Difestol

DIFESTOL® GEL
Applied on the skin

Active ingredient: Each tube (30 ml), 0.36g 1.2% diphenhydramine hydrochloride; 0.6g 2%
Contains lidocaine hydrochloride.
Excipients: HPMC, glycerin, propylene glycol, potassium sorbate and deionized water

Carefully follow this USE INSTRUCTIONS before you start using this medicine.
read it because it contains important information for you.

Keep these instructions for use. You can need to read again.
If you have other questions, please talk your doctor or pharmacist.
This medicine has been prescribed for you personally, do not pass it on to others.
During the use of this medicine, when you go to the doctor or hospital,
Tell your doctor.
Follow exactly what is written in this instruction. Other than the recommended dose for the drug, high or
Do not use low doses

In this Instructions for Use:
1. What is DIFESTOL® and what is it used for?
2. Things to consider before using DIFESTOL®
3. How to use DIFESTOL®?
4. What are the possible side effects?
5. Storage of DIFESTOL®

Headings are included.

1. What is DIFESTOL® and what is it used for?
It is used for insect, fly, bee stings and light sun burns.
DIFESTOL® is available in a 30 ml plastic bottle with a spray cap in a box.
DIFESTOL is a colorless, homogeneous, odorless gel.
DIFESTOL, local anesthetics (locally applied drugs) and antipruritics (itching
prevention) is a drug included in the group.

2.Things to watch out for before using DIFESTOL®
DO NOT USE BDIFESTOL® in the following situations
If,

• DIFESTOL® contains diphenhydramine hydrochloride, lidocaine hydrochloride and
• if you are allergic to any of the excipients.
  Inflamed skin diseases with infected wounds, inflamed skin infections and infectious
• Do not use the drug if there are diseases.
• People with known sensitivity to local anesthetic agents before
  do not use.
• If you are not in the hospital and medication for an irregular heartbeat (such as amiodarone or sotalol)If you are buying, do not use this product.
  In babies, premature babies, breastfeeding mothers due to the risk of antihistamines,
  Those who are extremely sensitive to diphenhydramine HCl and other antihistamines of similar structure and
  MAO (used in the treatment of depression and anxiety (internal distress)) in drug users
  should not be used.
  It should be used under the supervision of a doctor in children under the age of two. Doctorate
  should not be used without consulting.
  It should not be applied before X-Ray applications.
  It should not be applied to mucous and open wounds.

  USE DIFESTOL® CAREFULLY in the following situations.

• Hypersensitive to light and allergic to sunlight
  Use it carefully in people.
  Be careful against microbe growth during application in areas where the skin is damaged.
  must be.
  If the drug is used in large areas, especially in cases of chickenpox,
  A drug containing the active ingredient diphenhydramine is used orally.
  use it carefully.
  DIFESTOL® should not be used on large body surfaces.
  If you have a severe infection (sepsis) in which bacteria got into the blood.
  If you have a known drug allergy. Be careful when using DIFESTOL®. In patients who are allergic to paraaminobenzoic acid derivatives (such as procaine, tetracaine, benzocaine)
  No sensitivity to lidocaine has been observed.
  Using DIFESTOL effectively and safely is about the appropriate dose. Is possible
  It is recommended to use small doses. Especially in elderly patients and children
  Please pay attention to this issue in applications.
  If you have a serious heart condition
  Especially on large skin surfaces and especially under occlusion (closed dressing)
  When administered, it can lead to heart rhythm disturbances, difficulty breathing, coma and even death.
  can open.
  Avoid contact of DIFESTOL with eyes. Eye irritation has been observed and
  There is also the possibility of corneal irritation and potential wear due to loss of reflexes. Eye
  In the event of contact, rinse your eyes immediately with water or saline and restore sensation.
  protect your eyes until it arrives.
  If you are being treated with amiodarone to treat your irregular heartbeat. This
  In this case, you should be kept under close observation and have your electrocardiogram taken
  should be considered.
• If you have an infection where the gel will be applied. If this applies to you, your doctor
  He or she may ask you to use another medicine with DIFESTOL.
  DIFESTOL, the substance that forms the structure of hemoglobin in red blood cells.
  arising due to the synthesis disorder, coming in attacks and many organ systems
  only if it is a safer alternative in patients with the disease affecting (porphyria)
  should be given. Appropriate precautions should be taken for vulnerable patients.

If these warnings are valid for you, even at any time in the past, please
consult your doctor,

Using DIFESTOL® with food and drink:
Interaction of DIFESTOL® with food and beverages in terms of application method
does not have

Pregnancy
Consult your doctor or pharmacist before using this medication.
Diphenhydramine hydrochloride and lidocaine hydrochloride in the composition of DIFESTOL®
Its reliability for use in pregnancies has not been established.
DIFESTOL® should not be used during pregnancy unless absolutely necessary.
If you notice that you are pregnant during your treatment, contact your doctor or pharmacist immediately.
Please consult.

Breast-feeding
Consult your doctor or pharmacist before using this medication.
Since DIFESTOL® passes into breast milk, this medicine should not be used during breastfeeding.

Vehicle and machine use
Although no effect of diphenhydramine HCl has been reported, lidocaine HCl
Although it is present in quantity, it creates a local numbness in the area where it is applied,
Caution is recommended when using vehicles and machines.

Important information about some of the excipients contained in DIFESTOL®
This medicinal product contains propylene glycol. May cause skin irritation.

Use with other drugs

• For the treatment of heart rhythm disturbances such as tocoainide, mexiletine, amiodarone or sotalol
  used drugs,
• Other medicines that lower blood pressure such as beta blockers (e.g. cimetidine, propranolol),
• Other local anesthetics.

If you are currently using any prescription or over-the-counter medication or have recently
If you have used, please inform your doctor or pharmacist about them.

3. How to use DIFESTOL®?
Instructions for appropriate use and dose / frequency of administration:
Unless recommended otherwise by your doctor, use in the following doses.
DIFESTOL® is applied to the lesioned area several times a day.
How much DIFESTOL® you use and how long you should continue
will decide what is needed. It should not be used for more than 7 days.

Application way and method:
DIFESTOL® is applied to the lesioned area of ​​the skin as a thin layer.

Different age groups:

Use in children:
If the person using the medicine is a child, your doctor may recommend a lower dose.

Use in the elderly:
There is no specific information about its use in the elderly, but you will see the effect as much as possible.
Use low doses.

Special use cases:

Liver / Kidney failure:
Caution should be exercised when using in patients with mild to moderate renal impairment.
Caution should be exercised in patients with mild to moderate hepatic impairment.
In severe liver failure, administration of the drug to smaller areas may be considered.
If you have an impression that the effect of DIFESTOL® is too strong or too weak
Talk to your doctor or pharmacist.

If you have used more DIFESTOL than you should:
If you have used more DIFESTOL® than you should use, contact your doctor or pharmacist.
talk.

If you forget to use DIFESTOL®:
Do not apply double to the skin to compensate for forgotten doses.
Effects that may occur when treatment with DIFESTOL® is terminated:
No adverse effects are expected when DIFESTOL® treatment is terminated.

4. What are the possible side effects?
Like all medicines, people who are sensitive to the substances in the content of DIFESTOL®
there may be effects.
Side effects are listed as shown in the categories below.

Very common: It can be seen in at least 1 of 10 patients.
Common: less than one in 10 patients, but more than one in 100 patients.
Uncommon: less than one in 100 patients, but more than one in 1000 patients.
Rare: may be seen less than one in 1000 patients.
Very Rare: Less than one in 10000 patients can be seen.

