Patient Information Leaflet: Information for the User

Velitix 200 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.

If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

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 would like more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
If you are an adult, consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days if you have fever, or after 4 days if you are taking this medicine for pain. Consult your doctor after 3 days if your child/adolescent child does not feel better or worsens after 3 days.

Contents of this leaflet:

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

1. What Velitix is and what it is 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 of at least 20 kg (aged 7 years and older), it is used for the short-term symptomatic treatment of mild to moderate pain and/or fever.
Consult your doctor if you do not feel better or if you feel worse after 3 days if you have a fever, or after 4 days if you are taking this medicine for pain.
Consult your doctor after 3 days if your child/adolescent child does not feel better or worsens after 3 days.

2. What you need to know before taking Velitix

Do not take Velitix if

you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may 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 that can cause shortness of breath)], asthma, runny, itchy and inflamed nose with sneezing, hives (an itchy rash) or angioedema (swelling under the skin) when taking ibuprofen, acetylsalicylic acid or other similar painkillers (NSAIDs);
you suffer from blood disorders of unknown origin;
you have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two separate episodes of confirmed ulcers or bleeding);
you have had gastrointestinal bleeding or perforation associated with previous NSAID treatments;
you have active bleeding in the brain (cerebrovascular bleeding) or any other active bleeding;
you suffer from severe liver, kidney or heart failure;
you are severely dehydrated (e.g. due to vomiting, diarrhoea or insufficient fluid intake);
you are in the last three months of pregnancy.

Warnings and precautions
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Discuss treatment 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 affecting connective tissue);
you have or have had gastrointestinal diseases (ulcerative colitis, Crohn’s disease), as your condition may worsen;
you suffer from inherited blood disorders (e.g. acute intermittent porphyria);
you have impaired 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 pulmonary disease, as you are at higher risk of developing allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), sudden swelling (Quincke’s oedema) or hives;
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), must be avoided.
Gastrointestinal bleeding, ulcers and perforation
Gastrointestinal bleeding, ulcers and perforation, sometimes fatal, have been reported with all NSAIDs. These may occur at any time during treatment, with or without warning symptoms or 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 higher with increasing NSAID doses. These patients should start treatment with the lowest available dose.
Concomitant use of protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered both for these patients and for those taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events.
If you have experienced gastrointestinal adverse effects – especially if you are elderly – inform your doctor of any unusual gastrointestinal symptoms (particularly gastrointestinal bleeding), especially 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) like 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 must be stopped and you must consult a doctor if gastrointestinal bleeding or ulceration occurs during use of Velitix.

Effects on the cardiovascular system
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking 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 arterial disease (blood circulation problems in legs or feet due to narrowed or blocked 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 area (angioedema) and chest pain, have been reported with ibuprofen.
Immediately stop treatment with Velitix and contact your doctor or emergency medical services if you notice any of these signs.

Skin reactions
Serious skin reactions have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized exanthematous pustulosis (PEAG). Discontinue use of 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 recommended to avoid use of Velitix during chickenpox infection.

Infections
Velitix may mask symptoms of infections such as fever and pain. Therefore, Velitix could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the infection symptoms persist or worsen, seek immediate medical advice.

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 must be stopped and a doctor must be consulted. Any appropriate medical procedures according to the symptoms should be performed by medical personnel.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation in blood). Therefore, patients with blood coagulation disorders should be closely monitored.
Regular monitoring of liver function parameters, renal function and blood cell counts is required during prolonged use of Velitix.
If you use painkillers for a long time, this may cause headaches, which should not be treated with other painkillers. If you think this applies to you, discuss it with your doctor.
In general, habitual use of painkillers, particularly combinations of different types of painkillers, may lead to permanent kidney damage. This risk may increase during physical exercise associated with loss of salts and dehydration. Therefore, such use should be avoided.
The risk of kidney failure is increased in dehydrated patients, the elderly and those taking 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, particularly gastrointestinal bleeding and perforation, which can be fatal (also refer to 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
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Velitix may affect or be affected by other medicines. For example:

