Capsamol Dolor 0.05% cream

For external use in adults and children over 12 years of age
Hot peppers, dense standardized extract (4-7: 1), corresponding to 53 mg Capsaicinoids, calculated as Capsaicin
(Capsici fructus extraction spissum normatum (4-7: 1), corresponding to 53 mg Capsaicinoides calculated as Capsaicin)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. This medicine is available without a prescription. However, to get the best results from the application of Capsamol Dolor 0.05% cream, you must carefully follow the instructions for use of the drug.
Save this leaflet. You may need to read it again.
If you need more information or advice, ask your pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better or your condition worsens after 8 weeks, you should seek medical advice.

What this leaflet contains:
1. What Capsamol Dolor 0.05% cream is and what it is used for
2. What you need to know before you use Capsamol Dolor 0.05% cream
3. How to use Capsamol Dolor 0.05% cream
4. Possible side effects
5. How to store Capsamol Dolor 0.05% cream
6. Contents of the pack and other information

1. WHAT KAPSAMOL dolor 0,05% CREAM AND WHAT IT IS USED
Kapsamol dolor 0,05% cream is a product that belongs to the group of medicines used as topical (local) analgesic and contains capsaicin, the main component of hot peppers thick standardized extract.

Therapeutic indications
This medicinal product is used to reduce foot / lower leg pain caused by chronic painful nerve damage from diabetes (polyneuropathy) in adults.
The application of this product is effective only as part of a general therapeutic concept. It just can't heal nerve damage.

2. WHAT YOU NEED TO KNOW BEFORE USING CAPSAMOL DOLOR 0.05% CREAM
Do not use Capsamol Dolor 0.05% cream:

if you are allergic to the fruits of hot peppers or other plants such as pepper (Capsicum) or the other ingredients of this medicine (listed in section 6);
on injured skin (open injuries, wounds, inflammations, skin infections, eczema);
on the mucosa and near the eyes;
if you are pregnant or breast-feeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Capsamol Dolor 0.05% cream:

If you have acute leg pain (even if it is only one-sided) or an ulcer (open wound). In such cases, treatment should be re-evaluated;
Provide appropriate foot care;
Do not scratch the treated area of ​​skin to avoid skin damage;
Wash your hands after contact with the cream;
During treatment, avoid additional heating (for example, from radiation or from a heating pad);
Treatment with Capsamol Dolor 0.05% cream is effective only when your diabetes treatment continues. Therefore, continue to take the medication that your doctor has prescribed to treat your diabetes.

Children
Capsamol Dolor 0.05% cream should not be used in children under 12 years of age, as no data are available on its efficacy and safety.

Other medicines and Capsamol Dolor 0.05% cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with other drugs have not been studied.
You should not apply another topical medicine to the area of ​​skin treated with Capsamol Dolor 0.05% cream at the same time, as this may increase the effect of Capsamol Dolor 0.05% cream. Interactions can occur even a few hours after applying the cream.

Capsamol Dolor 0.05% cream with food, drink and alcohol
No interactions with food, drink and alcohol have been studied.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your pharmacist or pharmacist for advice before taking this medicine.
You should not use Capsamol Dolor 0.05% cream during pregnancy and breast-feeding (see Do not use Capsamol Dolor 0.05% cream).

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.

3. HOW TO USE CAPSAMOL DOLOR 0.05% CREAM
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is:
Unless otherwise prescribed, in adults with painful diabetic nerve damage (polyneuropathy) a 2 cm long strip of cream (corresponding to 1.1 mg capsaicinoids) should be applied 3 times a day to the painful areas and to rub. It is expected to be absorbed by the skin.
Wash your hands thoroughly after applying the cream.

Use in children and adolescents
Capsamol Dolor 0.05% cream should not be used in children under 12 years of age as no data are available on its safety and efficacy.

Duration of treatment The
efficacy and tolerability of the cream were tested in a clinical trial for 8 weeks. Prolonged use on the same area can damage the sensory nerve fibers.
If your problems worsen or do not improve after 8 weeks, you must consult your doctor.
Please consult your doctor or pharmacist if you have the impression that the effect of Capsamol Dolor 0.05% cream is too strong or too weak.

If you use more Capsamol Dolor 0.05% cream than you should The
use of Capsamol Dolor 0.05% cream may cause a warming effect on your skin. If the feeling is too strong, you can remove the remnants of cream with cold water and soap.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you forget to use Capsamol Dolor 0.05% cream
Do not take a double dose to make up for a forgotten dose.

If you stop using Capsamol Dolor 0.05% cream
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

The following data on the frequency of side effects were used to evaluate side effects:

Very common: may affect more than 1 in 10 people;
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people;
Rare: may affect up to 1 in 1,000 patients;
Very rare: may affect up to 1 in 10,000 patients;
Not known: the frequency cannot be determined from the available data.

Possible side effects:

Uncommon : Uncommon: sensory disturbances and ulceration may occur;
Rare: Skin hypersensitivity reaction (blistering).

Information:
The active substance of the cream, hot peppers, thick standardized extract, in most patients leads to increased blood supply with severe redness of the skin and a feeling of warmth. These reactions are part of the normal action of the medicine and usually go away after a short period of time. In addition, in the first days of treatment, a burning sensation, sharp pain or itching may occur.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

Bulgaria, Bulgarian
Medicines Agency,
8 Damyan Gruev Str.,
1303 Sofia,
Tel .: +35 928903417,
website: www.bda.bg

By reporting side effects, you can help to get more information about the safety of this medicine.

5. HOW TO STORE CAPSAMOL DOLOR 0.05% CREAM
Keep out of the reach and sight 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 that month.

Shelf life after first opening the container:
3 months (40 g tube) / 6 months (100 g tube).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACKAGE LEAFLET AND FURTHER INFORMATION
What Capsamol Dolor 0.05% cream
contains The active substance is: Chili peppers, thick standardized extract (4-7: 1), corresponding to 53 mg Capsaicinoids, calculated as Ka.

100 g Capsamol Dolor 0.05% cream contain:
662.70 - 1829.19 mg hot peppers, thick standardized extract (4-7: 1), extractant: ethanol 80% (v / v); corresponding to 53 mg Capsaicinoids, calculated as Capsaicin.

The other ingredients are:
Sorbitan stearate, macrogol stearate, glycerol 85%, triglycerides, medium chain, carbomer 980, phenoxyethanol, purified water, rosemary oil, sodium hydroxide, glucose syrup, titanium dioxide E 171.

What Capsamol Dolor 0.05% cream looks like and contents of the pack:
Capsamol Dolor 0.05% cream is a light reddish-brown homogeneous cream with a specific odor.
Package sizes: 40 g, 100 g in aluminum tubes.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Worwag Pharma GmbH & Co. KG KG, Germany.

Manufacturer:
CPM Contract Pharma GmbH & Co. KG, Germany.