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What Piroxicam is and what it is used for
Piroxicam cream contains the active substance piroxicam and belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). It is used to relieve pain and reduce inflammation and swelling in the following cases:
Mild to moderate muscle pain;
Acute musculoskeletal disorders, such as post-traumatic pain or inflammation of tendons (tendinitis), ligaments, muscles and joints (sprains, sprains and bruises);
Mild to moderate rheumatic pain characteristic of the acute phase of chronic degenerative joint diseases (osteoarthritis), in particular in arthrosis of the cervical vertebrae (causing pain in the neck area), lumbar arthrosis (causing back pain) and arthrosis of the knee joint ( causes knee pain).
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you use Piroxicam
Do not use Piroxicam:
if you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6.);
if taking acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) cause symptoms of asthma, rhinitis, angioneurotic edema or urticaria;
if you are pregnant or breastfeeding; in children under 12 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Piroxicam.
Due to the possibility of skin absorption of Piroxicam Ecopharm, the risk of systemic effects cannot be excluded. The risk of these reactions depends on the size of the surface to which it is applied and the duration of use. If you have or have recently had gastrointestinal bleeding or a peptic ulcer, consult your doctor before using Piroxicam Ecopharm.
Serious skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (severe disease with blistering of the skin, mouth, eyes and genitals) and toxic epidermal necrolysis (severe disease with blistering on the skin) associated with the use of NSAIDs have been reported very rarely (see section 4). The risk of these reactions is higher at the beginning of treatment, and in most cases they occur during the first month of treatment. Application of Piroxicam Ecopharm should be discontinued at the first signs of rash, mucosal lesions or other signs of hypersensitivity.
If you develop a rash or skin symptoms, you should immediately stop using Piroxicam Ecopharm, seek medical help and tell your doctor that you are using this medicine.
Do not apply the cream in the eyes, mucous membranes, open skin lesions or skin conditions that affect or disrupt the structure and normal functioning of the skin. If this happens, the affected area should be flushed with plenty of water.
Do not expose the treated area to the sun during treatment and for two weeks after stopping treatment.
Children and adolescents
Piroxicam Ecopharm is not recommended for use in children under 12 years of age, as the indications and dosage for use in this age group have not yet been established. The use of Piroxicam Ecopharm cream in children should only be done on a doctor's prescription and under supervision.
Other medicines and Piroxicam
You should tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Before using Piroxicam, check with your doctor whether you are taking medicinal products for blood pressure control (diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin II antagonists). NSAIDs, to which piroxicam belongs, can reduce the effectiveness of these medicinal products. Concomitant use may lead to deterioration of renal function in some patients with impaired renal function (for example, dehydrated patients or elderly patients with impaired renal function) and should be used with caution, especially if Piroxicam Ecopharm is applied to large areas of the skin, for a long time.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine, as the safety of the medicinal product during pregnancy and breast-feeding has not been established.
Driving and using machines
There is no evidence that Piroxicam Ecopharm affects the ability to drive and operate machinery.
Piroxicam contains stearyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and propylene glycol.
Stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Methyl parahydroxybenzoate and propyl parahydroxybenzoate can
3. How to use Piroxicam Ecopharm
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 1 g Piroxicam Ecopharm cream (10 mg piroxicam) applied to the affected area (about 3 cm of cream squeezed from the tube) 2 to 3 times a day. After application, massage gently until fully absorbed into the skin.
Use in children and adolescents
Indications and dosage for use in children under 12 years of age have not been established.
Use in elderly patients, patients with liver or kidney damage
No dose adjustment or special attention is needed when using Piroxicam Ecopharm by elderly patients, patients with liver impairment and patients with renal impairment.
Method and way of application
Piroxicam Ecopharm is for external use only (application to the skin).
Apply to the affected area, where you have pain or swelling, with light massage movements, until the cream is completely soaked.
Do not use occlusive dressings.
Hands should be washed after application, except in cases where the hands are being treated.
Duration of treatment
The duration of treatment depends on the nature and severity of the disease being treated. If after 7 days of use you do not feel better, or if your condition worsens, you should consult a doctor.
If you have used more than the required dose of Piroxicam Ecopharm
If you have used more than the required dose of Piroxicam Ecopharm, remove the cream with a wipe. An overdose with Piroxicam Ecopharm is unlikely.
If you forget to use Piroxicam Ecopharm
Do not use double the amount of cream to make up for a missed dose. If you have forgotten to use Piroxicam Ecopharm, apply it as soon as you remember and continue the treatment according to the usual schedule.
If you have any further questions about the use of this medicine, ask your doctor» pharmacist or nurse.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions related to treatment have been reported rarely. The following dermatological conditions have been reported post-marketing:
Common (may affect up to 1 in 10 people): mild to moderate local irritation, erythema (redness), skin rash, skin discoloration and peeling, pruritus (itching) and application site reactions.
Rare (may affect up to 1 in 1,000 people): contact dermatitis, eczema, skin photosensitivity reactions, mild skin discoloration.
Very rare (may affect up to 1 in 10,000 people): bullous reactions including Stevens-Johnson syndrome (severe disease^ accompanied by blistering of the skin, mouth, eyes and genitals) and toxic epidermal necrolysis (severe disease accompanied by with blistering of the skin).
With an unknown frequency (an estimate cannot be made from the available data): fixed drug eruption (may appear as round or oval plaques of red and swollen skin), blisters (hives), itching.
If signs of reddening of the skin at the application site appear, discontinue the use of Piroxncam Ecopharm and consult a doctor.
5. How to store Piroxicam Ecopharm
Keep out of the reach of children.
To be stored below 25°C.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.
Do not use more than 1 year after first opening the tube.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What does Piroxicam Ecopharm contain?
Active substance: 10 mg of piroxicam in 1 g of cream.
Other ingredients: stearic acid, decyl oleate, macrogolcetostearyl ether 12, macrogolcetostearyl ether 20, methyl parahydroxybenzoate (£218), propyl parahydroxybenzoate (E216), self-emulsifying glycerin monostearate, stearyl alcohol/cetearet 20, polysorbate 80/cetyl acetate/acetylated lanolin alcohol, propylene glycol, sodium hydroxide, flavoring essence R123175, purified water.
What Piroxncam Ecopharm looks like and what the package contains
Each carton contains 1 aluminum tube of 100 g with a PE screw cap.
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