VOLTAREN

VOLTAREN Actigo pain gel 11.6 mg/g

Important notes (mandatory information)

Voltaren Actigo Pain Gel. Active ingredient: Diclofenac-N-ethylamine. Area of application: Voltaren Actigo Pain Gel is a pain-relieving medicine from the group of non-steroidal anti-inflammatory drugs/analgesics

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Voltaren Actigo Pain Gel 11.6 mg/g, for adults and adolescents aged 14 and over
Active ingredient: Diclofenac-N-ethylamine

Read the entire package leaflet carefully before you start using this medicine, as 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 3 to 5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS VOLTAREN ACTIGO PAIN GEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VOLTAREN ACTIGO PAIN GEL?
3. HOW TO USE VOLTAREN ACTIGO PAIN GEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VOLTAREN ACTIGO PAIN GEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS VOLTAREN ACTIGO PAIN GEL AND WHAT IS IT USED FOR?

Voltaren Actigo Pain Gel is a pain-relieving medicine with the active ingredient diclofenac from the group of non-steroidal anti-inflammatory drugs/analgesics (anti-inflammatory pain reliever).

Area of application for adolescents aged 14 and over and adults

For the local, symptomatic treatment of pain in acute sprains, strains or bruises resulting from blunt trauma, e.g. sports and accident injuries.

For adolescents aged 14 and over, the medicine is intended for short-term treatment.

2. WHAT SHOULD YOU CONSIDER BEFORE USING VOLTAREN ACTIGO PAIN GEL?

Voltaren Actigo Pain Gel must not be used:

• if you are allergic to diclofenac, benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, D-limonene, eugenol, farnesol, geraniol or linalool or any of the other ingredients of this medicine listed in section 6
• if you have reacted to acetylsalicylic acid or another non-steroidal anti-inflammatory drug (e.g. ibuprofen) in the past with breathing problems (asthma, bronchospasm), skin reactions (hives), runny nose or swelling of the face or tongue. If you are not sure, ask your doctor or pharmacist.
• on open wounds, inflammation or infections of the skin as well as on eczema or mucous membranes
• in the last trimester of pregnancy
• in children and adolescents under 14 years of age

Warnings and precautions
Please talk to your doctor or pharmacist before using Voltaren Actigo Pain Gel.
If Voltaren Actigo Pain Gel is applied to a large area of skin and used over a long period of time, the occurrence of side effects that affect a particular organ system or even the entire organism cannot be ruled out. These side effects are comparable to those that may occur under certain circumstances when taking other diclofenac-containing medicines. Do not use Voltaren Actigo Pain Gel for longer than indicated or in higher doses than indicated without medical advice.

Voltaren Actigo Pain Gel should only be applied to intact, non-diseased or injured skin and not to open wounds. Eyes and oral mucous membranes must not come into contact with the medicine and it must not be swallowed. If Voltaren Actigo Pain Gel gets into your eyes, rinse them thoroughly with water. Consult your doctor or pharmacist if the symptoms persist.

You can use a bandage, but not an occlusive bandage (tightly closing bandage). Voltaren Actigo Pain Gel should be allowed to dry on the skin for a few minutes before applying a bandage. In acute conditions accompanied by severe redness, swelling or overheating of joints, persistent joint pain or severe back pain radiating into the legs and/or associated with neurological symptoms (e.g. numbness, tingling), a doctor should be consulted.

If symptoms do not improve or worsen after 3 - 5 days, a doctor should be consulted.

If you suffer from asthma, hay fever or nasal mucosal swelling (so-called nasal polyps) or chronic bronchoconstrictive (obstructive) respiratory diseases, chronic respiratory infections (especially coupled with hay fever-like symptoms) or hypersensitivity to other pain relievers and rheumatism medicines of all kinds, you are more at risk of asthma attacks (so-called analgesic intolerance/analgesic asthma), local skin or mucosal swelling (so-called Quincke's edema) or urticaria when using Voltaren Actigo Pain Gel than other patients. In this case, Voltaren Actigo Pain Gel may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies to patients who are also hypersensitive (allergic) to other substances, such as with skin reactions, itching or hives.

If a rash occurs during treatment with Voltaren Actigo Pain Gel, discontinue treatment. During treatment, photosensitivity with skin reactions after exposure to light may occur. Care should be taken to ensure that children do not come into contact with rubbed-in skin areas with their hands.

Children and adolescents

Voltaren Actigo Pain Gel must not be used in children and adolescents under 14 years of age.

Use of Voltaren Actigo Pain Gel with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions have been reported to date with the intended external application of Voltaren Actigo Pain Gel.

Pregnancy and

breastfeeding

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

Pregnancy:
Voltaren Actigo Pain Gel should only be used after consulting a doctor in the first and second trimesters of pregnancy. You must not use Voltaren Actigo Pain Gel in the last trimester of pregnancy, as an increased risk of complications for mother and child cannot be ruled out.

Breastfeeding

Diclofenac passes into breast milk in small amounts. Voltaren Actigo Pain Gel should only be used during breastfeeding after consulting a doctor. In this case, the medicine should not be applied to the breast area or over a long period of time to large other areas of skin.

Driving and operating machinery

Voltaren Actigo Pain Gel has no or negligible influence on the ability to drive and use machines.

Voltaren Actigo Pain Gel contains propylene glycol This medicine contains 200mg propylene glycol per maximum single dose of 4g (corresponding to 50mg/g). Propylene glycol can cause skin irritation. Do not apply Voltaren Actigo Pain Gel to open wounds or large areas of broken or damaged skin (such as burns).

Voltaren Actigo Pain Gel contains fragrances

This medicine contains a fragrance with benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, D-limonene, eugenol, farnesol, geraniol and linalool, which can cause allergic reactions.

3. HOW TO USE VOLTAREN ACTIGO PAIN GEL?

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

Age	Single dose	Total daily dose
Adults and adolescents aged 14 and over	Depending on the size of the painful area to be treated, a cherry- to walnut-sized amount, corresponding to 1 - 4g of gel (11.6 - 46.4mg diclofenac-N-ethylamine), is required.	The maximum daily dose is 16g of gel (corresponding to 185.6 mg diclofenac-N-ethylamine).

Unless otherwise prescribed by your doctor, Voltaren Actigo Pain Gel should be applied 3-4 times a day. If symptoms do not improve or worsen after 3 - 5 days, a doctor should be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Voltaren Actigo Pain Gel is too strong or too weak.

Elderly patients

No special dose adjustment is required. However, elderly people should pay particular attention to side effects when using it and, if necessary, consult their doctor or pharmacist.

Impaired renal or hepatic function

No dose reduction is required.

Use in children and adolescents (under 14 years of age)

There are no sufficient data on the efficacy and tolerability in children and adolescents under 14 years of age (see section 2, "Voltaren Actigo Pain Gel must not be used").

Adolescents (aged 14 and over)

In adolescents aged 14 and over, the patient/parents are advised to consult a doctor if the medicine is needed for pain relief for more than 7 days or if symptoms worsen.

Method of administration

Voltaren Actigo Pain Gel is for external use only. Do not ingest!
Apply Voltaren Actigo Pain Gel thinly to the affected area of the body and rub in gently. It should not be rubbed in with pressure. Afterwards, the hands should be wiped on a paper towel and then washed, unless they are the area to be treated. The paper towel should be disposed of in the residual waste.

Voltaren Actigo Pain Gel should be allowed to dry on the skin for a few minutes before applying a bandage. Also wait until the gel has dried on the skin before showering or bathing.

Duration of use

The duration of use depends on the symptoms and the underlying condition. Voltaren Actigo Pain Gel should not be used for longer than 1 - 3 weeks without medical advice. Do not use more Voltaren Actigo Pain Gel than necessary and only for the minimum duration of use required.

If you have used more Voltaren Actigo Pain Gel than you should

Overdosage is unlikely due to the low absorption of diclofenac into the overall organism when applied topically. If the recommended dosage is significantly exceeded when applied to the skin, the gel should be removed (e.g. with a paper towel) and washed off with water.

In the event of accidental ingestion (e.g. also in children) of Voltaren Actigo Pain Gel, please contact your doctor immediately, who will decide on appropriate measures.

If you forget to use Voltaren Actigo Pain Gel

Do not use double the amount if you have forgotten the previous 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.

The following side effects can have serious consequences, stop using Voltaren Actigo Pain Gel and see your doctor as soon as possible

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

• skin inflammation with blistering (bullous dermatitis)

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

• wheezing, shortness of breath or tightness in the chest (asthma)
• swelling of the face, lips, tongue or throat (angioedema)

Other side effects are possible

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

Skin rash, eczema, skin redness (erythema), dermatitis (including contact dermatitis), itching (pruritus)

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

• scaling, drying of the skin, swelling (edema)

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

• pustular skin rash
• gastrointestinal complaints
• hypersensitivity reactions (including hives)
• photosensitivity with skin reactions after exposure to light (photosensitization)

If Voltaren Actigo Pain Gel is applied to a large area of skin and used over a long period of time, the occurrence of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions), as may occur under certain circumstances after systemic use of diclofenac-containing medicines, cannot be ruled out.

Benzyl benzoate, benzyl alcohol, citral, citronellol, coumarin, D-limonene, eugenol, farnesol, geraniol and linalool can cause allergic reactions.

If you notice or suspect any of the above side effects, stop using Voltaren Actigo Pain Gel and inform your doctor or pharmacist.

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 TO STORE VOLTAREN ACTIGO PAIN GEL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the container after "Use by". The expiry date refers to the last day of the month indicated.

The medicine is stable for 3 years after opening, but not beyond the expiry date stated on the pack. Keep the tube upright on the lid after use. Do not store above 25°C.

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 stop using it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittel-entsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Voltaren Actigo Pain Gel contains

The active ingredient is: Diclofenac-N-ethylamine 11.6mg in 1 g of gel (corresponding to 10mg diclofenac sodium).

The other ingredients are:
Purified water; 2-propanol; propylene glycol; cocoyl caprylocaprate (Ph.Eur.); paraffin; cetomacrogol; carbomer 974 P; N-ethylethanamine; perfume cream (contains benzyl benzoate).

What Voltaren Actigo Pain Gel looks like and contents of the pack

White to slightly milky gel.
Packs of 60 g and 100 g gel.

Pharmaceutical entrepreneur

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

This package leaflet was last revised in March 2024.

Source: Information from the package leaflet
Status: 11/2024
Active ingredient: Diclofenac-N-ethylamine. Area of application: Voltaren Actigo Pain Gel is a pain-relieving medicine from the group of non-steroidal anti-inflammatory drugs/analgesics