Muscoril pain and inflammation
Italy
Table of Contents
Package leaflet: Information for the user
TOFENAL 4% Gel
Diclofenac sodium
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 7 days.
Contents of this leaflet:
- What Tofenal is and what it is used for
- What you need to know before using Tofenal
- How to use Tofenal
- Possible side effects
- How to store Tofenal
- Contents of the pack and other information
1. What Tofenal is and what it is used for
Tofenal contains the active substance diclofenac sodium and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation.
Tofenal is used for the local treatment of pain and inflammation of rheumatic or traumatic origin affecting 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 should know before using Tofenal
Do not use Tofenal
- if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6).
- if you have experienced asthma attacks, hives, 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 14 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Tofenal.
If the medicine is used over large areas of skin and for prolonged periods, the possibility of systemic adverse effects (i.e. effects that may involve various parts of the body) cannot be ruled out (see section 4 “Possible side effects”).
Stop treatment immediately and consult your doctor if a skin rash occurs after applying the gel.
Children and adolescents
There is insufficient data 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.
Other medicines and Tofenal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Since absorption of diclofenac after topical application is very low, interactions with other medicines are highly unlikely.
Pregnancy and breastfeeding
Do not use Tofenal after the sixth month of pregnancy. It is also advisable to avoid using Tofenal during the early stages of pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Topical application of diclofenac does not affect the ability to drive or operate machinery.
Tofenal contains propylene glycol (E1520) and ethanol
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 exactly as stated 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 daily.
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 daily.
Caution: Use Tofenal only for short-term 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 adult dosage may be used.
Children under 14 years of age
There is insufficient data 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.
Instructions for use:
Wash and dry the Apply to the affected area Gently massage to
painful area promote absorption
- After application, wash your hands thoroughly, otherwise they will also be treated with the gel.
- DO NOT USE on diseased skin, skin wounds, or open lesions.
- Avoid contact with eyes or mucous membranes.
- Do not ingest.
- Do not use an occlusive dressing that does not allow air passage.
If you use more Tofenal than you should
In case of accidental ingestion or overdose of Tofenal, contact your doctor immediately or go to the Emergency Department of the nearest hospital.
If you forget to use Tofenal
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If the medicine is used on extensive skin areas and for a prolonged period, systemic side effects (which may affect various parts of the body) such as nausea, indigestion, stomach burning, excitation, altered taste sensation, conjunctivitis cannot be ruled out.
If you notice any of these symptoms, stop treatment and consult your doctor.
Common side effects (may occur in up to 1 in 10 patients):
- Skin rash
- Itching
Uncommon side effects (may occur in up to 1 in 100 patients):
- Skin redness and burning
- Skin rash with blisters and vesicles
- Skin peeling
- Tingling
- Involuntary muscle contractions
Very rare side effects (may occur in up to 1 in 10,000 patients):
- Allergic reactions (hypersensitivity, including urticaria)
- Rapid swelling of the skin and mucous membranes
- Increased sensitivity of the skin to sunlight
- Asthma
Side effects not known (frequency cannot be estimated from available data):
-
- Burning sensation at the application site
-
- Dry skin
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton and on the bottle after Exp. The expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Tofenal contains
- The active substance is sodium diclofenac. Each 100 g of gel contains 4 g of sodium diclofenac.
- The other components are: propylene glycol (E1520), isopropyl alcohol, ethyl alcohol, soybean lecithin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, edetate disodium, ascorbyl palmitate, peppermint flavor, purified water.
Description of the appearance of Tofenal and package contents
Tofenal is a topical gel, available in packages containing a 15 g bottle with dispenser.
Marketing Authorization 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)