Digoxin, phenytoin and lithium: concomitant use of Velitix with digoxin (used to strengthen the heart), phenytoin (used to treat seizures/epilepsy) or lithium (used, for example, to treat depression) may increase blood levels of these medicines. Serum lithium levels should be monitored. Monitoring of serum digoxin and phenytoin levels is generally not required if used according to instructions (maximum 3 or 4 days).
Anticoagulants (i.e. blood thinners/anticoagulants, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effects of anticoagulants such as warfarin.
Diuretics and high blood pressure medicines: 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). Combined administration of Velitix and potassium-sparing diuretics (some types of diuretics) may lead to increased blood potassium levels.
Medicines that reduce hypertension (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 to treat heart failure and high blood pressure). In addition, there is an increased risk of renal dysfunction during combined use.
Cholestyramine (a medicine used to lower cholesterol) used in combination with Velitix may reduce the absorption of Velitix in the gastrointestinal tract. However, the clinical relevance is unknown.
Other painkillers: concomitant use of Velitix with other anti-inflammatory and pain-relieving NSAIDs, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.
Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
Methotrexate: administration of Velitix within 24 hours before or after methotrexate (used to treat certain types of cancer or rheumatism) may lead to increased methotrexate concentrations and increased adverse 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 to treat gout) may delay excretion of ibuprofen. This may cause accumulation of Velitix in the body, leading to increased adverse effects.
Sulfonylureas: during concomitant use of Velitix and sulfonylureas (medicines used to treat diabetes), blood sugar levels should be monitored as a precaution.
Zidovudine: evidence suggests a higher risk of haemarthrosis (blood accumulation in joints) and bruising (haematomas) in HIV-positive haemophiliacs using zidovudine (an antiviral medicine used to treat HIV infection) together with ibuprofen.
Quinolone antibiotics: the risk of seizures (convulsive fits) may be increased when antibiotics known as quinolones, such as ciprofloxacin, are taken simultaneously with ibuprofen.
Aminoglycosides: concomitant use of Velitix with aminoglycosides (a type of antibiotic) and NSAIDs may reduce excretion of aminoglycosides.
Voriconazole and fluconazole (CYP2C9 inhibitors) used to treat fungal infections, as the effect of ibuprofen may increase. A reduction in the dose of ibuprofen should be considered, 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: concomitant use of mifepristone with other anti-inflammatory and pain-relieving NSAIDs (e.g. ibuprofen) may reduce the effect of mifepristone.
Ritonavir: concomitant use with ritonavir (an antiviral medicine used to treat HIV infections) may increase plasma concentrations of NSAID painkillers.
Alcohol, bisphosphonates and pentoxifylline: concomitant use of ibuprofen with alcohol, bisphosphonates (used in osteoporosis) or pentoxifylline (used in peripheral arterial circulatory disorders) may increase gastrointestinal adverse effects and the risk of bleeding and ulcers.
Baclofen (a muscle relaxant), as baclofen toxicity may increase.
Medicines for treating inflammation (corticosteroids), due to an increased risk of gastrointestinal ulcers or bleeding.

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Velitix during the last three months of pregnancy, as it may harm the foetus or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect your and your baby’s tendency to bleed and may cause labour to start later or last longer than expected. You should not take Velitix during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, Velitix may cause kidney problems in the unborn child, leading 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, since no harmful effects on infants have been reported so far, breastfeeding generally does not need to be interrupted 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 upon discontinuation of treatment. Inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.

Driving and using machines
Ibuprofen generally does not affect or affects only negligibly the ability to drive vehicles or operate machinery. However, since adverse effects on the central nervous system such as fatigue and dizziness may occur at high doses, in isolated cases the ability to react and the capacity for active driving and operating machinery may be impaired. This effect is enhanced by concomitant alcohol intake.

Velitix contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 exactly as stated 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 for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
The dose should be based on the information in the following table. In children and adolescents, Velitix is dosed according to body weight or age, usually with a single dose ranging between 7 and 10 mg/kg of body weight, up to a maximum of 30 mg/kg of body weight as the total daily dose.

Body weight Single dose Maximum daily dose
(age)
1 film-coated tablet 3 film-coated tablets
20 kg – 29 kg (equivalent to 200 mg of (equivalent to a maximum of
(Children: 7 – 9 years) ibuprofen) 600 mg of ibuprofen)
1 film-coated tablet 4 film-coated tablets
30 kg – 39 kg (equivalent to 200 mg of (equivalent to
(Children: 10 – 11 years) ibuprofen)

		800 mg of ibuprofen)
40 kg or above (Adults and adolescents aged 12 years and over)	1 - 2 film-coated tablets (equivalent to 200 – 400 mg of ibuprofen)	6 film-coated tablets (equivalent to 1200 mg of ibuprofen)

The respective dosing interval should be chosen according to 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 with a body weight below 20 kg.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
If you have severe liver or kidney disease or are elderly, your doctor will advise you on 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 in order to avoid irritation of the stomach or throat.
Patients with a sensitive stomach are advised to take Velitix with food.
This medicine is intended for short-term use only.
For adults
If in adults this medicine is required for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen, consult a doctor.
For children and adolescents
If in children and adolescents this medicine is required for more than 3 days 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 accidentally taken this medicine, always contact a doctor or the nearest hospital to obtain advice on the risk and guidance on the necessary actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), or less commonly, diarrhea. In addition, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and uncontrolled eye movements, worsening of asthma in asthmatic patients. At high doses, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, coma, seizures (especially in children), dizziness, weakness, and vertigo, blood in the urine, low blood potassium levels, low blood pressure, increased blood potassium levels, prolonged 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 the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effects are related to the gastrointestinal tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, especially in elderly patients (see section 2: "Warnings and precautions"). After use, nausea, vomiting, diarrhoea, flatulence, constipation, digestive disturbances, abdominal pain, black tarry stools, vomiting blood, mouth and throat ulcers (ulcerative stomatitis), worsening of colitis and Crohn's disease have been reported (see section 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 dose and duration of treatment.
Fluid retention (oedema), hypertension and heart failure have been reported in association with NSAID therapy.

More serious side effects

Stop taking Velitix and contact a doctor immediately if you experience severe general allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people): This may present as:
swelling of the face (facial oedema), tongue or throat (laryngeal oedema with airway constriction)
difficulty breathing
rapid heartbeat
- drop in blood pressure leading 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 from available data)]
You must consult a doctor immediately if you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems. Velitix may 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)], resulting in reduced resistance to infections. It is important to inform your doctor about the medicine you are taking.
Stop taking ibuprofen and consult a doctor immediately if you notice any of the following symptoms:
flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell) [frequency not known (frequency cannot be estimated from available data)].
skin rash or mucosal lesions. Severe skin rashes may include blisters on the skin, particularly on the legs, arms, hands and feet, which may also involve the face and lips. This may worsen if blisters enlarge 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 people)].
widespread, red, scaly rash, with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption) [frequency not known (frequency cannot be estimated from available data)].
Stop taking Velitix and inform your doctor immediately if you experience severe upper abdominal pain, vomiting blood, bloody and/or dark stools.
Fluid retention (oedema), particularly in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis which may be accompanied by acute kidney failure (renal failure) [a very rare side effect (may affect up to 1 in 10,000 people)]. Reduced urine output, fluid accumulation in the body (oedema) and malaise (general feeling of being unwell) may be signs of kidney failure.

If any of the listed symptoms occur or worsen, you must 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, diarrhoea, constipation, indigestion and mild gastrointestinal bleeding, which in rare cases may lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

Disorders of the central nervous system, such as headache, dizziness, insomnia, restlessness, irritability or fatigue
Visual disturbances. In this case, you must stop using ibuprofen and inform your doctor.
Gastric/intestinal ulcers (peptic ulcers), sometimes with bleeding and perforation (rupture in the wall of the digestive tract), which may be fatal, especially in elderly patients, ulcerative stomatitis (inflammation of the mouth mucosa with ulceration), worsening of colitis or Crohn's disease (inflammation of the colon).
Inflammation of the inner lining 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 must inform your doctor immediately and stop taking Velitix.

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

Ringing in the ears (tinnitus)
Hearing loss
Kidney tissue damage (papillary necrosis), increased blood uric acid concentration, elevated blood urea concentration.

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

Blood cell formation disorders, such as decreased number of red blood cells or haemoglobin (anaemia), white blood cells (leucopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anaemia or haemolytic anaemia). Initial symptoms may include fever, sore throat, superficial mouth ulcers, 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; NSAIDs, to which Velitix also belongs), worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) has been reported. If signs of infection appear or worsen during treatment with Velitix (e.g. redness, swelling, warmth, pain, fever), consult a doctor immediately. Your doctor will assess whether you need antibiotic therapy.
During ibuprofen use, symptoms of aseptic meningitis (inflammation of the membranes covering the brain without infection), such as severe headache, nausea, vomiting, fever, neck stiffness or altered consciousness, have been observed. The risk appears to be higher in patients already suffering from certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
Low blood sugar levels (hypoglycaemia)
Low sodium levels in the blood (hyponatraemia)
Palpitations, weakened heart muscle (heart failure), heart attack
High blood pressure (hypertension)
Inflammation of blood vessels (vasculitis)
Inflammation of the oesophagus or pancreas (pancreatitis), narrowing of the intestine (intestinal diaphragm stenosis)
Psychotic reactions, hallucinations, confusion, depression and anxiety
Asthma, breathing difficulties (dyspnoea), bronchospasm
Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage, especially during long-term therapy, liver failure, acute inflammation of the liver (hepatitis).
Hair loss (alopecia), red or purple spots on the skin (purpura) or photosensitivity reactions (triggered by sunlight).
In very rare cases, if you have chickenpox, serious skin infections and soft tissue complications (chickenpox-related infection) may occur.

Frequency not known (frequency cannot be estimated from available data)

Inflammation of the nasal mucosa (rhinitis)
Sensation of pins and needles (paraesthesia) and inflammation of the optic nerve (optic neuritis)
Kidney malfunction

Medicines such as Velitix may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
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 stated on the carton and blister after "EXP." The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Velitix contains

The active substance is ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen.
The other excipients are:
Tablet core: hypromellose, sodium croscarmellose, monohydrate lactose, 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, white to almost white in colour, round, with a diameter of 10.25 mm and smooth on both sides.
Packs containing 10, 12, 16, 20, 24, 30, 36, 48, 50, 60 or 96 film-coated tablets.
Not all pack sizes may be marketed.

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

Sales License Holder
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany IbuARISTO akut 200 mg
Italy Velitix
Poland Axoprofen
Portugal Diltix

Package leaflet: information for the user

Velitix 400 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.

If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
If you are an adult, consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days if you have fever, or after 4 days if you are taking this medicine for pain. Consult your doctor after 3 days if your adolescent child does not feel better or worsens after 3 days.

Contents of this leaflet:

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

1. What Velitix is and what it is 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 with a body weight of at least 40 kg (aged 12 years and above), it is used for the short-term symptomatic treatment of mild to moderate pain and/or fever.
If you do not feel better or feel worse after 3 days when treating fever, or after 4 days when treating pain, consult your doctor.
If your adolescent child does not feel better or worsens after 3 days, consult your doctor.

2. What you need to know before taking Velitix

Do not take Velitix if

you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may 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 that can cause shortness of breath)], asthma, runny, itchy and inflamed nose with sneezing, hives (an itchy rash) or angioedema (swelling under the skin) when taking ibuprofen, acetylsalicylic acid or other similar painkillers (NSAIDs);
you suffer from blood disorders of unknown origin;
you have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two separate episodes of confirmed ulcers or bleeding);
you have experienced gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs;
you have bleeding in the brain (cerebrovascular bleeding) or any other active bleeding;
you suffer from severe liver, kidney or heart failure;
you have severe dehydration (e.g. caused by vomiting, diarrhoea or insufficient fluid intake);
you are in the last three months of pregnancy.

Warnings and precautions
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Discuss treatment 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 affecting connective tissue);
you have or have had gastrointestinal diseases (ulcerative colitis, Crohn’s disease), as your condition may worsen;
you suffer from hereditary blood disorders (e.g. acute intermittent porphyria);
you suffer from impaired 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 pulmonary disease, as you are at higher risk of developing allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), sudden swelling (Quincke’s oedema) or hives;
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 fatal, have been reported with all NSAIDs. These may occur at any time during therapy, with or without warning symptoms or 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.
Concomitant use of protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered both for these patients and for patients who are also taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events.
If you have experienced gastrointestinal adverse effects – especially if you are elderly – inform your doctor of any unusual gastrointestinal symptoms (particularly gastrointestinal bleeding), especially during the initial 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 must be stopped and you must consult a doctor if gastrointestinal bleeding or ulceration occurs during use of Velitix.

Effects on the cardiovascular system
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking 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 (circulation problems in the legs or feet due to narrowing or blockage of 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.

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute exanthematous pustulosis (GEP). Discontinue use of 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 may mask symptoms of infections such as fever and pain. Therefore, Velitix may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms 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 must be stopped and a doctor must be consulted. Any appropriate medical procedures according to symptoms must be performed by medical personnel.
Ibuprofen may temporarily inhibit platelet function (blood platelet aggregation). Therefore, patients with blood clotting disorders should be closely monitored.
Regular monitoring of liver function parameters, kidney function and blood cell counts is required during prolonged use of Velitix.
If you use painkillers for a prolonged period, this may cause headaches, which should not be treated with other painkillers. If you think this applies to you, discuss it with your doctor.
In general, habitual use of painkillers, particularly in combination with different types of analgesics, may lead to permanent kidney damage. This risk may increase during physical exercise associated with loss of salts and dehydration. Therefore, such use should be avoided.
The risk of kidney failure is increased in dehydrated patients, the elderly and those taking 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, particularly gastrointestinal bleeding and perforation, which may be fatal (also refer to 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
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Velitix may affect or be affected by other medicines. For example:

Digoxin, phenytoin and lithium: concomitant use of Velitix with digoxin (used to strengthen the heart), phenytoin (used to treat seizures/epilepsy) or lithium (used, for example, to treat depression) may increase the blood concentration of these medicines. Serum lithium levels should be monitored. Monitoring of serum digoxin and phenytoin levels is generally not required if used according to instructions (maximum 3 or 4 days).
Anticoagulants (i.e. blood thinners/anticoagulants, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effects of anticoagulants such as warfarin.
Diuretics and blood pressure medicines: 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). Combined administration of Velitix and potassium-sparing diuretics (some types of diuretics) may lead to increased 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 to treat heart failure and high blood pressure). In addition, combined use increases the risk of kidney dysfunction.
Cholestyramine (a medicine used to lower cholesterol) used in combination with Velitix may reduce the absorption of Velitix in the gastrointestinal tract. However, the clinical relevance is unknown.
Other painkillers: concomitant use of Velitix with other NSAIDs and painkillers, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.
Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
Methotrexate: administration of Velitix within 24 hours before or after methotrexate (used to treat certain types of cancer or rheumatism) may lead to increased methotrexate concentrations and increased adverse 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 to treat gout) may delay the excretion of ibuprofen. This may cause accumulation of Velitix in the body, leading to increased adverse effects.
Sulfonylureas: during concomitant use of Velitix and sulfonylureas (medicines used to treat diabetes), blood sugar levels should be monitored as a precaution.
Zidovudine: evidence suggests an increased risk of haemarthrosis (bleeding into joints) and bruising (haematomas) in HIV-positive haemophiliacs taking zidovudine (an antiviral medicine used to treat HIV infection) together with ibuprofen.
Quinolone antibiotics: the risk of seizures (convulsive fits) may be increased when quinolone antibiotics such as ciprofloxacin are taken simultaneously with ibuprofen.
Aminoglycosides: concomitant use of Velitix with aminoglycosides (a type of antibiotic) and NSAIDs may reduce the excretion of aminoglycosides.
Voriconazole and fluconazole (CYP2C9 inhibitors) used to treat fungal infections, as the effect of ibuprofen may increase. A reduction in the dose of ibuprofen should be considered, 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: concomitant use of mifepristone with other NSAIDs and painkillers (e.g. ibuprofen) may reduce the effect of mifepristone.
Ritonavir: concomitant use with ritonavir (an antiviral medicine used to treat HIV infections) may increase plasma concentrations of NSAID painkillers.
Alcohol, bisphosphonates and pentoxifylline: concomitant use of ibuprofen with alcohol, bisphosphonates (used in osteoporosis) or pentoxifylline (used for peripheral arterial circulatory disorders) may increase gastrointestinal adverse effects and the risk of bleeding and ulcers.
Baclofen (a muscle relaxant), as the toxicity of baclofen may increase.
Medicines for treating inflammation (corticosteroids), due to an increased risk of gastrointestinal ulcers or bleeding.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Velitix during the last three months of pregnancy, as it may harm the foetus or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect your and your baby’s tendency to bleed and may cause labour to start later or last longer than expected. You should not take Velitix during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, Velitix may cause kidney problems in the unborn child, leading 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, since no harmful effects on infants have been reported 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. Inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.

