Ibuprofen Zentiva

Package leaflet: Information for the patient

IBUPROFEN ZENTIVA 200 mg soft capsules, 400 mg soft capsules

Equivalent medicine
Please read all of this leaflet carefully before taking 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 instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days in children and adolescents, or in adults after 4 days for pain or after 3 days for migraine or fever.

Contents of this leaflet:

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

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

The name of the medicine is IBUPROFENE ZENTIVA 200 mg or IBUPROFENE ZENTIVA 400 mg.
The active substance (the component that 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 rapidly into the bloodstream and therefore reaches the site of pain quickly.
IBUPROFENE ZENTIVA is used to relieve headache, migraine, toothache, backache, menstrual pain, muscular pain, fever, and symptoms of cold and flu.
Additionally, on medical prescription, IBUPROFENE ZENTIVA is also used to relieve nerve pain (neuralgia), joint swelling and 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 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 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 substance in 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 (NSAIDs) and experience shortness of breath, asthma, runny nose, swelling or hives;
• if you have an active or recurrent stomach or duodenal ulcer or bleeding, or if you have had such problems repeatedly in the past (i.e. at least twice);
• if you have ever had gastrointestinal bleeding or perforation related to previous NSAID therapy;
• if you suffer from a blood clotting disorder or a blood formation disorder;
• if you have 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 kidney or liver disease;
• you suffer from bronchial asthma;
• you suffer from allergic rhinitis, nasal polyps or chronic obstructive respiratory disorders, due to an increased risk of allergic reactions;
• you are also taking medications that could increase the risk of gastric toxicity or bleeding (see below);
• you suffer from systemic lupus erythematosus (an immune system disorder) or mixed connective tissue disease (risk of aseptic meningitis);
• you suffer from an inflammatory ulcerative disease of the gastrointestinal tract 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 artery 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;
• if you develop a skin rash or skin symptoms, you must stop taking ibuprofen immediately, consult a doctor promptly, and inform the doctor that you are taking this medicine;
• if you develop symptoms or signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including rash, fever, swollen lymph nodes and increased levels of a type of white blood cells (eosinophilia).

Infections
Ibuprofen may mask signs of infections such as fever and pain. Therefore, ibuprofen could delay appropriate treatment of the infection, which may lead to an increased 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, consult a 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 duration of treatment advised. Any risks are more likely with high doses or prolonged treatment.
Signs of an allergic reaction to this medicine have been reported with ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
Stop treatment with IBUPROFENE ZENTIVA immediately and contact your doctor or emergency medical 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 increases with higher doses, in patients with a history of ulcers, and in elderly patients. Certain concomitant medications 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, 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 because of) regular use of headache medications, consult your doctor before taking another analgesic. Treatment must be discontinued if medication-overuse headache is diagnosed.

Skin reactions
Serious skin reactions have been reported in association with treatment with IBUPROFENE ZENTIVA, 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). Discontinue use of 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
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
IBUPROFENE ZENTIVA may affect or be affected by certain medicines. For example:

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

Also inform your doctor if you are taking:

• other NSAIDs (anti-inflammatory and pain-relieving medicines) and glucocorticoids (medicines containing cortisone or cortisone-like substances), as these medicines may increase the risk of gastrointestinal ulcers or bleeding;
• selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression), as they may increase the risk of gastrointestinal bleeding;
• antiplatelet agents, as they may increase the risk of bleeding;
• diuretic tablets, because ibuprofen may reduce their effectiveness and may increase the risk to the kidneys;
• potassium-sparing diuretics, as they may lead to hyperkalemia;
• quinolone antibiotics, as they may increase the risk of seizures;
• aminoglycosides (antibiotics), because ibuprofen may reduce aminoglycoside clearance; co-administration may increase the risk of nephrotoxicity and ototoxicity;
• sulfonylureas (antidiabetic medicines), due to possible interactions with ibuprofen;
• products containing lithium (a medicine for bipolar disorder 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 excretion of ibuprofen may be delayed;
• clinical data indicate that NSAIDs may increase plasma levels of baclofen;
• mifepristone (a medicine for termination of pregnancy), because ibuprofen may reduce the effect of this medicine;
• cyclosporine, tacrolimus (immunosuppressive medicines), because kidney damage may occur;
• pemetrexed (a medicine for cancer), because ibuprofen may increase the toxic effects of the medicine;
• zidovudine (a medicine for treatment of HIV/AIDS), because use of ibuprofen may increase the risk of joint bleeding or bleeding causing swelling in HIV-positive haemophiliacs.

Some medicines may also affect or be affected by treatment with IBUPROFENE ZENTIVA. Therefore, you should 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 take the product with food. Consumption of alcohol and smoking should be avoided during treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Do not take IBUPROFENE ZENTIVA 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 the tendency for you and your baby to bleed and may delay or prolong labour more than expected.
You should not take IBUPROFENE ZENTIVA during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible 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 for more than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
Do not take Ibuprofen if you are breastfeeding.

Fertility
This product belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after stopping treatment.

Driving and using machines
Ibuprofen does not affect or has a negligible effect on the ability to drive and use machines.

IBUPROFENE ZENTIVA contains sorbitol
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine.

