DICLAC AMP 75MG 3ML N5

ATC code: M01AB05 

Active substances: Diclofenacum Natricum

Vendor, principal: Hexal Ag/salutas Pharma Gmbh. 
DICLAC AMP 75MG 3ML N5 is compensated medicine in Latvia. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

DICLAC 50MG/1G 50G

Patient Leaflet: Information for the user

Diclac 5%, gel

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, pharmacist or nurse 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, pharmacist or nurse. 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 Diclac 5% is and what it is used for
2.   What you need to know before you use Diclac 5%
3.   How to use Diclac 5%
4.   Possible side effects
5.   How to store Diclac 5%
6.   Contents of the pack and other information

1.   What Diclac 5% is and what it is used for

Diclac 5% is a non-steroidal anti-inflammatory and analgesic agent, which is used for topical pain relief in painful and inflammatory conditions of soft tissues in adults and adolescents over the age of 14.

2.   What you need to know before you use Diclac 5%

Do not use Diclac 5%:

-   if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
-   if acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory agents cause asthma attacks or episodes of urticaria or acute rhinitis for you:
-   during the last trimester of pregnancy
-   if you are younger than 14 years of age.

Warnings and precautions

General recommendations:
-   if you are planning to use the medicine on larger areas of skin for a longer period, read the leaflets for systemic diclofenac preparations.
-   Diclac 5% gel can only be applied to undamaged skin (with no open wounds or injuries). You should avoid the medicine from getting into the eyes or onto mucous membranes and ingesting the gel.
Do not apply the gel onto skin which has:
•   a rash or eczema
•   wounds
If a rash develops after application of this medicine, stop the treatment.
Make sure not to get the gel into the eyes, the mouth or on any other mucous membranes.
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Avoid application onto large areas of skin or during an extended period, except when told to do so by your doctor.
Be careful when being exposed to sunlight or using a tanning bed, as your skin may be more sensitive to sunlight after using Diclac 5% gel.
Diclac 5% gel can be used with ordinary bandages, but not with airtight bandages.

Other medicines and Diclac

No interactions with other medicines have been reported when Diclac 5% gel was used in the correct manner. Nevertheless, tell your doctor or pharmacist if you have used or are planning to use any other medicines, including those purchased without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
•   You must not use Diclac 5% gel during the last 3 months of pregnancy, as it could damage your unborn child or cause problems with childbirth.
•   Do not use Diclac 5% gel during the first six months of pregnancy, unless it is considered necessary by your doctor.
•   Use of Diclac 5% gel during breast-feeding is not recommended. Should your doctor recommend using this medicine during breast-feeding, Diclac 5% gel must not be applied onto the breasts or other large areas of skin or during longer periods.

Diclac 5% contains alcohol.

The gel contains alcohol (2-propranolol), so contact with open wounds, mucous membranes and eyes should be avoided.

Driving and using machines

Cutaneous administration of diclofenac will not affect the ability to drive or use machines.

3. How to use Diclac 5%

Always use Diclac 5% exactly as your doctor has told you. Check with your doctor or pharmacist if you have any concerns.

Adults and adolescents over the age of 14

Gently squeeze a small amount of gel out of the tube and apply it onto the painful or swollen area twice a day by slowly rubbing it into the skin.
The necessary amount depends on the extent of the painful or swollen area. For example, 2-4 g of diclofenac gel (a cherry-sized amount to a walnut-sized amount) is sufficient for treating a surface area of about 400-800 cm². Avoid use on large areas of skin and for an extended period, unless directed to do so by your doctor.
Two applications must be at least four hours apart. Do not apply the gel for more than 4 times in 24 hours.
Do not use Diclac 5% gel for over two weeks without advising with your doctor.
Ask advice from your doctor if you do not feel better or if you feel worse.

Method of application

Remove the tube from the box. Break the protective membrane on the tube with the sharp end of the cap before first use. Do not use if the protective membrane is damaged.
The gel is for external use only. Do not use in the mouth, notify your doctor at once after accidental ingestion.
Make sure not to get the gel into the eyes or on the mucous membranes.
If that happens, rinse your eyes with clean water. Turn to your doctor or pharmacist if discomfort persists. Do not apply the gel onto wounds or damaged areas of skin.
Do not use airtight bandages or pressure bandages after applying the gel. The gel can be used with ordinary bandages.
You may feel a slight cooling sensation when applying the gel.
Wash your hands after using Diclac 5% gel, unless the area being treated is your hands.
Screw the cap back on.

If you use more Diclac 5% than you should

Overdosing is unlikely if Diclac gel 5% is used on the skin. However, turn to your doctor or go to the emergency medicine department if you or your child accidentally ingests Diclac 5% gel. Take the package with you to show it to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diclac 5% can cause side effects, although not everybody gets them.
Some rare or very rare side effects may be severe.
Stop using Diclac 5% gel and turn to your doctor if you get any of the following symptoms:
•   skin rash with blisters, urticaria (bullous dermatitis) (rare: may affect up to 1 person in 1,000);
•   swelling of the face, lips, tongue or throat (very rare: may affect up to 1 person in 10,000);
•   sudden onset of breathing difficulties and tightness in the chest with wheezing breathing or coughing (asthma) (very rare: may affect up to 1 person in 10,000).
Other side effects
Common side effects (may affect up to 1 person in 10):
•   skin rash, pruritus, burning sensation, redness or stinging of the skin.
Very rare side effects (may affect up to 1 person in 10,000):
•   hypersensitivity, urticaria-type rash;
•   pustular rash;
•   increased skin sensitivity to sunlight. Possible symptoms may include sunburn with pruritus, swelling and blisters.
Stop using this medicine if you get a skin rash.

Reporting of side effects

If you get any side effects, ask advice from 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/en. By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Diclac 5%

Do not store above 25 °C.
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 pack. The expiry date refers to the last day of that month.
The gel can be used within 12 months after first opening.
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 Diclac 5% contains

-   The active ingredient is diclofenac sodium
-   The other excipients include isopropyl alcohol, hypromellose, macrogol glycerol cocoate, purified water

What Diclac 5% looks like and contents of the pack

Diclac 5% is a clear or slightly yellowish gel with no air bubbles and with a characteristic scent of isopropyl alcohol.
Pack: 50 g or 100 g of gel in a tube.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Sandoz d.d.
Verovškova 57 1000 Ljubljana Slovenia
Manufacturers:
Salutas Pharma GmbH Otto-von-Guericke Allee 1 39179 Barleben Germany
Salutas Pharma GmbH Lange Göhren 3 39171 Osterweddingen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Sandoz d.d. Estonian branch
Pämu mnt 105 EE - 11312 Tallinn Phone: +372 6652 400

This leaflet was last revised in August 2018.

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