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P-PHOR PERIOD PAIN

Active substance(s): IBUPROFEN

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Package Leaflet: Information for the patient
Phor Backache 300mg Capsules
(Ibuprofen)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Phor Backache 300mg Capsules. It will be referred to as Phor Backache
Capsules for ease hereafter.
What is in this leaflet
1. What Phor Backache Capsules are and what they are used for
2. What you need to know before you take Phor Backache Capsules
3. How to take Phor Backache Capsules
4. Possible side effects
5. How to store Phor Backache Capsules
6. Contents of the pack and other information
1. What Phor Backache Capsules are and what they are used for
Phor Backache Capsules contain ibuprofen and belong to a group of medicines called non-steroid antiinflammatory drugs (NSAID's). These medicines reduce pain and inflammation, and bring down a high
temperature.
Phor Backache Capsules are used for treatment of various conditions affecting the joints (such as
rheumatoid arthritis, including rheumatoid arthritis in children over 12 years of age, osteoarthritis and
ankylosing spondylitis), muscles (e.g. low back pain, soft tissue injuries, such as sprains and strains)
and areas of inflammation within tendons. It is also used for treatment of dental pain and after operations.
2. What you need to know before you take Phor Backache Capsules
Do not take Phor Backache Capsules if:
• You are allergic to ibuprofen, aspirin or similar medicines, or any of the other
ingredients of this medicine (listed in Section 6);
• You have or previously have had a peptic ulcer (ulcer in your stomach, or intestines) or
bleeding in your stomach, or have had two or more episodes of peptic ulcer, stomach
bleeding or perforation;
• You suffer from severe heart, liver or kidney disease;
• You are using other similar medicines (anti-inflammatory
drugs);
• You have a history of bleeding in your intestines, which is linked to previous use of

anti-inflammatory drugs;
• You have a condition which increases your tendency to bleeding;
• You have known allergic reactions such as described above including asthma,
inflammation of the nose or blotches on the skin on taking aspirin or other non-steroidal
anti-inflammatory drugs;
• You are in your last three months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Phor Backache Capsules if:
• You have had an ulcer or some other problem affecting your stomach, or intestines in the past;
• You have asthma or wheezing attacks (or if you have had asthma in the past);
• You have any heart, liver or kidney problems; there is a risk of kidney problems in dehydrated
children and adolescents;
• You are elderly;
• You are female and trying for a baby;
• You are suffering from Systemic Lupus Erythematosus (SLE) – a condition of the immune
system resulting in joint pain, skin change and disorders of other organs;
• You have disease of the stomach or intestines (e.g. ulcerative colitis or Crohn’s disease)
• If you are having a medical examination, tell the doctor that you are taking Phor Backache Capsules as
they reduce the signs of fever and inflammation which would otherwise be noticed;
• If you are also being treated for blood clotting, you should be monitored by your doctor for the first few
days of treatment with Phor Backache Capsules.
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of
heart attack or stroke, particularly 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 Phor Backache Capsules
if you:
- have heart problems including heart failure, angina (chest pain), or if you have had a heart attack,
bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked
arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or
if you are a smoker.
Other medicines and Phor Backache Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Phor Backache Capsules may affect or be affected by the following medicines:
For example
- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid,
warfarin, ticlopidine)
- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of Phor Backache Capsules. You
should therefore always seek the advice of your doctor or pharmacist before you use Phor Backache
Capsules with other medicines.

• Diuretics (to make you pass more water);
• Cholestyramine (a drug used to lower cholesterol);
• Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes);
• Voriconazole or fluconazole (types of anti-fungal drugs);
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with
ibuprofen);
• Lithium (for depression);
• Antiplatelet tablets (to prevent blood clots, e.g. clopidogrel);
• Zidovudine (an anti-viral drug);
• SSRIs such as fluoxetine or sertraline (for depression);
• Medicines for the treatment of heart failure (e.g. digoxin);
• A corticosteroid (e.g. for asthma and various inflammatory conditions);
• Antibiotics (for an infection, e.g. quinolone such as ciprofloxacin);
• Aminoglycosides (a type of antibiotic);
• Any other NSAID (for painful or inflammatory conditions e.g. aspirin);
• Mifepristone (used to terminate pregnancies);
• Methotrexate (which can be used to treat certain tumours and other diseases including psoriasis and
rheumatoid arthritis);
• Ciclosporin and Tacrolimus (used to suppress the body's immune system, e.g. following transplants or in
diseases such as psoriasis and rheumatoid arthritis).
Phor Backache Capsules with food, drink and alcohol
It is best to take Phor Backache Capsules with or after food. The capsules should be swallowed whole
with a large glass of water. Do not chew or suck the capsules. If you find it hard to swallow the capsules,
you may sprinkle the contents onto a spoonful of soft food or yogurt.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
The use of Ibuprofen whilst pregnant or breast-feeding should be avoided. Ibuprofen should not be used
in late (the last three months) pregnancy and should only be taken in the first six months of pregnancy on
the advice of your doctor. Phor Backache Capsules may make it more difficult to become pregnant.
Driving and using machines
Ibuprofen may make you feel dizzy, drowsy, tired or you may have difficulty seeing. If the capsules
affect you in this way do not drive, operate machinery or do anything that requires you to be alert.
Phor Backache Capsules contain sucrose
This medicine also contains the sugar, sucrose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Phor Backache Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Medicines such as Phor Backache Capsules may be associated with a small increased risk of heart
attack ("myocardial infarction") or stroke. Any risk is more likely with higher doses and
prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Adults: The usual dose is two capsules, twice a day, taken morning and night. This may be increased to
three capsules twice a day until your condition is controlled.
As a general principle, the smallest effective dose should be used.
Elderly: If you are elderly, your doctor may want to reduce the usual adult dose and check that the
medicine is suiting you, especially during the first four weeks of treatment. Be sure to follow your doctor's
instructions carefully and to keep your appointments.
Use in children and adolescents:
Phor Backache Capsules are not recommended for use in children under 12 years.
Method of administration:
For oral use only
Swallow each capsule whole with a little water, with or after food.
If you take more Phor Backache Capsules than you should
If you (or someone else) take too many of these capsules, contact your doctor, or hospital immediately
for advice. Bring the pack with any remaining capsules with you.
If you forget to take your Phor Backache Capsules
If you miss a dose, leave it out and take the next dose whenever it is due. After that, just carry on as
before. Do not take double the dose.
If you stop taking Phor Backache Capsules
Consult your doctor, before you interrupt or terminate the treatment with Phor Backache Capsules.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden
wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially
affecting your whole body) should be reported to a doctor immediately.
STOP TAKING the medicine and tell your doctor immediately or seek urgent medical advice if you
experience:
• Rashes, hives, itching, chest constriction, shortness of breath or swelling of face, lips, hands / feet, fever,
fainting. Severe skin reactions such as pale red raised itchy rashes, red or purple discoloration on the skin,
scaling of the skin, inflamed skin lesions, blisters, sores or ulceration. If you have them, you may have had
a serious allergic reaction to ibuprofen. You may need urgent medical attention or hospitalization;
• Drug eruption (adverse skin reaction such as rashes that looks like measles, rashes with pus, redness of
the skin) occur that subsides after withdrawn ibuprofen;
• Serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);