Driving and using machines
Ibuprofen generally does not affect or affects only slightly the ability to drive or use machines. However, at high doses, adverse effects on the central nervous system such as fatigue and dizziness may occur, and in isolated cases, reaction ability and active driving skills or use of machinery may be impaired. This effect is enhanced by concomitant alcohol intake.

Velitix contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Take this medicine exactly as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.

Recommended dose
Adults and adolescents weighing at least 40 kg (aged 12 years and older):
Half a tablet (200 mg) or one whole tablet (400 mg) as a single dose. If needed, additional doses may be taken as half a tablet or one whole tablet. The respective dosing interval should be adjusted according to 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 duration necessary to control symptoms.

If you have severe liver or kidney disease or are elderly, your doctor will advise you on the correct dose, which will correspond to the lowest possible dose.

Method of administration
Velitix is for oral use.
Take the tablet with a glass of water.
Do not crush, chew or suck the tablets to avoid irritation of the stomach or throat.
Patients with a sensitive stomach are advised to take Velitix with food.

This medicine is intended for short-term use only.

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

For adolescents
If in adolescents this medicine is required for more than 3 days 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 accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on necessary actions.

Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), or more rarely diarrhoea. In addition, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and uncontrolled eye movements may occur. Worsening of asthma in asthmatic patients may also occur. At high doses, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, coma, seizures (especially in children), dizziness, weakness, and vertigo have been reported. Other symptoms include blood in the urine, low blood potassium levels, low blood pressure, increased blood potassium levels, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, feeling cold, and breathing difficulties.

If you forget to take Velitix
Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most commonly observed side effects affect the gastrointestinal tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2: "Warnings and precautions"). After use, nausea, vomiting, diarrhoea, flatulence, constipation, digestive disturbances, abdominal pain, black tarry stools, vomiting blood, mouth and throat ulcers (ulcerative stomatitis), worsening of colitis and Crohn's disease have been reported (see section 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 dose and duration of treatment.
Fluid retention (oedema), hypertension and heart failure have been reported in association with NSAID therapy.

