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Ketalgo 50 mg. 6 sachets

€12

The active substance in the medicine KETALGO, which is responsible for its action, is ketoprofen (as a lysine salt). It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which relieve inflammation by changing the body's response to pain, swelling and fever.

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What KETALGO is and what it is used for

The active substance in the medicine KETALGO, which is responsible for its action, is ketoprofen (as a lysine salt). It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which relieve inflammation by changing the body's response to pain, swelling and fever.

KETALGO is used for short-term, symptomatic treatment of pain of various origins and nature, e.g. for headache (including migraine), toothache, neuralgia, painful menstruation (dysmenorrhea), muscle pain, bone and joint pain.

2. What you need to know before you take KETALGO

Do not use KETALGO if:

you have a hypersensitivity (allergy) to ketoprofen or to any of the other ingredients of this medicine (listed in section 6);

you have a hypersensitivity (allergy) to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin. Symptoms of an allergic reaction include: rash, swelling or breathing problems, swelling of the lips, face, throat or tongue;

you have or have had an ulcer or bleeding in the stomach or intestines;

you have severe heart failure;

you have severe liver or kidney problems;

you have a tendency to bleed;

you are in the last 3 months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking KETALGO if:

you have asthma;

you have ulcerative colitis or Crohn's disease;

you have a disease that damages the skin, joints and kidneys (systemic lupus erythematosus);

you are 65 years of age or older;

you have heart problems, you have had a stroke or you think you are at risk of developing such conditions (you have high blood pressure, diabetes, high cholesterol or you are a smoker). Medicines such as KETALGO may be associated with a slightly increased risk of myocardial infarction or stroke. The risk is increased at high doses or prolonged use. Therefore, the recommended dose or duration of treatment should not be exceeded.

Talk to your doctor or pharmacist if you have heart problems, have had a stroke or are at risk for these conditions, such as:

you have high cholesterol;

you have diabetes;

you smoke;

you have kidney or liver problems;

you are taking water tablets (diuretics).

Children and adolescents

KETALGO is not indicated for use in children and adolescents under 16 years of age.

Other medicines and KETALGO

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

Talk to your doctor before taking KETALGO if you are taking:

other non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen;

water tablets (diuretics);

medicines to treat high blood pressure or heart failure;

digoxin (a medicine used to control heart rhythm or heart failure);

drugs that suppress blood clotting or dissolve blood clots, such as acetylsalicylic acid, heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban, edoxaban, streptokinase, alteplase, reteplase or tenecteplase;

medicines used to treat infections (antibiotics), such as ciprofloxacin, levofloxacin or ofloxacin;

medicines to treat depression, such as fluoxetine, sertraline, citalopram or paroxetine;

corticosteroids - drugs used to treat inflammation, such as hydrocortisone, betamethasone or prednisolone;

cyclosporine and tacrolimus, which are used after an organ transplant to prevent an organ rejection reaction;

mifepristone - used to terminate a pregnancy;

lithium - a drug for the treatment of mental illness;

methotrexate, used to treat cancer or psoriasis;

pentoxifylline, which is used in case of impaired blood supply to the limbs;

sulfonylurea antidiabetic drugs, such as glimepiride, gliclazide, glibenclamide and glipizide;

probenecid - used for gout;

zidovudine (used to treat AIDS).

Pregnancy, lactation 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.

You should not take this medicine if you are in the last 3 months of pregnancy. Talk to your doctor before taking KETALGO if you are in the first 6 months of pregnancy. Breast-feeding is not recommended when taking KETALGO. Small amounts of the drug may pass into breast milk.

KETALGO belongs to a group of medicines that have been shown to make it difficult to conceive. This effect is reversible upon discontinuation of treatment. Talk to your doctor if you are planning to become pregnant or have problems getting pregnant.

Driving and using machines

There are no data on the effect of the medicinal product on the ability to drive and use machines. However, as dizziness and blurred vision may cause side effects when taking non-steroidal anti-inflammatory drugs, do not drive or use machines if these symptoms occur.

Important information about some of the ingredients of KETALGO

This medicine contains 25 mg of sodium (the main ingredient in table salt) in each sachet. This amount is equivalent to 1.2% of the recommended maximum daily sodium intake for an adult.

3. How to take KETALGO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 16 years of age:

1 sachet up to 3 times a day.

The interval between doses should not be less than 8 hours.

Elderly patients:

The dose should be determined by a physician, who may reduce the dose recommended above if necessary. See section 2 "Warnings and precautions".

Patients with renal or hepatic insufficiency:

In patients with mild to moderate renal or hepatic impairment, it is preferable to reduce the starting dose and administer treatment at the lowest effective dose.

KETALGO should not be used in patients with severe renal or hepatic impairment.

Application method

KETALGO is intended for oral use. Dissolve the contents of 1 sachet in a glass of water (about 100 ml), mix well for about 30 seconds until the granules are completely dissolved and drink.

The solution should be used immediately after preparation.

Duration of application

Adolescents: You should seek medical attention after 3 days if you do not feel better or your condition worsens.

Adults: You should seek medical attention after 5 days if you do not feel better or your condition worsens.

If you take more KETALGO than you should

In case of overdose you may feel drowsy, stomach pain, nausea or vomiting. It is necessary to consult a doctor in case of taking a higher dose than recommended, even if you feel well.

If you forget to take KETALGO

Take the next dose when you remember. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TREATMENT with this medicinal product and consult a physician immediately if the following side effects occur:

Rare (may affect less than 1 in 1,000 people)

asthma attack symptoms;

severe pain and burning in the stomach, with a feeling of hunger and emptiness.

Not known (cannot be estimated from the available data)

blistering, scaling, or bleeding in any part of the skin, with or without an itchy, raised rash. This includes the lips, eyes, mouth, nose, genitals, hands or feet. You may also have flu-like symptoms at the same time. You may have a severe skin problem that requires immediate medical attention, incl. Stavens-Johnson syndrome and toxic epidermal necrolysis.

appearance of blood in the urine, change in the amount of urine excreted or swelling of the legs, ankles and feet. This can be caused by severe kidney problems.

chest pain or sudden severe headache. Medicines such as KETALGO may be associated with a slightly increased risk of myocardial infarction or stroke. See item 2 "Warnings and precautions".

swelling of the face, lips or throat, causing difficulty swallowing, shortness of breath, wheezing or tightness in the chest. These may be symptoms of a severe allergic reaction.

vomiting blood, severe stomach pain, dark, tarry black stools.

Tell your doctor as soon as possible if you experience any of the following side effects:

Rare (may affect less than 1 in 1,000 people)

unusual skin sensations, such as tingling, tingling, tingling, burning or chills (paresthesia);

tendency to lighter than usual bruising or prolonged bleeding. These may be symptoms of a blood disorder.

paleness, feeling tired, weak or dizzy. You may have anemia.

blurred vision;

yellowing of the whites of the eyes or skin (jaundice). This may be a sign of liver disease.

Not known (cannot be estimated from the available data)

exacerbation of intestinal disease, so-called Crohn's disease or colitis, gastrointestinal bleeding and perforation;

photosensitivity (skin reaction to light or solar lamps);

seizures.

Other side effects:

Common (may affect up to 1 in 10

5. How to store KETALGO

Keep out of reach of children.

This medicine does not require any special storage conditions. Store in the original package in order to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton and sachet after the abbreviation "EXP" or "EXP". The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What KETALGO contains

The active substance is ketoprofen lysinate. Each sachet contains 50 mg of ketoprofen, which corresponds to 80 mg of ketoprofen lysinate.

The other ingredients (excipients) are: mannitol, povidone K25, sodium chloride, sodium cyclamate, saccharin sodium, mint flavor, colloidal anhydrous silica.

What KETALGO looks like and contents of the pack

White to off-white fine granules with a characteristic mint odor, in PE / Al / P sachets placed together with a patient leaflet in a cardboard box.

Types of packaging: 6 and 12 sachets.

Not all pack sizes may be marketed.

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