Patient Information Leaflet

Hotlec
(100 mg + 10 mg + 5 mg + 5 mg)/g, ointment
Please read the entire 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 physician or pharmacist.

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 or pharmacist. See section 4.
If your symptoms do not improve or worsen, consult your doctor.

Table of Contents

What is Hotlec and what is it used for
Important information before using Hotlec
How to use Hotlec
Possible side effects
How to store Hotlec
Contents of the pack and other information

1. What is Hotlec and what is it used for

Hotlec is an ointment containing substances that exert local warming and analgesic effects.
Indications
For adjunctive relief of mild pain, such as joint pain, neuralgia, muscle pain, and sciatica.
If there is no improvement or if symptoms worsen, consult a doctor.

2. Important information before using Hotlec

When not to use Hotlec

if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
if the patient has damaged skin, wounds, or if applied around the eyes or on mucous membranes;
if the patient has previously experienced asthma attacks, urticaria, or rhinitis after taking medications 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 with a doctor or pharmacist:

if the patient has impaired liver or kidney function.

While using Hotlec, observe the following warnings:

discontinue use if allergic reactions occur;
if contact with mucous membranes occurs, rinse thoroughly 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 currently taking, has recently taken, or plans to take.
Methyl salicylate enhances the therapeutic effect and adverse effects of concomitantly used anti-inflammatory drugs.
Probenecid may reduce the rate of excretion of salicylates.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Hotlec has no effect on the ability to drive or operate machinery.

3. How to use Hotlec

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For topical application.
Recommended dose:
Adults and adolescents over 12 years of age:
Apply a small amount of the ointment (2–4 g, approximately 3–5 cm) and massage into the painful areas of skin 1 to 3 times daily. Use of the medicine, especially at night, is recommended.
Children
Do not use in children under 12 years of age.
Use of more than the recommended dose
If more than the recommended amount of Hotlec has been used, contact a doctor immediately.
Missed dose of Hotlec
Continue using the medicine as before; do not increase the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
Possible adverse reactions:

skin irritation;
local pain;
skin hyperaemia;
allergic reactions;
in patients with hypersensitivity – asthma attack and shock. If any of the above symptoms occur, discontinue use of the medicine.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hotlec

Keep the medicine out of the 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 stated month.
Shelf-life after first opening: 2 years, but not beyond the expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Hotlec contains

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

What Hotlec looks like and contents of the pack
Hotlec is an ointment.
Packaging: an internally lacquered aluminium tube protected with a membrane and a polyethylene cap, packed in a cardboard box containing 30 g of ointment.

Marketing Authorisation 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