• Painful red area appear on the skin that spreads quickly, skin may peel without blistering, fever,

condition spread to eyes, mouth/throat and genital parts, feeling burning sensation under skin (toxic
epidermal necrolysis);
• Heart attack or stroke. Medicines such as ibuprofen may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke;
• Inflammation of the protective membrane surrounding the brain and may be associated with stiff neck,
headache, nausea, vomiting, fever or disorientation, sensitivity to light (aseptic meningitis);
• Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia);
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely
(aplastic anaemia);
• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness
(haemolytic anaemia);
• Progressive worsening of your vision in both eyes, particularly in colour vision (toxic optic
neuropathy);
• Increased risk of brain hemorrhage by potentiating the process of clot formation in one of the arteries
that supply blood to your brain (thrombotic stroke);
• Frequent severe abdominal pain (pains in your stomach) or other abnormal
stomach symptoms;
• Pass blood or mucus in your stools/motions;
• Pass black tarry stools;
• Vomit any blood or dark particles that look like coffee grounds;• Inflammation of the liver (hepatitis);
• Liver failure;
• Yellowing of the skin and whites of your eyes (jaundice);
• Blood in the urine, dark coloured urine;
• Inflammation of the pancreas (pancreatitis).

Other Side Effects:
Not known: frequency cannot be estimated from the available data
• Abdominal pain during eating;
• Indigestion or heart burn;
• Feeling sick (nausea);
• Vomiting;
• Diarrhoea;
• Passing wind;
• Infrequent stools and hard stools;
• Painful round or oval sores that form in the mouth;
• Burning stomach pain, abdominal bloating, hiccups, loss of appetite, indigestion (gastritis);
• Irritation and bleeding inside the nose (rhinitis);
• Sleeplessness (insomnia);
• Confusion, feeling anxious;
• Feeling depressed and stressed;
• Loss of ability to think;
• Sees, hears, smells, tastes or feels things that don't exist (hallucinations);
• Eye pain;

• Blurred/disturbed/reduced vision;
• Headache;
• Pricking, burning, tingling or numbing sensation on hands and feet;
• Dizziness;
• State of near sleep (somnolence);
• Spinning head (vertigo);
• Hearing disturbances;
• Ringing in the ears (tinnitus);
• Abnormal liver function test;
• Fatigue;
• Unexpected sensitivity of the skin to the sun;
• Abnormal kidney test report;
• Increase or decrease in the amount of urine passed;
• Feeling of discomfort;
• Burning pain in stomach;
• Fluid retention (e.g. swollen ankles and swelling of face);
• Asthma (coughing, wheezing, chest tightness and breathlessness);
• Increase in blood pressure;
• Exacerbation of inflammation of the colon (colitis) and Crohn's disease.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting system at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Phor Backache Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the
last day of that month. They should be stored in a cool, dry place, below30°C. Keep in original container
to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Phor Backache Capsules contains
The active substance is ibuprofen. Each capsule contains 300 mg ibuprofen.
The other ingredients are sucrose, maize starch, povidone, ethanol, IMS 99.
What Phor Backache Capsules look like and contents of the pack
Phor Backache Capsules are size 0, opaque hard gelatin prolonged release capsules with an opaque
maroon body and opaque pink cap containing off-white almost spherical pellets. They are packed in
plastic securitainers containing 30, 60 or 120 capsules or aluminium blister packs containing 30 capsules.

Marketing Authorisation Holder: Mercury Pharma Group Ltd, Capital House, 85
King William Street, London EC4N 7BL, UK
Manufacturer: Eurand France S.A.S., 14 rue du Clos Barrois, ZI de Nogent-Oise, 60183 Nogent Cedex,
France.
This leaflet was last revised in March 2017.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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