For topical application. For short-term use.

 

For symptomatic treatment of mild pain following acute blunt traumas (e.g. contusions, sprains).

If symptoms persist for more than two days or get worse, a doctor should be consulted.

Posology

Gel for cutaneous application.

 

Reparil-Gel should be applied 3 times daily. Depending on the size of the aching area to be treated, a cherry- or walnut-sized amount, equivalent to approx. 2.5 to 6.0 g of Reparil-Gel (approx. 81 to 195 mg of salicylate) will be required.

 

The maximum daily dose is 20 g of gel, equivalent to approx. 650 mg of salicylate.

 

Paediatric population

No adequate investigations are available on the use of Reparil-Gel in children. Use of Reparil-Gel in children younger than 12 years of age is therefore not recommended.

 

Older patients

No special adjustment of the dose is required. Older patients should be carefully monitored because of the possible side effect profile.

 

Renal impairment

No dose reduction is required in patients with impaired renal function.

 

Hepatic impairment

No dose reduction is required in patients with impaired liver function.

 

Method of administration

 

For topical application only! Do not ingest!

 

A thin layer of Reparil-Gel should be applied to the affected areas of the body and rubbed in gently.

 

Before applying a bandage, Reparil-Gel should dry on the skin for several minutes. The application of an occlusive bandage is not recommended.

 

The attending physician will decide on the duration of treatment. As a rule, application over 1 to 2 days is sufficient.

Reparil-Gel must not be applied: • in patients with a history of hypersensitivity to the active substance salicylate and/or aescin, as well as to d-limonene, farnesol and linalool – constituents of lavender oil and neroli oil/orange bitter flower oil -, or to any of the excipients of the medicinal product listed in section 6.1 or other analgesics and anti-rheumatics (non-steroidal anti-rheumatics); • on open wounds, inflammations or infections of the skin or to eczemas and mucous membranes as well as areas of the skin that have been exposed to radiation treatment. For use of Reparil-Gel during pregnancy and lactation, see section 4.6 Pregnancy and Lactation.

When using Reparil-Gel, patients suffering from asthma, hay fever, swelling of the nasal mucosa (so-called nasal adenoids) or chronic obstructive respiratory tract

 

diseases or chronic respiratory tract infections (particularly in combination with hay fever-like symptoms) and patients with hypersensitivity to analgesics and anti-rheumatics of any kind are at a greater risk than other patients by asthma attacks (so-called analgesic intolerance and analgesic asthma), local skin or mucosal swelling (so-called Quincke’s oedema) or urticaria.

In these patients, Reparil-Gel may only be used when specific precautionary measures are taken and direct medical supervision is performed. The same applies to patients who also react allergically to other substances, e.g. with cutaneous reactions, pruritus or urticaria.

In acute conditions involving pronounced reddening, swelling or overheating of joints with persisting or worsening complaints, a doctor should be consulted.

 

Reparil-Gel contains as fragrances lavender oil and neroli oil/bitter orange flower oil with d-limonene, farnesol and linalool. These substances may cause allergic reactions.

 

Reparil-Gel must not get into contact with the eyes.

 

Paediatric population

Children’s hands should be ensured not to get in touch with skin areas treated with the medicine.

See section 4.2 for further information on the application of the gel in children.

No interactions have become known to date for Reparil-Gel if used as directed. Nevertheless, the treating physician should be informed which medicines are used at the same time and/or have been used recently.

No data are available on the use of Reparil-Gel in pregnant women. No adequate animal experimental studies on the reproductive toxicity of the ingredients of Reparil-Gel are available (see section 5.3).

 

Use of Reparil-Gel during pregnancy is therefore not recommended. Particularly application on a large area should be avoided.

 

It is not known if the ingredients of Reparil-Gel pass into human breast milk. Animal experimental studies on ingredients passing into breast milk are not available.

Therefore the use of Reparil-Gel during breast-feeding is not recommended. In particular, its application in the breast area must be avoided.

