Vegedol

Patient Information Leaflet: Information for the user

Vegedol 400 mg film-coated tablets

ibuprofen as ibuprofen lysinate
Please read all of 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 told you to do.

• 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, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not feel better or if you feel worse after 3 days (in adolescents).
• Consult your doctor if you do not feel better or if you feel worse after 3 days for fever and/or migraine, or after 5 days for pain treatment (in adults).

Contents of this leaflet

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

1. What Vegedol is and what it is used for

The active substance is ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by altering the body's response to pain, swelling, and high temperature.
Vegedol is used for the short-term symptomatic treatment of:

• mild to moderate pain such as headache, migraine, toothache, dysmenorrhoea (menstrual pain), muscular pain, lower back pain, rheumatic pain
• fever
• febrile conditions and symptoms of cold and flu

Vegedol is indicated for use in adults and adolescents over 12 years of age and weighing at least 40 kg.

2. What you should know before taking Vegedol

Do not take Vegedol

• If you are allergic to ibuprofen, aspirin (acetylsalicylic acid), or other painkillers, or to any of the other ingredients of this medicine (listed in section 6),
• If you have experienced breathlessness, asthma, runny nose, swelling, or hives after taking aspirin (acetylsalicylic acid) or similar painkillers (NSAIDs),
• If you have (or have had two or more episodes of) gastric/duodenal ulcer or gastrointestinal bleeding,
• If you have had gastrointestinal bleeding or perforation related to previous use of NSAIDs,
• If you have severe heart, liver, or kidney failure,
• If you have unexplained blood disorders, or severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake),
• If you are in the last three months of pregnancy,
• If you are an adolescent weighing 40 kg or less, or under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vegedol if you:

• Have or have had asthma or an allergic condition, as this may cause breathlessness,
• Suffer from hay fever, nasal polyps, or chronic obstructive respiratory diseases, as there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema, or urticaria,
• Have kidney, heart, liver, or intestinal problems,
• Have a history of gastrointestinal disease (such as ulcerative colitis or Crohn's disease),
• Have certain inherited blood disorders (e.g., acute intermittent porphyria),
• Have systemic lupus erythematosus (SLE) or mixed connective tissue disease, immune system conditions causing joint pain, skin changes, and organ dysfunction,
• Have chickenpox; it is recommended not to take Vegedol as your condition may worsen,
• Have recently undergone major surgery,
• Have a problem with dehydration,
• Are taking other NSAIDs. Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided,
• Are in the first 6 months of pregnancy.

Other warnings

• Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small 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 must discuss treatment with your doctor or pharmacist before taking Vegedol if: you have heart problems including heart attack, angina (chest pain), or history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including 'mini-stroke' or "TIA", transient ischaemic attack), or if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Rarely, potentially life-threatening skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of NSAIDs. Patients are at higher risk of such reactions during the first month of therapy. Stop taking Vegedol and contact your doctor or pharmacist if you notice a skin rash, mucosal lesions, or any other signs of allergic reactions.
Adverse effects can be minimized by using the lowest effective dose for the shortest possible time. Elderly patients have an increased risk of developing adverse effects.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with blood clotting disorders should be closely monitored. You should ask for advice from your doctor or dentist, or inform them, if Vegedol is administered before surgical procedures.
Regular use of various types of painkillers may cause permanent kidney damage and risk of kidney failure. This risk may be increased during physical exertion associated with loss of salts and dehydration. Regular use of painkillers should therefore be avoided.
Prolonged use of any type of painkiller for headaches may worsen symptoms. If this situation occurs or is suspected, consult your doctor and discontinue treatment. Medication Overuse Headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medications.
During prolonged administration of Vegedol, liver and kidney function tests and blood counts should be monitored regularly.
NSAIDs may mask symptoms of infection and fever.
Children and adolescents
Do not give this medicine to adolescents weighing less than 40 kg or to children under 12 years of age.
In dehydrated adolescents, there is a risk of impaired kidney function.
Other medicines and Vegedol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Medicines that are anticoagulants (i.e., make the blood thinner / prevent clotting, e.g., aspirin (acetylsalicylic acid), warfarin, ticlopidine),
• Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan),
• Aspirin (acetylsalicylic acid) or other NSAIDs, as these may increase the risk of ulcer or gastrointestinal bleeding,
• Digoxin (for heart failure), as the effect of digoxin may be enhanced,
• Glucocorticoids (medicines containing cortisone or similar substances), as this may increase the risk of ulcer or gastrointestinal bleeding,
• Antiplatelet agents, as this may increase the risk of gastrointestinal bleeding,
• Phenytoin (for epilepsy), as the effect of phenytoin may be enhanced,
• Selective serotonin reuptake inhibitors (medicines used for depression), as this may increase the risk of gastrointestinal bleeding,
• Lithium (a medicine for bipolar disorder and depression), as the effect of lithium may be enhanced,
• Probenecid and sulfinpyrazone (medicines for gout), as ibuprofen excretion may be delayed,
• Potassium-sparing diuretics, as this may lead to elevated potassium levels in the blood,
• Methotrexate (a medicine for cancer or rheumatic diseases), as the effect of methotrexate may be enhanced,
• Tacrolimus and cyclosporine (immunosuppressive medicines), as kidney damage may occur,
• Mifepristone (for termination of pregnancy), as the effect of mifepristone may be reduced,
• Zidovudine (a medicine for treatment of HIV/AIDS), as the use of ibuprofen may increase the risk of bleeding into joints or bleeding leading to swelling in HIV-positive haemophiliac patients,
• Sulphonylureas (antidiabetic medicines), due to possible interactions,
• Quinolone antibiotics, as the risk of seizures may be increased,
• Medicines that inhibit the CYP2C9 enzyme, such as antifungal agents voriconazole or fluconazole, as exposure to ibuprofen may be increased,
• An herbal remedy called Ginkgo biloba, as you may bleed more easily if taking ibuprofen and Ginkgo biloba together,
• Do not take Vegedol if you are taking more than 75 mg of aspirin (acetylsalicylic acid) per day. If you are on low-dose aspirin (acetylsalicylic acid) (up to 75 mg per day), talk to your doctor or pharmacist before taking Vegedol.

Some other medicines may also affect or be affected by treatment with Vegedol.
Therefore, you should always consult your doctor or pharmacist before using Vegedol with other
medicines.
Vegedol with alcohol
Some adverse effects, such as those affecting the gastrointestinal system or central nervous system, may be more likely when taking Vegedol with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during the last three months of pregnancy. Avoid using this medicine during the first six months of pregnancy unless otherwise directed by your doctor.
Only small amounts of ibuprofen and its metabolites pass into breast milk. This medicine may be taken during breastfeeding if used at the recommended dose and for the shortest possible duration.
Vegedol belongs to a group of medicines that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

3. How to take Vegedol

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.
This product should only be used short-term. Take the lowest effective dose for the shortest duration necessary to relieve symptoms.

Use in adults and adolescents weighing at least 40 kg (12 years of age and older)

• Take 1 tablet with water, up to three times a day as needed.
• Leave at least six hours between doses.
• Do not take more than three tablets (1200 mg of ibuprofen) in 24 hours.

Children and adolescents
Do not give to children under 12 years of age or to adolescents weighing less than 40 kg.
Vegedol film-coated tablets have a break line on one side.
The break line is intended to facilitate splitting the tablet if you have difficulty swallowing it whole.

Duration of treatment
If in children and adolescents aged between 12 and 18 years this medicine is required for more than 3 days, or if symptoms worsen, a doctor must be consulted.
In adults, consult a doctor if symptoms persist or worsen, or if the medicine is needed for longer than 5 days for pain relief or for more than 3 days for the treatment of migraine or fever.

If you take more Vegedol than you should
If you have taken more Vegedol than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately to obtain advice on the risk and actions to take.
Symptoms may include nausea, stomach ache, diarrhoea, tinnitus, headache, vomiting (possibly with traces of blood), blood in stools, confusion, and uncontrolled eye movements. At high doses, drowsiness, excitement, disorientation, chest pain, palpitations, low blood pressure, kidney failure, liver damage, bluish discoloration of the skin and mucous membranes (cyanosis), loss of consciousness, coma, seizures (especially in children), increased tendency to bleeding, weakness and dizziness, blood in the urine, feeling cold, and breathing difficulties may occur. In asthmatic patients, worsening of asthma may occur.

If you forget to take Vegedol
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects can be minimized by taking the lowest effective dose for the shortest time necessary to relieve symptoms. Elderly patients using this medicine are at increased risk of developing problems related to side effects.
Medicines such as Vegedol may be associated with modest increases in the risk of heart attack ("myocardial infarction") or stroke (see section 2, Other warnings).

Stop taking the medicine and contact a doctor immediately if you experience:

• Uncommon signs of intestinal bleeding (may affect up to 1 in 100 people), such as stomach pain, bright red stools, passage of tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Very rare but serious signs of allergic reaction (may affect up to 1 in 10,000 people), such as swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These may occur even with the first use of the medicine.
• Uncommon but serious signs of allergic reaction (may affect up to 1 in 100 people), such as asthma attacks (possibly with low blood pressure), worsening of asthma, wheezing or shortness of breath of unknown cause.
• Very rare but serious skin reactions (may affect up to 1 in 10,000 people), such as rashes affecting the entire body, skin exfoliation, blisters or peeling of the skin (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis).
• A serious skin reaction known as DRESS syndrome (frequency cannot be estimated from available data). Symptoms of DRESS include rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• Inflammation of the pancreas, characterized by severe pain in the upper abdomen, often with nausea and vomiting, occurring very rarely (may affect up to 1 in 10,000 people).
• Problems with blood cell production (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds and skin bleeding), occurring very rarely (may affect up to 1 in 10,000 people).
• Very rare signs of aseptic meningitis (may affect up to 1 in 10,000 people) (inflammation of the lining of the brain with symptoms such as neck stiffness, headache, nausea, feeling unwell, fever or confusion). Patients with autoimmune diseases (SLE, mixed connective tissue disease) are more likely to be affected.

Tell your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):

• Gastrointestinal disorders, such as heartburn (pyrosis), abdominal pain, feeling unwell, bloating, flatulence, diarrhoea, constipation and minor gastric and/or intestinal bleeding which may exceptionally lead to anaemia.

Uncommon (may affect up to 1 in 100 people):

• Gastric or intestinal ulcers, sometimes with bleeding and perforation
• Inflammation of the oral mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease
• Disorders of the central nervous system such as headache, dizziness, insomnia, agitation, irritability or fatigue
• Visual disturbances
• Allergic reactions, such as skin rashes and itching
• Various types of skin rashes.

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

• Ringing in the ears (tinnitus)
• Kidney damage (papillary necrosis) and elevated levels of uric acid in the blood.

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

• Inflammation of the oesophagus, intestinal stenosis
• Possible severe skin infections and complications in soft tissues in case of chickenpox
• Fluid retention in body tissues, especially in patients with hypertension or kidney problems, swelling and foamy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) with possible acute kidney failure
• Psychotic reactions, depression
• With the use of certain painkillers (NSAIDs), worsening of infectious inflammation (e.g., necrotizing fasciitis) has been reported. If signs of infection appear or worsen during ibuprofen use, you should seek medical advice immediately. It remains to be determined whether anti-infective/antibiotic therapy is indicated.
• Hypertension, inflammation of blood vessels, palpitations, heart failure, heart attack
• Liver dysfunction, liver damage (especially with long-term use), liver failure, acute inflammation of the liver (hepatitis)
• Hair loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vegedol

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.
Store below 30 °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 Vegedol contains
The active substance is ibuprofen lysine. Each film-coated tablet contains 684 mg of ibuprofen lysine (equivalent to 400 mg of ibuprofen).

• Other components are: Tablet core: silicified microcrystalline cellulose, copovidone, sodium starch glycolate, magnesium stearate. Film coating (Opadry II White): hypromellose, titanium dioxide (E171), polydextrose, talc, maltodextrin, medium-chain triglycerides.

Description of the appearance of Vegedol and package contents
Vegedol is in the form of oblong, biconvex, film-coated tablets, white to cream in colour, with a score line on one side. Each tablet measures approximately 20 mm x 8 mm.
The score line is intended solely to facilitate breaking the tablet for easier swallowing and does not allow for division into equal doses.
The film-coated tablets are packaged in a blister with a white PVC/PVDC/Al foil, or alternatively, a white reinforced PVC/PVDC/Al foil with a child-resistant PET layer.
Vegedol is available in blister packs containing 10, 12, 20, or 24 tablets.

Marketing Authorization Holder
Pietrasanta Pharma S.p.A.
Via di Caprino, 7
55012 Capannori (LU)
Italy

Manufacturer
ALKALOID-INT d.o.o.
Šlandrova ulica 4
Ljubljana-Črnuče, 1231, Slovenia
email: [email protected]

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Vegedol
Bulgaria: BlokMAX Rapid 400 mg film-coated tablets
Croatia: BlokMAX Rapid 400 mg filmom obložene tablete
Poland: Vegedol
United Kingdom: Ibuprofen Lysine 684 mg film-coated tablets
Czech Republic: Dolirief
Slovak Republic: Dolirief 400 mg, filmom obalené tablety
Romania: Paduden Expres 400 mg comprimate filmate
Slovenia: Dolirief 400 mg filmsko obložene tablete
Hungary: Dolowill Rapid Forte 684 mg filmtabletta