Diclofenac Sandoz Care 23.2 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Diclofenac Sandoz Care 23.2 mg/g gel

diclofenac diethylamine

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

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

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

3. How to use Diclofenac Sandoz Care

4. Possible side effects

5. How to store Diclofenac Sandoz Care

6. Contents of the pack and other information

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

Diclofenac Sandoz Care contains the active substance diclofenac diethylamine, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Diclofenac is used in adults and adolescents from 14 years of age:

for the treatment of mild to moderate pain associated with muscular and joint injuries, such as sports injuries.

This medicine is intended for short-term treatment only.

2. What you need to know before starting to use Diclofenac Sandoz Care

Do not use Diclofenac Sandoz Care:

• if you are allergic to
• diclofenac,
• other medicines used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (a substance also used to prevent blood clotting), or
• any of the other components 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; nasal discharge.

If you are unsure, 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

Consult your doctor or pharmacist before starting to use diclofenac if:

You are more likely than other patients to experience asthma attacks (so-called analgesic intolerance/analgesic-induced asthma), local skin or mucosal inflammation (so-called Quincke's edema), or hives if you suffer from asthma, hay fever, nasal mucosa inflammation (so-called nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially associated with symptoms typical of hay fever), or hypersensitivity to other analgesic and anti-rheumatic medicines of any kind.

In these patients, diclofenac may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies to patients who are also allergic to other substances, e.g., with skin reactions, pruritus, or hives.

When diclofenac is applied over a large area of skin and for prolonged periods, systemic side effects resulting from the application of diclofenac cannot be ruled out.

Apply diclofenac only to intact, healthy, and undamaged skin. Avoid contact with eyes and oral mucous membranes. The gel must not be ingested orally.

After applying the gel to the skin, you may use a permeable (non-occlusive) dressing, but allow the gel to dry on the skin for several minutes first. Do not use an airtight occlusive dressing.

If symptoms worsen or do not improve within 7 days, consult a doctor.

The use of diclofenac should be discontinued if you develop a skin rash.

Avoid exposure to sunlight, including sunbeds, while using this medicine.

Ensure children do not touch the area where the gel has been applied.

Children and adolescents

Diclofenac is contraindicated in children and adolescents under 14 years of age.

Other medicines and Diclofenac Sandoz Care

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions are known to date with the intended topical use of diclofenac.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 if you are in the last 3 months of pregnancy. Diclofenac should not be used during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is required during this period, the lowest dose for the shortest possible duration should be used.

Oral formulations (e.g., tablets) of diclofenac may cause adverse effects on the fetus. It is unknown whether the same risk applies to diclofenac when used topically on the skin.

Breastfeeding

Diclofenac should only be used under medical advice during breastfeeding, as diclofenac passes into breast milk in small amounts. Do not apply diclofenac to the breasts if you are breastfeeding, or to other large areas of skin or for prolonged periods.

Driving and use of machines

Diclofenac has no or negligible influence on the ability to drive or operate machinery.

Effects of other ingredients (excipients)

Diclofenac Sandoz Care contains:

• 50 mg of propylene glycol (E1520) in each gram of gel, which may cause skin irritation,
• 0.2 mg of butylated hydroxytoluene (E321) in each gram of gel, which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes,
• up to 0.01 mg of hexyl benzoate in each gram of gel, which may cause local irritation,
• fragrance containing citral and eugenol, which may cause allergic reactions. In addition to allergic reactions in sensitized patients, non-sensitized patients may become sensitized.

3. How to use Diclofenac Sandoz Care

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents aged 14 years and older

Diclofenac is used twice daily (preferably in the morning and at night).

Depending on the size of the affected area to be treated, an amount the size of a cherry to a walnut is required, corresponding to 2–4 g of gel.

The maximum daily dose is 8 g of gel.

Elderly patients

No special dose adjustment is necessary. If you are an elderly patient, you should pay particular attention to possible side effects and, if necessary, consult a doctor or pharmacist.

Renal and hepatic impairment

Dose reduction is not required.

Use in children and adolescents (under 14 years of age)

This medicine is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use Diclofenac Sandoz Care”).

Instructions for use

Before first use, remove the plastic seal from the tube. Do not use if the seal is broken.

Diclofenac is for topical use only (must only be applied to the skin).

Apply the gel to the affected areas of the body in a thin layer and gently rub it into the skin. Afterwards, wipe your hands with a paper towel and then wash them, unless the hands are the area being treated.

If too much gel is accidentally applied, wipe off the excess with a paper towel.

Dispose of the paper towel in household waste to prevent unused product from entering the aquatic environment.

Allow the gel to dry for a few minutes on the skin before applying a dressing.

Duration of treatment

The duration of treatment depends on the symptoms and the underlying condition.

This medicine should not be used for more than 7 days without medical advice.

If symptoms worsen or do not improve after 7 days, consult a doctor.

If you use more Diclofenac Sandoz Care than you should

Overdose is unlikely if you use more diclofenac than you should, as absorption into the bloodstream is low when used topically. However, if the recommended dose is significantly exceeded during topical use, the gel should be removed and the skin washed with water.

If you accidentally ingest this medicine, contact your doctor immediately.

If you forget to use Diclofenac Sandoz Care

If you miss a dose, apply it as soon as possible. Do not use a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some rare and very rare side effects can be serious.

If you experience any of the following signs of allergy, stop using diclofenac and inform your doctor or pharmacist immediately:

• Blistering rash; hives (rare: may affect up to 1 in 1,000 people).
• Wheezing, difficulty breathing, or tightness in the chest (asthma) (very rare: may affect up to 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 possible adverse effects:

Frequent adverse effects (may affect up to 1 in 10 people):

• Skin rash, itching, redness, eczema, dermatitis (skin inflammation), including contact dermatitis.

Very rare side effects (may affect up to 1 in 10,000 people):

• Pustular eruption.
• Hypersensitivity reactions (including hives).
• Photosensitivity with skin reactions appearing after exposure to sunlight.

When diclofenac is applied over a large area of skin and for a prolonged period, the possibility of systemic adverse effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) cannot be completely ruled out, as may occur with systemic administration of medicines containing diclofenac.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diclofenac Sandoz Care

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 CAD/EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C. Do not refrigerate or freeze.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Diclofenac Sandoz Care

• The active substance is diethylamine diclofenac. 1 gram of gel contains 23.2 mg of diethylamine diclofenac, equivalent to 20 mg of sodium diclofenac.
• The other components are: propylene glycol (E1520), oleyl alcohol, isopropyl alcohol, butylhydroxytoluene (E321), diethylamine, light liquid paraffin, macrogol cetostearyl ether, carbomer 980 F, cocoyl caprylocaprate, perfume cream 1876601 (containing hexyl benzoate, citral, eugenol) and purified water.

Appearance of the product and contents of the package

Diclofenac Sandoz Care is a white, viscous gel with a characteristic fragrance and a pH between 6.5 and 8.0.

The gel is presented in an aluminum laminated tube with a high-density polyethylene liner, sealed with a tamper-evident closure and a polypropylene cap.

Package sizes: 50 g, 100 g, 150 g and 180 g tubes.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Kern Pharma, S.L.

Venus 72

Polígono Ind. Colón II

08228 Terrassa

Barcelona

Spain

or

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Date of the most recent review of this leaflet: February 2025.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/