DEEP RELIEF PAIN RELIEF GEL, DEEP RELIEF, DEEP RELIEF ANTI-INFLAMMATORY GEL - patient leaflet, side effects, dosage

DEEP RE Li EF

ANTI-INFLAMMATORY GEL

Ibuprofen & Levomenthol

FOR BACK, RHEUMATIC AND MUSCULAR PAIN

Read all of this leaflet carefully before you start using this medicine.

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription.

However, you still need to use Deep Relief Anti-inflammatory Gel carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must see a doctor if your symptoms do not improve after 2 weeks.
• If any of the side effects gets severe or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet:

• 1. What Deep Relief Anti-inflammatory Gel is and what it is used for

• 2. Before you use Deep Relief Anti-inflammatory Gel

• 3. How to use Deep Relief Anti-inflammatory Gel

• 4. Possible side effects

• 5. How to store Deep Relief Anti-inflammatory Gel

• 6. Further information

1. what deep relief anti-inflammatory gel is and what it is used for

Deep Relief Anti-inflammatory Gel is a pain relieving gel to be applied to the skin. It is used for the relief of:

• Rheumatic pain (in muscles, tendons, joints or bones)
• Muscular aches and pains
• Pains and swellings such as strains, sprains and sports injuries.

Deep Relief Anti-inflammatory Gel contains two active ingredients.

• Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which provide effective pain relief and reduce both inflammation and swelling.
• Levomenthol provides a soothing sensation to calm the pain.

2. before you use deep relief anti-inflammatory gel

Do not use Deep Relief Anti-inflammatory Gel if you:

• have an allergy to ibuprofen, menthol, or any of the ingredients in Deep Relief Anti-inflammatory Gel (see end of Section 2 and Section 6)
• have an allergy to aspirin or other pain-relieving medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) including those you take orally by mouth
• have asthma and know that aspirin or NSAIDs may bring on an asthma attack, a runny nose (rhinitis), itching or rashes
• are more than 6 months pregnant
• are breast feeding
• have broken skin or your skin is infected or inflamed.

Do not use Deep Relief Anti-inflammatory Gel on:

• children under 12 years old
• your lips, nostrils, eyes, genital or anal areas, or other sensitive areas. If this occurs accidentally, wash away with plenty of clean water.
• the same area with other medicines that you put on the skin.

Deep Relief Anti-inflammatory Gel is only for use on the skin. Do not take by mouth.

Take special care with Deep Relief Anti-inflammatory Gel

See your doctor before using Deep Relief Anti-inflammatory Gel if you:

• have ever had allergic symptoms such as skin rashes or itching caused by medicines or cosmetics
• have a kidney problem (now or in the past)
• have a stomach ulcer (now or in the past)
• are up to 6 months pregnant or think you might be pregnant
• are having problems conceiving or having fertility treatment.

Avoid getting Deep Relief Anti-inflammatory Gel on or near the eyes and other sensitive areas.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you have bought without a prescription.

See your doctor before using Deep Relief Anti-inflammatory Gel if you are taking:

• aspirin
• any other pain relieving medicine
• any other medicines regularly.

Pregnancy and breast feeding

See your doctor if you are pregnant or think you might be pregnant. Do not use Deep Relief Anti-inflammatory Gel if you are more than 6 months pregnant.

Ibuprofen is excreted into breast milk in minimal amounts and no effects on the breastfed infant are anticipated. Ibuprofen alone applied on skin can be used during breastfeeding. However, there is insufficient information on the excretion of levomenthol, the second compound of Deep Relief Anti-inflammatory Gel in breast milk.

Continued overleaf

Therefore, due to the absence of sufficient data, the use of Deep Relief Anti-inflammatory Gel during breastfeeding is not recommended.

Do not use Deep Relief Anti-inflammatory Gel if you are breast feeding.

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

Important information about some of the ingredients of Deep Relief Anti-inflammatory Gel Deep Relief Anti-inflammatory Gel contains:

• propylene glycol which may cause skin irritation.

3. how to use deep relief anti-inflammatory gel

Deep Relief Anti-inflammatory Gel is for adults and children over 12 years old.

• Always try on a small area first.
• Use 1–4 cm of gel each time you use Deep Relief Anti-inflammatory Gel.
• Apply the gel as a thin layer over the affected area.
• Gently rub in the gel until it is absorbed. You may notice a tingling sensation.
• Do not use more gel than recommended.
• Repeat these steps up to 3 times a day but no more. Do not use more often than every 4 hours. If the pain or swelling continues after using the gel for 2 weeks see your doctor.
• Unless you are treating your hands always wash your hands immediately after use.
• Replace the cap tightly.
• Stop using Deep Relief Anti-inflammatory Gel if you get excessive skin irritation or other unwanted effects.

Do not cover the skin with bandages, plasters or any other dressing. However, it is safe to cover the skin with your clothes.

If you use more Deep Relief Anti-inflammatory Gel than you should

If you accidently squeeze out too much gel use a tissue to wipe off any excess.

If you or a child accidentally swallow the gel contact your doctor or hospital immediately.

If you forget to use Deep Relief Anti-inflammatory Gel

Apply Deep Relief Anti-inflammatory Gel again when you remember making sure you do not use the gel more than 3 times in one day or more often than every 4 hours.

4. possible side effects

Like all medicines, Deep Relief Anti-inflammatory Gel can cause side effects, although not everybody gets them.

Stop using Deep Relief Anti-inflammatory Gel straight away and tell your doctor if you experience any of the following effects:

• unexplained wheezing
• shortness of breath
• burns, blisters or a rash on the skin
• itching, redness or bruising of the skin
• swelling of the face

A slight redness, drying, tingling or burning feeling may occur where you have applied the gel. This is not a cause for concern. However, if this gets worse stop using Deep Relief Anti-inflammatory Gel and tell your doctor. Unwanted effects may be reduced if you use the smallest dose for as short a time as possible.

Skin becomes sensitive to light – frequency unknown

More rarely you may suffer from:

• stomach pains or indigestion
• kidney problems if you have kidney disease.

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:. By reporting side effects you can help provide more information on the safety of medicines.

5. how to store deep relief anti-inflammatory gel

Keep out of the sight and reach of children.

Close the cap tightly and store in a cool place (below 25°C).

Do not use Deep Relief Anti-inflammatory Gel after the expiry date which is printed on the carton and tube. The ‘expiry’ date refers to the last day of that month.

Take any Deep Relief Anti-inflammatory Gel that is out of date to a pharmacist for disposal.

• 6. Further information

What Deep Relief Anti-inflammatory Gel contains

The active substances are:

• ibuprofen (5%w/w)
• levomenthol (3%w/w)

What Deep Relief Anti-inflammatory Gel looks like and contents of the pack

Deep Relief Anti-inflammatory Gel is a clear gel. Each tube contains 30, 50 or 100g.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

Menthotatum

The Mentholatum Company Limited, East Kilbride, G74 5PE, UK.

Tel: 01355 848484

PL 00189/0027

For any information about this product please contact the manufacturer at the above address.

This leaflet was last revised July 2021.