IBUPROFEN PHARMADEV

Package leaflet: Information for the patient

IBUPROFENE PHARMADEV 200 mg film-coated tablets, 400 mg film-coated tablets

Ibuprofen
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.
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 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 any improvement or if you experience worsening of symptoms after: IBUPROFENE PHARMADEV 200 mg film-coated tablets
• 3 days for children and adolescents
• 3 days for fever and 4 days for pain in adults. IBUPROFENE PHARMADEV 400 mg film-coated tablets
• 3 days for children and adolescents
• 3 days for fever or migraine and 4 days for pain in adults.

Contents of this leaflet

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

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

IBUPROFENE PHARMADEV belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
IBUPROFENE PHARMADEV 200 mg film-coated tablets
For adults, adolescents and children weighing at least 20 kg (aged 6 years and older)
Short-term symptomatic treatment of:

• Mild to moderate pain
• Fever

IBUPROFENE PHARMADEV 400 mg film-coated tablets
For adults and adolescents weighing at least 40 kg (aged 12 years and older)
Short-term symptomatic treatment of:

• Mild to moderate pain
• Fever
  For adults: Short-term symptomatic treatment of acute migraine with or without aura

2. What you should know before taking IBUPROFENE PHARMADEV

Do not take IBUPROFENE PHARMADEV

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6),
• If you are in the last three months of pregnancy,
• If you have experienced allergic reactions (e.g. shortness of breath, asthma, runny nose, angioedema, hives) to acetylsalicylic acid or to other anti-inflammatory medicines,
• If you currently have or have a history of recurrent gastroduodenal ulcer (peptic ulcer) or bleeding (at least two separate episodes of ulcer or bleeding confirmed),
• If you have previously experienced gastrointestinal bleeding or perforation related to prior treatment with NSAIDs,
• If you have cerebral haemorrhage (cerebrovascular haemorrhage) or other bleeding conditions,
• If you have unspecified blood disorders,
• If you have severe liver, kidney, or heart failure,
• If you are severely dehydrated (caused by vomiting, diarrhoea, or insufficient fluid intake), IBUPROFENE PHARMADEV 200 mg film-coated tablets
• Children weighing less than 20 kg or under 6 years of age. IBUPROFENE PHARMADEV 400 mg film-coated tablets
• Adolescents weighing less than 40 kg and children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking IBUPROFENE PHARMADEV.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Talk to your doctor or pharmacist before taking IBUPROFENE PHARMADEV if you:

• Have heart problems, including heart failure, angina (chest pain), or a history of heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or "TIA", transient ischaemic attack).

• Have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

• Have or have had systemic lupus erythematosus (SLE, sometimes known as lupus) or mixed connective tissue disease (autoimmune diseases affecting connective tissue).

• Have or have previously had gastrointestinal disorders (ulcerative colitis, Crohn's disease), as your condition may worsen.

• Have inherited blood disorders (e.g. acute intermittent porphyria).

• Have impaired liver or kidney function.

• Have recently undergone major surgery.

• Are dehydrated.

• Have or have had asthma or allergic diseases, as breathing difficulties may occur.

• Have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as you may be at higher risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), rapid swelling (Quincke's oedema), or hives.

• If you have an infection – see the section "Infections" below.

Effects on the gastrointestinal tract
The combined use of IBUPROFENE PHARMADEV with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), must be avoided.
Gastrointestinal bleeding, ulcers, and perforations:
Gastrointestinal bleeding, ulcers, and perforations have been reported with all NSAIDs, sometimes with fatal outcomes. These may occur at any time during treatment, with or without warning symptoms or previous serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers, and perforations increases with higher NSAID doses and is higher in patients with a history of ulcers, especially with complications such as bleeding or perforation (see section 2 "Do not take IBUPROFENE PHARMADEV") and in elderly patients. These patients should start treatment with the lowest available dose. For these patients, as well as for those requiring additional treatment with low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal disorders, concomitant treatment with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
If you have previously experienced gastrointestinal side effects—especially if you are elderly—you should contact a doctor if you develop unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Caution is also advised if you are taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) like warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders, including depression), or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 "Other medicines and IBUPROFENE PHARMADEV").
Treatment must be stopped and a doctor consulted if gastrointestinal bleeding or ulcers occur during treatment with IBUPROFENE PHARMADEV.

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment. Stop taking IBUPROFENE PHARMADEV and seek immediate medical advice if you develop skin rashes, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

Infections
IBUPROFENE PHARMADEV may mask signs of infection such as fever and pain. Therefore, IBUPROFENE PHARMADEV may delay appropriate treatment of the infection, increasing the 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. During chickenpox, the use of this medicine is advised to be avoided.

Other warnings
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking IBUPROFENE PHARMADEV, treatment must be stopped and a doctor consulted. Necessary medical measures, appropriate to the symptoms, must be initiated by trained personnel.
Ibuprofen may temporarily inhibit blood platelet function (platelet aggregation). Patients with blood coagulation disorders should therefore be closely monitored.
Regular monitoring of liver function tests, kidney function tests, and blood counts is necessary during prolonged use of IBUPROFENE PHARMADEV.
Prolonged use of any type of painkiller for headache treatment may worsen headache. If this occurs or is suspected, a doctor should be consulted and treatment discontinued. The diagnosis of medication-overuse headache (MOH) should be suspected in patients with frequent or daily headaches, despite (or because of) regular use of headache medicines.
In general, habitual use of painkillers, especially when combining multiple painkillers, may cause permanent kidney damage, with risk of kidney failure (analgesic nephropathy). This risk may increase during physical exertion associated with salt loss and dehydration. Such use should therefore be avoided.
If you experience vision disturbances, stop taking IBUPROFENE PHARMADEV and contact your doctor.

Elderly population:
Elderly patients should be aware of the increased risk of adverse events, particularly gastrointestinal bleeding and perforation, which may be fatal.
IBUPROFENE PHARMADEV 200 mg film-coated tablets
Children and adolescents
There is a risk of kidney impairment in dehydrated children and adolescents.
IBUPROFENE PHARMADEV 400 mg film-coated tablets
Adolescents
There is a risk of kidney impairment in dehydrated adolescents.

Other medicines and IBUPROFENE PHARMADEV
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those purchased without a prescription.
IBUPROFENE PHARMADEV may affect or be affected by other medicines, for example:

• Digoxin, phenytoin, and lithium: concomitant use of IBUPROFENE PHARMADEV with digoxin (used to strengthen the heart), phenytoin (used to treat seizures/epilepsy), or lithium (used to treat, for example, depression) may increase blood levels of these medicines. Monitoring of serum lithium, digoxin, and phenytoin levels is generally not required if these are used according to instructions (for up to 3 or 4 days).

• Anticoagulants (i.e. blood thinners/preventing clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effects of anticoagulants such as warfarin.

• Diuretics and antihypertensive medicines: IBUPROFENE PHARMADEV may reduce the effect of medicines used to increase urine production (diuretics) and lower blood pressure (antihypertensives, e.g. ACE inhibitors, beta-blockers, and angiotensin II receptor antagonists). Concomitant administration of IBUPROFENE PHARMADEV with potassium-sparing diuretics (some types of diuretics) may lead to increased potassium levels in the blood.

• Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan): IBUPROFENE PHARMADEV may reduce the effect of ACE inhibitors (used to treat heart failure and high blood pressure). In addition, during concomitant use, there is an increased risk of kidney dysfunction.

• Cholestyramine (a medicine used to lower cholesterol) used in combination with IBUPROFENE PHARMADEV may reduce the absorption of IBUPROFENE PHARMADEV in the gastrointestinal tract. However, the clinical significance is unknown.

• Other painkillers: concomitant use of IBUPROFENE PHARMADEV with other anti-inflammatory and pain-relieving medicines of the NSAID group, including COX-2 inhibitors (e.g. celecoxib).

• Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.

• Methotrexate: administration of IBUPROFENE PHARMADEV within 24 hours before or after methotrexate (used to treat certain types of cancer or rheumatic diseases) may lead to increased methotrexate concentration and increased side effects.

• Cyclosporine and tacrolimus: there is an increased risk that immunosuppressive medicines such as cyclosporine and tacrolimus may cause kidney damage.

• Probenecid or sulfinpyrazone: medicines containing probenecid or sulfinpyrazone (used to treat gout) may delay the excretion of ibuprofen. This may cause accumulation of IBUPROFENE PHARMADEV in the body and increased side effects.

• Sulfonylureas: when IBUPROFENE PHARMADEV is used concomitantly with sulfonylureas (medicines used to treat diabetes), monitoring of blood sugar levels is recommended as a precautionary measure.

• Zidovudine: evidence suggests an increased risk of haemarthrosis (blood accumulation in joints) and bruising (haematomas) in HIV-positive haemophiliac patients taking zidovudine (an antiviral medicine used in the treatment of HIV infections) concomitantly with ibuprofen.

• Quinolone antibiotics: the risk of epileptic seizures (convulsions) may increase when quinolone antibiotics such as ciprofloxacin are taken simultaneously with ibuprofen.

• Aminoglycosides: combined use of IBUPROFENE PHARMADEV with aminoglycosides (a type of antibiotic) and NSAIDs may reduce the excretion of aminoglycosides.

• Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections, as they may increase the effect of ibuprofen. Dose reduction of ibuprofen should be considered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.

• Ginkgo biloba (herbal medicine) may increase the risk of bleeding if taken together with NSAIDs.

• Mifepristone: combined use of mifepristone with other anti-inflammatory and pain-relieving medicines of the NSAID group (i.e. ibuprofen) may reduce the effect of mifepristone.

• Ritonavir: combined use with ritonavir (an antiviral medicine used in the treatment of HIV infections) may increase plasma concentrations of NSAID painkillers.

• Alcohol, bisphosphonates, and oxpentifilline (pentoxifylline): combined use of ibuprofen with alcohol, bisphosphonates (used in the treatment of osteoporosis), or pentoxifylline (used in peripheral arterial circulation disorders) may increase gastrointestinal side effects and the risk of bleeding and ulcers.

• Baclofen (a muscle relaxant) due to its high toxicity.

• Medicines used to treat inflammation (corticosteroids), due to increased risk of ulcers or gastrointestinal bleeding. Other medicines may affect or be affected by treatment with IBUPROFENE PHARMADEV. Therefore, always consult your doctor or pharmacist before taking IBUPROFENE PHARMADEV with other medicines.

IBUPROFENE PHARMADEV and alcohol
Alcohol may increase the side effects of IBUPROFENE PHARMADEV, especially those affecting the central nervous system and gastrointestinal tract. Do not consume alcoholic beverages during treatment with IBUPROFENE PHARMADEV.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take the medicine during the last three months of pregnancy. Avoid using this medicine during the first six months of pregnancy unless otherwise advised by your doctor.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. IBUPROFENE PHARMADEV may be used during breastfeeding, provided it is taken at the recommended dose and for the shortest possible duration.
Fertility
This product belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine.

Driving and using machines
The effect of ibuprofen on the ability to drive and use machines is generally none or negligible. However, at higher doses, undesirable effects on the central nervous system such as fatigue and dizziness may occur, which may impair reaction ability, driving, and machine use in individual cases. This is more pronounced when combined with alcohol.

IBUPROFENE PHARMADEV contains sodium
IBUPROFENE PHARMADEV 200 mg film-coated tablets
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".
IBUPROFENE PHARMADEV 400 mg film-coated tablets
This medicine contains 45 mg (approximately 2 mmol) of sodium (main component of table salt) per film-coated tablet, equivalent to 2.3% of the maximum daily recommended sodium intake for an adult.

3. How to take IBUPROFENE PHARMADEV

Always take this medicine exactly as described in this leaflet or as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The lowest effective dose should be taken 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).

