Voltadol Forte Schmerzgel

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Voltadol Forte Pain Gel contains the active ingredient diclofenac, which belongs to the group of medicines known as non-steroidal anti-inflammatory/antirheumatic drugs (NSAIDs, anti-inflammatories and painkillers).

Application

What is Voltadol Forte Pain Gel and what is it used for?

Voltadol Forte Pain Gel contains the active ingredient diclofenac, which belongs to the group of medicines known as non-steroidal anti-inflammatory/antirheumatic drugs (NSAIDs, anti-inflammatories and painkillers). The gel has been specially developed to be rubbed into the skin and penetrates the skin. The active ingredient specifically reaches deep inflamed tissue.

Voltadol Forte Pain Gel is used in adults and adolescents aged 14 years and over for the local treatment of
- Pain caused by muscle tension, including lumbago,
- Pain and swelling after blunt injuries and sports injuries (such as sprains, strains, bruises). Voltadol Forte Pain Gel quickly relieves even moderate to severe pain, improves patient mobility and helps restore mobility.

If you do not feel better or even worse after 7 days, contact your doctor.

How is it used?

What is Voltadol Forte Pain Gel and what is it used for?

Voltadol Forte Pain Gel contains the active ingredient diclofenac, which belongs to the group of medicines known as non-steroidal anti-inflammatory/antirheumatic drugs (NSAIDs, anti-inflammatories and painkillers). The gel has been specially developed to be rubbed into the skin and penetrates the skin. The active ingredient specifically reaches deep inflamed tissue.

Voltadol Forte Pain Gel is used in adults and adolescents aged 14 years and over for the local treatment of
- Pain caused by muscle tension (including lumbago).
- Pain and swelling after blunt injuries and sports injuries (such as sprains, strains, bruises).

If you do not feel better or even worse after 7 days, contact your doctor.

What should you consider before taking it?

What should you consider before using Voltadol Forte Pain Gel?

Voltadol Forte Pain Gel 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 other non-steroidal anti-inflammatory drugs used to treat pain, fever or inflammation, such as ibuprofen or aspirin (acetylsalicylic acid).
Ask your doctor or pharmacist if you are not sure.
An allergic reaction can cause the following symptoms: wheezing or shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, runny nose.
- if you are in the last 3 months of pregnancy.
- on the breasts of breastfeeding mothers.
- in children and adolescents under 14 years of age.

If any of these apply to you, you must not use Voltadol Forte Pain Gel.

Warnings and precautions

Please talk to your doctor or pharmacist before using Voltadol Forte Pain Gel.

- Do not apply to areas of skin with cuts, open wounds or to areas of skin with a rash or eczema. Stop treatment if a rash develops after applying the product.

- Do not use more gel than necessary and do not use for a long period of time unless you are under medical supervision.

- Voltadol Forte Pain Gel is for external use only. You must not use the medicine in the mouth or on mucous membranes. You must not swallow the medicine. Be careful not to get Voltadol Forte Pain Gel in your eyes. If this happens, rinse your eyes thoroughly with clean water. Contact your doctor or pharmacist if symptoms persist.

- Splints or bandages commonly used for injuries such as sprains can be used, but the gel should not be used under airtight (plastic) dressings.

- When used locally, the likelihood of general side effects is lower than when taking tablets. However, if Voltadol Forte Pain Gel is used on relatively large areas of skin and over long periods of time, possible general side effects cannot be ruled out (see also section 4).

- If you suffer from asthma, hay fever, swelling of the nasal mucosa (nasal polyps) or chronic respiratory diseases, you may very rarely experience asthma attacks, local skin or mucous membrane oedema and hives. In these cases, you should only use Voltadol Forte Pain Gel with special caution.

- Inform your doctor if you suffer from other illnesses, have allergies or are taking or using other medicines (including those bought without a prescription).

- Care should be taken to ensure that children do not come into contact with treated areas of skin with their hands.

Children and adolescents under 14 years of age
Voltadol Forte Pain Gel must not be used in children and adolescents under 14 years of age.

Using Voltadol Forte 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.

Interactions cannot be ruled out with certainty when used externally over a large area. No interactions with other medicines have been reported to date when the gel is used as directed.

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

Voltadol Forte Pain Gel must not be used during the last 3 months of pregnancy, as this could harm your unborn child or cause problems during labour/delivery. Voltadol Forte Pain Gel should only be used during the first 6 months of
pregnancy under medical supervision, the dose should be kept as low and the duration of treatment as short as possible.


Voltadol Forte Pain Gel should only be used during breastfeeding under medical supervision,
as diclofenac passes into breast milk in small amounts. However, Voltadol Forte Pain Gel must not be used on the breasts of breastfeeding mothers or on other large areas of skin or for a long period of time.

Driving and using machines
Using Voltadol Forte Pain Gel on the skin has no influence on the ability to drive or use machines.

Voltadol Forte Pain Gel contains:
- Propylene glycol: This medicine contains 50 mg propylene glycol per g of gel, which can cause skin irritation.
- Butylhydroxytoluene (E 321): May cause local skin irritation (e.g. contact dermatitis), irritation to the eyes and mucous membranes.

How should the medicine be taken?

How to use Voltadol Forte Pain Gel?

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

How often and in what quantity should Voltadol Forte Pain Gel be used?

Adults and adolescents aged 14 years and over
The gel is applied to the painful area of the body 2 times a day (preferably in the morning and evening) and gently rubbed into the skin, providing lasting pain relief for up to 12 hours at a time.

Elderly patients (over 65 years of age) and patients with impaired kidney or liver function
No dose reduction is required.

Use in children and adolescents
As there is insufficient experience with Voltadol Forte Pain Gel in the age group under
18 years, Voltadol Forte Pain Gel must not be used in children and adolescents under 14 years of age and in adolescents between 14 and 18 years of age only under medical supervision and on a small area. Please pay particular attention to possible general side effects in children and adolescents due to absorption of the active ingredient into the circulation and contact your doctor in this case.

How is Voltadol Forte Pain Gel used?

Voltadol Forte Pain Gel is for external use only. Do not swallow!
Apply Voltadol Forte Pain Gel thinly to the affected area of the body and rub in gently. It should not be rubbed in with pressure. Wash your hands afterwards, unless they are the area being treated.
Allow Voltadol Forte Pain Gel to dry on the skin for a few minutes before applying a dressing.

After use:
- Wipe your hands with absorbent paper (e.g. tissue, not a wet wipe) and then wash them, unless they are the treatment area. The paper used should then be disposed of in household waste.
- Wait until Voltadol Forte Pain Gel has been absorbed into the skin before showering or bathing.
How long is Voltadol Forte Pain Gel used for?
Voltadol Forte Pain Gel should not be used for longer than 2 weeks unless your doctor recommends a longer period of use.
Contact your doctor if the pain and swelling do not improve within
7 days or get worse.

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

If you have used more Voltadol Forte Pain Gel than you should - If you have used more gel than you should, wipe off the excess with absorbent paper (e.g. tissue, not a wet wipe).
- If you have swallowed the gel, contact a doctor immediately. If you experience symptoms such as vomiting, diarrhoea or bleeding, please inform a doctor immediately.

If you forget to use Voltadol Forte Pain Gel
If you forget to use Voltadol Forte Pain Gel at the right time, use it as soon as you remember and then continue using it as usual. 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.

What side effects are possible?

How should Voltadol Forte Pain Gel be stored?

• This medicine does not require any special storage conditions.
• 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 tube after "EXP". The expiry date refers to the last day of the month indicated.
• After first opening the tube: see the expiry date on the tube.
• Do not dispose of medicines in wastewater (e.g. in the toilet or sink) or household waste. Ask your pharmacist how to dispose of the medicine when you have finished using it. This helps to protect the environment.

Special storage instructions

How should Voltadol Forte Pain Gel be stored?

This medicine does not require any special temperature storage conditions.
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 tube after "EXP". The expiry date refers to the last day of the month indicated.
After first opening the tube: see the expiry date on the tube.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you have finished using it. This helps to protect the environment.

Special notes on the content

Contents of the pack and further information

What Voltadol Forte Pain Gel contains
- The active ingredient is: Diclofenac diethylamine. 1 g of gel contains 23.2 mg of diclofenac diethylamine, corresponding to 20 mg of diclofenac sodium.
- The other ingredients are:
This medicine contains 50 mg propylene glycol and 0.2 mg butylhydroxytoluene (E321) in each g of gel.
Other ingredients: Carbomer, coco-caprylocaprate, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl alcohol, eucalyptus perfume and purified water (for further information see end of section 2).

What Voltadol Forte Pain Gel looks like and contents of the pack
Voltadol Forte Pain Gel is a white to off-white, creamy gel.
The medicine is available in packs of 30 g, 100 g, 150 g, 180 g gel.

Not all pack sizes may be marketed.