Diclofenac diethilamine Teva

Leaflet accompanying the packaging: patient information

Diclofenac diethylamine Teva, 10 mg/g, gel

Diclofenac sodium
(in the form of Diclofenac diethylammonium)
For use in adults and adolescents from 14 years of age

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

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• 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 any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3-5 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 diethylamine Teva and what is it used for
• 2. Important information before using Diclofenac diethylamine Teva
• 3. How to use Diclofenac diethylamine Teva
• 4. Possible side effects
• 5. How to store Diclofenac diethylamine Teva
• 6. Contents of the pack and other information

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

Diclofenac diethylamine Teva contains the active substance diclofenac, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Diclofenac diethylamine Teva is indicated for use in adults and adolescents from 14 years of age.

Adults

Local symptomatic treatment of pain:

• in acute strains, sprains or bruises caused by blunt trauma
• to soft tissues in the joint areas (e.g. capsules, tendons, tendon sheaths, ligaments, muscle attachments, and joint capsules) in degenerative joint disease of the knee and finger joints;
• in lateral epicondylitis of the humerus (epicondylitis, also known as tennis elbow or golfer's elbow);
• in acute muscle pain, e.g. back pain.

Adolescents from 14 years of age

For short-term treatment.
For local symptomatic treatment of pain in acute strains, sprains or bruises caused by blunt trauma.

2. Important information before using Diclofenac diethylamine Teva

When not to use Diclofenac diethylamine 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 breathing difficulties (asthma, bronchospasm), skin reactions (e.g. urticaria), or nasal congestion or swelling of the face or tongue after taking or using medicines containing acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g. ibuprofen);
• on open wounds, inflammatory or infected skin lesions, as well as on skin with eczema and mucous membranes;
• in the last trimester of pregnancy; see section "Pregnancy";
• in children and adolescents under 14 years of age.

Warnings and precautions

Before starting treatment with Diclofenac diethylamine Teva, the patient should discuss it with their doctor or pharmacist:
if the patient has a higher than average risk of asthma attacks (so-called analgesic asthma), local skin or mucous membrane swelling (Quincke's edema) or urticaria if the patient has asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease, chronic respiratory infections (especially those associated with symptoms typical of hay fever) or if the patient is hypersensitive to other painkillers and various anti-rheumatic drugs.
In these patients, Diclofenac diethylamine Teva may only be used with certain precautions (be prepared for sudden reactions) and under direct medical supervision. The same applies to patients with allergies to other substances, e.g. skin reactions, itching or urticaria.
If Diclofenac diethylamine Teva is used on large areas of skin or for a long time, it cannot be ruled out that systemic side effects may occur.
Diclofenac diethylamine Teva should only be used on intact, undamaged, and non-diseased skin. Contact with the eyes and mucous membranes of the mouth should be avoided. The gel should not be used orally.
After applying the gel to the skin, a breathable (non-occlusive) bandage can be used, but you should wait a few minutes until the gel dries on the skin. Do not use occlusive dressings.
In case of use in acute conditions with severe redness, swelling, or overheating of the joints, in cases of prolonged joint pain or severe back pain radiating to the legs and (or) associated with neurological disorders (e.g. numbness or tingling), consult a doctor.
In case of worsening symptoms or lack of improvement within 3-5 days of use, consult a doctor.
In case of skin rash, treatment with Diclofenac diethylamine Teva should be discontinued.
During use of this medicine, avoid exposure to sunlight, including sunbeds.
Measures should be taken to prevent children from coming into contact with the skin to which the gel has been applied.

Children and adolescents

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

Diclofenac diethylamine Teva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
To date, no interactions have been found when using Diclofenac diethylamine Teva topically as recommended.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Do not useDiclofenac diethylamine Teva in the last trimester of pregnancy, as it may have a harmful effect on the fetus or cause difficulties during delivery. During the first and second trimesters of pregnancy, Diclofenac diethylamine Teva should only be used after consulting a doctor.
Breastfeeding
Diclofenac diethylamine Teva may be used during breastfeeding only on the advice of a doctor, as diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breast area in breastfeeding women, or to large areas of skin or for extended periods.

Driving and using machines

Using Diclofenac diethylamine Teva does not affect, or has negligible effect on, the ability to drive or operate machinery.

Diclofenac diethylamine Teva contains propylene glycol (E1520)

This medicine contains 50 mg of propylene glycol in 1 g of gel.

Diclofenac diethylamine Teva contains fragrances

This medicine contains a fragrance composition, which includes benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalol – these substances may cause allergic reactions. Additionally, benzyl alcohol may cause local, mild irritation.

3. How to use Diclofenac diethylamine Teva

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Adults and adolescents from 14 years of age

Diclofenac diethylamine Teva should be used 3-4 times a day.
Depending on the size of the area to be treated, apply 1g to 4g of gel, i.e. an amount corresponding to the size of a cherry to a walnut.
The maximum daily dose is 16g of gel.

Elderly patients

No special dose adjustment is necessary. Elderly patients should pay particular attention to side effects and consult a doctor or pharmacist if necessary.

Renal or hepatic impairment

Dose reduction is not required.

Use in children and adolescents under 14 years of age

Diclofenac diethylamine Teva is contraindicated in children and adolescents under 14 years of age (see section 2 "When not to use Diclofenac diethylamine Teva").

Before first use, open as follows

• 1. Unscrew the cap from the tube. To remove the protective membrane from the tube, pierce it with the reverse side of the cap. Do not use scissors or other sharp objects!
• 2. Twist and remove the plastic sealing ring from the tube. Use the gel as described in this leaflet. If the ring is broken, do not use the gel.

How to use the medicine

Diclofenac diethylamine Teva is intended for use on the skin.
Apply a thin layer of gel to the affected area of the body and gently massage into the skin. Then wash your hands, unless they are the area being treated.

Treatment duration

The duration of treatment depends on the symptoms and underlying disease. Diclofenac diethylamine Teva should not be used for more than 1 week without consulting a doctor.
In case of worsening symptoms or lack of improvement within 3-5 days of use, consult a doctor.

Using more than the recommended dose of Diclofenac diethylamine Teva

Overdose of Diclofenac diethylamine Teva is unlikely due to its low absorption into the bloodstream when used topically. If the recommended dose is significantly exceeded, the gel should be removed from the skin and the skin rinsed with water.
In case of accidental ingestion of Diclofenac diethylamine Teva, contact a doctor, who will advise on the appropriate course of action.

Missing a dose of Diclofenac diethylamine Teva

Do not use a double dose to make up for a missed dose.
In case of doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects are rare or very rare but can be serious.

If any of the following symptoms occur, which may be symptoms of an allergic reaction, stop using Diclofenac diethylamine Teva immediately and contact a doctor or pharmacist.

• Bullous skin rash; urticaria (may affect up to 1 in 1,000 people).
• Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in 10,000 people).
• Swelling of the face, lips, tongue, or throat (may affect up to 1 in 10,000 people).

Other possible side effects:
Common side effects(may affect up to 1 in 10 people):
Skin rash, itching, redness, eczema, skin inflammation, including contact dermatitis.
Uncommon side effects(may affect up to 1 in 100 people):
Peeling skin, dry skin, swelling.
Rare side effects(may affect up to 1 in 10,000 people)
Papular rash, gastrointestinal disorders, hypersensitivity reactions (including urticaria), hypersensitivity to light with skin reactions after exposure to sunlight.
Frequency not known(frequency cannot be estimated from the available data):
Burning sensation at the site of application, skin dryness.
In case of using Diclofenac diethylamine Teva on large areas of skin or for a long time, it cannot be ruled out that systemic side effects may occur (e.g. unwanted effects on the gastrointestinal tract, liver, or kidneys, systemic hypersensitivity reactions), which may occur after systemic use of medicines containing diclofenac.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 this medicine.

5. How to store Diclofenac diethylamine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.
Store in the original tube to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Do not apply the gel shortly before bathing. This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac diethylamine Teva contains

• The active substance is diclofenac.
• 1g contains 11.6mg of diclofenac diethylammonium, which corresponds to 10mg of diclofenac sodium.
• Other ingredients are: carbomer, cetearyl alcohol, macrogol cetostearyl ether, liquid paraffin, diethylamine, isopropyl alcohol, propylene glycol (E1520), fragrance (containing citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, and eugenol), purified water.

What Diclofenac diethylamine Teva looks like and contents of the pack

Diclofenac diethylamine Teva is a homogeneous gel, white to almost white in color, packaged in aluminum-laminated tubes with PE sealing rings and PP caps, in a cardboard box. Pack sizes: tubes of 30g, 50g, 60g, 100g, 120g, 150g.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands
Phone: (22) 345 93 00
Manufacturer
Merckle GmbH
Graf-Arco-Str.3
89079 Ulm
Germany

Date of last revision of the leaflet: