DICLOFENAC AL Pain Relief Gel, diclofenac sodium

ALIUD Pharma GmbH

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DICLOFENAC AL Pain Relief Gel 10 mg/g, diclofenac sodium

Diclofenac AL pain relief gel 10 mg/g, gel,  diclofenac sodium



For use in adults and adolescents aged 14 and over.

Active ingredient: diclofenac sodium.

Diclofenac AL is used in adults for the local, symptomatic treatment of: mild to moderate acute muscle pain or pain associated with acute sprains, strains or contusions resulting from blunt trauma. Diclofenac AL is used for the short-term treatment of adolescents from the age of 14: for the local, symptomatic treatment of pain in acute sprains, strains or bruises as a result of blunt trauma.
Contains propyl 4-hydroxybenzoate, methyl 4-hydroxybenzoate and propylene glycol.



For DICLOFENAC AL Pain Relief Gel, diclofenac sodium risks and side effects, read the leaflet and ask your doctor or pharmacist.


ALIUD PHARMA® GmbH, Postfach 1380, 89146 Laichingen
Status: March 2019

DICLOFENAC AL Pain Relief Gel, diclofenac sodium. Diclofenac AL Pain

Gel Diclofenac AL: For mild to moderately severe, acute muscle pain

DICLOFENAC AL Pain Relief Gel, diclofenac sodium

For the local symptomatic treatment in adults of:
• mild to moderately severe, acute muscle pain,
• pain from acute sprains , strains or bruises resulting from blunt trauma.

For the short-term treatment of adolescents from the age of 14:
• for the local, symptomatic treatment of pain in acute sprains, strains or bruises as a result of blunt trauma.

DICLOFENAC AL Pain Relief Gel, diclofenac sodium Musculoskeletal disorders

The musculoskeletal system is a complex organ system in the human body. It serves to secure the body shape and posture and enables us to move and move. The musculoskeletal system consists of active and passive components. The active musculoskeletal system is primarily formed by the skeletal muscles and their auxiliary organs, including fascia and tendons. The passive musculoskeletal system (= supporting apparatus) consists of the skeleton and its various parts, such as bones, cartilage and joints.
Pain within the musculoskeletal system can be caused by diseases as well as acute injuries or incorrect loads. Injuries and inflammations, as the causes of pain, often cannot be clearly distinguished from one another. Sprains, strains and bruises in particular often occur as a result of (sports) accidents. The lumbago (lumbago), on the other hand, is characterized by muscle hardening after jerky movement, excessive exertion or stress. Joint pain in particular is often accompanied by swelling of the affected joint, which significantly limits mobility.

Studies show the effectiveness of the active ingredient diclofenac when used topically (externally) to treat acute muscle and joint pain after bruises, strains and sprains. 78 out of 100 patients experienced a reduction in pain by at least half after seven days, while only 20 out of 100 patients reported pain relief on placebo.1

Help with acute muscle pain

Diclofenac AL Pain Relief Gel contains the active substance diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs/analgesics (NSAIDs). By inhibiting prostaglandin synthesis by cyclooxygenase 2 (COX-2), diclofenac reduces pain and swelling caused by inflammation. 2,3 After topical application, the active ingredient is well absorbed into the subcutaneous layers of the skin. Only very small amounts get into the bloodstream, which relieves the organism.

RECOMMENDATIONS FOR USE:
Diclofenac AL pain relief gelis applied thinly to the affected part of the body 3 to 4 times a day as required and rubbed in gently. An amount the size of a cherry to walnut, equivalent to 2-4 g of gel (20-40 mg of diclofenac sodium) is required depending on the affected area.2 The maximum total daily dose is 16 g of gel.
Diclofenac AL Pain Relief Gel may only be used on intact skin. Skin wounds, open injuries, eyes and mucous membranes must not come into contact with the pain gel. Wash hands after application, unless this is the area to be treated.2 If symptoms have not improved after 3-5 days or if they worsen, consult a doctor.2

Note:Diclofenac AL Pain Relief Gel must not be used in the last trimester of pregnancy and by children or adolescents under the age of 14. The treated skin areas should not be exposed to sunlight.2

Tip: You can protect the treated body area with an air-permeable bandage.3 Blunt

trauma

DICLOFENAC AL Pain Relief Gel, diclofenac sodium

injuries Sprains , strains or bruises often result from injuries caused by sports accidents. While a sprain causes the affected joint to twist beyond its natural radius, strains result from overstretching the muscles. Contusions, on the other hand, result from blunt trauma and are closed injuries that cause bleeding into the surrounding tissue.

In these acute injuries, the LUCKY rule helps reduce pain and swelling:
P: Rest
E: Ice
C: Compression
H: Elevation Keep

moving: 5 steps after acute injuries

1. Start at the right time
Patience is required here: Give your body time to heal. It is best to talk to your doctor about starting light weight training.


2. Set up easily
Shift down a big gear. And it is best to increase your exercise plan in small steps.

3. Reconsider your goals
Adjust your goals before breaching reality. Don't overexert yourself after an injury break. This is how you get the fun out of movement.

4. Learn Lessons from the Injury
Perhaps the injury reveals your weaknesses. The injury break gives you the opportunity to rethink certain movement sets and add new ones.

5. Install the basic program – this includes:

• Daily, preferably in the morning, 5 – 10 minutes of stretching exercises.
• Compensate for muscular weaknesses with circuit training 1-2 times a week.
• Treat tense muscle groups to a massage, e.g. B. in the evening or after training.

DICLOFENAC AL Pain Relief Gel, diclofenac sodium Frequently asked questions and answers

What advantages does Diclofenac AL pain gel offer compared to taking Diclofenac in tablet form?
The drug level in the blood is much lower with topical application than with oral application. The occurrence of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions), which can occur under certain circumstances after systemic use of medicinal products containing diclofenac, cannot be ruled out if the gel is applied to the skin over a large area and over a longer period of time is applied. However, since the systemic absorption of diclofenac when applied topically is very low, such side effects are less likely.2

Is an overdose of Diclofenac AL painkiller possible?
Overdose with limited topical use is unlikely due to low systemic absorption. However, if far too much gel has been applied (clearly exceeding the recommended dose), the gel should be washed off the skin with water.3

When should the Diclofenac AL Pain Relief Gel not be used?
If you are hypersensitive to the active substance propyl 4-hydroxybenzoate, methyl 4-hydroxybenzoate or any other component of the Diclofenac AL pain gel, it must not be used. In case of previous allergic reactions (e.g. asthma, bronchospasm, urticaria, runny nose or angioedema) after taking acetylsalicylic acid or other NSAIDs, Diclofenac AL Pain Relief Gel should not be used. Likewise, the Diclofenac AL pain gel may not be used in the last third of pregnancy and in children and adolescents under the age of 14.2

Are interactions with other medicines known?
Since the systemic absorption of diclofenac when applied topically is very low, interactions with other medicinal products are very unlikely.3

References:
1. Derry S et al. Topical NSAIDs for acute musculoskeletal pain in adults. Cochrane Database of Systems Rev 2015; 6(6): CD007402.
2. Prescribing information for Diclofenac AL, as of March 2020.
3. Instructions for use, Diclofenac AL pain gel, as of March 2020.
4. GSK, Global Pain Index Research, Laura Boros 2017, report.