Hotlec

Leaflet attached to the packaging: patient information

Hotlec

(100 mg + 10 mg + 5 mg + 5 mg)/g, ointment

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, contact a doctor.

Table of contents of the leaflet

• 1. What is Hotlec and what is it used for
• 2. Important information before using Hotlec
• 3. How to use Hotlec
• 4. Possible side effects
• 5. How to store Hotlec
• 6. Package contents and other information

1. What is Hotlec and what is it used for

Hotlec is an ointment containing substances that have a local warming and analgesic effect.

Indications for use

As an aid in relieving pain, e.g. in joint pain, neuralgia, muscle pain, sciatica.
If there is no improvement or the patient feels worse, consult a doctor.

2. Important information before using Hotlec

When not to use Hotlec

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has damaged skin, wounds, in the eye area and on mucous membranes;
• if the patient has had asthma attacks, hives, or nasal mucosal inflammation after using medicines containing acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs);
• in children under 12 years of age.

Warnings and precautions

Before starting to use Hotlec, discuss it with your doctor or pharmacist:

• if the patient has liver or kidney function disorders.

While using Hotlec, follow these warnings:

• stop using the medicine in case of a tendency to allergies;
• in case of contact with mucous membranes, wash the medicine off with warm water.

Children

Do not use in children under 12 years of age.

Hotlec and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Methyl salicylate enhances the therapeutic effect and side effects of concurrently used anti-inflammatory medicines.
Probenecid may reduce the rate of salicylate elimination.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
It is not recommended to use the medicine during pregnancy and breastfeeding.

Driving and using machines

Hotlec has no effect on the ability to drive and use machines.

3. How to use Hotlec

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Apply to the skin.

Recommended dose:

Adults and adolescents over 12 years of age:
a small amount of ointment (2-4g, approx. 3-5 cm) should be rubbed into the skin in the painful areas 1 to 3 times a day. It is recommended to use the medicine especially at night.

Children

Do not use in children under 12 years of age.

Using more than the recommended dose of Hotlec

In case of using more Hotlec than recommended, contact a doctor immediately.

Missing a dose of Hotlec

Continue using the medicine, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

• skin irritation;
• local pain;
• skin redness;
• allergic reactions;
• in patients with hypersensitivity - asthma attack and shock. If the above symptoms occur, stop using the medicine.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hotlec

Keep the medicine out of sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Shelf life after first opening: 2 years, not later than the expiry date.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Hotlec contains

• The active substances of the medicine are: methyl salicylate, camphor, pine oil, turpentine oil.
• 1g of ointment contains 100mg of methyl salicylate, 10mg of camphor, 5mg of pine oil, 5mg of turpentine oil.
• The other ingredient is: white petrolatum.

What Hotlec looks like and what the package contains

The medicine is an ointment.
The package contains: an aluminum tube, internally lacquered, protected with a membrane and a polyethylene screw cap, in a cardboard box, containing 30g of ointment.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer

Przedsiębiorstwo Produkcji Farmaceutyczno-Kosmetycznej
„Profarm” Sp. z o.o.
ul. Słupska 18
84-300 Lębork

Date of last update of the leaflet: