Feloran gel 60 g.

What is Feloran Actavis is and what it is used
The active substance contained in this product is diclofenac sodium. It belongs to the group etc. nonsteroidal anti-inflammatory drugs (NSAIDs). Relieves pain and has a beneficial effect swelling due expressed their anti-inflammatory and analgesic effects.

Feloran Actavis is administered for treatment of pain, swelling and inflammation of a variety of conditions affecting muscles, joints, tendons and soft tissues:
Post-traumatic inflammation of the musculoskeletal system (tendons, muscles, joints), as sprains, dislocations, strains, bruises, sports injuries;
Limited forms of non-arthritic rheumatism, as tendinitis (inflammation of the tendon), bursitis (inflammation of the periarticular sacs), shoulder-hand syndrome (sudden localized pain in the shoulder joint, shoulder and lower cervical vertebrae, which spreads to the fingers) and periartropatiya;
Some forms of arthritis of the hands, feet and spine.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.

2. What you should know before using Feloran Actavis
Do not use Feloran Actavis
If you are allergic to the active substance or to any of the other with this medicine (listed in section 6);
If you have an allergy (e. Bouts of asthma, rhinitis, urticaria) to acetylsalicylic acid (which is also used as an anti-clotting agent), or other drugs used for treating pain, fever and inflammation, such as ibuprofen, indomethacin, ketoprofen, nimesulide and etc .;
During the last three months of pregnancy;
If you are under 14 years.
If any of these conditions apply to you, please tell your doctor or pharmacist because Feloran Actavis is not suitable for you in these circumstances.

Warnings and Precautions
Feloran Actavis is intended only for external use on healthy, undamaged skin. Never take it orally.
Do not use Feloran Actavis on open skin wounds or injuries.
Watch Feloran Actavis not fall on your eyes. If this happens, rinse your eyes with clean water.
If the rash at the application site, discontinue treatment. Avoid prolonged use of the product, especially on large skin areas. Travmagel can be used in elastic bandages and gauze, which are commonly used in trauma such as sprains or dislocations, but should not be used under occlusive (firming and stifle) dressings.

Children and adolescents
Data on safety and efficacy in children and adolescents under 14 years of age are inadequate.
If you need this product to be used more than 7 days for pain relief in children 14 years and older or if their symptoms worsen the patient / or parents should consult / consult their physician.

Other medicines and Feloran Actavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, although there are no known interactions of applications on the skin Feloran Actavis with other medicines.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

pregnancy
Feloran Actavis does not apply during the last three months of pregnancy because it may harm your baby or cause birth complications. In the first six months of pregnancy can be used only on medical advice, the dose should be as low and duration of treatment as short as possible.

breastfeeding
Feloran Actavis may be used during lactation only on prescription. In the period of lactation Feloran Actavis should not be applied to the skin of the breasts of lactating mothers, nor on the other large skin surfaces or for an extended period of time.

Driving and using machines
This product applied to the skin does not adversely affect the ability to drive and use machines.

3. How to use Feloran Actavis
Always take this medicine exactly as described in this leaflet or as you have been told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

dosage
Adults and children 14 years and more:
Feloran Actavis is applied 3-4 times a day by gently rubbing the affected area. The amount for one application is determined depending on the size of the affected area. Usually 2-4 g gel (quantity as cherry to walnut) are sufficient for skin surface with dimensions 400-800 cm2.
The gel is not recommended to be used for more than 14 days at a trauma or soft tissue rheumatism, or 21 days of arthritis, unless directed by a physician.

Elderly:
No adjustment in dosage.

Method of administration
The product is intended for use on healthy skin.
After coating the hands should be washed unless they are treated area.
Feloran Actavis may be used in complex therapy simultaneously with the tablet formulation. It is appropriate to be applied simultaneously with ultrasonic therapy.

If you use more than the amount Feloran Actavis
If you accidentally have used more than the prescribed dose, contact your doctor or pharmacist. One tube of 60 g contains 3 g diclofenac sodium. Do not use the medicine more often or for longer than prescribed, although the likelihood of overdose in topical use is small.
If swallowed accidentally may experience symptoms such as nausea, vomiting, abdominal pain, like an overdose as a result of the adoption of tablets containing diclofenac. In these cases, contact a doctor or go to a medical facility.
If the gel accidentally gets in your eyes, immediately rinse the affected eye with clean lukewarm water.

If you forget to use Feloran Actavis
Apply the usual dose as soon as possible after you remember and continue treatment as usual.
Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some rare and very rare side effects can be serious. If you notice any of these signs of an allergy, stop using Feloran Actavis and tell your doctor or pharmacist:
Red and itchy rash (hives) at the injection site - can affect up to 1 in 10,000 patients applied or blistering of the skin (dermatitis), which may affect up to 1 in 1000 patients;
Wheezing, shortness of breath or tightness in the chest (asthma) - may affect up to 1 in 10,000 patients applied the product;
Swelling (edema) of the face, lips, tongue or throat - may affect up to 1 in 10 000 patients treated.
Other side effects that may occur are usually mild, transient and harmless.
Skin rash, eczema, itching, redness or dermatitis (incl. Contact dermatitis) - may affect up to 1 in 10 patients using the product;
In very rare cases, the skin can become more sensitive to sun and may occur with burning itching, swelling and blisters - may be affected up to 1 in 10,000 patients treated.
If Feloran Actavis is applied on large skin surfaces for a prolonged period of time can be observed adverse effects, which are characteristic of the treatment with diclofenac tablets.

If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Feloran Actavis
Keep out of reach of children!
Do not store above 25 ° C.
Shelf life after first opening the tube: 6 months.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Feloran Actavis
The active ingredient in 1 g of gel is diclofenac sodium (diclofenac sodium) 50 mg. Other ingredients are: hypromellose, macrogol-7-glycerol cocoate, isopropyl alcohol, fragrance of green tea, purified water.