ZENTIFENACT 200 mg Фильм-Coated Таблетки

Содержание инструкции

1. Zentifenact 200 mg film-coated tablets, 400 mg film-coated tablets
   1. What is Zentifenact and what is it used for
   2. What you need to know before taking Zentifenact
   3. How to take Zentifenact
   4. Possible side effects
   5. How to store Zentifenact
   6. Contents of the pack and other information

Zentifenact 200 mg film-coated tablets, 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.

• 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 3 days in children and adolescents or, in the case of adults, after 4 days for pain or 3 days for migraine or fever.

Contents of this leaflet:

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

1. What is Zentifenact and what is it used for

Zentifenact contains ibuprofen, a medicine that belongs to a class of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs) which work by reducing pain and fever.
Zentifenact is used for the short-term symptomatic treatment of mild to moderate pain such as
headache, including migraine, toothache, menstrual pain and/or fever.
Zentifenact is indicated in adults and adolescents weighing 40 kg or more (12 years and
over).

2. What you need to know before taking Zentifenact

Do not take Zentifenact

• If you are allergic to ibuprofen or 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 suffer from an ulcer or bleeding in the stomach or duodenum (small intestine) or if you have had two or more of these episodes in the past.
• If you have ever had gastrointestinal bleeding or perforation related to a previous therapy with NSAIDs.
• If you suffer from unexplained disorders of blood formation.
• If you suffer from severe heart, liver or kidney failure.
• If you suffer from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).
• If you have active bleeding (including in the brain).
• If you are a woman in the last 3 months of pregnancy.

Do not use Zentifenact in adolescents weighing less than 40 kg or in children under 12 years of age.

Warnings and precautions
You should discuss your treatment with your doctor or pharmacist before taking
Zentifenact:

• If you have problems with the kidneys, liver or heart.
• If you suffer from bronchial asthma.
• If you suffer from allergies, hay fever, nasal polyps or chronic obstructive respiratory disorders due to an increased risk of allergic reactions.
• If you have inherited a disease of the hemoglobin pigment of the blood (porphyria).
• If you have systemic lupus erythematosus (an autoimmune disorder) or a mixed connective tissue disease (risk of aseptic meningitis).
• If you have an inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• If you have disorders in the formation of blood cells.
• If you have problems with the normal blood clotting mechanism.
• If you have recently undergone major surgery.
• If you are in the first six months of pregnancy.
• If you are breastfeeding.
• In case of infection, see the "Infections" section below.

Infections
Zentifenact can mask the symptoms of infections such as fever and pain. It is therefore possible that
Zentifenact 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, consult your doctor immediately.

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

Effects on the heart and brain
Anti-inflammatory/pain relieving medicines like ibuprofen may be associated with a slight
increased risk of heart attack or stroke, especially if used at high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss the treatment with your doctor or pharmacist before taking Zentifenact if:

• you have heart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries) or a type of stroke (including 'mini-stroke' or transient ischemic attack “TIA”).
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Ulcers, perforation and bleeding in the stomach or intestine
If you have previously had an ulcer in the stomach or intestine, especially if this was
complicated by perforation or accompanied by bleeding, you should pay attention to
any unusual symptoms in the abdomen and report them immediately to your doctor, especially if these
symptoms occur at the beginning of treatment. This is because in this case the risk of
bleeding or ulceration of the digestive tract is greater, especially in elderly patients. In case of
bleeding or ulceration of the digestive tract, treatment should be discontinued.
Bleeding, ulceration or perforation of the stomach or intestine can occur without
any warning signs even in patients who have never had these problems before.
It may also be fatal.
The risk of ulcers, perforation or bleeding in the stomach or intestine generally increases
with higher doses of ibuprofen. The risk also increases if some other medicines are taken
simultaneously with ibuprofen (see Other medicines and Zentifenact below).
Side effects can be minimized by using the lowest effective dose for the
shortest duration necessary to control the symptoms.

Skin reactions
Serious skin reactions have been reported in association with treatment with Zentifenact. Stop
taking Zentifenact and consult your doctor immediately if you experience rash,
mucous membrane lesions, blisters or other signs of allergy, as these may be the first signs of a
very serious skin reaction. See section 4.
During chickenpox, it is advisable to avoid the use of this medicine.

Effects on the kidneys
Ibuprofen can cause problems with kidney function even in patients who have not
had kidney problems before. This can cause swelling of the legs and may also lead to
heart failure or hypertension in predisposed individuals.
Ibuprofen can cause kidney damage especially in patients who already have kidney, heart
or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping
ibuprofen, however, generally leads to recovery.

Other precautions
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.
Immediately stop treatment at the first signs of a hypersensitivity reaction after
taking Zentifenact and inform your doctor immediately.
Ibuprofen can temporarily inhibit platelet function (platelet aggregation) and
prolong bleeding time. Patients with blood coagulation disorders must
therefore be carefully monitored.
Prolonged use of any type of pain reliever for headaches can worsen them. If this occurs or is
suspected, stop taking ibuprofen and consult your doctor. A diagnosis of medication-overuse
headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or
because of) regular use of headache medications.
Zentifenact may reduce the chances of becoming pregnant. You should inform your doctor if you are
planning a pregnancy or if you have difficulty becoming pregnant.

Children and adolescents
Do not administer this medicine to adolescents weighing less than 40 kg or to children under 12 years of age.
There is a risk of kidney failure in dehydrated adolescents.

Other medicines and Zentifenact
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Zentifenact can influence or be influenced by some medicines. For example:

• other NSAIDs including COX-2 inhibitors, as this may increase the risk of gastrointestinal ulcers and bleeding
• medicines that are anticoagulants (i.e. thin the blood/prevent clotting e.g. acetylsalicylic acid, warfarin, ticlopidine)
• methotrexate (used for the treatment of cancer and autoimmune diseases)
• digoxin (for the treatment of various heart diseases), as the effect of digoxin may be enhanced
• phenytoin (used in the prevention of seizures), as the effect of phenytoin may be enhanced
• lithium (used to treat depression and mania), as the effect of lithium may be enhanced
• diuretics (medicines to urinate), as the effect of diuretics may be weakened
• potassium-sparing diuretics, as they can cause hyperkalemia
• medicines that lower blood pressure (ACE inhibitors, e.g. captopril, beta-blockers like atenolol, angiotensin II antagonists like losartan)
• cholestyramine (used to treat high cholesterol)
• aminoglycosides (medicines against some types of bacteria), as NSAIDs can reduce the excretion of aminoglycosides
• SSRIs (medicines against depression) such as paroxetine, sertraline, citalopram as they can increase the risk of gastrointestinal bleeding
• cyclosporine, tacrolimus (for immunosuppression after organ transplantation), as kidney damage may occur
• zidovudine or ritonavir (used for the treatment of patients with HIV)
• mifepristone, as NSAIDs can reduce the effect of mifepristone
• probenecid or sulfinpyrazone (for the treatment of gout), as the excretion of ibuprofen may be delayed
• quinolone antibiotics, as the risk of convulsions (seizures) may be increased
• sulfonylureas (for the treatment of type 2 diabetes), as blood sugar levels may be altered
• glucocorticoids (used against inflammation), as they can increase the risk of gastrointestinal ulcers or bleeding
• bisphosphonates (used in osteoporosis, Paget's disease and to reduce high calcium levels in the blood)
• oxpentifylline (pentoxifylline) used in the treatment of circulatory diseases of the arteries of the legs or arms)
• baclofen (a muscle relaxant), due to the high toxicity of baclofen
• the herbal medicine Ginkgo biloba (there is a possibility that you bleed more easily if you take it together with ibuprofen)
• voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), as the effect of ibuprofen may increase. A reduction in the dose of ibuprofen should be considered, especially when using high doses of ibuprofen with voriconazole or fluconazole.

Some other medicines may also influence or be influenced by treatment with Zentifenact.
Therefore, always consult your doctor or pharmacist before using Zentifenact with other medicines.

Zentifenact with alcohol
Avoid alcohol as it can increase the side effects of Zentifenact, especially those
affecting the stomach, intestines or central nervous system.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and breastfeeding
During the first and second trimester of pregnancy, your doctor will prescribe this medicine only
if it is clearly necessary due to the potential risk of miscarriage or birth defects. In
this case, the dose should be kept as low as possible and the duration of treatment as
short as possible.
NEVER take Zentifenact in the last 3 months of pregnancy as it can cause serious heart, lung and
kidney problems in the newborn or even fatal consequences for the baby. If used at the end
of pregnancy, it can cause bleeding tendencies in both mother and baby and weaken
the strength of uterine contractions delaying the onset of labor.
If you have taken this medicine during pregnancy, tell your doctor/midwife immediately
so that appropriate monitoring can be considered.
Ibuprofen passes into breast milk in very small amounts and it is usually not necessary
to stop breastfeeding during short-term treatments. However, if a
longer treatment is prescribed, early weaning should be considered.
Fertility
The product belongs to a group of medicines (NSAIDs) that can impair fertility in
women. The effect is reversible after discontinuation of treatment with the medicine.

Driving and using machines
As side effects on the central nervous system such as fatigue and dizziness may occur with the use of ibuprofen at higher doses, reaction ability and the ability to actively participate in road traffic and operate machinery may be impaired in isolated cases.
This is even more true in combination with alcohol.

Zentifenact contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
“sodium-free”.

3. How to take Zentifenact

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The lowest effective dose should be used for the shortest duration 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).
For short-term use only.
The dose of ibuprofen depends on the patient's age and body weight. The recommended dose is:

Pain and fever from mild to moderate

Adults and adolescents with a body weight ≥ 40 kg (12 years and over):

Zentifenact 200 mg
1-2 tablets administered in a single dose or 3-4 times a day at an interval of at least 6 hours
as needed.
The maximum daily dose should not exceed 6 tablets (1,200 mg).

Zentifenact 400 mg
1 tablet administered in a single dose or 3 times a day at an interval of at least 6 hours
as needed. The maximum daily dose should not exceed 3 tablets (1,200 mg).

Migraine

Adults and adolescents weighing 40 kg or more (12 years of age or older):

Zentifenact 200 mg
2 tablets administered in a single dose, if necessary 2 tablets at intervals of at least 6 hours.
The maximum daily dose should not exceed 6 tablets (1,200 mg).

Zentifenact 400 mg
1 tablet administered in a single dose, if necessary 1 tablet at intervals of at least 6 hours.
The maximum daily dose should not exceed 3 tablets (1,200 mg).

Menstrual pain

Adults and adolescents ≥ 40 kg body weight (12 years of age or older):

Zentifenact 200 mg
1-2 tablets 1-3 times a day, at an interval of at least 6 hours, as needed. The maximum
daily dose should not exceed 6 tablets (1,200 mg).

Zentifenact 400 mg
1 tablet 1-3 times a day, at an interval of at least 6 hours, as needed. The maximum
daily dose should not exceed 3 tablets (1,200 mg)
Elderly
If you are elderly, you are more likely to experience side effects, particularly bleeding and perforation of
the digestive tract, which can be fatal. Your doctor will advise you accordingly.
Impaired liver or kidney function
If you have reduced kidney or liver function, always consult your doctor before using Zentifenact.
Your doctor will advise you accordingly.

Use in children and adolescents
Zentifenact should not be used in adolescents weighing less than 40 kg or in children under the age of 12.
Other dosage forms of ibuprofen suitable for this age group should be used.
If you are an adult and feel worse or do not feel better after 4 days for pain or 3 days for
migraine or fever, or if new symptoms appear, consult your doctor or pharmacist.
If a child or adolescent needs this medicine for more than 3 days, or if symptoms
worsen, a doctor should be consulted.

