CIBALGINA 200 mg Coated Tablet

Зміст інструкції

1. Cibalgina Due Fast 200 mg gastro-resistant tablets
   1. What is Cibalgina Due Fast and what is it used for
   2. What you need to know before taking Cibalgina Due Fast
   3. How to take Cibalgina Due Fast
   4. Possible side effects
   5. How to store Cibalgina Due Fast
   6. Contents of the pack and other information

Cibalgina Due Fast 200 mg gastro-resistant tablets

ibuprofen

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 would like 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 2-3 days of treatment.

Contents of this leaflet:

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

1. What is Cibalgina Due Fast and what is it used for

Cibalgina Due Fast contains the active ingredient ibuprofen, which belongs to the class of medicines known
as non-steroidal anti-inflammatory drugs (NSAIDs). Cibalgina Due Fast works by reducing pain,
inflammation and fever.
Cibalgina Due Fast is indicated for the treatment of pain of various origins and nature, including:

• headache
• toothache
• neuralgia
• bone and joint pain
• muscle pain
• menstrual pain The medicine is also indicated as adjunctive therapy in the treatment of symptoms of fever and influenza. See your doctor if you do not feel better or if you feel worse after 2-3 days of treatment.

2. What you need to know before taking Cibalgina Due Fast

Do not take Cibalgina Due Fast

• if you are allergic to ibuprofen, or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or other medicines used to reduce pain (analgesics), fever (antipyretics) such as non-steroidal anti-inflammatory drugs (NSAIDs), especially when the allergy is associated with swelling of the nasal mucosa (nasal polyps), asthma and swelling generally to eyes, lips, tongue, throat, and presents with an asthmatic reaction (bronchospasm), urticaria or severe cold (acute rhinitis) (see section “Warnings and precautions”);
• if you have had a severe ulcer in the stomach or the first part of the intestine
• if you have a current ulcer
• if you have had bleeding or an ulcer that occurred repeatedly (two or more distinct episodes of demonstrated ulceration or bleeding)
• if you have had bleeding (hemorrhage) of the stomach and/or intestine or perforation after previous treatments with other medicines
• if you have bleeding in the brain (cerebrovascular hemorrhage) or other types of bleeding
• if you have a severe form of liver or kidney failure
• if you have a severe form of heart failure
• if you have an alteration in the production of blood cells, the cause of which is unknown
• if you are in the last 3 months of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• if the patient is a child under the age of 12 years.

Warnings and precautions
Consult your doctor or pharmacist before taking Cibalgina Due Fast.
Anti-inflammatory/pain-relieving drugs 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 the duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking Cibalgina Due Fast if you 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);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Pay particular attention and ask your doctor or pharmacist:

• if you are a woman and are planning a pregnancy
• if you are a woman and have fertility problems or are undergoing fertility investigations, because you should stop treatment with Cibalgina Due Fast
• if the patient is an adolescent with dehydration, because in this case the medicine may cause kidney problems
• if you have asthma
• if you have seasonal allergic rhinitis (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
• in case of difficulty breathing (bronchospasm)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have problems with the liver, kidneys, or heart except in the case where you have a severe form of liver, kidney or heart failure because in these latter cases you should not take Cibalgina Due Fast (see section 2 “Do not take Cibalgina Due Fast”). If you have doubts, consult your doctor.
• if you have hepatic porphyria
• if you have or have had ulcerative colitis or Crohn's disease because these conditions may worsen
• if you are using medicines that increase urine production (diuretics) or other medicines that can affect kidney function
• if you have a reduced volume of body fluids (e.g. before or after major surgery)
• if you are going to undergo or have undergone major surgery
• if you have problems with the stomach or intestines, except in the case where you have one or more conditions for which you should not take Cibalgina Due Fast (see section “Do not take Cibalgina Due Fast”)
• if you are taking medicines that can increase the risk of bleeding, ulcerations and perforations such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids administered orally, by injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Cibalgina Due Fast”)
• if you have an autoimmune disease e.g. Lupus erythematosus or connective tissue diseases
• if you have an infection - see section «Infections» below.

In these cases, the doctor will keep you under strict control and periodically re-evaluate the need for treatment
with Cibalgina Due Fast. In addition, the doctor may have you undergo periodic tests (such as
monitoring kidney function) to assess your condition during treatment with Cibalgina
Due Fast.

Skin reactions
Serious skin reactions have been reported in association with treatment with Cibalgina Due Fast.
Stop taking Cibalgina Due Fast and consult your doctor immediately if you develop
skin 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.

Infections
Cibalgina Due Fast can mask the symptoms of infections such as fever and pain. Therefore, it is possible that
Cibalgina Due Fast may delay adequate treatment of the infection, which could increase the
risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections
related to varicella. If you take this medicine while you have an infection and the symptoms
of the infection persist or worsen, consult your doctor immediately.

Stop treatment and inform your doctor if during treatment with Cibalgina Due Fast
develops:

• gastrointestinal bleeding or ulceration
• sudden or severe skin reactions, because very rarely serious skin reactions have been reported that can also be fatal
• mucosal lesions or any other sign of allergic reaction
• fluid retention and swelling from fluid accumulation (edema)
• signs and symptoms of liver problems or if liver function parameters are not normal (visible from blood tests)
• unusual symptoms in the stomach and intestines, especially at the beginning of treatment with Cibalgina Due Fast
• fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, profound fatigue, unexplained bruising and bleeding because you may have a reduction in white blood cells (agranulocytosis)
• stiffness in the neck, headache, nausea, vomiting, fever, disorientation because you may suffer from aseptic meningitis. Patients with autoimmune diseases (Systemic Lupus Erythematosus, connective tissue disease) appear to be more predisposed to developing aseptic meningitis
• symptoms of an infection (e.g. headache, fever) or if you notice a worsening of an infection as Cibalgina Due Fast can mask the signs and symptoms of the infection.

In these cases, the doctor will assess whether to continue or discontinue treatment with Cibalgina Due Fast.

Other important information:

• During treatment with NSAIDs, including ibuprofen, gastrointestinal bleeding, ulcerations or perforations may occur, which can also be fatal, and can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. You should take the lowest effective dose of ibuprofen to reduce the risk of gastrointestinal toxicity and your doctor may prescribe you medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• Adverse effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Cibalgina Due Fast”).
• Avoid the use of ibuprofen during treatment with other NSAIDs administered orally, by injection and rectally, including cyclooxygenase-2 selective inhibitors, as it increases the possibility that you will have adverse effects.
• Cases of aseptic meningitis have been reported during treatment with ibuprofen, although they are more likely in patients with Lupus erythematosus or connective tissue disease.

Children
Cibalgina Due Fast is contraindicated in children under the age of 12 years.

Elderly patients
Elderly patients are more likely to experience adverse reactions, especially
bleeding in the stomach or intestines and perforation which are generally more serious and can be
fatal.
If you are elderly, you should take the lowest dose of Cibalgina Due Fast.
As a precaution, your doctor may have your kidney function checked and prescribe you
medicines that act by protecting the gastrointestinal mucosa such as misoprostol or proton
pump inhibitors.
Inform your doctor of any unusual symptoms in the stomach and intestines, especially at the beginning of
treatment with this medicine.

Other medicines and Cibalgina Due Fast
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pay particular attention and inform your doctor if you need to take Cibalgina Due Fast and are already taking
one or more of the medicines listed below, the doctor will keep you under control and have you undergo tests.
Cibalgina Due Fast can affect or be affected by other medicines. For example:

• acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, corticosteroids)
• lithium (medicine for mood disorders)
• digoxin (medicine for the heart)
• 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, including potassium-sparing diuretics, especially if you have kidney problems
• antidepressants such as selective serotonin reuptake inhibitors (medicines for depression)
• sulfonamides (medicine for diabetes), in this case the doctor may advise you to monitor your blood glucose level
• methotrexate (medicine for tumors)
• cyclosporine and tacrolimus (immunosuppressants used to modify the body's immune response)
• medicines to fight bacterial infections of the quinolone class
• phenytoin (medicine for epilepsy)
• cholestyramine and colestipol (medicines to lower cholesterol)
• sulfinpyrazone, fluconazole and voriconazole
• zidovudine (medicine for the treatment of AIDS)
• aminoglycosides (a class of antibiotics).

Even some other medicines can influence or be influenced by the treatment with Cibalgina Due
Fast. Therefore, always consult your doctor or pharmacist before using Cibalgina Due Fast with other
medicines.

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

• Do not take Cibalgina Due Fast in the last 3 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 labor longer than expected. You should not take Cibalgina Due Fast in the first 6 months of pregnancy unless absolutely necessary and under the advice of a doctor. If you need treatment 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, Cibalgina Due Fast may cause kidney problems in the fetus, if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may advise additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts, however, no adverse effects on the baby are known to date.
However, do not use Cibalgina Due Fast during breastfeeding unless you have consulted your doctor.
Fertility
Anti-inflammatory drugs, including Cibalgina Due fast, may cause a decrease in fertility in women,
which returns to normal after discontinuation of treatment. Women who are planning a pregnancy
should be careful.

Driving and using machines
Cibalgina Due Fast can cause dizziness, fatigue and visual disturbances that can affect your
ability to drive vehicles and use machinery.
If you experience these symptoms, avoid driving a vehicle or using machinery.

Cibalgina Due Fast contains sodium
Cibalgina Due Fast contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Cibalgina Due Fast

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.

Use in adults, elderly patients and adolescents over 12 years

• The recommended dose is 1-2 gastro-resistant tablets 2-3 times a day.
• Take the tablets during or after meals, especially if you have stomach problems. Cibalgina Due Fast tablets dissolve quickly in the mouth without leaving any unpleasant taste, by pressing them with your tongue against the palate. If you wish, you can drink water or another liquid after taking them. Be careful not to exceed the recommended dose and in any case do not exceed the maximum dose of 6 tablets (1200 mg) per day. Use this medicine only for short periods of time. If you are elderly, you should use the lowest possible dose of those reported above. 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 the symptoms (e.g. fever and pain) persist or worsen (see paragraph 2). Consult your doctor:
• if after 2-3 consecutive days of treatment with Cibalgina Due Fast you do not notice any appreciable results
• if the patient is an adolescent who has taken Cibalgina Due Fast for 3 days and it is necessary to continue the treatment
• if you notice a worsening of the symptoms of the disease

Consult your doctor if you do not feel better or if you feel worse after 2-3 days of treatment.

If you take more Cibalgina Due Fast than you should
If you have taken more Cibalgina Due Fast than you should or if your child has taken this medicine by mistake, always contact a doctor or the nearest hospital to get an opinion on the risk and advice on the actions to be taken.
If you take an excessive dosage (overdose) of ibuprofen, you may more commonly experience the following symptoms: nausea, stomach pain, vomiting (possibly with traces of blood), abdominal pain, a state of deep sleep with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, confusion, involuntary eye movements (nystagmus), ringing in the ears (tinnitus), involuntary body movements (convulsions, especially in children), feeling faint and loss of consciousness.
Rarely, it may present: increased acids in the blood (metabolic acidosis), reduced blood clotting time, lowering of body temperature (hypothermia), effects on the kidney, bleeding of the stomach and intestines, profound loss of consciousness (coma), temporary interruption of breathing (apnea), bluish discoloration of the skin and mucous membranes (cyanosis), diarrhea, reduction of the activity of the nervous system (depression of the Central Nervous System) and respiratory activity (depression of the respiratory system).
Furthermore, you may also experience: disorientation, a state of excitement, fainting, lowering of blood pressure (hypotension), decrease or increase in heartbeats (bradycardia or tachycardia), chest pain, palpitations, weakness, blood in the urine, feeling of coldness in the body and breathing problems or worsening of a pre-existing respiratory problem (asthma).
If you take excessive doses of ibuprofen, you may experience serious damage to the kidneys and liver.
The symptoms of an overdose may appear within 4-6 hours of taking ibuprofen.
If you have any doubts about the use of Cibalgina Due Fast, consult your doctor or pharmacist.

If you forget to take Cibalgina Due Fast
Do not take a double dose to make up for a 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 everybody gets them.
Side effects can be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control the symptoms.
Side effects depend on the dose and can vary from patient to patient.
If any of these effects occur during treatment with Cibalgina Due Fast, it is advisable to
stop using the medicine and consult your doctor.
The most commonly observed adverse events affect the stomach and/or intestine. Gastric or duodenal ulcers (peptic ulcer), perforation or
bleeding from the stomach and/or intestine can occur, which can also be fatal, particularly in the elderly.
In particular, the risk of bleeding from the stomach and/or intestine is dose-dependent and duration-dependent.
In addition to the side effects listed below, dark stools with blood (melena) and vomiting blood (hematemesis) due to bleeding from the
stomach, esophagus and duodenum have been reported after administration of Cibalgina Due Fast.
Drug reaction with eosinophilia and systemic symptoms:
It is possible to experience a severe skin reaction known as DRESS (Drug reaction with eosinophilia and systemic symptoms). The symptoms of DRESS include: skin rash, fever, swollen
lymph nodes and increased eosinophils (a type of white blood cells).
Medicines like Cibalgina Due Fast may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke (see section “Warnings and precautions”).

Common side effects (may affect up to 1 in 10 people)

• difficulty digesting (dyspepsia)
• abdominal pain
• nausea
• vomiting
• drowsiness

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reactions including skin rash, hives, itching and asthma attacks
• headache
• dizziness
• insomnia
• agitation
• irritability
• fatigue
• skin rash

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

• ringing and buzzing in the ears (tinnitus)
• hearing impairment
• stomach or duodenal ulcer (peptic ulcer)
• perforation or bleeding from the stomach and/or intestine
• inflammation of the oral mucosa with ulceration (ulcerative stomatitis)
• inflammation of the stomach (gastritis)
• worsening of inflammation of the colon (colitis)
• worsening of a chronic inflammatory bowel disease (Crohn's disease)
• kidney failure
• kidney tissue damage (papillary necrosis) (particularly with long-term therapy)
• increased concentration of uric acid in the blood

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

• worsening of inflammation associated with infection (e.g. development of necrotizing fasciitis)
• decreased number of platelets in the blood (thrombocytopenia)
• anemia
• decreased number of white blood cells in the blood (leukopenia, agranulocytosis)
• decreased number of all cells in the blood (pancytopenia)
• severe allergic reaction (anaphylactic reaction)
• swelling due to fluid accumulation (angioedema)
• aseptic meningitis (infection of the meninges, membranes of the brain)
• alterations in tests to assess liver function
• liver problems, e.g. inflammation of the liver (hepatitis) and yellowing of the skin, mucous membranes and eyes (jaundice)
• liver damage, particularly with long-term therapy
• skin and mucous membrane reactions, also severe (bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Side effects with unknown frequency (frequency cannot be estimated from available data)

• mental alterations (psychotic reactions)
• depression
• visual disturbances
• irregular heartbeat (palpitations)
• swelling (edema)
• heart failure
• heart attack
• high blood pressure (hypertension)
• inflammation of the esophagus (esophagitis)
• inflammation of the pancreas (pancreatitis)
• obstructions of the small intestine following the formation of a thin wall
• gas emission (flatulence)
• diarrhea
• constipation
• formation of edema particularly in patients with high blood pressure or kidney problems (renal insufficiency, nephrotic syndrome, interstitial nephritis) which may be accompanied by acute kidney failure
• widespread, red and scaly skin rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Cibalgina Due Fast if you develop these symptoms and contact your doctor immediately. See also paragraph 2.
• the skin becomes sensitive to light.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 Cibalgina Due Fast

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package and on the blister after “Exp.”. 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cibalgina Due Fast contains

• The active ingredient is ibuprofen. Each tablet contains 200 mg of ibuprofen.
• The other ingredients are ethylcellulose, cellulose acetate phthalate, corn starch, microcrystalline cellulose, saccharin, sodium croscarmellose, strawberry aroma, fumaric acid, silicon dioxide, magnesium stearate, dibasic calcium phosphate anhydrous.

Description of the appearance of Cibalgina Due Fast and contents of the pack
Each pack of Cibalgina Due Fast contains 12 or 24 gastro-resistant tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (Netherlands)

Manufacturer
Adare Pharmaceuticals S.r.l.
via Martin Luther King 13
Pessano con Bornago (MI)
(batch number identified by the letter D)
Doppel Farmaceutici S.r.l.
via Volturno 48
Rozzano (MI)
(batch number identified by the letter M)