Voltadol Forte Pain Gel

Voltadol Forte Schmerzgel contains the active substance diclofenac, which belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Application

What is Voltadol Forte Schmerzgel and what is it used for?

Voltadol Forte Schmerzgel contains the active substance diclofenac, which belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The gel is specially developed to be rubbed into the skin and penetrates the skin. The active substance specifically reaches deep inflamed tissues.

Voltadol Forte Schmerzgel is used in adults and adolescents aged 14 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 relieves, even moderate to severe, pain quickly, improves patient mobility and supports the restoration of mobility.

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

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How is it applied?

What is Voltadol Forte Schmerzgel and what is it used for?

Voltadol Forte Schmerzgel contains the active substance diclofenac, which belongs to the group of medicines called non-steroidal anti-inflammatory drugs/anti-inflammatory drugs (NSAIDs, inflammation and pain inhibitors). The gel was specially developed for rubbing into the skin and penetrates the skin. The active ingredient specifically reaches deep inflamed tissues.

Voltadol Forte Schmerzgel is used in adults and adolescents aged 14 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, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before using Voltadol Forte Schmerzgel?
Voltadol Forte Schmerzgel 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 medicines used to treat pain, fever or inflammation, such as ibuprofen or aspirin (acetylsalicylic acid).
Consult your doctor or pharmacist if you are not quite sure.
An allergic reaction may cause the following: whistling breath or shortness of breath (asthma), skin rash with blistering or hives, swelling of the face or tongue, runny nose.
- if you are in the last 3 months of pregnancy.
- on the breast of nursing mothers.
- in children and adolescents under 14 years of age.

If any of these circumstances apply to you, you must not use Voltadol Forte Schmerzgel.

Warnings and precautions

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

- Do not apply to skin areas with cuts, open wounds or to skin areas with rashes or eczema. Stop the treatment if a rash appears after applying the preparation.

- Do not use more gel than necessary and not for a prolonged period unless you are under medical advice.

- Voltadol Forte Schmerzgel is for external use only. You must not use the medicine in the mouth or on mucous membranes. You must not take the medicine. Make sure that Voltadol Forte Schmerzgel does not get into your eyes. If this happens, you must rinse your eyes well 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 must not be used under airtight (plastic) dressings.

- When used topically, the likelihood of general side effects is low compared to taking tablets. However, if Voltadol Forte Schmerzgel is used on relatively large areas of skin and for 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 mucous membranes (nasal polyps) or chronic respiratory diseases, asthma attacks, local skin or mucous membrane oedema and hives may very rarely occur. In these cases, you must only use Voltadol Forte Schmerzgel with particular caution.

- Inform your doctor if you suffer from other diseases, have allergies or are taking or externally applying other medicines (including those you have bought yourself).

- Care should be taken to ensure that children do not bring their hands into contact with rubbed skin areas.

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

Use Voltadol Forte Schmerzgel with other medicines
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

In the case of large-scale external application, interactions cannot be ruled out with certainty. When the gel is used in the correct dose, no interactions with other medicines have been reported so far.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

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

Voltadol Forte Schmerzgel must only be used under medical supervision during breast-feeding
because small amounts of diclofenac pass into breast milk. However, Voltadol Forte pain gel must not be used on the breasts of breast-feeding mothers, nor in other places on large areas of the skin or for a long period of time.

Driving and ability to operate machines
The application of Voltadol Forte Schmerzgel to the skin has no effect on the ability to drive or operate machines.

Voltadol Forte Schmerzgel contains:
- Propylene glycol: This medicinal product contains 50 mg of propylene glycol per g of gel, which may cause skin irritation.
- Butylhydroxytoluene (E 321): May cause localised skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes.

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How should the medicine be taken?

How to use Voltadol Forte Schmerzgel?

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

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

Adults and adolescents from 14 years
The gel is applied 2 times a day (best in the morning and evening) to the painful body region and gently rubbed into the skin, this causes permanent pain relief of up to 12 hours each time.

Older patients (over 65 years) and patients with impaired renal or hepatic function
No dose reduction is required.

Application in children and adolescents
As there is insufficient experience with Voltadol Forte Schmerzgel in the age group under
18 years, Voltadol Forte Schmerzgel must not be used at all in children and adolescents under 14 years of age and only under medical supervision and on small areas in adolescents between 14 and 18 years of age. In children and adolescents, please pay special attention to possible general side effects due to the absorption of the active substance into the circulation and consult your doctor in this case.

How is Voltadol Forte pain gel used?
Voltadol Forte Schmerzgel is only intended for use on the skin. Do not ingest!
Apply a thin layer of Voltadol Forte Pain Gel to the affected area of the body and rub in gently. It should not be rubbed in with pressure. Hands should then be washed, unless they are the area to be treated.
Before applying a dressing, Voltadol Forte Schmerzgel should be allowed to dry on the skin for a few minutes.

After application:
- Wipe hands with absorbent paper (e.g. facial tissue, not a wet wipe) and wash afterwards, unless they are the treatment area. The paper used should then be disposed of in the household waste.
- Wait until Voltadol Forte Schmerzgel has been absorbed into the skin before showering or bathing.
How long is Voltadol Forte Schmerzgel used for?
Voltadol Forte Schmerzgel must 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 or get worse within
7 days.

Adolescents aged 14 years and over
For adolescents aged 14 years 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 the symptoms worsen.

If you have used a larger amount of Voltadol Forte Schmerzgel than you should- If you have used a larger amount of the gel than you should, wipe off the excess amount with absorbent paper (e.g. cosmetic tissue, not a wet wipe).(e.g. a cosmetic tissue, not a wet wipe).
- If you have ingested the gel, contact a doctor immediately. In case of complaints such as vomiting, diarrhoea or bleeding, please inform a doctor immediately.

If you forget to use Voltadol Forte Schmerzgel
If you forget to use Voltadol Forte Schmerzgel at the right time, use it as soon as you remember and then continue using it as usual. Do not use twice the amount if you have forgotten to use it before.

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

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What are the possible side effects?

How to store Voltadol Forte Schmerzgel?

• No special storage conditions are required for this medicinal product
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• Keep this medicine out of the reach of children.
• You must 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 opening the tube for the first time: see the expiry date stated on the tube.
• Do not dispose of medicines in waste water (e.g. in the toilet or sink) or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special instructions for storage

How to store Voltadol Forte Schmerzgel?

No special storage conditions are required for this medicinal product with regard to temperature.
Keep this medicine out of the reach of children.
You must not use this medicine after the expiry date which is stated on the outer carton and tube after ,,EXP". The expiry date refers to the last day of the month indicated.
After opening the tube for the first time: see the expiry date indicated on the tube.
Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and further information
What Voltadol Forte Schmerzgel contains
- The active substance is: diclofenac diethylamine. 1 g gel contains 23.2 mg diclofenac diethylamine, corresponding to 20 mg diclofenac sodium.
- The other ingredients are:
This medicinal product contains 50 mg propylene glycol and 0.2 mg butylated hydroxytoluene (E321) in each g of gel.
Other ingredients: Carbomer, coco-capryl caprate, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl alcohol, eucalyptus perfume and purified water (see end of section 2 for more information).

How Voltadol Forte Schmerzgel looks and contents of the pack
Voltadol Forte Schmerzgel is a white to practically white, cream-like gel.
The medicine is available in packs of 30 g, 50 g, 100 g, 150 g gel.

Not all pack sizes may be placed on the market.