PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFENE DOC Generici 600 mg effervescent granules

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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IBUPROFENE DOC Generici IS AND WHAT IT IS USED FOR

Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) derived from propionic acid.
IBUPROFENE DOC Generici is indicated in the following conditions:

As an anti-rheumatic
In the treatment of rheumatoid arthritis (including juvenile idiopathic arthritis), osteoarthritis, ankylosing spondylitis, and seronegative arthropathies.
For the treatment of other non-articular rheumatic conditions, IBUPROFENE DOC Generici is indicated in periarticular disorders such as "frozen shoulder" (capsulitis), bursitis, tendinitis, and low back pain. It may also be used in cases of soft tissue injuries such as sprains and strains.

As an analgesic
IBUPROFENE DOC Generici granules are also indicated as an analgesic for mild to moderate pain, such as dysmenorrhea, toothache, headache, migraine, and postoperative pain.

As an antipyretic
For fever due to various causes.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IBUPROFENE DOC Generici

Do not take IBUPROFENE DOC Generici:

If you are allergic (hypersensitive) to ibuprofen or to any other excipient of IBUPROFENE DOC Generici.
If you have a history of asthma, rhinitis, urticaria, angioedema, or bronchospasm associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
If you have a history of gastrointestinal bleeding with perforation related to previous treatment with NSAIDs.
If you currently have a peptic ulcer or gastrointestinal bleeding, or a history of recurrent peptic ulcer or gastrointestinal bleeding.
If you suffer from severe heart failure.
If you have severe renal impairment, in the case of high doses of ibuprofen (> 1600 mg per day).
If you have blood coagulation disorders.
If you are pregnant or breastfeeding.

Warnings and precautions
Take special care with IBUPROFENE DOC Generici:

If you have a history of gastrointestinal disease.
If severe or unusual abdominal symptoms occur (especially gastrointestinal bleeding), stop treatment immediately and inform your doctor.
If you are elderly.
Avoid administering IBUPROFENE DOC Generici concurrently with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
If you have asthma or a history of bronchial asthma, consult your doctor before starting treatment with IBUPROFENE DOC Generici.
If you suffer from renal, hepatic, or cardiac insufficiency, consult your doctor before starting therapy with IBUPROFENE DOC Generici.
If you suffer from heart failure and/or hypertension, ibuprofen should be administered with caution. Inform your doctor if you notice swelling or fluid retention.
Like all NSAIDs, ibuprofen may mask the signs of infection.
If you suffer from systemic lupus erythematosus or any other autoimmune disorder, ibuprofen should be used with caution.
Inform your doctor immediately if you experience loss of appetite, nausea, vomiting, or jaundice during treatment with IBUPROFENE DOC Generici.
If you develop skin or mucosal reactions, stop treatment and contact your doctor.
In the case of dysmenorrhea, inform your doctor if you notice any other unusual symptoms.
If you experience visual disturbances during ibuprofen therapy, stop treatment and consult your doctor immediately.
Ibuprofen may reduce fertility and is therefore not recommended for women attempting to conceive.

Anti-inflammatory/pain-relief medicines such as ibuprofen may be associated with a small increased 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 IBUPROFENE DOC Generici if you have:

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

Children and adolescents
The use of ibuprofen is not recommended in children under 6 months of age.
Other medicines and IBUPROFENE DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
IBUPROFENE DOC Generici may affect or be affected by other medicines. For example:

medicines with anticoagulant effects (i.e., substances that thin the blood and 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)
diuretics
lithium
methotrexate
cyclosporine.

Other medicines may also affect or be affected by treatment with IBUPROFENE DOC Generici. Therefore, always consult your doctor or pharmacist before using IBUPROFENE DOC Generici with other medicines.
IBUPROFENE DOC Generici with food and drinks
Taking ibuprofen with food does not significantly alter its absorption.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you become pregnant while taking IBUPROFENE DOC Generici, inform your doctor.
Epidemiological studies indicate an increased risk of miscarriage, cardiac malformations, and gastroschisis with the use of prostaglandin synthesis inhibitors during early pregnancy.
During the first and second trimesters of pregnancy, IBUPROFENE DOC Generici should not be administered unless strictly necessary.
IBUPROFENE DOC Generici is contraindicated during the third trimester of pregnancy.
IBUPROFENE DOC Generici is not recommended during breastfeeding.
Driving and using machines
In general, single doses or short-term therapy with IBUPROFENE DOC Generici do not interfere with the ability to drive or operate machinery. However, due to the possibility of adverse effects such as dizziness and confusion following ibuprofen administration, the ability to drive or operate machinery may be impaired.
IBUPROFENE DOC Generici contains lactose and sodium
IBUPROFENE DOC Generici contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 162.5 mg of sodium (the main component of table salt) per sachet. This corresponds to 8.1% of the maximum daily sodium intake recommended in an adult's diet.
The maximum daily recommended dose of this medicine corresponds to 487.5 mg of sodium (main component of table salt). This equals 24.4% of the maximum daily sodium intake recommended in an adult's diet. Talk to your doctor or pharmacist if you need to take 3 sachets per day of this medicine for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. HOW TO TAKE IBUPROFENE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
IBUPROFENE DOC Generici is for oral use. It should preferably be taken after a meal.
Pour the entire contents of one sachet into a glass of water, stir, and drink immediately.

Adults and children over 12 years of age
The recommended daily dose is 1200 mg – 1800 mg of ibuprofen, divided into 2 or 3 doses (one sachet of 600 mg two or three times daily), at eight-hour intervals. In some patients, doses between 600 mg and 1200 mg daily may be sufficient.
When used as an antipyretic, the recommended maximum daily dose is 1200 mg, divided into 2 doses (one 600 mg sachet twice daily).
Treatment of juvenile idiopathic arthritis may require higher doses, which in no case should exceed a daily dose of 40 mg/kg of ibuprofen.
The interval between doses depends on the progression of symptoms, but must never be less than 4 hours.

In the elderly
Dose adjustment is not usually necessary in elderly patients, except in cases of severe renal or hepatic impairment.

Renal impairment
Caution must be exercised when administering an NSAID to patients with renal impairment.
In patients with mild to moderate renal impairment, the initial dose should be reduced. IBUPROFENE DOC Generici must not be taken by patients with severe renal impairment.

If you feel that IBUPROFENE DOC Generici is too strong or too weak, consult your doctor or pharmacist.

If you take more IBUPROFENE DOC Generici than you should
If you have taken more IBUPROFENE DOC Generici than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and what actions to take.
Overdose, even at very high doses, is generally well tolerated when no other medicines are taken concomitantly.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), central nervous system disturbances such as headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties may occur. Hypotension, respiratory depression, and cyanosis may subsequently develop.
In case of overdose, standard measures for poisoning should be taken, such as gastric lavage and activated charcoal (if ibuprofen was ingested within the last 30 to 60 minutes), and, if necessary, electrolyte replacement. There is no specific antidote for ibuprofen.
In case of accidental ingestion or overdose, contact your doctor or pharmacist immediately, stating the name of the medicine and the amount ingested.

If you forget to take IBUPROFENE DOC Generici
Do not take a double dose to make up for a missed dose. Follow these instructions:
If more than 4 hours remain before the next dose, take the missed dose as soon as possible and continue treatment as recommended by your doctor. If less than 4 hours remain before the next dose, skip the missed dose and wait for the next scheduled dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Gastrointestinal disorders: the most commonly observed adverse events are gastrointestinal in nature. Life-threatening peptic ulcers, gastrointestinal perforation, or gastrointestinal bleeding may occur, particularly in the elderly. Nausea, dyspepsia, vomiting with or without blood, flatulence, abdominal pain, diarrhea, constipation, melena (dark stools due to blood), ulcerative stomatitis, and exacerbation of colitis or Crohn's disease have been reported during treatment with this medicine. Gastritis has been observed less frequently.
Hepatobiliary disorders: mild, transient increases in transaminases (ALT, AST), alkaline phosphatase, and γ-GT. Rare, sometimes fatal cases of acute cytolytic hepatitis or severe cholestatic hepatitis have been reported.
Nervous system disorders: dizziness, headache, and nervousness. Depression, insomnia, confusion, mood changes, somnolence, aseptic meningitis with fever, and coma have also been reported. Rare cases of tingling sensations (paresthesia), hallucinations, and idiopathic intracranial hypertension have been reported.
Skin and subcutaneous tissue disorders: redness with spots, better known as eruptions (maculopapular cutaneous erythema), and pruritus. Vesiculobullous eruptions, urticaria, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, hair loss, and acne have been reported. Rare cases of toxic epidermal necrolysis (Lyell's syndrome) and light sensitivity (photosensitivity) have been reported. A serious 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 cells).
Ear and labyrinth disorders: ringing in the ears (tinnitus) and reduced hearing ability.
Eye disorders: amblyopia (blurred vision, scotomata, and/or changes in color vision). Rare cases of conjunctivitis, diplopia, optic neuritis, and cataract have been reported.
Blood and lymphatic system disorders: coagulation disorders, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreased hemoglobin levels. Rare cases of epistaxis and menorrhagia have been reported.
Endocrine disorders: decreased appetite. Rare cases of gynecomastia, hypoglycemia, and acidosis have been reported.
Cardiac and vascular disorders: swelling (edema) and fluid retention have been reported. Congestive heart failure (in patients with marginal cardiac function), hypertension, and palpitations may occur. Rare cases of arrhythmia (bradycardia or sinus tachycardia) have been reported. Medicines such as IBUPROFENE DOC Generici may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
Respiratory, thoracic and mediastinal disorders: asthma, eosinophilic pneumonia, and bronchospasm.
Renal and urinary disorders: renal failure (acute or chronic), decreased creatinine clearance, azotemia, polyuria, dysuria, and hematuria. Rare cases of renal papillary necrosis, acute tubulointerstitial nephritis, and nephrotic syndrome have been reported.
Other: anaphylaxis, serum sickness, angioneurotic edema, Henoch-Schönlein purpura. Cases of ulcerative stomatitis, esophagitis, pancreatitis, rhinitis, and fever have been reported. Hyponatremia.

If any of the adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IBUPROFENE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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 no longer used. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What IBUPROFENE DOC Generici contains

The active substance is ibuprofen. Each effervescent granule sachet contains 600 mg of ibuprofen.
The other components (excipients) are: anhydrous citric acid, sodium lauryl sulfate, povidone, sodium saccharin, sodium carbonate, sodium bicarbonate, anhydrous colloidal silica, lactose, orange flavour.

Description of the appearance of IBUPROFENE DOC Generici and contents of the pack
IBUPROFENE DOC Generici is presented as effervescent granule sachets, each containing 600 mg of ibuprofen. It is available in packs of 10, 20 and 30 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.

Manufacturer

Kern Pharma, S.L. - C/ Venus, 72 - Polígono Industrial Colón II - E-08228 Terrassa (Barcelona) - Spain.
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (Frosinone) - Italy.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Ibuprofeno Pharmakern 600 mg granulado efervescente
Italy: IBUPROFENE DOC Generici 600 mg granulato effervescente