Norvectan 600 mg powder for oral suspension
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Norvectan 600 mg powder for oral suspension
Ibuprofen (lysine)
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Norvectan is and what it is used for
- What you need to know before taking Norvectan
- How to take Norvectan
- Possible side effects
- How to store Norvectan
- Contents of the pack and other information
1. What Norvectan is and what it is used for
Norvectan belongs to a group of medicines known as analgesics. The active substance in this medicine, ibuprofen, is a non-steroidal analgesic, antipyretic, and anti-inflammatory agent presented in the form of a soluble salt (Ibuprofen lysine).
This medicine is used for the symptomatic treatment of mild to moderate pain and non-chronic inflammatory conditions, such as headache, dental pain, postoperative pain, musculoskeletal pain, and menstrual pain.
2. What you need to know before taking Norvectan
Do not take Norvectan if
- You are allergic (hypersensitive) to ibuprofen, to any other non-steroidal anti-inflammatory drug (NSAID), to acetylsalicylic acid, or to any of the excipients of this medicine.
- You have previously had a stomach or duodenal bleed or experienced a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug.
- You have worsening of an inflammatory bowel disease (ulcerative colitis).
- You have severe liver or kidney disease.
- You have severe heart failure.
- You are in the third trimester of pregnancy.
Warnings and precautions
Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately stop using Norvectan and contact your doctor or emergency services if you experience any of these symptoms.
Consult your doctor or pharmacist before starting to take this medicine.
Gastrointestinal precautions
-
If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, and even without prior warning symptoms.
-
This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medication.
-
Inform your doctor if you have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as this medicine may worsen these conditions.
Precautions with other medicines
- If you are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
Cardiovascular precautions
Non-steroidal 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.
You should discuss your treatment with your doctor or pharmacist before taking this medicine if:
- You have heart problems, including heart failure, angina (chest pain), a history of heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
- You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
Also, these types of medicines may 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 ibuprofen administration has been associated with an increased risk of congenital malformations or miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration of treatment should be kept to the minimum possible.
Administration of ibuprofen is contraindicated during the third trimester.
For women of childbearing age, it should be noted that ibuprofen has been associated with reduced fertility.
Other disorders and considerations
If you have had kidney or liver disease.
If you have asthma or any other respiratory disorder.
In other conditions that predispose to fluid retention, ibuprofen should be administered with caution and under medical supervision. In elderly patients, patients with blood disorders, a tendency to bleeding, systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), or mixed connective tissue disease, aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial cause) may occur.
Skin reactions
Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
- If you have an infection, see the “Infections” heading below.
Infections
Ibuprofen may mask signs of infection, such as fever and pain. Therefore, this medicine 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 the symptoms of infection persist or worsen, consult a doctor without delay.
Other medicines and Norvectan
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those obtained without a prescription, especially furosemide, thiazide diuretics, digoxin, phenytoin, lithium, methotrexate, oral hypoglycemics, insulin, zidovudine, corticosteroids, bisphosphonates, or oxypentifylline. The use of this medicine together with salicylates, phenylbutazone, indomethacin, or other non-steroidal anti-inflammatory drugs may increase gastrointestinal damage, and therefore combined therapy is not recommended.
This medicine may affect or be affected by other medicines. For example:
- Anticoagulant medicines (e.g., to treat or prevent clotting problems, e.g., acetylsalicylic acid, warfarin, ticlopidine)
- Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan)
Other medicines may also affect or be affected by treatment with this medicine. Therefore, you should always consult your doctor or pharmacist before using it with other medicines.
Taking Norvectan with food, drinks, and alcohol
This medicine can be taken regardless of meals.
Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before using any medicine.
Ibuprofen should not be taken during the third trimester. (See section on precautions during pregnancy and in women of childbearing age.)
The use of this medicine during breastfeeding is not recommended.
Therefore, if you become pregnant or are breastfeeding, consult your doctor.
Use in elderly patients
Dosage adjustment is generally not required, although in some cases a lower dose may be necessary.
Use in children
Administration is not recommended in children under 12 years of age due to the dose of active ingredient it contains.
Driving and use of machines
Ibuprofen may cause drowsiness or dizziness as rare adverse reactions, which could impair the ability to drive or operate machinery.
Norvectan contains cyclodextrin (betadex) (E-459), sucrose, and sodium.
-
This medicine contains 3 g of cyclodextrin per sachet.
-
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.
-
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., it is essentially "sodium-free".
