Nuroflex for muscle and joint pain

Package leaflet: Information for the user

NUROFLEX Muscle and Joint Pain, 200 mg medicated patch

For use in adults and adolescents aged 16 years and older
Ibuprofen
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 5 days.

Contents of this leaflet

1. What NUROFLEX Muscle and Joint Pain is and what it is used for
2. What you need to know before using NUROFLEX Muscle and Joint Pain
3. How to use NUROFLEX Muscle and Joint Pain
4. Possible side effects
5. How to store NUROFLEX Muscle and Joint Pain
6. Contents of the pack and other information

1. What NUROFLEX Muscle and Joint Pain is and what it is used for

The active substance is ibuprofen. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which work by altering the body's response to pain, swelling, and increased temperature. The medicated patch continuously releases ibuprofen locally into the affected painful area over the 24-hour application period.

NUROFLEX Muscle and Joint Pain is indicated in adults and adolescents aged 16 years and older for short-term symptomatic treatment of localized pain due to acute muscle strains. It is also indicated for mild trauma-related sprains affecting the joints of the upper or lower limbs.

2. What you should know before using NUROFLEX Muscle and Joint Pain

Do not use NUROFLEX Muscle and Joint Pain:

• if you are allergic to ibuprofen, acetylsalicylic acid, other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced allergic reactions such as asthma, wheezing, itching, runny nose, skin rash, or swelling after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or acetylsalicylic acid;
• if you are in the third trimester of pregnancy;
• on damaged skin (such as abrasions, cuts, burns), infected skin, skin affected by exudative dermatitis or eczema, eyes, lips, or mucous membranes.

Warnings and precautions
Consult your doctor or pharmacist before using NUROFLEX Muscle and Joint Pain:

• if you have or have ever had asthma or suffer from allergies;
• if you have gastric/duodenal ulcer, intestinal, heart, kidney, or liver problems;
• if you have a tendency to bleeding;
• if you are in the first 6 months of pregnancy or breastfeeding.

During use of NUROFLEX Muscle and Joint Pain

• At the first sign of any skin reaction (rash, peeling, blisters) or any other sign of allergic reaction, stop using the medicated patch and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• If you are elderly, you may be at higher risk of experiencing adverse effects.
• If your symptoms do not improve, worsen, or new symptoms develop, consult your doctor.
• Avoid exposing the treated area to strong sources of natural and/or artificial light (e.g. sunbeds) during treatment and for one day after removing the medicated patch, in order to reduce the risk of photosensitivity.

Adverse effects can be minimized by reducing the duration of treatment.
Children and adolescents
This medicine is not recommended for use in children and adolescents under 16 years of age.
Other medicines and NUROFLEX Muscle and Joint Pain
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially if you are taking any of the following:

• medicines to lower blood pressure;
• medicines to thin the blood, e.g. warfarin;
• acetylsalicylic acid or other NSAIDs – used for inflammation and pain.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine if you are in the last trimester of pregnancy.
If you are in the first 6 months of pregnancy, speak to your doctor before using this medicine.
No harmful effects are known when using this medicine during breastfeeding. However, as a precautionary measure, do not apply the medicated patch directly on the breast if you are breastfeeding.

Driving and using machines
NUROFLEX Muscle and Joint Pain does not affect or affects negligibly the ability to drive and use machinery.

3. How to use NUROFLEX Muscle and Joint Pain

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Adults or adolescents aged 16 years and older:
One dose corresponds to one medicated patch. The maximum dose within a 24-hour period is one medicated patch.
This medicine is not recommended for use in children and adolescents under 16 years of age.
For topical use on intact skin.
It is recommended to wash and thoroughly dry the area to be treated before applying the patch. The patch may be applied at any time of day or night, but must be removed at the same time the following day to apply a new patch.
The patch is flexible and anatomical and, if necessary, can be applied over or near joints, allowing normal joint movement.
You must not:

• cut the patch, as it must be used whole;
• apply it to damaged or broken skin;
• cover it with other plasters, bandages, or occlusive dressings;
• wet the patch.

Method of application:

1. To take a medicated patch, tear or cut the sachet along the dotted line.
2. Remove the plastic film labeled (A) and place the adhesive strip in the center of the painful area.
3. Remove the plastic film labeled (B) and gently press to ensure this part of the medicated patch adheres well to the skin.
4. Remove the plastic film labeled (C).
5. Gently pull and press to ensure the remaining part of the medicated patch adheres well to the skin.

Duration of treatment:
Use the lowest effective dose needed for the shortest time necessary to relieve your symptoms.
Do not use this medicine for more than 5 days. Consult your doctor if symptoms persist beyond 5 days.
If you use more NUROFLEX Muscle and Joint Pain than you should
Accidental overdose with a medicated patch is unlikely.
Consult your doctor. Signs of overdose may include feeling unwell, stomach discomfort, or more rarely, diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
STOP USING the medicine and contact your doctor immediately if you experience:

• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash;
• signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blisters, skin shedding or ulceration.

Inform your doctor or pharmacist if you notice any of the following side effects or any unlisted effect:
Not known ( frequency cannot be estimated from the available data )

• skin reactions such as redness, burning, itching, blisters, pain or oozing;
• skin becomes sensitive to light;
• asthma, difficulty breathing, shortness of breath;
• stomach pain, indigestion;
• kidney impairment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NUROFLEX Muscle and Joint Pain Patches

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the carton after Exp. . The expiry date refers to the last day of that month.
Do not store above 25°C (2 patches per sachet).
Do not store above 30°C (4 patches per sachet).
Store in the original packaging to protect the medicine from light.
Shelf life after first opening of the sachet: 6 months.
Do not dispose of used medicated patches by flushing them down the toilet.
Do not throw any medicine into wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NUROFLEX Muscle and Joint Pain contains:
The active substance is ibuprofen. Each medicated patch contains 200 mg of ibuprofen.
The other components are:
Adhesive layer:
Macrogol 400, Macrogol 20000, Levomenthol, Styrene-Isoprene-Styrene block copolymer,
Polyisobutylene, Glycerol rosin hydrogenated ester, Liquid paraffin.
Support layer:
Non-woven fabric made of Polyethylene Terephthalate (PET).
Protective film:
Silicone-coated Polyethylene Terephthalate (PET).
Description of the appearance of NUROFLEX Muscle and Joint Pain and contents of the
package
The medicated patch consists of a colourless self-adhesive layer applied on a flexible, skin-coloured non-woven fabric support measuring 10 cm x 14 cm, covered by a protective film.
Each sachet contains 2 or 4 medicated patches.
Pack sizes: 2, 4, 6, 8 or 10 medicated patches.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Reckitt Benckiser Healthcare (Italia) S.p.A. - Via G. Spadolini, 7 - 20141 Milan (Italy)
Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands
SIA ELVIM, Kurzemes pr.3G, Riga LV-1067, Latvia