1. What Kalmo is and what it is used for

Pharmacotherapeutic group:

Kalmo is a non-steroidal anti-inflammatory drug

(NSAID) and anti-rheumatic drug of the oxicam class.

Therapeutic indication:

It is intended for short term relief of acute mild to

moderate pain.

2. Before you take Kalmo

Do not take these tablets:

• If you are allergic to lornoxicam or any of the other ingredients of this medicine.

• If you are taking other NSAIDs such as acetylsalicylic acid (for instance, aspirin), ibuprofen and COX-2 inhibitors.

• If you are hypersensitive to other NSAIDs including acetylsalicylic acid (for instance, aspirin).

• If you suffer from thrombocytopenia (low blood platelet count which increases risk of bleeding or bruising).

• If you suffer from severe heart failure.

• If you suffer from gastrointestinal bleeding, rupture and bleeding of a blood vessel in the brain, or other bleeding disorders.

• If you have a history of gastrointestinal bleeding or perforation, related to previous therapy with NSAIDs.

• If you suffer from an active peptic ulcer or have a history of recurrent peptic ulcer.

• If you suffer from severe liver impairment.

• If you suffer from severe kidney impairment.

• If you are in the last three months of your pregnancy.

When taking Kalmo:

Talk to your doctor or pharmacist before taking Kalmo.

This is particularly important:

• If you have impaired kidney function.

• If you have a history of high blood pressure and ⁄or heart failure.

• If you suffer from ulcerative colitis or Crohn’s disease.

• If you have a history of bleeding tendency.

• If you have a history of asthma.

• If you suffer from SLE (lupus erythematosus, a rare immunological disease).

Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate

bronchospasm in such patients. In patients with systemic lupus erythematosus (SLE) and mixed

connective tissue disorders there may be an increased risk of aseptic meningitis. Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications.

To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of lornoxicam in case of varicella.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the

Lapplactase deficiency or glucose-galactose malabsorption should not take this medicine.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID. The risk appears greater

at higher doses.

Your doctor may have to monitor you by laboratory tests on a frequent basis if

• You suffer from blood coagulation disorder.

• You suffer from impaired liver function.

• You are elderly.

• Or you will be treated with Kalmo for more than 3 months.

You should inform your doctor if you are going to be treated with heparin or tacrolimus, while taking at the

same time Kalmo.

If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, damage to the internal lining of the nostrils, mouth, eyelids, ears, genitals or anus, or other signs of hypersensitivity, you should stop taking Kalmo and contact your doctor immediately.

Medicines such as Kalmo may be associated with a small increase of the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or the duration of treatment.

You should discuss your treatment with

your doctor or pharmacist if

• You have heart problems.

• You had previously a stroke.

• Or you think that you might be at risk of developing these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or you are a smoker). Avoid using Kalmo during varicella (chickenpox) infections.

RISK OF SERIOUS CARDIOVASCULAR AND

GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

• Lornoxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and

Perforation

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal event.

PATIENT COUNSELING INFORMATION

Cardiovascular Thrombotic Events

• Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately.

Heart Failure and Edema

• Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur.

Taking other medicines

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

Do not take Kalmo if you are taking other NSAIDs such as acetylsalicylic acid (for instance, aspirin), ibuprofen and COX-2 inhibitors. Ask your doctor or pharmacist if you are uncertain.

Kalmo may interfere with other medicines. Be particularly careful if you are taking any of the following:

• Cimetidine - used in the treatment of heartburn and peptic ulcers.

• Anticoagulants, such as heparin or phenprocoumon - used to prevent the formation of blood clots.

• Corticosteroids.

• Methotrexate- used in treatment of cancer and immunological diseases.

• Lithium.

• Immunosuppressive agents, such as ciclosporin or tacrolimus.

• Heart medicines, such as digoxin, ACE-inhibitors, beta-adrenergic blockers.

• Diuretics.

• Quinolone antibiotics.

• Anti-platelet agents- medicines used to prevent heart attacks and strokes.

• SSRI (Selective Serotonin Reuptake Inhibitors)- used in the treatment of depression.

• Sulphonylureas, for instance glibenclamide- used inthe management of diabetes.

• Inducers and inhibitors of CYP2C9-isoenzymes (such as the antibiotic rifampicin or the antifungal medicine fluconazole), as they might have an effect on the way in which your body breaks down Kalmo.

• Angiotensin II receptor blocker -used to treat high blood pressure, kidney damage due to diabetes and congestive heart failure.

• Pemetrexed - used to treat some forms of lung cancer.

Taking Kalmo with food and drink

Kalmo film-coated tablets are intended for oral use.
Take this medicine before meals with a sufficient amount of liquid.

Taking this medicine with food is not recommended because this may reduce its effectiveness.

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.

Pregnancy

During the first 6 months of pregnancy treatment with

Kalmo is not recommended, unless explicitly advised by your doctor.

You must not take Kalmo during the last three months of your pregnancy.

Breast-feeding

If you are breastfeeding treatment with Kalmo is not recommended, unless explicitly advised by your doctor.

Fertility

Using Kalmo may impair fertility and is not recommended for women attempting to become pregnant. Women who have difficulties becoming pregnant, or who are undergoing investigation of infertility, should consult with a doctor and consider stopping treatment with Kalmo.

Driving and using machines

Kalmo has negligible or no influence on the ability to drive or use machinery.

Important information about some of the

ingredients of Kalmo:

Kalmo contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking the medicinal product.

3. How to take Kalmo

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you

are not sure.

The usual dose for adults: is 8-16 mg divided in doses of 8 mg: 8 mg taken twice a day or 16 mg taken once a day.

On the first day you take Kalmo the dose can be 16 mg followed by 8 mg 12 hours later. After the first day do not take more than 16 mg a day.

If you have a liver or kidney impairment: Reduction of dose of Kalmo to once.

For all patients the appropriate dosing regimen should be based upon individual response to treatment.

Acute pain:

8-16 mg lornoxicam given in doses of 8 mg. An initial dose of 16 mg followed by 8 mg 12 hours later can be given on the first treatment day. After the first treatment day the maximum recommended daily dose is 16 mg.

Kalmo film-coated tablets are supplied for oral administration and should be taken with a sufficient quantity of liquid.

Additional information on special

populations

Children and adolescents:

Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.

Elderly:

No special dosage modification is required for elderly patients above age 65 unless renal or hepatic function is impaired. Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group.

Renal impairment:

Reduction of dose frequency of Kalmo to once daily in patients suffering from renal impairment is recommended.

Hepatic impairment:

Reduction of dose frequency of Kalmo to once daily in patients suffering from hepatic impairment is recommended.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Kalmo tablets must be swallowed with sufficient amounts of liquid. Do not take with a meal, as food can reduce the effectiveness of Kalmo.

Kalmo is not recommended for children and adolescents below 18 years old, due to lack of data.

If you take more Kalmo than you should

Please contact your doctor or the pharmacist if you have taken more Kalmo than prescribed.
In case of an overdose, you may expect the following symptoms: nausea, vomiting, symptoms associated with central nervous system (such as dizziness or disturbances in vision).

If you forget to take Kalmo

Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

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

In this leaflet, when a side effect is described as “common” this means that it has been reported in at least 1 in 10 patients taking the medicine. When a side effect is described as “uncommon”, this means it has been reported in more than 1 in every 100 patients, but less than 1 in every 10 patients. When a side effect is described as “rare”, this means it has been reported in more than 1 in every 1,000 patients, but less than 1 in every 100 patients. When a side effect is described as “very rare” this means that it has been reported in at least 1 in 10,000 patients taking the medicine. Medicines such as Kalmo may be associated with a small increase in the risk of heart attack or stroke. If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, damage to the internal lining of the nostrils, mouth, eyelids, ears, genitals or anus, or other signs of hypersensitivity, you should stop taking Kalmo and contact your doctor immediately. If you get any of the following side effects, stop taking this medicine and tell your doctor immediately, or contact the emergency department at your nearest hospital:

• Shortness of breath, chest pains, or ankle swelling appears or get worse.

• Severe or continuous stomach pain or your stools become black.

• Yellowing of the skin and eyes (jaundice) – these are signs of liver problems.

• An allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing.

• Fever, blistering eruption or inflammation especially on hands and feet or in the mouth area (Stevens- Johnson’s syndrome).

• Exceptionally, serious infections of the skin in case of varicella (chickenpox).

Undesirable e_ects associated with using

Kalmo are given below.

Common side effects

• Mild and passing headache and dizziness,

• Nausea, abdominal pain, upset stomach, diarrhea and vomiting.

Uncommon side effects

• Weight loss (anorexia), inability to sleep, depression.

• Eye discharges (conjunctivitis).

• Feeling dizzy, ringing in the ears (tinnitus).

• Cardiac failure, irregular heartbeat, rapid heart rate, feeling blushed.

• Constipation, excessive wind (flatulence), belching, dry mouth, gastritis, peptic ulcer, upper abdominal pain,duodenal ulcer, mouth ulcers.

• Increase in liver function tests (as seen from blood tests) and feeling un-well (malaise).

• Rash, itching, increased sweating, redness of the skin (erythema), angioedema (rapid swelling of the deeper layers of skin, usually of the face), hives (urticaria), edema, stuffy nose as a result of an allergy (rhinitis).

• Hair loss.

• Arthralgia (pain in the joints).

Rare side effects

• Sore throat.

• Anemia, reduction in the blood cell count (thrombocytopenia and leukopenia), weakness.

• Hypersensitivity, anaphylactoid reaction and anaphylaxis ( the reaction is characterized usually by face swelling, flushing, difficulties breathing and lightheadedness).

• Confusion, nervousness, agitation, feeling sleepy (somnolence), paraesthesia (tingling sensations), abnormal sense of taste, tremor, migraine, visual disturbances.

• Elevated blood pressure, hot flush.

• Bleeding, hematoma (bruising), prolonged bleeding time.

• Difficulty in breathing (dyspnoea), cough,

bronchospasm.

• Perforated ulcer, vomiting of blood, gastrointestinal bleeding, black tarry stools.

• Inflammation in the mouth, oesophagitis (inflammation of the gullet), gastro-oesophageal reflux, difficulty in swallowing, aphthous stomatitis (ulcers), inflammation of the tongue.

• Abnormal liver function.

• Skin problems, such as eczema, rash.

• Bone pain, muscle cramp, muscle pain.

• Urinary problems, such as the need to wake up and urinate during the night (nocturnia) or an increase in the levels of urea and creatinine in the blood.

Very rare side effects

• Liver damage, hepatitis (inflammation of the liver), jaundice, cholestasis (interrupted flow of bile from the liver);

• Bruising, oedema, severe skin disorder (Stevens-Johnson syndrome, Toxic epidermal necrolysis);

• Aseptic meningitis;

• NSAID class effects: neutropenia, agranulocytosis, aplastic anaemia, hemolytic anaemia, kidney toxicity). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Kalmo

• Keep out of the reach and sight of children.

• Do not store above 30°C.

• Store in the original package in order to protect from moisture.

• Do not use Kalmo after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.