Fenbid Spansule Capsules (Ibuprofen)

What are Fenbid Spansule Capsules and what they are used for

Fenbid” Spansule” Capsules contain ibuprofen and belong to a group of medicines called non-steroid anti-inflammatory drugs (NSAID’s). These medicines reduce pain and inflammation, and bring down a high temperature.

Fenbid” Spansule” 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.

Before you take Fenbid Spansule Capsules

• You know that you are allergic to ibuprofen, aspirin or similar medicines, or any of the other ingredients in these capsules
• 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-inflammatories)
• You have a history of bleeding in your intestines, which is linked to previous use of anti-inflammatories
• You are in your last three months of pregnancy.

Take special care with Fenbid   Spansule   Capsules and check with your doctor or pharmacist before taking your medicine 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
• 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.

If you are having a medical examination, tell the doctor that you are taking Fenbid”  Spansule*

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 Fenbid” Spansule” Capsules.

If you have heart problems or suffered from a previous stroke or think that you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription.

Fenbid Spansule Capsules may affect or be affected by the following medicines:

Can you take Fenbid Spansule Capsule with other medicines?

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine), some medicines that reduces high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-ll receptor antagonists such as losartan), and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacists before you take ibuprofen with other medicines.

• Diuretics (to make you pass more water)
• 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)
• Any other NSAID (for painful or inflammatory conditions e.g. aspirin)
• Medicines for the treatment of diabetes
• 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).

Pregnancy and breast feeding

Do not take Fenbid” Spansule” Capsules if you are pregnant (or think you may be), or are breast feeding unless your doctor has decided that it is in your best interests. If taken, the lowest effective dose should be used. You should NOT take this medicine during the last three months of pregnancy as it may affect the baby’s circulation.

Fenbid” Spansule” Capsules 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Sugar intolerance

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

Driving and using machines

Fenbid” Spansule” Capsules should not affect the ability to drive or use machines. However, if you feel dizzy when you start to use Fenbid” Spansule” Capsules, do not drive or use machines.

Important information about some of the ingredients of Fenbid Spansule Capsules

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 medicine. Taking Fenbid Spansule Capsules with Food and drink

It is best to take Fenbid Spansule 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 yoghurt.

How to take Fenbid Spansule Capsules

Make sure you take your capsules exactly as directed. The instructions will be written on the label. You should check with your doctor or pharmacist if you are not sure.

Medicines such as Fenbid  Spansule 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.

Swallow each capsule whole with a little water, with or after food.

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.

Children:

Fenbid” Spansule” Capsules are not recommended for use in children under 12 years.

If you take more Fenbid Spansule Capsules than you should:

If you (or someone else) takes 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 Fenbid Spansule 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 have any further questions about these capsules, ask your doctor or pharmacist.

Possible side effects

Like all medicines Fenbid” Spansule” Capsules 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 if you experience:

• Indigestion or heart burn
• Abdominal Pain (pains in your stomach) or other abnormal stomach symptoms.

If you suffer from any of the following at anytime during your treatment STOP TAKING the medicine and see a doctor immediately.

• Pass blood in your stools/motions
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds. Other side effects:
• Mouth ulcers may occasionally occur
• If a skin rash or yellowness of the skin and eyes (jaundice) occur, or an unexplained fever or persistent sore throat, tell your doctor
• You may notice skin bruising, or urinary symptoms such as blood in the urine or an increase or decrease in the amount of urine, ankle swelling, weakness, persistent headache
• Symptoms such as sleep disturbance, difficulty concentrating, mental dullness, depression, confusion, hallucinations (imagining sensations), noise in the ears or impaired hearing, vertigo, dizziness, tingling or other odd sensations, visual disturbances, fatigue, drowsiness, malaise or hair loss have occasionally been reported
• Skin irritation or rash from sunlight.

Medicines such as Fenbid” Spansule” Capsules may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

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.

How to store Fenbid Spansule Capsules

Keep out of the reach and sight of children.

Do not use Fenbid” Spansule” Capsules after the expiry date which is stated on the label. They should be stored in a cool, dry place, below 25°C. Keep in original container to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Remember:

This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.