PATIENT INFORMATION LEAFLET

About your treatment

The name of your treatment is Ibugel Forte 10%. It contains 10% of ibuprofen as the active ingredient. It also contains the inactive ingredients IMS, carbomers, diethylamine and purified water. This tube contains 100 g of Ibugel Forte 10%. It is a clear or slightly hazy gel that contains no fragrance. It is also non-sticky and non-greasy.

Ibuprofen is a proven non-steroidal anti-inflammatory drug (NSAID), which works by relieving pain, reducing swelling and easing inflammation. Ibugel Forte 10% is specially formulated to allow rapid absorption of ibuprofen through the skin for effective relief at the point of pain.

IBUGEL FORTE 10% IS MADE FOR THE MARKETING AUTHORISATION HOLDER

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Your doctor has recommended Ibugel Forte 10% because you are suffering from one or more of the following conditions:

• Backache
• Rheumatic or Muscular Pain
• Sprain
• Strain
• Neuralgia

This product is also recommended for the relief of pain in common arthritic conditions.

Before you apply Ibugel Forte 10%

Make sure it is appropriate for you to use Ibugel Forte 10%.

Because Ibugel Forte 10% is applied to the skin, directly over the painful area, there is less risk of the complications that sometimes arise when ibuprofen (or similar anti-inflammatory painkillers) are taken by mouth. However, there are certain categories of patients who may be at risk in rare cases.

Do not use Ibugel Forte 10% in any of the following cases without having sought medical advice from a doctor or pharmacist:

• If you have ever suffered from asthma.
• If you have a stomach ulcer (also called a peptic or gastric ulcer).
• If you have ever suffered from kidney problems.
• If you have ever shown intolerance to aspirin or ibuprofen taken by mouth.

How to apply Ibugel Forte 10%

Ibugel Forte 10% is for external use only.

• Unscrew the cap, turn it upside-down and use the spike of the cap to pierce the tube membrane.
• Lightly apply 2 to 5 cm of gel (50 to 125 mg ibuprofen) over the affected area.
• Massage gently until absorbed.
• Wash hands after use, unless treating them.
• Apply the gel, up to three times a day, or as directed by your doctor.
• Treatment does not normally last for more than a few weeks, but your doctor may want you to continue treatment for longer than this. If your symptoms persist or get worse, consult your doctor.
• Do not exceed the stated dose.

Ibugel Forte 10% tube squeezer key: To make the Ibugel Forte 10% tube easier and more economical to use, a tube squeezer key has been provided. Once fitted to the tube (see instructions below), simply turning the key will dispense the Ibugel Forte 10% more easily for patients who experience difficulty in squeezing tubes. For economy, the key will help expel the last few grams of Ibugel Forte 10% when the tube is nearly empty.

 

Before using the key, ensure that the tube nozzle has been pierced using the point in the top of the tube cap.
1. Slide the slit in the key over the folded end of the tube (diagram 1).
2. Carefully turn the key to roll up the tube until the required amount of Ibugel Forte 10% has been expelled (diagram 2).
3. Always replace the cap after use, leaving the key in place on the end of the tube.

During your treatment

Because the preparation is applied to the skin, directly over the affected area, there is less risk of the complications that can sometimes arise when ibuprofen is taken by mouth. However, undesirable effects can occur very occasionally. Mostly these involve application site skin rashes, itching or irritation. Very rarely, wheezing may occur in people who already have a history of asthma or allergic problems, or kidney problems may occur in people with kidney disease. Abdominal pain or stomach upset have been reported in rare instances, as have non-specific allergic reactions. If you are in any doubt about your treatment, or if you experience any of the following, stop treatment immediately and tell your doctor or pharmacist: unexplained bruising, wheezing, shortness of breath, skin rash, itching, facial swelling, or any other undesirable effect.

How to store Ibugel Forte 10%

This product should not be used after the expiry date shown on the fold of the tube. Always replace the cap tightly after use. Do not store Ibugel Forte 10% above 25°C. Keep Ibugel Forte 10% in a safe place where children cannot see or reach it.