Trosicam

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

TROSICAM

7.5 mg Orodispersible Tablets

Meloxicam

Read the contents of the leaflet before taking the medicine because 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 the 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 after 20 days there is no improvement or the patient feels worse, they should consult a 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 an allergy (hypersensitivity) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has had symptoms of asthma (wheezing), nasal polyps with watery discharge, 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 pains after aortic coronary bypass surgery.

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

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 with 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 a 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 you are taking now or have taken recently, and about any medicines you plan to take. Do not take other medicines, including those available without a prescription, without consulting a doctor or pharmacist if you are taking Trosicam.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Trosicam is notrecommended for women who are pregnant or breastfeeding. Immediatelytell your doctor if you are pregnant, think you may be pregnant, or are breastfeeding. Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Do not drive or operate machinery until you know how Trosicam affects you. Do notdrive or operate machinery if you experience dizziness, drowsiness, or vision disturbances after taking the medicine.

Trosicam contains

• Mannitol, the medicine may have a mild laxative effect.
• The medicine contains 4 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. Beforetaking the medicine, consult a doctor.
• The medicine contains 20 mg of sorbitol in each tablet. If you have 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 you have dry mouth, moisten it with water first.
• Nevertake more than the recommended maximum dose, which is 15 mg (two tablets) per day.

Dosage

The dose depends on the disease being treated. Your doctor will tell you how to take the medicine. Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Treatment of osteoarthritis flare-ups: The recommended dose is 7.5 mg (one tablet) per day. Your doctor may increase the dose to 15 mg (two tablets) per day if necessary. Treatment of rheumatoid arthritis and ankylosing spondylitis: The recommended dose is 15 mg (two tablets) per day. Your doctor may reduce the dose to 7.5 mg (one tablet) per day if necessary. For patients 65 years and olderwith rheumatoid arthritis and ankylosing spondylitis, the recommended dose is 7.5 mg (one tablet) per day. If you have any of the situations listed in section 2 "When to be particularly careful when taking Trosicam", your doctor may reduce the dose to 7.5 mg (one tablet) per day. If you think the effect of Trosicam is too strong or too weak, or if there is no improvement after a few days of treatment, consult your 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 forgotten dose. Take the usual dose the next day.

Stopping treatment with Trosicam

If you have any further questions 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 you have had stomach or intestinal problems when taking anti-inflammatory medicines in the past, your doctor may want to monitor your condition during treatment. Clinical trials and scientific data suggest that taking some NSAIDs (especially in high doses and long-term) 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

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

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

Consult a doctorif you experience the following side effects:

• Pancreatitis.

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

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

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

• hypersensitivity;
• hives;
• dizziness, ringing in the ears, drowsiness;
• irregular heartbeat, increased 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 per 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;
• hepatitis;
• kidney failure.

If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 "Expiry Date" (EXP). The expiry date refers to the last day of the month stated.
• Do not take this medicine if you notice 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 is meloxicam. Each tablet contains 7.5 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 corn starch), crospovidone, povidone K30, talc, sodium lauryl sulfate, and magnesium stearate.

What Trosicam looks like and contents of the pack

Trosicam tablets are round, light yellow, flat (200 mg and 9 mm in diameter), marked with AX6 on one side. 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
Slovakia: Oramellox 7.5 mg
United Kingdom: Meloxicam 7.5 mg Orodispersible Tablets
Date of revision of the leaflet:12/04/2021