Vegetallumina for pain and fever: detailed information

Patient Information Leaflet: Information for the Patient

VEGETALLUMINA PAIN AND FEVER 400 mg oral solution granules in sachet

sodium ibuprofen
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:
1 What VEGETALLUMINA PAIN AND FEVER is and what it is used for
2 What you need to know before taking VEGETALLUMINA PAIN AND FEVER
3 How to take VEGETALLUMINA PAIN AND FEVER
4 Possible side effects
5 How to store VEGETALLUMINA PAIN AND FEVER
6 Contents of the pack and other information

1. What is VEGETALLUMINA PAIN AND FEVER and what is it used for

This medicinal product contains the active substance ibuprofen, belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) which work by relieving pain (analgesic effect) and reducing symptoms of inflammation (anti-inflammatory effect).
VEGETALLUMINA PAIN AND FEVER is indicated for the treatment of pain or inflammatory conditions in the following cases:

treatment of pain: headache, toothache, menstrual pain, neuralgia, osteoarticular (bone) and muscular pain,
treatment of fever and flu-like symptoms, in addition to other medicines. Consult a doctor if you do not feel better or if you feel worse.

2. What you need to know before taking VEGETALLUMINA DOLORE E FEBBRE

Do not take VEGETALLUMINA DOLORE E FEBBRE

if you are allergic to ibuprofen, to other similar medicines, or to any of the other ingredients of this medicine (listed in section 6);
if you have previously suffered from stomach or intestinal disorders associated with bleeding (gastrointestinal haemorrhage or perforation related to previous treatment with anti-inflammatory medicines (NSAIDs) or history of recurrent peptic ulcer bleeding/ulceration, with two or more distinct episodes of proven ulceration or bleeding);
if you suffer from stomach or intestinal disorders associated with lesions and bleeding (active or recurrent peptic ulcer);
if you have gastrointestinal bleeding (gastrointestinal haemorrhage);
if you currently have other bleeding conditions such as cerebrovascular haemorrhage;
if you suffer from ulcerative colitis or Crohn’s disease;
if you have severe liver or kidney problems (severe hepatic or renal insufficiency);
if you suffer from bleeding disorders (haemorrhagic diathesis);
if you suffer from severe heart problems (severe heart failure);
if in the past, after taking acetylsalicylic acid or other anti-inflammatory medicines (NSAIDs), you experienced facial swelling due to fluid retention, especially around the mouth and eyes (angioedema), severe breathing difficulties (bronchospasm), breathing problems (asthma), skin irritation (urticaria), inflammation of nasal mucosa (rhinitis), or nasal polyps;
if you suffer from systemic lupus erythematosus or other skin diseases (collagen diseases);
if you are in the third trimester of pregnancy (See section “Pregnancy, breastfeeding and fertility”);
if you have phenylketonuria, a condition in which levels of certain substances in urine and blood are altered.

Warnings and precautions
Talk to your doctor or pharmacist before taking VEGETALLUMINA DOLORE E FEBBRE.
Talk to your pharmacist or nurse if you have an infection – see section “Infections” below.
Infections
VEGETALLUMINA DOLORE E FEBBRE may mask symptoms of infections such as fever and pain. Therefore, VEGETALLUMINA DOLORE E FEBBRE could delay appropriate treatment of the infection, which might increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
With ibuprofen, signs of an allergic reaction to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
Stop taking VEGETALLUMINA DOLORE E FEBBRE immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Take this medicine with caution if:

you are already taking other anti-inflammatory medicines (including selective COX-2 inhibitors, see section “Other medicines and VEGETALLUMINA DOLORE E FEBBRE”);
you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin (See section “Other medicines and VEGETALLUMINA DOLORE E FEBBRE”);
you have previously suffered from high blood pressure (hypertension), as, in association with NSAID therapy, you may experience fluid retention (fluid retention) and swelling due to fluid accumulation (edema);
you have previously suffered from intestinal disorders (ulcerative colitis, Crohn’s disease);
you suffer from heart disorders (mild to moderate congestive heart failure);
you have previously suffered from breathing problems (bronchospasm), especially following use of medicines. In patients who suffer or have suffered from bronchial asthma or allergic diseases, bronchospasm may worsen. In these cases, especially for prolonged treatments, your doctor may recommend periodic tests;
you suffer from coagulation disorders or reduced function of the heart, liver, or kidneys; in these cases, especially for prolonged treatments, periodic tests may be necessary. Hypersensitivity to VEGETALLUMINA DOLORE E FEBBRE may cause liver problems (hepatotoxic reactions);
you suffer from systemic lupus erythematosus, a chronic autoimmune disease that may affect various organs and tissues and cause facial lesions and pain, or suffer from other skin diseases (collagen diseases); consult your doctor before taking VEGETALLUMINA DOLORE E FEBBRE;
you intend to become pregnant, as the use of VEGETALLUMINA DOLORE E FEBBRE may impair female fertility; use of VEGETALLUMINA DOLORE E FEBBRE should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Risk of stroke and heart attack
Anti-inflammatory/pain-relief medicines may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking VEGETALLUMINA DOLORE E FEBBRE if you have:

heart problems including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries), or any type of stroke (including ‘mini-stroke’ or “TIA”, transient ischaemic attack);
high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Gastrointestinal risks
At any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding (gastrointestinal haemorrhage), formation of serious lesions (ulceration and perforation), which may be fatal, have been reported.
If you have previously suffered from ulcers, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased NSAID doses. Your doctor may recommend taking specific medicines to protect the stomach such as misoprostol or proton pump inhibitors, especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems).
If you suffer or have suffered from stomach or intestinal problems (gastrointestinal toxicity), especially at the beginning of treatment with VEGETALLUMINA DOLORE E FEBBRE, inform your doctor of any gastrointestinal symptoms you may experience (especially bleeding). At doses exceeding 1000 mg per day, prolongation of bleeding time may occur.
If you experience gastrointestinal bleeding or ulceration, discontinue treatment with VEGETALLUMINA DOLORE E FEBBRE and contact your doctor or the nearest hospital.
Exercise particular caution with VEGETALLUMINA DOLORE E FEBBRE:
Serious skin reactions
Serious skin reactions have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using VEGETALLUMINA DOLORE E FEBBRE and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Discontinue use of VEGETALLUMINA DOLORE E FEBBRE and consult your doctor immediately if you develop skin rash, mucosal lesions, blisters, or other signs of allergy, as they may be the first signs of a very serious skin reaction. See section 4.
Vision problems
If you experience vision disturbances, discontinue treatment with this medicine and consult an ophthalmologist.
Elderly patients
If you are elderly, the risk of adverse effects is higher, especially gastrointestinal bleeding and perforation (gastrointestinal events) which may be fatal. The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased NSAID doses. Therefore, start treatment with the lowest available dose and take VEGETALLUMINA DOLORE E FEBBRE for the shortest possible duration needed to control symptoms. Your doctor may recommend medicines that provide gastric protection (misoprostol or proton pump inhibitors), especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems). If you suffer or have suffered from stomach or intestinal problems (gastrointestinal toxicity), especially at the beginning of treatment with VEGETALLUMINA DOLORE E FEBBRE, inform your doctor of any gastrointestinal symptoms you may experience (especially bleeding). At doses exceeding 1000 mg per day, prolongation of bleeding time may occur. If you experience gastrointestinal bleeding or ulceration, discontinue treatment with VEGETALLUMINA DOLORE E FEBBRE and contact your doctor or the nearest hospital.
Children and adolescents
This medicine should be administered with caution in dehydrated adolescents because there is an increased risk of kidney problems (see section 3 “Use in adolescents aged 12 to 18 years”). Use caution when starting treatment with ibuprofen if you suffer from severe dehydration.
Ibuprofen may mask objective and subjective signs of infection. Therefore, use ibuprofen therapy cautiously in case of infection.
NSAIDs may cause an increase in liver function test results.
Pay particular attention in the above cases, bearing in mind that any risk is more likely when using this medicine at high doses and during prolonged treatment.
Other medicines and VEGETALLUMINA DOLORE E FEBBRE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The use of VEGETALLUMINA DOLORE E FEBBRE, like other similar medicines (non-steroidal anti-inflammatory drugs, analgesics, antipyretics), may cause allergic reactions (hypersensitivity), even severe ones (see section “Possible side effects”). Do not use VEGETALLUMINA DOLORE E FEBBRE if you are taking other anti-inflammatory medicines (e.g., analgesics, antipyretics, and other NSAIDs such as acetylsalicylic acid/aspirin), as the risk of adverse effects may increase. If you are taking acetylsalicylic acid (aspirin) products for heart problems, do not take VEGETALLUMINA DOLORE E FEBBRE simultaneously, as the cardioprotective effect may be reduced.
VEGETALLUMINA DOLORE E FEBBRE may affect or be affected by other medicines. For example:

