Nurofen Immedia Ultra, 400 mg, 24 dragees

Indications:
Nurofen Immedia Ultra 400 mg tablets contain ibuprofen in the form of ibuprofen sodium dihydrate, which is absorbed significantly faster into the bloodstream, so that it reaches the source of pain faster.

Therefore, a clinical study with Nurofen Immedia Ultra 400 mg tablets demonstrated a faster onset of action compared to standard ibuprofen tablets. The onset of effect following administration of a 400 mg dose occurred within 15 minutes. Therefore, the drug provides very rapid pain relief.

Nurofen Immedia Ultra 400 mg tablets are intended for the symptomatic relief of mild to moderate pain, such as headache, backache, menstrual pain, toothache, neuralgia, rheumatic and muscular pain, pain in mild forms of arthritis, migraine, as well as fever and pain associated with the common cold.

Nurofen Immedia Ultra 400 mg tablets also reduce inflammation and have antipyretic effects in febrile conditions.
The medicine can be used by adults and adolescents aged at least 12 years.

Contraindications:
Hypersensitivity to ibuprofen or any of the excipients of this medicine.

Precautions:
Before using Nurofen Immedia Ultra, consult your doctor or pharmacist.

Pregnancy, lactation and fertility:
No specific studies have been conducted with ibuprofen sodium.

Pregnancy:
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Data from epidemiological studies raise a question mark regarding the increased risk of spontaneous abortion and cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor during the first trimester of pregnancy. The risk may increase depending on the dose administered and the duration of therapy.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause an increased incidence of pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular malformations, have been reported in animals given a prostaglandin synthesis inhibitor during the period of organogenesis.
It is recommended that ibuprofen should not be administered during the first and second trimesters of pregnancy unless clearly necessary. If ibuprofen is used by women attempting to conceive or during the first or second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should be as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose
- the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligohydramnios;
- the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregation effect which may occur even after administration of very low doses;
- inhibition of uterine contractions, which causes delay or prolongation of labour.
Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Breastfeeding:
Ibuprofen and its metabolites may pass into breast milk in low concentrations. To date, no harmful effects on the newborn are known, so that in the case of short-term treatment with the recommended dose for pain and fever, it is generally not necessary to interrupt breastfeeding.
Fertility:
The use of ibuprofen may impair fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are being investigated for infertility, discontinuation of ibuprofen should be considered.

Driving and using machines:
At the recommended doses and for short-term treatment, no influence of the medicine on the ability to drive and use machines has been observed.

How to take:
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

Adults and adolescents aged 12 years and over
The initial dose is 1 tablet of Nurofen Immedia Ultra 400 mg tablets, then 1 tablet every 8 hours as needed.
Leave at least four hours between doses and do not exceed 3 tablets of Nurofen Immedia Ultra 400 mg tablets (1200 mg ibuprofen) in 24 hours.

Nurofen Immedia Ultra 400 mg tablets are not for use in children under 12 years of age.

If you have any further questions on this medicine, ask your doctor or pharmacist.

Composition:
- The active substance is ibuprofen. Each dragee contains 400 mg ibuprofen (as ibuprofen sodium dihydrate 512 mg).
- The other ingredients are: core - croscarmellose sodium, xylitol, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica coating - carmellose sodium, talc, Acacia Spray Dried, sugar, titanium dioxide (E171), macrogol 6000; printing ink - Opacode S-1-15094 Red [shellac, red iron oxide (E172), propylene glycol, ammonium hydroxide, simethicone.

Presentation:
24 dragees