Package leaflet: Information for the patient

Diclofenac Teva BV 20 mg/g gel

diclofenac (as diethylammonium diclofenac)
For adults and adolescents aged 14 years and older
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet

What Diclofenac Teva BV is and what it is used for
What you need to know before using Diclofenac Teva BV
How to use Diclofenac Teva BV
Possible side effects
How to store Diclofenac Teva BV
Contents of the pack and other information

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

Diclofenac Teva BV contains the active substance diclofenac, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Diclofenac Teva BV is indicated in adults and adolescents aged 14 years and older.
Adults and adolescents aged 14 years and older
For the local symptomatic treatment of pain associated with acute muscle strains, sprains, or bruises resulting from impact injuries.
In adolescents aged 14 years and older, the medicine is indicated for short-term treatment.

2. What you need to know before using Diclofenac Teva BV

Do not use Diclofenac Teva BV

if you are allergic to diclofenac or to any of the other ingredients of this medicine listed in section 6;
if you have developed breathing problems (asthma, bronchospasm), hives, nasal inflammation or swelling of the face or tongue after taking or using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (for example, ibuprofen);
on open wounds, inflamed or infected skin, on eczema or on mucous membranes;
during the last trimester of pregnancy (see "Pregnancy");
in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor before using Diclofenac Teva BV.
If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic obstructive pulmonary disease, chronic respiratory infections (particularly associated with symptoms resembling 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), local swelling of the skin or mucous membranes (so-called Quincke's edema), or hives.
In such patients, Diclofenac Teva BV 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 who may experience, for example, skin reactions, itching or hives.
When Diclofenac Teva BV is applied over a large area of skin and for prolonged periods, systemic adverse effects associated with application cannot be ruled out.
Apply Diclofenac Teva BV only to intact, healthy, unbroken skin. Avoid contact with the eyes and oral mucous membranes. The gel must not be swallowed.
After applying the gel to the skin, a permeable (non-occlusive) dressing may be used, but allow the gel to dry on the skin for a few minutes first. Occlusive dressings that do not allow air passage must not be used.
Consult your doctor if symptoms worsen or do not improve within 3–5 days.
Stop using Diclofenac Teva BV if you develop a skin rash.
Avoid exposure to sunlight, including sun lamps, while using this medicine.
Take appropriate precautions to prevent children from touching the area where the gel has been applied.

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

Other medicines and Diclofenac Teva BV
Inform your doctor or pharmacist if you are taking, have recently taken, or might take or use any other medicines.
To date, no interactions have been reported with the intended topical use of Diclofenac Teva BV.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Diclofenac Teva BV during the last trimester of pregnancy, as it may harm the unborn baby or cause complications during delivery. During the first and second trimesters of pregnancy, Diclofenac Teva BV should only be used after consulting your doctor.

Breastfeeding
During breastfeeding, Diclofenac Teva BV should only be used under medical supervision, as diclofenac is excreted in small amounts in breast milk. If you are breastfeeding, do not apply Diclofenac Teva BV to the breast or to large areas of skin for prolonged periods.

Driving and using machines
Diclofenac Teva BV does not affect or affects negligibly the ability to drive or use machinery.

Diclofenac Teva BV contains propylene glycol (E1520)
This medicine contains 54 mg of propylene glycol in 1 g of gel.

Diclofenac Teva BV contains butylated hydroxytoluene (E321)
Butylated hydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.

Diclofenac Teva BV contains fragrances
This medicine contains a fragrance with benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool, which may cause allergic reactions.
In addition, benzyl alcohol may cause mild local irritation.

3. How to use Diclofenac Teva BV

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents aged 14 years and older
Diclofenac Teva BV should be used twice daily (preferably in the morning and evening).
Depending on the size of the area to be treated, the amount of gel required varies between that of a cherry and a walnut, corresponding to 1–4 g of gel.
The maximum daily dose is 8 g of gel.
Elderly patients
No special dose adjustments are necessary. If you are elderly, you should pay particular attention to possible side effects and, if necessary, consult your doctor or pharmacist.
Hepatic or renal impairment
Dose reductions are not required.
Use in children and adolescents (under 14 years of age)
Diclofenac Teva BV is contraindicated in children and adolescents under 14 years of age (see section 2 “Do not use Diclofenac Teva BV”).
Before using the medicine for the first time, open it as follows:

Unscrew the tube cap. To open the safety seal of the tube, invert the cap and insert it into the nozzle. Do not use scissors or other sharp objects.
Twist and remove the plastic seal from the tube. Apply the gel as described in this package leaflet. Do not use the medicine if the seal is broken.

How to apply Diclofenac Teva BV
Diclofenac Teva BV is intended for topical use only.
Apply a thin layer of gel to the affected areas of the body and gently rub in until it is absorbed into the skin. Wash your hands after applying the gel, unless the hands are the area being treated.
Duration of treatment
The duration of use depends on the symptoms and underlying condition. Diclofenac Teva BV should not be used for longer than one week without consulting a doctor.
If symptoms worsen or do not improve within 3–5 days, consult your doctor.
If you use more Diclofenac Teva BV than you should
It is unlikely that an overdose will occur if you apply more Diclofenac Teva BV than recommended, since absorption into the bloodstream is low when the medicine is used on the skin. If you apply a significantly higher dose than recommended, remove the gel and rinse the area with water.
If Diclofenac Teva BV is accidentally ingested, contact your doctor. The doctor will determine the necessary measures to be taken.
If you forget to use Diclofenac Teva BV
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some rare and very rare side effects can be serious.
If you experience any of the following signs of allergy, stop using Diclofenac Teva BV and contact your doctor or pharmacist immediately:

Skin rash with blisters; hives (may affect up to 1 in 1,000 people).
Wheezing, shortness of breath, or tightness in the chest (asthma) (may affect fewer than 1 in 10,000 people).
Swelling of the face, lips, tongue, or throat (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.
Uncommon side effects (may affect up to 1 in 100 people)
Peeling, skin dryness, swelling (oedema).
Very rare side effects (may affect up to 1 in 10,000 people)
Rash with pustules, gastrointestinal disturbances, hypersensitivity reactions (including hives), photosensitivity with skin reactions following exposure to sunlight.
Side effects with unknown frequency (frequency cannot be estimated from the available data)
Burning sensation at the application site, dry skin.
When Diclofenac Teva BV is applied over a large area of skin and for prolonged periods, systemic side effects (e.g., renal, hepatic, or gastrointestinal effects, systemic hypersensitivity reactions) similar to those observed after systemic administration of diclofenac-containing medicines cannot be excluded.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at: 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 Teva BV

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. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the medicine in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Do not apply the gel shortly before taking a bath or shower.
This will help protect the environment.

6. Package contents and other information

What Diclofenac Teva BV contains

The active substance is diclofenac.
One gram contains 23.2 mg of diethylammonium diclofenac, equivalent to 20 mg of sodium diclofenac.
Excipients: isopropyl alcohol, propylene glycol (E1520), caprylic/capric triglyceride, liquid paraffin, carbomer, macrogol cetostearyl ether, diethanolamine, oleic acid, butylated hydroxytoluene, fragrance (containing citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Description of the appearance of Diclofenac Teva BV and contents of the pack
Diclofenac Teva BV is a homogeneous gel, white or almost white, packed in laminated aluminium tubes sealed with a PE seal and screw caps made of PP. It is available in the following pack sizes: 30 g, 50 g, 60 g, 100 g, 150 g and 180 g tubes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands

Manufacturer:
Merckle GmbH
Graf-Arco Strasse 3
D-89079 Ulm
Germany