DOC IBUPROFEN

DOC IBUPROFEN Pain Gel 5%

Important notes (mandatory information)

doc Ibuprofen Schmerzgel, 5% gel.

Indications

for sole or supportive external treatment of swelling or inflammation of soft tissue near the joints (e.g. bursa, tendons, tendon sheaths, ligaments and joint capsule) and/or sports and accident injuries such as bruises, sprains, strains. Warning: Contains fragrances with benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, D-limonene and linalool.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

doc Ibuprofen Schmerzgel, 5% gel

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, talk to your doctor.

What this package leaflet contains

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

1. WHAT IS DOC IBUPROFEN SCHMERZGEL AND WHAT IS IT USED FOR?

doc Ibuprofen Schmerzgel is an analgesic and anti-inflammatory medicine for rubbing into the skin.

Indications

For sole or supportive external treatment of swelling or inflammation of soft tissue near the joints (e.g. bursa, tendons, tendon sheaths, ligaments and joint capsule) and/or sports and accident injuries such as bruises, sprains, strains.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOC IBUPROFEN SCHMERZGEL

doc Ibuprofen Schmerzgel must not be used:

• if you are allergic to ibuprofen, dimethyl isosorbide, benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, D-limonene, linalool, other painkillers and anti-rheumatics (non-steroidal anti-inflammatory drugs) or any of the other ingredients of this medicine listed in section 6.
• on open wounds, inflammation or infections of the skin as well as on eczema or on mucous membranes.
• under airtight dressings.
• in the last trimester of pregnancy.

Warnings and precautions

Please talk to your doctor or pharmacist before using doc Ibuprofen Schmerzgel:

• if you suffer from asthma, hay fever, nasal mucosa swelling (so-called nasal polyps), chronic obstructive airway diseases or chronic respiratory tract infections (especially coupled with hay fever-like symptoms) or have a hypersensitivity to painkillers and anti-rheumatics of all kinds. These patients are more at risk of asthma attacks (so-called analgesic intolerance/analgesic asthma), local skin and mucous membrane swelling (so-called Quincke's oedema) or urticaria when using doc Ibuprofen Schmerzgel than other patients. In these patients, doc Ibuprofen Schmerzgel may only be used under certain precautions 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 the symptoms persist for more than 3 days. In this case, a doctor should be consulted.

It should be ensured that children do not come into contact with the skin areas rubbed with the medicine with their hands.

Children and adolescents

doc Ibuprofen Schmerzgel should not be used in children and adolescents under 14 years of age, as there are no sufficient studies for this age group.

Using doc Ibuprofen Schmerzgel with other medicines

Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines. No interactions have been reported to date when doc Ibuprofen Schmerzgel is used as intended.

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

If pregnancy is discovered while using doc Ibuprofen Schmerzgel, the doctor must be notified. You may only use ibuprofen in the first and second trimesters of pregnancy after consulting your doctor. In the last trimester of pregnancy, doc Ibuprofen Schmerzgel must not be used due to the increased risk of complications for mother and child.

Breastfeeding

The active substance ibuprofen and its degradation products pass into breast milk in only small amounts. Since adverse effects on the infant have not been reported to date, a short-term use will generally not require discontinuation of breastfeeding. However, a daily dose of 15 g gel should not be exceeded and early weaning should be considered for longer use. To avoid absorption by the infant, breastfeeding mothers should not use the medicine in the breast area.

Driving and using machines

No special precautions are required.

This medicine contains fragrances with benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, D-limonene and linalool

These substances can cause allergic reactions.

3. HOW TO USE DOC IBUPROFEN SCHMERZGEL

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

The recommended dose is

doc Ibuprofen Schmerzgel is used 3 times a day. Depending on the size of the painful area to be treated, a 4 - 10 cm long gel strand, corresponding to 2 - 5 g gel (100 - 250 mg ibuprofen), is required. The maximum total daily dose is 15 g gel, corresponding to 750 mg ibuprofen.

Use in children and adolescents

doc Ibuprofen Schmerzgel should not be used in children and adolescents under 14 years of age, as there are no sufficient studies for this age group.

Method of administration

For external use only! Do not ingest! doc Ibuprofen Schmerzgel is applied to the skin and gently rubbed in. Increased penetration of the active substance through the skin can be achieved by using iontophoresis (a special form of electrotherapy). In this case, doc Ibuprofen Schmerzgel should be applied under the cathode (negative pole). The current strength should be 0.1 -0.5 mA per 5 cm2 electrode surface, the application time approx. 10 minutes.

Duration of use

The duration of treatment is determined by the treating physician. As a rule, an application over 2 - 3 weeks is sufficient. The therapeutic benefit of an application beyond this period has not been proven.

If you have used more doc Ibuprofen Schmerzgel than you should

If the recommended dosage is exceeded when applied to the skin, the gel should be removed and washed off with water. If significantly too large amounts are used or doc Ibuprofen Schmerzgel is accidentally ingested, the doctor must be notified. A specific antidote does not exist.

If you forget to use doc Ibuprofen Schmerzgel

Do not use double the amount to make up for a forgotten 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.

Possible side effects

Common - may affect up to 1 in 10 people

Local skin reactions such as skin redness, itching, burning, rash, also with pustules or wheals.

Uncommon - may affect up to 1 in 100 people

Hypersensitivity reactions or local allergic reactions (contact dermatitis).

Very rare - may affect up to 1 in 10,000 people

Airway narrowing (bronchospasms).

Not known - frequency cannot be estimated from the available data

The skin becomes sensitive to light.

If doc Ibuprofen Schmerzgel is applied to a large area of skin and used over a longer period of time, the occurrence of side effects that affect a specific organ system or even the entire organism, as may occur after systemic use of ibuprofen-containing medicines, cannot be ruled out. Benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, D-limonene and linalool can cause allergic reactions.

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, 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 DOC IBUPROFEN SCHMERZGEL

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and container after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. After opening, doc Ibuprofen Schmerzgel can be stored for 30 months, but no longer than the stated expiry date. 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 helps to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. Contents of the pack and further information

What doc Ibuprofen Schmerzgel contains

The active substance is: Ibuprofen. 1 g doc Ibuprofen Schmerzgel contains 50 mg ibuprofen. The other ingredients are: Dimethyl isosorbide, 2-propanol, poloxamer, medium-chain triglycerides, lavender oil, bitter orange blossom oil, purified water.

What doc Ibuprofen Schmerzgel looks like and contents of the pack

doc Ibuprofen Schmerzgel is a clear, colourless gel. doc Ibuprofen Schmerzgel is available in packs of 50 g, 100 g, 150 g and 200 g (2 x 100 g) gel. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Hermes Arzneimittel Gmbh
Georg-Kalb-Straße 5 - 8
82049 Pullach i. Isartal
Phone: 089/79 102 - 0
Fax: 089/79 102 - 280
E-mail: kontakt@hermes-arzneimittel.com

Manufacturer

Hermes Pharma GmbH
Georg-Kalb-Straße 5
82049 Pullach i. Isartal

This leaflet was last revised in July 2021.

Source: Package leaflet information
Status: 04/2023
Indications: for sole or supportive external treatment of swelling or inflammation of soft tissue near the joints (e.g. bursa, tendons, tendon sheaths, ligaments and joint capsule) and/or sports and accident injuries such as bruises, sprains, strains. Warning: Contains fragrances with benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, D-limonene and linalool.