Xefo Rapid

Package Leaflet: Information for the User

Xefo Rapid 8 mg Coated Tablets

Lornoxicam

Read the package 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 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Xefo Rapid and what is it used for
• 2. Important information before taking Xefo Rapid
• 3. How to take Xefo Rapid
• 4. Possible side effects
• 5. How to store Xefo Rapid
• 6. Contents of the pack and other information

1. What is Xefo Rapid and what is it used for

Xefo Rapid is a nonsteroidal anti-inflammatory drug (NSAID) and anti-rheumatic belonging to the oxycam group. The medicine is intended for adults for:

• short-term, symptomatic treatment of mild to moderate acute pain.

2. Important information before taking Xefo Rapid

When not to take Xefo Rapid:

• if you are allergic to lornoxicam or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with hypersensitivity to other NSAIDs, including acetylsalicylic acid (e.g. aspirin);
• if you have been diagnosed with thrombocytopenia (low platelet count, which increases the risk of bleeding or bruising);
• if you have been diagnosed with severe heart failure;
• if you have been diagnosed with gastrointestinal bleeding, perforation, and bleeding from a blood vessel in the brain or other hemorrhagic complications;
• if you have been diagnosed with perforation of the gastrointestinal tract or gastrointestinal bleeding associated with NSAID treatment;
• if you have been diagnosed with active or recurrent gastric or duodenal ulcer;
• if you have been diagnosed with severe liver dysfunction;
• if you have been diagnosed with severe kidney dysfunction;
• if you are in the last three months of pregnancy.

Warnings and precautions

Before starting to take Xefo Rapid, discuss it with your doctor or pharmacist. This is especially important:

• in patients with kidney dysfunction;
• in patients who have been diagnosed with high blood pressure and/or heart failure;
• in patients who have been diagnosed with ulcerative colitis or Crohn's disease;
• in patients with a history of bleeding tendencies;
• in patients with a history of asthma;
• in patients with systemic lupus erythematosus (SLE, lupus erythematosus, a rare autoimmune disease).

Your doctor may order regular laboratory tests to monitor your condition, if:

• you have been diagnosed with blood clotting disorders,
• you have been diagnosed with liver dysfunction,
• you are elderly,
• or you will be taking Xefo Rapid for more than 3 months.

Tell your doctor if you are planning to take heparin or tacrolimus while taking Xefo Rapid.
The patient should stop taking Xefo Rapid and contact their doctor immediately
if they experience
any unusual abdominal symptoms such as gastrointestinal bleeding, skin reactions such as rash, mucosal damage to the nostrils, mouth, eyelids, ears, genitals, or anus, or other symptoms of hypersensitivity.
Medicines like Xefo Rapid may slightly increase the risk of heart attack(myocardial infarction) or stroke.
The risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose of the medicine or the duration of treatment.
The patient should consult their doctor or pharmacist if

• they have been diagnosed with heart disease,
• they have had a stroke in the past,
• or they think they are at risk of developing these diseases (e.g. they have high blood pressure, diabetes, or high cholesterol, or they smoke).

Avoid taking Xefo Rapid while suffering from chickenpox.

Xefo Rapid and other medicines

Tell your doctor or pharmacist about all medicinesyou are taking or have recently taken, as well as any medicines you plan to take.
Avoid taking Xefo Rapid if you are taking other NSAIDs, such as acetylsalicylic acid(e.g. aspirin), ibuprofen, or COX-2 inhibitors.
Xefo Rapid may affect the action of other medicines. Be particularly careful if you are taking any of the following medicines:

• cimetidine - used to treat heartburn and stomach ulcers;
• anticoagulants, such as warfarin, heparin, or phenprocoumon - used to prevent blood clots;
• corticosteroids;
• methotrexate - used to treat cancer and autoimmune diseases;
• lithium;
• immunosuppressants, such as cyclosporine or tacrolimus;
• cardiac glycosides, such as digoxin, ACE inhibitors, beta-blockers;
• diuretics;
• quinolone antibiotics (e.g. levofloxacin, ofloxacin);
• antiplatelet agents (e.g. clopidogrel) - used to prevent heart attacks and strokes;
• selective serotonin reuptake inhibitors (SSRIs) - used to treat depression;
• sulfonylurea derivatives, such as glibenclamide - used to treat diabetes;
• medicines that stimulate or inhibit the CYP2C9 enzyme system (such as the antibiotic rifampicin or the antifungal agent fluconazole), as they may affect how the body breaks down Xefo Rapid;
• angiotensin II receptor blockers - used to treat high blood pressure, kidney damage due to diabetes, or congestive heart failure;
• pemetrexed - used to treat certain types of lung cancer.

Xefo Rapid with food and drink

Xefo Rapid coated tablets are intended for oral administration. The medicine should be taken before meals, with a sufficient amount of water.
Taking the medicine with food is not recommended, as it may reduce its effectiveness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Fertility

Xefo Rapid may have a negative effect on fertility, so its use is not recommended in women planning to become pregnant.

Consult your doctor and consider stopping Xefo Rapidif you have problems getting pregnant or are undergoing infertility diagnosis.
Pregnancy

Do not take Xefo Rapid during the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery.

The medicine may cause kidney and heart problems in the unborn child.It may affect the tendency to bleed in the mother and her child and may cause prolonged or delayed delivery. Do not take Xefo Rapid during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If treatment is needed during this period or while trying to become pregnant, use the lowest dose of the medicine for the shortest possible time. Xefo Rapid used for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding

Xefo Rapid is not recommended during breastfeeding, unless clearly indicated by your doctor.

Driving and using machines

Xefo Rapid has no or negligible influence on the ability to drive and use machines.

3. How to take Xefo Rapid

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose of the medicine for adultsis 8-16 mg in divided doses of 8 mg:
8 mg taken twice a day or 16 mg taken once a day.
On the first day of taking Xefo Rapid, you can take a dose of 16 mg, and then after 12 hours, take an additional 8 mg.
After the first day, do not take more than 16 mg per day.
Xefo Rapid tablets should be swallowed, with a sufficient amount of water. Do not take Xefo Rapid during meals, as food may reduce its effectiveness.
Due to the lack of sufficient data, the use of Xefo Rapid is not recommended in children and adolescents under 18 years of age.

Taking a higher dose of Xefo Rapid than recommended

If you take more Xefo Rapid than prescribed, contact your doctor or pharmacist.
In case of overdose, the following symptoms may occur: nausea, vomiting, symptoms from the central nervous system (such as dizziness or vision disturbances). Serious symptoms, such as ataxia (leading to coma and muscle spasms), liver and kidney damage, and possibly blood clotting disorders, may also occur.

Missing a dose of Xefo Rapid

Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xefo Rapid can cause side effects, although not everybody gets them.
Medicines like Xefo Rapid may slightly increase the risk of heart attackor stroke.
If you experience any unusual abdominal symptoms such as gastrointestinal bleeding, skin reactions such as rash, mucosal damage to the nostrils, mouth, eyelids, ears, genitals, or anus, or other symptoms of hypersensitivity, stop taking Xefo Rapid and contact your doctor immediately.
If you experience any of the following side effects, stop takingthe medicine and seek medical attention immediatelyat the nearest hospital emergency department:

• shortness of breath, chest pain, or swelling of the ankles;
• severe or persistent abdominal pain or black stools;
• yellowing of the skin and eyes (jaundice) - a sign of liver dysfunction;
• allergic reactions - which can include skin problems, such as ulcers or blisters, or swelling of the face, lips, tongue, or throat, which can cause difficulty breathing;
• fever, blisters, or inflammation of the skin, especially on the hands and feet or in the mouth (Stevens-Johnson syndrome);
• exceptionally, severe skin infections during chickenpox.

Frequent side effects(may affect up to 1 in 10 people)

• mild and transient headache and dizziness;
• nausea, abdominal pain, stomach upset, diarrhea, and vomiting.