medicines used to reduce inflammation and treat allergies (oral corticosteroids); VEGETALLUMINA DOLORE E FEBBRE may increase the risk of ulcers or gastrointestinal bleeding;
medicines with anticoagulant effect (i.e., substances that thin the blood, preventing clot formation, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine); VEGETALLUMINA DOLORE E FEBBRE may enhance the effect of these medicines, and your doctor may therefore require you to undergo appropriate tests to assess whether your therapy needs adjustment. VEGETALLUMINA DOLORE E FEBBRE may also increase the risk of gastrointestinal bleeding when taken concomitantly with antiplatelet agents;
medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan). VEGETALLUMINA DOLORE E FEBBRE may alter the effect of the medicines you are taking. Furthermore, if you have kidney problems, especially if you are elderly or dehydrated, VEGETALLUMINA DOLORE E FEBBRE may worsen your condition if you are taking ACE inhibitors or angiotensin II antagonists; in these cases, it is necessary to maintain adequate fluid intake, and your doctor may periodically monitor your kidney function after starting treatment;
medicines used to treat depression and anxiety disorders (serotonin reuptake inhibitors); VEGETALLUMINA DOLORE E FEBBRE may increase the risk of gastrointestinal bleeding;
medicines based on lithium and phenytoin;
medicines used to treat heart problems such as digoxin;
non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors. VEGETALLUMINA DOLORE E FEBBRE should be used cautiously in combination with other NSAIDs, as it may increase the risk of adverse gastrointestinal reactions;
medicines based on methotrexate, used for uncontrolled proliferation of blood cells (leukaemia), chronic inflammatory skin diseases (psoriasis), and chronic inflammatory joint diseases associated with skin conditions (psoriatic arthritis). VEGETALLUMINA DOLORE E FEBBRE may increase methotrexate plasma levels;
medicines based on zidovudine used to treat Human Immunodeficiency Virus (HIV) infection. VEGETALLUMINA DOLORE E FEBBRE may increase the risk of bleeding in joints or muscles in HIV-positive haemophiliac patients;
medicines based on tacrolimus and cyclosporine used to prevent rejection in patients receiving liver, kidney, or heart transplants. VEGETALLUMINA DOLORE E FEBBRE may increase the risk of renal toxicity;
medicines used to lower blood sugar levels, hypoglycaemics and insulin. Dose adjustment may be necessary;
medicines based on cyclosporine used to reduce immune system activity in autoimmune diseases. VEGETALLUMINA DOLORE E FEBBRE may increase the risk of renal toxicity;
medicines with antifungal effect, based on voriconazole and fluconazole. Dose adjustment of VEGETALLUMINA DOLORE E FEBBRE may be necessary;
medicines based on mifepristone used to terminate pregnancy. Dose adjustment of VEGETALLUMINA DOLORE E FEBBRE may be necessary. Moreover, the effectiveness of mifepristone may theoretically be reduced;
medicines used to treat bacterial infections, such as quinolone antibiotics. VEGETALLUMINA DOLORE E FEBBRE may increase the risk of seizures;
medicines used to treat bacterial infections, such as aminoglycosides. VEGETALLUMINA DOLORE E FEBBRE may reduce their elimination;
products containing ginkgo biloba. VEGETALLUMINA DOLORE E FEBBRE may enhance the risk of bleeding.

VEGETALLUMINA DOLORE E FEBBRE may affect the results of the following diagnostic tests:

tests to evaluate the time required to stop blood loss after bleeding (bleeding time may be prolonged up to one day after discontinuation of therapy);
tests to evaluate blood sugar concentrations (concentrations may decrease);
tests to evaluate kidney function through creatinine measurement, potassium and nitrogen levels (levels may increase);
tests to evaluate blood composition and haemoglobin (values may decrease);
tests to evaluate liver function through transaminase measurement (values may increase). Other medicines may also affect or be affected by treatment with VEGETALLUMINA DOLORE E FEBBRE. Therefore, always consult your doctor or pharmacist before using VEGETALLUMINA DOLORE E FEBBRE with other medicines.

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
Before starting treatment, ensure you are not pregnant; discontinue if you become pregnant.
Do not take VEGETALLUMINA DOLORE E FEBBRE during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause heart, lung, or kidney problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. You should not take VEGETALLUMINA DOLORE E FEBBRE during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is necessary during this period or during attempts to conceive, the lowest possible dose for the shortest possible duration should be used. From week 20 of pregnancy, VEGETALLUMINA DOLORE E FEBBRE may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Avoid taking VEGETALLUMINA DOLORE E FEBBRE during breastfeeding.
Fertility
Do not take VEGETALLUMINA DOLORE E FEBBRE if you have fertility problems.
Driving and using machines
This medicine may cause drowsiness, dizziness, headache, and depression, which may impair your ability to drive or operate machinery. If these effects occur, avoid driving and operating machinery.
VEGETALLUMINA DOLORE E FEBBRE 400 mg granules for oral solution in sachet contains:

sodium: this medicine contains 46 mg (1.94 mmol) of sodium (main component of table salt) per sachet, equivalent to 2.3% of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium for an adult.
sucrose: if your doctor has diagnosed you with intolerance to certain sugars (e.g., sucrose), contact them before taking this medicine. One sachet contains 2.148 g of sucrose (sugar). This should be considered in people with diabetes mellitus.
potassium: this medicine contains 2.3 mmol (90 mg) of potassium per sachet. This should be considered if you have reduced kidney function or are on a low-potassium diet;
aspartame: this medicine contains 20 mg of aspartame per sachet, equivalent to 20 mg/3 g (total weight of the sachet). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it;
sulphites: rarely may cause severe hypersensitivity reactions and bronchospasm.

3. How to take VEGETALLUMINA DOLORE E FEBBRE

Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults and adolescents (from 12 years of age)
The recommended dose is 1 sachet, 2–3 times daily.
Do not exceed the maximum recommended daily dose of 1200 mg (3 sachets).
Dissolve the contents of one sachet in a glass of water (50–100 ml) and take immediately after dissolving. Take the solution with food.

Use in adolescents aged between 12 and 18 years
Consult your doctor if treatment longer than 3 days is required or if symptoms worsen.

Use in elderly patients
If you are elderly, adhere to the lower dosage recommendations mentioned above. However, always consult your doctor, as dose adjustment may be necessary.

Use in patients with impaired renal, hepatic, or cardiac function
If you have impaired renal, hepatic, or cardiac function, always consult your doctor, as dose reduction may be necessary. In cases of severe renal, hepatic, or cardiac insufficiency, the use of VEGETALLUMINA DOLORE E FEBBRE is contraindicated (see section “Do not take VEGETALLUMINA DOLORE E FEBBRE”).

Do not exceed the recommended dose or duration of treatment. The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible time.

If you take more VEGETALLUMINA DOLORE E FEBBRE than you should
If you have taken more VEGETALLUMINA DOLORE E FEBBRE than recommended, or if your child has accidentally ingested this medicine, contact your doctor immediately or go to the nearest hospital for advice on the potential risk and necessary actions.

In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus (ringing in the ears), confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.

Additional symptoms may include: gastrointestinal bleeding, abdominal pain, diarrhoea, deep sleep with reduced response to normal stimuli (lethargy), double vision, loss of muscle coordination (ataxia), severe muscle problems (rhabdomyolysis), epileptic seizures, disorientation, or profound loss of consciousness (coma), lowering of body temperature (hypothermia), kidney-related effects, temporary cessation of breathing (apnea), reduced activity of the central nervous system and respiratory depression. Other possible symptoms include: fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).

If significantly excessive doses of ibuprofen are taken, severe kidney damage (renal failure) and liver damage may occur.
Symptoms of overdose may appear within 4–6 hours after ibuprofen intake.

If you have any doubts about the use of VEGETALLUMINA DOLORE E FEBBRE, consult your doctor or pharmacist.

If you forget to take VEGETALLUMINA DOLORE E FEBBRE
Do not take a double dose to make up for the missed dose.
If you have any doubts, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using VEGETALLUMINA PAIN AND FEVER if you develop any of these symptoms and contact your doctor immediately. See also section 2:

Reddish, non-elevated spots, 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, toxic epidermal necrolysis];
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
Widespread, extensive, red, scaly rash with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular exanthema).

The following side effects may occur:
Very common (may affect more than 1 in 10 people)

Indigestion (dyspepsia);
Diarrhea.

Common (may affect up to 1 in 10 people)

Abdominal pain or discomfort, burning sensation in the stomach (pyrosis);
Nausea, flatulence;
Headache (cephalalgia), dizziness;
Skin disorders, skin rash (rash).

Uncommon (may affect up to 1 in 100 people)

Formation of stomach or intestinal lesions (peptic ulcers or hemorrhages), sometimes fatal, particularly in the elderly;
Vomiting;
Presence of blood in stools (melena);
Inflammation of the stomach (gastritis);
Inflammation of the mouth (stomatitis);
Confusion;
Drowsiness;
Itching, skin irritation (urticaria, exanthema), serious skin condition associated with bleeding (purpura);
Swelling of the face, lips, mouth, tongue, or throat, which may cause breathing or swallowing difficulties (angioedema);
Allergic reactions;
Breathing difficulties (asthma, worsening of asthma, bronchospasm, dyspnea).

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

Formation of stomach or intestinal lesions (gastrointestinal perforation);
Constipation;
Presence of blood in vomit (hematemesis);
Inflammation of the mouth associated with lesions (ulcerative stomatitis);
Worsening of certain chronic inflammatory bowel diseases (colitis, Crohn's disease);
Hearing disorders, ringing in the ears (tinnitus);
Vision disorders (blurred vision, amblyopia);
Changes in platelet, white blood cell, and red blood cell levels (thrombocytopenia, agranulocytosis, aplastic anemia, hemolytic anemia, granulocytopenia);
Presence of blood in urine (hematuria);
Difficulty passing urine (dysuria);
Liver problems;
Abnormal liver function tests (elevated transaminases);
Problems distinguishing colors;
Severe allergic reaction (anaphylaxis).

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

Impairment of sensory and orientation functions (mental confusion);
Severe skin disorders (exfoliative dermatitis, reactions including Stevens-Johnson syndrome and erythema multiforme, toxic epidermal necrolysis, allergic vasculitis);
Kidney problems (interstitial nephritis, papillary necrosis, renal failure, including acute form).

Not known (frequency cannot be estimated from available data)

Decreased appetite and body weight (anorexia);
Swelling of part of the body due to fluid accumulation (edema);
Fever;
Heart problems (heart failure);
Increased blood pressure (hypertension);
Blood circulation problems (thrombosis);
Decreased blood pressure (hypotension);
Depression and mental disorders (psychotic reaction);
Infection of the membranes surrounding the brain without bacterial growth in culture (aseptic meningitis);
Swelling at the point where the optic nerve connects to the eye (papilledema);
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell);
A widespread, red, scaly rash with pustule formation under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular exanthema);
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
Unexpected and exaggerated skin reactions to sun exposure (photosensitivity reaction);
Anemia;
Muscle stiffness;
Increased levels of uric acid in the blood (uricemia);
Poor excretion of sodium and fluids, resulting in swelling (edema);
Menstrual cycle disorders;
Inflammation of the liver (hepatitis), liver damage, jaundice;
Abnormal kidney function tests;
Severe clinical reaction triggered in a sensitized individual upon contact with a specific allergen (anaphylactic shock);
Burning and pain in the throat (throat irritation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website: 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 VEGETALLUMINA DOLORE E FEBBRE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

The active substance is ibuprofen sodium dihydrate 512 mg, equivalent to 400 mg of ibuprofen (see section VEGETALLUMINA DOLORE E FEBBRE contains sodium).
The other ingredients are sucrose (see section VEGETALLUMINA DOLORE E FEBBRE contains sucrose), potassium bicarbonate, acesulfame potassium (see section VEGETALLUMINA DOLORE E FEBBRE contains potassium), orange flavour (contains sulphites; see section VEGETALLUMINA DOLORE E FEBBRE contains sulphites), aspartame (E951) (see section VEGETALLUMINA DOLORE E FEBBRE contains aspartame).

Description of the appearance of VEGETALLUMINA DOLORE E FEBBRE and pack contents
VEGETALLUMINA DOLORE E FEBBRE is presented in heat-sealed sachets made of multilayer paper/polyethylene/aluminium/surlyn containing granules, or alternatively in heat-sealed sachets made of multilayer paper/aluminium/polyethylene containing granules.
Pack contents: 12 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pietrasanta Pharma S.p.A.
Via di Caprino, 7
55012 Capannori (LU)
Manufacturer
E-Pharma Trento S.p.A.
Frazione Ravina - Via Provina, 2
38123 Trento (TN)