Diclofenac Sandoz GmbH

Package leaflet: Information for the patient

Diclofenac Sandoz GmbH 20 mg/g gel

Read this entire leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement, or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What Diclofenac Sandoz GmbH is and what it is used for

Diclofenac Sandoz GmbH contains the active substance diclofenac diethylammonium, which belongs to a
class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Diclofenac Sandoz GmbH is indicated in adults and adolescents aged 14 years and older
for the treatment of mild to moderate pain associated with muscular and joint injuries, such as
sports injuries.
This medicine is indicated for short-term treatment.

2. What you need to know before using Diclofenac Sandoz GmbH

Do not use Diclofenac Sandoz GmbH

• if you are allergic to:
  • diclofenac
  • other medicines used to treat pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid (also used to prevent blood clots)
  • any of the other ingredients of this medicine (listed in section 6)

Symptoms of an allergic reaction may include: wheezing or difficulty breathing (asthma;
bronchospasm); blistering rash or hives; swelling of the face, tongue or throat;
runny nose.
If in doubt, consult your doctor or pharmacist.

• if you are in the last 3 months of pregnancy
• in children and adolescents under 14 years of age

Warnings and precautions
Talk to your doctor or pharmacist before using Diclofenac Sandoz GmbH.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps), or chronic obstructive pulmonary disease, chronic respiratory infections (particularly associated with symptoms similar to allergic rhinitis), or hypersensitivity to other painkillers and anti-rheumatic drugs of any kind, you are at higher risk than other patients of experiencing asthma attacks (so-called analgesic intolerance or analgesic-induced asthma), localised swelling of the skin or mucous membranes (so-called Quincke's oedema), and hives.
In such patients, Diclofenac Sandoz GmbH should only be used with specific precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are allergic to other substances and experience, for example, skin reactions, itching or hives.
When Diclofenac Sandoz GmbH is applied over a large area of skin and for prolonged periods, the possibility of systemic adverse effects associated with application cannot be ruled out.
Apply Diclofenac Sandoz GmbH only to intact, healthy, unbroken skin. Avoid contact with eyes and oral mucous membranes. The gel must not be taken orally.
After applying the gel to the skin, a permeable dressing (non-occlusive) may be used, but only after allowing the gel to dry on the skin for a few minutes. Occlusive dressings that do not allow air passage must not be used.
Consult your doctor if symptoms worsen or do not improve within 7 days.
The use of Diclofenac Sandoz GmbH must be discontinued if a skin rash develops.
Avoid exposure to sunlight, including sunlamps, while using this medicine.
Appropriate precautions must be taken to prevent children from touching the area where the gel has been applied.
Children and adolescents
Diclofenac Sandoz GmbH is contraindicated in children and adolescents under 14 years of age.
Other medicines and Diclofenac Sandoz GmbH
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
To date, no interactions are known with the intended topical use of Diclofenac Sandoz GmbH.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your
doctor or pharmacist before using this medicine.

• Pregnancy

Do not use Diclofenac Sandoz GmbH during the last trimester of pregnancy.
You must not use Diclofenac Sandoz GmbH during the first 6 months of pregnancy unless considered necessary and advised by your doctor. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g. tablets) of diclofenac medicines may cause adverse effects in the fetus. It is not known whether the same risk applies to Diclofenac Sandoz GmbH when used on the skin.

• Breastfeeding

During breastfeeding, Diclofenac Sandoz GmbH may only be used under medical supervision, as diclofenac is excreted in small amounts in breast milk. If you are breastfeeding, do not apply Diclofenac Sandoz GmbH to the breast or to other large areas of skin or for prolonged periods.
Driving and using machines
Diclofenac Sandoz GmbH has no effect on the ability to drive or operate machinery.
Effects of other ingredients (excipients)
Diclofenac Sandoz GmbH contains:

• 50 mg of propylene glycol per gram of gel, which may cause skin irritation
• 0.2 mg of butylated hydroxytoluene (E321) per gram of gel, which may cause localised skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes
• Up to 0.01 mg of hexyl benzoate per gram of gel, which may cause local irritation
• Fragrance containing citral and eugenol, which may cause an allergic reaction. In addition to allergic reactions in sensitised patients, non-sensitised patients may become sensitised.

3. How to use Diclofenac Sandoz GmbH

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults and adolescents aged 14 years and older
Diclofenac Sandoz GmbH should be used twice daily (preferably in the morning and evening).
Depending on the size of the area to be treated, apply a quantity of gel ranging from the size of a cherry to that of a walnut, corresponding to 2–4 g of gel.
The maximum daily dose is 8 g of gel.
Elderly patients
No special dose adjustment is required. If you are elderly, you should pay particular attention to possible adverse effects and, if necessary, consult your doctor or pharmacist.
Impaired liver or kidney function
Dose reduction is not required.
Use in children and adolescents (under 14 years of age)
Diclofenac Sandoz GmbH is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use Diclofenac Sandoz GmbH”).
How to apply
Before first use, remove the plastic seal from the tube. Do not use the medicine if the seal is broken.
Diclofenac Sandoz GmbH is intended for topical use (it must be used only on the skin).
Apply the gel as a thin layer to the affected areas of the body and gently rub it into the skin. Afterwards, clean your hands with a paper towel and then wash them, unless your hands are the area being treated.
If too much gel is accidentally applied, remove the excess gel with a paper towel.
The paper towel must be disposed of in household waste to prevent unused product from entering the aquatic environment.
Allow the gel to dry on the skin for a few minutes before applying a dressing.
Duration of treatment
The duration of use depends on the symptoms and underlying condition.
This medicine must not be used for more than one week without consulting a doctor.
If symptoms worsen or do not improve within 7 days, consult your doctor.
If you use more Diclofenac Sandoz GmbH than you should
Overdose is unlikely when applying more Diclofenac Sandoz GmbH than recommended, as absorption into the bloodstream is low when the medicine is used on the skin. However, if a significantly higher than recommended dose is applied to the skin, remove the gel and rinse the area with water. If Diclofenac Sandoz GmbH is accidentally ingested, contact your doctor immediately.
If you forget to use Diclofenac Sandoz GmbH
If you forget to apply a dose, apply it as soon as you remember. 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 everybody gets them.
Some rare and very rare side effects can be serious.
If you experience any of the following signs of allergy, stop using Diclofenac Sandoz GmbH and contact your doctor or pharmacist immediately:

• Skin rash with blisters; hives (rare: may affect up to 1 in 1,000 people).
• Wheezing, shortness of breath or tightness in the chest (asthma) (very rare: may affect fewer than 1 in 10,000 people).
• Swelling of the face, lips, tongue or throat (very rare: may affect up to 1 in 10,000 people).

Other side effects may also occur:
Common side effects (may affect up to 1 in 10 people)
Skin rash, itching, redness, eczema, dermatitis (inflammation of the skin), including contact dermatitis.
Very rare side effects (may affect up to 1 in 10,000 people)

• Rash with pustules
• Hypersensitivity reactions (including hives)
• Light sensitivity causing skin reactions after exposure to sunlight

When Diclofenac Sandoz GmbH is applied over a large area of skin and for prolonged periods, systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those observed after systemic administration of diclofenac-containing medicines cannot be ruled out.
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 Diclofenac Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube after "Exp". The expiry date refers to the last day of that month.
Store below 25 °C. Do not refrigerate or freeze.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Diclofenac Sandoz GmbH contains

• The active substance is diclofenac diethylammonium. 1 gram of gel contains diclofenac as 23.2 mg of diclofenac diethylammonium, equivalent to 20 mg of sodium diclofenac.
• The other ingredients are: propylene glycol (E1520), oleic alcohol, isopropyl alcohol, butylhydroxytoluene (E321), diethylethanolamine, light liquid paraffin, macrogol cetostearyl ether, cocoyl caprylocaprate, cream fragrance 1876601 (containing hexyl benzoate, citral, eugenol) and purified water.

Description of the appearance of Diclofenac Sandoz GmbH and package contents
Diclofenac Sandoz GmbH is a white, viscous gel with a characteristic odour and a pH between 6.5 and
8.0.
The gel is packaged in a laminated aluminium tube, with an HDPE shoulder sealed with a closure and
a cap made of polypropylene.
Available pack sizes are: 50 g, 100 g, 150 g and 180 g tubes. Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer
Kern Pharma S.L.
Calle Venus 72
Poligono Industrial Colon II
08228 Terrassa Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the European Economic Area countries under the
following names:
Austria: Diclac forte Sandoz – Gel
Denmark: Diclac Forte
Estonia: Diclac
Ireland: Diclac Relief Max 2% w/w gel
Italy: Diclofenac Sandoz GmbH
Netherlands: Diclofenac Sandoz Extra sterk 2,32 %, gel
Portugal: Diclofenac Sandoz Care
Spain: Diclofenaco Sandoz Care 23,2 mg/g gel
Hungary: Titoplac 20 mg/g gel