KETONAL INTENSIVE sachet 50 mg * 12

What you need to know before you take Ketonal / Ketonal Intensive

Do not take Ketonal / Ketonal Intensive if:
you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
you have had an allergic reaction in the past after taking acetylsalicylic acid or a painkiller - ketoprofen, ibuprofen or diclofenac, such as:
asthma, difficulty breathing;
swelling of the face, lips, tongue or throat;
hives, itchy nose with runny nose;
another type of allergic reaction.
Serious skin reactions, rarely fatal, have been observed in these patients.

stomach / duodenal ulcers or have had gastrointestinal bleeding, ulceration or perforation in the past;
diseases of the digestive tract called ulcerative colitis or Crohn's disease;
severe heart failure;
severely reduced liver or kidney function;
tendency to bleed;
during the last 3 months of pregnancy.
You should not use Ketonal / Ketonal Intensive without the explicit recommendation of your doctor if your stomach is at increased risk, for example if you are elderly or use some other medicines such as anticoagulants, antithrombotic, corticosteroids, other NSAIDs or selective reuptake inhibitors. serotonin (SSRXs) (see also sections “Warnings and precautions” and “Other medicines and Ketonal” below).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketonal / Ketonal Intensive if you are:

asthma combined with prolonged inflammation in the nose or sinuses and / or nasal polyps;
heart disease or have had in the past, such as mild to moderate congestive heart failure. Signs of such heart failure are accumulation of fluid in the lungs, abdomen, arms or legs. See also the fourth subsection in point 2 “Do not take Ketonal”.
mild or moderate renal or hepatic disease, including changes in liver or kidney function tests. See also the fifth point in section 2 “Do not take Ketonal / Ketonal Intensive”.
high blood pressure, or you have had in the past;
diseases of the blood vessels in the arteries of the arms and / or legs, or the brain;
diabetes or high cholesterol;
smoking;
old age. Elderly patients are at increased risk of adverse reactions to painkillers such as ketoprofen, in particular gastrointestinal bleeding and perforation, which can be fatal. Therefore, elderly patients should be closely monitored for any unusual symptoms, especially gastrointestinal bleeding, especially at the beginning of treatment. Your doctor will monitor you closely.
Gastrointestinal bleeding, ulcers and perforation, in some cases fatal, have been reported during treatment in all painkillers such as ketoprofen. Such effects have been observed at any time, with or without warning symptoms, or in severe gastrointestinal events in the past.

The risk of gastrointestinal bleeding, ulcers or perforation increases with increasing dose. It is greater in patients with ulcers in the past, especially if they are associated with bleeding or perforation, as well as in elderly patients. See also section 2 “Do not take Ketonal / Ketonal Intensive”. Ketoprofen may be associated with an increased risk of severe gastrointestinal toxicity, especially at high doses.

Your doctor may recommend treatment with precautionary drugs if these conditions apply to you. This also applies if you need additional therapy with low doses of acetylsalicylic acid or other medicines that may increase the risk of stomach and intestinal problems.

Stop taking Ketonal / Ketonal Intensive immediately and tell your doctor if you notice any signs of gastrointestinal bleeding, ulcers or perforation. See section 4 “Possible side effects”.

Medicines such as Ketonal / Ketonal Intensive may be associated with a slightly increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. Tell your doctor or pharmacist if you have heart problems, if you have had a stroke or are at risk for these conditions, for example if:

you have high blood pressure, diabetes or high cholesterol, or
you smoke.
Serious skin reactions with redness and blistering, some of which are fatal, have been reported very rarely with painkillers such as ketoprofen. See section 4 “Possible side effects”. If these reactions occur, in most cases within the first month of treatment, stop taking Ketonal / Ketonal Intensive immediately and tell your doctor if you develop a skin rash, mucosal lesions or other signs of hypersensitivity.

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration required for 

controlling symptoms. Do not exceed the recommended dose or duration of treatment.

Ketonal / Ketonal Intensive may mask the symptoms of an infection, such as fever.

Children and adolescents
Do not use this medicine in children under 16 years of age.

Your doctor may perform frequent check-ups when this medicine is taken by adolescents aged 16 years or older.

Other medicines and Ketonal / Ketonal Intensive
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ketonal / Ketonal Intensive is not recommended if you use:
other painkillers, such as:
ketoprofen-like drugs such as ibuprofen, diclofenac, naproxen;
acetylsalicylic acid, in doses for the treatment of pain and inflammation, or for lowering fever;
medicines to treat pain, inflammation or rheumatism with active substances whose names end in "coxib".
drugs that suppress blood clotting or dissolve blood clots such as acetylsalicylic acid, warfarin, clopidogrel, ticlopidine, heparin.
lithium used to treat depression and mental disorders.
methotrexate used to treat cancer at doses of 15 mg per week or more.
certain medicines to treat seizures (epilepsy), such as phenytoin.
medicines called sulphonamides in certain water tablets or to treat bacterial infections.
You should be closely monitored by your doctor if concomitant use of Ketonal with the above medicines cannot be avoided.

Other medicines may also be affected or may affect your treatment with Ketonal / Ketonal Intensive. Therefore, you should always consult your doctor or pharmacist before using Ketonal / Ketonal Intensive with other medicines. This applies in particular to:
drugs that increase the excretion through the kidneys and lower the blood pressure, which are also called 'water tablets'.
methotrexate, for the treatment of cancer, severe joint inflammation and skin disease psoriasis, in doses below 15 mg per week.
medicines to lower high blood pressure, with an active substance whose name ends in 'pril' or 'sartan', such as losartan, or 'olol'.
medicines to treat depression, called selective serotonin reuptake inhibitors.
corticosteroids used to treat inflammation, allergies, prevent transplant rejection, such as cortisone.
pentoxifylline, which is used to treat muscle pain due to disease of the blood vessels in the arms and / or legs.
probenecid, which is used to treat gout and high levels of uric acid in the blood.
cyclosporine and tacrolimus, which are used to suppress the immune system, for example after an organ transplant.
medicines to dissolve blood clots.
zidovudine for the treatment of AIDS.
diabetes medicines such as glibenclamide or glimepiride.

Pregnancy, lactation and fertility
Do not take Ketonal / Ketonal Intensive during the last 3 months of pregnancy.

Do not take Ketonal / Ketonal Intensive during the first 6 months of pregnancy unless your doctor decides that it is important to take it.

Breast-feeding is not recommended if you are taking Ketonal / Ketonal Intensive. It is not known whether ketoprofen passes into breast milk.

Tell your doctor if you are planning to become pregnant or if you have problems getting pregnant. Medicines such as ketoprofen can make it difficult to conceive,

Driving and using machines
In general, Ketonal / Ketonal Intensive does not affect the ability to drive and use machines. However, do not drive or use machines if you experience side effects such as dizziness, drowsiness, fainting, or blurred vision.

How to take Ketonal / Ketonal Intensive
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 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
Ketonal Intensive 50 mg granules for oral solution in sachets
Half double sachet, up to three times a day or one whole double sachet, up to twice a day.
The interval between doses should not be less than 8 hours.

Adverse reactions can be minimized by using the lowest effective dose needed to control symptoms in the shortest possible time. Do not exceed the dose or duration of treatment recommended by your doctor.

Use in the elderly
The dose will be determined by your doctor, who will decide whether to reduce the above doses. See section 2 "Warnings and precautions".

Decreased liver function
Your doctor may reduce the dose if your liver function is mild to moderate.

Do not take Ketonal / Ketonal Intensive if you have severe liver problems.

How to use

Ketonal Intensive 50 mg granules for oral solution in sachets
Open the sachet along the line marked "half dose" to get the dose of half sachet.
Open the sachet along the line marked "full dose" to get a dose from the whole sachet.
Empty the contents of the sachet into a glass of about 100 ml of water.
Stir well for about 30 seconds until the granules dissolve.
Take immediately after cooking, with meals.

Duration of use
Adults: You should seek medical attention if you do not feel better or your condition worsens after 3 days in case of fever or after 5 days in case of pain.
Adolescents: You should seek medical attention if the adolescent does not feel better or his condition worsens after 3 days.
If you take more Ketonal / Ketonal Intensive than you should
Tell your doctor immediately or go to the nearest hospital.

In most cases, overdose leads to lethargy, drowsiness, nausea, vomiting or stomach pain in the upper abdomen.

If you forget to take Ketonal / Ketonal Intensive
Take the missed dose as soon as 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ketonal / Ketonal Intensive and see your doctor or hospital immediately if you have / receive:

Rare (may affect up to 1 in 1,000 people):
asthma attack;
severe, burning pain in the stomach, with a feeling of emptiness and hunger. This may be due to a stomach / intestinal ulcer.

Not known:
vomiting of blood, severe stomach pain or bowel movements of dark, tarry black stools that are a sign of bleeding or perforation of the stomach / intestines;
blisters, peeling or bleeding in any part of the skin, with or without an itchy, raised rash. This includes the lips, eyes, mouth, nose, genitals, palms of the hands or the soles of the feet. This may be accompanied by flu-like symptoms. You may have a serious skin problem that requires urgent medical treatment, including Stevens-Johnson syndrome and toxic epidermal necrolysis;
blood in the urine, change in the amount of urine passed, or sweating, especially on the legs, ankles or feet. This can be due to serious kidney problems;
chest pain (a sign of a heart attack) or sudden severe headache, nausea, dizziness, numbness, inability or difficulty speaking, paralysis (signs of a stroke). Medicines such as Ketonal / Ketonal Intensive may be associated with a slightly increased risk of heart attack or stroke. See section 2 "Warnings and precautions",
signs of severe allergic reactions, such as:
swelling of the face, lips, mouth, throat or larynx, which causes wheezing or difficulty swallowing or breathing;
chest tightness, rapid heartbeat, drop in blood pressure leading to shock;
itching, rash;
laryngeal spasms that cause difficulty breathing;
infections easier than usual, which may be due to a serious blood disorder called agranulocytosis;
seizure.
Tell your doctor as soon as possible if you have any of the following side effects:

Rare (may affect up to 1 in 1,000 people):
unusual skin sensations, such as tingling, numbness, tingling, burning or chills;
pale skin, fatigue, fainting or dizziness, possibly caused by a lack of red blood cells due to bleeding;
blurred vision;
yellowing of the skin or whites of the eyes, which may be a sign of liver problems.

Not known:
bruising, easier than usual, or bleeding that lasts a long time. This can be a serious blood problem, such as a low platelet count;
exacerbation of intestinal diseases called Crohn's disease or colitis;
skin reaction to light or solar lamps.

Other side effects may occur with the following frequency:
Common (may affect up to 1 in 10 people):

indigestion, stomach pain;
nausea, vomiting.

Uncommon (may affect up to 1 in 100 people):

inflammation of the lining of the stomach;
constipation, diarrhea, gas;
skin rash, itching;
water retention, which can cause swelling of the arms or legs;
headache, dizziness or drowsiness;
fatigue or malaise.

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

noise in the ears;
weight gain;
sores and inflammation in the mouth.
Not known:
heart failure, signs of which may include shortness of breath while lying down, swelling of the feet or legs;
palpitations;
high or low blood pressure;
redness, which is a sign of dilated blood vessels;
rapid heartbeat;
mood swings;
excitement;
difficulty falling asleep;
changes in taste sensations;
acids;
swelling around the eyes;
runny nose, itching, sneezing and stuffy nose;
hair loss;
hives, redness or inflammation of the skin, raised rash.
Blood tests
Blood test results may show changes in your liver or kidney function.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help to get more information about the safety of this medicine.

 

5. How to store Ketonal / Ketonal Intensive

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.

Use the solution immediately after preparation.This medicine does not require any special storage conditions. 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

Ketonal Intensive 50 mg granules for oral solution in sachets
The active substance is ketoprofen. Each sachet contains 50 mg of ketoprofen, which corresponds to 80 mg of ketoprofen lysine salt.
The other ingredients are: mannitol (E421), povidone, mint flavor (contains maltodextrin and gum arabic), sodium chloride, saccharin sodium, colloidal silicon dioxide, anhydrous.
What Ketonal / Ketonal Intensive looks like and contents of the pack
White or yellowish granulate.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Sandoz d.d., Slovenia.