METAFEN MAX 200mg/500mg x 20 tabl
Package leaflet: information for the user Metafen Max 200 mg/500 mg film-coated tablets
ibuprofen/paracetamol
Metafen Max 200 mg/500 mg film-coated tablets
ibuprofen/paracetamol
Read all of this leaflet carefully before you start 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.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after 3 days or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Metafen Max is and what it is used for
2. What you need to know before you take Metafen Max
3. How to take Metafen Max
4. Possible side effects
5. How to store Metafen Max
6. Contents of the pack and other information
1. What Metafen Max is and what it is used for
This medicine is called Metafen Max.
Metafen Max contains two active ingredients (which contribute to the action of the drug). These are ibuprofen and paracetamol.
Ibuprofen is in a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain and swelling and lowering high fever.
Paracetamol is a painkiller that works differently than ibuprofen to relieve pain and high fever.
Metafen Max is used for the temporary relief of mild to moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, rheumatic and muscular pain, cold and flu symptoms, sore throat and fever.
2. What you need to know before you take Metafen Max
Do not take Metafen Max if:
- you are already taking another medicine containing paracetamol;
- you are taking other painkillers, including ibuprofen, high dose acetylsalicylic acid (more than 75 mg daily) or other non-steroidal anti-inflammatory drugs (NSAIDs), including specific cyclooxygenase-2 (COX-2) inhibitors;
- you are allergic to ibuprofen, paracetamol or any of the other ingredients of this medicine (listed in section 6);
- you are allergic to acetylsalicylic acid or other NSAID painkillers;
- you have or have ever had an ulcer or bleeding in the stomach or duodenum (small intestine);
- you have a blood clotting disorder (coagulation);
- you suffer from heart, liver or kidney failure;
- you are in the last 3 months of pregnancy;
- you are under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Metafen Max if:
- you have an infection – see the heading “Infections” below;
- you are elderly;
- you have or have had asthma;
- you have kidney, heart, liver or intestinal problems;
- you have systemic lupus erythematosus (SLE) - an immune system disorder affecting connective tissue, leading to joint pain, skin changes and involvement of other organs, or another mixed connective tissue disease;
- you have gastrointestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease);
- you are in the first 6 months of pregnancy or breastfeeding;
- you are planning to become pregnant.
Infections
Metafen Max may mask the signs of infection, such as fever and pain. Metafen Max may therefore delay appropriate treatment of the infection, which may increase the risk of complications. This is seen in pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection and the symptoms of the infection persist or worsen, you should consult a doctor immediately.
Severe skin reactions have been reported in association with the use of Metafen Max. You should stop taking Metafen Max and seek medical attention immediately if you notice a skin rash, mucous membrane disorders, peeling or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.
Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Metafen Max if:
- You have heart problems, including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or any heart attack (including a “mini-heart attack” or transient ischemic attack).
- High blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or you are a smoker.
Other medicines and Metafen Max
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Metafen Max with
- other medicines containing paracetamol;
- other medicines containing NSAIDs, such as acetylsalicylic acid, ibuprofen.
Metafen Max may affect or be affected by the action of some other medicines. For example:
- corticosteroids;
- antibiotics (e.g. chloramphenicol or quinolones);
- medicines against nausea and vomiting (e.g. metoclopramide, domperidone);
- anticoagulant drugs (i.e. blood thinners/prevents clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
- cardiac stimulants (e.g. glycosides);
- medicines for high cholesterol (e.g. cholestyramine);
- diuretics (increase urination);
- medicines that lower high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin-II receptor antagonists, such as losartan);
- medicines that suppress the immune system (e.g. methotrexate, cyclosporine, tacrolimus);
- medicines for mania or depression (e.g. lithium or selective serotonin reuptake inhibitors (SSRIs));
- mifepristone (for termination of pregnancy);
- HIV medicines (e.g. zidovudine).
Some other medicines may also affect or be affected by taking Metafen Max. Therefore, you should always consult a doctor or pharmacist before taking Metafen Max with other medicines.
Metafen Max with food, drink and alcohol
To reduce the likelihood of side effects, take Metafen Max with food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Metafen Max if you are in the last 3 months of pregnancy. Take special care if you are in the first 6 months of pregnancy.
Metafen Max may make it difficult to get pregnant. Ibuprofen is in a group of medicines that can impair fertility in women. This is reversible when the medicine is stopped. You should tell your doctor if you have problems getting pregnant.
Driving and using machines
After taking NSAIDs, side effects such as dizziness, drowsiness, fatigue and visual disturbances are possible. If they have complaints, patients should not drive or operate machinery.
Metafen Max contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.
3. How to take Metafen Max
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
For oral administration and for short-term use only.
The lowest effective dose should be used for the shortest possible time to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
You should not take Metafen Max for more than 3 days. If symptoms worsen or persist, consult your doctor.
The recommended dose is 1 tablet, taken with water and food, up to 3 times daily.
There should be at least a 6-hour interval between doses.
If one tablet does not control symptoms, no more than 2 tablets can be taken up to three times daily.
Do not take more than six tablets per day (this corresponds to 3000 mg of paracetamol, 1200 mg of ibuprofen daily).
Use in children and adolescents
This medicine is not suitable for use in children and adolescents under 18 years of age.
If you take more Metafen Max than you should
If you take more Metafen Max than you should or if children have taken Metafen Max by mistake, always consult a doctor or the nearest hospital about the risks and what action to take.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and rapid eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, a feeling of coldness in the body, and difficulty breathing have been reported.
Talk to your doctor straight away if you take too much of this medicine, even if you feel well. This is essential as paracetamol can cause serious delayed liver damage.
If you forget to take Metafen Max
Do not take a double dose to make up for a missed dose. If you miss a dose, take it as soon as you remember and wait at least 6 hours before taking your next dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING the medicine and talk to your doctor in case of:
- heartburn, indigestion;
- signs of intestinal bleeding (severe stomach pain, vomiting blood or liquid that looks like coffee grounds, blood in the stools/faeces, tarry black stools);
- signs of inflammation of the brain lining, such as: stiff neck, headache, nausea or vomiting, fever or disorientation;
- signs of a severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing, worsening of existing asthma);
- severe skin reactions such as blistering - see information below;
- high blood pressure, fluid retention;
- liver problems (causing yellowing of the skin and whites of the eyes);
- kidney problems (causing increased or decreased urination, swelling of the legs);
- heart failure (causes shortness of breath, swelling);
- a severe skin reaction called DRESS syndrome (frequency not known). Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).
Other possible side effects
Common (may affect up to 1 in 10 people):
- stomach pain or discomfort, nausea or vomiting, diarrhea;
- high levels of liver enzymes (in blood tests);
- excessive sweating.
Uncommon (may affect up to 1 in 100 people):
- headache and dizziness, gas and constipation, skin rashes, facial swelling;
- decrease in the number of red blood cells or increase in the number of platelets (cells responsible for blood clotting).
Very rare (may affect up to 1 in 10,000 people):
- reduction in blood cell counts (causing sore throat, mouth ulcers, flu-like symptoms, severe fatigue, bleeding, bruising and nosebleeds for unknown reasons);
- visual disturbances, tinnitus, feeling of dizziness;
- confusion, depression, hallucinations;
- fatigue, general malaise.
Not known (frequency cannot be estimated from the available data):
- a red, scaly rash on a broad base with bumps under the skin and blisters, localized mainly in the skin folds, the body and upper limbs, accompanied by high fever, at the beginning of treatment (acute, generalized exanthematous pustulosis). Stop taking Metafen Max if you notice these symptoms and seek medical help immediately.
Medicines such as Metafen Max may be associated with a slightly increased risk of heart attack (“myocardial infarction”) or stroke (see section 2).
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street,
1303 Sofia,
Tel.: +35 928903417,
website: www.bda.bg.
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Metafen Max
Keep out of the reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP and on the blister and bottle after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Metafen Max contains
- The active substances are ibuprofen and paracetamol. Each film-coated tablet contains 200 mg ibuprofen and 500 mg paracetamol.
- The other ingredients are: croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, stearic acid, magnesium stearate.
Film coating: macrogol-poly(vinyl alcohol), graft copolymer, talc, mica-based pearl pigment (Mica/Titanium dioxide (E171)), poly(vinyl alcohol), glycerol monocaprylocaprate, titanium dioxide (E171), black iron oxide (E172).
What Metafen Max looks like and contents of the pack
Metafen Max are gray, oblong, film-coated tablets with shine and the inscription "200 M 500" on one side. Size of the film-coated tablet: length: 18.9-19.4 mm, width: 8.9-9.3 mm.
Metafen Max are packaged in:
- Al/PVC/PVDC blisters. Pack sizes contain 10 or 20 film-coated tablets.
- HDPE bottle with LDPE cap with desiccant. The pack contains 30 film-coated tablets.
Not all types of packaging can be released for sale.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
street Pelplińska 19, 83-200 Starogard Gdański
Poland
Manufacturer
Zakłady Farmaceutyczne POLPHARMA SA
street Pelplińska 19, 83-200 Starogard Gdański
Poland
This medicinal product is authorised in the Member States of the EEA under the following names:
Latvia: Metafenex 200mg/500mg film-coated tablets
Bulgaria: Metafen Max 200 mg/500 mg film-coated tablets
Lithuania: Metafenex 200mg/500mg plėvele dengta tabletės
Date the leaflet was last revised