Trosicam

PATIENT INFORMATION LEAFLET: USER INFORMATION

TROSICAM

15 mg Orodispersible Tablets

Meloxicam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

TABLE OF CONTENTS OF THE LEAFLET:

1. What is Trosicam and what is it used for

2. Important information before taking Trosicam

3. How to take Trosicam

4. Possible side effects

5. How to store Trosicam

6. Contents of the pack and other information

1. WHAT IS TROSICAM AND WHAT IS IT USED FOR

Trosicam belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce inflammation and pain in joints and muscles. (Orodispersible tablets dissolve easily in the mouth). Trosicam is used for:

• short-term treatment of symptoms of osteoarthritis flare-ups;
• long-term treatment of symptoms of:
• rheumatoid arthritis,
• ankylosing spondylitis (spinal disease).

If there is no improvement after 20 days or the patient feels worse, they should consult their doctor.

2. IMPORTANT INFORMATION BEFORE TAKING TROSICAM

When not to take Trosicam:

• if the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or plans to become pregnant or is breastfeeding;
• if the patient has a hypersensitivity (allergy) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has had asthma symptoms (wheezing), nasal polyps with runny nose, skin swelling, or hives after taking acetylsalicylic acid or other anti-inflammatory drugs;
• if the patient has had stomach or duodenal ulcers;
• if the patient has any bleeding disorders or has had bleeding from the stomach, intestines, or cerebral vessels;
• if the patient has severe liver failure;
• if the patient has severe kidney failure but is not on dialysis;
• if the patient has severe heart failure;
• if the patient has Crohn's disease;
• if the patient has ulcerative colitis;
• if the patient has pain after aortic coronary bypass surgery.

Do not take Trosicam if any of these situations apply to the patient. First, consult a doctorand follow their recommendations.

Warnings and precautions

Discuss taking Trosicam with a doctor or pharmacist before starting treatment.

When to be particularly careful when taking Trosicam

Tellyour doctor or pharmacist beforetaking this medicine:

• if the patient has high blood pressure;
• if the patient has heart, liver, or kidney disease;
• if the patient has diabetes;
• if the patient is elderly (65 years or older);
• if the patient has a hereditary disease called phenylketonuria, as this medicine contains aspartame (E951);
• if the patient has been told they have an intolerance to some sugars, as this medicine contains sorbitol (E420), a type of sugar;
• if the patient has reduced blood volume, which may occur in cases of severe blood loss or burns, surgery, or reduced fluid intake;
• if the patient has had high potassium levels in the blood in the past.

Tell your doctorif any of these situations apply to the patient.

Warning

Taking medicines like Trosicam may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or for longer than recommended. If you have heart problems, have had a stroke, or suspect you are at risk of these disorders - such as high blood pressure, diabetes, high cholesterol, or smoking - discuss your treatment with your doctor or pharmacist.

Children and adolescents

Do notgive this medicine to children and adolescents under 16 years of age.

Trosicam and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines they plan to take. Do not take other medicines, including those available without a prescription, without consulting a doctor or pharmacist if the patient is taking Trosicam.

• Tellyour doctor or pharmacist about taking the followingmedicines:
• othernonsteroidal anti-inflammatory drugs, includingacetylsalicylic acid;
• blood-thinning medicines, such as warfarin;
• medicines that dissolve blood clots;
• medicines used to treat high blood pressure;
• oral corticosteroids;
• cyclosporine;
• all diuretics (the doctor may monitor kidney function while taking diuretics);
• lithium used in mental illnesses;
• selective serotonin reuptake inhibitors used to treat depression;
• methotrexate;
• cholestyramine;
• an intrauterine contraceptive device, also known as an intrauterine spiral.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Trosicam is notrecommended for women who are pregnant or breastfeeding. Immediatelyinform your doctor if the patient is pregnant, suspects they are pregnant, or is breastfeeding. Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Do not drive or operate machinery until the patient knows how Trosicam affects them. Do notdrive or operate machinery if the patient experiences dizziness, drowsiness, or vision disturbances after taking the medicine.

Trosicam contains

• Mannitol, the medicine may have a mild laxative effect.
• The medicine contains 8 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. Beforetaking the medicine, consult a doctor.
• The medicine contains 40 mg of sorbitol in each tablet. If the patient has ever been diagnosed with problems tolerating certain sugars, beforetaking the medicine, consult a doctor.

3. HOW TO TAKE TROSICAM

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Read the leaflet carefully.

Taking the medicine

• Place the tablet on the tongue.
• Allow it to dissolve slowly over 5 minutes (do not chew or swallow it whole).
• Swallow it with water (240 ml).
• If the patient has dry mouth, moisten it with water first.
• Nevertake more than the recommended maximum dose, which is 15 mg (one tablet) per day.

Dosage

The dose depends on the disease being treated. The doctor will inform the patient about the dosage of the medicine. This medicine should always be taken exactly as described in the patient information leaflet or as directed by the doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. Treatment of osteoarthritis flare-ups: The recommended dose is 7.5 mg (half a tablet) per day. The doctor may increase the dose to 15 mg (one tablet) per day if necessary. Treatment of rheumatoid arthritis and ankylosing spondylitis: The recommended dose is 15 mg (one tablet) per day. The doctor may reduce the dose to 7.5 mg (half a tablet) per day if necessary. For patients 65 years of age and olderwith rheumatoid arthritis and ankylosing spondylitis, the recommended dose is 7.5 mg (half a tablet) per day. If the patient has any of the situations listed in section 2 "When to be particularly careful when taking Trosicam", the doctor may reduce the dose to 7.5 mg (half a tablet) per day. If the patient thinks that the effect of Trosicam is too strong or too weak, or if there is no improvement after a few days of taking the medicine, they should consult their doctor or pharmacist.

Taking a higher dose of Trosicam than recommended

Immediatelycontact a doctor or pharmacist, or immediatelygo to the nearest hospital emergency department, taking this leaflet or the tablets with you.

Missing a dose of Trosicam

Do not take a double dose to make up for a missed dose. Take the usual dose the next day.

Stopping treatment with Trosicam

If you have any further doubts about taking 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.

• If the patient has had gastrointestinal problems in the past when taking anti-inflammatory medicines, the doctor may consider monitoring the patient's condition during treatment. Clinical trials and scientific data suggest that taking some NSAIDs (especially in high doses and for a long time) may be associated with a small increased risk of arterial thrombosis (e.g., heart attack or stroke).

Contact a doctor or go to the nearest hospital emergency department

immediately(taking this leaflet or the tablets with you) if the following side effects occur:

• severe allergic reactions, including fainting, shortness of breath, skin reactions, and asthma attacks (frequent side effects: occur in 1 to 10 patients out of 100);
• bleeding from the stomach or intestines, stomach ulcers, pain or inflammation of the mouth or throat (uncommon side effects: occur in 1 to 10 patients out of 1,000);
• severe skin reactions, including blistering or peeling of the skin, swelling of the eyelids, lips, and face, sun-induced rash (rare side effects: occur in 1 to 10 patients out of 10,000).

Consult a doctorif the following side effects occur:

• Pancreatitis.

Frequent side effects(occur in 1 to 10 patients out of 100):

• indigestion, nausea, and vomiting, stomach pain, constipation, bloating with gas, diarrhea, rash, and itching;
• dizziness, headache;
• swelling of the ankles and feet;
• anemia.

Uncommon side effects(occur in 1 to 10 patients out of 1,000):

• hypersensitivity;
• hives;
• dizziness, ringing in the ears, drowsiness;
• irregular heartbeat, high blood pressure, flushing;
• abnormal white blood cell or platelet count;
• liver function disorders;
• fluid and salt retention, high potassium levels, kidney function disorders.

Rare side effects(occur in 1 to 10 patients out of 10,000):

• perforation of the intestinal wall, inflammation, or pain in the stomach or intestines (stomach or duodenal ulcers, bleeding, and perforation of the stomach or intestines may occur at any time during treatment; sometimes - especially in elderly patients - they can be severe and very rarely, less than 1 in 10,000 treated patients, can be fatal);
• disorientation, mood changes, insomnia, nightmares;
• vision disturbances, including blurred vision;
• liver inflammation;
• kidney failure.

If any of the side effects get worse or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TROSICAM

• Keep the medicine out of the sight and reach of children.
• Do not transfer the tablets to another container.
• The product does not require any special storage conditions in European Union countries.
• Do not take this medicine after the expiry date stated on the carton after the term "Expiry Date" (EXP). The expiry date refers to the last day of the month stated.
• Do not take this medicine if you notice any visible signs of deterioration.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Trosicam contains

The active substance of the medicine is meloxicam. Each tablet contains 15 mg of meloxicam. The other ingredients are: mannitol (E421), aspartame (E951), sorbitol (E420), citric acid anhydrous, yogurt flavor (flavoring substances identical to natural ones, flavoring preparations, natural flavors, corn maltodextrin, glycerol triacetate EP), forest fruit flavor (flavoring substances identical to natural ones, flavoring preparations, natural flavors, corn maltodextrin, glycerol triacetate EP, modified cornstarch), povidone K30, crospovidone, talc, sodium lauryl sulfate, and magnesium stearate.

What Trosicam tablets look like and what the pack contains

Trosicam tablets are round, light yellow, flat with a dividing line (weighing 400 mg and 12 mm in diameter), marked with AX5 on one side. The tablet can be divided into two equal doses. The tablets are available as:

• packs containing 2 blisters of 10 tablets each,
• packs containing 3 blisters of 10 tablets each,
• packs containing one HDPE bottle with a PP cap with a desiccant, child-resistant, in a cardboard box. The bottle contains 30 tablets.
• packs containing one HDPE bottle with a PP cap with a desiccant, child-resistant, in a cardboard box. The bottle contains 200 tablets.

Marketing authorization holder

ALPEX PHARMA (IRL) LIMITED
Stradbrook House, Stradbrook Road,
Blackrock, Co. Dublin
A94X9A2 - Ireland

Manufacturer

Kymos, S.L.
Ronda de Can Fatjó, 7B
(Parque Tecnológico del Vallès),
Cerdanyola del Vallès, 08290 Barcelona
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria and Poland: Trosicam
Czech Republic: Oramellox 15 mg
Slovakia: Oramellox 15 mg
United Kingdom: Meloxicam 15 mg Orodispersible Tablets
Date of revision of the leaflet:12/04/2021