Diclofenac Ipsopharma

Patient Information Leaflet

DICLOFENAC IPSO PHARMA 20 mg/g gel

For adults and adolescents aged 14 years and older
Diclofenac, equivalent to diclofenac sodium (as diethylamine salt)
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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet

1. What DICLOFENAC IPSO PHARMA is and what it is used for
2. What you need to know before using DICLOFENAC IPSO PHARMA
3. How to use DICLOFENAC IPSO PHARMA
4. Possible side effects
5. How to store DICLOFENAC IPSO PHARMA
6. Contents of the pack and other information

1. What DICLOFENAC IPSO PHARMA is and what it is used for

DICLOFENAC IPSO PHARMA contains the active substance diclofenac, which belongs to a class of
medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
DICLOFENAC IPSO PHARMA 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.
For adolescents aged 14 years and older, the medicine is indicated for short-term treatment.

2. What you need to know before using DICLOFENAC IPSO PHARMA

Do not use DICLOFENAC IPSO PHARMA

• 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 areas, on eczema, or on 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 DICLOFENAC IPSO PHARMA.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (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 swelling of the skin or mucous membranes (so-called Quincke's edema), or hives.
In these patients, DICLOFENAC IPSO PHARMA may be used only 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 IPSO PHARMA 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 DICLOFENAC IPSO PHARMA only to intact, healthy, and non-injured skin. Avoid contact with 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.
The use of DICLOFENAC IPSO PHARMA must be discontinued if you develop a skin rash.
Avoid exposure to sunlight, including sunlamps, while using this medicine.
Appropriate precautions must be taken to prevent children from touching the area where the gel has been applied.

Children and adolescents
DICLOFENAC IPSO PHARMA is contraindicated in children and adolescents under 14 years of age.

Other medicines and DICLOFENAC IPSO PHARMA
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 topical use intended for DICLOFENAC IPSO PHARMA.

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 DICLOFENAC IPSO PHARMA during the last three months of pregnancy. Do not use DICLOFENAC IPSO PHARMA 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 (e.g., tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies with DICLOFENAC IPSO PHARMA when used on the skin.

Breastfeeding
Diclofenac passes into breast milk in small amounts.
Consult your doctor before using DICLOFENAC IPSO PHARMA while breastfeeding. In any case, if you are breastfeeding, do not apply DICLOFENAC IPSO PHARMA directly to the breast or to large skin areas or for prolonged periods (see section 2 "Warnings and precautions").

Driving and using machines
DICLOFENAC IPSO PHARMA does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

DICLOFENAC IPSO PHARMA 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 IPSO PHARMA

Use this medicine exactly as described 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 quantity of gel ranging from the size of a cherry to a walnut, corresponding to 1–4 g of gel.
Apply DICLOFENAC IPSO PHARMA 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 hepatic or renal impairment
Dose reduction is not required.

Use in children and adolescents under 14 years of age
DICLOFENAC IPSO PHARMA is contraindicated in children and adolescents under 14 years of age (see section 2, “Do not use DICLOFENAC IPSO PHARMA”).

Adolescents aged 14 years and older
If this medicine is needed for more than 7 days to treat pain, or if symptoms worsen, the patient or the adolescent’s parents are advised to consult a doctor.

Method of administration
DICLOFENAC IPSO PHARMA is for cutaneous 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.
Allow the gel to dry on the skin for a few minutes before applying a bandage. Also, wait until the gel has dried before taking a shower or bath.

How to remove the seal for first use:

• Unscrew and remove the cap of the tube.
• To remove the safety seal of the tube, use the back of the cap.

Duration of treatment
The duration of treatment depends on the indication and the patient’s response. DICLOFENAC IPSO PHARMA 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 IPSO PHARMA than you should
Overdose is unlikely if you apply more DICLOFENAC IPSO PHARMA than recommended, since absorption into the bloodstream is low when the medicine is applied to the skin. If a significantly higher than recommended dose is applied to the skin, remove the excess gel (e.g. with a paper towel) and rinse the area with water.
In case of accidental ingestion of DICLOFENAC IPSO PHARMA, contact your doctor immediately or go to the nearest hospital emergency department. If the contents of a tube of DICLOFENAC IPSO PHARMA are accidentally ingested, adverse effects may occur similar to those observed after ingestion of an excessive dose of systemically administered diclofenac.

If you forget to use DICLOFENAC IPSO PHARMA
Do not use 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 IPSO PHARMA 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)

• 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 pustule formation
• Gastrointestinal disorders
• 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 application site.

When DICLOFENAC IPSO PHARMA 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 observed after systemic administration of diclofenac-containing medicines 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 DICLOFENAC IPSO PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 the 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 IPSO PHARMA contains

• The active substance is diclofenac. 1 g of gel contains 23.2 mg of diethylamine diclofenac, 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 fragrance (contains limonene), butylated hydroxytoluene (E 321), oleic alcohol, purified water.

Description of the appearance of DICLOFENAC IPSO PHARMA and contents of the pack
DICLOFENAC IPSO PHARMA is a homogeneous gel, white to almost white.
Each pack contains one 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
Ipso Pharma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ) - Italy

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy