IBUPROFENE 400 mg Film-Coated Tablets

Зміст інструкції

1. Ibuprofene Dr. Max Pharma 400 mg film-coated tablets
   1. What is Ibuprofene Dr. Max Pharma and what is it used for
   2. What you need to know before taking Ibuprofene Dr. Max Pharma
   3. How to take Ibuprofene Dr. Max Pharma
   4. Possible side effects
   5. How to store Ibuprofene Dr. Max Pharma
   6. Package contents and other information
2. Ibuprofene Dr. Max Pharma 400 mg film-coated tablets
   1. What is Ibuprofene Dr. Max Pharma and what is it used for
   2. What you need to know before taking Ibuprofene Dr. Max Pharma
   3. How to take Ibuprofene Dr. Max Pharma
   4. Possible side effects
   5. How to store Ibuprofene Dr. Max Pharma
   6. Package Contents and Other Information

Ibuprofene Dr. Max Pharma 400 mg film-coated tablets

Ibuprofene

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ibuprofene Dr. Max Pharma and what is it used for

Ibuprofene Dr. Max Pharma belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which work by reducing fever (antipyretic), as a pain reliever (analgesic) and with an anti-inflammatory effect.
Ibuprofene Dr. Max Pharma is used for the symptomatic short-term treatment of mild to moderate pain such as headache including migraine, back pain, toothache, menstrual pain, postoperative pain, muscle and joint pain accompanying the flu, for the symptomatic treatment of soft tissue injuries such as sprains and muscle strains, and fever.
Ibuprofene Dr. Max Pharma is indicated for the treatment of adults and adolescents with a body weight of 40 kg or more (over 12 years of age).
See a doctor if you do not feel better or if you feel worse after 3 days in adolescents and after 3 days in adults in case of fever and 5 days in case of pain.

2. What you need to know before taking Ibuprofene Dr. Max Pharma

Do not takeIbuprofene Dr. Max Pharma

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if you have had allergic reactions such as asthma, runny nose, hives or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid or other medicines for pain and inflammation (NSAIDs),
• if you have suffered from perforation or bleeding in the stomach or duodenum (the first part of the small intestine) in connection with previous use of medicines for pain and inflammation (NSAIDs),
• if you suffer from an ulcer or bleeding in the stomach or duodenum or if you have had two or more episodes in the past,

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• if you have severe problems with the liver, kidneys or heart,
• if you are in the last 3 months of pregnancy,
• if you suffer from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake),
• if you have any active bleeding (including bleeding in the brain).

Warnings and precautions
Talk to your doctor before taking Ibuprofene Dr. Max Pharma:

• if you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers), Crohn's disease (inflammation affecting the digestive tract), these conditions may worsen. If you suffer from diseases of the digestive system, you can only use the medicine with caution, as it may increase the risk of bleeding and other complications in the digestive system. Patients who have had a stomach or duodenal ulcer are at greater risk of gastrointestinal bleeding.
• if you suffer from asthma, the risk of developing bronchospasm (a convulsive constriction of the bronchi) may increase.
• if you are taking medicines that affect the blood clotting mechanism, Ibuprofene Dr. Max Pharma or other medicines in this group may prolong bleeding time or cause ulcers.
• if you suffer from hay fever, nasal polyps or chronic respiratory diseases, the risk of an allergic reaction may increase.
• if you suffer from kidney disease, Ibuprofene Dr. Max Pharma should only be used with caution and always at the lowest effective dose, as medicines in this group can impair kidney function. The same warnings apply if you suffer from liver disease.
• if you have an infection - see the “Infections” section below.

The risk of side effects increases with increasing dose and in the elderly. It is therefore necessary
to start treatment with the lowest possible dose and continue treatment for the shortest time
necessary to treat the symptoms.

Ulcers, perforation and bleeding in the stomach or intestine
Occasionally, gastrointestinal bleeding, ulceration or perforation may occur during treatment.
If you notice unusual disturbances in the digestive tract, immediately talk to your
doctor.

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome,
toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS),
acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment
with ibuprofen. Stop using Ibuprofene Dr. Max Pharma and consult your doctor immediately if
you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular and cerebrovascular effects
Anti-inflammatory/pain-relieving medicines such as 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 treatment with your doctor or pharmacist before taking Ibuprofene Dr. Max
Pharma if:

• you have heart problems including heart failure, angina pectoris (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 any type of stroke (including “mini-stroke” or transient ischemic attack “TIA”).

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• you have high blood pressure, diabetes, high cholesterol, or have a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop
Ibuprofene Dr. Max Pharma immediately and contact your doctor or emergency room
immediately if you notice any of these signs.

Aseptic meningitis (inflammation of the brain membrane without bacterial infection).
Rarely, “aseptic” meningitis has been reported in patients treated with ibuprofen. However, this
disease is more likely to occur in patients with connective tissue diseases, belonging
to the so-called “collagenoses”, such as lupus erythematosus.

Infections
Ibuprofene Dr. Max Pharma can mask the symptoms of infections such as fever and pain. It is therefore
possible that Ibuprofene Dr. Max Pharma may delay adequate treatment of the infection, with
consequent increased risk of complications. This has been observed in pneumonia caused by bacteria
and bacterial skin infections related to chickenpox. If you are taking this medicine while you have
an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.
It is recommended not to take Ibuprofene Dr. Max Pharma in case of chickenpox.

Further precautions
Prolonged use of painkillers for headaches can worsen them. If this occurs or is suspected, you should stop taking Ibuprofene Dr. Max Pharma and contact your doctor.
Ibuprofen can temporarily inhibit platelet function.

Children and adolescents
There is a risk of kidney failure in dehydrated children and adolescents.
Due to the high amount of active ingredient, Ibuprofene Dr. Max Pharma is not intended for children
under 12 years of age and adolescents weighing less than 40 kg.

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

• acetylsalicylic acid - can increase the risk of side effects
• other NSAIDs (including COX-2 inhibitors) - can increase the risk of gastrointestinal bleeding and ulcers
• anticoagulants (e.g. warfarin): ibuprofen can enhance the effect of these medicines
• methotrexate (used to treat cancer and autoimmune diseases): ibuprofen can affect its elimination
• lithium (used to treat depression and mania) and phenytoin (used to prevent seizures) - ibuprofen can increase their blood levels
• cardiac glycosides (e.g. digoxin): ibuprofen can increase their levels in the blood and can worsen heart failure
• diuretics (water pills): can increase the side effects of ibuprofen, ibuprofen can reduce the effect of these medicines
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) - ibuprofen can reduce the effect of these medicines

3/18

• cholestyramine (used to treat high cholesterol) - concomitant use with ibuprofen can reduce the absorption of ibuprofen in the gastrointestinal tract
• aminoglycosides (medicines against some types of bacteria): the excretion of aminoglycosides may be prolonged and ibuprofen may increase their toxicity
• antiplatelet agents (used to prevent blood clotting, e.g. acetylsalicylic acid, ticlopidine) and SSRIs (medicines against depression) such as paroxetine, sertraline, citalopram - can increase the risk of gastrointestinal bleeding
• cyclosporine and tacrolimus (for immunosuppression after organ transplantation) - ibuprofen can increase the risk of nephrotoxicity
• zidovudine (used to treat patients with HIV): ibuprofen can increase the risk of side effects
• mifepristone (used to terminate pregnancy): ibuprofen can reduce its effectiveness
• probenecid or sulfinpyrazone (for the treatment of gout) - ibuprofen can reduce the effect of these medicines
• quinolone antibiotics (medicines against some types of bacteria): can increase the risk of seizures
• sulfonylureas (for the treatment of type 2 diabetes): ibuprofen can enhance the effects of these medicines. Cases of hypoglycemia (low blood sugar levels) have been rarely reported with simultaneous use of these drugs.
• corticosteroids (used against inflammation) - can increase the risk of gastrointestinal side effects (ulceration or gastrointestinal bleeding)
• voriconazole or fluconazole (a type of antifungal drug): concomitant use may increase exposure to ibuprofen
• herbal medicine ginkgo biloba - can potentiate the risk of bleeding

Even some other medicines can influence or be influenced by the treatment with Ibuprofene Dr.
Max Pharma. Therefore, always consult your doctor or pharmacist before using Ibuprofene Dr. Max
Pharma with other medicines.

Ibuprofene Dr. Max Pharma with alcohol
You should not drink alcohol while taking Ibuprofene Dr. Max Pharma as it may increase
the side effects of Ibuprofene Dr. Max Pharma, especially those affecting the gastrointestinal tract or the central nervous system.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ibuprofene Dr. Max Pharma if you are in the last 3 months of pregnancy as it could
harm the fetus or cause problems in childbirth. It may cause problems with the fetus's kidneys and heart.
It may affect your and your baby's tendency to bleed and cause labor to be later or longer than expected. Do not take Ibuprofene Dr. Max Pharma during the first 6 months of
pregnancy unless absolutely necessary and recommended by your doctor. If you need
treatment during this period or while trying to become pregnant, you should use the lowest dose
for the shortest time possible. If taken for more than a few days from the 20th week of
pregnancy onwards, Ibuprofene Dr. Max Pharma may cause kidney problems in the fetus that may lead
to low levels of amniotic fluid surrounding the baby (oligohydramnios) or to the narrowing of a
blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than
a few days, your doctor may recommend additional monitoring.
Breastfeeding
Long-term treatment is not recommended in women who are breastfeeding. Ibuprofen and its
metabolites pass into breast milk in very small amounts and it is usually not necessary
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to stop breastfeeding if ibuprofen is used at the recommended dose and for the shortest
time possible.
Fertility
Ibuprofene Dr. Max Pharma belongs to a group of medicines (NSAIDs) that can impair
fertility in women. This effect is reversible with discontinuation of the medicine.

Driving and using machines
Ibuprofene Dr. Max Pharma does not alter or negligibly alters the ability to drive and use
machinery. However, if you experience dizziness, drowsiness, fatigue, visual disturbances or other
symptoms affecting the central nervous system while taking this medicine, you should not drive or
use machinery. This is especially true in combination with alcohol

Ibuprofene Dr. Max Pharma contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

Ibuprofene Dr. Max Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Ibuprofene Dr. Max Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
For short-term use only.
The lowest effective dose should be used for the shortest period necessary to relieve the
symptoms. If you have an infection, consult a doctor immediately if the symptoms (such as fever and
pain) persist or worsen (see paragraph 2).

Adults and adolescents with a body weight of 40 kg or more (over 12 years of age)
The recommended dose for the treatment of acute pain or fever is 1 tablet
(400 mg) administered as a single dose or up to 3 times a day, if necessary, with an interval of 4-
6 hours between doses.
The maximum daily dose should not exceed 3 tablets (1,200 mg).
No dose adjustment is required for elderly patients (over 65 years of age).
If this medicine is required for more than 3 days in adults in case of fever or 5 days in case of
pain, or if the symptoms worsen, a doctor should be consulted.
If this medicine is required for more than 3 days in adolescents or if the symptoms worsen, a
doctor should be consulted.

Use in children and adolescents
Ibuprofene Dr. Max Pharma is not indicated for children under 12 years of age and adolescents of
less than 40 kg body weight. Other formulations and dosages of ibuprofen are available for this group.
Method of administration
The tablet of Ibuprofene Dr. Max Pharma must be swallowed whole with plenty of water. Do not
chew, break in half or crush the tablets to avoid irritation of the mouth or throat.
A faster action can be obtained by administering the dose on an empty stomach. Patients with gastric
sensitivity should take Ibuprofene Dr. Max Pharma with food.
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If you take more Ibuprofene Dr. Max Pharma than you should
If you have taken more Ibuprofene Dr. Max Pharma than you should, or if the child has taken this
medicine by mistake, always contact your doctor or the nearest hospital for an opinion on the risk and
advice on actions to be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with
traces of blood), headache, ringing in the ears, confusion and oscillating eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in
children), weakness and dizziness, blood in the urine, low potassium levels
in the blood, feeling cold and breathing problems have been reported. Other symptoms of overdose include
lethargy or dry mouth. In case of severe overdose, kidney failure may occur
and liver damage.

If you forget to take Ibuprofene Dr. Max Pharma
Do not take a double dose to make up for a missed dose.
If you have further questions on 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 everybody gets them.
The side effects reported with Ibuprofene Dr. Max Pharma are the same as those associated with other
non-steroidal anti-inflammatory drugs.
Stop using Ibuprofene Dr. Max Pharma if you develop these symptoms and consult your doctor immediately (see also section 2):

• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis], very rare (may affect up to 1 in 10,000 patients),
• a widespread, red and scaly rash, with pustules under the skin and blisters located mainly in the skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), frequency not known (the frequency cannot be estimated from the available data),
• 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), frequency not known (the frequency cannot be estimated from the available data).

The following side effects may occur with ibuprofen, in order of frequency:

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

• feeling unwell, vomiting, diarrhea, constipation, flatulence, indigestion, abdominal pain, gastrointestinal bleeding (black stools or vomiting blood)
• feeling dizzy or tired
• headache
• skin rash

Uncommon(may affect up to 1 in 100 people):
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• various forms of kidney disorders, such as inflammation of the kidneys, nephrotic syndrome (a set of symptoms of a kidney disease) and kidney failure
• runny nose (rhinitis)
• inflammation of the stomach
• ulcer in the stomach or intestine, perforation in the wall of the digestive tract
• mouth ulcers
• hepatitis, jaundice, liver failure
• shortness of breath, bronchial asthma, bronchospasm
• tingling or "pins and needles" sensation
• difficulty sleeping
• feeling sleepy
• feeling anxious
• hives, itching, purpura (skin bruising)
• angioedema (swelling that manifests in various parts of the body such as the subcutaneous tissue of the face, the mucous membranes of the respiratory and digestive tract, causing problems in the affected area)
• skin sensitivity to light
• blurred or disturbed vision (visual impairment)
• hearing disorders, ringing in the ears (tinnitus)
• balance disorders

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

• aseptic meningitis (inflammation of the protective membrane surrounding the brain)
• feeling depressed or confused
• optic neuritis (inflammation of the optic nerve), toxic optic neuropathy (damage to the optic nerve)
• swelling

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

• inflammation of the pancreas
• liver failure
• heart failure
• heart attack
• hypertension
• severe kidney damage (papillary necrosis), especially with long-term use
• severe forms of skin reaction
• severe allergic reaction causing swelling of the face, tongue or throat, shortness of breath, rapid heartbeat, low blood pressure (anaphylaxis or severe shock)
• blood abnormalities - the first signs are: fever, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, nosebleeds and bruising

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

• worsening of Crohn's disease or colitis
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you experience more serious reactions such as facial swelling or difficulty breathing, visual disturbances or black stools,
stop taking the medicine and consult a doctor immediately.
Medicines like Ibuprofene Dr. Max Pharma may be associated with a slight increase in the 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 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 Ibuprofene Dr. Max Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after “Scad”
or “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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. Package contents and other information

What Ibuprofene Dr. Max Pharma contains

• The active ingredient is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, povidone, corn starch, sodium lauryl sulfate, magnesium stearate (E 470) Film coating: hydroxypropylcellulose (E 463), hypromellose 2910/3 (E 464), hypromellose 2910/6 (E 464), macrogol 400, titanium dioxide (E 171)

Description of the appearance of Ibuprofene Dr. Max Pharma and package contents
Film-coated tablets, white, capsule-shaped, smooth on both sides with dimensions of approximately
16.7 x 7.8 mm.

Packs of:24, 30, 36, 48, 50 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
The marketing authorization holder is:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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Italy Ibuprofene Dr. Max Pharma
Poland: Ibuprofen Dr. Max Pharma
Czech Republic: Ibuprofen Dr. Max Pharma
Romania: Ibuprofen Dr. Max Pharma 400 mg film-coated tablets
Slovakia: Ibuprofen Dr. Max Pharma 400 mg film-coated tablets
9/18

Ibuprofene Dr. Max Pharma 400 mg film-coated tablets

Ibuprofen

Read 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 told you to do.

• 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days in case of fever or 5 days in case of pain in adults, and in adolescents after 3 days of treatment.

Contents of this leaflet:

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

1. What is Ibuprofene Dr. Max Pharma and what is it used for

Ibuprofene Dr. Max Pharma belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which work by reducing fever (antipyretic), as a pain reliever (analgesic) and anti-inflammatory effect.
Ibuprofene Dr. Max Pharma is used for the symptomatic short-term treatment of mild to moderate pain such as headache including migraine, back pain, toothache, menstrual pain, postoperative pain, muscle and joint pain accompanying the flu, for the symptomatic treatment of soft tissue injuries such as sprains and muscle strains, and fever.
Ibuprofene Dr. Max Pharma is indicated for the treatment of adults and adolescents with a body weight of 40 kg or more (over 12 years of age).
Consult a doctor if you do not feel better or if you feel worse after 3 days in adolescents and after 3 days in adults in case of fever and 5 days in case of pain.

2. What you need to know before taking Ibuprofene Dr. Max Pharma

Do not takeIbuprofene Dr. Max Pharma

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if you have had allergic reactions such as asthma, runny nose, hives or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid or other medicines for pain and inflammation (NSAIDs),
• if you have suffered from perforation or bleeding in the stomach or duodenum (the first part of the small intestine) related to previous use of medicines for pain and inflammation (NSAIDs),

10/18

• if you suffer from an ulcer or bleeding in the stomach or duodenum, or if you have had two or more episodes in the past,
• if you suffer from serious problems with the liver, kidneys or heart,
• if you are in the last 3 months of pregnancy,
• if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake),
• if you have any active bleeding (including bleeding in the brain).

Warnings and precautions
Talk to your doctor before taking Ibuprofene Dr. Max Pharma:

• if you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers), Crohn's disease (inflammation affecting the digestive tract), these conditions may worsen. If you suffer from diseases of the digestive system, you can only use the medicine with caution, as it may increase the risk of bleeding and other complications in the digestive system. Patients who have had a stomach or duodenal ulcer are at greater risk of gastrointestinal bleeding.
• if you suffer from asthma, the risk of developing bronchospasm (a convulsive constriction of the bronchi) may increase.
• if you are taking medicines that affect the blood clotting mechanism, Ibuprofene Dr. Max Pharma or other medicines in this group may prolong bleeding time or cause ulcers.
• if you suffer from hay fever, nasal polyps or chronic respiratory diseases, the risk of an allergic reaction may increase.
• if you suffer from kidney disease, Ibuprofene Dr. Max Pharma should only be used with caution and always at the lowest effective dose, as medicines in this group can impair kidney function. The same warnings apply if you suffer from liver disease.
• if you have an infection - see the “Infections” section below.

The risk of side effects increases with increasing dose and in the elderly. It is therefore necessary
to start treatment with the lowest possible dose and continue treatment for the shortest time
necessary to treat the symptoms.

Ulcers, perforation and bleeding in the stomach or intestine
Occasionally, gastrointestinal bleeding, ulceration or perforation may occur during treatment.
If you notice unusual disturbances in the digestive tract, immediately tell your
doctor.

Skin reactions
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome,
toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS),
acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment
with ibuprofen. Stop using Ibuprofene Dr. Max Pharma and consult your doctor immediately if
you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular and cerebrovascular effects
Anti-inflammatory/pain-relieving medicines such as 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 Ibuprofene Dr.
Max Pharma if:
11/18

• you have heart problems including heart failure, angina pectoris (chest pain), or if you have had a heart attack, a bypass operation, peripheral artery disease (poor circulation in the legs or 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, high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including
breathing difficulties, swelling of the face and neck (angioedema) and chest pain have been reported
with ibuprofen. Stop Ibuprofene Dr. Max Pharma immediately and contact your doctor or
emergency room immediately if you notice any of these signs.

Aseptic meningitis (inflammation of the brain membrane without bacterial infection).
Rarely, “aseptic” meningitis has been reported in patients treated with ibuprofen. However, this
disease is more likely to occur in patients with connective tissue diseases, belonging to the so-called
“collagenoses”, such as lupus erythematosus.

Infections
Ibuprofene Dr. Max Pharma can mask the symptoms of infections such as fever and pain. Therefore,
Ibuprofene Dr. Max Pharma may delay adequate treatment of the infection, with
consequent increase in the risk of complications. This has been observed in pneumonia caused by
bacteria and bacterial skin infections related to varicella. If you are taking this medicine while
you have an infection and the symptoms of the infection persist or worsen, consult your doctor
immediately.
It is recommended not to take Ibuprofene Dr. Max Pharma in case of varicella.

Further precautions
Prolonged use of pain relievers for headaches can worsen them. If this occurs or you suspect this
situation, you should stop taking Ibuprofene Dr. Max Pharma and contact your doctor.
Ibuprofen can temporarily inhibit platelet function.

Children and adolescents
There is a risk of kidney failure in dehydrated children and adolescents.
Due to the high amount of active ingredient, Ibuprofene Dr. Max Pharma is not intended for
children under 12 years of age and adolescents weighing less than 40 kg.

Other medicines and Ibuprofene Dr. Max Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines.
Ibuprofene Dr. Max Pharma can affect or be affected by other medicines. For example:

• acetylsalicylic acid - may increase the risk of side effects
• other NSAIDs (including COX-2 inhibitors) - may increase the risk of gastrointestinal bleeding and ulcers
• anticoagulants (e.g. warfarin): ibuprofen may enhance the effect of these medicines
• methotrexate (used to treat cancer and autoimmune diseases): ibuprofen may affect its elimination
• lithium (used to treat depression and mania) and phenytoin (used to prevent seizures) - ibuprofen may increase their blood levels
• cardiac glycosides (e.g. digoxin): ibuprofen may increase their levels in the blood and may worsen heart failure

12/18

• diuretics (water pills): may increase the side effects of ibuprofen, ibuprofen may reduce the effect of these medicines
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) - ibuprofen may reduce the effect of these medicines
• cholestyramine (used to treat high cholesterol) - concomitant use with ibuprofen may reduce the absorption of ibuprofen in the gastrointestinal tract
• aminoglycosides (medicines against some types of bacteria): the excretion of aminoglycosides may be prolonged and ibuprofen may increase their toxicity
• antiplatelet agents (used to prevent blood clotting, e.g. acetylsalicylic acid, ticlopidine) and SSRIs (medicines against depression) such as paroxetine, sertraline, citalopram - may increase the risk of gastrointestinal bleeding
• cyclosporine and tacrolimus (for immunosuppression after organ transplantation) - ibuprofen may increase the risk of nephrotoxicity
• zidovudine (used to treat patients with HIV): ibuprofen may increase the risk of adverse effects
• mifepristone (used to terminate pregnancy): ibuprofen may reduce its effectiveness
• probenecid or sulfinpyrazone (for the treatment of gout) - ibuprofen may reduce the effect of these medicines
• quinolone antibiotics (medicines against some types of bacteria): may increase the risk of seizures
• sulfonylureas (for the treatment of type 2 diabetes): ibuprofen may enhance the effects of these medicines. Cases of hypoglycemia (low blood sugar levels) have been rarely reported with the simultaneous use of these drugs.
• corticosteroids (used against inflammation) - may increase the risk of gastrointestinal side effects (ulceration or gastrointestinal bleeding)
• voriconazole or fluconazole (a type of antifungal drug): concomitant use may increase exposure to ibuprofen
• herbal medicine ginkgo biloba - may enhance the risk of bleeding

Also, some other medicines may influence or be influenced by the treatment with Ibuprofene
Dr. Max Pharma. Therefore, always consult your doctor or pharmacist before using Ibuprofene Dr.
Max Pharma with other medicines.

