IBUPROFENE ZEN 400MG SOFT CAPSULES, 10 CAPSULES IN PVC/PVDC/AL BLISTER

Name
IBUPROFENE ZENTIVA 200 mg soft capsules
IBUPROFENE ZENTIVA 400 mg soft capsules
Equivalent medicine


What is it and what is it used for?
The name of the medicine is IBUPROFENE ZENTIVA 200 mg or IBUPROFENE ZENTIVA 400 mg.

The active ingredient (which makes the medicine effective) is ibuprofen. It belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve pain by altering the body's response to pain, swelling, and high temperature.

IBUPROFENE ZENTIVA in the form of soft capsules with liquid contents dissolves easily in the body, the active ingredient is absorbed more rapidly into the bloodstream and therefore quickly reaches the site of pain.

IBUPROFENE ZENTIVA is used to relieve headache, migraine, toothache, backache, menstrual cramps, muscle aches, fever, and cold and flu symptoms.

Additionally, on prescription , IBUPROFENE ZENTIVA is also used to relieve pain felt along the nerves (neuralgia), swelling and joint pain (rheumatic pain), and non-severe inflammation of the joints (non-severe arthritis).

IBUPROFENE ZENTIVA 400 mg is recommended for adults and adolescents over 12 years of age (body weight of at least 40 kg).

Given the quantity of active ingredient contained in one capsule, IBUPROFENE ZENTIVA 200 mg is recommended for adults and children over 6 years of age (body weight of at least 20 kg).


What you need to know before taking the medicine
Do not take IBUPROFENE ZENTIVA:
- if you are allergic to ibuprofen (the active substance of the product IBUPROFENE ZENTIVA) or to any of the other ingredients of this medicine (listed in section 6);
- if you are hypersensitive to nonsteroidal anti-inflammatory drugs and experience shortness of breath, asthma, runny nose, swelling or hives;
- if you have an active or recurrent ulcer or bleeding in your stomach or duodenum or if you have ever had this problem repeatedly (i.e. at least twice) in the past;
- if you have ever had gastrointestinal bleeding or perforation related to previous NSAID therapy;
- if you suffer from a blood formation disorder or a blood clotting disorder;
- if you suffer from severe heart, liver or kidney failure;
- if you are a woman in the third trimester of pregnancy.


Warnings and precautions
You should discuss your treatment with your doctor or pharmacist before taking IBUPROFENE ZENTIVA if:
- suffer from kidney or liver disease;
- suffers from bronchial asthma;
- suffer from allergic rhinitis, nasal polyps or chronic obstructive respiratory disorders, due to the increased risk of allergic reactions;
- are also taking medications that may increase the risk of gastric toxicity or bleeding (see below);
- suffer from systemic lupus erythematosus (immune system disease) or mixed connective tissue disease (risk of aseptic meningitis);
- suffer from an inflammatory ulcerative disease of the digestive tract such as Crohn's disease or ulcerative colitis;
- have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs and feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA");
- have high blood pressure, diabetes, or high cholesterol, or have a family history of heart disease or stroke, or are a smoker;
- have an infection – see “Infections” section below;
- if a rash or skin symptoms occur, you should stop taking ibuprofen immediately, consult a doctor promptly, and tell your doctor that you are taking this medicine;
- develops symptoms or signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which include rash, fever, swollen lymph nodes, and an increase in a type of white blood cell (eosinophilia).

Infections
Ibuprofen can hide signs of infection, such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, consult a doctor immediately.

Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment. Risks are more likely with high doses or prolonged treatment.

Signs of an allergic reaction to ibuprofen, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking Ibuprofen Zentiva immediately and contact your doctor or emergency services immediately if you notice any of these signs.

Gastrointestinal bleeding, ulceration, or perforation may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration, or perforation is greater with increasing doses, especially in patients with a history of ulcers and in the elderly. Some concomitant medications may increase the risk of gastric toxicity or bleeding (other nonsteroidal anti-inflammatory drugs, corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as aspirin). In patients at increased risk of gastrointestinal toxicity, concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered. Prolonged use of any type of analgesic for headache may worsen the condition. If you suffer from frequent or daily headaches despite (or as a result of) the regular use of headache medications, talk to your doctor before taking another painkiller. Treatment should be discontinued if medication-induced headaches are diagnosed. Skin reactions: Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment with Ibuprofen Zentiva. Stop using Ibuprofen Zentiva and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children and adolescents
There is a risk of renal impairment in dehydrated children and adolescents.


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

STOP taking IBUPROFENE ZENTIVA immediately and consult a doctor if any of the following conditions occur, which may be possible signs of serious adverse events:
• hypersensitivity reaction such as skin rash, mucosal lesions, urticaria;
• sudden appearance of swelling around the eyes;
• feeling of discomfort in the chest with difficulty breathing or swallowing;
• epigastric pain;
• vision disorders;
• bleeding from the digestive tract (vomiting blood or black stools);
• non-raised, target-shaped or circular reddish patches on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• a widespread, red, scaly rash with subcutaneous bumps and blisters accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Side effects that may occur are listed below by frequency:
Uncommon (may affect up to 1 in 100 people):
• heachache;
• abdominal pain, malaise (nausea), indigestion;
• various skin rashes, hypersensitivity reactions (such as hives and itching).

Rare (may affect up to 1 in 1,000 people):
• malaise (vomiting), diarrhea, constipation, flatulence.

Very rare (may affect up to 1 in 10,000 people):
• problems in the production of blood cells (the first signs are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, tiredness, nose and skin bleeding);
• sterile inflammation of the meninges (particularly in patients with connective tissue diseases or systemic lupus erythematosus);
• inflammation, ulceration or perforation of the mucous membrane of the digestive tract (black stools and vomiting blood), inflammation of the mouth;
• inability of the kidneys to eliminate waste substances (acute renal failure), blood in the urine and fever may be signs of kidney damage (papillary necrosis);
• liver function disorders;
• severe forms of skin reactions, including rashes with redness and blisters, severe hypersensitivity reactions (edema of the face, tongue and larynx, dyspnea, tachycardia, hypotension, severe shock).

Not known (frequency cannot be estimated from the available data):
• hearing disorders;
• heart failure, edema, arterial hypertension;
• worsening of an existing intestinal disease (colitis or Crohn's disease);
• renal failure;
• difficulty breathing (mainly in patients with bronchial asthma), worsening of asthma;
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly in the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using IBUPROFENE ZENTIVA if you develop these symptoms and contact your doctor immediately. See also section 2;
• increased sensitivity of the skin to the sun;
• fixed drug eruption (which manifests itself as redness in round or oval patches and swelling of the skin, possibly with itching);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines containing ibuprofen (or some other NSAIDs), such as IBUPROFENE ZENTIVA, may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of side effects
If you experience any side effects, including any 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.