Reparil-Gel has no or negligible influence on the ability to drive and use machines.

The following convention has been used for the classification of side effects in terms of frequency:

 

Very common:              ≥ 1/10

Common:                      ≥ 1/100 to < 1/10

Uncommon:                  ≥ 1/1,000 to < 1/100

Rare:                             ≥ 1/10,000 to < 1/1,000

Very rare:                      < 1/10,000

Not known:                   Frequency cannot be estimated from the available data.

 

Skin and subcutaneous tissue disorders:

Very rare: Dehydration of the skin, eczema including pustule or wheal formation, erythema, dermatitis (including contact dermatitis), pruritus, urticaria, scaling.

 

If Reparil-Gel is applied on large areas of the skin, the occurrence of systemic side effects affecting a specific organ system (e.g. hepatic, renal or gastro-intestinal side effects) or even the entire organism (e.g. hypersensitivity reactions, asthma) as they may appear after systemic use of medicines containing salicylate, cannot be excluded.

 

Reparil-Gel contains as fragrances lavender oil and neroli oil/bitter orange flower oil with d-limonene, farnesol and linalool. These substances may cause allergic reactions.

 

Reporting of suspected adverse reactions

 

Reporting suspected adverse reactions after authorisation of the product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Please report adverse drug events to:

The National Pharmacovigilance Centre (NPC):

Fax: +966-11-205-7662

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa  

If the recommended dose for cutaneous application is exceeded, the gel should be removed and rinsed off with water. If considerably excessive amounts are applied or Reparil-Gel has been ingested inadvertently, a doctor should be contacted.

No specific antidote is available.

Pharmacotherapeutic group: Non-steroidal antiphlogistic/analgesic, saponin, ATC Code: M02AC55

Salicylates belong to the group of non-steroidal antiphlogistics/analgesics that has proven effective in common animal experimental inflammation models by inhibition of prostaglandin synthesis. In humans, salicylates reduce inflammation-induced pain.

Furthermore, salicylates reversibly inhibit ADP (adenosine-5’-diphosphate) and collagen-induced platelet aggregation.

 

Aescin is a mixture of approximately 30 saponins. Characteristics attributed to saponins include anti-inflammatory properties. Even small amounts of saponins already exhibit haemolytic properties.

Following cutaneous application salicylate/aescin is probably absorbed in a dermal depot and slowly released from there to the central compartment. The percutaneous absorption rate (bioavailability) of salicylate, obtained from comparative studies (oral/local), comes to approximately 15%.

 

The observed therapeutic efficacy is primarily explained by therapeutically relevant tissue concentations of the medicinal product beneath the application site. In this respect the penetration to the site of action may differ, depending on the extent and nature of the affection as well as on the site of application and action.

Animal experimental investigations on local tolerability were performed.

 

Following daily applications to the dorsal skin over 4 weeks (rats, rabbits) and/or 12 weeks (pigs), no macroscopically or histologically specific local skin damage was detected.

 

Following single instillation into the conjunctival sac of rabbits, reversible low to high-grade inflammatory changes occurred in the conjunctiva.

 

In humans, Reparil-Gel must therefore not be applied to mucous membranes or wounds (see section 4.3).

 

Reparil-Gel has not been sufficiently tested for reproductive toxicity. Fertility studies and investigations of postnatal effects of in utero exposure have not been carried out.

Disodium edetate (Ph.Eur.), Carbomer 980, Macrogol-6-glycerol caprylocaprate (Ph. Eur.), Trometamol, Propan-2-ol (Ph. Eur.), Lavender oil, Neroli oil/Bitter orange flower oil, Purified water.

Not applicable.

The shelf life of Reparil-Gel is 3 years Shelf life after first opening of the container: 6 months This medicine must not be used after the expiry date.

Store below 30°C, in a dry place

Packs of 40 g and 100 g of gel

None.