IBUPROFENE 600 mg Эффервесцентные Гранулы

Содержание инструкции

1. IBUPROFENE DOC Generici 600 mg effervescent granules
   1. WHAT IBUPROFENE DOC Generici IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING IBUPROFENE DOC Generici
   3. HOW TO TAKE IBUPROFENE DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE IBUPROFENE DOC Generici
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

IBUPROFENE DOC Generici 600 mg effervescent granules

Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

As an antirheumatic
In the treatment of rheumatoid arthritis (including juvenile idiopathic arthritis), osteoarthritis, ankylosing spondylitis and seronegative arthropathies.
In the treatment of other extra-articular forms of rheumatism, IBUPROFENE DOC Generici is indicated
in periarticular pathologies such as "frozen shoulder" (capsulitis), bursitis, tendinitis and lower back pain; it can also be used in case 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 post-
operative pain.

As an antipyretic
In 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.
• If you have a history of gastrointestinal bleeding with perforation associated with a previous treatment with NSAIDs.
• If you have an active peptic ulcer/bleeding or a history of peptic ulcer/recurrent bleeding.
• If you suffer from severe heart failure.
• If you have severe kidney failure, 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 and abnormal abdominal symptoms (particularly gastrointestinal bleeding) appear, immediately stop treatment and inform your doctor.
• If you are elderly.
• Avoid administering IBUPROFENE DOC Generici in conjunction with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
• If you are asthmatic or have a history of bronchial asthma, consult your doctor before starting treatment with IBUPROFENE DOC Generici.
• If you suffer from kidney, liver or heart failure, consult your doctor before starting therapy with IBUPROFENE DOC Generici.
• If you suffer from heart failure and/or hypertension, ibuprofen must be administered with caution. Inform your doctor if you notice the appearance of swelling or fluid retention.
• Like all NSAIDs, ibuprofen can mask the signs of infection.
• If you suffer from systemic lupus erythematosus or any other autoimmune disease, ibuprofen must be used with caution.
• Immediately inform your doctor if you experience loss of appetite, nausea, vomiting or jaundice during treatment with IBUPROFENE DOC Generici.
• If you experience reactions on the skin or mucous membranes, stop treatment and contact your doctor.
• In the case of dysmenorrhea, inform your doctor if you notice the appearance of any other unusual event.
• If you experience changes in vision during therapy with ibuprofen, stop treatment and consult your doctor immediately.
• Ibuprofen may reduce fertility and, therefore, is not recommended in women who are planning a pregnancy.

Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a modest
increased risk of heart attack or stroke, especially if administered in high doses. Do not
exceed the recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking IBUPROFENE DOC Generici
if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to the

legs or feet due to narrowing or blockage of the 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
Tell 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 can affect or be affected by other medicines. For example:

• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, 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.

Even some other medicines can 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 drink
Taking ibuprofen with food does not alter its absorption significantly.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are taking IBUPROFENE DOC Generici and become pregnant, inform your doctor.
Epidemiological studies indicate an increased risk of abortion, cardiac malformations and
gastroschisis with the use of a prostaglandin synthesis inhibitor in the early stages of
pregnancy.
During the first and second trimester of pregnancy, IBUPROFENE DOC Generici should not be
administered unless strictly necessary.
IBUPROFENE DOC Generici is contraindicated in 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 does not
interfere with the ability to drive vehicles and operate machinery. However, due to the possibility
that some undesirable effects such as dizziness and confusion may occur following
ibuprofen administration, the ability to drive vehicles and operate machinery may be
altered.

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 him before taking this medicine.
This medicine contains 162.5 mg of sodium (the main component of table salt) per
sachet. This is equivalent to 8.1% of the maximum recommended daily intake with the diet
of an adult.
The maximum recommended daily dose of this medicine corresponds to 487.5 mg of sodium
(the main component of table salt). This is equivalent to 24.4% of the maximum daily
intake of sodium recommended with the diet of an adult. Talk to your doctor or pharmacist if you
need 3 sachets a 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 following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
IBUPROFENE DOC Generici is for oral use. It should be taken preferably after a meal.
Pour the entire contents of one sachet into a glass of water, mix 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 2 or 3 times a day) at intervals of eight hours. In some patients, 600 mg to 1200 mg
per day may be sufficient.
When used as an antipyretic, the maximum recommended daily dose is 1200 mg, divided into
2 doses (one 600 mg sachet 2 times a day).
The 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 evolution of the symptoms, but should never be less than 4
hours.