3. How to take Norvectan
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
Adults
In adults and adolescents from 14 years of age, one sachet (600 mg of ibuprofen) every 6–8 hours is recommended, depending on the severity of symptoms and the course of treatment.
Generally, the recommended daily dose is 1200 mg of ibuprofen, divided into 3 or 4 doses. In some treatments, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg of ibuprofen in adults and 1,600 mg in adolescents aged 12 to 18 years.
Children
This medicine is not recommended for use in children and adolescents under 14 years of age due to the dose of active substance it contains.
Elderly patients
Your doctor may prescribe you a lower than usual dose. If so, this dose may only be increased once your doctor has confirmed that you tolerate the medicine well.
Patients with kidney and/or liver disease:
If you have kidney and/or liver disease, your doctor may prescribe you a lower than usual dose. If so, take exactly the dose prescribed by your doctor.
Method of administration
For oral administration.
Pour the contents of one sachet into half a glass of water, stir, and take immediately.
Patients experiencing stomach discomfort should take the medicine during meals.
Your doctor will advise you on the duration of your treatment with this medicine. Do not stop the treatment earlier than indicated.
If you take more Norvectan than you should:
If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, consult a doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested, to obtain information about the risk and advice on the measures to be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and breathing difficulties have been reported.
In cases of ingestion of large amounts, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes following ingestion.
If you forget to take Norvectan
Do not take a double dose to make up for forgotten doses.
If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The adverse effects observed are described below according to frequency of occurrence: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from the available data).
Gastrointestinal:
The most common adverse effects with ibuprofen are gastrointestinal: nausea, vomiting, diarrhoea and dyspepsia. Peptic ulcers, gastrointestinal bleeding, and perforations (in some cases fatal) have occurred uncommonly, particularly in elderly patients. Other effects observed (frequency not known) include flatulence, constipation, heartburn, abdominal pain, gastritis, blood in stools, oral ulcers, and worsening of ulcerative colitis and Crohn's disease.
Cardiovascular:
This medicine may be associated with a moderate increase in the risk of myocardial infarction ("heart attack") or stroke.
Edema (fluid retention), arterial hypertension, and heart failure have rarely been observed (frequency not known) in association with treatments using medicines of the ibuprofen type.
Frequency not known: Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
Dermatological:
Immune system:
This medicine may, in very rare cases, be associated with severe blistering reactions such as Stevens-Johnson syndrome (a clinical condition affecting the skin, mucous membranes, and other internal organs) and toxic epidermal necrolysis (a skin disease characterized by the appearance of blisters and exfoliative skin lesions).
Hypersensitivity reactions (exaggerated immune system response), manifesting as skin rash with or without itching, and anaphylactic reactions, may rarely occur.
Very rarely, and in any case only in predisposed patients, bronchospasm (bronchial constriction) may occur.
Frequency not known: A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell). Generalized red, scaly rash with nodules under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue this medicine if you experience these symptoms and seek immediate medical attention. See also section 2. The skin may become sensitive to light.
Central nervous system:
Headache and somnolence may rarely occur. Neurological-type reactions such as depression, confusion, and dizziness have also been reported.
Very rarely, aseptic meningitis (inflammation of the meninges not caused by bacteria) has been reported.
Auditory:
Tinnitus (ringing in the ears) may rarely occur.
Ocular:
Very rarely, visual disturbances such as blurred vision, decreased visual acuity, or changes in color perception may occur, which resolve spontaneously.
Blood and lymphatic system:
Rarely, hematological disorders such as thrombocytopenia (reduced platelet count), agranulocytosis (reduced neutrophil count, a type of white blood cell), aplastic anemia (reduced red blood cells due to impaired production), and hemolytic anemia (reduced red blood cells due to premature destruction) may occur.
Hepatic:
This medicine may, in rare cases, be associated with liver injury.
If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:
- Flat, reddish, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
- Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Norvectan
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after (EXP). The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Norvectan
- The active substance is Ibuprofen (lysine). Each sachet contains 600 mg of Ibuprofen (provided by 1025 mg of Ibuprofen lysine).
- The other components (excipients) are betadex (E-459), lemon flavour (containing gum arabic (E-414), ascorbic acid (E-300) and corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate and sucrose.
Appearance of Norvectan and contents of the pack
It is presented as a white powder, packed in sachets.
Each pack contains 20 unit-dose sachets.
Marketing Authorization Holder and Manufacturer
LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.
Grassot, 16 - 08025 Barcelona (Spain).
Date of the most recent revision of this leaflet: January 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/