Metafen ibuprofen capsules

Patient Information Leaflet

Metafen IBUPROFEN CAPS, 200 mg, soft capsules
Ibuprofenum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, please consult your doctor.

Table of Contents

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

1. What Metafen IBUPROFEN CAPS is and what it is used for

The active substance in Metafen IBUPROFEN CAPS is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic, and anti-inflammatory properties.
Metafen IBUPROFEN CAPS is intended for use in children from 6 years of age, adolescents, and adults in the following conditions:

• Mild to moderate pain of various origins:
  • headaches (including migraine),
  • toothache,
  • muscle, joint, and bone pain,
  • pain following injuries,
  • neuralgia,
  • pain associated with colds and flu,
  • painful menstruation,
  • ear pain occurring in middle ear inflammation.
• Fever of various origins (e.g., during flu, colds, or other infectious diseases).

2. Important information before using Metafen IBUPROFEN CAPS

When not to use Metafen IBUPROFEN CAPS:

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced allergic symptoms such as nasal inflammation, urticaria, facial swelling, swelling of the tongue, lips or throat, bronchospasm or asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has had gastrointestinal bleeding or perforation following previous treatment with NSAIDs;
• if the patient has gastric or duodenal ulceration and/or bleeding (or has had two or more episodes of confirmed ulceration or bleeding);
• if the patient has severe liver, kidney or heart failure;
• if the patient has unexplained disorders of the blood-forming system (e.g. thrombocytopenia);
• if the patient has cerebral haemorrhage or any other active bleeding;
• if the patient has significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
• during the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Before starting treatment with Metafen IBUPROFEN CAPS, discuss this with your doctor or
pharmacist.
Allergic reactions to ibuprofen have been reported, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain.
If any of these symptoms occur, stop taking Metafen IBUPROFEN CAPS immediately and contact your doctor or emergency medical services without delay.
Inform your pharmacist or doctor if the patient has an infection – see below, section titled “Infections”.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms to minimise the risk of adverse effects.
Elderly patients are more susceptible to adverse effects, particularly gastrointestinal bleeding and perforation, which may be fatal.
Taking anti-inflammatory/analgesic 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.
Before using Metafen IBUPROFEN CAPS, the patient should discuss treatment with a doctor or
pharmacist if:

• the patient has heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack – TIA);
• the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker;
• the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease;
• the patient has gastrointestinal disorders or chronic bowel diseases (ulcerative colitis, Crohn's disease);
• the patient has impaired kidney function;
• the patient has impaired liver function;
• the patient has blood clotting disorders;
• the patient has inherited porphyria metabolism disorders (e.g. acute intermittent porphyria);
• the patient has bronchial asthma (or has asthma) or has experienced allergic reactions (bronchospasm may occur after taking the medicine);
• the patient has chickenpox – see below, section titled “Infections”.

Exercise caution when using the medicine immediately after major surgery.
There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be life-threatening and may occur without warning symptoms, or in patients who have previously experienced such symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with gastrointestinal disorders, especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of treatment.
Concurrent, long-term use of various analgesics may lead to kidney damage with risk of kidney failure (analgesic nephropathy). This risk may increase with physical exertion leading to salt loss and dehydration. Therefore, avoid concurrent, long-term use of multiple analgesics.
Avoid concomitant use of ibuprofen with other non-steroidal anti-inflammatory drugs, including those known as cyclooxygenase-2 (COX-2) inhibitors.
Severe cutaneous adverse reactions (SCAR)
Severe cutaneous adverse reactions (SCAR), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have been reported with ibuprofen use (see section 4.8). Most of these reactions occurred within the first month.
If the patient develops any symptoms related to these severe skin reactions described in section 4, discontinue Metafen IBUPROFEN CAPS immediately and seek medical help.
Discontinue ibuprofen and contact a doctor immediately if any of the following symptoms occur (angioedema):

• swelling of the face, tongue or throat,
• difficulty swallowing,
• urticaria and difficulty breathing.

