Diclofenac Teva

Leaflet attached to the packaging: information for the user

Diclofenac Teva, 10 mg/g (1%), gel

Diclofenac sodium

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet, or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Diclofenac Teva and what is it used for
• 2. Important information before using Diclofenac Teva
• 3. How to use Diclofenac Teva
• 4. Possible side effects
• 5. How to store Diclofenac Teva
• 6. Contents of the pack and other information

1. What is Diclofenac Teva and what is it used for

Diclofenac Teva is a colorless gel for application to the skin. The gel should not be rubbed in, but rather allowed to be absorbed. The active substance of the medicine, diclofenac, belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Diclofenac Teva also has a soothing and cooling effect.

Diclofenac Teva is indicated for use in adults and adolescents over 14 years of age.

The product has analgesic, anti-inflammatory, and anti-edematous effects.

It is used for local treatment of:

Adults and adolescents over 14 years of age:

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., due to sprains, strains, or bruises)
• back pain
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.

Adults (over 18 years of age)

• mild and limited forms of osteoarthritis

2. Important information before using Diclofenac Teva

When not to use Diclofenac Teva

• if the patient is hypersensitive to diclofenac or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever had an allergic reaction (e.g., rash, difficulty breathing, or coughing fit) after using medicines containing acetylsalicylic acid, ibuprofen, or other medicines used to treat joint and muscle pain
• if the patient is in the last three months of pregnancy
• in children and adolescents under 14 years of age.

When to exercise special caution when using Diclofenac Teva

• the gel should not be applied to damaged skin, open wounds, or eczema
• contact between the gel and the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed with clean water and medical attention should be sought
• the gel should not be ingested
• contact between the gel and mucous membranes (e.g., the mouth) should be avoided.

Systemic side effects cannot be ruled out when using Diclofenac Teva on large areas of skin or for prolonged periods. Caution should be exercised when using the medicine in patients with active gastric or duodenal ulcers, severe liver or kidney impairment, especially if long-term use is necessary.

Treatment should be discontinued if a rash develops after using the medicine.

The medicine should not be used under occlusive dressings.

The duration of treatment depends on the indications and the patient's response to treatment.

In adults and adolescents over 14 years of age, in the case of strains and soft tissue rheumatism, the medicine should not be used for more than 14 days without consulting a doctor.

In adults (over 18 years of age) with osteoarthritis-related pain, the medicine should not be used for more than 21 days without consulting a doctor, unless otherwise advised by the doctor.

Medical supervision is recommended after 7 days of using the gel if there is no improvement or if the symptoms worsen.

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

There is insufficient data on the efficacy and safety of using the medicine in children and adolescents under 14 years of age.

Use in adolescents (over 14 years of age)

In adolescents over 14 years of age, if the medicine needs to be used for more than 7 days to treat pain or if the symptoms worsen, the patient should consult a doctor.

Diclofenac Teva and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Diclofenac Teva should not be used during the last three months of pregnancy. During the first six months of pregnancy, the medicine should not be used unless it is necessary and advised by a doctor. If use is necessary, the smallest dose should be given for the shortest possible time.

After oral administration of diclofenac-containing medicines (e.g., tablets), side effects may occur in the unborn child. It is not known whether the same risk applies to Diclofenac Teva when used on the skin.

Breastfeeding

The use of Diclofenac Teva is not recommended during breastfeeding. If there is a justified need to use the medicine during lactation, it should not be applied to the breast or large areas of skin, or used for prolonged periods.

Driving and using machines

Using the medicine does not affect the ability to drive or operate machinery.

3. How to use Diclofenac Teva

Diclofenac Teva should be applied locally to the skin three or four times a day.

The amount of gel should be adjusted according to the size of the affected area: 2 g to 4 g of Diclofenac Teva (an amount equivalent to the size of a cherry or a walnut) is sufficient to treat an area of approximately 400 cm² to 800 cm². After applying the gel, the hands should be washed unless they are the area being treated.

Method of administration

Diclofenac Teva is intended for use on the skin only.

A thin layer of gel should be applied to the affected area and gently massaged into the skin. After applying the medicine, the hands should be wiped with a paper towel and then washed, unless the hands are the area being treated.

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

The used paper towel should be disposed of in a household waste bin to prevent the unused medicine from entering the water environment.

Before applying a bandage, wait a few minutes for the gel to dry on the skin.

To improve the absorption of the active substance, hydroxypropyl cellulose has been used in the medicine, which leaves a thin film on the skin when drying.

Do notuse the medicine for longer than:

• in adults and adolescents over 14 years of age: 14 days in the case of strains and soft tissue rheumatism,
• in adults (over 18 years of age): 21 days in the case of osteoarthritis-related pain, unless otherwise advised by the doctor.

If the pain and swelling do not improve within 7 days or worsen, the patient should consult their doctor.

Using a higher dose of Diclofenac Teva than recommended

The patient should immediately consult their doctor if they use more Diclofenac Teva than recommended or accidentally ingest the medicine.

Missing a dose of Diclofenac Teva

The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about using the medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Diclofenac Teva can cause side effects, although not everybody gets them.

Some side effects are rare or very rare and may be serious.

If any of the following symptoms occur, which may be signs of an allergic reaction, the patient should stop using the medicine immediately, consult their doctor, or go to the nearest hospital:

• Bullous skin rash; urticaria. These symptoms may occur in less than 1 in 1,000 people. (Rare)
• Asthma, facial, lip, tongue, or laryngeal edema. These symptoms may occur in less than 1 in 10,000 people. (Very rare)

Other side effects

Other side effects that may occur when using Diclofenac Teva are usually mild, harmless, and temporary. If the patient experiences any of the following symptoms, they should inform their doctor or pharmacist as soon as possible:

• Skin rash, itching, redness, or burning of the skin are commonly observed after using the medicine. These symptoms may occur in no more than 1 in 10 people.
• Very rarely, increased skin sensitivity to sunlight may occur. Symptoms of photosensitivity are sunburn with itching, edema, and blisters. These symptoms may occur in less than 1 in 10,000 people.
• Burning sensation at the application site, dry skin. The frequency of these symptoms is unknown and cannot be estimated from the available data.

After local application of diclofenac, systemic absorption is very low compared to the concentration of the active substance in the blood after oral administration. The likelihood of systemic side effects (such as gastrointestinal disorders, liver or kidney function disorders, bronchospasm) is therefore very low after local application compared to the frequency of side effects associated with oral diclofenac administration. Nevertheless, if diclofenac is applied to large areas of skin and for prolonged periods, systemic side effects may occur.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Diclofenac Teva

The medicine should be kept out of the sight and reach of children.

There are no special precautions for storing the medicine.

Diclofenac Teva should not be used after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac Teva contains

• The active substance of the medicine is diclofenac sodium.
• The other ingredients of the medicine are diisopropyl adipate, hydroxypropyl cellulose, lactic acid, sodium metabisulfite, isopropyl alcohol, purified water. 1 g of gel contains 10 mg of diclofenac sodium and excipients

What Diclofenac Teva looks like and contents of the pack

Diclofenac Teva is a colorless, transparent gel with a characteristic odor, available in tubes of 40 g and 100 g.

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Tel: +48 223459300

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Date of last revision of the leaflet: