VOLTAREN

VOLTAREN 24-hour pain patch

Important notes (mandatory information)

Voltaren 24 Hour Pain Patch.Active ingredient:Diclofenac sodium. Area of application: Is a pain-relieving medicine.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Voltaren 24 Hour Pain Patch is used for adolescents from 16 years of age and adults
Active ingredient: Diclofenac sodium

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist.
• This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS VOLTAREN 24 HOUR PAIN PATCH AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VOLTAREN 24 HOUR PAIN PATCH?
3. HOW IS VOLTAREN 24 HOUR PAIN PATCH USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VOLTAREN 24 HOUR PAIN PATCH BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS VOLTAREN 24 HOUR PAIN PATCH AND WHAT IS IT USED FOR?

Voltaren 24 Hour Pain Patch is a pain-relieving medicine. It belongs to the group of non-steroidal anti-inflammatory/antirheumatic drugs (NSAIDs). Voltaren 24 Hour Pain Patch is used for adolescents from 16 years of age and adults for the local, symptomatic short-term treatment (max. 7 days) of pain in acute strains, sprains or bruises on the arms and legs as a result of blunt injuries.

2. WHAT SHOULD YOU CONSIDER BEFORE USING VOLTAREN 24 HOUR PAIN PATCH?

Voltaren 24 Hour Pain Patch must not be used:

• if you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6
• if you are allergic to another non-steroidal anti-inflammatory/antirheumatic drug (NSAID, e.g. acetylsalicylic acid or ibuprofen)
• if you have ever experienced asthma attacks, a rash (hives) or swelling and irritation in the nose after taking acetylsalicylic acid or another NSAID
• if you have an active stomach or intestinal ulcer
• on injured skin (e.g. abrasions, cuts, burns), infected skin or inflamed skin (exudative dermatitis) or skin affected by eczema
• if you are in the last trimester of pregnancy
• if you are a child or adolescent under 16 years of age

Warnings and precautions:

• Please talk to your doctor or pharmacist before using Voltaren 24 Hour Pain Patch, - if you have or have had bronchial asthma or allergies; you may experience a spasm of the bronchial muscles (bronchospasm), which makes breathing difficult.
• if you notice a rash that occurs after applying the patch. In this case, remove the medicated patch immediately and discontinue treatment.
• if you have kidney, heart or liver disease or if you have had a stomach or intestinal ulcer or inflammatory bowel disease or a bleeding tendency in the past.

Side effects can be reduced by using the lowest effective dose for the shortest possible period of time.

Important precautions:

• The medicated patch must not come into contact with the eyes and mucous membranes or be applied there.
• Elderly patients should use Voltaren 24 Hour Pain Patch with caution, as they are more likely to experience side effects.
• Avoid exposing the treated skin area to direct sunlight or UV radiation in a solarium after removing the medicated patch to reduce the risk of a photosensitivity reaction.
• Do not use Voltaren 24 Hour Pain Patch at the same time as other diclofenac-containing or other non-steroidal pain-relieving and anti-inflammatory medicines, regardless of whether they are applied externally or taken orally.

Children and adolescents

Diclofenac must not be used in children and adolescents under 16 years of age. There is insufficient data on the safety and efficacy in children and adolescents under 16 years of age (see section "Voltaren 24 Hour Pain Patch must not be used").

Use of Voltaren 24 Hour Pain Patch with other medicines

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

Provided that Voltaren 24 Hour Pain Patch is used as directed, only a small amount of diclofenac is absorbed into the body, so that the occurrence of interactions, as described for orally taken diclofenac-containing medicines, is unlikely.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

In the first and second trimesters of pregnancy or if you are planning to become pregnant, Voltaren 24 Hour Pain Patch should only be used after consulting your doctor.

In the last trimester of pregnancy, Voltaren 24 Hour Pain Patch must not be used, as an increased risk of complications for mother and child cannot be ruled out (see "Voltaren 24 Hour Pain Patch must not be used").

Breastfeeding

Diclofenac passes into breast milk in small amounts. Talk to your doctor before using Voltaren 24 Hour Pain Patch while breastfeeding. Under no circumstances should Voltaren 24 Hour Pain Patch be applied directly to the breast area during breastfeeding.

Driving and operating machinery

Voltaren 24 Hour Pain Patch has no influence on your ability to drive or operate machinery.