Patients with systemic lupus erythematosus or mixed connective tissue disease may have an increased risk of aseptic meningitis.
Infections
Metafen IBUPROFEN CAPS may mask symptoms of infection such as fever and pain. Therefore, Metafen IBUPROFEN CAPS may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and symptoms persist or worsen, consult a doctor immediately.
Ibuprofen, the active substance in Metafen IBUPROFEN CAPS, may temporarily inhibit platelet aggregation. Patients with coagulation disorders should be closely monitored.
During prolonged use of Metafen IBUPROFEN CAPS, regular monitoring of liver enzyme activity, kidney function and blood morphology is necessary.
There is a risk of kidney failure in dehydrated children and adolescents.
Do not use ibuprofen in patients with significant dehydration caused by vomiting, diarrhoea or insufficient fluid intake.
During prolonged use of analgesics, headache may occur, which should not be treated by increasing the dose of the medicine.
During ibuprofen use, isolated cases of visual disturbances have been reported; therefore, if any visual disturbances occur, consult a doctor.
Metafen IBUPROFEN CAPS and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
Metafen IBUPROFEN CAPS may affect the action of other medicines or other medicines may affect the action of Metafen IBUPROFEN CAPS. For example:

• anticoagulant medicines (i.e. blood thinners and those preventing clot formation, such as aspirin, i.e. acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan);
• analgesic medicines;
• other non-steroidal anti-inflammatory drugs;
• diuretics;
• lithium, selective serotonin reuptake inhibitors (antidepressants);
• methotrexate – used in cancer or rheumatoid arthritis treatment;
• corticosteroids – used orally in inflammatory conditions;
• cyclosporine – used after organ transplants;
• cardiac glycosides (e.g. digoxin) – used in heart failure;
• tacrolimus – used after organ transplants;
• mifepristone – used in abortion procedures;
• zidovudine or ritonavir – used in HIV-positive individuals or those with AIDS;
• quinolone or aminoglycoside antibiotics – used in bacterial infections;
• voriconazole or fluconazole – used in fungal infections;
• probenecid or sulfinpyrazone – used in gout treatment;
• oral antidiabetic medicines (sulfonylurea derivatives);
• cholestyramine – used to lower high cholesterol levels;
• phenytoin – used in epilepsy;
• baclofen – used in muscle spasticity.

Some other medicines may also be affected by or influence treatment with Metafen
IBUPROFEN CAPS. Therefore, always consult a doctor or pharmacist before using Metafen
IBUPROFEN CAPS with other medicines.
Metafen IBUPROFEN CAPS with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not use Metafen IBUPROFEN CAPS during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Metafen IBUPROFEN CAPS may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both the patient and her child and may delay or prolong labour.
Do not take Metafen IBUPROFEN CAPS during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. Metafen IBUPROFEN CAPS taken for longer than a few days starting from the 20th week of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. There are no known cases of adverse effects in breastfed infants whose mothers took ibuprofen. It is not necessary to interrupt breastfeeding during short-term use of ibuprofen at doses used for pain and fever relief.
Effect on fertility
This medicine belongs to the group of non-steroidal anti-inflammatory drugs which may negatively affect female fertility. This effect is reversible after discontinuation of treatment.
Driving and operating machinery
Metafen IBUPROFEN CAPS may cause dizziness, fatigue and visual disturbances. If these occur, do not drive or operate machinery. Avoid any activities requiring concentration.
Metafen IBUPROFEN CAPS contains sorbitol (E 420), liquid maltitol (E 965), potassium and sodium
The medicine contains 28.8 mg of sorbitol (E 420) in each capsule.
The medicine contains 15 mg of liquid maltitol (E 965) in each capsule.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 0.27 mmol (10.6 mg) of potassium in each capsule, which should be considered in patients with reduced kidney function and in patients monitoring potassium intake in their diet.
Patent Blue, an ingredient of the medicine (capsule coating), contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Metafen IBUPROFEN CAPS

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Take orally.
Can be taken during meals or independently of meals. The capsules should be swallowed whole with a glass of water. Do not chew, suck or crush the capsules.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms and reduce the risk of adverse effects.
If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not exceed the recommended dosage.
The usual single dose of ibuprofen is 7 to 10 mg per kg of body weight; the daily dose is 20 to 30 mg per kg of body weight.
Recommended dose

The medicine should not be used in children under 6 years of age or weighing less than 20 kg.
The medicine is intended for short-term use only.
If it is necessary to use this medicine for longer than 3 days or if symptoms worsen, consult a doctor.

Use of Metafen IBUPROFEN CAPS in patients with renal and/or hepatic impairment
In patients with mild to moderate renal and/or hepatic impairment, the lowest possible doses should be used. Use in patients with severe renal and/or hepatic impairment is contraindicated.

Use of Metafen IBUPROFEN CAPS in elderly patients
Dosage adjustment is not required in elderly patients.

