Diclofenac Pharmeg
Italy
Table of Contents
Package leaflet: Information for the patient
DICLOFENAC PHARMEG 20 mg/g gel
For adults and adolescents aged 14 years and over
Diclofenac, equivalent to diclofenac sodium (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 adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3-5 days.
Contents of this leaflet
- What DICLOFENAC PHARMEG is and what it is used for
- What you need to know before using DICLOFENAC PHARMEG
- How to use DICLOFENAC PHARMEG
- Possible side effects
- How to store DICLOFENAC PHARMEG
- Contents of the pack and other information
1. What DICLOFENAC PHARMEG is and what it is used for
DICLOFENAC PHARMEG contains the active substance diclofenac, which belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
DICLOFENAC PHARMEG 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 bruises following impact injuries, such as sports injuries and accidents.
In adolescents aged 14 years and older, the medicine is indicated for short-term treatment.
2. What you need to know before using DICLOFENAC PHARMEG
Do not use DICLOFENAC PHARMEG
- 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, on eczema, or on mucous membranes;
- during 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 DICLOFENAC PHARMEG.
If you suffer from asthma, allergic rhinitis, nasal mucosa swelling (nasal polyps), or chronic obstructive bronchopulmonary 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 swelling of the skin or mucous membranes (so-called Quincke's edema), or hives.
In such patients, DICLOFENAC PHARMEG 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 who experience, for example, skin reactions, itching, or hives.
When DICLOFENAC PHARMEG is applied over a large skin area and for prolonged periods, systemic adverse effects associated with the application cannot be ruled out.
Apply DICLOFENAC PHARMEG only to intact, healthy, and uninjured skin. Avoid contact with the eyes and oral mucous membranes. The gel must not be swallowed.
After applying the gel to the skin, a breathable (non-occlusive) dressing may be used, but you must first allow the gel 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.
Use of DICLOFENAC PHARMEG must be discontinued if a skin rash develops.
Avoid exposure to sunlight, including sunlamps, while using this medicine.
Take necessary precautions to prevent children from touching the area where the gel has been applied.
Children and adolescents
DICLOFENAC PHARMEG is contraindicated in children and adolescents under 14 years of age.
Other medicines and DICLOFENAC PHARMEG
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 cutaneous use of DICLOFENAC PHARMEG.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use DICLOFENAC PHARMEG during the last three months of pregnancy. Do not use DICLOFENAC PHARMEG during the first six months of pregnancy unless strictly necessary and under medical advice.
If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g., tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with DICLOFENAC PHARMEG when used on the skin.
Breastfeeding
Diclofenac passes into breast milk in small amounts.
Consult your doctor before using DICLOFENAC PHARMEG while breastfeeding. In any case, if you are breastfeeding, do not apply DICLOFENAC PHARMEG directly on the breast or elsewhere over large skin areas or for prolonged periods (see section 2 "Warnings and precautions").
Driving and using machines
DICLOFENAC PHARMEG does not affect or affects negligibly the ability to drive or use machinery.
DICLOFENAC PHARMEG 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, which may cause local skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.
This medicine contains a fragrance with limonene, which may cause allergic reactions.
3. How to use DICLOFENAC PHARMEG
Use this medicine exactly as stated in this leaflet or as instructed 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 a thin layer of gel ranging from the size of a cherry to that of a walnut, corresponding to 1–4 g of gel.
DICLOFENAC PHARMEG 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 adjustment is required. However, 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 reduction is not required.
Use in children and adolescents under 14 years of age
DICLOFENAC PHARMEG is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use DICLOFENAC PHARMEG”).
Adolescents aged 14 years and older
If this medicine is needed for more than 7 days for pain treatment, or if symptoms worsen, the patient or the adolescent’s parents are advised to consult a doctor.
Method of administration
DICLOFENAC PHARMEG is for topical use only.
Apply a thin layer of gel to the affected areas of the body and gently massage into the skin.
After application, clean your hands with a paper towel and then wash them thoroughly, 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.
Dispose of the paper towel in household waste to prevent unused product from entering the aquatic environment.
Wait a few minutes to allow the gel to dry 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 cap from the tube.
- To remove the safety seal inside the tube, use the back of the cap.
Duration of treatment
The duration of treatment depends on the condition being treated and the patient’s response. DICLOFENAC PHARMEG 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 DICLOFENAC PHARMEG than you should
Overdose is unlikely when applying more DICLOFENAC PHARMEG than recommended, as absorption into the bloodstream is low when the medicine is applied to the skin. However, if a significantly larger than recommended amount is applied, the excess gel should be removed (e.g. with a paper towel) and the area rinsed with water.
In case of accidental ingestion of DICLOFENAC PHARMEG, contact your doctor immediately or go to the nearest hospital emergency department. If the contents of a tube of DICLOFENAC PHARMEG are accidentally ingested, adverse effects may occur similar to those observed after an overdose of systemically administered diclofenac.
If you forget to use DICLOFENAC PHARMEG
Do not apply a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects can be serious. Stop using DICLOFENAC PHARMEG and contact your doctor immediately:
Rare side effects (may affect up to 1 in 1,000 people)
- Inflammation of the skin 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)
- Skin rash, redness of the skin (erythema), dermatitis (including contact dermatitis), itching.
Uncommon (may affect up to 1 in 100 people)
- Skin peeling, skin dryness, edema.
Very rare (may affect up to 1 in 10,000 people)
- Skin rash with appearance of pustules
- Gastrointestinal disturbances
- Hypersensitivity reactions, including urticaria
- Skin tightness or erythema 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 DICLOFENAC PHARMEG is applied over a large area of skin and for prolonged periods, systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those occurring after systemic administration of diclofenac-containing medicines cannot be ruled out.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak 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 DICLOFENAC PHARMEG
Keep this medicine out of the 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 can 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What DICLOFENAC PHARMEG 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, coco caprylocaprate, macrogol cetyl stearyl ether, isopropyl alcohol, liquid paraffin, propylene glycol (E1520), eucalyptus fragrance (contains limonene), butylated hydroxytoluene (E 321), oleic alcohol, purified water.
Description of the appearance of DICLOFENAC PHARMEG and contents of the pack
DICLOFENAC PHARMEG is a homogeneous gel, white to almost white.
Each pack contains a tube, sealed with a tamper-evident 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
Pharmeg S.r.l. - Via dei Giardini, 34 - 85033 Episcopia (PZ) - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy