Celecoxib Almus 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Celecoxib Almus 200 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Celecoxib Almus is and what it is used for
2. What you need to know before taking Celecoxib Almus
3. How to take Celecoxib Almus
4. Possible side effects
5. How to store Celecoxib Almus
6. Contents of the pack and other information

1. What Celecoxib Almus is and what it is used for

Celecoxib belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins, which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces higher amounts of prostaglandins. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

Celecoxib Almus is indicated in adults for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medicine will start to work a few hours after taking the first dose, but you may not experience the full effect until several days have passed.

2. What you need to know before taking Celecoxib Almus

Your doctor has prescribed this medicine for you. The following information will help you get the best results from this medicine. If you have any further questions, please ask your doctor or pharmacist.

Do not take Celecoxib Almus

Inform your doctor if any of the following apply to you, as patients with these conditions should not take Celecoxib Almus:

• if you are allergic to celecoxib or to any of the other ingredients of celecoxib (see section 6),
• if you have ever had an allergic reaction to any medicine in the group called “sulfonamides” (e.g., some antibiotics used to treat infections),
• if you currently have a stomach or intestinal ulcer or bleeding,
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or other anti-inflammatory medicines: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy skin rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing,
• if you are pregnant. If you could become pregnant during treatment, you should discuss contraceptive methods with your doctor.
• if you are breastfeeding,
• if you have severe liver disease,
• if you have severe kidney disease,
• if you have inflammatory bowel disease such as ulcerative colitis or Crohn’s disease,
• if you have heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, e.g., you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction in blood flow to the brain; also known as “mini-stroke”), angina, or blockage of blood vessels to the heart or brain,
• if you have or have had circulatory problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor or pharmacist before taking Celecoxib Almus:

• if you have previously had an ulcer or bleeding in your stomach or intestine (Do not take Celecoxib Almus if you currently have a stomach or intestinal ulcer or bleeding),
• if you are taking acetylsalicylic acid (even at low doses, such as for heart protection),
• if you are taking antiplatelet therapies,
• if you are receiving medications to reduce blood clotting (e.g., warfarin/warfarin analogues or new oral anticoagulants, e.g., apixaban),
• if you are receiving corticosteroid medicines (e.g., prednisone),
• if you are taking Celecoxib Almus at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided,
• if you are a smoker, or have diabetes, high blood pressure, or high cholesterol,
• if your heart, liver, or kidneys do not function properly, your doctor may want to monitor you regularly,
• if you have fluid retention (such as swollen feet or ankles),
• if you are dehydrated, for example, due to an illness with vomiting or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body),
• if you have had a severe allergic reaction or a serious skin reaction to any medicine,
• if you feel unwell due to an infection or think you may have an infection, as taking Celecoxib Almus may mask fever or other signs of infection and inflammation,
• if you are over 65 years of age, your doctor may want to monitor you regularly,
• alcohol consumption and NSAIDs may increase the risk of gastrointestinal problems.

Like other NSAIDs (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may monitor it periodically.

There have been reports of serious liver reactions with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the onset was reported, most serious liver reactions occurred within the first month of treatment.

Celecoxib Almus may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Taking Celecoxib Almus with other medicines

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

• Dextromethorphan (used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat high blood pressure and heart failure).
• Fluconazole and rifampicin (used to treat bacterial and fungal infections).
• Warfarin or other warfarin analogues (agents that reduce blood clotting), including newer agents such as apixaban.
• Lithium (used to treat certain types of depression).
• Other medicines used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat.
• Neuroleptics (used to treat certain mental disorders).
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia).
• Carbamazepine (used to treat epilepsy/seizures and certain types of pain or depression).
• Barbiturates (used to treat epilepsy/seizures and certain sleep disorders).
• Cyclosporine and tacrolimus (used for immunosuppression, e.g., after transplants).

Celecoxib Almus may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice before taking both medicines together.

Taking Celecoxib Almus with food and drink

Food and drink do not affect the action of Celecoxib Almus.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Celecoxib Almus must not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who are not using an adequate contraceptive method) during treatment. If you become pregnant while taking Celecoxib Almus, you must stop treatment and contact your doctor for an alternative treatment.