Use of a higher than recommended dose of Metafen IBUPROFEN CAPS
If a patient has taken a higher than recommended dose of Metafen IBUPROFEN CAPS or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to obtain advice regarding possible health risks and actions to be taken in such a case.

Symptoms of overdose may include nausea, epigastric pain, vomiting (blood traces may be present), gastrointestinal bleeding (see also point 4 below), diarrhea, headache, tinnitus, disorientation, and nystagmus. Excitation, drowsiness, disorientation, or coma may also occur. Seizures may occasionally occur in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, hematuria, hypokalemia, feeling of cold, and breathing difficulties have been reported. Additionally, prothrombin time (INR) may be prolonged, probably due to impaired blood coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, hypotension and breathing difficulties may occur.

Overdose cases are rare. There is no specific antidote. Treatment is symptomatic and supportive. The doctor may consider administering activated charcoal if less than one hour has passed since the overdose.

Missed dose of Metafen IBUPROFEN CAPS
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) – very rare.
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome) – frequency not known.
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis) – frequency not known.

Metafen IBUPROFEN CAPS is generally well tolerated; however, adverse effects may occur during its use.
The adverse effects listed below have been observed during short-term use of ibuprofen at over-the-counter doses. The most commonly observed adverse effects involve the gastrointestinal tract.
Common (occurring in fewer than 1 in 10 patients):

• Heartburn, abdominal pain, nausea, vomiting, bloating with gas release, diarrhoea, constipation, minor gastrointestinal bleeding which may exceptionally lead to anaemia.

Uncommon (occurring in fewer than 1 in 100 patients):

• Headache, dizziness, insomnia, drowsiness, restlessness, irritability, fatigue.
• Oral ulceration;
• Gastritis, exacerbation of ulcerative colitis and Crohn's disease, dyspepsia;
• Visual disturbances (blurred vision);
• Allergic reactions with rash and itching, as well as asthma attacks (possibly occurring together with low blood pressure), various types of skin rashes.

Rare (occurring in fewer than 1 in 1,000 patients):

• Dizziness;
• Tinnitus (ringing in the ears).

Very rare (occurring in fewer than 1 in 10,000 patients):

• Oesophagitis, pancreatitis, formation of diaphragm-like intestinal strictures;
• Gastric ulcer, perforation or bleeding from the gastrointestinal tract, vomiting blood, black tarry stools, sometimes with fatal outcome, especially in elderly patients;
• Kidney function disorders manifested by decreased or increased urine volume, cloudy urine, blood in urine, back pain and development of oedema (especially in legs). Increased urea concentration, renal failure, nephrotic syndrome, interstitial nephritis, possibly leading to acute renal failure. Chronic abuse of various painkillers may in rare cases lead to serious kidney problems.
• Liver function disorders, liver damage and acute hepatitis, especially during long-term use, liver failure;
• Blood cell production disorders (anaemia, leukopenia – reduced number of white blood cells, thrombocytopenia – reduced number of platelets, pancytopenia – haematological disorder characterised by deficiency of all blood components: erythrocytes, leukocytes and platelets, agranulocytosis – reduced number of granulocytes). Initial symptoms include:

fever, sore throat, mucosal erosions in the mouth, flu-like symptoms, severe exhaustion, bleeding (e.g. bruising, petechiae, purpura and nosebleeds).

• Severe skin infections during chickenpox;
• Facial, throat and tongue swelling, dyspnoea, rapid heartbeat, low blood pressure, shock;
• Worsening of inflammatory conditions associated with infection (e.g. necrotising fasciitis). During ibuprofen use in patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or disturbances in consciousness have been observed.
• Oedema, hypertension, palpitations, heart failure;
• Psychotic reactions and depression.

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

• Skin becomes sensitive to light;
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

Taking medicines such as Metafen IBUPROFEN CAPS may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Metafen IBUPROFEN CAPS

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Metafen IBUPROFEN CAPS contains

• The active substance is ibuprofen. Each capsule contains 200 mg of ibuprofen.
• Other ingredients: macrogol 600, potassium hydroxide, purified water; Capsule shell: gelatin; sorbitol liquid, non-crystallising (E 420); maltitol liquid (E 965); patent blue (E 131); purified water.

What Metafen IBUPROFEN CAPS looks like and contents of the pack
Metafen IBUPROFEN CAPS are soft blue gelatin capsules.
Pack contents: 6, 10, 20, 30, 50 capsules in PVDC/PVC/Aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz