DICLO BETA

DICLO BETA Schmerzgel

Important notes (mandatory information)

Diclo beta Schmerzgel 10 mg/g Gel. Active ingredient: Diclofenac sodium.

Area of application for adults

For external symptomatic treatment of pain in acute strains, sprains or bruises resulting from blunt trauma, e.g. sports and accident injuries; of the soft tissues near the joints (e.g. bursa, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of the knee and finger joints; in tendonitis in the elbow area, often called tennis elbow (epicondylitis) and in acute muscle pain, e.g. in the back area.

Area of application for adolescents over 14 years of age

For short-term treatment for local, symptomatic treatment of pain in acute bruises, strains or sprains resulting from blunt trauma.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Diclo beta Schmerzgel 10 mg/g Gel for adults and adolescents from 14 years of age
Active ingredient: Diclofenac sodium

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 directed by your doctor or pharmacist.

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

What this package leaflet contains

1. WHAT IS DICLO BETA SCHMERZGEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING DICLO BETA SCHMERZGEL?
3. HOW TO USE DICLO BETA SCHMERZGEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DICLO BETA SCHMERZGEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS DICLO BETA SCHMERZGEL AND WHAT IS IT USED FOR?

Diclo beta Schmerzgel is a pain-relieving medicine with the active ingredient diclofenac from the group of non-steroidal anti-inflammatory/analgesic drugs (anti-inflammatory pain relievers).

Area of application for adults

For external symptomatic treatment of pain:

• in acute strains, sprains or bruises resulting from blunt trauma, e.g. sports and accident injuries;
• of the soft tissues near the joints (e.g. bursa, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of the knee and finger joints;
• in tendonitis in the elbow area, often called tennis elbow (epicondylitis);
• in acute muscle pain, e.g. in the back area.

Area of application for adolescents over 14 years of age

For short-term treatment for local, symptomatic treatment of pain in acute bruises, strains or sprains resulting from blunt trauma.

2. WHAT SHOULD YOU CONSIDER BEFORE USING DICLO BETA SCHMERZGEL?

Diclo beta Schmerzgel 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 reacted to acetylsalicylic acid or another non-steroidal anti-inflammatory drug (e.g. ibuprofen) in the past with breathing problems (asthma, bronchospasm), skin reactions (hives), runny nose or swelling of the face or tongue. If you are not sure, ask your doctor or pharmacist.
• on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes. Eyes and mucous membranes must not come into contact with the preparation. Care should be taken that the hands do not come into contact with the skin areas rubbed with Diclo beta Schmerzgel.
• over a long period of time and over a large area during breastfeeding.
• in the last trimester of pregnancy.
• in children and adolescents under 14 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Diclo beta Schmerzgel. If Diclo beta Schmerzgel is applied over a large area of the skin and used over a long period of time, the occurrence of side effects that affect a specific organ system or even the entire organism cannot be ruled out. These side effects are comparable to those that may occur under certain circumstances when taking other medicines containing diclofenac. Do not use Diclo beta Schmerzgel for a long period of time or in higher doses than indicated without medical advice.

Diclo beta Schmerzgel should only be applied to intact, non-diseased or injured skin and not to open wounds. Eyes and oral mucous membranes must not come into contact with the medicine and it must not be taken. If Diclo beta Schmerzgel gets into your eyes, rinse them thoroughly with water. Consult your doctor or pharmacist if the symptoms persist. You can use a bandage, but not an occlusive bandage (tightly closing bandage). Before applying a bandage, Diclo beta Schmerzgel should dry on the skin for a few minutes.

Special care is required when using it in acute conditions associated with severe redness, swelling or overheating of the joints. If joint pain persists or if severe back pain radiates into the legs and/or is associated with neurological symptoms (e.g. numbness, tingling), a doctor should be consulted.

If symptoms do not improve or worsen after 3 to 5 days, you should see a doctor. If you suffer from asthma, hay fever or nasal mucosal swelling (so-called nasal polyps) or chronic bronchoconstrictive (obstructive) respiratory diseases, chronic respiratory infections (especially coupled with hay fever-like symptoms) or hypersensitivity to other pain and rheumatic drugs of all kinds, you are more at risk of asthma attacks (so-called analgesic intolerance/analgesic asthma), local skin or mucosal swelling (so-called Quincke's edema) or urticaria when using Diclo beta Schmerzgel than other patients. In this case, Diclo beta Schmerzgel may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies to patients who are also hypersensitive (allergic) to other substances, such as with skin reactions, itching or hives. If a rash occurs during treatment with Diclo beta Schmerzgel, discontinue treatment. Photosensitivity with skin reactions after exposure to light may occur during treatment. Care should be taken to ensure that children do not come into contact with rubbed skin areas with their hands.

Children and adolescents

Diclo beta Schmerzgel must not be used in children and adolescents under 14 years of age.

Use of Diclo beta Schmerzgel together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions have been reported to date with the intended external application of Diclo beta Schmerzgel.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, 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

In the first and second trimesters of pregnancy, Diclo beta Schmerzgel should only be used after consulting a doctor. You must not use Diclo beta Schmerzgel in the last trimester of pregnancy, as there is an increased risk of complications for the mother and child.

breastfeeding

Diclofenac passes into breast milk in small amounts. Diclo beta Schmerzgel should only be used during breastfeeding after consulting a doctor. In this case, the medicine should not be applied to the breast area or over a long period of time to other large areas of skin.

Driving and operating machinery

Diclo beta Schmerzgel has no or negligible influence on the ability to drive and use machines.

Diclo beta Schmerzgel contains propylene glycol

This medicine contains 50 mg propylene glycol per 1 g gel.

3. HOW TO USE DICLO BETA SCHMERZGEL?

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

Age Single dose Total daily dose
Adults and adolescents from 14 years of age Depending on the size of the painful area to be treated, a cherry- to walnut-sized amount, corresponding to 1 - 4 g gel (10 - 40 mg diclofenac sodium), is required. The maximum daily dose is 16 g gel (corresponding to 160 mg diclofenac sodium).

Unless otherwise prescribed by your doctor, Diclo beta Schmerzgel should be applied 3 to 4 times a day. If symptoms do not improve or worsen after 3 - 5 days, a doctor should be consulted.

Please talk to your doctor or pharmacist if you have the impression that the effect of Diclo beta Schmerzgel is too strong or too weak.

Elderly patients

No special dose adjustment is required. However, elderly people should pay particular attention to side effects when using it and, if necessary, consult their doctor or pharmacist.

Impaired renal or hepatic function

No dose reduction is required.

Children and adolescents (under 14 years of age)

There is insufficient data on the efficacy and tolerability in children and adolescents under 14 years of age (see section 2. "Diclo beta Schmerzgel must not be used").

Adolescents (from 14 years of age)

In adolescents aged 14 years and older, the patient/parents are advised to see a doctor if symptoms worsen.

Method of application

Diclo beta Schmerzgel is for external use only. Do not ingest! Apply Diclo beta Schmerzgel thinly to the affected area of the body and rub in gently. It should not be rubbed in with pressure. Afterwards, the hands should be wiped on a paper towel and then washed, unless they are the area to be treated. The paper towel should be disposed of in the residual waste. Before applying a bandage, Diclo beta Schmerzgel should dry on the skin for a few minutes. Use Diclo beta Schmerzgel only on unbroken skin. Open wounds, inflammations or infections of the skin as well as eyes and mucous membranes must not come into contact with the medicine. Care should be taken that the hands do not come into contact with the skin areas rubbed with Diclo beta Schmerzgel.

Duration of use

As a rule, a period of use of 1 - 3 weeks is sufficient, depending on the symptoms and the underlying disease. Do not use more Diclo beta Schmerzgel than necessary and only for the minimum necessary period of use.

If you have used more Diclo beta Schmerzgel than you should

Due to the low absorption of diclofenac into the entire organism with limited application to the skin, an overdose is unlikely. If the recommended dosage is significantly exceeded when applied to the skin, the gel should be removed (e.g. with a paper towel) and washed off with water. In the event of accidental ingestion (e.g. also in children) of Diclo beta Schmerzgel, please contact your doctor immediately, who will decide on appropriate measures.

If you forget to use Diclo beta Schmerzgel

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 have side effects, although not everybody gets them. The following side effects can have serious consequences, stop using Diclo beta Schmerzgel and see your doctor as soon as possible

Rare side effects (may affect up to 1 in 1,000 people):

• skin inflammation with blistering (bullous dermatitis).

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

• wheezing, shortness of breath or tightness in the chest (asthma).
• swelling of the face, lips, tongue or throat (angioedema).

Other side effects are possible

Common side effects (may affect up to 1 in 10 people):

• rash, eczema, skin redness (erythema), dermatitis (including contact dermatitis), itching (pruritus).

Uncommon side effects (may affect up to 1 in 100 people):

• scaling, drying of the skin, swelling (edema).

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

• pustular skin rash.
• gastrointestinal disorders.
• hypersensitivity reactions (including hives).
• photosensitivity with skin reactions after exposure to light (photosensitization).

If Diclo beta Schmerzgel is applied over a large area of the 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 under certain circumstances after systemic use of medicines containing diclofenac, cannot be ruled out. If you notice or suspect any of the above side effects, stop using Diclo beta Schmerzgel and inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, 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 DICLO BETA SCHMERZGEL?

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 tube after "use by". The expiry date refers to the last day of the month indicated.

Note on shelf life after opening

The medicine can be stored for 1 year after opening.

This medicinal product does not require any special storage conditions. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Diclo beta Schmerzgel contains

The active ingredient is diclofenac sodium 10 mg in 1 g gel. The other ingredients are: Purified water, 2-propanol (Ph. Eur.), propylene glycol, medium-chain triglycerides, liquid paraffin, cetomacrogol 1000, carbomer 974 P, N-ethylethanamine.

What Diclo beta Schmerzgel looks like and contents of the pack

Whitish gel in aluminium tubes with plastic screw cap. Packs of 50 g and 100 g gel. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Phone 0821 748810
Fax 0821 74881420

Manufacturer

C.P.M. Contract Pharma GmbH
Frühlingstraße 7
83620 Feldkirchen-Westerham

This leaflet was last revised in March 2021.

Source: Information from the package leaflet
Status: 11/2021
Active ingredient: Diclofenac sodium. Area of application for adults: For external symptomatic treatment of pain in acute strains, sprains or bruises resulting from blunt trauma, e.g. sports and accident injuries; of the soft tissues near the joints (e.g. bursa, tendons, tendon sheaths, ligaments, muscle insertions and joint capsules) in osteoarthritis of the knee and finger joints; in tendonitis in the elbow area, often called tennis elbow (epicondylitis) and in acute muscle pain, e.g. in the back area. Area of application for adolescents over 14 years of age: For short-term treatment for local, symptomatic treatment of pain in acute bruises, strains or sprains resulting from blunt trauma.