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FENBID BIPHASIC 400 MG CAPSULES

Active substance(s): IBUPROFEN

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FENBID BIPHASIC 400MG CAPSULES
Read all of this leaflet carefully before start taking this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse.
What is in this leaflet:
1. What Fenbid Biphasic capsules are and what are they used
for
2. What you need to know before you take Fenbid Biphasic
Capsules
3. How to take Fenbid Biphasic Capsules
4. Possible side effects
5. How to store Fenbid Biphasic Capsules
6. Contents of the pack and other information

1. What Fenbid Biphasic Capsules are and
what they are used for
• Fenbid Biphasic 400mg Capsules are provided as capsules
containing Ibuprofen Ph.Eurto be taken by mouth.
• Each capsule contains 400mg Ibuprofen Ph.Eur. with immediate
and sustained release components of this active ingredient.
The capsules are packaged in blister packs of 56 and 112
capsules.
• Fenbid is a so-called non-steroidal anti-inflammatory drug,
commonly called a NSAID.
It has analgesic (pain relieving) and antipyretic (temperature
lowering) effects. Fenbid Biphasic Capsules are prescribed for
adults, the elderly and children aged over 12 years for the
treatment of rheumatoid arthritis, ankylosing spondylitis,
osteoarthritis, sprains and strains, headache, dental pain, pain
after operations, period pain, backache, rheumatic and muscular
pain. They are not recommended for children under 12 years of
age.
• These capsules reduce pain, swelling and temperature.

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2. What you need to know before you take
Fenbid Biphasic Capsules
Do not take Fenbid Biphasic Capsules
• If you are sensitive to any of the contents of this medicine, or
you have had a sensitivity reaction to aspirin or other NSAID’s
in the past.
• If you are pregnant or breast feeding.
• Do not take if you have, or have ever had, peptic ulceration
(ulcer in your stomach or duodenum) or bleeding in your
digestive tract.
• If you have asthma or a history of asthma, or other allergic
diseases.
• If you have a history of gastrointestinal disease.
• If you have kidney or liver disease, or heart disease.
• If you have blood clotting problems.
• If you are taking other medicines, ask your doctor to verify
that it is alright to take Fenbid Biphasic Capsules. Some
medicines may interact with this medicine, such as:
Diuretics (water tablets), Antihypertensive drugs (to treat high
blood pressure), Anticoagulants (to treat blood clots),
Cyclosporin, Heart drugs, Lithium, Methotrexate, Mifepristine,
other analgesics and NSAID’s, corticosteroids, Quinoline
antibiotics, Coumarin, Drospirenone, Baclofen, Alondronic Acid,
Abciximab, Cilostazol, Desirudin, Dipyridamole, Epoprostenol,
Eptifibatide, Heparin, Lepirudin, Phenindione, thrombolytics
(antclotting drugs), Ticlopidine, Aspirin, Aminoglycosides,
Cisplatin, Tarclimus, Vancomycin, and ACE Inhibitors (for the
treatment of blood pressure and heart failure). If you are in
doubt, ask your doctor.
Warnings and Precautions
• If you have been told by your doctor that you are suffering
from a disease of the intestine (Ulcerative colitis & Crohn’s
disease) or any other gastrointestinal disease.
• If you have been told by your doctor that you are suffering
from a disease of skin & joints (Systemic lupus erythematosus
i.e SLE).
• If you are taking medications belonging to the group of
Cardiac glycosides.
• There is a risk of renal impairment in dehydrated children and
adolescents.

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 Ibuprofen 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.
There are no specific contra-indications to the taking of Fenbid
Biphasic Capsules, except for those mentioned above.
Other medicines and Fenbid Biphasic Capsules:
Fenbid Biphasic Capsules may affect or be affected by some
other 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)
Tell your doctor or pharmacist if you have recently taken, any
other medicines-even those not prescribed. See the list drugs
which may interact with these capsules.
Taking Fenbid Biphasic Capsules with food and drink.
• It is recommended that you take Fenbid Biphasic Capsule
with or after food.
• You should swallow the capsule with a liberal quantity of
water. Do not chew or suck the capsules.
Pregnancy
• Do not take Fenbid Biphasic Capsules unless instructed by
your doctor.
• Fenbid Biphasic Spansules may make it more difficult to
become pregnant. You should inform your doctor if you are
planning to become pregnant or if you have problems
becoming pregnant.
IXXXXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

3. How to take Fenbid Biphasic Capsules
• The dose and frequency of dosing will be advised by your
doctor depending in the severity and duration of your illness.
The usual starting dose is one capsule taken twice daily.
This dose may be increased to two capsules twice daily.
The dosage will be described on the product label, but the
usual routine is to take the first dose with breakfast and the
second dose 8 to 12 hours later. If you do not understand the
dosage instructions, or you are in any doubt, ask your doctor
or pharmacist.
• Do not chew or suck the capsules, but swallow them with a
glass of water.
• Take the capsules at the same time each day in order to have
the best effect. This may help you to remember to take the
medicine.
• Your doctor will tell you how long to take Fenbid Biphasic
Capsules. Do not stop taking the capsules early.
• If you have the impression that the effect if Fenbid Biphasic
Capsules is too strong or too weak, talk to your doctor or
pharmacist.
If you (or someone else) take more Fenbid Biphasic
Capsules than you (or they) should:
• If you (or someone else) have taken more Fenbid Biphasic
Capsules than you (or they) should, contact your doctor or
pharmacist, or contact your nearest hospital immediately.
If you forget to take Fenbid Biphasic Capsules:
• Do not take a double dose to make up for forgotten individual
dose, but take the dose as soon as you remember and then
take the next dose when you should take it.
If you see another doctor or go into hospital:
• If you see another doctor or go into hospital, tell the doctor or

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hospital staff that you are taking Fenbid Biphasic 400mg
Capsules:
Effect when treatment with Fenbid Biphasic Capsules is
stopped:
• No significant effects.

4. Possible side effects
• Like all medicines, Fenbid Biphasic Capsules can have side
effects.
• In common with other NSAID’s, Fenbid Biphasic Capsules
can cause some serious side effects. If any of the following
occur, tell your doctor immediately or go to the Casualty
Department of your nearest hospital.
• Swelling of the hands, feet, ankles, lips, mouth, or throat
which may cause difficulty in swallowing or breathing (so
called anaphylactic reactions).
• Problems with vision. If this occurs, stop taking this medicine
and contact your doctor.
• Gastrointestinal effects, such as nausea, vomiting, diarrhoea,
abdominal pain which may be severe, blood in the stools
which may be black or tarry, and blood in vomit. The above
serious side effects are rare.
• Other side effects are rashes, difficulty in breathing and asthma
attacks, skin itching, oedema (swelling), nervousness, hearing
disturbances, unpleasant taste, insomnia, blood disorders,
confusion, depression, dizziness, fatigue, drowsiness, and
photosensitivity (reaction to sunlight).
• Rarely there may be an adverse effect on your kidney and
liver functions.
• Medicines such as Ibuprofen tablets may be associated with
a small increased risk of heart attack (myocardial infarction)
or stroke.
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate
medical help:
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds
• STOP TAKING the medicine and tell your doctor if you
experience: Indigestion or heartburn.
• Abdominal pain (pains in your stomach) or other abnormal
stomach symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information

5. How to store Fenbid Biphasic Capsules
• Keep Fenbid Biphasic Capsules and all medicines out of the
sight and reach of children.
• Store Fenbid Biphasic Capsules in the original container below
250C in a dry place, protected from light.
• Do not use this medicine after the expiry date (EXP.) which is
stated on the carton. The expiry date refers to the last day of
that month.
• 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
• The active substance is Ibuprofen
• The other ingredients are:sugar spheres USP (containing
maize starch and sucrose), povidone BP and sodium starch
glycollate BP
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
info@bristol-labs.co.uk
Email:
Fenbid Biphasic 400mg Capsules; PL 17907/0293
This leaflet was last revised in October 2015.
To request a copy of this leaflet in Braille, large print or audio
format, please contact the license holder at the address (or
telephone, fax, email) above.

V2 13-10-15 D2

IXXXXX

Breast Feeding
• Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machinery
• No contraindications to taking Fenbid Biphasic Capsules.
Important information about some of the ingredients
Fenbid Biphasic Capsules
• Fenbid Biphasic Capsules contain sucrose and maize starch,
povidone and sodium starch glycollate.

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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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