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ORTOFEN (DICLOFENAC) UNG 2% 30G

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
ORTOFEN-DICLOFENAC-drug/medicine aproximate price on "ORTOFEN (DICLOFENAC) UNG 2% 30G" in Riga city, Latvia is:
  • 4.24€  4.59$  3.64£  490Rub  48.8SEK  18PLN  16.78₪ 


Check max allowed state price from goverment drugs agency webpage on ### "ORTOFEN (DICLOFENAC) UNG 2% 30G" ###

Reģ. Nr.: 05-0519

ATC codeM02AA15 

Active substances: Diclofenacum Natricum

 


Vendor, principal: Tallinas Farm. Fabrika
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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 .

ORTOFEN 20MG/1G 30G

Package leaflet: Information for user

ORTOFEN, 20 mg/g ointment Diclofenac

Read all of this leaflet carefully before you start using this medicine because 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.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

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

1. What Ortofen is and what it is used for

Ortofen ointment contains active substance diclofenac sodium, which belongs to a group of analgesic and non-steroidal anti-inflammatory drugs.
Ortofen ointment is used for topical alleviation of mild to moderate pain and inflammation in case of painful and inflammatory conditions of soft tissues.

2. What you need to know before you use Ortofen

Do not use Ortofen:

-   if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
-   if you are allergic to acetyl salicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), expressed as asthma attack, urticaria or acute rhinitis;
-   if you have open wounds, skin inflammation or infections; do not apply the medicine on eczema or mucosa;
-   during the third trimester of pregnancy;
-   in children under 14 years of age, because there is insufficient data on using it in this age group.

Warnings and precautions

Ointment is for external use only.
Discontinue treatment if you get rash after administering the medicine.
To prevent irritation, avoid contact with the eyes, mucosa or damaged skin. Take care not to touch the application area with your hands.
It is not recommended to cover the ointment application area with compression bandage.
The medicine may increase skin’s sensitivity to sunlight. This can be prevented by avoiding exposure of treated area to direct sunlight during treatment. Care should be taken when using Ortofen in patients with peptic ulcer, moderate or severe renal insufficiency and asthma.
Using Ortofen on large skin areas increases the risk of side effects, especially upon prolonged use.

Children

As there is insufficient data on using diclofenac in children under 14 years of age, Ortofen is contraindicated in this age group (See section Do not use Ortofen).

Other medicines and Ortofen

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Concomitant use of orally administered non-steroidal anti-inflammatory drugs may increase the risk of developing side effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ortofen should be avoided during the first and the second trimester of pregnancy.
This medicine must not be used during the third trimester of pregnancy.
Diclofenac is excreted in breast milk in small quantities. This medicine can be used during breast-feeding only under the supervision of a doctor. Avoid applying ointment on large skin areas and prolonged use. During the breast-feeding period, the medicine must not be applied to breasts to avoid direct contact of the baby with the ointment.

Driving and using machines

Ortofen has no effect on the ability to drive or use machines.

Ortofen contains benzyl benzoate

Benzyl benzoate has weak irritant effect on skin and mucosa.

3. How to use Ortofen

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For external use.
When first used, reverse the cap and press it against the foil at the end of the tube.
Adults:
Apply thin layer of 2-4 g of ointment on painful area 3-4 times a day. Maximum daily dose is 8 g of ointment. Duration of treatment is individual (1-14 days) and depends on the nature and
2
severity of disease. Estimated quantity of ointment per 1 dm area is approximately 0.5 g and one course of treatment requires on average 2.. .3 tubes of ointment.
Wash your hands carefully after using the ointment, unless the hands are not intended for treatment.
Elderly
No dosage adjustment is required in elderly.
Patients with hepatic impairment
No dosage adjustment is required in patients with hepatic impairment.
If you feel that the effect of Ortofen is too strong or too weak, talk to your doctor or pharmacist.

If you use more Ortofen than you should

Due to low absorption of the active substance diclofenac sodium into the bloodstream, topical administration of the medicine is not likely to cause intoxication. However, side effects caused by accidental ointment overdose cannot be excluded. Possible side effects include: gastrointestinal disorders (upper abdominal pain, nausea, flatulence, loss of appetite) and/or disorders of the central nervous system (headache, dizziness, confusion).
If you exceed recommended cutaneous dose, wipe the ointment off and wash the skin with water.

If you accidentally swallow Ortofen

Swallowing of ointment is not generally dangerous. If you have or somebody else has swallowed the ointment, contact a doctor immediately.

If you forget to use Ortofen ointment

If you forget to use Ortofen, use it as soon as you remember, and then continue with your regular treatment.
If it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When used for long period and/or in large quantities, the ointment may cause systemic side effects typical to non-steroidal anti-inflammatory drugs - gastrointestinal disorders (upper abdominal pain, nausea, flatulence, loss of appetite) and/or disorders of the central nervous system (headache, dizziness, confusion).
Other possible side effects are:
Very rare (occurs in less than one in 10,000 users):
•   hypersensitivity (incl. urticaria), angioedema
•   pustular rash
•   asthma
photosensitivity reactions
Rare (occurs in less than one in 1,000 users):
•   bullous (blistering) dermatitis
Common (occurs in less than one in 10 users):
•   rash, eczema, erythema, dermatitis (incl. contact dermatitis, intense itching).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ortofen

Do not store above 25 °C.
Do not refrigerate.
Do not freeze.
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. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Ortofen contains

-   The active substance is diclofenac sodium (Diclofenacum natricum). 1 g of ointment contains 20 mg diclofenac sodium.
-   The other ingredients are benzyl benzoate, carbomer, polysorbate 80, sodium hydroxide, imide urea, purified water.

What Ortofen looks like and contents of the pack

White or off-white ointment.
30 g ,50 g, 75 g or 100 g ointment in aluminium tube. Aluminium tube in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia Tel: +371 67083205
Fax: +371 67083505 e-mail: [email protected]

Manufacturer

Tallinna Farmaatsiatehase AS Tondi 33, 11316 Tallinn
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AS Grindeks Eesti filiaal Tondi 33,
11316 Tallinn.
Phone: +372 6120224 Fax: +372 6120331

This leaflet was last revised in August 2017.






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




[*1]

Information source DDD German Institute of Medical Documentation and Information - DIMDI [23.11.2011]


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