BRUFEN 40 mg Granules

Зміст інструкції

1. BRUFEN DOLORE 40 mg granules
   1. What is BRUFEN DOLORE and what is it used for
   2. What you need to know before you take BRUFEN DOLORE
   3. How to take BRUFEN DOLORE
   4. Possible side effects
   5. How to store BRUFEN DOLORE
   6. Contents of the pack and other information

BRUFEN DOLORE 40 mg granules

Lysine Ketoprofen

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after short periods of treatment.

Contents of this leaflet:

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

1. What is BRUFEN DOLORE and what is it used for

BRUFEN DOLORE contains the active ingredient ketoprofen, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and
inflammation.
BRUFEN DOLORE is indicated in adults and adolescents over 15 years of age for the
treatment of acute mild to moderate pain.

2. What you need to know before you take BRUFEN DOLORE

Do not take BRUFEN DOLORE

• if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory medicines (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if taking medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) has caused you problems in the past such as asthma (asthma attacks), difficulty breathing due to temporary narrowing of the bronchi (bronchospasm) or the presence of nodules inside the nose (nasal polyps), cold (acute rhinitis), allergic reactions affecting the skin such as hives or swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (angioedema). In this case, a sudden allergic reaction may occur, which may be life-threatening;
• if you suffer from or have suffered from a problem with your stomach or intestines (active or recurrent peptic ulcer), or digestive disorders;
• if you suffer from or have suffered from bleeding or perforation of the stomach and intestines, even following the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have severe heart problems (heart failure);
• if you have severe liver or kidney problems (hepatic or renal failure);
• if you have a predisposition to bleeding (haemorrhagic diathesis) or a problem due to a defect in blood coagulation or are taking medicines to improve blood fluidity (anticoagulants);
• if you are in the last three months of pregnancy or breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if the person who needs to take the medicine is a child or adolescent under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRUFEN DOLORE.
Pay particular attention with BRUFEN DOLORE if:

• you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and BRUFEN DOLORE”);
• you are elderly, as this increases the possibility of injury or bleeding in the stomach or intestines, which can be life-threatening;
• you suffer from or have suffered in the past from problems with the stomach and/or intestines (e.g. peptic ulcers, perforation or bleeding from the stomach and intestines). In this case, the doctor may decide to keep you under strict control and treat you with an additional medicine to protect the stomach (for example misoprostol or medicines that block the production of acid in the stomach);
• you suffer from a disease called systemic lupus erythematosus or a mixed connective tissue disease (immune system disorders affecting connective tissue);
• you suffer from allergies or have had allergic problems in the past;
• you have problems with your kidneys, liver or heart and have fluid retention, or have suffered from any of these conditions in the past. In these cases, the doctor will need to keep you under strict control;
• you have hepatic porphyria (a rare blood disease characterized by an alteration in the activity of one of the liver enzymes), as the medicine may trigger an attack;
• you have suffered in the past from a chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• you are taking medicines that may increase the risk of peptic ulcer or bleeding, for example oral corticosteroids, some antidepressants (selective serotonin reuptake inhibitors) or agents that prevent blood clot formation such as aspirin or anticoagulants such as warfarin (see section “Other medicines and BRUFEN DOLORE”). In these cases, consult your doctor before taking BRUFEN DOLORE because you may need to take an additional medicine to protect your stomach (for example misoprostol or medicines that block the production of acid in the stomach);
• you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with your fertility;
• you have heart problems such as heart failure, ischemic heart disease, peripheral arterial disease, previous stroke or think you may be at risk for these conditions (for example if you have high blood pressure, suffer from diabetes, have high cholesterol levels in your blood or are a smoker). BRUFEN DOLORE may be associated with a slight increase in the risk of heart attack and stroke. This risk is more likely at high doses and for prolonged periods. Do not exceed the recommended dose and duration of treatment;
• you suffer from asthma associated with chronic allergic rhinitis and/or nasal polyps;
• you have an infection - see paragraph «Infections» below.

As with other anti-inflammatory drugs, ketoprofen may cause small, transient increases in some
liver tests and also increases in transaminases, in case of significant increases, stop the
treatment and consult your doctor.

Infections
BRUFEN DOLORE can mask the symptoms of infections such as fever and pain. Therefore,
BRUFEN DOLORE may delay adequate treatment of the infection, which
could increase the risk of complications. This has been observed in pneumonia caused by
bacteria and bacterial skin infections related to chickenpox. If you take this medicine
while you have an infection and the symptoms of the infection persist or worsen, contact
your doctor immediately.
Avoid exposure to the sun during treatment with this medicine because the skin may become
more sensitive.
Take this medicine at the lowest doses and for short periods of time to reduce the occurrence
of side effects.

Stop taking this medicine and see your doctor immediately if

• you develop skin rashes, mucous membrane lesions or any other signs of hypersensitivity;
• you develop a severe skin reaction that is potentially life-threatening (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• you develop eye problems (such as blurred vision);
• you have burning, bleeding or pain in the stomach.

Children and adolescents
BRUFEN DOLORE should not be given to children and adolescents under 15
years of age.

Other medicines and BRUFEN DOLORE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Avoid taking this medicine if you are taking:

• other non-steroidal anti-inflammatory drugs (NSAIDs) and high doses of salicylates (more than 3 g per day);
• medicines used to slow down the blood clotting process (anticoagulants such as heparin and warfarin; antiplatelet agents such as ticlopidine and clopidogrel);
• lithium, used to treat depression or similar disorders;
• methotrexate at high doses (more than 15 mg per week), used to treat rheumatoid arthritis and cancer;
• hydantoins, used for epilepsy;
• sulfonamides, used for bacterial infections.

If you are taking any of the following medicines, tell your doctor who will monitor you:

• corticosteroids, used for inflammation;
• ACE inhibitors, diuretics, angiotensin II antagonists, beta-blockers, used for high blood pressure or heart problems;
• methotrexate at low doses (less than 15 mg per week), used to treat rheumatoid arthritis and cancer;
• pentoxifylline, used to treat chronic venous ulcers;
• zidovudine and tenofovir, used to treat AIDS;
• sulfonylureas, used for diabetes;
• thrombolytics, used for blood clotting problems;
• probenecid, used for gout;
• some antidepressants, known as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants;
• cyclosporine and tacrolimus, used after a transplant or to treat immune system disorders;
• some antibiotics, used against infections caused by bacteria;

The doctor will need to monitor you and may decide to reduce the dosage of
BRUFEN DOLORE.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take BRUFEN DOLORE in the last 3 months of pregnancy, as it may harm
the fetus or cause problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may
affect your and the baby's tendency to bleed and delay or prolong labor more than expected. You should not take BRUFEN DOLORE in the first 6 months of pregnancy unless
absolutely necessary and under the advice of a doctor. If treatment is necessary in this
period or during attempts to conceive, the minimum dose should be used for the shortest
possible time. From the 20th week of pregnancy, BRUFEN DOLORE may cause kidney problems
to the fetus, if taken for more than a few days, reducing the levels of amniotic fluid that
surrounds the baby (oligohydramnios) or causing the narrowing of a blood vessel (ductus
arteriosus) in the baby's heart. If treatment is needed for more than a few days, the
doctor may recommend additional monitoring.
Breastfeeding
Do not take BRUFEN DOLORE while breastfeeding.
Fertility
BRUFEN DOLORE may cause fertility problems in women. Therefore, if you plan to
become pregnant, you should inform your doctor because this medicine may reduce fertility.
Stop treatment if you have fertility problems and intend to become pregnant or
undergo fertility tests.

Driving and using machines
This medicine can cause dizziness, drowsiness or convulsions. If this happens to you, do not
drive vehicles or use machines.

BRUFEN DOLORE contains aspartame
This medicine contains 10.56 mg of aspartame per dose (1 sachet) equivalent to 31.7 mg per
maximum daily dose recommended (3 sachets) equivalent to 0.704 mg/kg.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare
genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it
correctly.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially
‘sodium-free’.

3. How to take BRUFEN DOLORE

The lowest effective dose should be used for the shortest period necessary to relieve the
symptoms. If you have an infection, consult your doctor immediately if symptoms (such as
fever and pain) persist or worsen (see section 2).
Take this medicine following exactly as stated in this leaflet or as instructed by your doctor or
pharmacist. If you have doubts, consult your doctor or pharmacist.

Use in adults and adolescents over 15 years of age
The recommended dose is 1 sachet, once, or repeated 2-3 times a day, for more intense
painful conditions.

Use in the elderly
If you are elderly, take the lowest possible daily dose (see section 2 “What you need to know
before taking BRUFEN DOLORE - Warnings and precautions”).

Use in people with liver problems
If you suffer from mild or moderate liver problems, take the lowest possible daily dose.
Do not take this medicine if you have severe liver problems (see section 2 “What you need to know
before taking BRUFEN DOLORE - Do not take BRUFEN DOLORE”).

Use in people with mild or moderate kidney problems
If you have mild or moderate kidney problems, consult your doctor who will need to monitor you
during treatment with this medicine.
Do not take this medicine if you have severe kidney problems (see section 2 “What you need to know
before taking BRUFEN DOLORE - Do not take BRUFEN DOLORE”).
Do not use for prolonged periods without your doctor's advice and do not exceed the recommended
doses.
Limit the duration of therapy to overcoming the painful episode.

Method of administration
BRUFEN DOLORE can be placed directly on the tongue. It dissolves with saliva; this allows
its use without water.
Take this medicine with a full stomach.
Take this medicine always using the minimum effective dose and for the shortest possible
period of time necessary to control symptoms in order to reduce the occurrence of adverse
effects.

If you take more BRUFEN DOLORE than you should
The most common symptoms of an overdose are: lethargy, drowsiness, nausea, vomiting and
stomach pain.
Other symptoms may include headache, dizziness, confusion, loss of consciousness,
low blood pressure, respiratory depression, bluish discoloration of the skin and mucous membranes (cyanosis)
kidney failure, convulsions and coma.
In case of accidental intake/ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the remaining medicine and its container to the hospital or doctor
so they know which medicine was taken.

If you forget to take BRUFEN DOLORE
If you forget to take a dose, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most commonly observed side effects are of a gastrointestinal nature. Stomach or intestinal disorders (peptic ulcers, perforation or bleeding from the stomach or intestine which can be life-threatening, particularly in elderly patients) may occur.
Immediately inform your doctor if you notice the onset of side effects in the stomach and/or intestine (stomach pain, burning, bleeding), especially if you are an elderly patient.
Immediately stop taking BRUFEN DOLORE and consult your doctor as soon as you notice the onset of skin rash, any lesion inside the mouth or on the genitals, or any sign of an allergic reaction.
The side effects that may occur with BRUFEN DOLORE are:

Common(may affect up to 1 in 10 people)
Nausea, vomiting, digestive difficulties (dyspepsia), abdominal pain/discomfort.

Uncommon(may affect up to 1 in 100 people)
Headache, dizziness, drowsiness, diarrhea, excessive production of gas in the gastrointestinal tract (flatulence), constipation, inflammation of the stomach lining (gastritis), skin rash, itching, swelling due to fluid retention (edema), fatigue.

Rare(may affect up to 1 in 1,000 people)
Reduction in the number of red blood cells following bleeding (hemorrhagic anemia), tingling and numbness of hands and feet (paresthesia), blurred vision, ringing in the ear (tinnitus), asthma, inflammation of the mouth (ulcerative stomatitis), problems with the stomach or intestine (peptic ulcer), liver problems (hepatitis, increased levels of transaminases and bilirubin in the blood), yellowing of the skin and whites of the eyes (jaundice), increased body weight.

Frequency not known(frequency cannot be estimated from available data)
Inflammation of the membranes lining the brain and spinal cord (aseptic meningitis), inflammation of the lymphatic vessels (lymphangitis), reduced number of platelets (thrombocytopenia), reduced number of white blood cells (agranulocytosis), increased number of white blood cells (leukocytosis), reduced number of white blood cells (leukopenia), reduced number of neutrophils, a type of white blood cell (neutropenia), formation of numerous hemorrhagic spots on the skin due to a reduction in the number of platelets (thrombocytopenic purpura), reduced activity of the bone marrow (myelodysplasia), destruction of red blood cells (hemolytic anemia), reduced production of red blood cells (aplastic anemia), sudden, potentially life-threatening allergic reaction (including anaphylactic shock), depression, seeing and hearing things that do not exist (hallucinations), mood alteration, hyperexcitability, insomnia, transient loss of consciousness (syncope), convulsions, altered taste (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), vertigo, swelling around the eyes due to fluid retention (periorbital edema), heart problems (heart failure), perception of one's heartbeat (palpitations), fast heartbeat (tachycardia), high blood pressure (hypertension), low blood pressure (hypotension), vasodilation, inflammation of blood vessels (vasculitis), swelling of the larynx, difficulty breathing (bronchospasm), common cold (rhinitis), shortness of breath (dyspnea), difficulty breathing due to constriction of the larynx (laryngospasm), acute respiratory failure, skin rash (exanthem, maculopapular rash), skin inflammation (erythema, dermatitis), excessive sensitivity to light (photosensitivity), hair loss (alopecia), hives, swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema), rare skin condition with blisters and bleeding of lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin disease (Lyell's syndrome, toxic epidermal necrolysis), worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), bleeding and perforation of the stomach and intestine, ulcer in the stomach or duodenum, heartburn, stomach pain, damage to the stomach lining without perforation resulting in bleeding (erosive gastritis), swelling of the mouth or tongue, inflammation of the pancreas, emission of blood with the stool (melena), vomiting blood (hematemesis), kidney problems such as blood in the urine (hematuria), acute renal failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormalities in kidney function tests, fluid retention, decreased urine production (oliguria), difficulty urinating (dysuria), chills, fatigue (asthenia), swelling of the extremities (peripheral edema), swelling of the face (facial edema).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 BRUFEN DOLORE

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 pack and other information

What BRUFEN DOLORE contains
The active ingredient is lysine ketoprofen.
Each sachet contains 40 mg of lysine ketoprofen (equivalent to 25 mg of ketoprofen).
The other ingredients are: mannitol, xylitol, lime flavour, lemon flavour, frescofort flavour,

aspartame, talc, basic butyl methacrylate copolymer, magnesium stearate, colloidal hydrated silica
hypromellose, stearic acid, povidone, sodium lauryl sulfate.

Description of the appearance of BRUFEN DOLORE and contents of the pack
BRUFEN DOLORE is available in the form of granules for oral use.
The pack contains 12 sachets, 24 sachets or 30 sachets

Marketing Authorisation Holder
Mylan S.p.A., via Vittor Pisani, 20 – 20124 Milano

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto De’ Stampi - Rozzano (MI)