Celecoxib Tecnigen: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

CELECOXIB TECNIGEN 100 mg hard capsules, 200 mg hard capsules

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Contents of this leaflet:

What CELECOXIB TECNIGEN is and what it is used for
What you need to know before taking CELECOXIB TECNIGEN
How to take CELECOXIB TECNIGEN
Possible side effects
How to store CELECOXIB TECNIGEN
Contents of the pack and other information

1. WHAT CELECOXIB TECNIGEN IS AND WHAT IT IS USED FOR

CELECOXIB TECNIGEN contains the active substance celecoxib.
CELECOXIB TECNIGEN is used to relieve the signs and symptoms of rheumatoid arthritis,
osteoarthritis, and ankylosing spondylitis.
CELECOXIB TECNIGEN belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and in particular to a subgroup known as COX-2 inhibitors. Your body produces prostaglandins which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces increased amounts of these substances. CELECOXIB TECNIGEN works by reducing the production of prostaglandins, thereby relieving pain and inflammation.

2. WHAT YOU SHOULD KNOW BEFORE TAKING CELECOXIB TECNIGEN

CELECOXIB TECNIGEN has been prescribed for you by your doctor. The following information will help you achieve the best results with CELECOXIB TECNIGEN. If you have any doubts about using this medicine, consult your doctor or pharmacist.
DO NOT TAKE CELECOXIB TECNIGEN
Contact your doctor if any of the following conditions apply to you, as patients with these characteristics must not take CELECOXIB TECNIGEN:

if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6.1);
if you have had an allergic reaction to any medicines called “sulfonamides” (antibiotics used to treat infections);
if you currently have a stomach or intestinal ulcer or bleeding in the stomach or intestines;
if you have experienced asthma, nasal polyps, severe nasal congestion, or allergic reactions such as skin rash with itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing after taking any other non-steroidal anti-inflammatory and pain-relieving medicine (NSAIDs);
if you are pregnant. If you could become pregnant during treatment, you must discuss appropriate contraceptive methods with your doctor;
if you are breastfeeding;
if you have severe liver disease;
if you have severe kidney disease;
if you have an inflammatory bowel disease such as ulcerative colitis or Crohn’s disease;
if you have heart failure, established ischemic heart disease, or cerebrovascular disease: for example, if you have had a heart attack, stroke, transient ischemic attack (temporary reduction in blood flow to the brain, also known as “mini-stroke”), angina, or blockage of blood vessels in the heart or brain;
if you have or have had circulation problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking CELECOXIB TECNIGEN:

if you have had a stomach or intestinal ulcer or bleeding in the stomach or intestines;
(Do not take CELECOXIB TECNIGEN 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 medicines that reduce blood clotting (for example, warfarin);
if you are taking CELECOXIB TECNIGEN together with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concurrent use of these medicines should be avoided;
if you smoke, have diabetes, high blood pressure, or high cholesterol;
if you have heart, liver, or kidney problems, your doctor may decide to monitor you regularly;
if you have fluid retention (swelling in ankles and feet);
if you are dehydrated, for example due to vomiting, diarrhea, or use of diuretics (medicines used to remove excess fluid from the body);
if you have had a severe allergic reaction or a severe skin reaction to any medicine;
if you have or suspect you have an infection, as CELECOXIB TECNIGEN may mask fever or other signs of infection and inflammation;
if you are over 65 years old, your doctor may decide to monitor you regularly.

Like other NSAIDs (for example, ibuprofen and diclofenac), this medicine may cause an increase in blood pressure. Therefore, your doctor may ask you to monitor your blood pressure regularly.
There have been reports of serious liver reactions associated with celecoxib use, including severe liver inflammation, liver damage, and liver failure (in some cases fatal or requiring liver transplantation). Among cases with reported onset times, the most severe liver reactions occurred within one month of starting treatment.
Taking CELECOXIB TECNIGEN may make it more difficult to become pregnant.
You should inform your doctor if you are planning a pregnancy or if you have fertility problems (see section “Pregnancy, breastfeeding and fertility”).

