PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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.

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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.

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

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

Email:    info@bristol-labs.co.uk

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.

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