Prospect: Information for the User

Reusin 8 mg/ml Cutaneous Spray Solution

indometacin

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Reusin and for what it is used

2.What you need to know before starting to use Reusin

3.How to use Reusin

4.Possible adverse effects

5Storage of Reusin

6.Contents of the package and additional information

Reusin belongs to the group of medications known as topical nonsteroidal anti-inflammatory drugs.

The indometacin, active ingredient of this medication, acts by reducing pain and inflammation.

Reusin is indicated in adults for the treatment of mild and occasional pain and inflammation in processes such as: Arthritis and acute and post-traumatic musculoskeletal disorders like tendinitis, tenosynovitis, sprains and lower back pain.

No use Reusin

• If you are allergic to indometacina or any of the other components of this medication (listed in section 6).
• If you have experienced an allergic reaction (hypersensitivity) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you have any other skin condition in the area to be treated.
• If the inflammation is caused by an infection.
• If you are pregnant or breastfeeding.
• .

Warnings and precautions

Consult your doctor or pharmacist before starting to use Reusin.

• If you use the medication on large areas for long periods of time, as it may cause the active ingredient to pass into the blood in significant amounts and produce more adverse effects.
• Do not use an occlusive dressing.
• Reusin should not be ingested.
• Do not apply Reusin to the eyes, mucous membranes, or open wounds.
• The aspiration of the solution may cause irritation of the respiratory tract.
• As it contains alcohol, the solution may be easily flammable.

Children

This medication should not be used in children and adolescents under 18 years of age due to the lack of data on its safety and efficacy.

Other medications and Reusin

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with Reusin. In these cases, it may be necessary to adjust the dose or discontinue treatment with some of the other medications.

Particularly, consult your doctor or pharmacist if you are using medications:

• That increase urine excretion (diuretics) as well as other medications for hypertension, as Reusin may reduce their effectiveness;
• For the treatment of hypertension and certain heart problems (angiotensin-converting enzyme inhibitors or angiotensin II antagonists), as their use with Reusin may affect kidney function.

It is not recommended to apply cosmetics or other skin products to the affected area without consulting your doctor first.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

During pregnancy, the use of indometacina is not recommended, as there is insufficient information on the use of indometacina in pregnant women when applied to the skin.

Breastfeeding

The use of this medication during breastfeeding is not recommended. It is unknown whether indometacina applied to the skin passes into breast milk, but it is known that it passes into breast milk when taken orally (capsules, tablets, etc.).

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described after the administration of indometacina through the skin.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again..

Reusin is intended exclusively for topical use (to apply on the skin).

The recommended dose is:

Adults

The usual dose is to apply 5 to 10 pulses, 3 to 4 times a day, unless your doctor has given you other instructions. This recommendation may be modified according to the extent of the area being treated.

For the treatment of large areas, it is recommended not to exceed 25 ml per day, equivalent to 200mg of indometacina (about 150 pulses)

Recommendations for a correct application:

1. When starting to use the package, press several times in a row to eliminate the air from the inner tube and achieve the correct release of the liquid.
2. Place the sprayer at a distance of between 10 cm and 15 cm from the affected area and press the valve as many times as necessary to complete the dosage.
3. After applying the medication to the affected area, extend it by gently massaging to facilitate the penetration of the medication.
4. It is recommended to wash your hands after using the medication.

Use in children

Reusin is not recommended for use in children and adolescents under 18 years old due to the lack of data on its safety and efficacy.

If you use more Reusin than you should

Since the application of this medication is for topical use, it is unlikely that poisoning will occur. However, in case of accidental ingestion of large quantities, symptoms of overdose may include nausea, disorientation, hearing loss, unusual buzzing in the ears, unusual excitement, convulsions, unusual drowsiness, rapid breathing, fever, and ultimately, unconsciousness and death.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forgot to use Reusin

Do not apply a double dose to compensate for the missed doses.

You should continue treatment normally without taking any particular action.

If you interrupt the treatment with Reusin

Discontinuing treatment with this medication does not require any particular action.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The adverse effects of indomethacin for topical use are generally local, mild, and transient.

The possible adverse effects that may be observed with the use of this medication are listed below in order of decreasing frequency:

Rare Adverse Effects(may affect up to 1 in 1,000 patients):

• Pruritus, redness, and local eruptions.
• Local dryness and burning of the skin.
• Sun-induced skin inflammation (dermatitis).

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not bring the container near the fire. Reusin contains alcohol, so it is a flammable product.

Do not use Reusin after the expiration date that appears on the container, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Reusin

• The active principle is indometacina. Each ml of skin spray solution contains 8 mg of indometacina. Each pump contains 1.3 mg of indometacina.
• The other components (excipients) are: isopropyl alcohol and isopropyl myristate.

Appearance of the product and content of the container

Reusin 8 mg/ml Skin spray solution, is a transparent, yellow-green solution, with a characteristic odor.

It is presented in a container containing 100ml.

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18

61118 - Bad Vilbel

Germany

Last review date of this leaflet: March 2021

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/