Other medicines and CELECOXIB TECNIGEN
Some medicines can affect the action of other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

dextromethorphan (used to treat cough);
ACE inhibitors or angiotensin II receptor antagonists (used to treat high blood pressure or heart failure);
diuretics (used to remove excess fluid from the body);
fluconazole and rifampicin (used to treat infections caused by fungi or bacteria);
warfarin or other oral anticoagulants (so-called “blood thinners” that prevent blood clots);
lithium (used to treat certain forms 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 to treat rheumatoid arthritis, psoriasis, and leukemia);
carbamazepine (used to treat epilepsy/seizures and certain painful forms of depression);
barbiturates (used to treat epilepsy/seizures and certain sleep disorders);
cyclosporine and tacrolimus (used for suppression of the immune system, for example after transplants).

CELECOXIB TECNIGEN may be taken with low-dose acetylsalicylic acid (up to 75 mg per day).
Ask your doctor for advice before taking these medicines together.

Pregnancy, breastfeeding and fertility
You must not take CELECOXIB TECNIGEN if you are pregnant or could become pregnant during treatment (for example, women of childbearing age who are not using adequate contraception).
If you become pregnant while taking CELECOXIB TECNIGEN, stop treatment immediately and consult your doctor for alternative therapy.
You must not take CELECOXIB TECNIGEN if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Before driving or operating machinery, you should be aware of how you react to CELECOXIB TECNIGEN. If you experience dizziness or drowsiness after taking CELECOXIB TECNIGEN, do not drive or operate machinery until these effects have disappeared.

CELECOXIB TECNIGEN contains lactose (a sugar)
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE CELECOXIB TECNIGEN

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
If you think or feel that the effect of CELECOXIB TECNIGEN is too strong or too weak, contact your doctor or pharmacist.
Your doctor has told you the dose to take. Since the risk of unwanted effects related to heart problems may increase with the dose and duration of treatment, it is important that you take the lowest effective dose for pain control and that the duration of symptomatic treatment with CELECOXIB TECNIGEN is no longer than necessary.
CELECOXIB TECNIGEN capsules must be swallowed whole with a glass of water. The capsules can be taken at any time of day, with or without food. However, try to take each dose of CELECOXIB TECNIGEN at the same time every day.
If you do not experience any benefit from using the medicine, consult your doctor within two weeks of starting treatment.

Dosage
100 mg hard capsules
For osteoarthritis
The recommended daily dose is 200 mg ( 1 hard capsule twice daily or 2 hard capsules once daily ). If necessary, your doctor may increase it up to a maximum of 400 mg ( 2 hard capsules twice daily ).
For rheumatoid arthritis
The recommended initial daily dose is 200 mg ( 1 hard capsule twice daily ). If necessary, your doctor may increase it up to a maximum of 400 mg ( 2 hard capsules twice daily ).
For ankylosing spondylitis
The recommended daily dose is 200 mg ( 1 hard capsule twice daily or 2 hard capsules once daily ). If necessary, your doctor may increase it up to a maximum of 400 mg ( 4 hard capsules once daily or 2 hard capsules twice daily ).

200 mg hard capsules
For osteoarthritis
The recommended daily dose is 200 mg ( 1 hard capsule once daily ). If necessary, your doctor may increase it up to a maximum of 400 mg ( 1 hard capsule twice daily ).
For rheumatoid arthritis
The recommended initial daily dose is 200 mg ( 1 hard capsule once daily ). If necessary, your doctor may increase it up to a maximum of 400 mg ( 1 hard capsule twice daily ).
For ankylosing spondylitis
The recommended daily dose is 200 mg ( 1 hard capsule once daily ). If necessary, your doctor may increase it up to a maximum of 400 mg ( 2 hard capsules once daily or 1 hard capsule twice daily ).

In case of kidney or liver problems: ensure that your doctor knows if you have kidney or liver problems, as in such cases a dose reduction may be necessary.
Elderly patients, especially those weighing less than 50 kg: if you are over 65 years old and weigh less than 50 kg, your doctor may decide to monitor you more closely.
Use in children and adolescents: CELECOXIB TECNIGEN is intended for adults only.
The use of this medicine is contraindicated in children and adolescents.
Do not take more than 400 mg of the medicine per day.

