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Bodegon APIROFENO_JUNY'16 (2)

Apirofeno suspensión oral 40 mg/ml

Ibuprofeno.

Antiinflamatorio y antipirético.

Cada ml contiene 40 mg de ibuprofeno.

Única concentración 40 mg/ml. Evita confusión.

No contiene azúcar.

Agradable sabor a fresa.

    50 ml bottle with safety cap.

    Unique market ibuprofen in 50ml bottle.

    Adapted to the needs of children up to 2 years.

    3 ml oral syringe graduated every 0.1 ml. High precision

    Financed by S.N.S. N.

    C. 664267.2

    150 ml bottle with safety cap.

    Contains a graduated oral syringe per ml and the weight of the child according to a dosage of 25 mg / kg / day divided into three doses.

    With the graduated oral syringe child's weight can be given the proper dosage overdose avoiding (as much) and underdosing (fewer).

    Financed by S.N.S.

    N.C. 656565.0

The dose of ibuprofen to be administered depends on the age and weight of the child. As a general rule, for children of 3 to 12 years old, the recommended dose is 20 to 30mg/kg of weight, split over three or four doses. It is recommended not to exceed the dose of 40mg/kg of ibuprofen. The use of this medicine in children younger than 3 months old is not recommended. The interval between doses will depend on the evolution of the symptoms but must never be less than 4 hours. Even so, as a means of orientation, the following dosing regime is recommended:


Adults and children older than 12 The recommended dose is 10 ml 3 times a day (equivalent to 1200 mg of ibuprofen). Patients with liver or kidney illnesses If you suffer from a kidney or liver illness, it is possible that your doctor will prescribe you a lower dose than normal. If this is the case, take the exact dose prescribed. The elderly If you are older than 60, it is possible that your doctor prescribes you a lower than normal dose. If this is the case, you will only be able o increase the dose once your doctor has ascertained that you tolerate the medicine well. It is important to use the smallest dose possible that alleviates/controls the pain and you should not take this medication for more time than necessary in order to control your symptoms.

MEDICATION GUIDE APIROFENO 40 mg/ml oral suspension Ibuprofen

Read the whole of this medication guide in detail, because it contains information that will be important to you. This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use APIRETAL 100 mg/ml SOLUCIÓN ORAL with care to obtain the best results. -Keep this medication guide; you may need to read it again. -If you have any doubts, consult your doctor or pharmacists. This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours. In this leaflet: 1. What are Apirofeno and what are they used for? 2. Before using Aprirofeno 3. How to use Apirofeno 4. Possible adverse effects 5. Storage of Apirofeno

1.What is Apirofeno and what is it used for?

Apirofeno belongs to the nonsteroidal anti inflammatory group of medicines (AINSs).This medicine is indicated in the symptomatic treatment of a temperature or with light or moderate pain.

2.Before taking Apirofeno

Do not take Apirofeno -If you are allergic (hypersensitive) to ibuprofen, or other medicines from the AINS group (eg acetyl salicylic acid, naproxen etc) or any of the other components of Apirofeno. Reactions indicated by the allergy could be itchy skin rashes, swelling of the face, lips and tongue, nasal secretion, difficulty breathing or asthma. -If you have had an ulcer or a haemorrhage of the stomach or duodenum or if you have had a perforation of the digestive apparatus. -If you vomit blood. -If you present black faeces or diarrhoea with blood. -If you suffer from serious cardiac insufficiency. -If you are in the third trimester of pregnancy. -If you suffer from a serious kidney or liver illness. -If you suffer from hemorrhagic disorders or those of coagulation of the blood or if you are taking anticoagulants (medicines to ‘fluidify’ the blood). If it is necessary to use anticoagulants at the same time, your doctor will realise blood coagulation tests. Be especially careful with Apirofeno Inform your doctor: -If you have suffered from or are developing a haemorrhage, ulcer or perforation of the stomach or duodenum, symptoms may be intense or persistent stomach pain, and /or black faeces or even without any previous warning symptoms. -This risk is greater when high doses are used or with extended periods of treatment, with patients with a history of peptic ulcers or elderly patients. In these cases the doctor will look at combining with a medicine that protects the stomach. -If you have edemas (retention of liquids). -If you have asthma or any other breathing disorder. -If you suffer or have suffered from any heart disorders or if you have high blood pressure. -If you suffer from a kidney or liver condition, are over 60 or need to take the medicine for a prolonged period (more than 1 or 2 weeks), it is possible that your doctor will have to do regular controls. Your doctor will involve you of the frequency of these controls. -If you suffer from symptoms of dehydration, for example: serious diarrhoea or vomiting drink abundant quantities of liquid, contact your doctor immediately as in this case, as a consequence of the dehydration ibuprofen could provoke renal insufficiency. -Inform your doctor if you simultaneously take anticoagulant medicines which alter the blood’s coagulation such as oral anticoagulants, antiplatelet agents like aspirin. You should also comment the use of any other medicines that could increase the risk of haemorrhages like corticoids and inhibitive anti-depressives selective for the reuptake of serotonin. -If you suffer from Crohn illness or ulcerative colitis, medicines like Apirofeno can worsen these pathologies. -If you are having treatment with diuretics (medicines to urinate) because your doctor must monitor the working of the kidney. -If you suffer from systematic lupus erythematosus (a chronic illness which affects the immune system and can affect various vital organs, the nervous system, blood cells, the skin and joints), as this medicine can provoke aseptic meningitis. -If you suffer from intermittent acute porphyria (a metabolic illness which affects the blood and can cause symptoms like the reddish coloration of urine, blood in urine or liver illnesses), so that your doctor can decide on the suitability of treatment with this medicine. -If you are receiving treatment with Apirofeno as it can hide a temperature which is an important symptom of infection, making the diagnostic more difficult. -If you suffer headaches after prolonged treatment you mustn’t take higher doses of the medicine. -It is possible that this medicine causes allergic reactions. -Your doctor will control more strictly after going through major surgery. -It is recommended not to take this medicine if you have chickenpox. -It is important to take the smallest dose that alleviates/controls the pain and you should not take this medicine for more time than is necessary to control the symptoms. Cardiovascular precautions Medicines such as Apirofeno can be associated with a moderate increase in the risk of suffering heart attacks (Myocardial infarction) or strokes. This risk is more probable with the use of high doses and with prolonged treatments. Do not exceed the recommended dose or length of treatment. If you have cardiac problems, a history of strokes or you think there is a risk you may suffer from these pathologies (for example, you have high blood pressure, diabetes, high cholesterol or smoke), you should consult the treatment with your doctor or pharmacist. This medicine can also produce the retention of liquids, especially in patients with cardiac insufficiency and/or high blood pressure (hypertension). Precautions during pregnancy and with women of reproductive age Due to the administration of medicines like Apirofeno having been associated with an increase in the risk of suffering congenital anomalies or abortions the administration of this medicine in the first 2 trimesters of pregnancy is not recommended unless it is considered strictly necessary. In these cases the dose and period of treatment shall be limited to the minimum possible. In the third trimester the administration of Apirofeno is contraindicated. For patients of reproductive age it should be considered that medicines like Apirofeno have associated with a reduced reproductive capacity. Use of other medicines Inform your doctor if you are using or have recently used any other medication, even those acquired without a prescription. The following medicines can interfere, and consequently shouldn’t be taken with Apirofeno without first consulting your doctor: -Anticoagulant medicines (medicines used to ‘fluidify’ the blood and prevent the apparition of clots) like acetylsalicylic acid and warfarin. -Corticoids like cortisone and predisnolone. -Selective inhibitors for the reuptake of serotonin (used with depression). -Other AINSs such as asperin. -Lithium (a medicine used in the treatment of depression). Your doctor may adjust the dose of this medicine. -Methotrexate (to treat cancer and inflammatory illnesses). Your doctor may adjust the dose of this medicine. -Mifepristone (inductor of abortions). -Digoxin and other cardio tonic glycosides (used in the treatment of heart disorders). -Hydantoins like fenitantoin (used in the treatment of epilepsy). -Sulfamides such as sulfametoxazole and cotrimoxazole (used in the treatment of some bacterial infections). -Diuretics (medicines used for the elimination of urine). -Penoxifiline (to treat intermittent claudication). -Probenecid (used with patients with gout or in conjunction with penicillin with some infections). -Antibiotics of the quinolones group such as norfloxacine). -Sulfinpyrazone (used in the treatment of gout). -Solfonylureas like tolbutamide (for diabetes). -Tacrolimus or cyclosporine (used in organ transplants to avoid rejection). -Anti hypertension (to reduce high blood pressure). -Thrombolytics (used for the treatment of thrombi). - Zidovudine (used in the treatment of the AIDS virus). -Aminoglycoside antibiotics such as neomycin. -Herb extracts (from the Ginkgo biloba tree). Taking Apirofeno with food and drink It is recommended to take Apirofeno with milk, with food or immediately after eating, in order to reduce the possibilities of stomach discomfort. Pregnancy and breast feeding Consult your doctor or pharmacist before taking any medicine. You should not take Apirofeno during pregnancy, particularly during the third trimester (see section on precautions during pregnancy and with women or reproductive age). Although only small quantities pass through to the maternal milk it is recommended not to take Apirofeno for prolonged periods while breast feeding. It is not necessary to interrupt breast feeding during a short period of treatment with the recommended dose for pain and fever. Consequently if you become pregnant or are breast feeding, consult your doctor. Driving and the use of machines If you only take one dose of Apirofeno or only during a short period, it is not necessary to take special precautions. If you experience dizziness, vertigo, alterations of vision or other symptoms while taking this medicine, you must not drive or use dangerous machinery. Important information about some of the components of Apirofeno This medicine can produce allergic reactions as it contains azorubine (E-122). It can provoke asthma particularly in patients allergic to acetyl salicylic acid. This medicine contains maltitol syrup (E-965). If your doctor has indicated that you suffer from an intolerance to certain sugars, consult with him/her before taking this medicine.

3.How to take Apirofeno

Follow the instructions given by your doctor exactly. Consult your doctor or pharmacist if you have doubts. Apirofeno is a suspension for oral administration. It can be administered either directly or diluted in water. For an exact dosage the containers come with a small double ended spoon with measures of 1.25, 2.5 or 5ml, or an oral syringe graduated to 3 or 5 ml. The syringe is introduced into the perforated lid, the bottle is inverted, the plunger is pulled back until the liquid reaches the required mark in ml, the bottle is returned to its original position and the syringe withdrawn. The syringe must be cleaned and dried after each use. Patients with stomach discomfort must take the medicine either with milk or during meals. Children The dose of ibuprofen to be administered depends on the age and weight of the child. As a general rule, for children of 3 to 12 years old, the recommended dose is 20 to 30mg/kg of weight, split over three or four doses. It is recommended not to exceed the dose of 40mg/kg of ibuprofen. The use of this medicine in children younger than 3 months old is not recommended. The interval between doses will depend on the evolution of the symptoms but must never be less than 4 hours. Even so, as a means of orientation, the following dosing regime is recommended: Adults and children older than 12 The recommended dose is 10 ml 3 times a day (equivalent to 1200 mg of ibuprofen). Patients with liver or kidney illnesses If you suffer from a kidney or liver illness, it is possible that your doctor will prescribe you a lower dose than normal. If this is the case, take the exact dose prescribed. The elderly If you are older than 60, it is possible that your doctor prescribes you a lower than normal dose. If this is the case, you will only be able o increase the dose once your doctor has ascertained that you tolerate the medicine well. It is important to use the smallest dose possible that alleviates/controls the pain and you should not take this medication for more time than necessary in order to control your symptoms. Consult your doctor if during the period of treatment your symptoms persist or get worse. If you consider the effect of this medicine to be too weak or too strong, communicate it to your doctor or pharmacist. If you take more Apirofeno than you should If you have taken more Apirofeno than you should or have accidentally ingested the contents of the container immediately consult your doctor, pharmacist or the Toxicology Information Service, telephone: 915620420, indicating the medicine and the amount ingested. It is recommended to take the container and information leaflet to health staff. The mild symptoms of an overdose are: abdominal pain, nausea, vomiting, indifference, tiredness, headaches, involuntary quick eye movements, buzzing in the ears and a lack of muscular coordination. It is rare that more serious symptoms such as an intestinal haemorrhage lowering of blood pressure, lowering of body temperature, metabolic acidosis, convulsions, alteration of the working of the kidneys, coma, breathing distress in adults and temporary stopping of breathing in children (after ingesting large quantities) occur. If serious intoxication has taken place, the doctor will adopt the necessary measures. In the case of ingestion of significant quantities active carbon will need to be administered. Emptying of the stomach will be considered if significant quantities have been ingested and during the 60 minutes following ingestion. If you forgot to take Apirofeno Do not take a double dose to compensate the forgotten ones. If you forget to take a dose, take it as soon as you remember. However, if the time for the next dose is very near, skip the dose you forgot and take the next dose at the customary time.

4.Possible side effects

As with all medicines Apirofeno can produce side effects, although not everyone suffers them. Side effects of medicines like Apirofeno are more common in patients older than 65. The incidence of side effects is less in short treatments and if the daily dose is below the maximum recommended dose. Frequencies are established according to the following classification: very frequent (more than 1 in 10 patients); frequent (between 1 and 10 every 100 patients); infrequent (between 1 and 10 every 1000 patients); rare (between 1 and 10 every 10000 patients); extremely rare (less than 1 every 10000 patients); unknown frequency (impossible to estimate from the available data). The following side effects have been observed: Gastrointestinal: The most frequent adverse effects that occur with medicines like Apirofeno are gastrointestinal: peptic ulcers, digestive haemorrhages, perforations (in some cases mortal) especially with elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, stomach ardour, abdominal pain, blood in faeces, vomiting blood, oral thrush, worsening of ulcerative colitis, and Chron illness (chronic illness in wich the immune system attacks the intestine provoking inflammation which generally produces diarrhoea with blood) have been observed. Less frequently gastritis has also been observed. Other adverse effects are: Infrequent: inflammation of oral mucosa with the formation of ulcers. Rare: inflammation of oesophagus, stretching of the oesophagus (estenosis esofagica), worsening of the illness of the intestinal diverticula, unspecific haemorrhaged colitis (gastroenteritis with diarrhoea with blood). Very rare: pancreatitis. Cardiovascular: Medicines like Apirofeno can be associated with a moderate increase in the risk of suffering a heart attack or stroke. The following have also been observed; edema (retention of liquids), high blood pressure, and cardiac insufficiency in association with treatments with the same type of medicines as Apirofeno. Cutaneous Medicines like Apirofeno can, on very rare occasions, be associated with very serious blistering reactions like Stevens Johnson syndrome (erosions disseminated which affect the skin and two or more mucouses and purple colour injuries, preferably on the trunk) and toxic epidermic necrolisis (erosion of the mucouses and painful injuries with necrosis and detachment of the epidermis). Other adverse effects are: Frequent: skin rashes. Infrequent: reddening of the skin, itching and swelling of the skin, purple or violet stains on the skin. Very rare: hair loss, erythema multiforme (injuries of the skin), skin reactions caused by the light, inflammation of the skin’s blood vessels. In exceptional cases serious cutaneous infections can occur as well as complications with the soft membrane during chickenpox. Immune system: Infrequent: passing edema in some skin areas, mucosa or viscera (angiodema), inflammation of the nasal mucosa, bronchi spasms (spasms of the bronchi which impede the passage of air to the lungs). Rare: serious allergic reactions (anaphylactic shock). In the case of a reaction and serious generalised hypersensibility the following can appear; swelling of the face, tongue and larynx, bronchi spasms, asthma, tachycardia, hypotension and shock. Very rare: aches in the joints and fever (lupus eritematoso). Central nervous system Frequent: fatigue or drowsiness, headaches and dizziness or a feeling of instability. Rare: parastheseia ( a feeling of sleepiness, tingling, numbness etc, more frequent in hands, feet, arms or legs). Very rare: aseptic meningitis (inflammation of the meninges which are the membranes which protect the brain and the spinal chord, not caused by bacteria). In most of the cases where aseptic meningitis with ibuprofen have been communicated the patient suffered from some kind of immune system illness (such as systematic lupus eritematoso or other illnesses of the collagen), which added a risk factor. Symptoms of aseptic meningitis observed were a stiff neck, headaches, nausea, vomiting, fever or disorientation. Psychiatric: Infrequent: insomnia, anxiety, alarm. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction. Heraring Frequent: Vertigo. Infrequent: buzzing or whistling in the ears. Rare: Hearing difficulty. Sight: Infrequent: alterations of vision. Rare: abnormal or blurred vision. Blood: Rare: decrease in the platelets, decrease in white blood cells (it can appear as the appearance of frequent infections with fever, shivers or a sore throat), decrease in red blood cells (this can appear as breathing difficulty and paleness), decrease in granulocytes (a type of white blood cell which can predispose to getting infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (severe decrease in the granulocytes), aplasic anaemia (insufficiency of the bone marrow to produce different types of cells) or haemolytic anaemia (premature destruction of the red blood cells). The first symptoms are: fever, a sore throat, superficial mouth ulcers, pseudo flulike symptoms, extreme tiredness, nasal or cutaneous haemorrhages. Very rare: Prolongation of time bleeding. Renal: Based on experience with AINSs in general the following cannot be ruled out instertitial nephritis (a kidney disorder), nephrotic syndrome (a disorder characterised by proteins in urine and swelling of the body) and renal insufficiency (sudden loss of the working of the kidney). Hepatic: Medicine like Apirofeno can, on rare occasions be associated with hepatic injuries. Other rare adverse effects are hepatitis (inflammation of the liver), anomalies in the hepatic function and jaundice (yellow colouring of the skin and eyes). Unknown frequency: hepatic deficiency (severe deterioration of the liver). General: Aggravation of inflammations during infectious processes. Until now allergic reactions to Apirofeno have not been communicated though they cannot be discarded. The manifestations of this kind of reaction could be; fever, skin rashes, back pain, intense and persistent headache, nausea, vomiting, swelling of the face, tongue and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure) or shock. If any of the following side effects appear interrupt the treatment and see your doctor immediately: -Allergic reactions such as skin rashes, swelling of the face, whistling in the chest or breathing difficulty. -Vomiting blood or with an appearance similar to coffee grinds. -Blood in faeces or diarrhoea. -Intense stomach pain. -Blistering or peeling of the skin. -Intense or persistent headaches. -Yellow colouring of the skin (jaundice). -Signs of serious hyper sensibility (see above in the corresponding section). -Swelling of the extremities or accumulation of liquid in the arms or legs. If you consider any of the side effects to be serious or appreciate a side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5.Conservation of Apirofeno

