SCHEDULING STATUS
S1
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
BRUFEN® 200 Film-coated tablets
Read Before Using BRUFEN® 200
BRUFEN® 200 is available without a doctor’s prescription for the treatment of a mild illness. It should still be used carefully to get the best results.
Keep this information because it may be needed again. If further questions arise, ask a doctor or pharmacist.
BRUFEN® 200 has been prescribed personally and should not be shared with other people. It may harm them, even if their symptoms are the same.
A doctor should be consulted if symptoms worsen or do not improve after 3 days.
1. What BRUFEN® 200 Contains
Each film-coated tablet contains 200 mg ibuprofen.
Other Ingredients
The other ingredients include:
| Other ingredients |
|---|
| Microcrystalline cellulose |
| Croscarmellose sodium |
| Lactose monohydrate |
| Colloidal anhydrous silica |
| Sodium laurilsulfate |
| Magnesium stearate |
| Hypromellose |
| Talc |
| Titanium dioxide |
| Dry color dispersion, white 06A28611 |
| Opaspray white M-1-7111B |
BRUFEN® 200 contains lactose monohydrate.
2. What BRUFEN® 200 Is Used For
BRUFEN® 200 is used for the treatment of mild to moderate pain of inflammatory origin and fever.
It may be used for:
| Uses |
|---|
| Soft tissue injuries such as sprains and strains |
| Headache |
| Back pain of musculo-skeletal origin |
| Fever |
| Muscular aches and pain |
| Menstrual pain |
| Toothache |
| Pain associated with migraine |
| Earache |
3. Before You Use BRUFEN® 200
Do Not Use BRUFEN® 200
Do not use BRUFEN® 200 if any of the following apply:
| Do not use BRUFEN® 200 if | Details |
|---|---|
| You are allergic to ibuprofen | This includes allergy to the active ingredient |
| You are allergic to any other ingredient in BRUFEN® 200 | Check the ingredients before use |
| You have experienced asthma after taking aspirin, ibuprofen or another NSAID | This may indicate sensitivity to NSAIDs |
| You have experienced skin rash or allergic-type reaction after aspirin, ibuprofen or another NSAID | This may indicate a serious allergy risk |
| You have a history of stomach or bowel perforation or bleeding related to NSAID use | BRUFEN® 200 may increase gastrointestinal risk |
| You have or have had peptic ulceration | BRUFEN® 200 may not be suitable |
| You have ulcerative colitis or Crohn’s disease | BRUFEN® 200 may worsen bowel problems |
| You have heart failure | BRUFEN® 200 should not be used |
| You have renal failure | BRUFEN® 200 should not be used |
| You are in the third trimester of pregnancy | BRUFEN® 200 should not be used |
| You are in labour or delivery | BRUFEN® 200 should not be used |
Take Special Care With BRUFEN® 200
Speak to your doctor or pharmacist before using BRUFEN® 200 if any of the following apply:
| Situation requiring care |
|---|
| You are allergic to ibuprofen |
| You are allergic to other medicines, colourants, preservatives or foods |
| You are taking other prescription medicines |
| You are taking medicines bought without a prescription |
| You are taking herbal medicines |
| You have asthma |
| You have high blood pressure |
| You have heart failure |
| You have a stomach ulcer |
| You have bleeding from the stomach or bowel |
| You have any other gastric complaint |
| You cannot tolerate milk or dairy products |
| You have lactose intolerance |
| You have a history of high blood pressure |
| You have a history of heart failure |
| You have a history of peptic ulcers or other stomach or bowel disease |
| You experience unusual abdominal symptoms, especially bleeding from the stomach or bowel |
| You are elderly |
Elderly patients may have an increased frequency of adverse reactions to NSAIDs, including gastrointestinal perforation, ulceration and bleeding, which may be fatal.
Serious skin reactions, some of them fatal, have been reported with non-steroidal anti-inflammatory medicines such as BRUFEN® 200. BRUFEN® 200 should be stopped at the first appearance of skin rash, skin lesion or any other sign of hypersensitivity.
Using Other Medicines With BRUFEN® 200
Always tell your healthcare professional if you are taking any other medicine, including complementary or traditional medicines.
Tell your doctor if you take:
| Medicine or medicine group | Possible interaction |
|---|---|
| Medicines for high blood pressure including diuretics | BRUFEN® 200 may reduce the effect of anti-hypertensives, ACE inhibitors, beta-blockers and diuretics |
| Lithium salts | BRUFEN® 200 may reduce lithium removal from the body, leading to lithium build-up |
| Methotrexate | BRUFEN® 200 may interact and increase risk of toxicity |
| Anti-coagulants or anti-platelet agents | BRUFEN® 200 may enhance their effect and increase bleeding risk |
| Selective serotonin reuptake inhibitors | May increase the risk of bleeding inside the digestive system |
| Aminoglycosides | BRUFEN® 200 may reduce removal of aminoglycosides, increasing their levels |
| Aspirin | Concomitant use is not recommended because of increased adverse effects |
| Digoxin | BRUFEN® 200 may reduce digoxin removal, increasing digoxin levels |
| Ciclosporin | May increase risk of kidney and liver damage |
| Corticosteroids | May increase risk of gastrointestinal ulceration or bleeding |
| Other non-steroidal anti-inflammatory medicines | Use of more than one NSAID may increase side-effect risk |
| Ginkgo biloba | May increase risk of bleeding |
| Mifepristone | BRUFEN® 200 may decrease the efficacy of mifepristone |
| Quinolone antibiotics | May increase the risk of seizures |
| Tacrolimus | May increase the risk of kidney damage |
| Zidovudine | May increase the risk of blood toxicity |
Keep a list of medicines you take and show it to your doctor and pharmacist whenever you receive a new medicine.
Pregnancy and Breastfeeding
Do not use BRUFEN® 200 in the last 3 months of pregnancy or during labour.
Do not use BRUFEN® 200 while breastfeeding.
If pregnant or breastfeeding, consult a doctor, pharmacist or other healthcare professional before taking BRUFEN® 200.
Driving and Using Machinery
BRUFEN® 200 may make you feel drowsy or sleepy, tired, and may disturb your vision.
Do not drive, use tools or operate machines if affected.
4. How to Take BRUFEN® 200
Always take BRUFEN® 200 exactly as instructed by a doctor or pharmacist. Check with a doctor or pharmacist if unsure.
If the effect of BRUFEN® 200 seems too strong or too weak, speak to a doctor or pharmacist.
The lowest effective dose should be used for the shortest possible duration.
Usual Dose of BRUFEN® 200
| Patient group | Dose |
|---|---|
| Adults | 1200 mg daily in divided doses |
| Adults: practical dosing | 1 to 2 tablets every four hours |
| Children under 12 years | Do not give BRUFEN® 200 |
BRUFEN® 200 may be used for relief of:
| Conditions |
|---|
| Mild to moderate pain of soft tissue injuries such as sprains and strains |
| Toothache |
| Back pain of musculo-skeletal origin |
| Earache |
| Headache |
| Pain associated with migraine |
| Muscular aches and pains |
| Fever |
| Period pain |
If You Take More BRUFEN® 200 Than You Should
The most common symptoms of overdose are pain in the upper middle part of the abdomen and nausea.
Other symptoms may include:
| Possible overdose symptoms |
|---|
| Vomiting |
| Dizziness |
| Convulsion |
| Loss of consciousness |
| Depression of the central nervous system |
| Depression of the respiratory system |
If BRUFEN® 200 was taken recently, gastric lavage may remove unabsorbed medicine. Treatment is symptomatic and supportive.
In the event of overdose, consult a doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.
If You Forget to Take BRUFEN® 200
If a dose is missed, take it as soon as remembered unless it is almost time for the next dose.
If it is almost time for the next dose, do not take the missed dose.
Do not take a double dose to make up for forgotten individual doses.
5. Possible Side Effects
BRUFEN® 200 can have side effects.
