Trosicam

TROSICAM
7.5 mg Orodispersible Tablets
Meloxicam
Please read the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

TABLE OF CONTENTS:
1. What Trosicam is and what it is 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 TROSICAM IS AND WHAT IT IS USED FOR

Trosicam belongs to a group of medicines called non-steroidal 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 during flare-ups of osteoarthritis;
• Long-term treatment of symptoms of:
  • Rheumatoid arthritis,
  • Ankylosing spondylitis (spinal arthritis).

If there is no improvement after 20 days, or if the patient feels worse, medical advice should be sought.

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, planning pregnancy, or breastfeeding;
• If the patient has allergy (hypersensitivity) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• If the patient previously experienced asthma (wheezing), nasal polyps, watery nasal discharge, skin swelling, or urticaria after taking acetylsalicylic acid or other anti-inflammatory medicines;
• If the patient currently or previously had gastric or duodenal ulcer disease;
• If the patient has any bleeding disorders or a history of gastrointestinal, intestinal, or cerebral bleeding;
• If the patient has severe liver failure;
• If the patient has severe renal failure and 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 following coronary artery bypass graft (CABG) surgery.

Do not take Trosicam if any of the above conditions apply.
First, consult your doctor and follow their advice.

Warnings and precautions

Before starting Trosicam, discuss it with your doctor or pharmacist.

When to exercise special caution with Trosicam

Inform your doctor or pharmacist before taking 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 of age or older);
• If the patient has a hereditary condition called phenylketonuria, as this medicine contains aspartame (E951);
• If the patient has been told they have intolerance to certain carbohydrates (sugars), as this medicine contains sorbitol (E420), a type of sugar;
• If the patient has reduced blood volume, which may occur due to severe blood loss, burns, surgery, or insufficient fluid intake;
• If the patient has previously been diagnosed with high potassium levels in the blood.

Tell your doctor if any of the above situations apply.

Warning

Taking medicines such as 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. Do not take higher doses or use the medicine for longer than recommended. If you have heart problems, have had a stroke, or are at risk of such conditions—such as high blood pressure, diabetes, high cholesterol, or smoking—discuss treatment options with your doctor or pharmacist.

Children and adolescents

Do not give this medicine to children or adolescents under 16 years of age.

Trosicam and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not take other medicines, including over-the-counter medicines, without consulting your doctor or pharmacist if you are taking Trosicam.

Tell your doctor if you are taking any of the following:

• Other non-steroidal anti-inflammatory drugs, including acetylsalicylic 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 diuretics (your doctor may monitor kidney function while using diuretics);
• Lithium, used in psychiatric disorders;
• Selective serotonin reuptake inhibitors (SSRIs), used to treat depression;
• Methotrexate;
• Cholestyramine;
• Intrauterine contraceptive device (IUD), commonly known as a "coil."

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Trosicam is not recommended for women during pregnancy or breastfeeding.
Immediately inform your doctor if you are pregnant, suspect pregnancy, or are breastfeeding.
Always consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

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

Trosicam contains:

• Mannitol – the medicine may have a mild laxative effect.
• 4 mg of aspartame per 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 improper excretion. Before taking the medicine, consult your doctor.
• 20 mg of sorbitol per tablet. If you have ever been diagnosed with difficulty tolerating certain sugars, before taking the medicine, consult your doctor.

3. HOW TO USE THE MEDICINAL PRODUCT TROSICAM

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist. Read the package leaflet carefully.
Taking the medicine

• Place the tablet on the tongue.
• Allow it to dissolve slowly for five minutes (do not chew or swallow it undissolved).
• Swallow it with water (240 ml).
• If the patient experiences dryness of the mouth, moisten the mouth with water first.
• Never take more than the recommended maximum dose of 15 mg (two tablets) per day.

Dosage
The dose depends on the disease being treated. The physician will inform the patient about the appropriate dosage.
This medicine should always be taken exactly as described in the patient leaflet or as directed by the
physician or pharmacist. In case of doubt, consult your doctor or pharmacist.
Treatment of exacerbation of osteoarthritis:
The recommended dose is 7.5 mg (one tablet) daily. The physician may increase the dose to 15 mg (two tablets) daily if deemed necessary.
Treatment of rheumatoid arthritis and ankylosing spondylitis:
The recommended dose is 15 mg (two tablets) daily. The physician may reduce the dose to 7.5 mg (one tablet) daily if deemed necessary.
For patients aged 65 years and older, the recommended dose in the treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (one tablet) daily.
If the patient has any of the conditions listed in section 2, “When to exercise special caution when using Trosicam”, the physician may reduce the dose to 7.5 mg (one tablet) daily.
If the patient feels that the effect of Trosicam is too strong or too weak, or if there is no improvement after several days of treatment, the patient should consult a doctor or pharmacist.
Taking more Trosicam than recommended
Immediately contact a doctor or pharmacist, or immediately go to the nearest hospital emergency department, remembering to bring this leaflet or the tablets with you.
Missed dose of Trosicam
Do not take a double dose to make up for a missed dose.
Take the usual dose the next day.
Stopping Trosicam
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.

• If the patient has previously experienced gastrointestinal problems while taking anti-inflammatory medicines, the doctor may consider it appropriate to monitor the patient's condition during treatment. Clinical studies and scientific data suggest that taking certain NSAIDs (especially at high doses and for prolonged periods) may be associated with a small increased risk of arterial thrombosis (e.g. heart attack or stroke).

Contact a doctor immediately or go to the nearest hospital emergency department
(taking this leaflet or the tablets with you), if any of the following adverse reactions occur:

• severe allergic reactions, including fainting, shortness of breath, skin reactions, and asthma attacks (common adverse reactions: occur in 1 to 10 patients out of 100);
• bleeding from the stomach or intestines, stomach ulcer, pain or inflammation of the mucous membrane of the mouth or oesophagus (uncommon adverse reactions: occur in 1 to 10 patients out of 1,000);
• severe blistering of the skin or peeling of the outer layer of skin, swelling of the eyelids, lips and face, rash caused by exposure to sunlight (rare adverse reactions: occur in 1 to 10 patients out of 10,000).

Contact a doctor if the following adverse reactions occur:

• Pancreatitis.

Common adverse reactions (occur in 1 to 10 patients out of 100):

• indigestion, nausea and vomiting, abdominal pain (stomach ache), constipation, bloating with gas release, diarrhoea, rash and itching;
• feeling of emptiness in the head, headache;
• swelling of ankles and legs;
• anaemia.

Uncommon adverse reactions (occur in 1 to 10 patients out of 1,000):

• hypersensitivity;
• urticaria;
• dizziness, tinnitus, drowsiness;
• irregular heartbeat, increased blood pressure, facial flushing;
• abnormal white blood cell or platelet count;
• liver function disorders;
• salt and water retention, excess potassium, kidney function disorders.

Rare adverse reactions (occur in 1 to 10 patients out of 10,000):

• intestinal wall perforation, inflammation or pain in the stomach or intestines (gastric or duodenal ulcer, bleeding and perforation of the stomach or intestines may occur at any time during treatment; sometimes - especially in elderly patients - they may be severe and, very rarely, in less than 1 out of 10,000 treated patients, may lead to death);
• disorientation, mood swings, insomnia, nightmares;
• visual disturbances, including blurred vision;
• hepatitis;
• kidney failure.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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.
• In European Union countries, this product is not subject to any special storage requirements.
• Do not use this medicine after the expiry date stated on the outer carton following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
• Do not use this medicine if you notice any visible signs of deterioration.

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Trosicam contains
The active substance is meloxicam. Each tablet contains 7.5 mg of meloxicam.
Other ingredients are: mannitol (E421), aspartame (E951), sorbitol (E420), anhydrous citric acid, yoghurt flavour (flavouring substances identical to natural ones, flavouring preparations, natural flavours, corn maltodextrin, glyceryl triacetate EP), forest fruit flavour (flavouring substances identical to natural ones, flavouring preparations, natural flavours, corn maltodextrin, glyceryl triacetate EP, modified starch), crospovidone, povidone K30, talc, sodium lauryl sulfate and magnesium stearate.

What Trosicam tablets look like and contents of the pack
Trosicam tablets are round, light yellow, flat (weighing 200 mg and with a diameter of 9 mm), marked AX6 on one side.
Tablets are available in:

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

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Bulgaria and Poland: Trosicam
Slovakia: Oramellox 7.5 mg
United Kingdom: Meloxicam 7.5 mg Orodispersible Tablets