In the Elderly
It is not necessary to modify the dose in elderly patients, except in cases where there is
severe renal or hepatic impairment.

Renal Insufficiency
Precautions should be taken when administering an NSAID to patients with renal
insufficiency.
In patients with mild to moderate impairment of renal function, the initial dose should be reduced.
IBUPROFENE DOC Generici should not be taken by patients with severe renal insufficiency.
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 you should or if your child has taken this
medicine by mistake, always contact a doctor or the nearest hospital in order to receive an
opinion on the risk and advice on the actions to be taken.
Overdosage, even at very high doses, is generally well tolerated when no other medicines are
administered concurrently.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of
blood), central nervous system disorders associated with headache, ringing in the ears,
confusion and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in
children), weakness and dizziness, blood in the urine, feeling of coldness in the body and breathing problems have been reported.
Consequently, hypotension, respiratory depression and cyanosis may occur.
In case of overdose, normal measures common to other poisonings should be adopted
such as gastric lavage and activated charcoal (if ibuprofen was taken within the last 30 or 60
minutes) and, if necessary, electrolyte repletion. There is no specific antidote for
ibuprofen.
In case of accidental ingestion or overdose, contact your doctor or
pharmacist immediately, informing them of 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 the missed dose. Follow these instructions:
if more than 4 hours remain until the next dose, take the forgotten dose as soon as possible and
continue treatment as recommended by your doctor. If less than 4 hours remain until the next
dose, do not take the forgotten dose and wait for the next dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

• Gastrointestinal disorders:The most commonly observed adverse events are of a gastrointestinal nature. Peptic ulcers or perforation or gastrointestinal bleeding dangerous to life can occur, particularly in the elderly. Nausea, dyspepsia, vomiting with or without blood, flatulence, abdominal pain, diarrhea, constipation, melena (dark stools due to the presence of blood), ulcerative stomatitis, exacerbation of colitis or Crohn's disease have been reported with the administration of this medicine. Less commonly, cases of gastritis have been observed.
• Hepatobiliary disorders:Transient mild increase in transaminases (ALT, AST), alkaline phosphatase and γ-GT. Rare and 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 alteration, drowsiness, aseptic meningitis with fever and coma. Rare cases of tingling (paresthesia), hallucinations and idiopathic intracranial hypertension have been reported.
• Skin and subcutaneous tissue disorders:Reddening with spots, better known as rashes (maculopapular skin rash) and itching. Vesicular-bullous rashes, urticaria, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, hair loss and acne. Rare cases of toxic epidermal necrolysis (Lyell's syndrome) and sensitivity to

light (photosensitivity) have been reported. It is possible that a serious skin reaction known as
DRESS syndrome may occur. The symptoms of DRESS include: rash, fever, swollen
lymph nodes and increased eosinophils (a type of white blood cells).

• Ear and labyrinth disorders:Tinnitus (ringing in the ears) and reduced hearing ability.
• Eye disorders:Amblyopia (blurred vision, scotomas and/or alterations in color vision). Rare cases of conjunctivitis, diplopia, optic neuritis and cataract.
• Hematopoietic system disorders:Disorders of coagulation, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia and reduced hemoglobin. Rare cases of epistaxis and menorrhagia.
• Endocrine disorders:Reduced appetite. Rare cases of gynecomastia, hypoglycemia and acidosis.
• Valvular and cardiac disorders:Edema (swelling) and fluid retention have been reported. Congestive heart failure (in patients with marginal cardiac function), hypertension and palpitations. Rare cases of arrhythmia (bradycardia or sinus tachycardia). 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 tubulo-interstitial nephritis and nephrotic syndrome.
• Other:Anaphylaxis, serum sickness, angioedema, Henoch-Schönlein purpura. Cases of ulcerative stomatitis, esophagitis, pancreatitis, rhinitis and fever have been reported. Hyponatremia.

If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at
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 IBUPROFENE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What IBUPROFENE DOC Generici contains

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

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

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – 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 authorised in the Member States of the European Economic Area with the
following denominations:
Portugal: Ibuprofeno Pharmakern 600 mg effervescent granules
Italy: IBUPROFENE DOC Generici 600 mg effervescent granules