Package leaflet: Information for the patient

BRUFEN PAIN 40 mg granules

Lysine salt of Ketoprofen
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

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

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

2. What you need to know before taking BRUFEN PAIN

Do not take BRUFEN PAIN

if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (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 previously caused you problems such as asthma (asthma attacks), difficulty breathing due to temporary narrowing of the bronchi (bronchospasm), nasal polyps, acute rhinitis, allergic skin reactions such as urticaria, or swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema). In such cases, a sudden allergic reaction may occur, which could be life-threatening;
if you currently have or have previously had stomach or intestinal problems (active or recurrent peptic ulcer), or digestive disorders;
if you currently have or have previously had gastrointestinal bleeding or perforation, 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 insufficiency);
if you have a tendency to bleed (haemorrhagic diathesis) or a blood clotting disorder, or if you are taking medications to improve blood fluidity (anticoagulants);
if you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
if the person taking the medicine is a child or adolescent under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRUFEN PAIN.
Be especially careful when taking BRUFEN PAIN if:

you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and BRUFEN PAIN”);
you are elderly, as this increases the risk of stomach or intestinal injury or bleeding, which may be life-threatening;
you currently have or have previously had stomach and/or intestinal problems (e.g. peptic ulcers, perforation, or gastrointestinal bleeding). In this case, your doctor may decide to monitor you closely and prescribe additional medication to protect your stomach (e.g. misoprostol or drugs that inhibit gastric acid production);
you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
you have allergies or have previously experienced allergic reactions;
you have kidney, liver, or heart problems, or fluid retention, or have previously suffered from any of these conditions. In such cases, your doctor should monitor you closely;
you have hepatic porphyria (a rare blood disorder caused by impaired activity of a liver enzyme), as this medicine could trigger an attack;
you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
you are taking medications that may increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as aspirin or anticoagulants like warfarin (see section “Other medicines and BRUFEN PAIN”). In these cases, consult your doctor before taking BRUFEN PAIN, as you may need additional medication to protect your stomach (e.g. misoprostol or acid-reducing drugs);
you are a woman with fertility problems and are planning a pregnancy, as this medicine may affect your fertility;
you have heart problems such as heart failure, ischemic heart disease, peripheral arterial disease, or a history of stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels, or are a smoker). BRUFEN PAIN may be associated with a slight increase in the risk of heart attack and stroke. This risk is higher at high doses and with prolonged use. Do not exceed the recommended dose or duration of treatment;
you suffer from asthma associated with chronic allergic rhinitis and/or nasal polyps;
you have an infection – see section “Infections” below.

As with other anti-inflammatory drugs, ketoprofen may cause minor transient increases in liver function tests and elevations of transaminases. If significant increases occur, stop treatment and consult your doctor.
Infections
BRUFEN PAIN may mask symptoms of infection such as fever and pain. Therefore, BRUFEN PAIN may delay appropriate treatment of an 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, consult your doctor immediately.
Avoid exposure to sunlight during treatment with this medicine, as your skin may become more sensitive.
Take this medicine at the lowest effective dose and for the shortest possible duration to reduce the risk of side effects.
Stop taking this medicine and contact your doctor immediately if:

you develop skin rashes, mucosal lesions, or any other signs of hypersensitivity;
you experience a severe, potentially life-threatening skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis);
you develop eye problems (such as blurred vision);
you experience stomach burning, bleeding, or pain.

Children and adolescents
BRUFEN PAIN must not be administered to children or adolescents under 15 years of age.
Other medicines and BRUFEN PAIN
Inform 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) or high-dose salicylates (more than 3 g per day);
medicines used to slow blood clotting (anticoagulants such as heparin and warfarin; antiplatelet agents such as ticlopidine and clopidogrel);
lithium, used to treat depression or similar disorders;
high-dose methotrexate (more than 15 mg per week), used to treat rheumatoid arthritis or cancer;
hydantoins, used for epilepsy;
sulfonamides, used for bacterial infections.

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

corticosteroids, used for inflammatory conditions;
ACE inhibitors, diuretics, angiotensin II antagonists, beta-blockers, used for high blood pressure or heart problems;
low-dose methotrexate (less than 15 mg per week), used to treat rheumatoid arthritis or cancer;
pentoxifylline, used to treat chronic venous ulcers;
zidovudine and tenofovir, used to treat AIDS;
sulfonylureas, used for diabetes;
thrombolytics, used for blood clotting disorders;
probenecid, used for gout;
certain antidepressants, known as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants;
cyclosporine and tacrolimus, used after organ transplantation or to treat immune system disorders;
certain antibiotics used against bacterial infections.

Your doctor should monitor you and may decide to reduce the dose of BRUFEN PAIN.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take BRUFEN PAIN during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labour. You should not take BRUFEN PAIN during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required 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, BRUFEN PAIN may cause fetal kidney problems 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 for more than a few days is needed, your doctor may recommend additional monitoring.
Breastfeeding
Do not take BRUFEN PAIN while breastfeeding.
Fertility
BRUFEN PAIN may cause fertility problems in women. Therefore, if you are planning a pregnancy, inform your doctor, as this medicine may reduce fertility. Stop treatment if you have fertility problems and are planning a pregnancy, or if you are undergoing fertility testing.
Driving and using machines
This medicine may cause dizziness, drowsiness, or seizures. If this occurs, avoid driving or operating machinery.
BRUFEN PAIN contains aspartame
This medicine contains 10.56 mg of aspartame per dose (1 sachet), equivalent to 31.7 mg for the maximum recommended daily dose (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 disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.
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 for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult your doctor immediately if symptoms (for example fever and pain) persist or worsen (see section 2).
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has recommended. If you are unsure, consult your doctor or pharmacist.

Use in adults and adolescents over 15 years of age
The recommended dose is 1 sachet, taken once only, or repeated 2–3 times daily, in cases of more intense pain.

Use in elderly patients
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 patients 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 patients 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 medical advice and do not exceed the recommended doses.
Limit the duration of treatment to the time needed to overcome the painful episode.

Method of administration
BRUFEN DOLORE can be placed directly on the tongue. It dissolves with saliva, allowing it to be taken without water.
Take this medicine with food.
Always use the lowest effective dose for the shortest possible time needed 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 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, seizures, and coma.
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Take this leaflet, any remaining medicine, and its container with you to the hospital or doctor so they know which medicine has been 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 for your next dose. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The most commonly observed adverse effects are gastrointestinal in nature. Stomach or intestinal disorders may occur (peptic ulcers, perforation or bleeding from the stomach or intestine, which can be life-threatening, particularly in elderly patients).
Inform your doctor immediately if you notice any adverse effects affecting the stomach and/or intestines (stomach pain, burning sensation, bleeding), especially if you are an elderly patient.
Stop taking BRUFEN PAIN immediately and contact your doctor as soon as you notice a skin rash, any lesions inside the mouth or on the genitals, or any signs of an allergic reaction.

The adverse effects that may occur with BRUFEN PAIN are:

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

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

Rare (may affect up to 1 in 1,000 people)
Reduction in red blood cell count due to bleeding (haemorrhagic anaemia), tingling and numbness in hands and feet (paraesthesia), blurred vision, ringing in the ears (tinnitus), asthma, inflammation of the mouth (ulcerative stomatitis), stomach or intestinal problems (peptic ulcer), liver problems (hepatitis, increased levels of transaminases and bilirubin in the blood), yellowing of the skin and whites of the eyes (jaundice), weight gain.

Frequency not known (frequency cannot be estimated from the available data)
Inflammation of the membranes covering the brain and spinal cord (aseptic meningitis), inflammation of the lymphatic vessels (lymphangitis), reduction in platelet count (thrombocytopenia), reduction in white blood cell count (agranulocytosis), increase in white blood cell count (leucocytosis), reduction in white blood cell count (leucopenia), reduction in neutrophil count, a type of white blood cell (neutropenia), development of multiple small bleeding spots on the skin due to reduced platelet count (thrombocytopenic purpura), reduced bone marrow activity (myelophthisis), destruction of red blood cells (haemolytic anaemia), reduced production of red blood cells (aplastic anaemia), sudden potentially fatal allergic reaction (including anaphylactic shock), depression, seeing and hearing things that are not real (hallucinations), mood changes, hyperexcitability, insomnia, transient loss of consciousness (syncope), seizures, altered taste (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), dizziness, eye swelling due to fluid accumulation (periorbital oedema), heart problems (heart failure), awareness of your heartbeat (palpitations), rapid heartbeat (tachycardia), high blood pressure (hypertension), low blood pressure (hypotension), vasodilation, inflammation of blood vessels (vasculitis), swelling of the larynx, breathing difficulties (bronchospasm), runny nose (rhinitis), shortness of breath (dyspnoea), breathing difficulties due to laryngeal constriction (laryngospasm), acute respiratory failure, skin rash (exanthema, maculopapular exanthema), skin inflammation (erythema, dermatitis), excessive sensitivity to light (photosensitivity), hair loss (alopecia), hives, swelling of the face, lips, mouth, tongue or throat which may cause breathing and swallowing difficulties (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), gastrointestinal bleeding and perforation, gastric or duodenal ulcer, heartburn, stomach ache, damage to the stomach lining without perforation leading to bleeding (erosive gastritis), swelling of the mouth or tongue, inflammation of the pancreas, passage of blood in stools (melena), vomiting blood (haematemesis), kidney problems such as blood in urine (haematuria), acute kidney failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormalities in kidney function tests, fluid retention, reduced urine output (oliguria), difficulty urinating (dysuria), chills, tiredness (asthenia), swelling of extremities (peripheral oedema), facial swelling (facial oedema).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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 stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 BRUFEN DOLORE contains
The active substance is ketoprofen lysine salt.
Each sachet contains 40 mg of ketoprofen lysine salt (equivalent to 25 mg of ketoprofen).
The other components are: mannitol, xylitol, lime flavour, lemon flavour, freshfort flavour,
aspartame, talc, basic butyl methacrylate copolymer, magnesium stearate, hydrated colloidal silica,
hypromellose, stearic acid, povidone, sodium lauryl sulfate.

Description of the appearance of BRUFEN DOLORE and package contents
BRUFEN DOLORE is an oral granulate.
Pack sizes: 12 sachets, 24 sachets or 30 sachets.

Marketing Authorization Holder
Mylan S.p.A., via Vittor Pisani, 20 – 20124 Milan

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