IBUPROFENE 200 mg Soft Capsules

Зміст інструкції

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

IBUPROFENE ZENTIVA 200 mg soft capsules, 400 mg soft capsules

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

Contents of this leaflet:

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

1. What is IBUPROFENE ZENTIVA and what is it used for

The name of the medicine is IBUPROFENE ZENTIVA 200 mg or IBUPROFENE ZENTIVA
400 mg.
The active substance (which makes the medicine effective) is ibuprofen. It belongs to a group of
medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve pain
by modifying the body's response to pain, swelling and high temperature.
IBUPROFENE ZENTIVA in the form of soft capsules with liquid content dissolves easily
in the body, the active substance is absorbed more quickly into the bloodstream and therefore
quickly reaches the site of pain.
IBUPROFENE ZENTIVA is used to relieve headache, migraine, toothache, back pain, menstrual pain, muscle pain, fever and symptoms of the common cold and flu.
In addition, on medical prescription, IBUPROFENE ZENTIVA is also used to relieve pain
that is felt along the nerves (neuralgia), swelling and joint pain (rheumatic pain) and
mild inflammation of the joints (mild arthritis).
IBUPROFENE ZENTIVA 400 mg is recommended for adults and adolescents over 12 years of age
(body weight of at least 40 kg).
Due to the amount of active substance 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).

2. What you need to know before taking IBUPROFENE ZENTIVA

Do not take IBUPROFENE ZENTIVA

• if you are allergic to ibuprofen (the active ingredient of IBUPROFENE ZENTIVA) or to any of the other ingredients of this medicine (listed in section 6);
• if you are hypersensitive to non-steroidal anti-inflammatory drugs and experience shortness of breath, asthma, runny nose, swelling or hives;
• if you have an ulcer or active or recurrent bleeding in the 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 bleeding or perforation of the gastrointestinal tract related to a previous therapy with NSAIDs;
• if you suffer from a disorder of blood formation or a disorder of blood coagulation;
• 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:

• you suffer from a kidney or liver disease;
• you suffer from bronchial asthma;
• you suffer from allergic rhinitis, nasal polyps or chronic obstructive respiratory disorders, due to the increased risk of allergic reactions;
• you are also taking medicines that could increase the risk of gastric toxicity or bleeding (see below);
• you suffer from systemic lupus erythematosus (an autoimmune disease) or mixed connective tissue disease (the risk of aseptic meningitis);
• you suffer from an inflammatory bowel disease such as Crohn's disease or ulcerative colitis;
• you 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");
• you have high blood pressure, diabetes or high cholesterol or, have a family history of heart disease or stroke, or if you are a smoker.
• you have an infection - see the section “Infections” below.
• a rash or skin symptoms develop, you should immediately stop taking ibuprofen, promptly consult a doctor and inform the doctor that you are taking this medicine.
• you develop 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 cells (eosinophilia).

Infections
Ibuprofen can mask signs of infections such as fever and pain. It is therefore possible that
ibuprofen may delay appropriate treatment of the infection, which may lead to an increased
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.
Anti-inflammatory / pain-relieving medicines 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 the duration of treatment recommended. Any risks are more likely at high
doses or prolonged treatment.
Signs of an allergic reaction to this medicine, including
breathing difficulties, swelling of the face and neck region (angioedema) and chest pain have been reported with ibuprofen.
Immediately stop treatment with Ibuprofene Zentiva and contact your
doctor or emergency medical service immediately if you notice any of these signs.
Bleeding, ulceration or perforation of the gastrointestinal tract can occur at any time
during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of bleeding, ulceration or perforation
gastrointestinal is greater with increasing doses, in patients with a history of ulcer and in the elderly. Some concomitant medicines may increase the risk of gastric toxicity or bleeding (other non-steroidal
anti-inflammatory drugs, corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as acetylsalicylic acid). In patients at
higher risk of gastrointestinal toxicity, the use of protective agents (e.g.
misoprostol or proton pump inhibitors) should be considered. Prolonged use of any type of pain reliever for
headache can worsen the disorder. If you suffer from frequent or daily headaches despite (or
as a result of) regular use of headache medications, consult your doctor before taking
another pain reliever. Treatment should be discontinued if a headache caused by
excessive drug use is diagnosed.
Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrosis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with Ibuprofene Zentiva. Stop using Ibuprofene 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 kidney impairment in dehydrated children and adolescents.

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

• medicines that are anticoagulants (i.e. make the blood fluid / prevent clotting such as aspirin / acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers such as atenolol-based medicines, angiotensin II receptor antagonists, such as losartan).

Also tell your doctor if you are taking:

• other NSAIDs (anti-inflammatory and analgesic) and glucocorticoids (medicines containing cortisone or cortisone-like substances), as these medicines may increase the risk of ulcers or gastrointestinal bleeding;
• selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression), as they may increase the risk of gastrointestinal bleeding;
• antiplatelet agents, because they may increase the risk of bleeding;
• diuretic tablets, because ibuprofen may reduce the effects of these medicines and there may be an increased risk to the kidneys;
• potassium-sparing diuretics, because they may lead to hyperkalemia;
• quinolone antibiotics, because they may increase the risk of seizures;
• aminoglycosides (antibiotics), as ibuprofen may decrease the clearance of aminoglycosides, co-administration may increase the risk of nephrotoxicity and ototoxicity;
• sulfonylureas (antidiabetic drugs) due to possible interactions with ibuprofen;
• products containing lithium (a medicine for manic depressive illness and depression), digoxin (for heart failure), and methotrexate (a medicine for cancer or rheumatism), because ibuprofen may increase the effects of these medicines;
• sulfinpyrazone, probenecid (medicines for gout), because the excretion of ibuprofen may be delayed;
• there is clinical data indicating that NSAIDs may increase plasma levels of baclofen;
• mifepristone (a medicine for medical abortion), because ibuprofen may reduce the effect of this medicine;
• cyclosporine, tacrolimus (immunosuppressant drugs), because kidney damage may occur;
• pemetrexed (a medicine for cancer), because ibuprofen may increase the toxic effects of the medicine;
• zidovudine (a medicine for the treatment of HIV / AIDS), because the use of ibuprofen may increase the risk of bleeding in the joints or bleeding that causes swelling in HIV-positive hemophiliacs.

Some medicines can also affect or be affected by treatment with IBUPROFENE
ZENTIVA. You should therefore always consult your doctor or pharmacist before using IBUPROFENE
ZENTIVA with other medicines.

IBUPROFENE ZENTIVA with food, drinks and alcohol
The capsules should be swallowed whole with sufficient liquid. If gastrointestinal
problems occur during treatment, it is recommended to use the product with meals. The
consumption of alcohol and smoking should be avoided during treatment.

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 for advice before taking this medicine.
Pregnancy
Do not take Ibuprofene Zentiva if you are in the last 3 months of pregnancy as it may harm
the fetus or cause problems during childbirth. It can cause problems with the kidneys and heart in the fetus. It may affect
your and the baby's tendency to bleed and delay or prolong labor more than expected.
You should not take Ibuprofene Zentiva during the first 6 months of pregnancy unless it is
absolutely necessary and recommended by your doctor. If you need treatment during this
period or while trying to become pregnant, the lowest dose should be used for the shortest
possible time. If taken for more than a few days from the 20th week of pregnancy onwards,
Ibuprofene Zentiva may cause kidney problems in the fetus which may reduce the levels 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, the
doctor may recommend additional monitoring.
Breastfeeding
Do not take Ibuprofene if you are breastfeeding.
Fertility
The product belongs to a group of medicines (NSAIDs) that may impair fertility in
women. The effect is reversible after discontinuation of treatment with the medicine.

Driving and using machines
Ibuprofen does not alter or negligibly alters the ability to drive vehicles and use
machinery.

IBUPROFENE ZENTIVA contains sorbitol
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to
some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease
in which patients cannot metabolize fructose, talk to your doctor before you (or the
child) take this medicine.

3. How to take IBUPROFENE ZENTIVA

Take this medicine following exactly as described in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
This medicine is only for short-term use.
The lowest effective dose should be used for the shortest duration necessary to relieve the symptoms. In case of infection, consult a doctor immediately if the symptoms (such as fever and pain) persist or worsen (see paragraph 2).
Adults and adolescents starting from 12 years of age (body weight of at least 40 kg)
Take one or two capsules of IBUPROFENE ZENTIVA 200 mg or one capsule of IBUPROFENE ZENTIVA 400 mg with water, up to three times a day as needed.
Wait at least 4 hours between doses.
To relieve pain that is felt along the nerves (neuralgia), swelling and joint pain (rheumatic pain) and mild joint inflammation (mild arthritis), the medicine must be taken on a doctor's prescription, who will also determine the dose.
Do not take more than 6 capsules of IBUPROFENE ZENTIVA 200 mg or 3 capsules of IBUPROFENE ZENTIVA 400 mg in a period of 24 hours.
Children over 6 years of age (body weight from 20 to 39 kg)
IBUPROFENE ZENTIVA 200 mg is recommended for this age group.
The maximum total daily dose of ibuprofen is equal to 20-30 mg per kg of body weight, divided into 3-4 single doses.
Children over 6 years of age (body weight from 20 to 39 kg), take 1 capsule of IBUPROFENE ZENTIVA 200 mg;

• Children weighing 20 to 29 kg up to three times a day as needed. No more than 3 capsules (up to 600 mg of Ibuprofen) in a single 24-hour period. Wait at least 8 hours between doses.
• Children weighing 30 to 39 kg up to four times a day as needed. No more than 4 capsules (up to 800 mg of Ibuprofen) in a single 24-hour period. Wait at least 6-8 hours between doses.

Consult a doctor if the medicine is necessary for more than 3 days in children from 6 years of age and adolescents, or if the symptoms worsen.
Children under 6 years of age (body weight < 20 kg)
IBUPROFENE ZENTIVA 200 mg and IBUPROFENE ZENTIVA 400 mg should not be used in children weighing less than 20 kg (under 6 years of age) due to the amount of active ingredient contained in one capsule.
Elderly
The dose for the elderly is the same as for adults, but greater caution should be exercised.
Patients with impaired kidney or liver function
If you have reduced kidney or liver function, always consult your doctor before using IBUPROFENE ZENTIVA. The doctor will be able to give you the appropriate advice.
If you do not feel better or if you feel worse after 4 days in case of pain or 3 days in case of migraine or fever, or if new symptoms appear, consult your doctor or pharmacist.
Do not take the medicine for more than 10 days, unless prescribed by your doctor.

If you take more IBUPROFENE ZENTIVA than you should
If you have taken more IBUPROFENE ZENTIVA 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.
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, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, feeling cold to the body and breathing problems have been reported.
Seek immediate medical attention in case of overdose or accidental ingestion of capsules by a child.
You are at risk of serious damage to the stomach/intestines and kidneys, as well as at risk of very low levels of potassium in the blood.
IBUPROFENE ZENTIVA, if taken at doses higher than those recommended (for a short or prolonged period), can cause damage to the kidneys and impair their correct removal of acids from the blood in the urine (renal tubular acidosis). It can also lead to very low levels of potassium in the blood. This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and dizziness.

If you forget to take IBUPROFENE ZENTIVA
If you forgot 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 everybody gets them.

STOP taking IBUPROFENE ZENTIVA immediately and consult a doctor if any of the following occur, which may be possible signs of serious adverse reactions:

• hypersensitivity reaction such as skin rash, mucous membrane lesions, urticaria,
• sudden swelling around the eyes,
• chest discomfort with difficulty breathing or swallowing,
• epigastric pain,
• vision disturbances,
• bleeding from the digestive tract (vomiting blood or black stools),
• reddish, non-elevated, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis],
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• a widespread, red and scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The side effects that may occur are listed below according to their frequency:

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

• headache;
• abdominal pain, discomfort (nausea), indigestion;
• various skin rashes, hypersensitivity reactions (such as urticaria and itching). Rare (may affect up to 1 in 1,000 people):
• discomfort (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, fatigue, nosebleeds 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 of 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);
• disorders of liver function;
• severe forms of skin reactions, including rashes with redness and blisters; severe hypersensitivity reactions (swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension, severe shock). Not known (frequency cannot be estimated from available data):
• hearing disorders;
• heart failure, edema, high blood pressure;
• worsening of an existing bowel disease (colitis or Crohn's disease);
• renal failure;
• difficulty breathing (predominantly in patients with bronchial asthma), worsening of asthma;
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
• a widespread, red and scaly 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 IBUPROFENE ZENTIVA if you develop these symptoms and contact your doctor immediately. See also section 2.
• Increased sensitivity of the skin to sunlight.
• Fixed drug eruption (which manifests with patchy, round or oval redness 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 ibuprofen, may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

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 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 IBUPROFENE ZENTIVA

Keep this medicine out of sight and reach of children.
Store at a temperature below 25°C. Store in the original packaging to protect the
medicine from moisture.
Do not use this medicine after the expiry date which is stated on the packaging. 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 IBUPROFENE ZENTIVA contains
The active ingredient is ibuprofen.
Each capsule contains 200 mg or 400 mg of ibuprofen.
The other ingredients are macrogol 600, potassium hydroxide 85% (E525), gelatin, purified water,
partially dehydrated sorbitol liquid (E420), carmine 43% (E120)

Description of the appearance of IBUPROFENE ZENTIVA and contents of the pack
IBUPROFENE ZENTIVA 200 mg is an oval, transparent capsule, pink in colour (carmine) (approximately 13 x 8 mm).
IBUPROFENE ZENTIVA 400 mg is an oval, transparent capsule, pink/red in colour (carmine) (approximately 15 x 10 mm).
IBUPROFENE ZENTIVA 200 mg: The pack contains 12, 24 capsules.
IBUPROFENE ZENTIVA 400 mg: The pack contains 10, 12, 20 capsules.
Not all pack sizes may be marketed.

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

Manufacturer
Sanofi S.r.l.
S.S. 17, km 22
67019 Scoppito (AQ)

This medicinal product is authorised in the member states of the European Economic Area under the
following denominations: