Flectormove
Italy
Table of Contents
Patient Information Leaflet
FlectorMove 20 mg/g gel
For adults and adolescents aged 14 years and older
Diclofenac, equivalent to sodium diclofenac (as diclofenac diethylamine)
Please read this leaflet carefully before 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 instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If any side effects occur, including those not listed in this leaflet, speak to your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after 3–5 days.
Contents of this leaflet
- What FlectorMove is and what it is used for
- What you need to know before using FlectorMove
- How to use FlectorMove
- Possible side effects
- How to store FlectorMove
- Contents of the pack and other information
1. What FlectorMove is and what it is used for
FlectorMove contains the active substance diclofenac, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
FlectorMove is indicated
For adults and adolescents aged 14 years and older
For the local symptomatic treatment of pain associated with acute muscle strains, sprains or contusions following impact injuries, such as sports injuries and accidents.
For adolescents aged 14 years and older, the medicine is indicated for short-term treatment.
2. What you need to know before using FlectorMove
Do not use FlectorMove
- if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
- if you have experienced asthma attacks, hives, or runny nose (acute rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
- on open wounds, inflamed or infected skin, eczema, or mucous membranes;
- if you are in the last three months of pregnancy (see "Pregnancy and breastfeeding");
- in children and adolescents under 14 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FlectorMove.
If you suffer from asthma, allergic rhinitis, nasal mucosa swelling (nasal polyps), or chronic obstructive pulmonary disease, or chronic respiratory tract infections (particularly associated with symptoms similar to allergic rhinitis), you are at higher risk than other patients of experiencing asthma attacks (so-called analgesic intolerance/analgesic-induced asthma), local skin or mucosal swelling (so-called Quincke's edema), or hives.
In such patients, FlectorMove should only be used with specific precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are allergic to other substances and experience, for example, skin reactions, itching, or hives.
When FlectorMove is applied over a large skin area and for prolonged periods, the possibility of systemic adverse effects related to application cannot be ruled out.
Apply FlectorMove only to intact, healthy, and unbroken skin. Avoid contact with eyes and oral mucous membranes. The gel must not be ingested.
After applying the gel to the skin, a breathable (non-occlusive) dressing may be used, but the gel must first be allowed to dry on the skin for a few minutes. Occlusive dressings that do not allow air passage must not be used.
Consult your doctor if symptoms worsen or do not improve within 3–5 days.
Discontinue use of FlectorMove if you develop a skin rash.
Avoid exposure to sunlight, including sunlamps, while using this medicine.
Take appropriate precautions to prevent children from touching the area where the gel has been applied.
Children and adolescents
FlectorMove is contraindicated in children and adolescents under 14 years of age.
Other medicines and FlectorMove
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions have been reported with the intended topical use of FlectorMove.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use FlectorMove during the last three months of pregnancy. Do not use FlectorMove during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms of diclofenac (e.g., tablets) may cause adverse effects in the unborn child. It is not known whether the same risk applies to FlectorMove when used topically.
Breastfeeding
Diclofenac is excreted in small amounts in breast milk.
Consult your doctor before using FlectorMove during breastfeeding. In any case, if you are breastfeeding, do not apply FlectorMove directly to the breast or to large areas of skin or for prolonged periods (see section 2 "Warnings and precautions").
Driving and using machines
FlectorMove does not affect or affects negligibly the ability to drive or operate machinery.
FlectorMove contains propylene glycol (E1520), butylated hydroxytoluene (E 321), and a fragrance containing limonene
This medicine contains 60 mg of propylene glycol in each gram of gel.
This medicine contains butylated hydroxytoluene (E 321), which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.
This medicine contains a fragrance with limonene, which may cause allergic reactions.
3. How to use FlectorMove
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in adults and adolescents aged 14 years and older
Depending on the size of the area to be treated, apply an amount of gel ranging from cherry-sized to walnut-sized, corresponding to 1–4 g of gel.
FlectorMove should be applied twice daily (preferably in the morning and evening).
The maximum daily dose is 8 g of gel.
Use in elderly patients
No special dose adjustments are necessary. If you are elderly, you should pay particular attention to possible adverse effects and, if necessary, consult your doctor or pharmacist.
Use in patients with impaired liver or kidney function
Dose reductions are not required.
Use in children and adolescents under 14 years of age
FlectorMove is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use FlectorMove”).
Adolescents aged 14 years and older
If this medicine is needed for more than 7 days for pain treatment, or if symptoms worsen, patients/parents of adolescents are advised to consult a doctor.
Method of administration
FlectorMove is for topical use only.
Apply a thin layer of FlectorMove to the affected areas of the body and gently massage into the skin. Afterwards, clean your hands with a paper towel and then wash them, unless your hands are the area being treated.
If an excessive amount of gel is accidentally applied, wipe off the excess with a paper towel.
The paper towel should be disposed of in household waste to prevent unused product from entering the aquatic environment.
Allow the gel to dry on the skin for a few minutes before applying a bandage. Also, wait until the gel has dried on the skin before taking a shower or bath.
How to remove the seal upon first use:
- Unscrew and remove the tube cap.
- To remove the tube’s safety seal, use the back of the cap.
Duration of treatment
The duration of treatment depends on the indication and the patient’s response. FlectorMove must not be used for longer than one to two weeks without consulting a doctor. If symptoms worsen or do not improve within 3–5 days, consult your doctor.
If you use more FlectorMove than you should
Overdose is unlikely if you apply more FlectorMove than recommended, since absorption into the bloodstream is low when the medicine is used on the skin. If a significantly higher than recommended dose is applied to the skin, the excess gel should be removed (e.g. with a paper towel) and the area rinsed with water.
If you accidentally ingest FlectorMove, contact your doctor immediately or go to the nearest hospital emergency department. If you accidentally ingest the contents of a tube of FlectorMove, adverse effects similar to those observed after ingestion of an excessive dose of systemic diclofenac may occur.
If you forget to use FlectorMove
Do not apply a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects can be serious. Stop using FlectorMove and contact your doctor immediately:
Rare side effects (may affect up to 1 in 1,000 people)
- Skin inflammation with blisters (bullous dermatitis)
Very rare side effects (may affect up to 1 in 10,000 people)
- Asthma
- Swelling of the face, lips, tongue or throat (angioedema)
Other side effects:
Common (may affect up to 1 in 10 people)
- Rash, skin redness (erythema), dermatitis (including contact dermatitis), itching.
Uncommon (may affect up to 1 in 100 people)
- Skin peeling, skin dryness, oedema.
Very rare (may affect up to 1 in 10,000 people)
- Rash with appearance of pustules
- Gastrointestinal disorders
- Hypersensitivity reactions, including urticaria
- Light sensitivity with skin reactions following exposure to sunlight or sunlamps (photosensitivity reaction).
Frequency not known (frequency cannot be estimated from the available data)
- Burning sensation at the site of application.
When FlectorMove is applied over a large skin area and for prolonged periods, the possibility of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those occurring after systemic administration of medicines containing diclofenac cannot be excluded.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.
5. How to store FlectorMove
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store the medicine in its original packaging to protect it from light.
Do not refrigerate or freeze.
After first opening, the gel may be used for a period not exceeding 24 months, but not beyond the expiry date; after this period, any remaining gel should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What FlectorMove contains
- The active substance is diclofenac. 1 g of gel contains 23.2 mg of diclofenac diethylamine, equivalent to 20 mg of sodium diclofenac.
- The other components are: diethylamine, carbomer 974P, cocoile capril/caprate, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, propylene glycol (E1520), eucalyptus flavour (containing limonene), butylhydroxytoluene (E 321), oleic alcohol, purified water.
Description of the appearance of FlectorMove and contents of the pack
FlectorMove is a homogeneous gel, white to almost white.
Each pack contains one tube, closed with a seal and a screw cap, containing 60 g, 100 g, 120 g or 150 g of gel.
Not all pack sizes may be marketed.
Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia 2,
26900 Lodi, Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe 1,
29016 Cortemaggiore (PC), Italy
This medicinal product is authorised in the European Economic Area member states under the following names:
DE: Flector Schmerzgel
IT: FlectorMove