SAKITOL 400 mg Фильм-Coated Таблетки

Содержание инструкции

1. SAKITOL 400 mg film-coated tablets
   1. What is SAKITOL and what is it used for
   2. What you need to know before taking SAKITOL
   3. How to take SAKITOL
   4. Possible side effects
   5. How to store SAKITOL
   6. Contents of the pack and other information

SAKITOL 400 mg film-coated tablets

Ibuprofen
Generic medicine

Read this leaflet carefully before taking this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is SAKITOL and what is it used for

SAKITOL contains ibuprofen, which belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). These medicines work by reducing pain and swelling caused by inflammation and fever.
SAKITOL is used for the treatment of pain of various origins and nature: headache (migraine, cephalalgia), toothache, neuralgia, muscle and bone pain (muscular and osteoarticular), menstrual pain. SAKITOL is
also indicated as an adjunct in the treatment of symptoms of fever and influenza.
See a doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking SAKITOL

Do not take SAKITOL

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you have suffered from allergic reactions such as asthma, profuse nasal secretion, itchy skin rashes or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid (like aspirin) or other pain relievers or anti-inflammatory medicines (NSAIDs)
• if you have suffered from an ulcer or bleeding of the stomach or small intestine (duodenum) in connection with previous use of pain relievers or anti-inflammatory medicines (NSAIDs)
• if you suffer from an ulcer or bleeding of the stomach or small intestine (duodenum) or if you have suffered from two or more episodes of this type
• if you suffer from severe problems with the liver, kidneys or heart (hepatic or renal insufficiency, severe cardiac insufficiency)
• if you are in the last three months of pregnancy or if you are breastfeeding (see section “Fertility, pregnancy and breastfeeding”)
• if you have significant dehydration (caused by vomiting, diarrhea or insufficient fluid intake)
• if the person who needs to take the medicine is a child under the age of 12 years.

Warnings and precautions
Talk to your doctor or pharmacist before taking SAKITOL.
Take this medicine with cautionin the following situations:

• if you suffer from chronic inflammatory diseases of the intestine such as inflammation of the colon with ulcers (ulcerative colitis), inflammation of the digestive tract (Crohn's disease) or other diseases of the stomach and intestines
• if you suffer from problems related to the normal blood clotting mechanism
• if you suffer from allergies, hay fever, asthma, chronic swelling of the nasal mucosa, sinuses and adenoids or chronic obstructive diseases of the respiratory tract, because there is a greater risk of narrowing of the airways, with difficulty breathing (bronchospasm). Allergic reactions can manifest with difficulty breathing (asthma), swelling of the face (angioedema) and skin irritation (urticaria). At the first signs of allergy, stop treatment and see your doctor
• if you suffer from problems with the liver, kidneys, heart or high blood pressure, if the amount of fluid in the body is low (dehydration).
• if you have an infection - see section «Infections» below.

Infections
Sakitol can mask the symptoms of infections such as fever and pain. It is therefore possible that Sakitol may
delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to
chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or
worsen, see your doctor immediately.
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest increase in the
risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended
dose or duration of treatment.

You must discuss the therapy with your doctor or pharmacist before taking SAKITOL if you have:

• if you experience any unusual abdominal symptom, especially if these symptoms occur at the beginning of treatment. In fact, the risk of bleedingor ulcerationof the digestive tract is greater in this case, especially if you are elderly, if you take high doses of this medicine and if you take other medicines (see section “Other medicines and SAKITOL”). If bleeding or ulceration of the digestive tract occurs, treatment should be stopped because it can be fatal. You should be particularly careful if you have had a gastric or intestinal ulcer, especially if it has been complicated by perforation or accompanied by bleeding
• have heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in 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)
• have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker
• if you experience swelling in the legs, heart problems (heart failure) or high blood pressure, which may be symptoms of kidney problems. Be careful if you

are in a condition of considerable dehydration. SAKITOL can in fact cause
kidney problems especially in elderly people or who already have kidney problems, heart, liver or who take diuretics or ACE inhibitors. Stop treatment if
kidney problems occur. In adolescents, these problems may occur more
easily if they have a low level of fluids (dehydration).
This medicine can cause:

• problems with the brain (aseptic meningitis) in rare cases. This can occur especially in people who suffer from diseases such as systemic lupus erythematosus and connective tissue diseases
• permanent damage to the kidneys, with a risk of kidney failure. This can happen if you regularly take this medicine

Skin reactions
Severe skin reactions have been reported in association with treatment with SAKITOL. Stop
taking SAKITOL and consult your doctor immediately if you experience rash, mucous membrane lesions, blisters or other signs of allergy, as they may be the first signs of a very serious skin reaction. See section 4.
SAKITOL can mask the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong
bleeding time.

Children
This medicine should not be used in children under the age of 12 years.

Elderly
If you are elderly you may be more prone to side effects, especially bleeding and
perforation of the digestive tract, which can be fatal.

Other medicines and SAKITOL
Tell your doctor or pharmacist if you are taking or have recently taken or may take any
other medicines, including those without a prescription.
The side effects of SAKITOL may be increased if it is taken at the same time as
certain medicines. SAKITOL can also affect or be affected by other medicines. For
example:
Tell your doctor or pharmacist if you are taking any of the following medicines:

• COX-2 inhibitors and other NSAIDs (e.g.) acetylsalicylic acid, medicines for inflammation
• 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)
• platelet aggregation inhibitors(used against the formation of clots)
• methotrexate(used in the treatment of cancer and autoimmune diseases).
• phenytoin(used in the prevention of epileptic seizures)
• lithium(used to treat depression and mania)
• diuretics, including potassium-sparing diuretics
• medicines that lower blood pressure(ACE inhibitors, such as. captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• cholestyramine(used in the treatment of high cholesterol)
• aminoglycosides(medicines against some types of bacteria)
• SSRIs(medicines against depression)
• moclobemide(RIMA - a medicine used for the treatment of depressive illness or social phobia)
• cyclosporine, tacrolimus(used for immunosuppression after organ transplantation)
• zidovudine and ritonavir(used for the treatment of HIV-positive patients)
• mifepristone(used for medical abortion)
• probenecid or sulfinpyrazone(used for the treatment of gout)
• quinolone antibiotics
• sulfonylureas(used for the treatment of type 2 diabetes)
• corticosteroids(used against inflammation)
• bisphosphonates(used in osteoporosis, Paget's disease and to reduce high levels of calcium in the blood)
• oxpentifylline[(pentoxifylline) used in the treatment of circulatory disease of the arteries of the legs or arms]
• baclofen(a muscle relaxant)
• CYP2C9 inhibitors(such as voriconazole and fluconazole) used in the treatment of fungal infections.

Even some other medicines can affect or be affected by treatment with SAKITOL.
Therefore always consult your doctor or pharmacist before using SAKITOL with other medicines.
If you need to take other medicines during treatment with SAKITOL, you must drink an adequate amount
of fluids and undergo periodic kidney checks.

SAKITOL with alcohol
Avoid drinking alcohol as it may increase the side effects of SAKITOL, especially those
affecting the stomach, intestines or brain.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take SAKITOL in the last three months of pregnancy as it may harm the fetus or cause
problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may affect your and your baby's tendency to
bleeding and delay or prolong labor more than expected. You should not
take SAKITOL in the first 6 months of pregnancy, unless absolutely necessary and
under medical advice. If treatment is needed during this period or during attempts to
conceive, the minimum dose should be used for the shortest possible time. From the 20th week of
pregnancy, SAKITOL may cause kidney problems in the fetus, if taken for more than a few days, reducing
thus levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a
blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few
days, your doctor may recommend additional monitoring.

Breastfeeding
Avoid taking SAKITOL as it appears in breast milk in very small amounts and is
generally not necessary to stop breastfeeding during short-term treatments. However, if
prolonged treatment is prescribed, the doctor must assess the possibility of early weaning.

Fertility
SAKITOL may decrease the likelihood of becoming pregnant. Tell your doctor if you
are planning a pregnancy or have fertility problems.

Driving and using machines
SAKITOL may affect your ability to drive vehicles or operate machinery. If you experience
effects such as fatigue, drowsiness, dizziness (reported as common) and visual disturbances (reported
as uncommon), which may increase if you drink alcohol during treatment with SAKITOL, avoid
driving and using machinery.

3. How to take SAKITOL

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Undesirable effects can be minimised by using the lowest effective dose for the shortest period of time necessary to control the symptoms.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms.
If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The dose of SAKITOL depends on the patient's age and body weight.

Adults and adolescents from 12 years
The recommended dose is 1 tablet 2-3 times a day. Do not exceed the dose of 3 tablets per day.
Take the tablets with a full stomach.
The risk of undesirable effects is minimised if you use the lowest possible dose for a shorter treatment period.

Elderly and patients with liver or kidney problems
Your doctor will indicate the necessary dose in these cases. It is recommended to take the lowest possible dose for the shortest possible treatment period. Do not use SAKITOL if you suffer from severe liver problems
(see section “Do not take SAKITOL”).

If you take more SAKITOL than you should
If you have taken more SAKITOL than you should or if your child has taken this medicine by mistake,
always contact a doctor or the nearest hospital to obtain advice on the risk and recommendations on actions to be taken.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and uncontrolled eye movements. At high doses, marked drowsiness (lethargy), chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, a feeling of coldness in the body and breathing problems have been reported.
Symptoms of overdose generally appear within 4-6 hours.
Rarely, uncontrolled and rhythmic eye movements (nystagmus), increased blood acidity (metabolic acidosis), decreased body temperature (hypothermia), kidney problems, increased tendency to bleeding in the stomach and intestines, coma, reduced breathing (apnea), diarrhea and decreased activity of the central nervous system and breathing have also been reported.
Disorientation, a state of excitement, fainting, low blood pressure, decreased or increased heart rate (bradycardia or tachycardia) have been reported. In cases of significant overdose, renal failure and liver damage are possible.
If you ingest/take an excessive dose of this medicine, consult your doctor immediately or go to the nearest hospital.

If you forget to take SAKITOL
If you forget to take a dose, do not take a double dose to make up for the missed dose.
If you have any doubts 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 everybody gets them.
Side effects are more likely with higher doses and longer duration of treatment.
Stop treatment with SAKITOL and see your doctor immediately if you experience the following
side effects:
It is possible to develop a severe skin reaction known as DRESS syndrome. The symptoms
of DRESS include: skin rash, fever, swollen lymph nodes and increased
eosinophils (a type of white blood cells).

Common(may affect up to 1 in 10 people):

• dizziness, fatigue, malaise

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

• vision problems
• skin becomes sensitive to light
• reactions due to hypersensitivity, such as skin rashes (rash, urticaria, exanthem), itching, asthma attacks (sometimes accompanied by low blood pressure), severe skin irritation associated with bleeding (purpura)
• sleepiness, insomnia and anxiety
• inflammation of the stomach lining (gastritis)
• kidney problems, kidney inflammation and kidney failure
• abundant nasal secretion (rhinitis)
• difficulty breathing (bronchospasm, apnea, dyspnea), swelling of the face, tongue or throat (larynx), which can cause severe breathing difficulty (angioedema)
• ringing or buzzing in the ears, hearing disorders, vertigo
• liver problems (jaundice), liver inflammation (hepatitis), altered liver function
• paresthesia

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

• depression, confused state, hallucinations
• systemic lupus erythematosus
• reduction in the number of white blood cells (leukopenia, neutropenia, agranulocytosis)
• reduction in platelet levels (thrombocytopenia)
• reduction in red blood cell levels (hemolytic anemia)
• reduction in the levels of all blood components (aplastic anemia)
• nerve disorders of the eyes (optic neuritis, toxic optic neuropathy), visual disturbances
• swelling due to fluid accumulation
• infection of the membranes surrounding the brain (aseptic meningitis).

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

• severe hypersensitivity reaction with swelling of the face, tongue and throat, shortness of breath, wheezing, rapid heartbeat, severe drop in blood pressure or life-threatening shock (anaphylaxis)
• swelling due to fluid accumulation (edema, acute pulmonary edema)
• severe skin rash with blisters on the skin, especially on legs, arms, hands and feet, which can spread to the face and lips (exfoliative dermatitis and bullous dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis (a severe skin infection with skin destruction) and erythema multiforme (severe skin irritation))
• unpleasant awareness of heartbeat (palpitations), heart failure, heart attack or high blood pressure, myocardial infarction
• disorders of red blood cell formation (with symptoms such as: fever, sore throat, ulcers on the surface of the mouth, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding)
• inflammation of the pancreas (pancreatitis)
• liver failure

Not known(frequency cannot be estimated from available data)

• heartburn, abdominal pain, indigestion
• digestive tract disorders, such as diarrhea, nausea, vomiting, flatulence, constipation
• black stools or presence of blood in the stool (melena) or vomit (hematemesis, peptic ulcer with bleeding)
• peptic ulcer with or without perforation, even fatal (peptic ulcer, gastrointestinal bleeding), especially in elderly people
• burning sensation in the stomach (gastritis, heartburn), inflammation of the oral mucosa associated with lesion formation (ulcerative stomatitis)
• intestinal inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease)
• allergic reaction, even severe (non-specific allergic reaction, anaphylaxis)
• Medicines like SAKITOL may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. In association with NSAIDs, fluid retention (edema), high blood pressure and heart problems (heart failure) have been reported
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using SAKITOL if you develop these symptoms and contact your doctor immediately. See also paragraph 2.

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 SAKITOL

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 pack after “Exp.” The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 SAKITOL contains
SAKITOL 400 mg film-coated tablets

• The active ingredient is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: microcrystalline cellulose, corn starch, sodium starch glycolate (type A), magnesium stearate, talc, anhydrous colloidal silica, povidone, hypromellose, titanium dioxide, triacetin.

Description of the appearance of SAKITOL and contents of the pack
Pack of 6 or 12 tablets of 400 mg.

Marketing Authorisation Holder
Laboratori Alter S.r.l. Via Egadi, 7 - 20144 Milan

Manufacturer
Laboratorios Alter S.A., C/ Mateo Inurria, 30 – 28036 Madrid, Spain