If any of the following occur stop using DIFESTOL® and IMMEDIATELY
Inform your doctor or contact the emergency department of your nearest hospital:

• Topically used antihistamines rarely cause hypersensitivity reactions.
  can open.
• Widespread and severe rash and itching of the skin, difficulty in breathing, face, lips or
  swelling in the throat, sudden drop in blood pressure.
• Severe swelling in your hands, feet and ankles that happens suddenly.
• These are all very serious side effects.
• If you have one of these, you have a serious allergy to DIFESTOL®.
• You may need urgent medical attention or hospitalization.
• All of these serious side effects are very rare.

If you notice any of the following, tell your doctor:
DIFESTOL® side effects are similar to the side effects of other anesthetic drugs. These side effects
is often dose dependent and high dose administration or rapid absorption of the drug than necessary
may be seen depending on the increase in the amount passing into the blood. Besides that extreme
sensitivity, sensitivity reactions of unknown cause (idiosyncrasia) and decreased tolerance
related side effects may also occur. Serious side effects usually affect the whole body (systemic). This
Side effects include irritability, dizziness, visual disturbances, tremors (tremor), seizure
(convulsions), numbness, dizziness, numbness, blurred vision, rapid heartbeat, dry mouth,
skin irritation, rash, itching or rash, difficulty urinating, nausea, vomiting, diarrhea, upper
pain in the abdomen.
In case of hypersensitivity after long-term regional use and accidental eye contact,
irritation may occur.
These are mild side effects of DIFESTOL®.
These side effects disappear when the dose is reduced or treatment is discontinued.
If you encounter any side effects not mentioned in these instructions for use
inform your doctor or pharmacist

Reporting of side effects
In case of any side effects that are included in the instructions for use or not,
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the "Drug Side Effects Notification" icon on www.titck.gov.tr ​​or by clicking on 0 800 314
00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center (TÜFAM) What
report. The safety of the drug you are using by reporting the side effects that occur
You will contribute to obtaining more information about.

5. How to store DIFESTOL®
Keep DIFESTOL® out of the sight and reach of children and in its package.
Store at room temperature below 25 ° C.

Use in accordance with expiration dates.

Do not use DIFESTOL® after the expiry date on the package.

DIFESTOL® GEL
Applied on the skin

Active ingredient: Each tube (30 ml), 0.36g 1.2% diphenhydramine hydrochloride; 0.6g 2%
Contains lidocaine hydrochloride.
Excipients: HPMC, glycerin, propylene glycol, potassium sorbate and deionized water

Carefully follow this USE INSTRUCTIONS before you start using this medicine.
read it because it contains important information for you.

Keep these instructions for use. You can need to read again.
If you have other questions, please talk your doctor or pharmacist.
This medicine has been prescribed for you personally, do not pass it on to others.
During the use of this medicine, when you go to the doctor or hospital,
Tell your doctor.
Follow exactly what is written in this instruction. Other than the recommended dose for the drug, high or
Do not use low doses

In this Instructions for Use:
1. What is DIFESTOL® and what is it used for?
2. Things to consider before using DIFESTOL®
3. How to use DIFESTOL®?
4. What are the possible side effects?
5. Storage of DIFESTOL®

Headings are included.

1. What is DIFESTOL® and what is it used for?
It is used for insect, fly, bee stings and light sun burns.
DIFESTOL® is available in a 30 ml plastic bottle with a spray cap in a box.
DIFESTOL is a colorless, homogeneous, odorless gel.
DIFESTOL, local anesthetics (locally applied drugs) and antipruritics (itching
prevention) is a drug included in the group.

2.Things to watch out for before using DIFESTOL®
DO NOT USE BDIFESTOL® in the following situations
If,

• DIFESTOL® contains diphenhydramine hydrochloride, lidocaine hydrochloride and
• if you are allergic to any of the excipients.
  Inflamed skin diseases with infected wounds, inflamed skin infections and infectious
• Do not use the drug if there are diseases.
• People with known sensitivity to local anesthetic agents before
  do not use.
• If you are not in the hospital and medication for an irregular heartbeat (such as amiodarone or sotalol)If you are buying, do not use this product.
  In babies, premature babies, breastfeeding mothers due to the risk of antihistamines,
  Those who are extremely sensitive to diphenhydramine HCl and other antihistamines of similar structure and
  MAO (used in the treatment of depression and anxiety (internal distress)) in drug users
  should not be used.
  It should be used under the supervision of a doctor in children under the age of two. Doctorate
  should not be used without consulting.
  It should not be applied before X-Ray applications.
  It should not be applied to mucous and open wounds.

  USE DIFESTOL® CAREFULLY in the following situations.

• Hypersensitive to light and allergic to sunlight
  Use it carefully in people.
  Be careful against microbe growth during application in areas where the skin is damaged.
  must be.
  If the drug is used in large areas, especially in cases of chickenpox,
  A drug containing the active ingredient diphenhydramine is used orally.
  use it carefully.
  DIFESTOL® should not be used on large body surfaces.
  If you have a severe infection (sepsis) in which bacteria got into the blood.
  If you have a known drug allergy. Be careful when using DIFESTOL®. In patients who are allergic to paraaminobenzoic acid derivatives (such as procaine, tetracaine, benzocaine)
  No sensitivity to lidocaine has been observed.
  Using DIFESTOL effectively and safely is about the appropriate dose. Is possible
  It is recommended to use small doses. Especially in elderly patients and children
  Please pay attention to this issue in applications.
  If you have a serious heart condition
  Especially on large skin surfaces and especially under occlusion (closed dressing)
  When administered, it can lead to heart rhythm disturbances, difficulty breathing, coma and even death.
  can open.
  Avoid contact of DIFESTOL with eyes. Eye irritation has been observed and
  There is also the possibility of corneal irritation and potential wear due to loss of reflexes. Eye
  In the event of contact, rinse your eyes immediately with water or saline and restore sensation.
  protect your eyes until it arrives.
  If you are being treated with amiodarone to treat your irregular heartbeat. This
  In this case, you should be kept under close observation and have your electrocardiogram taken
  should be considered.
• If you have an infection where the gel will be applied. If this applies to you, your doctor
  He or she may ask you to use another medicine with DIFESTOL.
  DIFESTOL, the substance that forms the structure of hemoglobin in red blood cells.
  arising due to the synthesis disorder, coming in attacks and many organ systems
  only if it is a safer alternative in patients with the disease affecting (porphyria)
  should be given. Appropriate precautions should be taken for vulnerable patients.

If these warnings are valid for you, even at any time in the past, please
consult your doctor,

Using DIFESTOL® with food and drink:
Interaction of DIFESTOL® with food and beverages in terms of application method
does not have

Pregnancy
Consult your doctor or pharmacist before using this medication.
Diphenhydramine hydrochloride and lidocaine hydrochloride in the composition of DIFESTOL®
Its reliability for use in pregnancies has not been established.
DIFESTOL® should not be used during pregnancy unless absolutely necessary.
If you notice that you are pregnant during your treatment, contact your doctor or pharmacist immediately.
Please consult.

Breast-feeding
Consult your doctor or pharmacist before using this medication.
Since DIFESTOL® passes into breast milk, this medicine should not be used during breastfeeding.

Vehicle and machine use
Although no effect of diphenhydramine HCl has been reported, lidocaine HCl
Although it is present in quantity, it creates a local numbness in the area where it is applied,
Caution is recommended when using vehicles and machines.

Important information about some of the excipients contained in DIFESTOL®
This medicinal product contains propylene glycol. May cause skin irritation.

Use with other drugs

• For the treatment of heart rhythm disturbances such as tocoainide, mexiletine, amiodarone or sotalol
  used drugs,
• Other medicines that lower blood pressure such as beta blockers (e.g. cimetidine, propranolol),
• Other local anesthetics.

If you are currently using any prescription or over-the-counter medication or have recently
If you have used, please inform your doctor or pharmacist about them.

3. How to use DIFESTOL®?
Instructions for appropriate use and dose / frequency of administration:
Unless recommended otherwise by your doctor, use in the following doses.
DIFESTOL® is applied to the lesioned area several times a day.
How much DIFESTOL® you use and how long you should continue
will decide what is needed. It should not be used for more than 7 days.

Application way and method:
DIFESTOL® is applied to the lesioned area of ​​the skin as a thin layer.

Different age groups:

Use in children:
If the person using the medicine is a child, your doctor may recommend a lower dose.

Use in the elderly:
There is no specific information about its use in the elderly, but you will see the effect as much as possible.
Use low doses.

Special use cases:

Liver / Kidney failure:
Caution should be exercised when using in patients with mild to moderate renal impairment.
Caution should be exercised in patients with mild to moderate hepatic impairment.
In severe liver failure, administration of the drug to smaller areas may be considered.
If you have an impression that the effect of DIFESTOL® is too strong or too weak
Talk to your doctor or pharmacist.

If you have used more DIFESTOL than you should:
If you have used more DIFESTOL® than you should use, contact your doctor or pharmacist.
talk.

If you forget to use DIFESTOL®:
Do not apply double to the skin to compensate for forgotten doses.
Effects that may occur when treatment with DIFESTOL® is terminated:
No adverse effects are expected when DIFESTOL® treatment is terminated.

4. What are the possible side effects?
Like all medicines, people who are sensitive to the substances in the content of DIFESTOL®
there may be effects.
Side effects are listed as shown in the categories below.

Very common: It can be seen in at least 1 of 10 patients.
Common: less than one in 10 patients, but more than one in 100 patients.
Uncommon: less than one in 100 patients, but more than one in 1000 patients.
Rare: may be seen less than one in 1000 patients.
Very Rare: Less than one in 10000 patients can be seen.

If any of the following occur stop using DIFESTOL® and IMMEDIATELY
Inform your doctor or contact the emergency department of your nearest hospital:

• Topically used antihistamines rarely cause hypersensitivity reactions.
  can open.
• Widespread and severe rash and itching of the skin, difficulty in breathing, face, lips or
  swelling in the throat, sudden drop in blood pressure.
• Severe swelling in your hands, feet and ankles that happens suddenly.
• These are all very serious side effects.
• If you have one of these, you have a serious allergy to DIFESTOL®.
• You may need urgent medical attention or hospitalization.
• All of these serious side effects are very rare.

If you notice any of the following, tell your doctor:
DIFESTOL® side effects are similar to the side effects of other anesthetic drugs. These side effects
is often dose dependent and high dose administration or rapid absorption of the drug than necessary
may be seen depending on the increase in the amount passing into the blood. Besides that extreme
sensitivity, sensitivity reactions of unknown cause (idiosyncrasia) and decreased tolerance
related side effects may also occur. Serious side effects usually affect the whole body (systemic). This
Side effects include irritability, dizziness, visual disturbances, tremors (tremor), seizure
(convulsions), numbness, dizziness, numbness, blurred vision, rapid heartbeat, dry mouth,
skin irritation, rash, itching or rash, difficulty urinating, nausea, vomiting, diarrhea, upper
pain in the abdomen.
In case of hypersensitivity after long-term regional use and accidental eye contact,
irritation may occur.
These are mild side effects of DIFESTOL®.
These side effects disappear when the dose is reduced or treatment is discontinued.
If you encounter any side effects not mentioned in these instructions for use
inform your doctor or pharmacist

Reporting of side effects
In case of any side effects that are included in the instructions for use or not,
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the "Drug Side Effects Notification" icon on www.titck.gov.tr ​​or by clicking on 0 800 314
00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center (TÜFAM) What
report. The safety of the drug you are using by reporting the side effects that occur
You will contribute to obtaining more information about.

5. How to store DIFESTOL®
Keep DIFESTOL® out of the sight and reach of children and in its package.
Store at room temperature below 25 ° C.

Use in accordance with expiration dates.

Do not use DIFESTOL® after the expiry date on the package.