Diclac Max Gel 5% 50g

DESCRIPTION:

DICLAC MAX GEL 5% - 50 GR. SANDOZ

1. WHAT DICLAC IS AND WHAT IT IS USED FOR?

Diclac Gel is a medicinal product with a pain relieving and anti-inflammatory action (non-steroidal anti-inflammatory drug).

What Diclac Max Gel is used?

For topical use in pain, inflammation and swelling in:

-rheumatic diseases of soft tissues (inflammation of tendons and ligaments - tendinitis, tendinaginitis and bursitis, painful motion of the shoulder, inflammation of the muscles and joints);

-degenerative joint diseases (osteoarthritis of the large and small joints) of the limbs and in the spine;

-sports and domestic injuries (sprains, injuries, stretching).

2. WHAT YOU SHOULD KNOW BEFORE YOU USE DICLAC Max GEL?

Do not use Diclac Gel:

-if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);

-on open wounds, damaged skin areas, inflammation or skin infections;

-on mucous membranes;

-if you experience asthma, rashes, or a runny nose when you take acetylsalicylic acid / aspirin or other non-steroidal anti-inflammatory drugs;

-in children and adolescents;

-during the last three months of pregnancy.

Warnings and precautions:

if you suffer from asthma, hay fever, nasal polyps (swelling of the nasal mucosa), chronic lung diseases or chronic respiratory infections (symptoms similar to hay fever);

if you are hypersensitive to anti-inflammatory products in all groups, there is a higher risk of asthma attacks (so-called analgesic / analgesic asthma intolerance), local swelling of the skin and mucous membrane (the so-called Quinke edema) or urticaria administration of Diclac Gel than in other patients. In these patients, Diclac Gel can only be given with certain precautions and a follow-up check by a doctor. The same applies to patients who develop allergic reactions to other substances, that manifest themselves in skin reactions, itching or urticaria;

Care should be taken not to get the gel in contact with the eyes or mucous membranes.

Other Drugs and Diclac Max Gel:

It is unlikely that drug interactions will occur with the use of Diclac Max gel. However, you should inform the treating physician if you are taking or have recently taken other medicines before using Diclac Max gel.

Children and adolescents:

Diclac Max 5% gel should not be used in children and adolescents because there is insufficient data for this age group.

Fertility, pregnancy and lactation:

Women of childbearing potential

There is no data to suggest recommendations for women of childbearing potential.

Pregnancy

Because there is insufficient data on the safety of Diclac Max gel in pregnant women, Diclac Max gel should not be used during pregnancy. Diclac Max gel is contraindicated during the last three months of pregnancy.

Breast-feeding:

Since it is not known whether locally administered diclofenac passes into breast milk, its use during breastfeeding is not recommended. If there are urgent reasons for using diclofenac during breastfeeding, application on the chest area and prolonged use should be avoided.

Fertility:

There is no data on the effects on fertility in humans.

Important information about some of the ingredients of Diclac Max gel:

Diclac Max 5% gel contains alcohol (isopropyl alcohol) and should therefore not be in contact with open wounds, mucous membranes or eyes.

3. HOW TO APPLY Diclac Max GEL?

The following dosage is recommended if your doctor has not prescribed you Diclac Max Gel in another dosing regimen. Please follow these instructions for use. Otherwise, Diclac Max will not work to its full potential.

Diclac Max gel is applied in a thin layer on the respective areas of the skin 2-3 times a day.

Gently rub into the skin. Do not take orally.

Diclac Max gel is suitable for use in conducting iontophoresis. This form of electrotherapy enhances penetration through the skin. Diclac Max gel should be applied at the negative pole (cathode).

The product can be administered from 3 to 7 days depending on the specific case.

If you use more Diclac Max gel than you should

If the gel has been applied in significantly larger amounts than recommended or has been swallowed, the symptoms of overdosage may be: dizziness, headache, constipation, breathlessness, nausea, vomiting, abdominal pain , gastrointestinal bleeding, impaired hepatic and renal function, and convulsions in children. Seek medical attention immediately.

The gel should be washed off with water if you have exceeded the recommended dose for administration.

If you have forgotten to use Diclac Max:

If you have forgotten to apply the product, continue to apply it regularly.

Please check with your doctor if you are not sure about the discontinuation of the treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS:

Like all medicines, Diclac Max gel can cause side effects, although not everybody gets them.

Local skin reactions such as redness, itching, burning of the skin, skin rashes, with bubbling and urticaria are possible.

Diclac Max gel may, in rare cases, cause hypersensitivity reactions or so-called local allergic reactions (contact dermatitis).

In very rare cases, diclofenac gel may cause asthma attacks or photosensitivity reactions.

If Diclac Max gel is applied to large areas of the skin and for a prolonged period of time, the occurrence of systemic adverse reactions affecting certain organs and systems or even the whole organism, similar to those that may occur in diclofenac oral, intramuscular or intravenous administration is possible.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE Diclac Max GEL

Keep at a temperature below 25 ° C.

Keep out of reach of children.

Do not use Diclac Max Gel after the expiry date which is stated on the packaging.

Shelf life after initial opening of the tube is 12 months.

6. PACKAGE LEAFLET AND ADDITIONAL INFORMATION

What Diclac Max contains

The active substance is diclofenac sodium. 1 g of gel contains 50 mg diclofenac sodium.

The other ingredients are hypromellose, macrogol - 7 glycerol cocoate, aromatic substance, purified water.

Original packs containing 50 g and 100 g gel