Breastfeeding

Celecoxib Almus must not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Almus, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or are experiencing difficulty becoming pregnant.

Driving and using machines

You should be aware of how you react to Celecoxib Almus before driving or operating machinery. If you feel dizzy or drowsy after taking Celecoxib Almus, do not drive or operate machinery until these effects subside.

Celecoxib Almus contains lactose

Celecoxib Almus contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Celecoxib Almus contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, which is essentially “sodium-free”.

3. How to take Celecoxib Almus

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of celecoxib is too strong or too weak, inform your doctor or pharmacist.

Your doctor will determine the dose you should take. Since the risk of adverse effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest effective dose that controls your pain and not to take celecoxib for longer than necessary to control symptoms.

Method of administration

Celecoxib Almus is taken orally. The capsules can be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time every day.

If you have difficulty swallowing the capsules: you may sprinkle the entire contents of the capsule onto a teaspoon of soft food (cold or at room temperature, such as applesauce, rice porridge, yogurt, or mashed banana) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it vertically to keep the granules at the bottom; then squeeze the top and twist it off, taking care not to spill the contents. Do not chew or crush the granules.

Contact your doctor if you do not experience improvement within two weeks after starting treatment.

The recommended dose is:

The recommended dose for the treatment of osteoarthritis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once daily
• or 100 mg twice daily

The recommended dose for the treatment of rheumatoid arthritis is 200 mg per day (taken in two divided doses), which your doctor may increase, if necessary, up to a maximum of 400 mg (taken in two divided doses per day).

The recommended dose for the treatment of ankylosing spondylitis is 200 mg per day, which your doctor may increase, if necessary, up to a maximum of 400 mg per day.

The dose is usually:

• one 200 mg capsule once daily
• or 100 mg twice daily

The initial recommended dose of 200 mg (taken as a 100 mg capsule twice daily) cannot be administered with Celecoxib Almus 200 mg hard capsules. Please consult your doctor.

Patients with kidney or liver problems: ensure your doctor knows if you have liver or kidney problems, as you may require a lower dose.

Patients aged 65 years or older, especially those weighing less than 50 kg: your doctor may wish to monitor you more closely if you are over 65 years of age, particularly if you weigh less than 50 kg.

Do not take more than 400 mg per day.

Use in children: celecoxib is intended for adults only and is not indicated in children.

If you take more Celecoxib Almus than you should

Do not take more capsules than prescribed by your doctor. If you take more celecoxib than prescribed, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Celecoxib Almus

If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for missed doses.

If you stop taking Celecoxib Almus

Stopping treatment with celecoxib abruptly may cause worsening of symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor will advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects listed below were observed in patients with arthritis who were taking CelecoxibAlmus. The adverse effects marked with an asterisk (*) occurred in patients taking celecoxib for the prevention of colon polyps and have been classified according to the highest frequency of occurrence. The patients included in these studies took celecoxib at high doses and for a prolonged period of time.

If you experience any of the following adverse effects, stop treatment with CelecoxibAlmus and inform your doctor immediately:

If you have:

• An allergic reaction such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Heart problems such as chest pain.
• Severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark urine or blood-stained stools, or blood in vomit.
• A skin reaction such as rash, blisters, or peeling of the skin.
• Liver failure [symptoms may include nausea (feeling unwell), diarrhoea, jaundice (your skin or the whites of your eyes appear yellow)].

Adverse effects very common (may affect more than 1 in 10 people)

• Increase in blood pressure, including worsening of existing high blood pressure*

Adverse effects common (may affect up to 1 in 10 people)

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• Difficulty breathing*, sinusitis (inflammation and infection of the sinuses, blocked or painful sinuses), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhoea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Adverse effects uncommon (may affect up to 1 in 100 people)

• Stroke*
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• Abnormal blood test results related to the liver
• Abnormal blood test results related to the kidney
• Anaemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, tiredness, numbness, tingling sensation
• High levels of potassium in blood test results [may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations]
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, difficulty hearing*
• Constipation, burping, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy raised rash (urticarial rash)
• Eye inflammation
• Difficulty breathing
• Skin discolouration (bruising)
• Chest pain (generalised pain not related to the heart)
• Facial swelling

Adverse effects rare (may affect up to 1 in 1,000 people)

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (oesophagus)
• Low levels of sodium in the blood (a condition known as hyponatraemia)
• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising)
• Difficulty with muscular coordination of movements
• Feeling confused, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that may lead to lung inflammation
• Irregular heartbeat
• Flushing
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
• Bleeding from the stomach or intestines (may result in bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

Adverse effects very rare (may affect up to 1 in 10,000 people)

• Severe allergic reactions (including potentially life-threatening anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin), and acute generalized exanthematous pustulosis (symptoms include reddening of the skin with swollen areas and numerous small pustules)
• A delayed allergic reaction with possible symptoms such as rashes, facial swelling, fever, swollen glands and abnormal clinical test results [e.g.: liver, blood cells (eosinophilia, a type of increase in blood cell count)]
• Bleeding in the brain leading to death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea and yellowing of the skin or eyes)
• Inflammation of the kidneys and other kidney problems (such as nephrotic syndrome and minimal change disease which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (possibly more frequent and/or severe seizures)
• Blockage of an artery or vein in the eye leading to partial or complete vision loss
• Inflammation of blood vessels (may cause fever, pain, purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Disturbance of taste sensation
• Loss of taste

Adverse effects with frequency not known (frequency cannot be estimated from the available data)

• Decreased fertility in women, which is usually reversible if the medicine is discontinued

Adverse effects reported in clinical trials where celecoxib was administered at a dose of 400 mg daily for more than 3 years in patients with conditions unrelated to Arthritis or other arthritic conditions were:

Common (may affect up to 1 in 10 patients)

• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion and gas)
• Kidney stones (may cause stomach or back pain, blood in urine), difficulty urinating
• Weight gain

Uncommon (may affect up to 1 in 100 patients)

• Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness in the calf or difficulty breathing)
• Stomach problems: stomach infection (may cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia [chest infection (possible cough, fever, difficulty breathing)]
• Eye floaters causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, bleeding from haemorrhoids/piles, frequent bowel movements
• Fatty lumps under the skin or elsewhere, ganglion cyst (non-painful swelling in joints or tendons or around them, in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• High levels of sodium in blood test results

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Celecoxib Almus

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

Do not use this medicine after the expiry date stated on the packaging, following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Almus

The active substance is celecoxib. Each hard capsule contains 200 mg of celecoxib.

The other components (excipients) are:

Monohydrate lactose, sodium lauryl sulfate, povidone, sodium croscarmellose, magnesium stearate (E572) (granulate)

Gelatin (E441), titanium dioxide (E171), yellow iron oxide (172) (capsule shell)

Shellac lacquer (E904), propylene glycol (E1520), yellow iron oxide (172) (printing ink)

Appearance of the product and contents of the pack

White, opaque hard gelatin capsules. The body of the capsule features a yellow band, and the imprint “C90X-200” in white appears on the body.

The capsules are presented in PVC/aluminum blisters.

Pack sizes containing 1, 10, 20, 30, 40, 50, 60 and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

Synthon Hispania S.L.

Castelló, 1,

08830 Sant Boi de Llobregat,

Spain

Synthon BV

Microweg 22

6545 CM, Nijmegen

The Netherlands

EGIS PHARMACEUTICALS PLC.

Bökenyföldi ut 118-120

H-1165 Budapest, Hungary

Lek Pharmaceuticals d.d.

Verovškova 57

SI – 1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179, Barleben, Saxony-Anhalt

Germany

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

The Netherlands: Bixocel 200 mg, capsules, hard

Germany: Celecox-HEXAL 200 mg Hartkapseln

France: Celecoxib Sandoz 200 mg, gélule

Spain: Celecoxib Almus 200 mg hard capsules EFG

Portugal: Celecoxib Sandoz

Date of the most recent review of this leaflet: July 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/