Package leaflet: Information for the user

BRUFECOD 400mg/30mg film-coated tablets

ibuprofen/codeine
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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

The full name of the medicine is BRUFECOD 400mg/30mg film-coated tablets. In this
leaflet, the abbreviated name BRUFECOD is used.

1. What BRUFECOD is and what it is used for

This medicinal product contains both ibuprofen and codeine. Both are analgesics. By acting on the body in different ways, ibuprofen and codeine work together to relieve pain and soreness. Ibuprofen belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). Codeine belongs to a group of medicines called "opioid analgesics" which act to relieve pain. Each tablet contains 400 mg of ibuprofen and 30 mg of codeine phosphate hemihydrate.
This medicine is used for:

relieving mild to moderate pain in adults that is not relieved by using painkillers (such as paracetamol or ibuprofen).

It must not be used in children and adolescents.

2. What you need to know before taking BRUFECOD

Do not take BRUFECOD:

if you are allergic to ibuprofen, codeine, or any of the other ingredients of this medicine (listed in section 6)
if you have ever had an allergic reaction to ibuprofen, acetylsalicylic acid (e.g. aspirin), or other NSAIDs – signs may include skin redness or rash, swelling of the face or lips, or shortness of breath
if you currently suffer from (or have had two or more episodes of) stomach ulcer (peptic ulcer) or gastrointestinal bleeding
if you have ever had gastrointestinal bleeding or perforation while taking other NSAIDs
if you have severe liver or kidney problems
if you suffer from severe heart failure or coronary artery disease
if you have a disease that may increase your tendency to bleed
if you regularly suffer from constipation or are chronically constipated
if you have inflammatory bowel disease or intestinal bleeding
if you have breathing difficulties or respiratory problems
during the third trimester of pregnancy. For further information, see section below “Pregnancy, breastfeeding and fertility”
if you are breastfeeding. For further information, see section below “Pregnancy, breastfeeding and fertility”
if you know you metabolize codeine to morphine very rapidly. Do not take BRUFECOD if you are in any of the above conditions. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRUFECOD:

if you have systemic lupus erythematosus (SLE) (a disease affecting connective tissue – for example, joints and skin), because in rare cases, particularly in patients with pre-existing autoimmune diseases, aseptic meningitis has been observed, with symptoms such as headache, neck stiffness, confusion, fever, and sensitivity of the eyes to light.
if you have ever had stomach or intestinal problems (such as ulcerative colitis or Crohn’s disease)
if you have kidney, heart, or liver problems. Regular use of painkillers, especially the combined use of similar painkillers, may further increase the risk of kidney problems. Side effects can be minimized by using the lowest effective dose for the shortest time needed to control symptoms.
if you have severe stomach pain
if you have biliary tract disorders, such as acute pancreatitis
if you have recently undergone major surgery
if you have previously had allergic reactions to other medicines for other conditions
if you suffer from hay fever, nasal polyps (loss of smell, runny or blocked nose), or respiratory problems. There is an increased risk of allergic reactions, which may present as asthma attacks, skin swelling, or hives.
if you have ever had asthma
if you are elderly (aged 65 years or older), as you may be at higher risk of serious side effects; codeine may cause confusion and excessive drowsiness in the elderly
if you are dehydrated
if you are taking medicines that prevent blood clotting (anticoagulants)
if you are taking medicines that increase the risk of gastrointestinal bleeding
if you are regularly taking other painkillers, especially if you are physically active, a condition that could lead to loss of salts or dehydration
if you have had addiction problems
if you have low blood pressure
if you have an underactive thyroid
if you are prone to seizures
if you have had head injuries or feel increased pressure in your head.
if you have an infection – see section “Infections” below
if you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to higher doses of the medicine.

