DICLOFENAC 1% GEL - patient leaflet, side effects, dosage

Diclofenac 1% Gel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

—Keepthis-leafleT-You-may-need-to-read-it-agairk.......­.............­..............

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their signs of illness are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

• 1. What Diclofenac 1% Gel is and what it is used for

• 2. What you need to know before you use Diclofenac 1% Gel

• 3,.H ow-to -use -Diclofenac –1%. Gel..........­.............­.............­.............­.....

• 4. Possible side effects

• 5. How to store Diclofenac 1% Gel

• 6. Contents of the pack and other information

1. what diclofenac 1% gel is and what it is used for

This medicine is a gel containing 10 mg of diclofenac for each gram of gel. Diclofenac is a phenylacetic acid derivative. It leads to inhibition of cyclooxygenase activity, which, then, leads to the inhibition of prostaglandin synthesis and other inflammation mediators.

Diclofenac acts as an anti-inflammatory and analgesic agent in the treatment of: – mild to moderate muscle pains – contusions

• – post-traumatic pain.

Diclofenac 1% Gel is intended for adults and adolescents aged 14 years and over.

2. what you need to know before you use diclofenac 1% gel

DONOTusethis medicine:'''

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you are hypersensitive to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs), which may arise as asthma, urticaria or other allergic reactions.
• for children under 14 years of age.
• are in the last 3 months of your pregnancy (see also “Pregnancy and breast-feeding”)

' ” if you' have "kian'ey failure?'''

Warnings and precautions

It is important to know that the occurrence of systemic side effects with the topical use of diclofenac is low when compared with the frequency of side effects with the oral use of diclofenac.

As there is a possibility of this medicine cutaneous absorption, it is not possible to exclude the occurrence of systemic effects. The risk of the occurrence of these effects depends, among other factors, on the exposed surface, applied ■quantityand'ex­posare time:........­.............­.............­.............­.............

Cutaneous safety of NSAIDs: It has been reported, very rarely, serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the administration of NSAIDs. Apparently the risk of occurrence of these reactions is greater at the beginning of treatment, and in most cases these reactions are manifested during the first month of treatment. This medicine should be discontinued at the first signs of rash, mucosal lesions or other manifestations of hypersensitivity.

-This ■medicine -can -only be-ap plied- on-healthy-skin-(do- notapply -on- open-— wounds). This medicine cannot come in contact with conjunctive tissue or mucous membranes (for example in mouth). It cannot be ingested.

The area treated with this medicine should not be exposed to sunlight.

Other medicines and Diclofenac 1% Gel

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

This medicine may decrease the effectiveness of diuretics and other antihypertensive medicines, such as Angiotensin Converting Enzyme Inhibitors XACEjnhibitors)-and-Angiotensin.lLAn­tagonists-(AAll);..-.especialLywhen­........

Diclofenac gel is used on large areas of skin and/or for prolonged periods. In some patients with impaired renal function (for example, dehydrated patients or elderly with impaired renal function) the co-administration of an ACE inhibitor or AAII and cycloorygenase inhibitors may result in the progression of the renal function deterioration, including the possibility of acute renal failure, which is usually reversible. Patients should be properly hydrated.

Since systemic absorption of diclofenac from a topical application is very low such interactions are very unlikely.

Diclofenac 1% Gel with food and drink

There are no known interactions of this medicine with food and/or drinks.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

This" medicine musT not be'use'd'dOririg' theTast Tmonths' b'f pregnancy as" If" could harm your unborn child or cause problems at delivery. Diclofenac 1% Gel should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible.

Breast-feeding

This medicine passes into breast milk in small amounts. However, this medicine should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.

Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

Diclofenac 1% Gel contains propylhydroxy­benzoate, methylhydroxy­benzoate and propylene glycol

This medicine contains propylhydroxy­benzoate (E216) and ,metbylhydmxy­bejizQate.(E218)hwhic­b.mayj:aLis£a­llej’giGJ’fia£ti­ons,43assibly— delayed.

This medicine also contains propylene glycol which may cause skin irritation.

3. how to use diclofenac 1% gel

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in adults and adolescents aged 14 years and over

Apply thin layers of this medicine in the affected area, 3 to 4 times daily according lu ■ttTe‘n^ed'of­ttTe‘situatron'(2–4g,‘quaTitity­as'big‘a5'arhe­rryur‘a"“ walnut) and rub gently.

The treatment duration depends on the indications and on the response to the treatment. It is recommended that the treatment should be evaluated 7 days after its start.

In adolescents aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patients/parents of the adolescent is/are advised to consult a doctor.

Diclofenac 1% Gel can be used as additional treatment with the oral administration of non-steroidal anti-inflammatory drugs.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not.ey.eryhody^i­fi.ts.ih.ero.­.............­.............­.............­.............­.............­..

You should immediately stop the treatment with this medicine and contact your doctor immediately if you notice the following side effects (may affect up to 1 in 10,000 people):

• hypersensitivity, which is a kind of allergic reaction manifested by cutaneous rash (skin eruption with redness), shortness of breath and difficulty of swallowing;
• wheezing, shortness of breath or feeling of tightness in the chest (asthma) swelling.parti­culatLyjofihe­.fac£jips.and­.tbrciatj(aogi­Qedema)......­............

Apparently the risk of these reactions is greater at the beginning of the treatment and, in most cases, these reactions happen during the first month of the treatment.

Diclofenac 1% Gel is well tolerated.

Common (may affect up to 1 in 10 people)

• skin rash
• skin disorder (eczema)
• ’’'' redden in g of the ski n (erythe ma)’’’
• inflammation of the skin in the area of the application that is manifested by rash, swelling or papules (dermatitis, contact dermatitis)
• itching of the skin (pruritus)

5. how to store diclofenac 1% gel

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 carton and tube. The expiry date refers to the last day of that month.

Store below 25°C.

Do not use this medicine if you notice visible signs of deterioration.

After first opening, use the medicinal product for a maximum period of ‚6'mdntTis.‘ ”

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Diclofenac 1% Gel contains

The active substance is diclofenac sodium.

-The-other-ingredients-ftr-ersoditrm-hydroxide;-hydrexyethyl-eeHtflose;—■ carbomers, propylene glycol, medium-chain triglycerides, propylhydroxy­benzoate (E216), methylhydroxy­benzoate (E218) and purified water.

What Diclofenac 1% Gel looks like and contents of the pack

Aluminium tube with epoxy phenolic coating and closed aluminium membrane with a polypropylene screw cap, containing 30 g or 50 g of gel.

Aluminium tubes sealed by a membrane with a high-density polyethylene cap ■contain in g-60-g-or MOg-ofgelr.......­.............­.............­.............­.........

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

STADA, Linthwaite, Huddersfield, HD7 5QH, UK

Manufacturer

Laboratorios Basi – Industria Farmaceutica, S.A.

Parque Industrial Manuel Lourenqo Ferreira, Lotes 8,15 E16

–3450–232 -Me rtagua -Portugal.....­.............­.............­.............­............

This leaflet was last revised in July 2021

92900491908