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Dalsy is a nonsteroidal antiinflammatory drug (NSAID) indicated for the symptomatic treatment of fever and pain of mild to moderate intensity
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1. WHAT IS Dalsy 20 MG / ML ORAL SUSPENSION AND WHAT IT IS USED
Dalsy 20 mg / ml oral suspension is in a group of medicines called nonsteroidal antiinflammatory medicines (NSAIDs).
This medicine is indicated for the symptomatic treatment of fever and pain of mild to moderate intensity.
2. BEFORE YOU TAKE Dalsy 20 MG / ML ORAL SUSPENSION
Do not take Dalsy 20 mg / ml oral suspension if:
- If you are allergic (hypersensitive) to ibuprofen, other medicines group noesteroideos anti-inflammatory medicines (NSAIDs), aspirin or any of the other ingredients of Dalsy 20 mg / ml. The reactions that indicate allergy may include: itchy rash, swelling of the face, lips or tongue, runny nose, shortness of breath or asthma.
- If you have severe liver or kidneys.
- If you have had an ulcer or bleeding stomach or duodenum or have suffered a perforation of the digestive tract.
- If you vomit blood.
- If you have black stools or bloody diarrhea.
- If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "liquefy" the blood). If you need to use both anticoagulant medication, the doctor will perform some tests for blood clotting.
- If you have severe heart failure.
- If you are in the third trimester of pregnancy.
Take special care with Dalsy 20 mg / ml oral suspension
Tell your doctor:
- If you have edema (fluid retention).
- If you have or have had a heart problem or have high blood pressure.
- If you have asthma or other respiratory disorder.
- If you are being treated with Dalsy 20 mg / ml oral suspension as it may mask fever, which is an important sign of infection, making it difficult to diagnosis.
- If you have a kidney disease or liver disease, has over 60 years or need to take the medicine prolonged (more than 1-2 weeks), your doctor may need to carry out checks on a regular basis. Your doctor will indicate the frequency of these controls.
- If you have symptoms of dehydration, severe diarrhea or vomiting eg drink plenty of fluids and contact your doctor immediately as ibuprofen in this case could lead to dehydration as a result of kidney failure.
- If you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, and can be manifested by an intense or persistent abdominal pain and / or black stools, or even without prior warning signs color.
- This risk is higher when high doses and prolonged treatment used in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor will consider the possibility of associating a protective medicine stomach.
- If you take simultaneously altering medicines such as blood clotting, oral anticoagulants, antiplatelet agents aspirin type. You should also tell the use of other medicines that may increase the risk of bleeding such as corticosteroids and antidepressants selective inhibitors of serotonin reuptake.
- If you suffer from Crohn's disease (chronic disease in which the immune system attacks the intestine causing inflammation that causes bloody diarrhea usually) or ulcerative colitis medications for type Dalsy 20 mg / ml oral suspension may worsen these conditions.
- If you are being treated with diuretics (medicines to urinate) because your doctor should monitor your kidney function.
- If you suffer from lupus erythematosus (chronic disease that affects the immune system and can affect other vital organs, nervous system, blood vessels, skin and joints) since (inflammation of the meninges which are may aseptic meningitis occur the membranes that protect the brain and spinal cord, not caused by bacteria).
- If you have acute intermittent porphyria (metabolic disease that affects the blood and can cause symptoms such as redness of the urine, blood in urine or liver disease), to assess whether or not treatment with ibuprofen.
- If you suffer headaches after prolonged treatment should not take higher doses of the medicine.
- Allergic reactions may occur with this medicine.
- The doctor will perform a tighter control if you receive ibuprofen after undergoing major surgery.
- It is advisable not to take this medicine if you have chickenpox.
It is important that you use the lowest dose that alleviates / control pain and should not take this medicine for longer than necessary to control symptoms.
Medications such as Dalsy 20 mg / ml oral suspension may be associated with a moderate increase in the risk of heart attacks brain ( "myocardial infarction") or. This risk is more likely to occur when high doses and prolonged treatment are used. Do not exceed the dose or duration of treatment recommended.
If you have heart problems, history of stroke or think you might be at risk to suffer these pathologies (eg, have high blood pressure, suffers from diabetes, has increased cholesterol or smoking) should consult this treatment with your doctor or pharmacist .
Also these medicines can cause fluid retention, especially in patients with heart failure and / or high blood pressure (hypertension).
Precautions during pregnancy and in women of childbearing age
Because the medicine delivery rate Dalsy 20 mg / ml oral suspension has been associated with an increased risk of congenital / abortions abnormalities its administration is not recommended during the first and second trimester of pregnancy unless judged strictly necessary. In these cases the dose and duration will be limited to a minimum.
In the third quarter Dalsy administration of 20 mg / ml oral suspension is contraindicated.
For patients of childbearing age should take into account that type medicines Dalsy 20 mg / ml oral suspension have been associated with a decreased ability to conceive.
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Dalsy 20 mg / ml oral suspension with food and drink
It is recommended to take Dalsy 20 mg / ml oral suspension with milk or food, or immediately after eating, to reduce the possibility of discomfort occurring in the stomach.
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
Do not take Dalsy 20 mg / ml oral suspension during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age).
Although only small amounts of the medicine pass into breast milk, it is recommended not to take ibuprofen for long periods during lactation. No need to stop feeding for a short treatment with the recommended dose for pain and fever.
Therefore, if you become pregnant or breastfeeding, consult your doctor.
Driving and using machines
If you experience dizziness, vertigo, impaired vision or other symptoms while taking this medicine, you should not drive or operate hazardous machinery. If a dose of only Dalsy 20 mg / ml or for a short period, it is not necessary to take special precautions.
Important information about some of the ingredients of Dalsy 20 mg / ml oral suspension This medicinal product contains maltitol liquid. Patients with rare hereditary fructose intolerance should not take this medicine.
This medicine may cause allergic reactions because it contains azorubine. It can cause asthma, especially in patients allergic to aspirin.
This medicine contains 0.25 mmol (5.8 mg) of sodium per milliliter, which should be considered in the treatment of patients with sodium diet.
3. HOW TO TAKE Dalsy 20 MG / ML ORAL SUSPENSION
Follow the instructions exactly Management Dalsy 20 mg / ml prescribed by your doctor. Ask your doctor or pharmacist if you have doubts.
Dalsy 20 mg / ml is a suspension for oral administration. It may be administered directly or diluted in water.
For accurate dosing, packaging containing a graduated oral dosing. You must first shake the solution, then the dispenser is inserted into the drilled stopper, the bottle is inverted, pull the plunger until the liquid reaches the amount prescribed by the doctor, becomes the bottle to its original position and removed from the dispenser .
The dispenser must be disassembled, washed and dried after each use and can be sterilized by boiling in water or immersion in the solution used for sterilizing bottles.
Your doctor will indicate the duration of treatment with Dalsy 20 mg / ml. Do not stop treatment before, because then not obtain the expected results. Similarly Dalsy not use 20 mg / ml longer than directed by your doctor.
Patients with stomach upsets should take the medicine with milk and / or during meals.
The dose of ibuprofen depends on the age and weight of the child. As a rule, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg body weight, divided into three or four shots. It is recommended not to exceed the maximum daily dose of 40 mg per kg of ibuprofen.
the use of this medicine in children under 3 months is not recommended.
The interval between doses depend on the evolution of the symptoms, but will never be less than 4 hours. However, as a guideline, the following dosage schedule is recommended:
Children from 3 to 6 months ----- Approx. 5 to 7.6 kg ----- 2.5 ml 3 times per day (150 mg ibuprofen / day)
Children 6 to 12 months ----- Approx. 7.7 to 9 kg ----- 2.5 ml of 3 to 4 times a day (150 mg-200 mg ibuprofen / day)
Children 1 to 3 years old ----- Approx. 10 to 15 kg ----- 5 ml 3 to 4 times a day (300 mg-400 mg ibuprofen / day)
Children 4 to 6 years old ----- Approx. 16 to 20 kg ----- 7.5 ml 3 to 4 times a day (450 mg-600 mg ibuprofen / day)
Children 7 to 9 years old ----- Approx. 21 to 29 kg ----- 10 ml 3 to 4 times a day (600 mg-800 mg ibuprofen / day)
Children 10 to 12 years old ----- Approx. 30 to 40 kg ----- 15 ml 3 to 4 times a day (900 mg-1200 mg ibuprofen / day)
Adults and children over 12 years old:
Because the amount of ibuprofen Dalsy containing 20 mg / ml oral suspension, use more suitable for treatment with ibuprofen in adults and children over 12 years old presentations is recommended.
If you are over 60 years old your doctor may prescribe a lower dose than usual. If so, you can only increase the dose once your doctor has checked that tolerates the medicine well.
It is important that you use the lowest dose that alleviates / control pain and should not take this medicine for longer than necessary to control symptoms.
Consult your doctor if during the treatment period the symptoms persist or worsen.
If it considers that the action of Dalsy 20 mg / ml is too strong or too weak, talk to your doctor or pharmacist.
If you take more Dalsy 20 mg / ml oral suspension than you should:
If you have taken more Dalsy of what should or have accidentally ingested the contents of the package, immediately consult your doctor or pharmacist or poison control center, phone: +34 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the medication to health professionals. Mild symptoms of an overdose are: abdominal pain, nausea, vomiting, listlessness, sleep, headache, rapid involuntary eye movements, tinnitus and lack of muscle coordination.
It is rare that appear more severe symptoms such as intestinal bleeding, voltage drop, drop in body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress syndrome and transient stop breathing in children (after ingesting large quantities).
If there has been a serious poisoning, the doctor will take the necessary measures.
In case of ingestion of large quantities activated charcoal should be administered. Stomach emptying will arise if ingested significant amounts and for 60 minutes after ingestion.
If you forget to take Dalsy 20 mg / ml oral suspension:
Do not take a double dose to make up for missed doses.
If you miss a corresponding dose as soon as you remember. However, if when the next shot is very close, skip the missed dose and take the next dose at the usual time.
4. POSSIBLE SIDE EFFECTS
Like all Dalsy 20 mg / ml medications can cause side effects, although not everybody gets them all.
Adverse effects of medicines as Dalsy 20 mg / ml are more common in people over 65 years old.
The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.
The most common side effects that occur with medicines like Dalsy 20 mg / ml oral suspension are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforation (sometimes fatal), especially in the elderly. There have also been nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, vomiting blood, mouth sores, worsening of ulcerative colitis and Crohn's disease (chronic disease in which the immune system attacks It is causing the gut inflammation that causes bloody diarrhea usually). Less frequently it has been noticed an outbreak of gastritis.
Other side effects are: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: inflammation of the esophagus, narrowing of the esophagus (esophageal stricture), exacerbation of intestinal diverticula disease, unspecific haemorrhagic colitis (gastroenteritis that causes bloody diarrhea). Very rare: pancreatitis.
Medications such as Dalsy 20 mg / ml oral suspension may be associated with a modest increased risk of cerebral heart attack ( "myocardial infarction") or.
They have also been observed edema (fluid retention), hypertension, and heart failure in association with medicine treatments Dalsy type 20 mg / ml oral suspension.
Medications such as Dalsy 20 mg / ml may be associated, rarely to very severe bullous reactions such as Stevens Johnson syndrome (disseminated erosions affecting the skin and two or more mucous and purple lesions, preferably in the trunk) toxic epidermal necrolysis and (erosions and painful mucosal lesions with necrosis and loosening of the epidermis). Other side effects include: Common: rash. Uncommon: skin redness, itching or swelling of the skin, purple (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesions), skin reactions under the influence of light, inflammation of blood vessels in the skin. Exceptionally there may be serious skin infections and complications during chickenpox soft tissue.
- Immune system
Uncommon: edema passenger in areas of the skin, mucous membranes or sometimes viscera (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchial tubes that prevent the passage of air into the lungs). Rare: serious allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction may appear swollen face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock. Very rare: joint pain and fever (lupus erythematosus).
- Central nervous system:
Common: fatigue or drowsiness, headache and dizziness or instability. Rare: paresthesia (numbness, tingling, numbness, etc. most common in the hands, feet, arms or legs). Very rare: aseptic meningitis (inflammation of the meninges are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases in which aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as lupus erythematosus or other systemic collagen diseases) which was a risk factor. Symptoms of aseptic meningitis were observed stiff neck, headache, nausea, vomiting, fever or disorientation.
Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.
Common: vertigo. Uncommon: buzzing or ringing in the ears. Rare: hearing impairment.
Uncommon: impaired vision. Rare: abnormal or blurred vision.
Rare: decreased platelets, decreased white blood cells (can be manifested by the appearance of frequent infections with fever, chills or sore throat), decrease in red blood cells (can be manifested by respiratory distress and skin pallor), decreased granulocytes (a type of white blood cells that may predispose to infections constrict), pancytopenia (deficiency of red cells, white cells and platelets in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (failure of the bone marrow to produce different types of cells) or hemolytic anemia (premature destruction of red blood cells). The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds and skin. Very rare: prolonged bleeding time.
Based on the experience with NSAIDs in general, can not be excluded cases of interstitial nephritis (kidney disorder) nephrotic syndrome (disorder characterized by protein in the urine and swelling of the body) and renal failure (sudden loss of ability to function kidney).
Medications such as Dalsy 20 mg / ml may be associated in rare cases to liver damage. Other rare side effects include hepatitis (liver inflammation), abnormal liver function and jaundice (yellowing of the skin and eyes). Not known: liver failure (severe liver impairment).
Aggravation of inflammation during infections.
To date there have been no reports of serious allergic reactions with Dalsy 20 mg / ml, although they can not be excluded. The manifestations of these reactions may include fever, rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue and throat, difficulty breathing, asthma, palpitations, hypotension (blood pressure lower than usual) or shock.
5. HOW TO STORE Dalsy 20 MG / ML ORAL SUSPENSION
Keep out of reach and sight of children. Do not store above 25 ° C.
Do not use Dalsy 20 mg / ml oral suspension after the expiry date on the carton after "EXP". The expiry date is the last day of that month.
6. FURTHER INFORMATION.
- The active substance is ibuprofen.
- The other ingredients are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E-422), strawberry flavor, thaumatin, dye azorubine (E-122) and purified water.
Looks like and contents of the pack
Pink oral suspension. It is available in packs of 30, 100 and 150 ml. It includes a graduated oral dosing.
Authorization holder responsible for marketing and manufacturing
Abbott Laboratories, S.A. Avenida de Burgos, 91- 28050 Madrid
Responsible for manufacturing
Abbvie S.R.L., 04010 Campoverde di Aprilia, Latina. Italy.
MANUFACTURING FARMASIERRA S.L.00Ctra. Irun, km.26,200.00
San Sebastian de los Reyes 28700 (Madrid) Spain
Source: Spanish Agency for Medicines and Health Products