VELITIX 200 mg Tabletki Powlekane

Treść ulotki

1. Velitix 200 mg film-coated tablets
   1. What is Velitix and what is it used for
   2. What you need to know before taking Velitix
   3. How to take Velitix
   4. Possible side effects
   5. How to store Velitix
   6. Contents of the pack and other information
2. Velitix 400 mg film-coated tablets
   1. What is Velitix and what is it used for
   2. What you need to know before taking Velitix
   3. How to take Velitix
   4. Possible side effects
   5. How to store Velitix
   6. Contents of the pack and other information

Velitix 200 mg film-coated tablets

Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 of the side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you are an adult, see your doctor if you do not feel better or if your symptoms worsen after 3 days if you have a fever, or 4 days if you are taking this medicine for pain. See your doctor after 3 days if your child/adolescent does not feel better or worsens after 3 days.

Contents of this leaflet:

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

1. What is Velitix and what is it used for

Velitix contains the active substance ibuprofen.
Ibuprofen is a medicine that reduces fever and relieves pain (non-steroidal anti-inflammatory drugs, NSAIDs).
In adults, adolescents and children with a body weight starting from 20 kg (aged 7 years or older) it is used for the short-term symptomatic treatment of mild to moderate pain and/or fever.
Consult a doctor if you do not feel better or if you feel worse after 3 days, if you have a fever, or 4 days if you are taking this medicine for pain.
Consult a doctor after 3 days if your child/adolescent does not feel better or gets worse after 3 days.

2. What you need to know before taking Velitix

Do not takeVelitix if

• you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction can include swelling of the eyelids, lips, tongue or throat;
• you have ever had an allergic reaction [such as bronchospasm (tightening of the muscles in the lungs which can cause breathing difficulties)], asthma, runny, itchy and inflamed nose with sneezing, urticaria (an itchy skin rash) or angioedema (swelling under the skin) when taking ibuprofen, acetylsalicylic acid or other similar painkillers (NSAIDs);
• you suffer from disorders of unknown origin of blood formation
• you have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least 2 different episodes of confirmed ulcers or bleeding)
• you have had gastrointestinal bleeding or perforation associated with previous treatments with NSAIDs
• you have bleeding in the brain (cerebrovascular haemorrhage) or other active bleeding
• you suffer from severe liver, kidney or heart failure
• you are severely dehydrated (e.g. caused by vomiting, diarrhoea or insufficient fluid intake)
• you are in the last three months of pregnancy.

Warnings and precautions
Adverse effects can be minimised by using the lowest effective dose, for the
shortest period of time necessary to control symptoms.
Discuss the therapy with your doctor or pharmacist before taking Velitix if:

• you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases that affect connective tissue)
• you have or have had gastrointestinal diseases (ulcerative colitis, Crohn's disease), as your conditions may worsen
• you suffer from hereditary disorders of blood formation (e.g. acute intermittent porphyria)
• you suffer from reduced liver or kidney function
• you have recently undergone major surgery
• you are sensitive (allergic) to other substances
• you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, because you are at greater risk of developing allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's oedema) or urticaria
• you are dehydrated
• you have an infection - see section «Infections» below

Effects on the gastrointestinal tract
The combined use of Velitix with other non-steroidal anti-inflammatory drugs (NSAIDs), including
so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided.

Gastrointestinal bleeding, ulcers and perforation
Gastrointestinal bleeding, ulcers and perforation, sometimes with fatal outcome, have been
reported with all NSAIDs. These occurred at any time during therapy, with or
without prior warning symptoms or a previous history of serious gastrointestinal events.
In patients with a history of ulcers, especially if complicated by bleeding or perforation
(see section 2 “Do not take Velitix”), and in elderly patients, the risk of gastrointestinal
bleeding, ulceration or perforation is greater with increasing doses of NSAIDs. These
patients should start treatment with the lowest available dose.
It is advisable to consider the concomitant use of protective medicines (e.g. misoprostol or proton
pump inhibitors) both for these patients and for patients taking concomitant low
doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal
events.
If you have suffered from adverse effects affecting the gastrointestinal tract – particularly if you are
elderly - you should report any unusual gastrointestinal symptoms (especially
gastrointestinal bleeding) to your doctor, particularly in the early stages of treatment.
Caution is advised if you are also taking other medicines that could increase the risk
of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as
warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders
including depression) or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 “Other medicines and Velitix”).
Treatment should be discontinued and you should consult a doctor if gastrointestinal
bleeding or ulceration occurs during the use of Velitix.
Effects on the cardiovascular system
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight
increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking Velitix if:

• you suffer from heart problems, including heart failure and angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (problems with blood circulation to the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including “mini-stroke” or transient ischaemic attack “TIA”).
• you suffer from hypertension, diabetes or high cholesterol, have a family history of heart disease or stroke or if you smoke.

Signs of an allergic reaction to this medicine, including
breathing difficulties, swelling of the face and neck region (angioedema) and chest pain have been reported with ibuprofen.
Immediately stop treatment with Velitix and contact your
doctor or emergency medical service immediately if you notice any of these signs.
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis
(AGEP) have been reported in association with treatment with ibuprofen. Stop using Velitix and contact your doctor immediately if you notice
any of the symptoms related to these serious skin reactions described in section 4.
It is advisable to avoid the use of Velitix during chickenpox infection.
Infections
Velitix can mask the symptoms of infections such as fever and pain. Therefore, Velitix
may delay adequate treatment of the infection, which could increase the risk of
complications. This has been observed in pneumonia caused by bacteria and skin infections
related to chickenpox. If you are taking this medicine while you have an infection and the symptoms
of the infection persist or worsen, consult your doctor immediately.
Other warnings
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.
At the first signs of a hypersensitivity reaction after taking Velitix, treatment should be discontinued and a doctor should be consulted. Any medical procedure
appropriate to the symptoms must be performed by medical personnel.
Ibuprofen may temporarily inhibit platelet function (blood platelet aggregation).
Therefore, patients with blood coagulation disorders should be carefully
monitored.
During prolonged use of Velitix, regular checks of liver function parameters, kidney function and blood cell count are required.
If you use painkillers for a long time, this can cause headaches, which should not be
treated with other painkillers. If you think this is the case, talk to your doctor.
In general, the habitual intake of painkillers, especially the combination of different types of
painkillers, can lead to permanent kidney damage. This risk may increase during exercise
associated with loss of salts and dehydration. Therefore, this should be avoided.
The risk of kidney failure is increased in dehydrated patients, the elderly and those who
take diuretics and ACE inhibitors.
If you experience vision disturbances, contact your doctor.
Elderly patients
Elderly patients should be aware of their increased risk of adverse events, in particular
gastrointestinal bleeding and perforation, which can be fatal (see also the warning regarding
bleeding at the beginning of section 2).
Children and adolescents
In dehydrated children and adolescents there is a risk of impaired kidney function.

Other medicines and Velitix
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Velitix can influence or be influenced by other medicines. For example:

• Digoxin, phenytoin and lithium: the combined use of Velitix and digoxin (used to strengthen the heart), phenytoin (used for the treatment of convulsions/epilepsy) or lithium (used for example for the treatment of depression) can increase the concentration of these medicines in the blood. It is necessary to monitor serum lithium levels. Monitoring of serum digoxin and phenytoin levels is generally not required if use occurs according to instructions (maximum 3 or 4 days).
• Anticoagulants (i.e. blood thinners/inhibitors of blood coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may increase the effects of anticoagulants such as warfarin.
• Diuretics and medicines for high blood pressure: Velitix may reduce the effect of medicines used to increase urine production (diuretics) and lower blood pressure (antihypertensive medicines, e.g. ACE inhibitors, beta-blockers and angiotensin II receptor antagonists). The combined administration of Velitix and potassium-sparing diuretics (some types of diuretics) may lead to an increase in blood potassium levels.
• Medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan): Velitix may reduce the effect of ACE inhibitors (used for the treatment of heart failure and high blood pressure). In addition, during combined use, there is an increased risk of renal dysfunction.
• Cholestyramine (a medicine used to reduce cholesterol) used in combination with Velitix may reduce the absorption of Velitix in the gastrointestinal tract. However, the clinical relevance is not known.
• Other pain relievers: the combined use of Velitix with other anti-inflammatory and analgesic drugs of the NSAID group, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of ulcers and gastrointestinal bleeding.
• Platelet aggregation inhibitors and some antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
• Methotrexate: the administration of Velitix within 24 hours before or after the administration of methotrexate (used for the treatment of some types of tumors or rheumatism) may lead to an increase in methotrexate concentrations and an increase in its undesirable effects.
• Cyclosporine and tacrolimus: there is an increased risk that medicines known as immunosuppressants such as cyclosporine and tacrolimus may cause kidney damage.
• Probenecid or sulfinpyrazone: medicines containing probenecid or sulfinpyrazone (used for the treatment of gout) may delay the excretion of ibuprofen. This may cause Velitix to accumulate in the body, leading to an increase in its undesirable effects.
• Sulfonylureas: during the combined use of Velitix and sulfonylureas (medicines used for the treatment of diabetes), it is recommended to monitor blood sugar levels as a precaution.
• Zidovudine: there is evidence suggesting a higher risk of hemarthrosis (blood accumulation in the joints) and bruising (hematomas) in hemophilic, HIV-positive patients who use zidovudine (an antiviral medicine used for the treatment of HIV infection) together with ibuprofen.
• Quinolone antibiotics: the risk of convulsions (convulsive seizures) may be increased when antibiotics known as quinolones, such as ciprofloxacin, are taken simultaneously with ibuprofen.
• Aminoglycosides: the combined use of Velitix with aminoglycosides (a type of antibiotic) with NSAIDs may reduce the excretion of aminoglycosides.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used for the treatment of fungal infections, as the effect of ibuprofen may increase. The dose of ibuprofen should be considered for reduction, especially when high doses of ibuprofen are administered together with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medicine) may increase the risk of bleeding when taken with NSAIDs.
• Mifepristone: the combined use of mifepristone with other anti-inflammatory and analgesic drugs of the NSAID group (e.g. ibuprofen) may reduce the effect of mifepristone.
• Ritonavir: the combined use with ritonavir (an antiviral medicine used to treat HIV infections) may increase plasma concentrations of NSAID analgesics.
• Alcohol, bisphosphonates and pentoxifylline: the combined use of ibuprofen with alcohol, bisphosphonates (used in osteoporosis) or pentoxifylline (used in peripheral arterial circulatory problems) may increase gastrointestinal undesirable effects and the risk of bleeding and ulcers.
• Baclofen (a muscle relaxant) as the toxicity of baclofen may increase.
• Medicines for the treatment of inflammation (corticosteroids), due to an increased risk of gastrointestinal ulcers or bleeding.

Other medicines may also influence or be influenced by treatment with Velitix. Therefore,
always consult your doctor or pharmacist before using Velitix with other medicines.

Velitix with alcohol
Alcohol may increase the undesirable effects of Velitix, particularly those affecting the central
nervous system and the gastrointestinal tract. Do not drink alcohol during treatment with Velitix.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Velitix if you are in the last 3 months of pregnancy as it may harm the fetus or cause
problems with childbirth. It can cause problems with the kidneys and heart in the unborn baby. It may affect your
and your baby's tendency to bleed and cause labor to be later or longer than expected. You should not
take Velitix during the first 6 months of pregnancy unless absolutely necessary and
advised by your doctor. If you need treatment during this period or while trying
to become pregnant, the lowest dose should be used for the shortest possible time. If taken
for more than a few days from the 20th week of pregnancy onwards, Velitix may cause problems with the kidneys
in the unborn baby that may lead to low levels of amniotic fluid surrounding the baby
(oligohydramnios) or 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.
Breastfeeding
Only small amounts of ibuprofen pass into breast milk. However, as no harmful effects on infants are known so far,
it is generally not necessary to stop breastfeeding during
short-term treatment with the recommended dose of ibuprofen for fever and pain.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility
in women. This effect is reversible when treatment is stopped. You should inform your doctor
if you are planning a pregnancy or have difficulty getting pregnant.

Driving and operating machinery
Ibuprofen generally does not alter or alters negligibly the ability to drive vehicles or
operate machinery. However, as undesirable effects on the
central nervous system such as fatigue and dizziness may occur at high doses, in isolated cases the reaction ability and skill of
driving in traffic and operating machinery may be impaired. The effect is enhanced
by concomitant intake of alcohol.

Velitix contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

Velitix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take Velitix

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve 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 instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
The dose should be guided by the information in the following table. In children and adolescents,
Velitix is dosed based on body weight or age, generally with a single dose between
7 and 10 mg/kg of body weight, up to a maximum of 30 mg/kg of body weight as a
total daily dose.

Body weightSingle doseMaximum daily dose
20 kg – 29 kg
(Children: 7 – 9 years)

(age)
3 film-coated tablets
(equivalent to a maximum of
600 mg of ibuprofen)
30 kg – 39 kg
(Children: 10 – 11 years)
1 film-coated tablet
(equivalent to 200 mg of
ibuprofen)
1 film-coated tablet
(equivalent to 200 mg of
ibuprofen)
4 film-coated tablets
(equivalent to
The respective dosage range should be chosen in line with the observed symptoms and the
recommended maximum daily dose. It should not be less than 6 hours.
Velitix 200 mg is not indicated in children under 7 years of age or weighing less than 20
kg.
Adverse effects can be minimized by using the lowest effective dose, for the
shortest period of time necessary to control symptoms.
If you have severe liver and kidney disease or are elderly, your doctor will tell you the correct dose to take,
which will correspond to the lowest possible dose.

Method of administration
Velitix is for oral use.
Take the tablet with a glass of water.
The tablets should not be crushed, chewed or sucked to avoid irritation of the stomach
or throat.
Patients with a sensitive stomach are recommended to take Velitix with food.
This medicine is only for short-term use.

For adults
If this medicine is required for more than 3 days for fever or more than 4
days for pain in adults, or if symptoms worsen, consult a doctor.

For children and adolescents
If this medicine is required for more than 3 days in children and adolescents or if the
symptoms worsen, consult a doctor.

If you take more Velitix than you should
If you take more Velitix than you should or if your child has taken this medicine by mistake,
always contact a doctor or the nearest hospital to get advice on the risk and
advice on what actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with
traces of blood) or, more rarely, diarrhea. Also, headache, gastrointestinal bleeding,
blurred vision, ringing in the ears, confusion and uncontrolled eye movements,
worsening of asthma in asthmatics. At high doses, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, coma, convulsions
(especially in children), dizziness, weakness and dizziness, blood in the urine, low levels of potassium
in the blood, low blood pressure, increased levels of potassium in the blood, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis,
feeling of coldness in the body and breathing problems have been reported.

If you forget to take Velitix
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effects affect the digestive tract. They may include
stomach/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes
fatal, especially in elderly patients (see paragraph 2: “Warnings and precautions”). After
use, nausea, vomiting, diarrhea, flatulence, constipation, digestive disorders,
abdominal pain, tarry stools, vomiting blood, sores (ulceration) in the region of the
mouth and throat (ulcerative stomatitis), worsening of colitis and Crohn’s disease have been reported (see
paragraph 2: “Warnings and precautions”). Less commonly, inflammation of the
stomach lining (gastritis) has been observed. In particular, the risk of developing gastrointestinal
bleeding depends on the dosage and duration of treatment.
In association with treatment with NSAIDs, fluid retention (edema),
hypertension and heart failure have been reported.

More serious side effects

• Stop taking Velitix and contact your doctor immediatelyif you experience severe general allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people): It may manifest as:
• swelling of the face (facial edema), tongue or throat (laryngeal edema with airway constriction)
• difficulty breathing
• rapid heartbeat
• - a drop in blood pressure up to shockchest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome [frequency not known (frequency cannot be estimated based on available data)]
• You should consult your doctor immediatelyif you experience infection with symptoms such as fever and a significant worsening of your general condition, or fever with symptoms of local infection such as sore throat/pharyngitis/mouth or urinary problems. Velitix can cause a reduction in the number of white blood cells [agranulocytosis, a very rare side effect (may affect up to 1 in 10,000)] which causes reduced resistance to infections. It is important to inform your doctor about the medicine you are taking.
• Stop treatment with ibuprofen and consult your doctor immediately if you noticeany of the following symptoms:
• reddish, non-raised, target- or circular-shaped patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye sores. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome] [a very rare side effect (may affect up to 1 in 10,000)].
• Furthermore, a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells) [frequency not known (frequency cannot be defined based on available data)].
• skin rash or mucosal lesions. Severe skin rashes may include blisters on the skin, especially on legs, arms, hands and feet, which may also involve the face and lips. This can worsen if the blisters widen and spread and parts of the skin may detach (toxic epidermal necrolysis). [a very rare side effect (may affect up to 1 in 10,000)].
• extensive, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [frequency not known (frequency cannot be estimated based on available data)].
• Stop taking Velitixand inform your doctor immediately if you experience relatively severe pain in the upper abdomen, vomiting blood, bloody and/or tarry stools.
• Fluid retention (edema), especially in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure (kidney failure) [a very rare side effect (may affect up to 1 in 10,000)]. Reduced urine production, fluid accumulation within the body (edema) and malaise (general feeling of discomfort) can be signs of kidney failure.

If any of the listed symptoms occur or worsen, you should stop taking Velitix
and contact your doctor immediately.

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

• Gastrointestinal disorders, e.g. heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, digestive problems and mild gastrointestinal bleeding, which, in exceptional cases, can cause anemia.

Uncommon (may affect up to 1 in 100 people)

• Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability or fatigue
• Visual disturbances. In this case you should stop using ibuprofen and inform your doctor.
• Stomach/intestinal ulcers (peptic ulcers) may occur, sometimes with bleeding and perforation (rupture in the wall of the digestive tract), which can be fatal, especially in elderly patients, ulcerative stomatitis (inflammation of the mouth lining with ulceration), worsening of colitis or Crohn’s disease (inflammation of the colon).
• Inflammation of the inner wall of the stomach (gastritis)
• Hypersensitivity reactions such as skin rash and itching, as well as asthma attacks (sometimes accompanied by a drop in blood pressure). In such cases you should inform your doctor immediately and stop taking Velitix.

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

• Tinnitus (ringing in the ears)
• Hearing loss
• Damage to kidney tissue (papillary necrosis), increased concentration of uric acid in the blood, high concentration of urea in the blood.

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

• Blood cell formation disorders, such as a decrease in the amount of red blood cells or hemoglobin (anemia), white blood cells (leukopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia or hemolytic anemia). The first symptoms may be fever, sore throat, superficial wounds in the mouth, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding.
• In temporal association with the use of certain anti-inflammatory agents (non-steroidal anti-inflammatory drugs; to which Velitix also belongs), a worsening of inflammation related to infection (e.g. development of necrotizing fasciitis) has been reported. If signs of infection appear or worsen during the use of Velitix (e.g. redness, swelling, heat, pain, fever), consult a doctor immediately. The doctor will assess whether you need antibiotic therapy.
• During the use of ibuprofen, symptoms of aseptic meningitis (inflammation without infection of the membranes covering the brain) have been observed, such as severe headache, nausea, vomiting, fever, stiff neck or confusion. The risk appears to be greater in patients already suffering from certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
• Low blood sugar levels (hypoglycemia)
• Low sodium levels in the blood (hyponatremia)
• Palpitations, weak heart muscle (heart failure), heart attack
• High blood pressure (hypertension)
• Inflammation of blood vessels (vasculitis)
• Inflammation of the esophagus or pancreas (pancreatitis), narrowing of the intestine (intestinal diaphragm stenosis)
• Psychotic reactions, hallucinations, confusion, depression and anxiety
• Asthma, difficulty breathing (dyspnea), bronchospasm
• Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage, especially during long-term therapy, liver failure, acute liver inflammation (hepatitis).
• Hair loss (alopecia), reddish or purple patches on the skin (purpura) or photosensitivity reactions (triggered by sunlight).
• In exceptional cases, if you have chickenpox, serious skin infections and complications of soft tissues (varicella infection) may occur.

Frequency not known (frequency cannot be defined based on available data)

• Inflammation of the nasal mucosa (rhinitis)
• Feeling of pins and needles (paresthesia) and inflammation of the optic nerve (optic neuritis)
• Kidney malfunction

Medicines like Velitix may be associated with a slight increase in the risk of heart attack (“myocardial
infarction”) or stroke.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 Velitix

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 box and on the blister after
“EXP.” The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 Velitix contains

• The active ingredient is ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen.
• The other excipients are: Tablet core: hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, sodium lauryl sulfate and magnesium stearate Coating: hypromellose, titanium dioxide E171, talc, propylene glycol

Description of the appearance of Velitix and contents of the pack
Film-coated tablets, from white to almost white in color, round with a diameter of 10.25
mm and smooth on both sides.
Packs of 10, 12, 16, 20, 24, 30, 36, 48, 50, 60 or 96 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Marketing authorisation holder
Aristo Pharma Italy S.r.l.
[email protected]
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Germany IbuARISTO akut 200 mg
Italy Velitix
Poland Axoprofen
Portugal Diltix

Velitix 400 mg film-coated tablets

Equivalent medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 of the side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you are an adult, see your doctor if you do not feel better or if your symptoms worsen after 3 days if you have a fever, or 4 days if you are taking this medicine for pain. See your doctor after 3 days if your teenage child does not feel better or gets worse after 3 days.

Contents of this leaflet:

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

1. What is Velitix and what is it used for

Velitix contains the active substance ibuprofen.
Ibuprofen is a medicine that reduces fever and relieves pain (non-steroidal anti-inflammatory drugs, NSAIDs).
In adults and adolescents weighing 40 kg or more (aged 12 years or older) it is
used for the short-term symptomatic treatment of mild to moderate pain and/or fever.
See a doctor if you do not feel better or if you feel worse after 3 days, if you have a fever, or 4
days if you are taking this medicine for pain.
See a doctor after 3 days if your teenage child does not feel better or gets worse after 3
days.

2. What you need to know before taking Velitix

Do not takeVelitix if

• you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction can include swelling of the eyelids, lips, tongue or throat;
• you have ever had an allergic reaction [such as bronchospasm (tightening of the muscles in the lungs which can cause difficulty breathing)], asthma, runny, itchy and inflamed nose with sneezing, urticaria (an itchy rash) or angioedema (swelling under the skin) when taking ibuprofen, acetylsalicylic acid or other similar painkillers (NSAIDs);
• you suffer from disorders of unknown origin of blood formation
• you have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least 2 different episodes of confirmed ulcers or bleeding)
• you have had gastrointestinal bleeding or perforation associated with previous treatments with NSAIDs
• you have bleeding in the brain (cerebrovascular haemorrhage) or other active bleeding
• you suffer from severe liver, kidney or heart failure
• you are severely dehydrated (e.g. caused by vomiting, diarrhoea or insufficient fluid intake)
• you are in the last three months of pregnancy.

Warnings and precautions
Adverse effects can be minimised by using the lowest effective dose, for the
shortest period of time necessary to control symptoms.
Discuss the therapy with your doctor or pharmacist before taking Velitix if:

• you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases that affect connective tissue)
• you have or have had gastrointestinal diseases (ulcerative colitis, Crohn's disease), as your conditions may worsen
• you suffer from hereditary disorders of blood formation (e.g. acute intermittent porphyria)
• you suffer from reduced liver or kidney function
• you have recently undergone major surgery
• you are sensitive (allergic) to other substances
• you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, because you are at greater risk of developing allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's oedema) or urticaria
• you are dehydrated
• you have an infection - see section «Infections» below.

Effects on the gastrointestinal tract
The combined use of Velitix with other non-steroidal anti-inflammatory drugs (NSAIDs), including
so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided.

Gastrointestinal bleeding, ulcers and perforation
Gastrointestinal bleeding, ulcers and perforation, sometimes with fatal outcome, have been
reported with all NSAIDs. These occurred at any time during therapy, with or
without prior warning symptoms or a previous history of serious gastrointestinal events.
In patients with a history of ulcers, especially if complicated by bleeding or perforation
(see section 2 “Do not take Velitix”), and in elderly patients, the risk of gastrointestinal
bleeding, ulceration or perforation is greater with increasing doses of NSAIDs. These
patients should start treatment with the lowest available dose.
It is advisable to consider the concomitant use of protective medicines (e.g. misoprostol or proton pump inhibitors) both for these patients and for patients who are taking concomitant low
doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal
events.
If you have suffered from side effects that affect the gastrointestinal tract – in particular if you
are elderly - you should report any unusual gastrointestinal symptoms (especially
gastrointestinal bleeding) to your doctor, particularly in the early stages of treatment.
Caution is advised if you are also taking other medicines that could increase the risk
of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as
warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders
including depression) or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 “Other medicines and Velitix”).
Treatment should be discontinued and you should consult a doctor if gastrointestinal bleeding or
ulceration occurs during the use of Velitix.
Effects on the cardiovascular system
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight
increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking Velitix if:

• you suffer from heart problems, including heart failure and angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (problems with blood circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including “mini-stroke” or transient ischaemic attack “TIA”).
• you suffer from high blood pressure, diabetes or high cholesterol, have a family history of heart disease or stroke or if you smoke.

Signs of an allergic reaction to this medicine, including
breathing difficulties, swelling of the face and neck region (angioedema) and chest pain have been reported with ibuprofen.
Immediately stop treatment with Velitix and contact your doctor or emergency health service immediately if you notice any of these signs.
Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen. Stop using Velitix and contact your doctor immediately if you notice
any of the symptoms related to these severe skin reactions described in section 4.
It is recommended to avoid the use of Velitix during chickenpox infection.
Infections
Velitix can mask the symptoms of infections such as fever and pain. It is therefore possible that Velitix
may delay adequate treatment of the infection, which could increase the risk of
complications. This has been observed in pneumonia caused by bacteria and skin infections
related to chickenpox. If you are taking this medicine while you have an infection and the symptoms
of the infection persist or worsen, consult your doctor immediately.
Other warnings
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking Velitix, the
treatment must be discontinued and a doctor must be consulted. Any medical procedure
appropriate to the symptoms must be performed by medical personnel.
Ibuprofen may temporarily inhibit platelet function (blood platelet aggregation). Therefore, patients with blood coagulation disorders must be carefully
monitored.
During prolonged use of Velitix, regular checks of liver function parameters, kidney function and blood cell count are required.
If you use painkillers for a long time, this can cause headaches, which should not be
treated with other painkillers. If you think this is the case, talk to your doctor.
In general, the habitual intake of painkillers, especially the combination of different types of
painkillers, can lead to permanent kidney damage. This risk may increase during exercise
associated with loss of salts and dehydration. Therefore, this should be avoided.
The risk of kidney failure is increased in dehydrated patients, the elderly and those who
take diuretics and ACE inhibitors.
If you experience visual disturbances, contact your doctor.
Elderly patients
Elderly patients should be aware of their increased risk of adverse events, in particular
bleeding and perforation of the gastrointestinal tract, which can be fatal (see also the warning regarding bleeding at the beginning of section 2).
Adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.

Other medicines and Velitix
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Velitix can influence or be influenced by other medicines. For example:

• Digoxin, phenytoin and lithium: the combined use of Velitix and digoxin (used to strengthen the heart), phenytoin (used for the treatment of seizures/epilepsy) or lithium (used for example for the treatment of depression) may increase the concentration of these medicines in the blood. It is necessary to monitor serum lithium levels. Monitoring of serum digoxin and serum phenytoin levels is generally not required if use is as directed (maximum 3 or 4 days).
• Anticoagulants (i.e. blood thinners/inhibitors of blood coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may increase the effects of anticoagulants such as warfarin.
• Diuretics and medicines for high blood pressure: Velitix may reduce the effect of medicines used to increase urine production (diuretics) and lower blood pressure (anti-hypertensive medicines, e.g. ACE-inhibitors, beta-blockers and angiotensin II receptor antagonists). The combined administration of Velitix and potassium-sparing diuretics (some types of diuretics) may lead to an increase in blood potassium levels.
• Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan): Velitix may reduce the effect of ACE-inhibitors (used for the treatment of heart failure and high blood pressure). In addition, during combined use, there is an increased risk of renal dysfunction.
• Cholestyramine (a medicine used to reduce cholesterol) used in combination with Velitix may reduce the absorption of Velitix in the gastrointestinal tract. However, the clinical relevance is unknown.
• Other pain relievers: the combined use of Velitix with other anti-inflammatory and analgesic drugs of the NSAID group, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of ulcers and gastrointestinal bleeding.
• Platelet aggregation inhibitors and some antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
• Methotrexate: the administration of Velitix within 24 hours before or after the administration of methotrexate (used for the treatment of some types of tumors or rheumatism) may lead to an increase in methotrexate concentrations and an increase in its undesirable effects.
• Cyclosporine and tacrolimus: there is an increased risk that medicines known as immunosuppressants such as cyclosporine and tacrolimus may cause kidney damage.
• Probenecid or sulfinpyrazone: medicines containing probenecid or sulfinpyrazone (used for the treatment of gout) may delay the excretion of ibuprofen. This may cause Velitix to accumulate in the body, leading to an increase in its undesirable effects.
• Sulfonylureas: during the combined use of Velitix and sulfonylureas (medicines used for the treatment of diabetes), it is recommended to monitor blood sugar levels as a precaution.
• Zidovudine: there is evidence to suggest a higher risk of hemarthrosis (accumulation of blood in the joints) and bruising (hematomas) in hemophilic HIV-positive patients who use zidovudine (an antiviral medicine used for the treatment of HIV infection) together with ibuprofen.
• Quinolone antibiotics: the risk of seizures (convulsions) may be increased when antibiotics known as quinolones, such as ciprofloxacin, are taken simultaneously with ibuprofen.
• Aminoglycosides: the combined use of Velitix with aminoglycosides (a type of antibiotic) with NSAIDs may reduce the excretion of aminoglycosides.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used for the treatment of fungal infections, as the effect of ibuprofen may increase. The dose of ibuprofen should be considered for reduction, especially when high doses of ibuprofen are administered together with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medicine) may increase the risk of bleeding when taken with NSAIDs.
• Mifepristone: the combined use of mifepristone with other anti-inflammatory and analgesic drugs of the NSAID group (e.g. ibuprofen) may reduce the effect of mifepristone.
• Ritonavir: the combined use with ritonavir (an antiviral medicine used to treat HIV infections) may increase plasma concentrations of NSAID analgesics.
• Alcohol, bisphosphonates and pentoxifylline: the combined use of ibuprofen with alcohol, bisphosphonates (used in osteoporosis) or pentoxifylline (used in peripheral arterial circulatory problems) may increase gastrointestinal side effects and the risk of bleeding and ulcers.
• Baclofen (a muscle relaxant) as the toxicity of baclofen may increase.
• Medicines for the treatment of inflammation (corticosteroids), due to an increased risk of gastrointestinal ulcers or bleeding.

Other medicines may also influence or be influenced by treatment with Velitix. Therefore,
always consult your doctor or pharmacist before using Velitix with other medicines.

Velitix with alcohol
Alcohol may increase the undesirable effects of Velitix, particularly those affecting the central
nervous system and the gastrointestinal tract. Do not drink alcohol during treatment with Velitix.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Velitix if you are in the last 3 months of pregnancy as it may harm the fetus or cause
problems with delivery. It can cause problems with the kidneys and heart in the unborn child. It may affect your
and your baby's tendency to bleed and cause labor to occur later or last longer than expected. You should not
take Velitix during the first 6 months of pregnancy unless absolutely necessary and
advised by your doctor. If you need treatment during this period or while trying
to become pregnant, the lowest dose should be used for the shortest possible time. If taken
for more than a few days from the 20th week of pregnancy onwards, Velitix may cause problems with the kidneys
in the unborn child which may lead to low levels of amniotic fluid surrounding the baby
(oligohydramnios) or 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.
Breastfeeding
Only small amounts of ibuprofen pass into breast milk. However, as no harmful effects on newborns are known so far, it is generally not necessary to stop breastfeeding during
short-term treatment with the recommended dose of ibuprofen for fever and pain.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility
in women. This effect is reversible when treatment is stopped. You should inform your doctor
if you are planning a pregnancy or have problems getting pregnant.

Driving and operating machinery
Ibuprofen generally does not alter or alters negligibly the ability to drive vehicles or
operate machinery. However, as side effects affecting the
central nervous system such as fatigue and dizziness may occur at high doses, in isolated cases the reaction ability and driving skill in traffic and operating machinery may be impaired. The effect is enhanced
by the concomitant intake of alcohol.

Velitix contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

Velitix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take Velitix

Take this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve 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 instructed by your doctor or pharmacist. If
you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 12 years and over weighing 40 kg or more
Half a tablet (200 mg) or one whole tablet (400 mg) as a single dose. If necessary, additional doses may
be taken as half a tablet or one tablet. The respective dosage interval should be chosen in line with the observed symptoms and the maximum recommended daily
dose. It should not be less than 6 hours. Do not take more than 3 tablets (1,200 mg of
ibuprofen) within 24 hours.
Velitix 400 mg is not indicated in children under 12 years of age or weighing less than 40
kg.
Undesirable effects can be minimized by using the lowest effective dose, for the
shortest period of time necessary to control symptoms.
If you have severe liver and kidney disease or are elderly, your doctor will tell you the correct dose to take,
which will correspond to the lowest possible dose.

Method of administration
Velitix is for oral use.
Take the tablet with a glass of water.
The tablets must not be crushed, chewed or sucked to avoid irritation of the stomach
or throat.
It is recommended that patients with a sensitive stomach take Velitix with food.
This medicine is for short-term use only.

For adults
If the use of this medicine is required for more than 3 days for fever or more than 4
days for pain in adults, or if symptoms worsen, consult a doctor.

For adolescents
If the use of this medicine is required for more than 3 days in adolescents or if symptoms
worsen, consult a doctor.

If you take more Velitix than you should
If you take more Velitix than you should or if your child has taken this medicine by mistake,
always contact a doctor or the nearest hospital to obtain advice on the risk and
regarding the actions to be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with
traces of blood) or, more rarely, diarrhea. Also, headache, gastrointestinal bleeding,
blurred vision, ringing in the ears, confusion and uncontrolled eye movements,
worsening of asthma in asthmatics. At high doses, drowsiness, a state of
excitement, disorientation, chest pain, palpitations, loss of consciousness, coma, convulsions
(especially in children), dizziness, weakness and vertigo, blood in the urine, low levels of potassium
in the blood, low blood pressure, increased levels of potassium in the blood, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis,
feeling of coldness in the body and breathing problems have been reported.

If you forget to take Velitix
Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask 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 affect the digestive tract. They may include
stomach/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes
fatal, especially in elderly patients (see paragraph 2: “Warnings and precautions”). Following
use, nausea, vomiting, diarrhea, flatulence, constipation, digestive disorders,
abdominal pain, tarry stools, vomiting with blood, sores (ulceration) in the region of the
mouth and throat (ulcerative stomatitis), worsening of colitis and Crohn's disease (see
paragraph 2: “Warnings and precautions”) have been reported. Less commonly, inflammation of the
stomach lining (gastritis) has been observed. In particular, the risk of developing gastrointestinal
bleeding depends on the dosage and duration of treatment.
In association with treatment with NSAIDs, fluid retention (edema),
hypertension and heart failure have been reported.

More serious side effects

• Stop taking Velitix and contact your doctor immediatelyif you experience severe general allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people): It may manifest as:
• swelling of the face (facial edema), tongue or throat (laryngeal edema with airway constriction)
• difficulty breathing
• rapid heartbeat
• low blood pressure up to shock
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome [frequency not known (frequency cannot be estimated based on available data)]
• You should consult your doctor immediatelyif you experience infection with symptoms such as fever and a significant worsening of your general condition, or fever with symptoms of local infection such as sore throat/pharyngitis/mouth or urinary problems. Velitix can cause a reduction in the number of white blood cells [agranulocytosis, a very rare side effect (may affect up to 1 in 10,000 people)] which causes reduced resistance to infections. It is important to inform your doctor about the medicine you are taking.
• Stop treatment with ibuprofen and consult your doctor immediately if you noticeany of the following symptoms:or raised, non-itchy, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth sores, throat sores, nose sores, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome] [a very rare side effect (may affect up to 1 in 10,000 people)].
• In addition, a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells) [frequency not known (frequency cannot be defined based on available data)].
• rash or lesions of the mucous membranes. Severe skin rashes may include blisters on the skin, especially on legs, arms, hands and feet, which may also involve the face and lips. This can worsen if the blisters widen and spread and parts of the skin can detach (toxic epidermal necrolysis). [a very rare side effect (may affect up to 1 in 10,000 people)].
• extensive, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [frequency not known (frequency cannot be estimated based on available data)].
• Stop taking Velitixand inform your doctor immediately if you experience relatively severe pain in the upper abdomen, vomiting blood, bloody and/or dark stools.
• Fluid retention (edema), especially in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure (kidney failure) [a very rare side effect (may affect up to 1 in 10,000 people)]. Reduced urine production, fluid buildup inside the body (edema) and malaise (general feeling of discomfort) can be signs of kidney failure.

If any of the listed symptoms occur or worsen, you should stop taking Velitix
and contact your doctor immediately.

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

• Gastrointestinal disorders, such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, digestive problems and mild gastrointestinal bleeding, which, in exceptional cases, can cause anemia.

Uncommon (may affect up to 1 in 100)

• Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability or fatigue
• Visual disturbances. In this case, stop using ibuprofen and inform your doctor.
• Stomach/intestinal ulcers (peptic ulcers) may occur, sometimes with bleeding and perforation (rupture in the wall of the digestive tract), which can be fatal, especially in elderly patients, ulcerative stomatitis (inflammation of the mouth lining with ulceration), worsening of colitis or Crohn's disease (inflammation of the colon).
• Inflammation of the inner wall of the stomach (gastritis)
• Hypersensitivity reactions such as skin rash and itching, as well as asthma attacks (sometimes accompanied by a drop in blood pressure). In such cases, inform your doctor immediately and stop taking Velitix.

Rare side effects (may affect up to 1 in 1,000)

• Tinnitus (ringing in the ears)
• Hearing loss
• Damage to kidney tissue (papillary necrosis), increased concentration of uric acid in the blood, high concentration of urea in the blood.

Very rare side effects (may affect up to 1 in 10,000)

• Disorders of blood cell formation, such as a decrease in the amount of red blood cells or hemoglobin (anemia), white blood cells (leukopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia or hemolytic anemia). The first symptoms may be fever, sore throat, superficial wounds in the mouth, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding.
• Temporally associated with the use of certain anti-inflammatory agents (non-steroidal anti-inflammatory drugs; to which Velitix also belongs), a worsening of inflammation related to infection (e.g. development of necrotizing fasciitis) has been reported. If signs of infection appear or worsen during the use of Velitix (e.g. redness, swelling, heat, pain, fever), consult a doctor immediately. The doctor will assess whether you need antibiotic therapy.
• During the use of ibuprofen, symptoms of aseptic meningitis (inflammation without infection of the membranes lining the brain) have been observed, such as severe headache, nausea, vomiting, fever, stiff neck or confusion. The risk appears to be higher in patients already suffering from certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
• Low blood sugar (hypoglycemia)
• Low sodium levels in the blood (hyponatremia)
• Palpitations, weak heart muscle (heart failure), heart attack
• High blood pressure (hypertension)
• Inflammation of blood vessels (vasculitis)
• Inflammation of the esophagus or pancreas (pancreatitis), narrowing of the intestine (intestinal diaphragm stenosis)
• Psychotic reactions, hallucinations, confusion, depression and anxiety
• Asthma, difficulty breathing (dyspnea), bronchospasm
• Jaundice (jaundice), liver dysfunction, liver damage, especially during long-term therapy, liver failure, acute liver inflammation (hepatitis).
• Hair loss (alopecia), red or purple spots on the skin (purpura) or photosensitivity reactions (triggered by sunlight).
• In exceptional cases, if you have chickenpox, severe skin infections and complications of soft tissues (varicella infection) may occur.

Frequency not known (frequency cannot be defined based on available data)

• Inflammation of the nasal mucosa (rhinitis)
• Pins and needles sensation (paresthesia) and inflammation of the optic nerve (optic neuritis)
• Kidney malfunction

Medicines like Velitix may be associated with a slight increase in the risk of heart attack (“myocardial infarction”) or stroke.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 Velitix

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 package and on the blister after
“EXP.” The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 Velitix contains

• The active ingredient is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
• The other excipients are: Tablet core: hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, sodium lauryl sulfate and magnesium stearate Coating: hypromellose, titanium dioxide E171, talc, propylene glycol

Description of the appearance of Velitix and contents of the pack
Film-coated tablets, from white to almost white in color, round with a unilateral score line
with a diameter of 12 mm.
The tablet can be divided into equal doses.
Packs of 10, 12, 20, 24, 30, 50 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Marketing Authorisation Holder
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany IbuARISTO akut 400 mg
Spain Diltix 400 mg film-coated tablets EFG
Italy Velitix
Poland Axoprofen Forte