Diclofenac viatris

Package leaflet: Information for the user

Diklofenak Viatris, 180 mg, medicated patch (1.3%)
Diclofenacum epolaminum
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after a short period of treatment, or if the patient feels worse, consult a doctor.

Table of contents

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

1. What Diklofenak Viatris is and what it is used for

Diklofenak Viatris contains the active substance diclofenac epolamine and belongs to a group of medicines used to relieve pain and inflammation, known as non-steroidal anti-inflammatory drugs (NSAIDs).
Diklofenak Viatris is applied to the skin to relieve pain and inflammation of rheumatic or traumatic origin affecting joints, muscles, tendons, or ligaments.
If there is no improvement after a short period of treatment with Diklofenak Viatris, or if the patient feels worse, consult a doctor.

2. Important information before using Diklofenak Viatris

When not to use Diklofenak Viatris:

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs)
• during the last three months of pregnancy (see "Pregnancy, breastfeeding and fertility")
• if the patient has asthma, breathing problems, skin rash or rhinitis after taking acetylsalicylic acid (aspirin) or other NSAIDs
• if the skin at the intended site of patch application is damaged or injured, there are weeping or infected lesions, rash, burns or wounds
• if the patient has active gastric ulcer (peptic ulcer)
• in children and adolescents under 16 years of age.

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Warnings and precautions
Before starting treatment with Diklofenak Viatris, discuss this with your doctor or pharmacist:

• if the patient has breathing problems (allergic rhinitis, nasal polyps, asthma, chronic bronchial disease);
• if the patient has kidney, heart or liver disease;
• if the patient has had gastric or duodenal ulcer;
• if the patient has inflammatory bowel disease such as Crohn's disease or ulcerative colitis;
• if the patient has increased tendency to intestinal bleeding;
• if the patient is in the first 6 months of pregnancy or is breastfeeding.

Other important information
Always use the lowest effective dose of Diklofenak Viatris for the shortest duration necessary to control symptoms.
Caution should be exercised when using Diklofenak Viatris in elderly patients, in whom the likelihood of adverse reactions may be higher.
To minimize the frequency of adverse reactions, it is recommended to use the lowest effective dose for as short a time as possible.
Do not use Diklofenak Viatris simultaneously with other medicinal products containing diclofenac or other non-steroidal anti-inflammatory drugs (NSAIDs).
Avoid exposure to direct sunlight or sunbeds (tanning beds) for at least one day after removing the patch, to reduce the risk of undesirable light reactions (photosensitivity).
Like other topically applied medicines, Diklofenak Viatris may cause redness and itching of the skin (skin sensitization), especially with prolonged use. If a skin reaction occurs at the site of application after using this patch, treatment should be discontinued and the patient should consult a doctor or pharmacist.
Elderly patients
Greater attention should be paid to possible adverse reactions in these patients during treatment with Diklofenak Viatris.
Patients with impaired liver or kidney function
Greater attention should be paid to possible adverse reactions during treatment with Diklofenak Viatris in patients with impaired liver or kidney function.
Children and adolescents
Do not use in individuals under 16 years of age.
Diklofenak Viatris and other medicines
When used correctly, the risk of interactions with other medicines is very low. However, you should inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to take. In particular, inform the doctor if the patient is taking other medicines containing diclofenac or other NSAIDs.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine. Do not use Diklofenak Viatris starting from the 6th month of pregnancy onwards, as the medicine may harm the unborn child or cause complications during delivery.
Before the 6th month of pregnancy, Diklofenak Viatris should be used only on medical advice, at the lowest possible dose and for the shortest possible duration.
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Breastfeeding
During breastfeeding, Diklofenak Viatris should only be used on medical advice, because diclofenac passes into breast milk in small amounts. The medicine should not be applied during breastfeeding on the breasts of nursing mothers or on any other large area of skin or for prolonged periods.
Fertility
If the patient has difficulty becoming pregnant and is using Diklofenak Viatris, she should inform her doctor, as discontinuation of treatment may be necessary.
Driving and operating machinery
Diklofenak Viatris has no effect on the ability to drive and operate machinery.
Diklofenak Viatris contains propylene glycol, methyl parahydroxybenzoate and propyl parahydroxybenzoate

• This medicine contains 420 mg of propylene glycol in each medicated patch.
• Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed-type).

3. How to use Diklofenak Viatris

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is 1 or 2 patches per day, applied every 12 or 24 hours, for no longer than 14 days. The patch must not be cut. If there is no improvement after 14 days of treatment, or if symptoms worsen, consult your doctor.
Adolescents aged 16 to 18 years
The recommended dose is 1 or 2 patches per day, applied every 12 or 24 hours, for no longer than 7 days. The patch must not be cut. If there is no improvement after 7 days of treatment, or if symptoms worsen, consult your doctor.
Children and adolescents under 16 years of age
The medicinal patch must not be used in children and adolescents under 16 years of age due to insufficient available data on efficacy and safety.
Elderly patients
Caution is advised, as elderly patients are more likely to experience adverse reactions.
Patients with hepatic or renal impairment
Information on the use of diclofenac-containing medicinal patches in patients with hepatic or renal impairment is provided in section "Special warnings and precautions for use".
How to use Diklofenak Viatris
Tear open the top of the sachet and remove the patch.
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Carefully reseal the sachet.
Remove the protective liner from the adhesive surface.
Apply the patch to the skin over the painful or swollen area.

• If necessary, the patch may be further secured with an elastic mesh or bandage, available from your pharmacy.
• Do not cover the patch with an occlusive dressing, such as an impermeable plastic material or occlusive bandage.
• The medicinal patch should only be applied to intact, undamaged skin, avoiding cuts, wounds, or diseased skin areas. Do not use during bathing or showering.
• Avoid contact of the patch with the eyes, nose, mouth, genital area, or anus. In case of contact, rinse thoroughly with water.
• The patch must not be cut.
• The patch should be changed regularly.
• The patch should be removed every 12 or 24 hours and replaced with a new one.

In case of an overdose of Diklofenak Viatris, systemic (whole-body) adverse effects may occur, such as gastrointestinal disturbances. In such a case, contact your doctor immediately or go to the nearest hospital, as additional measures may be necessary.
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Missed dose of Diklofenak Viatris
Do not apply more than one patch at the same time. Do not apply an additional patch to make up for a missed dose. For further information, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the allergic symptoms listed below occur,
STOP using Diklofenac Viatris and inform your doctor or pharmacist:
Very rare (may affect up to 1 in 1,000 people)

• Swelling of the lips, eyes or tongue, wheezing or asthma attack, i.e. symptoms of acute allergic reaction

Common (may affect up to 1 in 10 people)

• Burning or stinging sensation at the site of patch application.

Generally, adverse reactions occur at the site of application.
Common (may affect up to 1 in 10 people)
Skin reactions: skin rash, dermatitis, redness and swelling of the skin, itching (pruritus).
Other possible adverse reactions
Rare (may affect up to 1 in 1,000 people): skin rash with blister formation, dry skin.
Very rare (may affect up to 1 in 10,000 people): allergic reaction also following exposure to sunlight or solarium irradiation (photosensitivity), urticaria.
Frequency not known (frequency cannot be estimated from the available data): burning sensation at the site of application.
If medicated patches are used correctly, the risk of adverse reactions is very low. However, the risk of systemic adverse reactions cannot be excluded when the patches are used for prolonged periods or together with other medicinal products containing diclofenac, especially those taken orally.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 4921 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions allows further collection of information on the safety of the medicine.
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5. How to store Diklofenac Viatris

Keep the medicine out of the sight and reach of children.
Do not use this medicine after 4 months from the date of first opening the sachet. After removing
each patch, always ensure the envelope is tightly resealed. Store in the original packaging to
protect from light and drying out. There are no special requirements regarding the storage
temperature of the medicine.
Do not use this medicine after the expiry date (EXP) stated on the sachet and the cardboard
package. The expiry date refers to the last day of the stated month.
Do not dispose of unused medicated patches via household waste; they should be disposed of in accordance with local regulations. Before disposal, fold the used patch in half with the adhesive side inwards.
Do not dispose of used patches in the toilet or in the drain.
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 Diklofenak Viatris contains
The active substance is diclofenac epolamine. Each medicinal patch contains a total of 180 mg
of diclofenac epolamine, equivalent to 140 mg of sodium diclofenac (1.3% w/w).
The other ingredients are:
Protective outer layer: polyester fiber.
Adhesive layer: sorbitol liquid (non-crystallizing), 1,3-butylene glycol, sodium polyacrylate,
heavy kaolin, sodium carmellose, propylene glycol (see section 2 "Diklofenak Viatris contains"),
gelatin, povidone (K90), tartaric acid, titanium dioxide (E171), glycine aluminum,
polysorbate 80, disodium edetate (E385), methyl parahydroxybenzoate (E218) (see section 2 "Diklofenak Viatris contains"), propyl parahydroxybenzoate (E216) (see section 2 "Diklofenak Viatris contains"), purified water.
Protective layer (to be removed): polypropylene.

What Diklofenak Viatris looks like and contents of the pack
Each medicinal patch consists of a white or yellowish paste evenly spread in a uniform layer on a polyester fiber backing, with a protective covering film over the adhesive side. Resealable sachets contain 5 patches each.
Diklofenak Viatris is available in cardboard boxes containing 5 or 10 patches.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60
1112AX Diemen
The Netherlands

Importer
MIAT S.p.A.
Piazza Pasolini 2
20159 Milano
Italy

This medicinal product is authorised in the European Economic Area member states under the following names:
Hungary: Diclofenac epolamine Cooper 180 mg gyógyszeres tapasz
Estonia: Diclofenac Mylan
Lithuania: Diclofenac Mylan 180 mg vaistinis pleistras
Slovakia: DicloMyl 180 mg liečivá náplasť

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