3. How to take IBUPROFENE ZENTIVA

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for short-term use only.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents aged 12 years and older (body weight 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.
Allow at least 4 hours between doses.
For relief of nerve pain (neuralgia), joint swelling and pain (rheumatic pain), and mild joint inflammation (mild arthritis), this medicine should be taken under medical prescription, and the dose will be determined by the doctor.
Do not take more than 6 capsules of IBUPROFENE ZENTIVA 200 mg or 3 capsules of IBUPROFENE ZENTIVA 400 mg within a 24-hour period.

Children over 6 years of age (body weight between 20 and 39 kg)
For this age group, IBUPROFENE ZENTIVA 200 mg is recommended.
The maximum total daily dose of ibuprofen is 20–30 mg per kg of body weight, divided into 3–4 individual doses.

• Children weighing 20–29 kg: take 1 capsule of IBUPROFENE ZENTIVA 200 mg up to three times a day as needed. Do not exceed 3 capsules (up to 600 mg of ibuprofen) in any 24-hour period. Allow at least 8 hours between doses.
• Children weighing 30–39 kg: take 1 capsule of IBUPROFENE ZENTIVA 200 mg up to four times a day as needed. Do not exceed 4 capsules (up to 800 mg of ibuprofen) in any 24-hour period. Allow at least 6–8 hours between doses.

Consult a doctor if the medicine is required for more than 3 days in children aged 6 years and older or in adolescents, or if symptoms worsen.

Children under 6 years of age (body weight < 20 kg)
IBUPROFENE ZENTIVA 200 mg and IBUPROFENE ZENTIVA 400 mg must not be used in children weighing less than 20 kg (under 6 years of age), due to the amount of active substance contained in a single capsule.

Elderly
The dose for elderly patients is the same as for adults, but greater caution should be exercised.

Patients with impaired renal or hepatic function
If you have reduced kidney or liver function, always consult your doctor before using IBUPROFENE ZENTIVA. Your doctor will provide appropriate advice.

If you do not feel better or if you feel worse after 4 days of treatment for pain, or after 3 days for migraine or fever, or if new symptoms appear, consult your doctor or pharmacist.
Do not take this medicine for more than 10 days unless otherwise prescribed by your doctor.

If you take more IBUPROFENE ZENTIVA than you should
If you have taken more IBUPROFENE ZENTIVA than recommended, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and necessary actions.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.
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 very low blood potassium levels.
IBUPROFENE ZENTIVA, when taken at doses higher than recommended (for a short or prolonged period), may cause kidney damage and impair the proper removal of acids from the blood into the urine (renal tubular acidosis). It may also lead to very low blood potassium levels. This is a serious condition requiring immediate treatment. Signs and symptoms include muscle weakness and dizziness.

If you forget to take IBUPROFENE ZENTIVA
If you forget to take a dose, do not take a double dose to make up for the missed dose.
If you have any questions 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 gets them.
STOP taking IBUPROFENE ZENTIVA immediately and consult a
doctor if you experience any of the following conditions, which may be possible signs of serious
adverse events:

• hypersensitivity reactions such as skin rash, mucosal lesions, urticaria,
• sudden onset of swelling around the eyes,
• chest tightness with difficulty breathing or swallowing,
• epigastric pain,
• visual disturbances,
• bleeding from the gastrointestinal tract (vomiting blood or black stools),
• non-elevated reddish patches, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions 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, scaly rash with subcutaneous bumps and blisters accompanied by fever. Symptoms usually occur early in treatment (generalized pustular eruption).

The side effects that may occur are listed below by 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 pruritus).
  Rare (may affect up to 1 in 1,000 people):
• discomfort (vomiting), diarrhoea, constipation, flatulence.
  Very rare (may affect up to 1 in 10,000 people):
• problems with blood cell production (early signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, nosebleeds and skin bleeding);
• aseptic inflammation of the meninges (particularly in patients with connective tissue diseases or systemic lupus erythematosus);
• inflammation, ulceration or perforation of the mucosal lining of the gastrointestinal tract (black stools and vomiting blood), inflammation of the mouth;
• inability of the kidneys to eliminate waste products (acute renal failure), blood in 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 (facial, tongue and laryngeal oedema, dyspnoea, tachycardia, hypotension, severe shock).
  Not known (frequency cannot be estimated from the available data):
• hearing disorders;
• heart failure, oedema, arterial hypertension;
• worsening of pre-existing bowel disease (colitis or Crohn's disease);
• renal failure;
• breathing difficulties (mainly in patients with bronchial asthma), worsening of asthma;
• 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).
• a widespread, red, scaly rash, with pustule formation under the skin and blisters located mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). 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.
• Drug-induced fixed eruption (appearing as round or oval red patches and skin swelling, possibly with itching).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines containing ibuprofen (or certain other NSAIDs), such as ibuprofen, may be associated with
a slight increase in the risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What IBUPROFENE ZENTIVA contains
The active substance is ibuprofen.
Each capsule contains 200 mg or 400 mg of ibuprofen.
The other components are macrogol 600, potassium hydroxide 85% (E525), gelatin, purified water,
partially dehydrated liquid sorbitol (E420), carmine red 43% (E120).

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

Marketing Authorization Holder and Manufacturer
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan, Italy

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

This medicinal product is authorized in the European Economic Area countries under the
following names: