Neo-capsiderm

Package leaflet: Information for the user

Neo-Capsiderm, ointment
Medicinal product intended for adults.
Please read the entire leaflet carefully before using the medicinal product, as it contains
important information for the patient.
This medicinal product should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If symptoms do not improve or if you feel worse, consult your doctor.

Table of contents:

1. What Neo-Capsiderm is and what it is used for
2. Important information before using Neo-Capsiderm
3. How to use Neo-Capsiderm
4. Possible side effects
5. How to store Neo-Capsiderm
6. Contents of the pack and other information

1. What Neo-Capsiderm is and what it is used for

Neo-Capsiderm is traditionally used as a warming agent in muscular pain (strains, painful muscle spasms), as an adjunctive treatment in joint inflammatory pain, and in neuralgic pain (radiculitis, sciatica).
When rubbed into the skin, Neo-Capsiderm exerts an irritant effect on the skin, causing hyperaemia and redness, producing a warming sensation. Vasodilation improves blood supply to the affected area and accelerates the resolution of oedema and inflammatory conditions. As inflammation subsides, pain symptoms gradually diminish.

2. Important information before using Neo-Capsiderm

When not to use Neo-Capsiderm

• do not use the medicine in children and adolescents;
• do not apply to damaged skin;
• do not use if the patient is allergic to the active substances (particularly nicotinamide) or to any of the other ingredients of this medicine (listed in section 6);
• do not use if the patient is allergic to Capsicum derivatives. If allergic symptoms occur, characterized by exudation or rash, use must be discontinued immediately.

Warnings and precautions
Before starting treatment with Neo-Capsiderm, consult your doctor, pharmacist, or nurse.
After applying the medicine, hands should be thoroughly washed with soap and water to remove any residual medicine from the skin.
At the beginning of treatment, a tingling or burning sensation may occur. In no case should a hot bath be taken before or after application of the medicine, as this may intensify the sensation of tingling or burning.
If redness persists or swelling occurs, treatment should be discontinued. It is recommended to cleanse the skin with hydrogen peroxide and consult a doctor.
Children and adolescents
Do not use Neo-Capsiderm in children and adolescents.
Neo-Capsiderm and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
There are no available data on drug interactions.
Pregnancy and breastfeeding
Due to lack of data confirming safety of use, Neo-Capsiderm should not be used during pregnancy or breastfeeding.
Driving and operating machinery
There is no information available regarding the effect on the ability to drive motor vehicles or operate machinery.
Neo-Capsiderm contains lanolin
Lanolin may cause local skin irritation (contact dermatitis).

3. How to use Neo-Capsiderm

Apply externally to the skin.
Adults: gently massage a small amount of the ointment into the painful area 1–2 times daily.
The interval between successive applications should be no less than 4 hours. A break of at least 14 days is required before reapplying to the same site. During application, avoid contact with eyes and mucous membranes. Do not apply to damaged skin.
Warning: prolonged use at the same site may cause damage to sensory nerves.
Duration of use
Do not use for longer than 2 days.
Use in children
Do not use Neo-Capsiderm in children.
Use of a higher than recommended dose of Neo-Capsiderm
Applying too much Neo-Capsiderm may cause skin irritation.
Missed dose of Neo-Capsiderm
Do not use a double dose to make up for a missed dose.
Discontinuation of Neo-Capsiderm
If you have any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.
Improper use
Accidental ingestion of Neo-Capsiderm ointment should be immediately reported to a doctor, who will recommend necessary treatment. Do not induce vomiting.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
In some cases, allergic reactions (urticarial rash) may occur.
If an allergic reaction persists after discontinuing the medicine, medical advice should be sought.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, the use of the medicine should be discontinued and a doctor or pharmacist should be informed.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 48 22 49 21 301, fax 48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Neo-Capsiderm

Store at a temperature not exceeding 25°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Neo-Capsiderm contains
100 g of the ointment contains the following active substances:
nonivamide (Nonivamidum) - 0.05 g, camphor (Camphora) - 5.3 g, turpentine oil from maritime pine (Terebinthinae aetheroleum a Pino pinastro) - 9.7 g, eucalyptus oil (Eucalypti aetheroleum) - 2.5 g.
The other ingredients (excipients) are: lanolin, hard paraffin, liquid paraffin, white soft paraffin.

What Neo-Capsiderm looks like and contents of the pack
Neo-Capsiderm is an ointment.
The available pack contains 30 g of ointment in an aluminum tube with a polyethylene cap, packed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder.

Marketing Authorisation Holder and Manufacturer
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47/51, 61-896 Poznań, Poland
tel. +48 61 886 18 00
fax +48 61 853 60 58