Sindolor gel, 50g, Fiterman

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

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

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 area. Its effect sets in within 15 minutes, and the pain is relieved for a long period, up to 12 hours. The recommended dose is 0.5 g - 1 g gel (approximately 3 - 4 cm) 2 times a day; massage gently until completely absorbed into the skin.
The duration of treatment depends on the type of disease and the clinical course. If after 7 days of starting treatment the symptoms do not improve, contact your doctor, who will re-evaluate 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 any of the other ingredients of this medicine (listed in section 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 in the last trimester of pregnancy.

Precautions:
Talk to your doctor or pharmacist before using Sindolor gel:
- if you use higher doses of Sindolor gel and:
- you have or have had stomach or intestinal problems such as irritation, gastric or duodenal ulcers and stomach bleeding;
- you have or have had heart, kidney or blood clotting problems;
- you are dehydrated, if you have lost fluids or if you have low blood pressure, as you have an increased risk of kidney toxicity when using 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 mucous membranes, eyes (in case of accidental application, wash the area with plenty of water), large areas of skin or areas of skin with lesions or covered with a dressing or tight clothing on the body.

Pregnancy, lactation 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 on the use of Sindolor gel during pregnancy.
The use of non-steroidal anti-inflammatory drugs (piroxicam) poses a risk to the fetus - the occurrence 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.
Due to the excretion of piroxicam and lidocaine, and probably also cyclobenzaprine, in milk, Sindolor gel is not recommended during breastfeeding.

Driving and using machines:
Administered as recommended, Sindolor gel does not affect the ability to drive or use machines.

Presentation:
50g

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.