Description

Sindolor gel, 100 g, Fiterman

Read the leaflet carefully and completely before you start using this medicine, because it contains important information for you. Always use this medicine as directed in this leaflet or as directed by your doctor or pharmacist.

Indications:

Sindolor gel is a medicine that relieves inflammation and pain.
Sindolor gel is indicated for adults and children over 15 years of age in the treatment of inflammatory or post-traumatic diseases of the joints and soft tissues, dislocations, sprains, contusions, muscle strains, meniscus diseases, tenosynovitis, contractures, hematomas (bruises).

Composition:
The active substances are: piroxicam, cyclobenzaprine hydrochloride and lidocaine. One gram of gel contains 5 mg piroxicam, 5 mg cyclobenzaprine hydrochloride and 20 mg lidocaine.

Dosage and administration:

Always use this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.
Use in adults and children over 15 years of age
Sindolor gel is applied to the painful surface. Its effect is established in 15 minutes, and the pain is relieved for a long period, up to 12 hours. The recommended dose is 0.5 g - 1 g of gel (approximately 3 - 4 cm) 2 times a day; gently massage until fully absorbed into the skin.
The duration of the treatment depends on the type of the condition and the clinical evolution. If after 7 days of starting the treatment the symptoms do not improve, contact the doctor, who will reevaluate the treatment.
Use in children and adolescents under 15 years of age
Sindolor gel is not recommended for use in these age groups due to a lack of data on safety and efficacy.

Contraindications:
Do not use Sindolor gel
- if you are allergic (hypersensitive) to piroxicam, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, cyclobenzaprine hydrochloride, lidocaine or to any of the other components of this medicine (listed in point 6);
- if you have had allergic attacks in the past induced by the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
- if you are pregnant in the last trimester.

Precautions:
Before using Sindolor gel, talk to your doctor or pharmacist:
- if you use higher doses of Sindolor gel and:
- you have or have had diseases of the stomach or intestines such as irritations, gastric or duodenal ulcer and bleeding in the stomach;
- you have or have had heart, kidney or blood clotting disorders;
- you are dehydrated, if you have lost fluids or if you have low blood pressure, because you have a risk of increased toxicity on the kidneys when you use Sindolor gel;
- you have or have had glaucoma (increased pressure inside the eyeball) or urinary retention.
- if you have or have had bronchial asthma, allergic rhinitis (allergy with nasal manifestations), nasal polyposis, chronic sinusitis (chronic inflammation of the membrane lining the nasal sinuses).
Sindolor gel should not be applied to the mucous membranes, the eyes (in case of accidental application, wash the area with plenty of water), to large areas of skin or areas of skin with injuries or covered with a dressing or tight clothing on the body.

Pregnancy, breast-feeding and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
To date, no relevant epidemiological data are available regarding the administration of Sindolor gel during pregnancy.
The administration of non-steroidal anti-inflammatory drugs (piroxicam) presents a risk to the fetus - the appearance of malformations, especially in the last trimester of pregnancy. In addition, there are insufficient data on the use of cyclobenzaprine during pregnancy. Therefore, Sindolor gel is not recommended for pregnant women in the first two trimesters of pregnancy and is contraindicated in the third trimester.
Because of the excretion in milk of piroxicam and lidocaine, and probably cyclobenzaprine, Sindolor gel is not recommended during breastfeeding.

Driving vehicles and using machines:
Administered according to the recommendations, Sindolor gel does not influence the ability to drive vehicles or use machines.

Presentation:
100 g