Ibuprofene Dr. Max Pharma with alcohol
You should not drink alcohol while taking Ibuprofene Dr. Max Pharma as it may
increase the side effects of Ibuprofene Dr. Max Pharma, especially those affecting the
gastrointestinal tract or the central nervous system.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ibuprofene Dr. Max Pharma if you are in the last 3 months of pregnancy as it may
harm the fetus or cause problems in childbirth. It may cause problems with the kidneys and heart of the fetus.
It may affect your and your baby's tendency to bleed and cause labor to be later or longer than expected. You should not take Ibuprofene Dr. Max Pharma 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, you should use the lowest
dose for the shortest time possible. If taken for more than a few days from the 20th week of
pregnancy onwards, Ibuprofene Dr. Max Pharma may cause kidney problems in the fetus which may
lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or to the
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narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need
treatment for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Long-term treatment is not recommended in women who are breastfeeding. Ibuprofen and its
metabolites pass into breast milk in very small amounts and it is usually not necessary
to stop breastfeeding if ibuprofen is used at the recommended dose and for the shortest
time possible.
Fertility
Ibuprofene Dr. Max Pharma belongs to a group of medicines (NSAIDs) that may
impair fertility in women. This effect is reversible with discontinuation of the medicine.

Driving and using machines
Ibuprofene Dr. Max Pharma does not alter or negligibly alters the ability to drive and use
machinery. However, if you experience dizziness, drowsiness, fatigue, visual disturbances or other
symptoms affecting the central nervous system while taking this medicine, you should not drive or
use machinery. This is especially true in combination with alcohol

Ibuprofene Dr. Max Pharma contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this
medicine.

Ibuprofene Dr. Max Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Ibuprofene Dr. Max Pharma

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.
For short-term use only.
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 symptoms (such as fever and
pain) persist or worsen (see section 2).

Adults and adolescents with a body weight of 40 kg or more (over 12 years of age)
The recommended dose for the treatment of acute pain or fever is 1 tablet
(400 mg) administered as a single dose or up to 3 times a day, if necessary, with an interval of 4-
6 hours between doses.
The maximum daily dose should not exceed 3 tablets (1200 mg).
No dose adjustment is required for elderly patients (over 65 years of age).
If this medicine is required for more than 3 days in adults in case of fever or 5 days in case of
pain, or if symptoms worsen, a doctor should be consulted.
If this medicine is required for more than 3 days in adolescents or if symptoms worsen, a
doctor should be consulted.

Use in children and adolescents
Ibuprofene Dr. Max Pharma is not indicated for children under 12 years of age and adolescents of
less than 40 kg in weight. Other formulations and dosages of ibuprofen are available for this group.
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Method of administration
The Ibuprofene Dr. Max Pharma tablet should be swallowed whole with plenty of water. Do not
chew, break in half or crush the tablets to avoid irritation of the mouth or throat.
A faster action can be obtained by administering the dose on an empty stomach. Patients with sensitivity
to the stomach should take Ibuprofene Dr. Max Pharma with food.

If you take more Ibuprofene Dr. Max Pharma than you should
If you have taken more Ibuprofene Dr. Max Pharma than you should, or if a child has taken this
medicine by mistake, always contact your doctor or the nearest hospital for advice on the risk
and recommendations on what actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with
traces of blood), headache, ringing in the ears, confusion and oscillating eye movements. Drowsiness, chest pain, palpitations, loss of
consciousness, convulsions (especially in children), weakness and dizziness, blood in
the urine, low levels of potassium in the blood, feeling cold and breathing problems have been reported at high doses. Other symptoms of overdose
include lethargy or dry mouth. In case of severe overdose, kidney failure and liver damage may occur.

If you forget to take Ibuprofene Dr. Max Pharma
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.
The side effects reported with Ibuprofene Dr. Max Pharma are the same as those associated with other
non-steroidal anti-inflammatory drugs.
Stop using Ibuprofene Dr. Max Pharma if you develop these symptoms and consult your doctor immediately (see also section 2):

• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis], very rare (may affect up to 1 in 10,000 patients),
• a widespread, red and scaly rash, with pustules under the skin and blisters located mainly in the skin folds, on the trunk and upper extremities, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), frequency not known (the frequency cannot be estimated based on available data),
• 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), frequency not known (the frequency cannot be estimated based on available data).

The following side effects may occur with ibuprofen, in order of frequency:

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

• feeling unwell, vomiting, diarrhea, constipation, flatulence, indigestion, abdominal pain, gastrointestinal bleeding (black stools or vomiting blood)

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• feeling dizzy or tired
• headache
• skin rash

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

• various forms of kidney disorders, such as kidney inflammation, nephrotic syndrome (a set of symptoms of kidney disease) and kidney failure
• runny nose (rhinitis)
• inflammation of the stomach
• ulcer in the stomach or intestine, perforation in the wall of the digestive tract
• mouth ulcers
• hepatitis, jaundice, liver failure
• shortness of breath, bronchial asthma, bronchospasm
• tingling or "pins and needles" sensation
• difficulty sleeping
• feeling anxious
• hives, itching, purpura (skin bruising)
• angioedema (swelling that occurs in various parts of the body such as the subcutaneous tissue of the face, the mucous membranes of the respiratory and digestive tract, causing problems in the affected area)
• skin sensitivity to light
• blurred or impaired vision (visual impairment)
• hearing disorders, ringing in the ears (tinnitus)
• balance disorders

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

• aseptic meningitis (inflammation of the protective membrane surrounding the brain)
• feeling depressed or confused
• optic neuritis (inflammation of the optic nerve), toxic optic neuropathy (damage to the optic nerve)
• swelling

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

• inflammation of the pancreas
• liver failure
• heart failure
• heart attack
• hypertension
• severe kidney damage (papillary necrosis), especially with long-term use
• severe forms of skin reaction
• severe allergic reaction causing swelling of the face, tongue or throat, shortness of breath, rapid heartbeat, low blood pressure (anaphylaxis or severe shock)
• blood count alterations - the first signs are: fever, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, nosebleeds and bruising

Frequency not known(the frequency cannot be estimated based on available data):

• worsening of Crohn's disease or colitis
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you experience more serious reactions such as facial swelling or shortness of breath, visual disturbances or black stools, stop taking the medicine and consult a doctor immediately.
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Medicines such as Ibuprofene Dr. Max Pharma may be associated with a slight increase in the
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 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 Ibuprofene Dr. Max Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
“Scad” or “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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. Package Contents and Other Information

What Ibuprofene Dr. Max Pharma contains

• The active ingredient is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, povidone, corn starch, sodium lauryl sulfate, magnesium stearate (E 470) Film coating: hydroxypropyl cellulose (E 463), hypromellose 2910/3 (E 464), hypromellose 2910/6 (E 464), macrogol 400, titanium dioxide (E 171)

Description of the appearance of Ibuprofene Dr. Max Pharma and contents of the pack
Film-coated tablets, white, capsule-shaped, smooth on both sides with dimensions of
approximately 16.7 x 7.8 mm.

Packs of:10, 12, 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
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Manufacturer
Medis international a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy Ibuprofene Dr. Max Pharma
Poland: Ibuprofen Dr. Max Pharma
Czech Republic: Ibuprofen Dr. Max Pharma
Romania: Ibuprofen Dr. Max Pharma 400 mg film-coated tablets
Slovakia: Ibuprofen Dr. Max Pharma 400 mg film-coated tablets
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