More serious side effects

Stop taking Velitix and contact a doctor immediately if you experience severe general allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people): This may present as:
swelling of the face (facial oedema), tongue or throat (laryngeal oedema with airway constriction)
difficulty breathing
rapid heartbeat
drop in blood pressure leading 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 from available data)]
Contact your doctor immediately if you develop signs of infection such as fever and a significant worsening of your general condition, or fever with local signs of infection such as sore throat/pharyngitis/mouth sores or urinary problems. Velitix may 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)], resulting in decreased resistance to infections. It is important to inform your doctor about the medicine you are taking.
Stop taking ibuprofen and contact your doctor immediately if you notice any of the following symptoms: or reddish, non-elevated target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell) [frequency not known (frequency cannot be determined from available data)].
skin rash or mucosal lesions. Severe skin rashes may include blisters on the skin, particularly on the legs, arms, hands and feet, which may also involve the face and lips. This may worsen if blisters spread and parts of the skin detach (toxic epidermal necrolysis). [a very rare side effect (may affect up to 1 in 10,000 people)].
widespread red, scaly rash, with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear early in treatment (generalized acute exanthematous pustulosis) [frequency not known (frequency cannot be estimated from available data)].
Stop taking Velitix and contact your doctor immediately if you experience relatively severe upper abdominal pain, vomiting blood, bloody and/or dark stools.
Fluid retention (oedema), particularly in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis which may be accompanied by acute kidney failure (renal failure) [a very rare side effect (may affect up to 1 in 10,000 people)]. Reduced urine output, fluid accumulation in the body (oedema) and malaise (general feeling of unwellness) may be signs of kidney failure.

If any of the listed symptoms occur or worsen, you must 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, diarrhoea, constipation, indigestion and mild gastrointestinal bleeding, which in rare cases may lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

Disorders of the central nervous system such as headache, dizziness, insomnia, agitation, irritability or fatigue
Vision disorders. In this case, you must stop using ibuprofen and inform your doctor.
Stomach/intestinal ulcers (peptic ulcers), sometimes with bleeding and perforation (rupture of the digestive tract wall), which may be fatal, especially in elderly patients, ulcerative stomatitis (inflammation of the oral mucosa with ulceration), worsening of colitis or Crohn's disease (inflammation of the colon).
Inflammation of the inner lining 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 must inform your doctor immediately and stop taking Velitix.

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

Ringing in the ears (tinnitus)
Hearing loss
Kidney tissue damage (papillary necrosis), increased blood uric acid concentration, elevated blood urea levels.

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

Blood cell formation disorders, such as reduced red blood cells or haemoglobin (anaemia), white blood cells (leucopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anaemia or haemolytic anaemia). Initial symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding.
A worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) has been reported in temporal association with the use of certain anti-inflammatory agents (non-steroidal anti-inflammatory drugs; NSAIDs, to which Velitix also belongs). If signs of infection appear or worsen during Velitix use (e.g. redness, swelling, warmth, pain, fever), consult a doctor immediately. The doctor will assess whether antibiotic therapy is needed.
Symptoms of aseptic meningitis (inflammation without infection of the membranes covering the brain), such as severe headache, nausea, vomiting, fever, neck stiffness or altered consciousness, have been observed during ibuprofen use. The risk appears to be higher in patients already affected by certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
Low blood sugar levels (hypoglycaemia)
Low sodium levels in the blood (hyponatraemia)
Palpitations, weakened heart muscle (heart failure), heart attack
High blood pressure (hypertension)
Inflammation of blood vessels (vasculitis)
Inflammation of the oesophagus or pancreas (pancreatitis), narrowing of the intestine (intestinal diaphragm stenosis)
Psychotic reactions, hallucinations, confusion, depression and anxiety
Asthma, breathing difficulties (dyspnoea), bronchospasm
Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage, especially during long-term therapy, liver failure, acute inflammation of the liver (hepatitis).
Hair loss (alopecia), red or purple spots on the skin (purpura) or photosensitivity reactions (triggered by sunlight).
In very rare cases, if you have chickenpox, serious skin infections and soft tissue complications (chickenpox-related infection) may occur.

Frequency not known (frequency cannot be determined from available data)

Inflammation of the nasal mucosa (rhinitis)
Sensation of pins and needles (paraesthesia) 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 experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via
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 carton and blister after
"EXP." The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Velitix contains

The active substance 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 pack sizes
Film-coated tablets, white to almost white, round, with a single-score line, 12 mm in diameter.
The tablet can be divided into equal doses.
Pack sizes 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

Selling Concessionaire
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: IbuARISTO akut 400 mg
Spain: Diltix 400 mg comprimidos recubiertos con pelicula EFG
Italy: Velitix
Poland: Axoprofen Forte