Method of administration
Swallow the tablet with a glass of water, preferably after a meal. If you have a sensitive
stomach, it is recommended to take this medicine with food.

If you take more Zentifenact than you should
If you have taken more Zentifenact than you should, or if children have taken this medicine
accidentally, always contact a doctor or the nearest hospital for an opinion on the risk and
advice on actions to be taken.
Symptoms may include nausea, stomach pain, vomiting (may be streaked with blood) or more
rarely diarrhea. In addition, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion and jerky eye movements and exacerbation
of asthma in asthmatics have been reported. At high doses, drowsiness, excitement, disorientation, chest pain,
palpitations, loss of consciousness, convulsions (especially in children), dizziness, weakness and
dizziness, blood in the urine, low blood pressure, hyperkalemia, metabolic acidosis, increased
prothrombin time/INR, acute renal failure, liver damage, respiratory depression,
cyanosis, feeling of coldness in the body and breathing problems.

If you forget to take Zentifenact
Do not take a double dose to make up for a missed dose.
If you have further 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 will experience them.
With regard to the following side effects, it should be considered that they largely depend on the dose
and vary from patient to patient.
The most commonly observed side effects are of a gastrointestinal nature. Peptic ulcers, perforation or
gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting,
diarrhea, flatulence, constipation, indigestion, abdominal pain, melena, hematemesis, ulcerative
stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration.
Less frequently, inflammation of the stomach lining (gastritis) has been observed.
Medicines like Zentifenact may be associated with a slight increase in the risk of heart attack (myocardial
infarction) or stroke. Fluid retention (edema), hypertension and heart failure have been reported in
association with NSAIDs.

The following side effects are important and if they occur will require immediate action.
You should stop taking Zentifenact and consult your doctor immediately if you experience the following
symptoms:
Common(may affect up to 1 in 10 people):

• Black tarry stools or vomit stained with blood (ulcer of the digestive tract with bleeding)

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

• Visual disturbances.
• Hypersensitivity reactions such as skin rashes, itching, purpura, exanthema, asthma attacks (sometimes with low blood pressure). Rare(may affect up to 1 in 1,000):
• Loss of vision.

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

• Swelling of the face, tongue or throat (larynx) which can cause great difficulty breathing (angioedema), rapid heartbeat, severe drop in blood pressure or potentially life-threatening shock.
• Sudden filling of the lungs with water resulting in difficulty breathing.
• A sudden allergic reaction with shortness of breath, wheezing and a drop in blood pressure.
• Severe skin rash with blisters on the skin especially on legs, arms, hands and feet which may also affect the face and lips (erythema multiforme, Stevens-Johnson syndrome). This can become even more severe, the blisters enlarge and spread and parts of the skin may detach (Lyell's syndrome). There may also be serious infections with destruction (necrosis) of the skin, subcutaneous tissue and muscles.

Not known(frequency cannot be estimated from the available data):

• A widespread red, scaly skin rash with bumps under the skin and blisters located mainly in skin folds, on the trunk and upper extremities accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Zentifenact if these symptoms develop and seek immediate medical attention. See also section 2. Other possible side effects with Zentifenact are:

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

• Digestive disorders such as heartburn, indigestion, feeling unwell, vomiting, flatulence, diarrhea, constipation

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

• Ulcer of the digestive tract with or without perforation.
• Inflammation of the intestine and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease) and complications of diverticula of the large intestine (perforation or fistula).
• Microscopic bleeding from the intestine which can cause anemia.
• Ulcers and inflammation of the mouth (ulcerative stomatitis).
• Headache, drowsiness, dizziness, lightheadedness, fatigue, agitation, insomnia and irritability.
• Inflammation of the stomach lining.
• Rhinorrhea.
• Difficulty breathing (bronchospasm).
• Various skin rashes.

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

• Depression, confusion, hallucinations.
• Lupus erythematosus syndrome.
• Increased blood urea, serum transaminases and alkaline phosphatase.
• Decreased values of hemoglobin and hematocrit, inhibition of platelet aggregation and prolonged bleeding time, decreased serum calcium and increased serum uric acid values.

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

• Unpleasant awareness of heartbeat, heart failure, heart attack or hypertension.
• Disorders of blood cell formation (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). The first signs or symptoms may include fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, nosebleeds and skin bruising.
• Sound or ringing in the ears.
• Inflammation of the esophagus or pancreas.
• Narrowing of the intestine.
• Acute inflammation of the liver, yellowish discoloration of the skin or whites of the eyes, liver dysfunction, liver damage especially with long-term use or liver failure.
• Inflammation of the brain membrane without bacterial infection (aseptic meningitis).
• Damage to kidney tissue.
• Kidney problems including the development of edema, inflammation of the kidneys and kidney failure.
• Hair loss.
• Psychotic reactions.
• Inflammation of blood vessels. Not known(frequency cannot be estimated from the available data):
• Numbness in the hands and feet.
• Anxiety.
• Hearing loss.
• General feeling of discomfort.
• Inflammation of the optic nerve which can cause vision problems.
• The skin becomes sensitive to light.
• 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).

Zentifenact can cause a reduction in the number of white blood cells and its resistance to infections
may be reduced. Consult your doctor immediately if you develop an infection with symptoms such as
fever and severe deterioration of general conditions, or fever with symptoms of local infection such as
sore throat/pharynx/mouth or urinary problems. A blood test will be performed to check for a
possible reduction in white blood cells (agranulocytosis). It is important to inform the doctor about the type
of medicine.
During treatment with ibuprofen, some cases of aseptic meningitis (which manifests with
stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed in patients with
existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue
disease.

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 Zentifenact

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C. Store in the original package to protect the
medicine from humidity.
Do not use this medicine after the expiry date which is reported on the package 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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zentifenact contains
The active ingredient is ibuprofen.
Each tablet contains 200 mg or 400 mg of ibuprofen.
The other ingredients are:
Granules: cellulose, microcrystalline; croscarmellose sodium; hypromellose; stearic acid; colloidal
anhydrous silica; magnesium stearate;
Coating for Zentifenact 200 mg film-coated tablet: hypromellose; macrogol; talc;
titanium dioxide (E171); yellow iron oxide (E172);
Coating for Zentifenact 400 mg film-coated tablet: hypromellose; macrogol; talc;
titanium dioxide (E171).

Description of the appearance of Zentifenact and contents of the pack
Zentifenact 200 mg film-coated tablet: round film-coated tablets of colour from
light yellow to beige with a diameter of 9 mm ± 1.0 mm.
Zentifenact 400 mg film-coated tablet: round film-coated tablets of colour from
white to off-white with a diameter of 12 mm ± 1.0 mm.
Packs:
Zentifenact 200 mg: The film-coated tablets in PVC/Al blisters are packaged in
packs of 12, 20, 24 and 30.
The film-coated tablets in PVC/Glassine blisters are
packaged in packs of 10, 20 and 50.
Zentifenact 400 mg: The film-coated tablets in PVC/Al blisters are packaged in
packs of 10, 12, 15 and 20.
The film-coated tablets in PVC/Glassine blisters are
packaged in packs of 10, 20 and 50.
The secondary packaging is a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano

Manufacturer
S.C. Zentiva S.A.
B-dul Theodor Pallady nr.50, sector 3
Bucurest

• 032266 – Romania Zentiva, k.s. U kabelovny 130, Dolní Měcholupy 102 37 Praha 10 Czech Rep.

This medicinal product is authorised in the member states of the European Economic Area under the
following denominations:
Portugal: Ibuprofeno Billev
Italy: Zentifenact
France: Ibuprofene Zentiva k.s.
Germany: Ibuprofene Billev Pharma East