Maintain it out of the sight and reach of children. Conserve the solution in its original container. It does not require any special means of conservation. Do not use Apirofeno after the expiry date that appears on the cardboard container after ‘CAD’. The expiry date is the last day of the month indicated. Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment.

6.Additional information

Composition of Apirofeno 40mg/ml oral suspension -The principal ingredient is ibuprofen. Each ml of oral suspension contains 40mg of ibuprofen as the principal ingredient. -The remaining components (excipients) are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), taumatine (E-957), aroma of strawberry, azorubine colouring (E-122), glycerol (E-422), and purified water. Appearance of the product and container contents Apirofeno 40 mg/ml oral suspension is a pink oral suspension. It is presented in containers of 30, 50, 100 and 150 ml. Holder of the authorisation for the commercialisation and fabrication of the product. LABORATORIOS ERN, S.A. Pedro IV, 499 - 08020 Barcelona, España Tel: 93 314 80 11 Fax: 93 314 40 96 Responsable for fabrication. Laboratorios ERN, S.A. Gorcs i LLadó, 188 – 08210 Barberá del Vallés, Barcelona. España. Laboratorios ERN, S.A. Perú, 228 – 08020 Barcelona. España This information leaflet was approved in May 2011 Detailed and updated information about this medicine is available on the web page of the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.es