Etoricoxib Alchemia 120 mg Filmdragerad tablett

Шведска - Шведски - Läkemedelsverket (Medical Products Agency)

Активни састојак:
etoricoxib
Доступно од:
Alchemia Limited
АТЦ код:
M01AH05
INN (Међународно име):
etoricoxib
Дозирање:
120 mg
Фармацеутски облик:
Filmdragerad tablett
Састав:
laktosmonohydrat Hjälpämne; etoricoxib 120 mg Aktiv substans
Тип рецептора:
Receptbelagt
Статус ауторизације:
Avregistrerad
Број ауторизације:
53668
Датум одобрења:
2017-02-03

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Package leaflet: Information for the user

Etoricoxib Alchemia 30 mg film-coated tablets

Etoricoxib Alchemia 60 mg film-coated tablets

Etoricoxib Alchemia 90 mg film-coated tablets

Etoricoxib Alchemia 120 mg film-coated tablets

etoricoxib

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Etoricoxib Alchemia is and what it is used for

What you need to know before you take Etoricoxib Alchemia

How to take Etoricoxib Alchemia

Possible side effects

How to store Etoricoxib Alchemia

Contents of the pack and other information

1.

What Etoricoxib Alchemia is and what it is used for

What is Etoricoxib Alchemia?

Etoricoxib Alchemia contains the active substance etoricoxib. Etoricoxib Alchemia is one of a

group of medicines called selective COX-2 inhibitors. These belong to a family of medicines

called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Etoricoxib Alchemia used for?

Etoricoxib Alchemia helps to reduce the pain and swelling (inflammation) in the joints and

muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing

spondylitis and gout.

Etoricoxib Alchemia is also used for the short term treatment of moderate pain after dental

surgery in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions

the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness,

swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in

other areas of the body.

What is gout?

Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the 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 large joints

2.

What you need to know before you take Etoricoxib Alchemia

Do not take Etoricoxib Alchemia:

if you are allergic to etoricoxib or any of the other ingredients of this medicine (listed in section

if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic

acid (aspirin) and COX-2 inhibitors (see Possible Side Effects, section 4)

if you have a current stomach ulcer or bleeding in your stomach or intestines

if you have serious liver disease

if you have serious kidney disease

if you are or could be pregnant or are breast-feeding (see ‘Pregnancy, breast feeding, and

fertility’)

if you are under 16 years of age

if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis

if you have high blood pressure that has not been controlled by treatment (check with your

doctor or nurse if you are not sure whether your blood pressure is adequately controlled)

if your doctor has diagnosed heart problems including heart failure (moderate or severe types),

angina (chest pain)

if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in

legs or feet due to narrow or blocked arteries)

if you have had any kind of stroke (including mini-stroke, transient ischaemic attack or TIA).

Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should

not be used in those who have already had heart problems or stroke.

If you think any of these are relevant to you, do not take the tablets until you have consulted your

doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Etoricoxib Alchemia:

if you have a history of stomach bleeding or ulcers.

if you are dehydrated, for example by a prolonged bout of vomiting or diarrhoea.

if you have swelling due to fluid retention.

if you have a history of heart failure, or any other form of heart disease.

if you have a history of high blood pressure. Etoricoxib Alchemia can increase blood pressure in

some people, especially in high doses, and your doctor will want to check your blood pressure

from time to time.

if you have any history of liver or kidney disease.

if you are being treated for an infection. Etoricoxib Alchemia can mask or hide a fever, which is

a sign of infection.

if you have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart

disease.

if you are a woman trying to become pregnant.

if you are over 65 years of age.

If you are not sure if any of the above apply to you, talk to your doctor before taking Etoricoxib

Alchemia to see if this medicine is suitable for you.

Etoricoxib Alchemia works equally well in older and younger adult patients. If you are over 65 years

of age, your doctor will want to appropriately keep a check on you. No dosage adjustment is necessary

for patients over 65 years of age.

Children and adolescents

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

Other medicines and Etoricoxib Alchemia

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

medicines, including medicines obtained without a prescription.

In particular if you are taking any of the following medicines, your doctor may want to monitor you

to check that your medicines are working properly, once you start taking Etoricoxib Alchemia:

medicines that thin your blood (anticoagulants), such as warfarin

rifampicin (an antibiotic)

methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid

arthritis)

ciclosporin or tacrolimus (drugs used for suppressing the immune system)

lithium (a medicine used to treat some types of depression)

medicines used to help control high blood pressure and heart failure called ACE inhibitors and

angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and

valsartan

diuretics (water tablets)

digoxin (a medicine for heart failure and irregular heart rhythm)

minoxidil (a drug used to treat high blood pressure)

salbutamol tablets or oral solution (a medicine for asthma)

birth control pills (the combination may increase your risk of side effects)

hormone replacement therapy (the combination may increase your risk of side effects)

acetylsalicylic acid, the risk of stomach ulcers is greater if you take Etoricoxib Alchemia with

acetylsalicylic acid.

acetylsalicylic acid for prevention of heart attacks or stroke:

Etoricoxib Alchemia can be taken with

low-dose

acetylsalicylic acid. If you are currently

taking low-dose acetylsalicylic acid to prevent heart attacks or stroke, you should not stop

taking acetylsalicylic acid until you talk to your doctor

acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take

high dose

acetylsalicylic acid or other anti-inflammatory medicines while

taking Etoricoxib Alchemia.

Etoricoxib Alchemia with food and drink

The onset of the effect of Etoricoxib Alchemia may be faster when taken without food.

Pregnancy, breast-feeding and fertility

Pregnancy

Etoricoxib Alchemia tablets must not be taken during pregnancy. If you are pregnant or breast-

feeding, think you may be pregnant or are planning to have a baby do not take the tablets. If you

become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you are

unsure or need more advice.

Breast-feeding

It is not known if Etoricoxib Alchemia is excreted in human milk. If you are breast-feeding, or

planning to breast-feed, consult your doctor before taking Etoricoxib Alchemia. If you are using

Etoricoxib Alchemia, you must not breast-feed.

Fertility

Etoricoxib Alchemia is not recommended in women attempting to become pregnant.

Driving and using machines

Dizziness and sleepiness have been reported in some patients taking Etoricoxib Alchemia.

Do not drive if you experience dizziness or sleepiness.

Do not use any tools or machines if you experience dizziness or sleepiness.

Etoricoxib Alchemia

contains lactose

If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor

before taking this medicinal product.

3.

How to take Etoricoxib Alchemia

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

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 important that you use the lowest dose that controls your pain

and you should not take Etoricoxib Alchemia for longer than necessary. This is because the risk of

heart attacks and strokes might increase after prolonged treatment, especially with high doses.

There are different strengths available for this medicinal product and depending on your disease your

doctor will prescribe the tablet strength that is appropriate for you.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.

Rheumatoid arthritis

The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.

Ankylosing spondylitis

The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.

Acute pain conditions

Etoricoxib should be used only for the acute painful period.

Gout

The recommended dose is 120 mg once a day which should only be used for the acute painful period,

limited to a maximum of 8 days treatment.

Postoperative dental surgery pain

The recommended dose is 90 mg once daily, limited to a maximum of 3 days treatment.

People with liver problems

If you have mild liver disease, you should not take more than 60 mg a day.

If you have

moderate

liver disease, you should not take more than

30 mg a day

Use in children and adolescents

Etoricoxib Alchemia tablets should not be taken by children or adolescents under 16 years of age.

Elderly

No dose adjustment is necessary for elderly patients. As with other medicines, caution should be

exercised in elderly patients.

Method of administration

Etoricoxib Alchemia is for oral use. Take the tablets once a day. Etoricoxib Alchemia can be taken

with or without food.

If you take more Etoricoxib Alchemia than you should

You should never take more tablets than the doctor recommends. If you do take too many Etoricoxib

Alchemia tablets, you should seek medical attention immediately.

If you forget to take Etoricoxib Alchemia

It is important to take Etoricoxib Alchemia as your doctor has prescribed. If you miss a dose, just

resume your usual schedule the following day. Do not take a double dose to make up for the forgotten

tablet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you develop any of these signs you should stop Etoricoxib Alchemia and talk to your doctor

immediately (see What you need to know before you take Etoricoxib Alchemia section 2):

shortness of breath, chest pains, or ankle swelling appear or if they get worse.

yellowing of the skin and eyes (jaundice) – these are signs of liver problems.

severe or continual stomach pain or your stools become black.

an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of

the face, lips, tongue, or throat which may cause difficulty in breathing.

The following side effects can occur during treatment with Etoricoxib Alchemia:

Very Common

(may affect more than 1 in 10 people):

stomach pain

Common

(may affect up to 1 in 10 people):

dry socket (inflammation and pain after a tooth extraction)

swelling of the legs and/or feet due to fluid retention (oedema)

dizziness, headache

palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)

increased blood pressure

wheezing or shortness of breath (bronchospasms)

constipation, wind (excessive gas), gastritis (inflammation of the lining of the stomach),

heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, being sick

(vomiting), inflammation of the oesophagus, mouth ulcers

changes in blood tests related to your liver

bruising

weakness and fatigue, flu-like illness

Uncommon

(may affect up to 1 in 100 people):

gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and

small intestine/stomach flu), upper respiratory infection, urinary tract infection

changes in laboratory values (decreased number of red blood cells, decreased number of white

blood cells, platelets decreased)

hypersensitivity (an allergic reaction including hives which may be serious enough to require

immediate medical attention)

appetite increases or decreases, weight gain

anxiety, depression, decreases in mental sharpness; seeing, feeling or hearing things that are not

there (hallucinations)

taste alteration, inability to sleep, numbness or tingling, sleepiness

blurred vision, eye irritation and redness

ringing in the ears, vertigo (sensation of spinning while remaining still)

abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness,

pressure or heaviness in the chest (angina pectoris), heart attack

flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure,

inflammation of the blood vessels

cough, breathlessness, nose bleed

stomach or bowel bloating, changes in your bowel habits, dry mouth, stomach ulcer,

inflammation of the stomach lining that can become serious and may lead to bleeding, irritable

bowel syndrome, inflammation of the pancreas

swelling of the face, skin rash or itchy skin, redness of the skin

muscle cramp/spasm, muscle pain/stiffness

high levels of potassium in your blood, changes in blood or urine tests relating to your kidney,

serious kidney problems

chest pain

Rare

(may affect up to 1 in 1,000 people)

angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may

cause difficulty in breathing or swallowing, which may be serious enough to require immediate

medical attention)/anaphylactic/anaphylactoid reactions including shock (a serious allergic

reaction that requires immediate medical attention)

confusion, restlessness

liver problems (hepatitis)

low blood levels of sodium

liver failure, yellowing of the skin and/or eyes (jaundice)

severe skin reactions

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Etoricoxib Alchemia

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

Do not use this medicine after the expiry date which is stated on the carton, blister or container after

“EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

Use within 6 months after first opening (applicable to plastic containers only).

6.

Contents of the pack and other information

What Etoricoxib Alchemia contains

The active substance is etoricoxib. Each film coated tablet contains 30, 60, 90 or 120 mg of

etoricoxib.

The other ingredients are:

Core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium,

anhydrous colloidal silica, hypromellose, magnesium stearate.

Tablet coating: hypromellose , titanium dioxide (E171), lactose monohydrate, triacetin (E1518).

What Etoricoxib Alchemia looks like and contents of the pack

Etoricoxib Alchemia film-coated tablets (tablets) are available in four strengths:

30 mg tablet: White to off white, 8.5 x 4.25 mm oval film-coated tablet debossed '716' on one side and

'A' on the other side.

60 mg tablet: White to off white, 11.5 x 5.75 mm oval film-coated tablet debossed '722' on one side

and 'A' on the other side.

90 mg tablet: White to off white, 12.5 x 6.25 mm oval film-coated tablet debossed '729' on one side

and 'A' on the other side.

120 mg tablet: White to off white, 13.5 x 6.75 mm oval film-coated tablet debossed '752' on one side

and 'A' on the other side.

The product will be packed in OPA/Alu/PVC – Alu push through blister foil and/or HDPE plastic

containers with polypropylene screw cap and one desiccant per container. The desiccant in the

container, used to keep the tablets dry, should not be swallowed.

30 mg tablets: Packs of 7, 14, 20, 28, 49 and 98 tablets in blister.

60 mg tablets: Packs of 5, 7, 10, 14, 20, 28, 30, 49, 50, 84, 90, 98 and 100 tablets in blister and 90

tablets in container.

90 mg tablets: Packs of 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 and 100 tablets in blister and 90 tablets in

container.

120 mg tablets: Packs of 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 and 100 tablets in blister and 30 tablets in

container.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

[To be completed nationally]

Manufacturer:

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Street,

Dupnitsa 2600

Bulgaria

Actavis Ltd.

BLB016, Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

<This medicinal product is authorised in the Member States of the EEA under the following

names:>

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised 1 December 2016

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