Bristaflam analgesic anti inflammatory and anti rheumatic activities to treat painful and local inflammatory conditions

Bristaflam 15 mg / g Cream
Micronized Aceclofenac

In this leaflet :

1- What Bristaflam is and what it is used for ?
2- What you need to know before you start usjng Bristaflam ?
3- How to use Bristaflam ?
4- Possible side effects ?
5- Storage of Bristaflam ?
6- Contents of the package and further information ?

1- What is Bristaflam and what it is used for :

Bristaflam 15 mg I 9 Cream Difucrem is a medication for cutaneous application. It contains micronized Aceclofenac which has analgesic, anti-inflammatory and anti-rheumatic activities.
Your doctor will prescribe this medicine to treat painful and local inflammatory conditions such as tendinitis, tenosynovitis, sprains, dislocations, joint pain, lumbago and stiff neck.

2- What you need to know before you start using Bristaflam :

Do not use Bristaflam
– If you are allergic to Aceclofenac, other anti-inflammatory medications or any of the other ing~edients_of this medicine             – If aspirin and other non-steroidal anti-inflammatory drugs caused you asthma, rhinitis, urticaria or other allergic reactions.

Warnings and Precautions
– Gastrointestinal risk : NSAIDs cause an increased risk of serious gastrointestinal adverse event including inflammation, bleeding, ulceration and perforation of the stomach or intestine, which can be fatal. These events can occur of any time during use and without warning symptoms. Elderly patients are at greater risk for serious
gastrointestinal events.
Cardiovascular Risk : NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk.
NSAIDs is contraindicated for the treatment of peri-operative pain in a setting of coronary artery bypass graft (CABG) surgery. Ask your doctor, pharmacist or nurse
before you start using Bristaflam:
– Do not use in eyes, on mucous membranes or open wounds.
– Do not use if the treatment area is irritated.
– The treated areas should not be exposed to the sun (even when cloudy) or UV lamps (UVA).
– Do not use with tight bandages. which do not allow proper aeration of the area.
– If you notice redness or injury of the treated area, stop treatment immediately and contact your doctor.
– Hypersensitivity reactions may occur very rarely. Allergic reactions are very serious (see section 4. Possible side effects). The risk is greatest during the first month of treatment. Discontinue treatment immediately on the first occurrence of cutaneous symptoms, mucosal lesions or other signs of hypersensitivity.
– In case of chickenpox, you should avoid using this medication because in rare cases it may be associated with severe skin infections.
Using Bristaflam with other medicines :
Tell your doctor or pharmacist if you are taking, have recently taken or might need to use any other medications. This is especially important if you are taking lithium, digoxin, diuretics, anticoagulants and pain medications.
Pregnancy and lactation :
If you are pregnant or lactating, you think you might be pregnant or planning a pregnancy, contact your doctor or pharmacist before using this medicine.
Driving and using machines :
There has been no effect on the ability to drive vehicles or use machines when applying Aceclofenac externally on the skin.

3- How to use Bristaflam :

Follow all instructions for use of this medicine provided by your doctor or pharmacist. In case of doubt, please check with your doctor or pharmacist. Your doctor will tell you the number of
applications, the frequency and duration of treatment. Generally. between 1.5 and 2 grams (approximately between 5 and 7 cm) is applied three times daily with a gentle massage to the affected area.
Use in children : Not recommended.
If you use Bristaflam more than you should :In case of accidental Ingestion, go immediately to a medical center.

4- Possible side effects :

Like all medicines, Brislaflam can cause side effects, although not everybody gets them.
Exceptionally, there have been serious skin infections during chickenpox. In rare cases (may affect up to 1 in 100 people), as a result of inadequate protection of treated skin areas, allergic reactions have been reported due to strong exposure to sunlight, irritation, redness and itching at the application site, which
disappears upon discontinuation. In very rare cases (may affect up to 1 in 10,000 people) reactions have been reported, including severe skin blisters like Stevens-Johnson syndrome and toxic
epidermal necrolysis. If you have any of these side effects, contact your doctor, pharmacist or nurse, even if it is not listed in this leaflet.

5- Storage of Bristaflam :

– Keep this medicine out of sight and reach of children.
– Store at room temperature.
– Do not use this medicine after the expiry date stated on the carton after the letters “EXP”. The expiry date refers to the last day of that month.

7- Contents of package and additional information :

Composition of Bristaflam
The active ingredient is micronized aceclofenac. Each 100 grams of cream contains 1.5 9 of micronized aceclofenac.
The other ingredients are propylparaben (Nipasol), methylparaben (Nipagin), Mineral oil (light liquid paraffin), Base EWA, purified
water.                                                                                                        Form of the product and contents of the package

Pack containing tube of 30 gm cream+ inner leaflet.

Manufacturer :

SmithKline Beecham – El Haram- Giza.