Uncommon side effects(may affect up to 1 in 100 people)

• weight loss (anorexia), insomnia, depression;
• eye discharge (conjunctivitis);
• dizziness, ringing in the ears (tinnitus);
• heart failure, irregular heartbeat, rapid heartbeat, sudden flushing;
• constipation, bloating (flatulence), belching, dry mouth, stomach inflammation, stomach ulcers, abdominal pain, duodenal ulcers, mouth ulcers;
• increased liver enzyme values (detected by blood tests) and malaise;
• rash, itching, excessive sweating, skin redness (flushing), angioedema (sudden swelling of the deeper layers of the skin, mainly of the face), hives, swelling, runny nose due to allergy (allergic rhinitis);
• hair loss (alopecia);
• joint pain (arthralgia).

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

• pharyngitis;
• anemia, decreased blood cell count (thrombocytopenia and leukopenia), weakness;
• hypersensitivity, including pseudo-allergic reactions and anaphylaxis (a reaction that can cause swelling of the face, lips, tongue, or throat, and difficulty breathing);
• disorientation, nervousness, agitation, drowsiness (somnolence), numbness (paresthesia), taste disturbances, tremors, migraines, vision disturbances;
• high blood pressure, hot flashes;
• bleeding, bruising (hematoma), prolonged bleeding time;
• breathing difficulties (dyspnea), cough, bronchospasm;
• perforation of ulcers, bleeding from the gastrointestinal tract, black stools;
• mouth inflammation, esophagitis, gastroesophageal reflux, difficulty swallowing, mouth ulcers (aphthous ulcers), tongue inflammation;
• liver dysfunction;
• skin problems, such as rash or hives;
• bone pain, severe muscle cramps, muscle pain;
• urinary system disorders, such as nocturia or increased levels of urea and creatinine in the blood.

Very rare side effects(may affect up to 1 in 10,000 people)

• liver damage, hepatitis, jaundice, bile duct obstruction (interrupted flow of bile from the liver);
• bruising, swelling, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• aseptic meningitis;
• side effects characteristic of NSAIDs: neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, toxic effects on the kidneys.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your 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 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
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 Xefo Rapid

Keep the medicine out of the sight and reach of children.

Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton or blister 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. This will help protect the environment.

6. Contents of the pack and other information

What Xefo Rapid contains

• The active substance is lornoxicam.
• One coated tablet contains 8 mg of lornoxicam.
• The other ingredients are: microcrystalline cellulose, sodium bicarbonate, calcium phosphate anhydrous, hypromellose, hypromellose low-substituted, calcium stearate (core); titanium dioxide (E171), talc, propylene glycol, hypromellose (coating).

What Xefo Rapid looks like and contents of the pack

Xefo Rapid 8 mg is a white to off-white, round, biconvex coated tablet.
Xefo Rapid is available in packs containing 6, 10, 20, 30, 50, or 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Takeda Pharma sp. z o.o.
ul. Prosta 68
00-838 Warsaw

Manufacturer

Takeda GmbH
Manufacturing site Oranienburg
Lehnitzstrasse 70-98
16515 Oranienburg
Germany
Delpharm Novara S.r.l
Via Crosa 86
28065 Cerano (NO)
Italy

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

DK/H/123/006
Austria
Xefo Rapid 8 mg - Filmtabletten
Bulgaria
Ксефо Рапид
Czech Republic
Xefo Rapid 8 mg
Denmark
Xefo Rapid
Greece
Xefo Rapid
Hungary
Xefo Rapid 8 mg filmtabletta
Lithuania
Xefo Rapid 8 mg pėvele dengtos tabletės
Latvia
Xefo Rapid 8 mg apvalkotā tablete
Poland
Xefo Rapid
Romania
Xefo Rapid 8 mg
Slovakia
Xefo Rapid filmom obalené tablety 8 mg

Date of last revision of the leaflet: 07/2023