If you take more CELECOXIB TECNIGEN than you should
Do not take more capsules than prescribed by your doctor. If you accidentally take too many capsules, contact your doctor, pharmacist, or go to the hospital, and bring the medicine with you.

If you forget to take CELECOXIB TECNIGEN
If you forget to take a capsule, take one as soon as you remember. Do not take a double dose to make up for the missed dose.

If you stop taking CELECOXIB TECNIGEN
Suddenly stopping treatment with CELECOXIB TECNIGEN may lead to a worsening of symptoms.
Stop taking CELECOXIB TECNIGEN only if your doctor has told you to do so.
Your doctor may ask you to gradually reduce the dose in the days leading up to complete discontinuation of treatment.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences
them.
The adverse reactions listed below have been observed in patients with rheumatoid arthritis
taking celecoxib. Adverse reactions marked with an asterisk (*) are reported at the higher
frequencies observed in patients taking celecoxib to prevent colon polyps. The patients involved
in these studies took celecoxib at high doses for long periods.
If you experience any of the following adverse reactions, stop taking CELECOXIB TECNIGEN and
contact your doctor immediately.
If you have:

an allergic reaction such as rash, facial swelling, wheezing or difficulty breathing;
heart problems such as chest pain;
severe stomach pain or signs of stomach or intestinal bleeding, such as black or bloody stools, or if you vomit blood;
a skin rash, blisters or peeling of the skin;
liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and whites of the eyes)).

Very common (affects more than 1 in 10 people)

high blood pressure*

Common (affects up to 1 in 10 people)

heart attack*;
fluid retention with swelling of the ankles, legs and/or hands;
urinary tract infections;
shortness of breath*, sinusitis (inflammation, infection, obstruction or painful paranasal sinuses); nasal congestion or runny nose, sore throat, cough, chills, flu-like symptoms;
dizziness, or sleep disturbances;
vomiting*, stomach ache, diarrhea, indigestion, flatulence;
skin rash, itching;
muscle stiffness;
difficulty swallowing*;
worsening of pre-existing allergies.

Uncommon (affects up to 1 in 100 people)

stroke*;
heart failure, palpitations (awareness of heartbeat), rapid heartbeat;
worsening of pre-existing high blood pressure;
abnormalities in liver function tests;
abnormalities in kidney function tests;
anemia (changes in red blood cells that may cause fatigue and shortness of breath);
anxiety, depression, tiredness, drowsiness and tingling sensations;
elevated potassium levels in the blood (may cause nausea (feeling unwell)), fatigue, muscle weakness or palpitations);
blurred or impaired vision, ringing in the ears, mouth pain, mouth ulcers, hearing loss*;
constipation, belching, inflammation of the stomach (indigestion, stomach ache or vomiting), worsening of pre-existing stomach or intestinal inflammation.

Rare (affects up to 1 in 1,000 people)

ulcers (bleeding) in the stomach, esophagus or intestine; intestinal perforation (may cause stomach pain, fever, nausea, vomiting and intestinal obstruction), black or dark stools, inflammation of the esophagus (may cause difficulty swallowing), inflammation of the pancreas (may cause stomach pain);
reduction in the number of white blood cells (helps protect the body from infections) and platelets (may increase the risk of bleeding or bruising);
difficulty in coordinating muscle movements;
feeling confused, changes in taste perception;
increased sensitivity to light;
hair loss.

Not known: frequency cannot be estimated from the available data

bleeding in the brain leading to death;
severe allergic reactions (including potentially fatal anaphylactic shock) which may cause rash, swelling of the face, lips, mouth, tongue and throat, wheezing or difficulty breathing, difficulty swallowing;
bleeding in the stomach or intestine (may cause blood in stools or vomiting), inflammation of the intestine or colon, nausea (feeling unwell);
severe skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis (may cause skin rash, blistering or peeling of the skin), and generalized acute exanthematous pustulosis (redness and swelling of the affected area with formation of many small pustules);
liver failure, liver damage and severe liver inflammation (sometimes fatal or requiring liver transplant). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills;
kidney problems (possible kidney failure or inflammation);
formation of blood clots in the pulmonary blood vessels. Symptoms of this event may include sudden shortness of breath, sharp pain when breathing or respiratory collapse;
irregular heartbeat;
meningitis (inflammation of the membrane surrounding the brain and spinal cord);
hallucinations;
worsening of epilepsy symptoms (possible increase in frequency and/or seizures);
inflammation of blood vessels (may cause fever, pain or purple spots on the skin);
blockage of an artery or vein in the eye leading to partial or complete loss of vision, conjunctivitis (inflammation of the conjunctiva), bleeding in the eye;
reduction in the number of red blood cells, white blood cells and platelets (may cause fatigue, bruising, frequent nosebleeds and increased risk of developing infections);
chest pain;
altered sense of smell;
changes in skin color (bruising), muscle pain and weakness, joint pain;
changes in menstrual cycle;
headache, hot flushes;
low levels of sodium in the blood (may cause loss of appetite, headache, nausea (feeling unwell), muscle cramps and weakness).

In clinical studies not involving patients with rheumatoid arthritis or other arthritic diseases
who were taking 400 mg of celecoxib daily for up to 3 years, the following adverse reactions
were observed:
Common (affects up to 1 in 10 people)

heart problems: angina (chest pain);
stomach problems: irritable bowel syndrome (may cause stomach pain, diarrhea, indigestion, gas in the stomach);
kidney stones (may cause stomach or back pain and blood in the urine);
weight gain.

Uncommon (affects up to 1 in 100 people)

deep vein thrombosis (formation of blood clots in the legs which may cause pain, swelling or redness in the calf, or breathing problems);
stomach problems: stomach infection (may cause irritation and ulcers in the stomach and intestine);
lower limb fractures;
shingles, skin infection, eczema (dry rash associated with itching), pneumonia (lung infection (with possible cough, fever and difficulty breathing));
floaters which may cause blurred vision or visual disturbances, dizziness due to inner ear disorders, irritation, inflammation or bleeding of the gums, mouth ulcers;
frequent urination at night, hemorrhoidal bleeding, frequent bowel movements;
formation of fatty deposits in the skin or other parts of the body, ganglion cysts (non-painful swelling near joints or tendons of the hand or foot), difficulty speaking, abnormal and heavy vaginal bleeding, breast pain;
high levels of sodium in the blood.

If you experience any adverse reaction, including those not listed in this leaflet, contact your
doctor, pharmacist or nurse.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your
doctor or pharmacist. You may also report adverse reactions directly via the national reporting
system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this
medicine.

5. HOW TO STORE CELECOXIB TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CELECOXIB TECNIGEN contains

The active substance is celecoxib. Each capsule contains 100 mg or 200 mg of celecoxib.
The other components are: monohydrate lactose, croscarmellose sodium, povidone K30, sodium lauryl sulfate, magnesium stearate. The coating of the 100 mg capsules contains gelatin, titanium dioxide (E171), indigotine (Carmine Indigo) (E132). The coating of the 200 mg capsules contains gelatin, titanium dioxide (E171).

Description of the appearance of CELECOXIB TECNIGEN and the contents of the pack
CELECOXIB TECNIGEN 100 mg capsules are white capsules with a blue coating.
CELECOXIB TECNIGEN 100 mg is packed in blisters in packs of 40 capsules.
CELECOXIB TECNIGEN 200 mg capsules are white capsules with a blue coating.
CELECOXIB TECNIGEN 200 mg is packed in blisters in packs of 20 and 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande 2, Abrunheira
2710-089 Sintra (Portugal)

Responsible manufacturers for batch release:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Celecoxib Atrolif
Italy: Celecoxib TecniGen, 100 mg, hard capsules
Celecoxib TecniGen, 200 mg, hard capsules
Spain: Celecoxib TecniGen 100 mg hard capsules EFG
Celecoxib TecniGen 200 mg hard capsules EFG

This patient information leaflet was last approved on