Package leaflet: Information for the patient

SAKITOL 400 mg film-coated tablets

Ibuprofen
Generic medicine
Please read all of this leaflet carefully before you take 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, please consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What SAKITOL is and what it is used for

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

2. What you should know before taking SAKITOL

Do not take SAKITOL

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have previously experienced allergic reactions such as asthma, excessive nasal discharge, itchy skin rashes, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other painkillers or anti-inflammatory drugs (NSAIDs)
if you have previously had stomach or small intestine (duodenum) ulcers or bleeding related to prior use of painkillers or anti-inflammatory medicines (NSAIDs)
if you currently suffer from stomach or small intestine (duodenum) ulcers or bleeding, or if you have had two or more episodes of such conditions
if you have severe liver, kidney, or heart problems (severe hepatic or renal insufficiency, severe heart failure)
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, diarrhoea, or insufficient fluid intake)
if the person taking the medicine is a child under 12 years of age.

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

if you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers), gastrointestinal inflammation (Crohn’s disease), or other stomach or intestinal disorders
if you have blood clotting disorders
if you suffer from allergies, hay fever, asthma, chronic swelling of the nasal mucosa, sinuses, or adenoids, or chronic obstructive respiratory diseases, as there is an increased risk of airway narrowing causing breathing difficulties (bronchospasm). Allergic reactions may present as breathing difficulties (asthma), facial swelling (Quincke’s oedema), or skin irritation (urticaria). If you notice any signs of allergy, stop treatment immediately and consult your doctor
if you have liver, kidney, heart problems, or high blood pressure, or if your body fluid levels are low (dehydration)
if you have an infection – see section “Infections” below.

Infections
SAKITOL may mask symptoms of infections such as fever and pain. Therefore, SAKITOL could delay appropriate treatment of the infection, potentially increasing 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.
Anti-inflammatory/painkillers such as ibuprofen may be associated with a modest 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 SAKITOL if you have:

any unusual abdominal symptoms, especially if they occur at the beginning of treatment. The risk of bleeding or ulceration of the gastrointestinal tract is higher in such cases, particularly if you are elderly, taking high doses of this medicine, or taking other medicines (see section “Other medicines and SAKITOL”). If gastrointestinal bleeding or ulceration occurs, treatment must be stopped as these may be life-threatening. Pay particular attention if you have previously had a gastric or intestinal ulcer, especially if it was complicated by perforation or accompanied by bleeding
heart problems including heart attack, angina (chest pain), or a history of heart attack, coronary 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)
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker
swelling in the legs, heart problems (heart failure), or high blood pressure, which may be symptoms of kidney problems. Be cautious if you

are significantly dehydrated. SAKITOL may cause
kidney problems, especially in elderly individuals or those with pre-existing kidney, heart, or liver conditions, or those taking diuretics or ACE inhibitors. Discontinue treatment if kidney problems occur. In adolescents, these problems may occur more easily if they have low fluid levels (dehydration).
This medicine may cause :

brain problems (aseptic meningitis) in rare cases. This may occur particularly in people with conditions such as systemic lupus erythematosus or related connective tissue diseases
permanent kidney damage, with risk of kidney failure. This may occur if you regularly take this medicine

Skin reactions
Severe skin reactions have been reported in association with SAKITOL treatment. Stop taking SAKITOL and consult your doctor immediately if you develop a rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.
SAKITOL may mask symptoms or signs of infection (fever, pain, swelling) and temporarily prolong bleeding time.
Children
This medicine must not be used in children under 12 years of age.
Elderly
If you are elderly, you may be more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which can be fatal.
Other medicines and SAKITOL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
The side effects of SAKITOL may be increased if taken together with certain medicines. SAKITOL may also affect or be affected by other medicines. For example:
Inform your doctor or pharmacist if you are taking any of the following medicines:

