Dip Rilif

Package Leaflet: Information for the Patient

DIP RILIF, (50 mg + 30 mg)/g, Gel

Ibuprofen + Menthol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What it is and what it is used for
• 2. Important information before using the medicine
• 3. How to use
• 4. Possible side effects
• 5. How to store
• 6. Contents of the pack and other information

1.

What it is and what it is used for

It is a medicine with a combined effect of two active substances: ibuprofen and menthol.
It quickly relieves pain after application to the skin.
The medicine has analgesic and anti-inflammatory effects. It reduces inflammation at the affected site,
relieves pain, and reduces swelling.
The medicine is for local analgesic and anti-inflammatory treatment in:

• rheumatic pain (including joint pain caused by degenerative and inflammatory changes)
• back pain
• muscle pain
• pain and swelling due to overexertion injuries, joint sprains, sports injuries
• pain in fibrous tissue, tendons, and ligaments
• lumbago (lower back pain).

2. Important information before using the medicine

When not to use the medicine:

The medicine should not be used:

• if the patient is allergic to ibuprofen, menthol, or any of the other ingredients of this medicine (listed in section 6), acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs
• during the last 3 months of pregnancy.
• in patients with asthma who have had bronchospasm, rash, rhinitis, or other allergic symptoms after using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs
• on mucous membranes, lips, nostrils, and genital areas
• in the eyes or on the skin around the eyes
• on damaged or inflamed skin
• in children under 12 years of age.

Warnings and precautions

Before starting to use the medicine, the patient should discuss it with their doctor or pharmacist:

• if the patient has an allergy to medicines or cosmetics
• if the patient has kidney disease
• if the patient is taking acetylsalicylic acid or other medicines
• if the patient has active peptic ulcer disease. The patient should stop using the medicine if they experience hives or skin irritation and consult their doctor.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP), have been reported with the use of ibuprofen. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately stop using DIP RILIF and seek medical attention.

Medicine interactions

Using the medicine together with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs may increase the frequency of side effects.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine should not be used during the last 3 months of pregnancy. The medicine should not be used during the first 6 months of pregnancy unless it is absolutely necessary and advised by a doctor. If treatment is necessary during this period, the patient should use the smallest dose for the shortest time possible.
Oral forms (e.g., tablets) of ibuprofen may cause side effects in the unborn child. It is not known if the same risk applies to the medicine when used on the skin.
Due to the lack of sufficient data, the medicine is not recommended during breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

The medicine contains propylene glycol and ethanol.

Propylene glycol

The medicine contains 100 mg of propylene glycol per gram of gel.
Propylene glycol may cause skin irritation.

Etanol

The medicine contains 300 mg of 96% ethanol per gram of gel.
It may cause burning of damaged skin.
The medicine is flammable; it should not be used near an open flame or a lit cigarette.

3. How to use

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
It is intended for topical use on the skin only.

Use in adults and adolescents over 12 years of age

• 1. A thin layer of gel should be applied to the painful area and gently massaged until the medicine is absorbed. This can be repeated no more than 3 times a day, with at least a 4-hour interval between applications. For tubes containing 30 g, 50 g, or 100 g of the medicine, 1-4 cm of gel should be used per application, and for tubes containing 15 g of the medicine, 4-10 cm of gel should be used.
• 2. After using the gel, the patient should always wash their hands unless they are the site of application.

The area where the gel is applied should not be covered with bandages or plasters.

Using more than the recommended dose

Overdose of the medicine during topical use is unlikely.
Symptoms of ibuprofen overdose are headache, vomiting, drowsiness, and decreased blood pressure.
If more than the recommended dose of the medicine is taken, the patient should immediately consult their doctor or pharmacist. It may be necessary to correct electrolyte disturbances.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are local reactions: redness, itching, burning, rash, hives, and burns at the application site.
Less common are gastrointestinal disorders - stomach pain and indigestion.
In susceptible individuals who have had asthma attacks or allergic diseases, bronchospasm may occur.
Skin sensitization to light - the frequency of this reaction is unknown.
If the patient experiences any of the following symptoms, they should immediately stop using ibuprofen and seek medical attention:

• Red, flat, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• Red, peeling rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting side effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store the medicine

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Store at a temperature below 25°C.
• Shelf life after first opening the tube: 3 months.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

The active substances of the medicine are ibuprofen and menthol.
1 g of gel contains 50 mg of ibuprofen and 30 mg of menthol.
The other ingredients are: carbomer, propylene glycol, 96% ethanol, diisopropanolamine, purified water.
The pack contains 15 g, 30 g, 50 g, or 100 g of gel.

Marketing authorization holder

The Mentholatum Company (Ireland) Limited
Ground Floor
71 Lower Baggot Street
DUBLIN
D02 P593
IRELAND
Importer:
The Mentholatum Company (Ireland) Limited
1st Floor, Building Two,
Dublin Airport Central,
Swords, Co.
Dublin, K67 E2H3,
Ireland
To obtain more detailed information, the patient should contact:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
phone: 22 417 92 00
Date of last revision of the package leaflet :