Voltaren 24 Hour Pain Patch contains butylhydroxyanisole (Ph.Eur.) (E320). Butylhydroxyanisole (Ph.Eur.) (E320) can cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes.

3. HOW IS VOLTAREN 24 HOUR PAIN PATCH USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one medicated patch once a day. Stick one medicated patch on the painful area once a day.
The maximum daily dose is one medicated patch, even if more than one injured area needs to be treated. Always treat only one painful area at a time.

Method of administration

For sticking to the skin (For application to the skin).

Instructions for use

1. Cut open the bag along the dotted line and take out the medicated patch.

Sticking on the patch

2. Remove one of the two protective films.
3. Stick the patch on the area to be treated and remove the remaining protective film.
4. Press the patch lightly with the palm of your hand until it adheres completely to the skin.

Removing the patch

5. Moisten the patch with water, peel off a corner of the patch and carefully pull it off the skin.
6. To remove patch residue, wash the affected area with water by gently rubbing it in circular motions with your fingers.

If necessary, the medicated patch can be fixed with a mesh bandage. Apply the patch only to intact, healthy skin. The medicated patch must not be used together with an airtight (occlusive) dressing. Do not wear the patch while bathing or showering. You must not divide the medicated patch.

Duration of use

Do not use Voltaren 24 Hour Pain Patch for longer than 7 days. If you need this medicine for pain relief for longer than 7 days or if the symptoms worsen, you should see a doctor.

If you have used more Voltaren 24 Hour Pain Patch than you should

Please inform your doctor if significant side effects occur after incorrect use or accidental overdose (e.g. in children). He will advise you on any necessary measures.

If you forget to use Voltaren 24 Hour Pain Patch

Do not use double the amount to make up for a forgotten application.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and remove the patch if you experience any of the following symptoms:

• Sudden itchy skin rash (hives).
• Swelling of the hands, feet, ankles, face, lips, mouth or throat; shortness of breath; drop in blood pressure or feeling faint.

The following side effects may occur

Common side effects (may affect up to 1 in 10 people)

Local skin reactions such as skin redness, burning sensation, itching, inflamed and reddened skin, rash, sometimes with pustules or wheals.

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

Hypersensitivity reactions or local allergic reactions (contact dermatitis).

In patients who have used medicines from the same group of active ingredients as diclofenac externally, isolated cases of generalised rash, hypersensitivity reactions such as swelling of the skin and mucous membranes and anaphylactic reactions with acute circulatory disorders and photosensitivity reactions have been reported.

Diclofenac is absorbed into the body through the skin to a very small extent, compared to the concentration of the active ingredient in the blood after taking diclofenac. Therefore, the likelihood of side effects occurring throughout the body (e.g. disorders of the gastrointestinal tract or kidneys or shortness of breath) is very low.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD VOLTAREN 24 HOUR PAIN PATCH BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the bag after "Use by". The expiry date refers to the last day of the month indicated. Store in the original package in order to protect from light and moisture. Do not use Voltaren 24 Hour Pain Patch if it is damaged.

Used patches should be folded in half with the adhesive side facing inwards. Never dispose of medicines via wastewater (e.g. not via the toilet or sink).

Ask your pharmacist how to dispose of the medicine when you no longer use it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelent-sorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Voltaren 24 Hour Pain Patch contains.
The active ingredient is diclofenac sodium. Each medicated patch contains diclofenac as 140mg diclofenac sodium.

The other ingredients are:

• Backing layer
• Polyester fleece
• Adhesive layer
• Poly(ethyl acrylate-co-methyl methacrylate) (2:1)
• Tributyl citrate
• Butylhydroxyanisole (Ph.Eur.) (E320)
• Protective film
• Paper, one side silicon-coated

What Voltaren 24 Hour Pain Patch looks like and contents of the pack

Voltaren 24 Hour Pain Patch is a white, 10 cm x 14 cm, self-adhesive medicated patch made of fleece on one side and paper on the other side.

Voltaren 24 Hour Pain Patch is available in packs of 2, 5, 7 and 10 medicated patches, each individually packed in a bag.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Haleon Germany GmbH
80258 Munich
Telephone: 0800 664 5626
E-mail: mystory.de@haleon.com

This package leaflet was last revised in January 2024.

Source: Information from the package leaflet
Status: 11/2024
Active ingredient:Diclofenac sodium. Area of application: Is a pain-relieving medicine.