DICLOFENAC 20 mg /G Gel

Зміст інструкції

1. DICLOFENAC IPSO PHARMA 20 mg/g gel
   1. What is DICLOFENAC IPSO PHARMA and what is it 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

DICLOFENAC IPSO PHARMA 20 mg/g gel

For adults and adolescents aged 14 years and over
Diclofenac, corresponding to diclofenac sodium (as diclofenac diethylamine)

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 you use 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 is DICLOFENAC IPSO PHARMA and what is it used for

DICLOFENAC IPSO PHARMA contains the active ingredient diclofenac which belongs to a class of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
DICLOFENAC IPSO PHARMA is indicated:
For adults and adolescents aged 14 years or older
For the symptomatic local treatment of pain associated with acute muscle strains, sprains or
contusions following impact trauma, for example injuries and sports accidents.
For adolescents aged 14 years or 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 developed asthma attacks, urticaria, runny nose (acute rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• on open wounds, inflammation or skin infections, on 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
Consult your doctor or pharmacist before using DICLOFENAC IPSO PHARMA.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive bronchopneumopathy, chronic respiratory tract infections (particularly associated with symptoms similar to allergic rhinitis), you are more likely than other patients to experience asthma attacks (so-called analgesic/asthma intolerance), local swelling of the skin or mucous membranes (so-called Quincke's edema) and urticaria.
In these patients, DICLOFENAC IPSO PHARMA can only be used with certain precautions (preparation for emergencies) and under direct medical supervision. The same applies to patients who are also allergic to other substances and experience, for example, skin reactions, itching or urticaria.
When DICLOFENAC IPSO PHARMA is applied to a large area of skin and for a prolonged period, the possibility of systemic adverse effects associated with the application cannot be excluded.
Apply DICLOFENAC IPSO PHARMA only to intact, healthy skin without wounds. Avoid contact with the eyes and oral mucous membranes. The gel should not be ingested.
After applying the gel to the skin, you can use a breathable (non-occlusive) bandage, but you must first allow the gel to dry on the skin for a few minutes. Do not use occlusive bandages that do not allow air to pass through.
Consult your doctor if symptoms worsen or do not improve within 3-5 days.
The use of DICLOFENAC IPSO PHARMA should be discontinued if you develop a skin rash.
Avoid exposure to sunlight, including solariums, while using this medicine.
Take necessary precautions to prevent children from touching the area to which 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
To date, no interactions are known to be associated with the cutaneous use intended for DICLOFENAC IPSO PHARMA.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use DICLOFENAC IPSO PHARMA if you are in the last 3 months of pregnancy. Do not use DICLOFENAC IPSO PHARMA during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is necessary during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can 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 during breastfeeding. In any case, if you are breastfeeding, do not apply DICLOFENAC IPSO PHARMA directly to the breast or elsewhere on large areas of skin or for a prolonged period (see section 2 “Warnings and precautions”).

Driving and operating machinery
DICLOFENAC IPSO PHARMA does not alter or alters negligibly the ability to drive vehicles or operate machinery.

DICLOFENAC IPSO PHARMA contains propylene glycol (E1520), butylhydroxytoluene (E 321) and a fragrance with limonene
This medicine contains 60 mg of propylene glycolper gram of gel.
This medicine contains butylhydroxytoluenewhich can 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 following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Use in adults and adolescents aged 14 years and over
Depending on the size of the area to be treated, apply an amount of gel varying between a cherry and a walnut, corresponding to 1-4 g of gel.
DICLOFENAC IPSO PHARMA should be applied twice a day (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 undesirable effects and, if necessary, consult your doctor or pharmacist.

Use in hepatic or renal impairment
No dose reductions are necessary.

Use in children and adolescents under 14 years
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 over
If this medicine is needed for more than 7 days for pain relief or if symptoms worsen, it is recommended that the patient/the adolescent’s parents consult a doctor.

Route of administration
DICLOFENAC IPSO PHARMA is for external use.
Apply a thin layer of gel to the affected parts of the body and massage gently into the skin.
Afterwards, wash your hands with a paper towel and then with water, unless they are the area to be treated.
If an excessive amount of gel is accidentally applied, the excess gel should be cleaned with a paper towel.
The paper towel should be disposed of in household waste to prevent unused product from reaching the aquatic environment.
Before applying a bandage, allow the gel to dry on the skin for a few minutes. Also, before showering or bathing, wait for the gel to dry on the skin.
How to remove the seal on 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 cannot be used for more than one to two weeks without consulting a doctor. If symptoms worsen or do not improve within 3-5 days, consult a doctor.

If you use more DICLOFENAC IPSO PHARMA than you should
An overdose is unlikely if you apply more DICLOFENAC IPSO PHARMA than you should, as absorption into the bloodstream is poor when the medicine is used on the skin. If a significantly higher dose than recommended is applied to the skin, the gel should be removed (e.g. with a paper towel) and the area rinsed with water.
In case of accidental ingestion of DICLOFENAC IPSO PHARMA, contact your doctor immediately or go to the nearest hospital emergency room. If you accidentally ingest the contents of a tube of DICLOFENAC IPSO PHARMA, side effects similar to those observed after ingestion of an excessive dose of diclofenac for systemic use may occur.

If you forget to use DICLOFENAC IPSO PHARMA
Do not use 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.
The following side effects may 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)

• Scaling, dehydration of the skin, edema.

Very rare (may affect up to 1 in 10,000 people)

• Skin rash with the appearance of pustules
• Gastrointestinal disorders
• Hypersensitivity reactions, including urticaria
• Skin tightness or erythema following exposure to sunlight or sunlamps (photosensitivity reaction).

Frequency not known(the frequency cannot be estimated from the available data)

• Burning sensation at the application site.

When DICLOFENAC IPSO PHARMA is applied to a large area of skin and for a prolonged period,
the possibility of systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those that may occur after systemic administration of medicines containing diclofenac cannot be excluded.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you 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 which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular 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 of no more than 24 months, but not beyond the expiry date; after this period, any remaining gel must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DICLOFENAC IPSO PHARMA contains

• The active ingredient is diclofenac. 1 g of gel contains 23.2 mg of diclofenac diethylamine, corresponding to 20 mg of diclofenac sodium.
• The other ingredients are: diethylamine, carbomer 974P, caprylic/capric triglyceride, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, propylene glycol (E1520), eucalyptus essence (contains limonene), butylhydroxytoluene (E 321), oleyl alcohol, purified water.

Description of the appearance of DICLOFENAC IPSO PHARMA and contents of the pack
DICLOFENAC IPSO PHARMA is a homogeneous gel, from white to almost white.
Each pack contains a tube, sealed with a seal and a screw cap, containing 60 g, 100 g, 120 g and 150
g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation 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