Product Information for the User
ACOXXEL 30Film-Coated Tablets
ACOXXEL 60Film-Coated Tablets
ACOXXEL 90Film-Coated Tablets
ACOXXEL 120Film-Coated Tablets
etoricoxib
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of theLeaflet
1.What ACOXXEL is and what it is used for
2.What you need to know before you start taking ACOXXEL
3.How to take ACOXXEL
4.Possible side effects
5.Storage of ACOXXEL
6.Contents of the pack and additional information
What is Acoxxel?
What is Acoxxel used for?
Osteoarthritis is a joint disease. It causes the gradual breakdown of the cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, sensitivity, stiffness, and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term inflammatory disease of the joints. It causes pain, stiffness, swelling, and progressive loss of mobility in the affected joints. It also causes inflammation in other areas of the body.
What is gout?
Gout is a disease of sudden and recurrent attacks of very painful and inflamed joints. It is caused by deposits of mineral crystals in the joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and long joints.
Etoricoxib may slightly increase your risk of heart attack and stroke, and therefore should not be used in patients who have had heart problems or a stroke.
If you think you fall into any of these cases, do not take the tablets until you have consulted your doctor.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Acoxxel if:
If you are unsure whether any of the above situations affect you,talk to your doctor before taking Acoxxelto check if this medicine is suitable for you.
Acoxxel works just as well in adult and young patients. If you are over 65years of age, your doctor will want to keep a close eye on you. No adjustment of the dose is needed in patients over 65years of age.
Children and adolescents
Do not administer this medicine to children and adolescents under 16years of age.
Other medicines and Acoxxel
Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including those obtained without a prescription.
In particular, if you are using any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly once you start taking Acoxxel:
Acoxxel can be taken withlow dosesof aspirin. If you are currently taking low doses of aspirin to prevent heart attacks or strokes, do not stop taking aspirin until you have spoken with your doctor
do not takehigh dosesof aspirin or other NSAIDs while taking Acoxxel.
Taking Acoxxel with food and drinks
The onset of Acoxxel's effect may be faster if taken without food.
Pregnancy, lactation and fertility
Pregnancy
Acoxxel tablets should not be taken during pregnancy. Do not take the tablets if you are pregnant, think you may be pregnant or are planning to become pregnant. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you have any doubts or need more information.
Lactation
The elimination of Acoxxel by breast milk is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Acoxxel. If you are taking Acoxxel, you should stop breastfeeding.
Fertility
Acoxxel is not recommended for women trying to become pregnant.
Driving and operating machinery
In some patients taking Acoxxel, dizziness and somnolence have been reported.
Do not drive if you experience dizziness or somnolence.
Do not use tools or machinery if you experience dizziness or somnolence.
Acoxxel contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Acoxxel contains sodium
This medicine contains less than 23mg of sodium (1mmol) per coated tablet; this is, essentially “sodium-free”.
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Do not take more than the recommended dose for your condition. Your doctor will want to discuss your treatment from time to time. It is essential to use the lowest dose that controls your pain and do not take Acoxxel for longer than necessary. This is because the risk of myocardial infarction and cerebral infarction may increase after prolonged treatment, especially with high doses.
There are different doses available for this medication, and depending on your condition, your doctor will prescribe the tablet with the dose that is suitable for you.
The recommended dose is:
Arthritis
The recommended dose is 30mg once a day, increasing up to a maximum of 60mg once a day if necessary.
Rheumatoid Arthritis
The recommended dose is 60mg once a day, increasing up to a maximum of 90mg once a day if necessary.
Ankylosing Spondylitis
The recommended dose is 60mg once a day, increasing up to a maximum of 90mg once a day if necessary.
Acute Pain Situations
Etoricoxib should only be used during the acute pain period.
Gout
The recommended dose is 120mg once a day, which should only be used during the acute pain period, limited to a maximum of 8days of treatment.
Postoperative Pain after Dental Surgery
The recommended dose is 90mg once a day, limited to a maximum of 3days of treatment.
Patients with Liver Problems
Use in Children and Adolescents
Children or adolescents under 16years of age should not take Acoxxel tablets.
Patients over 65years
No dose adjustment is necessary for patients over 65years. As with other medications, caution should be exercised in elderly patients.
Administration Form
Acoxxel is administered orally. Take the tablets once a day. Acoxxel can be taken with or without food.
If you take more Acoxxel than you should
You should never take more tablets than your doctor recommends. If you take too many Acoxxel tablets, seek medical attention immediately.
In case of overdose or accidental ingestion, you can also call the Toxicological Information Service, Tfno. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.
If you forgot to take Acoxxel
It is essential to take Acoxxel as your doctor has indicated. If you forget a dose, limit yourself to resuming the usual regimen the next day.Do not take a double dose to compensate for the missed doses.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you develop any of these signs, stop takingAcoxxeland talk to your doctor immediately (see section2.What you need to know before starting to take Acoxxel):
The frequency of possible side effects listed below is defined according to the following convention:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
The following side effects may occur during treatment with Acoxxel:
Very common:
Common::
Uncommon::
Rare::
Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medicationafter the expiration date that appears on the box. The expiration date is the last day of the month indicated.
Bottles: keep the container perfectly closed to protect it from moisture.
Blister packs: store in the original packaging to protect it from moisture.
Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.
Tablet core:calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Film coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E-171), triacetin. The 30, 60 and 120mg tablets also contain yellow iron oxide (E-172, coloring agent) and indigo carmine (E-132, coloring agent).
Appearance of the product and contents of the package
Acoxxel tablets are available in four doses:
30mg film-coated tablets, blue-green, apple-shaped, biconvex, engraved with ‘ACX 30’ on one side and ‘101’ on the other.
60mg film-coated tablets, dark green, apple-shaped, biconvex, engraved with ‘200’ on one side and smooth on the other.
90mg film-coated tablets, white, apple-shaped, biconvex, engraved with ‘202’ on one side and smooth on the other.
120mg film-coated tablets, pale green, apple-shaped, biconvex, engraved with ‘204’ on one side and smooth on the other.
Package sizes:
30mg:
Package sizes of2, 7, 14, 20, 28, 49, 98tablets ormulti‑packs containing 98(2packs of 49)tablets in blisters.
60mg:
Package sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100tablets ormulti‑packs containing 98 (2packs of 49)tablets in blisters; or 30 and 90tablets in bottles with desiccant. The desiccant (one or two packs) in the bottle, used to keep the tablets dry, should not be swallowed.
90 and 120mg:
Package sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100tablets ormulti‑packs containing 98 (2packs of 49)tablets in blisters; or 30 and 90tablets in bottles with desiccant. The desiccant (one or two packs) in the bottle, used to keep the tablets dry, should not be swallowed.
60, 90 and 120mg:
Aluminium/aluminium (single-dose) blisters in packs of 50 or 100tablets.
Only some package sizes may be marketed.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder Organon Salud, S.L. Paseo de la Castellana, 77 28046 Madrid Spain Tel.: 915911279 |
Responsible manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
or
Organon Heist bv
Industriepark30
2220Heist‑op‑den‑Berg
Belgium
This medicinal product is authorized in the member states of the European Economic Area with the following names:
GermanyACOXXEL30, 60, 90, 120mg Filmtabletten
SpainACOXXEL30,60, 90, 120mg film-coated tablets
PortugalACOXXEL30,60, 90, 120mg film-coated tablets
Last revision date of this leaflet:05/2021.
Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.