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some people have variations in this enzyme, which may affect them in different ways. In some individuals, morphine is not produced or is produced in very small amounts, resulting in insufficient pain relief. Others may be more likely to experience serious side effects because very high levels of morphine are produced. If you notice any of the following side effects, you must stop treatment immediately and contact a doctor: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
If you are in any of the above conditions, consult your doctor or pharmacist before taking BRUFECOD.
Tolerance, physical dependence, and psychological dependence
This medicine contains codeine, which is an opioid medicine.
Repeated use of opioids may lead to reduced effectiveness of the medicine (the body becomes accustomed to the medicine, a phenomenon known as tolerance).
Repeated use of BRUFECOD may also cause physical dependence, abuse, and psychological dependence, which may lead to potentially life-threatening overdose.
If you take BRUFECOD for longer than recommended or at higher doses than recommended, the risk of these adverse effects may increase, and you will also be at risk of serious stomach/intestinal and kidney damage, as well as very low potassium levels in the blood, which can be potentially fatal (see section 4).
Physical or psychological dependence may make you feel that you no longer have control over how much medicine you take or how often you take it.
The risk of physical or psychological dependence varies from person to person. You may be at higher risk of physical or psychological dependence on BRUFECOD if:

you or someone in your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs (“psychological dependence”).
you are a smoker
you have previously had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking BRUFECOD, it could be a sign of physical or psychological dependence:

you feel the need to take the medicine longer than advised by your doctor.
you feel the need to take higher amounts than the recommended dose.
you feel compelled to continue taking the medicine, even if it does not help relieve your pain.
you are using the medicine for reasons other than prescribed, for example, to “stay calm” or “help you sleep.”
you have tried several times to stop or control the use of this medicine without success.
you feel unwell when you stop taking the medicine, and feel better when you take it again (“withdrawal effects”).

If you notice any of these signs, consult your doctor to discuss the best treatment plan for you, including when and how to safely discontinue the medicine.
Respiratory effects
Like all opioids, codeine can cause serious breathing problems. Effects range from mild to potentially life-threatening.
Heart attack and stroke
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking BRUFECOD if you have:

heart problems such as heart failure, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or transient ischemic attack "TIA");
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker. With ibuprofen, signs of allergic reaction to the medicine have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. If you notice any of these signs, stop BRUFECOD immediately and contact your doctor or emergency services. Contact your doctor if you experience severe upper abdominal pain that may radiate to your back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Sleep-related breathing disorders
BRUFECOD may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nighttime awakening due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Skin reactions
Serious skin reactions have been reported in association with treatment with BRUFECOD.
Stop taking BRUFECOD and consult your doctor immediately if you develop a rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.
Infections
BRUFECOD may mask symptoms of infections such as fever and pain. Therefore, BRUFECOD may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Constipation
Chronic use of opioids, such as codeine, may cause or worsen chronic constipation.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and BRUFECOD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as BRUFECOD may affect how other medicines work. Similarly, other medicines may affect how BRUFECOD works.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

acetylsalicylic acid (e.g. aspirin). Do not use this medicine if you are taking a daily dose of acetylsalicylic acid higher than 75 mg
other NSAIDs, including COX-2 inhibitors (such as celecoxib). Do not use this medicine if you are taking other NSAIDs (including COX-2 inhibitors)
other medicines containing ibuprofen, such as those available without prescription
medicines for heart problems, such as digoxin
medicines for diabetes, such as glibenclamide
medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, or ticlopidine)
medicines that suppress the immune system, such as cyclosporine or tacrolimus
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
diuretics (medicines to increase urine production)
quinidine, used to treat heart rhythm abnormalities
steroids, used to treat inflammatory conditions
medicines used to treat depression, including selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, or monoamine oxidase inhibitors (MAOIs), such as iproniazide, phenelzine, moclobemide, toloxatone. The effects of central nervous system depressants (other opioids, antihistamines, anxiolytics, sedatives, hypnotics, antipsychotics, neuroleptics, including alcohol) may be enhanced by codeine
gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain)
sedative medicines such as benzodiazepines or related medicines. Concomitant use of BRUFECOD and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes BRUFECOD together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
certain antibiotics for the treatment of infections, including quinolones (such as ciprofloxacin) or aminoglycosides (such as gentamicin)
zidovudine, used to treat HIV or AIDS
methotrexate, used to treat certain forms of cancer
cholestyramine, used to lower cholesterol
lithium, used to treat certain forms of depression
voriconazole or fluconazole, used to treat fungal infections
mifepristone, used for medical termination of pregnancy
Ginkgo biloba, a herbal medicine often used to treat dementia. Concomitant use of Ginkgo biloba and ibuprofen may increase the risk of bleeding
anticholinergics (e.g., oxybutynin) or other medicines with anticholinergic activity.

If you are in any of the above conditions (or are unsure), discuss with your doctor or pharmacist before taking BRUFECOD.
Other medicines may also affect or be affected by treatment with BRUFECOD. Therefore, always consult your doctor or pharmacist before using BRUFECOD with other medicines.
BRUFECOD and alcohol
If you consume alcohol while being treated with this medicine, you may experience drowsiness and may be more susceptible to side effects.
Pregnancy, breastfeeding and fertility

Do not take this medicine during the third trimester of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It may affect your bleeding tendency and that of the baby, and may delay or prolong labor beyond the expected time.
Consult your doctor or pharmacist before taking this medicine if you are in the first six months of pregnancy. You should not take BRUFECOD during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, BRUFECOD may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels surrounding the baby (oligohydramnios), or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Consult your doctor or pharmacist before taking this medicine if you plan to become pregnant or if you have difficulty conceiving, as long-term use of this medicine may make it more difficult to become pregnant. However, occasional use of this medicine is unlikely to impair fertility. This effect is usually reversible upon discontinuation of the medicine.
Do not take BRUFECOD while breastfeeding. Codeine and morphine pass into breast milk.

Driving and use of machinery
This medicine may cause dizziness or drowsiness. If this occurs, do not drive or operate tools or machinery. Refrain from any activity requiring alertness.
BRUFECOD contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free.”

3. How to take BRUFECOD

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for short-term use only. The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using BRUFECOD, when and for how long you should take it, when to contact your doctor, and when you should stop taking it.

Dosage
Adults

The usual dose is 1 tablet every 4–6 hours, normally taken in the morning, afternoon, and evening.
Do not exceed a total of 6 tablets in 24 hours.

Patients with hepatic or renal impairment
If you have liver or kidney problems, your doctor will advise you on the correct dosage to take. This will be the lowest effective dose.

Elderly (over 65 years of age)
If you are elderly, your doctor will advise you on the correct dosage to take. This will be the lowest effective dose.

Use in children and adolescents
This medicine must not be given to children or adolescents under 18 years of age.

How to take this medicine
Take this medicine during or immediately after meals.

Swallow BRUFECOD tablets with a glass of water.
Make sure you swallow the tablet whole, without chewing, breaking, crushing, or sucking it.

If you take more BRUFECOD than you should
If you have taken an excessive dose of BRUFECOD, inform your doctor or go to the nearest hospital immediately. Take the medicine package with you.
The following symptoms may occur after an overdose: malaise, stomach pain, vomiting (sometimes with blood), headache, tinnitus, confusion, and oscillating eye movements (nystagmus). At high doses, loss of consciousness, seizures (particularly in children), weakness or dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.

If you forget to take BRUFECOD

If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

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

Serious side effects
Stop taking this medicine and go to the doctor immediately if you experience any of the following serious side effects. You may need urgent medical treatment:

signs of bleeding from the stomach or intestine, such as blood in the stools, black tarry stools, vomiting blood or dark particles resembling coffee grounds
swelling of the face, tongue or throat (larynx) causing severe difficulty in swallowing and breathing (angioedema), rapid heartbeat, severe drop in blood pressure or life-threatening shock
severe skin rash, skin peeling or blistering (which may also affect the inside of the mouth, nose and ears), such as “Stevens-Johnson syndrome”, “toxic epidermal necrolysis” or “erythema multiforme”
a serious skin reaction known as DRESS syndrome. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells)
widespread, red, scaly rash with pustules under the skin and blisters mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using BRUFECOD if you develop these symptoms and contact your doctor immediately. See also section 2.

Stop taking this medicine and go to the doctor immediately if you experience any of the above serious side effects.

Stop taking this medicine and consult your doctor if you experience any of the following side effects:

indigestion or heartburn
stomach (abdominal) pain or other unusual stomach symptoms

Stop taking this medicine and consult your doctor if you experience any of the above side effects.

Other side effects
Common (may affect up to 1 in 10 people):

rash
dizziness or tiredness
loss of appetite, diarrhoea, nausea, vomiting, flatulence, constipation
headache – if this effect occurs while taking this medicine, it is important not to take other painkillers
drowsiness

Uncommon (may affect up to 1 in 100 people):

anxiety
tingling sensation
sleep disturbances
urticaria, itching
skin sensitivity to light
vision disturbances, hearing problems
hepatitis, yellowing of the skin or eyes, reduced liver function
reduced kidney function, kidney inflammation, kidney failure
sneezing, nasal congestion, nasal itching, runny nose (rhinitis)
stomach or intestinal ulcers, perforation of the wall of the digestive tract
inflammation of the stomach lining
minor bruising on the skin or in the mouth, nose or ears
difficulty breathing, shortness of breath or cough, asthma or worsening of asthma
changes in blood cell counts – early signs include: high temperature, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, nosebleeds and skin bleeding
ringing in the ears (tinnitus)
sensation of spinning (vertigo)

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

feeling depressed or confused
fluid retention (oedema)
non-bacterial infection of the brain called 'aseptic meningitis'
loss of vision
liver damage

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

liver failure
inflammation of the pancreas (pancreatitis)

Not known (frequency cannot be estimated from the available data):

prolonged bleeding time
ulcerative colitis or Crohn's disease
burning sensation in the throat or mouth; this effect may occur shortly after taking this medicine
confusion
difficulty urinating
heart failure, heart attack, high blood pressure
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system (a condition involving an intestinal valve, called Oddi sphincter dysfunction), e.g., severe pain in the upper abdomen that may radiate to the back, nausea, vomiting or fever
skin reactions that often occur at the same site on the body after repeated administration of the drug

The following side effects have also been reported with other NSAIDs:

worsening of ulcers in the large intestine and Crohn's disease (a bowel disease)
slight increase in the risk of stroke

When using an NSAID, infection-related skin inflammation may develop or worsen (e.g., a condition such as necrotizing fasciitis characterized by severe pain, high fever, swollen and warm skin, blisters, necrosis). If signs of a skin infection appear or worsen during use of BRUFECOD, you are advised to consult a doctor immediately.

BRUFECOD may cause kidney damage and affect the proper elimination of acids from the blood into the urine (renal tubular acidosis), especially if taken at doses higher than recommended or for prolonged periods. It may also cause very low levels of potassium in the blood (see section 2). This is a very serious condition requiring immediate treatment. Signs and symptoms include muscle weakness and mental confusion.

Tolerance and dependence may develop, particularly with long-term use of large amounts of codeine.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BRUFECOD

Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place inaccessible to other people. It may cause serious harm or be fatal to individuals for whom it is not intended.
These film-coated tablets do not require any special storage precautions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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. Package contents and other information

What BRUFECOD contains

The active substances are ibuprofen and codeine phosphate hemihydrate. Each film-coated tablet contains 400 mg of ibuprofen and 30 mg of codeine phosphate hemihydrate.
The other components are: sodium glycolate starch, microcrystalline cellulose, anhydrous colloidal silica, L-leucine, talc and pregelatinized starch. The film coating contains: methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, talc, titanium dioxide (E171), macrogol 6000, simeticone emulsion, and sodium carmellose.

Description of the appearance of BRUFECOD and package contents
BRUFECOD is available as film-coated tablets. The medicine is packaged in
blister packs and contained in a cardboard box.
Each box contains 30 tablets.
Marketing Authorization Holder and Manufacturer :
Marketing Authorization Holder :
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milano, Italy
Manufacturer :
Farmasierra Manufacturing S.L., Ctra. de Irún, Km. 26,200. 28706 San Sebastián de los Reyes,
Madrid, Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Finland: Ardinex 400 mg/30 mg, kalvopäällysteiset tabletit
Belgium: Brufen Codeine 400 mg/30 mg filmomhulde tabletten
Estonia: Brufen Plus
Greece: Brufen Plus® 400 mg/30 mg Επικαλυμμένο με λεπτό υμένιο δισκίo
Italy: BRUFECOD 400mg/30mg Compresse Rivestite con Film
Latvia: Brufen Plus 400 mg/30 mg apvalkotās tabletes
Luxembourg: Brufen Codeine 400mg/30mg comprimés pelliculés
Romania: Brufen Plus 400mg/30mg comprimate filmate

Brufecod