Recommended dose:
IBUPROFENE PHARMADEV 200 mg film-coated tablets
The dose should be determined according to the information in the following table. In children and adolescents, IBUPROFENE PHARMADEV is administered based on body weight or age, usually 7–10 mg/kg body weight as a single dose, up to a maximum total daily dose of 30 mg/kg body weight.

| Body weight | Single dose | Maximum daily dose |
|-----------------|-----------------|------------------------|
| | | (Age) |
| 20 kg – 29 kg | 1 film-coated tablet | 3 film-coated tablets |
| (Children: 6 - 9 years) | (equivalent to 200 mg of ibuprofen) | (equivalent to 600 mg of ibuprofen) |
| 30 kg – 39 kg | 1 film-coated tablet | 4 film-coated tablets |
| (Children: 10 - 11 years) | (equivalent to 200 mg of ibuprofen) | (equivalent to 800 mg of ibuprofen) |
| 40 kg or above | 1 - 2 film-coated tablets | 6 film-coated tablets |
| (Adults and adolescents | (equivalent to 200 - 400 mg of ibuprofen) | (equivalent to 1200 mg of ibuprofen) |
| from 12 years of age) | | |

The respective dosing interval depends on symptoms and the total maximum daily dose. This must not be less than 6 hours.
For short-term use only.

If in children and adolescents administration of this medicine is required for more than 3 days, or if symptoms worsen, a doctor must be consulted.
If in adults administration of this medicine is required for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen, a doctor must be consulted.

IBUPROFENE PHARMADEV 400 mg film-coated tablets
For adults and adolescents with body weight of 40 kg or more (age 12 years and above)

For the treatment of mild to moderate pain and/or fever
Initial dose: 400 mg of ibuprofen. If necessary, an additional dose of 400 mg of ibuprofen may be taken. The respective dosing interval depends on symptoms and the total maximum daily dose. This must not be less than 6 hours. The dose of 1200 mg of ibuprofen must not be exceeded within a 24-hour period.

Adults
For the treatment of acute migraine with or without aura
Initial dose: 400 mg of ibuprofen. If necessary, an additional dose of 400 mg of ibuprofen may be taken. The respective dosing interval depends on symptoms and the total maximum daily dose. This must not be less than 6 hours. The dose of 1200 mg of ibuprofen must not be exceeded within a 24-hour period.

If migraine persists, it is recommended to consult a doctor.
For short-term use only.

If in adolescents administration of this medicine is required for more than 3 days, or if symptoms worsen, a doctor must be consulted.
If in adults administration of this medicine is required for more than 3 days for fever or migraine, or more than 4 days for pain, or if symptoms worsen, a doctor must be consulted.

Special populations
Elderly population:
No dose adjustment is necessary. Elderly patients should be monitored with particular care due to the possible adverse effect profile.

Renal impairment:
No dose reduction is required in patients with mild to moderate renal function impairment (for patients with severe renal failure, see section 2 “Do not take IBUPROFENE PHARMADEV”).

Hepatic impairment:
No dose reduction is required in patients with mild to moderate hepatic function impairment (for patients with severe hepatic dysfunction, see section 2 “Do not take IBUPROFENE PHARMADEV”).

Method of administration
IBUPROFENE PHARMADEV is for oral use.
The film-coated tablets should be swallowed whole with plenty of water, preferably during meals. The tablets must not be chewed.

If you take more IBUPROFENE PHARMADEV than you should
If you have taken more film-coated tablets than prescribed, or if children have accidentally taken this medicine, contact a doctor or the nearest hospital for advice on the risk and necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), or less commonly, diarrhoea. In addition, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, uncontrolled eye movements (nystagmus), and worsening of asthma in asthmatic patients may occur. At high doses, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood pressure, increased blood potassium levels, prolonged prothrombin time/INR, acute renal failure, liver damage, cyanosis, feeling of cold body, and breathing difficulties may be reported.

If you forget to take IBUPROFENE PHARMADEV
Do not take a double dose to make up for a forgotten 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 everyone will experience them.
It should be noted that the following side effects are mainly dose-dependent and may vary from person to person.
The most commonly observed side effects involve the gastrointestinal tract. After use, gastroduodenal ulcers (peptic ulcers), perforations or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2: "Warnings and precautions").
Nausea, vomiting, diarrhoea, flatulence, constipation, digestive disturbances, abdominal pain, black tarry stools, blood in vomit, mouth sores (ulcerations) in the oral cavity (ulcerative stomatitis), worsening of colitis and Crohn's disease (see section 2: "Warnings and precautions"). Less commonly, inflammation of the stomach lining (gastritis) has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.
Fluid accumulation in tissues (oedema), arterial hypertension and heart failure have been reported in association with NSAID treatment.

Particularly serious side effects

• Stop taking IBUPROFENE PHARMADEV and contact a doctor immediately if you experience severe generalized allergic reactions (hypersensitivity), a very rare adverse effect (may affect up to 1 in 10,000 people): These may present as:
  • swelling of the face (facial oedema), tongue or throat (laryngeal swelling with airway constriction)
  • difficulty breathing
  • rapid heartbeat
  • drop in blood pressure leading to fatal shock.
• You are advised to consult a doctor immediately if you develop an infection with symptoms such as fever and severe deterioration in general condition, or fever with signs of local infection such as sore throat / pharyngeal pain / mouth sores, or urinary problems. IBUPROFENE PHARMADEV may cause a reduction in the number of white blood cells [agranulocytosis, a very rare adverse effect (may affect 1 in 10,000 people)] resulting in reduced resistance to infection. It is important to inform your doctor that you are taking this medicine.
• Severe skin and mucosal reactions (bullous) have been reported, such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and/or erythema multiforme [a very rare adverse effect (may affect 1 in 10,000 people)]. In addition, a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell) [frequency not known (frequency cannot be determined from available data)]. Stop taking IBUPROFENE PHARMADEV and contact a doctor if you develop a skin rash or mucosal lesions. Severe skin rashes may include blisters on the skin, especially on legs, arms, hands and feet, which may also appear on the face and lips. This condition may worsen if blisters enlarge and spread, and in cases of skin exfoliation (toxic epidermal necrolysis).
• Stop taking IBUPROFENE PHARMADEV if you experience relatively severe pain in the upper abdomen, blood in vomit, blood in stools and/or black stools, and inform your doctor immediately.
• Fluid accumulation in tissues (oedema), particularly in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis which may be accompanied by acute kidney injury (renal failure) [a very rare adverse effect (may affect 1 in 10,000 people)]. Reduced urine output, fluid accumulation within the body (oedema) and malaise (general) may be signs of kidney disease and renal failure.

If any of the listed symptoms appear or worsen, discontinue use of IBUPROFENE PHARMADEV and contact your doctor immediately.

Other side effects
Common (may affect up to 1 in 10 people)

• Gastrointestinal disturbances such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, digestive problems and mild gastrointestinal bleeding which, in rare cases, may lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue.
• Visual disturbances. In this case, stop taking ibuprofen and inform your doctor.
• Gastrointestinal ulcers (peptic ulcers), sometimes with bleeding and perforation (holes in the wall of the digestive tract), sometimes fatal, particularly in elderly patients, ulcerative stomatitis (inflammation of the mouth lining with ulceration), worsening of colitis or Crohn's disease (inflammation of the colon).
• Inflammation of the stomach lining (gastritis)
• Hypersensitivity reactions such as skin rashes, itching and asthma attacks (sometimes with drop in blood pressure).

In these cases, inform a doctor immediately and discontinue use of IBUPROFENE PHARMADEV.

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

• Ringing in the ears (tinnitus)
• Hearing loss
• Kidney tissue damage (papillary necrosis), elevated blood uric acid levels, increased blood urea levels.

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

• Disorders of blood cell formation, such as decreased number of red blood cells or haemoglobin (anaemia), white blood cells (leucopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilic coagulopathy, neutropenia, aplastic anaemia or haemolytic anaemia). Initial symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding.
• Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) has been reported in association with the use of certain anti-inflammatory agents (non-steroidal anti-inflammatory drugs, including IBUPROFENE PHARMADEV). If signs of infection appear or worsen during treatment with IBUPROFENE PHARMADEV (e.g. redness, swelling, warmth, pain, fever), consult a doctor immediately. Your doctor will assess whether antibiotic treatment is necessary.
• Symptoms of aseptic meningitis (inflammation of the brain lining not caused by infection), such as headache, nausea, vomiting, fever, neck stiffness or confusion, have been observed during ibuprofen treatment. The risk appears to be higher in patients already affected by certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
• Low blood sugar levels (hypoglycaemia)
• Low sodium levels in the blood (hyponatraemia)
• Palpitations, weakened heart muscle (heart failure), heart attack
• High blood pressure (hypertension)
• Vascular inflammation (vasculitis)
• Inflammation of the oesophagus or pancreas (pancreatitis), intestinal narrowing (intestinal stricture)
• Psychotic reactions, hallucinations, confusion, depression and anxiety
• Asthma, breathing difficulties (dyspnoea), bronchospasm
• Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage, particularly during long-term therapy, liver failure, acute liver inflammation (hepatitis).
• Severe skin reactions, such as skin rash with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis - Lyell's syndrome), hair loss (alopecia), formation of red or purple spots on the skin (purpura).
• In very rare cases, severe skin infections and soft tissue complications (chickenpox infection) may occur during chickenpox.

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

• Inflammation of the nasal mucosa (rhinitis)
• Pins and needles (paraesthesiae) and optic nerve inflammation (optic neuritis)
• Kidney dysfunction
• Photosensitive skin
• A widespread, red, scaly rash with bumps under the skin and blisters located mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized exanthematous pustulosis). Discontinue use of the medicine if you develop these symptoms and contact a doctor immediately. See also section 2.

Medicines such as IBUPROFENE PHARMADEV 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 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/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IBUPROFENE PHARMADEV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 PHARMADEV contains
IBUPROFENE PHARMADEV 200 mg film-coated tablets

• The active substance is ibuprofen.
• Each film-coated tablet contains 200 mg of ibuprofen (as sodium dihydrate).
• The other components are:
  Tablet core: Copovidone, Mannitol (E421), Sodium croscarmellose, Hydrated colloidal silica, Magnesium stearate.
  Film coating: Polyvinyl alcohol, Talc, Titanium dioxide (E171), Glycerol monocapryl/caprate, Sodium lauryl sulfate.

IBUPROFENE PHARMADEV 400 mg film-coated tablets

• The active substance is ibuprofen.
• Each film-coated tablet contains 400 mg of ibuprofen (as sodium dihydrate).
• The other components are:
  Tablet core: Copovidone, Mannitol (E421), Sodium croscarmellose, Hydrated colloidal silica, Magnesium stearate.
  Film coating: Polyvinyl alcohol, Talc, Titanium dioxide (E171), Glycerol monocapryl/caprate, Sodium lauryl sulfate.

Description of the appearance of IBUPROFENE PHARMADEV and contents of the pack
IBUPROFENE PHARMADEV is presented as white, elongated, film-coated tablets.
Pack sizes: 12, 15, 24, 30 film-coated tablets in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
PHARMADEV HEALTHCARE LIMITED
The Black Church,
Saint Mary’s Place North,
Dublin 7, D07P4AX
Ireland

Manufacturer:
AESICA PHARMACEUTICAL GmbH
Alfred-Nobel-Strasse 10
Monheim am Rhein, Nordrhein-Westfalen 40789
Germany

This medicinal product is authorised in the EEA Member States under the following names:
IBUPROFENE PHARMADEV 200 mg film-coated tablets

IBUPROFEN PHARMADEV 400 mg film-coated tablets