known: bone marrow failure.

Immune system disorders

Hypersensitivity reactions may be non-specific reactions and anaphylaxis (severe allergic reaction, allergic shock).

Uncommon: skin allergic reactions (see Skin and subcutaneous tissue disorders). Respiratory system reactions including asthma, worsening asthma, difficulty in breathing (especially in patients hypersensitive to acetylsalicylic acid and other NSAIDs);

Very rare: angioedema and anaphylaxis.

Psychiatric disorders

Common: depression, nervousness, nightmares and drowsiness;

Rare: delirium with visual and auditory hallucinations, impaired orientation and speech;

Not known: mood swings.

Nervous system disorders

Common: headache, general weakness, fatigue, dizziness, vertigo, numbness and tingling of the skin;

Uncommon: drowsiness;

Not known: convulsions, taste changes.

Violations of eyes they

Common: visual disturbances;

Rare: blurred vision;

Very rare: Conjunctivitis has been reported.

Ear and labyrinth disorders

Common: tinnitus.

Cardiac disorders

Common: edema;

Uncommon: heart failure with concomitant manifestations such as shortness of breath, difficulty in breathing, leg swelling and lower legs, increased blood pressure.

Vascular disorders

Not known: high blood pressure, vasodilatation, redness of the face.

Clinical studies and epidemiological data indicate that the use of certain NSAIDs (especially at high doses and prolonged treatment) may lead to an increased risk of arterial thrombosis (eg myocardial infarction or stroke).

Uncommon: bleeding, difficulty in breathing, pharyngitis, rhinitis, bronchospasm (especially in patients with a history of hypersensitivity to acetylsalicylic acid or other NSAIDs), laryngeal edema (allergic reaction symptoms);

Rare: asthma;

Not known: runny nose, pruritus, sneezing and blocked nose.

Gastrointestinal disorders

The most common side effects are gastrointestinal tract.

Very common: indigestion;

Common: nausea, abdominal pain (decreased when taking the medicine with food), diarrhea , constipation, gas, vomiting and inflammation of the oral cavity;

Uncommon: inflammation of the lining of the stomach (gastritis);

Rare: peptic ulcer, aphtha and mouth ulceration;

Very rare: colitis, intestinal perforation, exacerbation of ulcerative colitis or Crohn’s disease, gastrointestinal haemorrhage and perforation, perforation enteritis, ulcers.

Enteropathy may be accompanied by mild bleeding and loss of protein.

Peptic ulcers, perforation or bleeding from the gastrointestinal tract, sometimes fatal, may occur especially in the elderly. Ulcer, haemorrhage or perforation may develop in 1% of patients after 3 to 6 months of treatment or in 2 to 4% of patients after 1 year of NSAID treatment.

Blood in stools, vomiting of blood and exacerbation of colitis and Crohn’s disease have been reported following administration of NSAIDs. Gastritis is less common.

Rare: hepatitis, elevated transaminases, elevated serum bilirubin as a result of liver disorders;

Very rare: serious liver disorders with jaundice.

Skin and subcutaneous tissue disorders

Common: skin rash;

Uncommon: hair loss, eczema, rash with multiple small skin bleeds, sweating, urticaria, exfoliative dermatitis, itchy skin;

Rare: photosensitivity or photodermatitis;

Very rare: Bullous reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome;

Not known: angioedema.

Renal and urinary disorders

Uncommon: fluid retention, which can cause swelling of the hands and feet;

Very rare: acute renal failure, nephritis, nephrotic syndrome and acute pyelonephritis;

Not known: blood test results may indicate changes in kidney or liver function.

Reproductive system and breast disorders

Uncommon: Uterine bleeding.

General violations

Uncommon: fatigue or fatigue;

Rare: Weight gain.

Research

Very common: limited increase in liver function values;

Uncommon: Significant elevations in ALT (SGPT) or AST (SGOT) in NSAID therapy. Ketone prolongs bleeding time.

Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially at high doses and prolonged intake) may be associated with an increased risk of arterial thrombosis (eg myocardial infarction or stroke).

asthma attack;

burning, acute stomach pain with a feeling of emptiness and hunger. This may be due to stomach or intestinal ulcer.

Not known:

Blood vomiting, severe stomach or dark stomach pains (a sign of bleeding from the stomach or intestines).

Blistering, scaling or bleeding from any part of the body with or without an itchy, constant rash. This also includes lips, eyes, hands or feet. You may have flu-like symptoms at the same time. You may have a severe skin problem that needs urgent medication treatment.

Blood in the urine, change in the amount of urine output or edema, especially in the legs, ankles or feet. This may be due to serious kidney problems.

Chest pain or unexpected severe headache. Medicines such as ketone may be associated with a slightly increased risk of a heart attack („myocardial infarction”) or stroke.

Swelling of the face, lips or throat that causes difficulty in swallowing, breathing or you may have wheezing or chest tightness, rapid heartbeat, pruritus, rashes, lowering of blood pressure, which can lead to shock. This may be a sign of a severe allergic reaction.

Tell your doctor immediately if you notice any of the following:

Rare (may affect up to 1 in 1,000 patients):

Unusual skin sensations such as tingling, itching, soreness, burning or tingling of the skin (paraesthesia);

Pale skin and a feeling of fatigue, loss of consciousness or dizziness. You may have anemia due to bleeding;

Blurred vision;

Yellowish skin or white eyes (jaundice). This may be a sign of liver problems.

Not known:

An easier appearance of bruising or bleeding, which lasts longer than usual. This may be due to a serious blood problem (such as a decreased number of platelets in the blood);

Worsening of Crohn’s disease or colitis;

Skin reactions to light or photoluminescence (photosensitivity);

Hair loss;

You can get infections easier than usual. This may be due to a serious blood disorder (agranulocytosis);

Seizures.

Tell

your doctor If you get any side effects, talk to your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system to:

The Bulgarian Drug Agency,

8 Damian Gruev Str.,

1303 Sofia,

tel .: + 359 2 890 34 17,

website: www.bda.bg.

Keep out of the reach and sight of children.

Store below 25 ° C in the original package.

Do not use after the expiry date stated on the package.

The active substance is ketoprofen. Each hard capsule contains 50 mg of ketoprofen.

The other ingredients are: lactose monohydrate, magnesium stearate, anhydrous colloidal silica, gelatin, titanium dioxide, coloring agent (E 131).

What Ketonal looks like and contents of the pack

Hard capsules.

Dark glass bottles containing 10 or 20 capsules; in cartons.