TOFENAL 4 % Gel

Зміст інструкції

1. TOFENAL 4% Gel
   1. What is Tofenal and what is it used for
   2. What you need to know before using Tofenal
   3. How to use Tofenal
   4. Possible side effects
   5. How to store Tofenal
   6. Contents of the pack and other information

TOFENAL 4% Gel

Diclofenac sodico

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after 7 days.

Contents of this leaflet:

• 1. What Tofenal is and what it is used for
• 2. What you need to know before using Tofenal
• 3. How to use Tofenal
• 4. Possible side effects
• 5. How to store Tofenal
• 6. Contents of the pack and other information

1. What is Tofenal and what is it used for

Tofenal contains the active ingredient diclofenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation.
Tofenal is used to treat local pain and inflammation of rheumatic or traumatic origin in the
joints, muscles, tendons and ligaments.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Tofenal

Do not use Tofenal

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• after the sixth month of pregnancy (see section “Pregnancy and breastfeeding”).
• in children and adolescents under the age of 14 years.

Warnings and precautions
Consult your doctor or pharmacist before using Tofenal.
If the medicine is used on large areas of skin and for a prolonged period, the possibility of systemic side effects (which can affect different parts of the body) cannot be excluded
(see section 4 “Possible side effects”).
Stop treatment immediately and consult your doctor if a skin rash occursafter
application of the gel.

Children and adolescents
There is insufficient data on efficacy and safety in children and adolescents under the age of
14 years. Therefore, do not use Tofenal in children under 14 years of age.

Other medicines and Tofenal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Since the absorption of diclofenac after topical application is very low, interactions with other medicines are very unlikely.

Pregnancy and breastfeeding
Do not use Tofenal after the sixth month of pregnancy. It is best to avoid using Tofenal even during the early
stages of pregnancy.
If you are currently pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Topical application of diclofenac does not impair the ability to drive vehicles or operate machinery.

Tofenal contains propylene glycol (E1520) and ethyl alcohol
This medicine contains 2.25 g of propylene glycol per bottle.
This medicine contains 6.7 mg of alcohol (ethanol) in each spray. It may cause a burning sensation
on damaged skin.

3. How to use Tofenal

Use this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults (over 18 years of age)
The recommended dose is three or four applications, depending on the size of the area to be treated, three times a day.

Use in children and adolescents (14 to 18 years of age)
Three to four applications, depending on the size of the area to be treated, three times a day.

Caution: use Tofenal only for short periods of treatment.
If you need to use Tofenal for more than 7 days to relieve pain or if symptoms worsen, consult your doctor.

Elderly:
The usual dosage intended for adults can be used.

Children under 14 years of age
Insufficient data are available on efficacy and safety in children and adolescents under 14 years of age. Therefore, do not use Tofenal in children under 14 years of age.

How to use:

Wash and dry
the painful area
thoroughly
Massage
gently to
promote
absorption
Apply to the area to
be treated

• After application, wash your hands, otherwise they will also be treated with the gel.
• DO NOT USE on diseased skin, on skin wounds or open lesions.
• Do not bring into contact with eyes or mucous membranes.
• Do not ingest.
• Do not use an occlusive bandage that does not allow air to pass through.

If you use more Tofenal than you should
In case of ingestion/accidental intake of an excessive dose of Tofenal, immediately notify your doctor or go to the Emergency Room of the nearest hospital.

If you forget to use Tofenal
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the medicine is used on large areas of skin and for a prolonged period, the possibility of systemic side effects (which can affect different parts of the body) cannot be excluded,
such as nausea, indigestion, heartburn, excitement, altered sense of taste, conjunctivitis;
if you notice any of these symptoms, stop treatment and consult your doctor.
Common side effects (may affect up to 1 in 10 people):

• Skin rash
• Itching

Uncommon side effects (may affect up to 1 in 100 people):

• Redness and burning of the skin
• Skin rash with blisters and vesicles
• Skin peeling
• Tingling
• Involuntary muscle contractions

Very rare side effects (may affect up to 1 in 10,000 people):

• Allergic reactions (hypersensitivity, including urticaria)
• Rapid swelling of the skin and mucous membranes
• Increased skin sensitivity to sunlight
• Asthma

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• - Burning sensation at the application site
• - Dry skin

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tofenal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the bottle after Exp. The
expiry date refers to the last day of that month.
The validity after first opening of the bottle is 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tofenal contains

• The active ingredient is diclofenac sodium. Each 100 g of gel contains 4 g of diclofenac sodium.
• The other ingredients are: propylene glycol (E1520), isopropyl alcohol, ethyl alcohol, soybean lecithin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, disodium edetate, ascorbyl palmitate, peppermint essence, purified water.

Description of the appearance of Tofenal and contents of the pack
Tofenal is a gel for topical use, available in packs containing a 15 g tube with an applicator.

Marketing Authorisation Holder
OP Pharma S.r.l. Via Monte Rosa, 61 - 20149 Milan

Manufacturer
Pharbil Waltrop GmbH Im Wirrigen, 25 - Waltrop (Germany)
Doppel Farmaceutici S.r.l. Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)