Dolofest

Package Leaflet: Information for the User

Dolofest, 180 mg, Medicinal Patch

Diclofenac Epolamine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by the doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after a short period of use, there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Dolofest and what is it used for
• 2. Important information before using Dolofest
• 3. How to use Dolofest
• 4. Possible side effects
• 5. How to store Dolofest
• 6. Contents of the package and other information

1. What is Dolofest and what is it used for

Dolofest belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. Dolofest is used to relieve pain and inflammation of rheumatic or traumatic origin in the joints, muscles, tendons, or ligaments. If after a short period of using Dolofest, there is no improvement or you feel worse, you should contact your doctor.

2. Important information before using Dolofest

When not to use Dolofest:

• if you are allergic to diclofenac, acetylsalicylic acid, other painkillers, or any of the other ingredients of this medicine (listed in section 6);
• if you have asthma, breathing problems, skin rash, or hay fever after using acetylsalicylic acid or other NSAIDs;
• if you are in the last three months of pregnancy (see section "Pregnancy, breastfeeding, and fertility");
• if you have an active stomach ulcer (peptic ulcer);
• if you have any skin damage, including weeping or infected skin lesions, eczema, or burns and wounds;
• in children and adolescents under 16 years of age.

If any of the above points apply to you, you should discuss this with your doctor or pharmacist.

Warnings and precautions

Before starting to use Dolofest, you should discuss this with your doctor or pharmacist if:

• you have heart disease;
• you have kidney disease;
• you have liver disease;
• you have had stomach ulcers in the past;
• you have non-specific intestinal inflammation, such as Crohn's disease or ulcerative colitis, or a tendency to bleed from the intestines;
• you have asthma;
• you have breathing problems, skin rash, or hay fever after using acetylsalicylic acid or other NSAIDs;
• you are taking diclofenac or other NSAIDs orally or topically;
• you regularly use a sunbed or are exposed to the sun (see also "Other important information");
• you are elderly, as you may be more prone to side effects.

Other important information

You should always use the smallest effective dose of Dolofest for the shortest time necessary to control the symptoms. Dolofest should be used with caution in elderly patients who may be more prone to side effects. The risk of side effects can be minimized by using the lowest effective dose for the shortest necessary period. You should not exceed the recommended dose of Dolofest, you should not apply it to large areas of skin, or use it for a longer period. You should not expose yourself to direct sunlight or UV lamps for at least one day after removing the patch; this will reduce the risk of an adverse reaction to light (photosensitivity). Like other topical medicines, especially in the case of prolonged treatment, Dolofest may cause redness and itching (sensitizing effect). If skin reactions occur at the site of application, you should discontinue treatment and consult your doctor or pharmacist.

Children and adolescents

Dolofest should not be used in children and adolescents under 16 years of age.

Dolofest and other medicines

If Dolofest is used as directed, the risk of interaction with other medicines is very low. However, you should inform your doctor or pharmacist about all medicines you have taken recently or are taking. In particular, you should inform your doctor if you are taking any other medicines containing diclofenac or other NSAIDs.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. PregnancyDo not use Dolofest during the last three months of pregnancy. During the first six months of pregnancy, you should not use Dolofest unless it is necessary and recommended by your doctor. If necessary, you should be given the lowest dose for the shortest time. After oral administration of diclofenac (e.g., tablets), side effects may occur in the unborn child. It is not known whether this risk also applies to Dolofest when used on the skin. BreastfeedingDuring breastfeeding, Dolofest should only be used on the advice of a doctor, as diclofenac passes into breast milk in small amounts. However, you should not use Dolofest on the breast or other large areas of skin or for a longer period. If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before using this medicine. FertilityIf you have problems getting pregnant and are using Dolofest, you should inform your doctor, as it may be necessary to discontinue treatment.

Driving and using machines

Using a medicinal patch containing diclofenac does not affect the ability to drive or use machines. Dolofest contains:

• preservatives known as parahydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate), which may cause allergic reactions (possible late reactions);
• 420 mg of propylene glycol per patch;
• polysorbate 80, polysorbates may cause allergic reactions.

3. How to use Dolofest

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Adults or adolescents from 16 years of age

Number of patches used

The recommended dose of Dolofest is one (1) patch once or twice a day (one application every 12 or 24 hours), applied to the most painful area for up to 14 consecutive days. If you do not feel any improvement within the recommended treatment period or your symptoms worsen, you should inform your doctor. If after 14 days of treatment, there is no improvement or you feel worse, you should consult your doctor.

Use in children and adolescents under 16 years of age

Dolofest should not be used in children and adolescents under 16 years of age. There is a lack of sufficient data on the efficacy and safety of use in children and adolescents under 16 years of age (see also section "When not to use Dolofest").

Adolescents from 16 years of age - in case of worsening symptoms, it is recommended that the patient and (or)

parents of the adolescent consult a doctor.If after 7 days of treatment, there is no improvement or you feel worse, you should inform your doctor.

How to use Dolofest

Cut the top of the sachet (with the possibility of re-closing) and remove the patch.

Carefully close the sachet.

Remove the plastic foil covering the adhesive layer of the patch.

Apply the patch to the skin in the painful or swollen area.

• If necessary, the patch can be additionally secured with a gauze bandage or tape strips that can be purchased at a pharmacy.
• Do not cover the patch with any other type of dressing.
• Do not cover the treated area with a material made of plastic or a bandage that prevents air from reaching it (occlusive dressing).
• The medicinal patch should only be applied to undamaged, healthy skin. Do not use on skin wounds or open injuries, and do not leave it on the skin during bathing or showering.
• Avoid contact of the patch with the eyes, nose, mouth, genital area, and anus. If the patch comes into contact with these areas, rinse them with water.
• Do not cut the patches.

Changing the patch.

• Remove the patch after 12 or 24 hours and apply a new one.

Missing a dose of Dolofest

Do not use an additional patch to make up for a missed dose. Just apply the next patch according to the schedule. If you have any doubts about using the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dolofest can cause side effects, although not everybody gets them. Commonside effects (may affect up to 1 in 10 people):

• Redness of the skin and skin rashes (rash, eczema, erythema), skin inflammation (dermatitis, including allergic and contact dermatitis), itching, or other reactions at the site of application of the patch.

Uncommonside effects (may affect up to 1 in 100 people):

• Small red or purple spots under the skin (purpura);
• feeling of heat.

Rareside effects (may affect up to 1 in 1,000 people):

• Blistering skin inflammation (bullous dermatitis).
• Dry, flaky skin.

Very rareside effects (may affect up to 1 in 10,000 people):

• Pustular skin inflammation (pustular rash);
• symptoms of allergic reactions (hypersensitivity and anaphylactic reaction), including hives, swelling of the face (angioedema), lips, eyes, or tongue, and difficulty breathing;
• asthma;
• skin rash worsening under the influence of sunlight (photosensitivity).

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Burning sensation at the site of application.

Since Dolofest is applied to the skin at the site of the disease, there is a lower risk of side effects such as gastrointestinal disorders, including pain, indigestion, or any symptoms of bleeding from the stomach or intestines, which may occur with oral diclofenac. However, if Dolofest is not used as directed, such side effects may occur. You should avoid using this medicine in combination with other medicines containing diclofenac, as the likelihood of skin reactions, including those caused by sun exposure, such as blistering, redness, and eczema, is increased. In rare cases, even severe reactions, such as rash with redness, blistering, and peeling (e.g., Stevens-Johnson syndrome, Lyell's syndrome), may occur.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this package leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dolofest

The medicine should be stored out of the sight and reach of children. Do not use this medicine after the expiry date stated on the sachet and carton after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage temperature. Do not use after four months from the first opening of the sachet. After removing each patch, the sachet should be closed tightly again. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the package and other information

What Dolofest contains

• The active substance is diclofenac epolamine. Each medicinal patch contains 180 mg of diclofenac epolamine, which corresponds to 140 mg of diclofenac sodium.
• The other ingredients are: gelatin, povidone (K90), liquid sorbitol (non-crystallizing), heavy kaolin, titanium dioxide (E171), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate (E385), tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80 (E433), purified water. The backing layer is made of polyester. The removable protective layer is made of polypropylene.

What Dolofest looks like and contents of the package

Each medicinal patch consists of a white to pale yellow paste spread in a uniform layer on a backing made of a fabric, with a protective foil covering the adhesive layer. The sachet with the possibility of re-closing contains 5 patches.

Package size

Dolofest is available in packages of 5 or 10 patches in a box. Not all package sizes may be marketed.

Marketing authorization holder

Solinea Sp. z o.o., Elizówka, ul. Szafranowa 6, 21-003 Ciecierzyn, Poland, Tel. 81 463-48-82

Manufacturer

Miat S.p.A., Piazza Giuseppe Pasolini 2, 20159 Milan, Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy - Muscoridol, Greece - Miniflampatch 180 mg φαρμακoỨxo έμπλαστρο, Belgium - Diclofenac Patch AB 140 mg pleister, Diclofenac Patch AB 140 mg emplâtre médicamenteux, Diclofenac Patch AB 140 mg wirksto_haltiges P_aster

Date of approval of the package leaflet: