DICLOX

DICLOX forte 20 mg/g Gel

Important notes (mandatory information)

Diclox forte 20 mg/g Gel. Active ingredient: Diclofenac (as diclofenac-N-ethylethanamine). Areas of application: For adults and adolescents aged 14 and over for local, symptomatic treatment of pain in acute strains, sprains or bruises resulting from blunt trauma. For adolescents aged 14 and over, the medicinal product is intended for short-term treatment.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Diclox forte 20 mg/g Gel, for adults and adolescents aged 14 and over
Active ingredient: Diclofenac (as diclofenac-N-ethylethanamine)

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 – 5 days, talk to your doctor.

What this package leaflet contains

1. WHAT IS DICLOX FORTE AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOX FORTE?
3. HOW TO USE DICLOX FORTE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DICLOX FORTE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS DICLOX FORTE AND WHAT IS IT USED FOR?

Diclox forte contains the active ingredient diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). Diclox forte is used in adults and adolescents aged 14 and over.

• For adults and adolescents aged 14 and over for local, symptomatic treatment of pain in acute strains, sprains or bruises resulting from blunt trauma.
• For adolescents aged 14 and over, the medicinal product is intended for short-term treatment.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOX FORTE?

Diclox forte must not be used:

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you have had problems with breathing (asthma, bronchospasm), hives, a runny nose or swelling of the face or tongue in the past after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug (e.g. ibuprofen).
• on open wounds, inflammation or infections of the skin as well as on eczema or mucous membranes.
• in the last trimester of pregnancy (see "Pregnancy and breast-feeding").
• in children and adolescents under 14 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Diclox forte. If you have asthma, hay fever, nasal swelling (so-called nasal polyps) or chronic bronchial obstructive (obstructive) respiratory diseases, chronic respiratory infections (especially associated with hay fever-like symptoms) or hypersensitivity to other pain relievers and anti-rheumatic drugs of all kinds, you are more at risk of asthma attacks (so-called analgesic intolerance/analgesic asthma), local skin or mucous membrane swelling (so-called Quincke's edema) or urticaria than other patients. In these patients, Diclox forte 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, such as with skin reactions, itching or hives.

If Diclox forte is applied to a large area of skin and used over a long period of time, the occurrence of systemic (affecting the entire body) side effects due to the use of Diclox forte cannot be ruled out. Diclox forte should only be applied to intact, non-diseased or injured skin. Eyes and oral mucous membranes must not come into contact with the medicine and it must not be ingested. After applying the gel to the skin, you can use a permeable (non-occlusive) dressing. However, the gel should be allowed to dry on the skin for a few minutes before applying a dressing. You must not use an airtight occlusive dressing.

See a doctor if your symptoms worsen or have not improved after 3 - 5 days. Stop treatment if a rash develops during treatment with Diclox forte. Avoid sun exposure, including solariums, when using this medicine. Care should be taken to ensure that children do not come into contact with treated areas of skin.

Children and adolescents

Diclox forte must not be used in children and adolescents under 14 years of age.

Using Diclox forte with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. No interactions have been reported to date when Diclox forte is used as directed on the skin.

Pregnancy and

breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

You must not use Diclox forte in the last trimester of pregnancy, as it could harm your unborn child or cause problems during childbirth. In the first and second trimesters of pregnancy, Diclox forte should only be used after consulting your doctor.

breast-feeding

Since diclofenac passes into breast milk in small amounts, Diclox forte should only be used during breast-feeding after consulting your doctor. If you are breast-feeding, you must not apply Diclox forte to the breast area, to large areas of skin or over a long period of time.

Driving and using machines

Diclox forte has no or negligible influence on the ability to drive and use machines.

Diclox forte contains propylene glycol (E 1520)

This medicine contains 54 mg propylene glycol per 1 g gel.

Diclox forte contains butylhydroxytoluene (Ph.Eur.) (E 321)

Butylhydroxytoluene can cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes.

Diclox forte contains fragrances

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

3. HOW TO USE DICLOX FORTE?

Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents aged 14 and over

Diclox forte should be applied twice a day (preferably in the morning and evening). Depending on the size of the affected area to be treated, a cherry- to walnut-sized amount, corresponding to 1 - 4 g of gel, is required. The maximum total 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 side effects and consult a doctor or pharmacist if necessary.

Impaired renal or hepatic function

No dose reduction is required.

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

Diclox forte must not be used in children and adolescents under 14 years of age (see section 2, "Diclox forte must not be used").

Open the tube as follows before first use:

1. Unscrew the cap from the tube. To open the safety seal, turn the cap upside down and insert it into the tube opening. Do not use scissors or other sharp objects!
2. Remove the plastic seal from the tube by turning it. Apply the gel as described in this package leaflet. If the seal is damaged, do not use the medicine.

Applying the gel:
Diclox forte is intended for use on the skin. Apply the gel thinly to the affected areas of the body and rub it gently into the skin. Wash your hands after rubbing in the gel, unless they are the area to be treated.

Duration of treatment:
The duration of use depends on the symptoms and the underlying condition. Diclox forte should not be used for longer than 1 week without medical advice. See a doctor if your symptoms worsen or have not improved after 3 - 5 days.

If you have used more Diclox forte than you should

Overdosage is unlikely if you have used more Diclox forte than you should, as absorption into the bloodstream is low when applied to the skin. If the recommended dose is significantly exceeded when applied to the skin, the gel should be removed and washed off with water. If Diclox forte is accidentally swallowed, contact your doctor, who will decide on appropriate measures.

If you forget to use Diclox forte

Do not use double the amount if you have forgotten the previous application.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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 notice any of the following signs of an allergy, stop using Diclox forte and contact a doctor or pharmacist immediately:

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

Other possible side effects are:

Common side effects (can affect up to 1 in 10 people treated)

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

Uncommon side effects (can affect up to 1 in 100 people treated)

Scaling, dry skin, swelling (edema).

Very rare side effects (can affect up to 1 in 10,000 people treated)

Pustular skin rash, gastrointestinal upset, hypersensitivity reactions (including hives), photosensitivity with skin reactions after exposure to light (photosensitization).

Frequency of side effects not known (frequency cannot be estimated from the available data)

Burning at the site of application, dry skin.

If Diclox forte is applied to a large area of skin and used over a long period of time, the occurrence of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions), as may occur after systemic use of diclofenac-containing medicines, cannot be completely ruled out.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DICLOX FORTE?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the tube. The expiry date refers to the last day of the month indicated. Store in the original tube to protect the contents from light. No special temperature storage conditions are required for this medicine. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This will help to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Diclox forte contains

The active ingredient is diclofenac. 1 g contains 23.2 mg diclofenac-N-ethylethanamine, corresponding to 20 mg diclofenac sodium. The other ingredients are: Carbomer 974P, cocoyl caprylocaprat (Ph.Eur.), macrogol cetylstearyl ether (Ph.Eur.) (22 EO units), liquid paraffin, N-ethylethanamine, 2-propanol (Ph.Eur.), propylene glycol (E 1520), oleic acid (E 570), butylhydroxytoluene (Ph.Eur.) (E 321), perfume oil (contains citronellol, geraniol, benzyl alcohol, linalool, D-limonene, citral, farnesol, coumarin, eugenol), purified water.

What Diclox forte looks like and contents of the pack

Diclox forte is a white to off-white, homogeneous gel, available in laminated aluminium tubes sealed with a PE seal and a PP screw cap.

Pack sizes

Tubes containing 30 g, 50 g, 60 g, 100 g, 150 g, 180 g gel. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer
Merckle GmbH

Business address

Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany

This package leaflet was last revised in July 2020.

Source: Information from the package leaflet
Status: 07/2021
Active ingredient: Diclofenac (as diclofenac-N-ethylethanamine). Areas of application: For adults and adolescents aged 14 and over for local, symptomatic treatment of pain in acute strains, sprains or bruises resulting from blunt trauma. For adolescents aged 14 and over, the medicinal product is intended for short-term treatment.