Nurofen SR, 300 mg, 12 extended-release tablets, Reckitt Benckiser

Indications:
The active substance (which determines the action of this medicine) is ibuprofen. Ibuprofen belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). These drugs work by reducing pain, fever, and inflammation.

Nurofen SR is used in adults aged 18 years and over for the symptomatic treatment of mild to moderate pain that is expected to last more than 6-8 hours, such as back pain, muscle pain, joint pain, menstrual pain and toothache.

This medicine is designed to release ibuprofen slowly over 12 hours

Contraindications:
Do not take Nurofen SR:
- if you are allergic to ibuprofen or any of the other components of this medicine.

Precautions:
Before using Nurofen SR, talk to your doctor or pharmacist.

Pregnancy, breast-feeding and fertility:
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Task:
Do not take this medicine during the last 3 months of pregnancy, as it may harm the fetus or cause problems at birth. It can cause heart and kidney problems in the fetus. It can affect your bleeding tendency (yours and your baby's) and cause labor to start later or last longer than expected. Avoid using this medicine during the first 6 months of pregnancy, unless your doctor tells you otherwise. If you need treatment during this time or while you are trying to conceive, the lowest dose should be used for the shortest possible time. If taken for more than a few days, starting in the 20th week of pregnancy, ibuprofen can cause
kidney problems in your foetus, which may lead to low levels of the amniotic fluid surrounding the fetus (oligohydroamnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding:
Only small amounts of ibuprofen and its metabolites are excreted in breast milk.
Nurofen SR can be administered during breastfeeding, if used in the recommended dose and for the shortest possible time.

Fertility:
This medicine is part of a group of medicines that can affect fertility in women. This effect is reversible upon discontinuation of the drug. Tell your doctor if you are planning to become pregnant or if you are having problems trying to become pregnant.

Driving vehicles and using machines:
This medicine has no or negligible influence on the ability to drive or use machines when administered in the recommended dose and for the recommended duration of treatment.

However, as side effects in the central nervous system such as fatigue and dizziness may occur at higher doses, the ability to react and the ability to actively participate in road traffic and use machines may be impaired in isolated cases. These effects may be worse when taken in combination with alcohol

Mode of administration:
Always take this medicine as directed in this leaflet or as directed by your doctor or pharmacist. Talk to your doctor or pharmacist if you are not sure.

Dose:
Adults over 18 years of age and the elderly:
Initial dose: take 2 tablets (2x 300mg).
If necessary, take another dose of two tablets (2 x 300mg) after 12 hours.
The time interval between doses should not be less than 12 hours.
Do not take more than 4 tablets in a 24-hour period.

Do not give this medicine to children and adolescents under 18 years of age.

Mode of administration:
For short-term oral administration.
Swallow the tablets whole with water. Do not chew, break, crush or suck the tablets.

Duration of treatment:
You should use the lowest dose necessary to relieve symptoms and for the shortest period of time. If you have an infection, see a doctor immediately if symptoms (such as fever and pain) do not go away or get worse (see point 2).

You should contact your doctor if symptoms worsen or do not improve after 4 days.

Do not exceed the recommended dose or duration of treatment.

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

Composition:
- The active substance is ibuprofen.
One prolonged-release tablet contains 300 mg of ibuprofen.
- The other ingredients are: colloidal hydrated silicon dioxide (E551), hypromellose (E464), microcrystalline cellulose (E460), croscarmellose sodium (E468), glycine (E640), stearic acid (E570), film (composed of hypromellose (E464) , titanium dioxide (E171), macrogol 400 and polysorbate 80 80 (E433)) and coating (containing carnauba wax (E903)).

Presentation:
12 extended-release tablets

Warning:
Read the leaflet carefully and completely before you start using this medicine because it contains important information for you.