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

Some other medicines may also 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 should drink an adequate amount of fluids and have periodic kidney checks.
SAKITOL and alcohol
Avoid drinking alcohol, as it may increase the side effects of SAKITOL, particularly those affecting the stomach, intestines, or brain.
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
Do not take SAKITOL during the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart 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 SAKITOL during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or when trying to conceive, the lowest effective dose for the shortest possible time should be used. From week 20 of pregnancy, SAKITOL may cause kidney problems in the fetus if taken for more than a few days, reducing the amount of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Avoid taking SAKITOL as it passes into breast milk in very small amounts. It is generally not necessary to stop breastfeeding during short-term treatment. However, if prolonged treatment is prescribed, your doctor should consider the possibility of early weaning.
Fertility
SAKITOL may reduce the likelihood of becoming pregnant. Inform your doctor if you are planning a pregnancy or have fertility problems.
Driving and using machines
SAKITOL may affect your ability to drive or operate machinery. If you experience effects such as fatigue, drowsiness, dizziness (reported as common) or vision disturbances (reported as uncommon), which may be worsened by alcohol consumption during SAKITOL treatment, avoid driving and using machinery.

3. How to take SAKITOL

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.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (for example, 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 of age
The recommended dose is 1 tablet 2–3 times daily. Do not exceed 3 tablets per day.
Take the tablets with food.
The risk of adverse effects is minimized if you use the lowest possible dose for the shortest possible treatment duration.

Elderly patients and patients with liver or kidney problems
Your doctor will determine the appropriate dose in these cases. It is recommended to use the lowest possible dose for the shortest possible duration. Do not use SAKITOL if you have 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 accidentally ingested this medicine, always contact a doctor or the nearest hospital for advice on the risk and guidance on necessary actions.
Symptoms may include nausea, stomach ache, 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, dizziness, blood in the urine, feeling cold, and breathing problems may occur.
Overdose symptoms generally appear within 4–6 hours.
Rarely, rhythmic and uncontrolled eye movements (nystagmus), increased blood acidity (metabolic acidosis), lowered body temperature (hypothermia), kidney problems, increased tendency to bleeding in the stomach and intestines, coma, reduced breathing (apnea), diarrhoea, and decreased activity of the central nervous system and respiration have also been reported.
Disorientation, excited state, fainting, low blood pressure, decreased or increased heart rate (bradycardia or tachycardia) have been reported. In cases of significant overdose, kidney failure and liver damage are possible.
In case of ingestion or intake of an excessive dose of this medicine, consult a 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects are more likely with higher doses and longer duration of treatment.
Stop treatment with SAKITOL and contact your doctor immediately if you experience any of the following side effects:
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 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 becoming sensitive to light
hypersensitivity reactions such as skin rashes (rash, urticaria, exanthema), itching, asthma attacks (sometimes accompanied by low blood pressure), severe skin irritation associated with bleeding (purpura)
drowsiness, insomnia, and anxiety
inflammation of the stomach lining (gastritis)
kidney problems, kidney inflammation, and kidney failure
excessive nasal discharge (rhinitis)
breathing difficulties (bronchospasm, apnea, dyspnea), swelling of the face, tongue, or throat (larynx), which may cause severe breathing difficulties (angioedema)
ringing or buzzing in the ears, hearing disturbances, vertigo
liver problems (jaundice), liver inflammation (hepatitis), altered liver function
paresthesia

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

depression, confusion, hallucinations
systemic lupus erythematosus
reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis)
reduced platelet levels (thrombocytopenia)
reduced levels of red blood cells (hemolytic anemia)
reduced levels of all blood components (aplastic anemia)
nerve disorders affecting the eyes (optic neuritis, toxic optic neuropathy), vision 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 potentially life-threatening shock (anaphylaxis)
swelling due to fluid accumulation (edema, acute pulmonary edema)
severe skin rash with blisters on the skin, particularly on legs, arms, hands, and feet, which may 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))
uncomfortable awareness of heartbeat (palpitations), heart failure, heart attack, or high blood pressure, myocardial infarction
disorders in red blood cell formation (with symptoms such as: fever, sore throat, mouth ulcers, influenza-like symptoms, severe fatigue, nosebleeds, and skin bleeding)
inflammation of the pancreas (pancreatitis)
liver failure

Not known (frequency cannot be determined from available data):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects 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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information

What SAKITOL contains
SAKITOL 400 mg Film-coated tablets

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

Description of the appearance of SAKITOL and contents of the pack
Pack of 6 or 12 tablets of 400 mg.
Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi, 7 - 20144 Milan, Italy
Manufacturer
Laboratorios Alter S.A., C/ Mateo Inurria, 30 – 28036 Madrid, Spain