Deep Relief Pain Relief gel, Deep Relief, Deep Relief Anti-inflammatory gel – patient leaflet, side effects, dosage

1. What Deep Relief Duo Pain Relief Gel is and what it is used for

Deep Relief Duo Pain Relief 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 Duo Pain Relief 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 Duo Pain Relief Gel

Do not use Deep Relief Duo Pain Relief Gel if you:

• have an allergy to ibuprofen, menthol, or any of the

  ingredients in Deep Relief Duo Pain Relief 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

• if you are in the last 3 months of pregnancy
• are breast feeding

• have broken skin or your skin is infected or inflamed.

  Do not use Deep Relief Duo Pain Relief 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 Duo Pain Relief Gel is only for use on the skin. Do not take by mouth.

Take special care with Deep Relief Duo Pain Relief Gel

See your doctor before using Deep Relief Duo Pain Relief 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 Duo Pain Relief Gel on or near the eyes and other sensitive areas.

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnsonsyndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using ibuprofen gel and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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 Duo Pain Relief 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 Duo Pain Relief 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 Duo Pain Relief Gel in breast milk. Therefore, due to the absence of sufficient data, the use of Deep DUO PAIN RELIEF GEL Ibuprofen & Levomenthol BLACK CUTTER

Scale Guide

CHECKLIST

Job Title:

CC No.:

Operator:

Client Signature

Comments:

Deep Relief Duo Pain Relief Gel 30/50/100g GSL PIL

AWCNXX/ARTXX

John Telfer

CHANGE CONTROL

Packaging Type:

Braille Text.:

Bar Width Reduction:

Leaflet

140 x 255mm

N/A

D4288-1

N/A

N/A

8.5pt

Relief Duo Pain Relief Gel during breastfeeding is not recommended.

Do not use Deep Relief Duo Pain Relief 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 Duo Pain Relief Gel

Deep Relief Duo Pain Relief Gel contains:

• 250 mg propylene glycol in each 2.5 g dose which is equivalent to 100 mg in 1g of gel. Propylene glycol may cause skin irritation
• 288 mg alcohol (ethanol) in each 1g of gel which is equivalent to 30%w/w. It may cause burning sensation on damaged skin.

Warnings and precautions

Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

3. How to use Deep Relief Duo Pain Relief Gel

Deep Relief Duo Pain Relief 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 Duo Pain Relief 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 Duo Pain Relief 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 Duo Pain Relief 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 Duo Pain Relief Gel

Apply Deep Relief Duo Pain Relief 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 Duo Pain Relief Gel can cause side effects, although not everybody gets them.

Stop using Deep Relief Duo Pain Relief 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

  Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme,

  StevensJohnson syndrome, toxic epidermal necrolysis].

  Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).

  A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis)

  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 Duo Pain Relief 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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of medicines.

5. How to store Deep Relief Duo Pain Relief 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 Duo Pain Relief 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 Duo Pain Relief Gel that is out of date to a pharmacist for disposal.

6. Further information

What Deep Relief Duo Pain Relief Gel contains

The active substances are:

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

The other ingredients are propylene glycol, carbomer, diisopropanolamine, ethanol and water (see the end of Section 2).

What Deep Relief Duo Pain Relief Gel looks like and contents of the pack

Deep Relief Duo Pain Relief Gel is a clear gel. Each tube contains 30, 50 or 100g.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

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 November 2024.

Scale Guide

CHECKLIST

Job Title:

CC No.:

Operator:

Client Signature

Comments:

Deep Relief Duo Pain Relief Gel 30/50/100g GSL PIL

AWCNXX/ARTXX

John Telfer

CHANGE CONTROL

Packaging Type:

Braille Text.:

Bar Width Reduction:

Leaflet

140 x 255mm

N/A

D4288-1

N/A

N/A

8.5pt