If any serious reaction occurs, stop taking BRUFEN® 200 and tell a doctor immediately or go to the casualty department at the nearest hospital.
Side Effects Table
| System / category | Frequency | Side effects / symptoms | Recommended action |
|---|---|---|---|
| Gastrointestinal system disorders | Common | Indigestion, nausea, vomiting, constipation, diarrhoea, abdominal pain, flatulence, black stools, vomiting of blood, bleeding from the stomach or bowel | Stop taking BRUFEN® 200 and seek medical advice immediately if bleeding, black stools, vomiting blood or severe symptoms occur |
| Gastrointestinal system disorders | Less frequent | Abdominal discomfort or pain, nausea, vomiting, gastro-intestinal ulcers, sometimes with bleeding | Tell your doctor immediately |
| General commonly reported effects | Common | Headache, dizziness and rash | Tell your doctor if troublesome or persistent |
| Immune disorders | Less frequent | Aseptic meningitis, meaning non-infectious inflammation of the membranes covering the brain | Seek urgent medical attention |
| Immune disorders | Less frequent | Angioedema, a type of swelling affecting deeper layers of the skin, often around the eyes and lips | Stop taking BRUFEN® 200 and seek urgent medical attention |
| Immune disorders | Less frequent | Anaphylaxis, a severe and potentially life-threatening allergic reaction | Stop taking BRUFEN® 200 and seek emergency medical help |
| Nervous system disorders | Frequent | Dizziness, nervousness, tinnitus, drowsiness and insomnia | Tell your doctor |
| Psychiatric disorders | Frequent | Depression | Tell your doctor |
| Eye disorders | Frequency not stated | Visual impairment, changes in visual colour perception, toxic amblyopia | Tell your doctor immediately |
| Renal and urinary disorders | Less frequent | Acute renal failure, cystitis, haematuria, interstitial nephritis and nephrotic syndrome | Tell your doctor immediately or seek urgent medical care |
| Hepatobiliary disorders | Less frequent | Hepatotoxicity and abnormalities in liver function tests | Tell your doctor immediately |
| Blood and lymphatic system disorders | Less frequent | Low blood cell count, anaemia, thrombocytopenia, neutropenia, eosinophilia and agranulocytosis | Tell your doctor immediately |
| Hypersensitivity disorders | Less frequent | Fever, rashes, exacerbation of asthma and bronchospasm | Stop taking BRUFEN® 200 and seek medical advice immediately |
| Cardiovascular disorders | Frequency unknown | Oedema, hypertension and cardiac failure | Tell your doctor immediately |
| Skin and subcutaneous tissue disorders | Frequency unknown | Bullous reactions, sensitivity of the skin to the sun, blistering and swelling | Stop taking BRUFEN® 200 and seek urgent medical attention |
| Skin and subcutaneous tissue disorders | Frequency unknown | Stevens-Johnson syndrome and toxic epidermal necrolysis | Stop taking BRUFEN® 200 and seek emergency medical help |
| Side effects not listed | Not applicable | Any side effect not mentioned or any worsening of general health | Consult a doctor, pharmacist or other healthcare professional |
6. Storing and Disposing of BRUFEN® 200
Keep all medicines out of the reach and sight of children.
Store at or below 25 °C.
Return any unused or expired medicines to a pharmacist for safe disposal.
7. Presentation of BRUFEN® 200
BRUFEN® 200 is supplied in PVC/Aluminium or PVC/PVDC/Aluminium blister strips.
Pack sizes:
| Pack size |
|---|
| 10 tablets |
| 20 tablets |
8. Identification of BRUFEN® 200
BRUFEN® 200 is a white, pillow-shaped, film-coated tablet.
9. Registration Number / Reference Number
BRUFEN® 200: A/3.1/0727
10. Name and Address of Registration Holder
Abbott Laboratories S.A. (Pty) Ltd.
Abbott Place
219 Golf Club Terrace
Constantia Kloof
1709
11. Date of Publication
2 October 2015
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist or other healthcare professional. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
