IBUTOP pain cream

Important notes (mandatory information)

ibutop Pain Cream 5% Cream. Active ingredient: Ibuprofen. Areas of application: For the sole or supportive external treatment of muscular rheumatism, degenerative painful joint diseases (arthrosis), inflammatory rheumatic diseases of the joints and spine, swelling or inflammation of the soft tissue near the joints (e.g. bursa, tendons, tendon sheaths, ligaments and joint capsule), frozen shoulder, lumbago, lumbago, sports and accident injuries such as bruises, sprains, strains.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

ibutop Pain Cream 5% Cream
Active ingredient: Ibuprofen

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 notice 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 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS IBUTOP PAIN CREAM AND WHAT IS IT USED FOR?

ibutop Pain Cream is an analgesic and anti-inflammatory medicine for rubbing into the skin. Areas of application: For the sole or supportive external treatment of muscular rheumatism, degenerative painful joint diseases (arthrosis), inflammatory rheumatic diseases of the joints and spine, swelling or inflammation of the soft tissue near the joints (e.g. bursa, tendons, tendon sheaths, ligaments and joint capsule), frozen shoulder, lumbago, lumbago, sports and accident injuries such as bruises, sprains, strains. If you do not feel better or even worse after 3 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING IBUTOP PAIN CREAM?

ibutop Pain Cream must not be used:

• if you are allergic to ibuprofen, other painkillers and anti-rheumatics (non-steroidal anti-inflammatory drugs), sodium methyl-4-hydroxybenzoate, propylene glycol or any of the other ingredients of this medicine listed in section 6,
• on open wounds, inflammations or infections of the skin, as well as on eczema or on mucous membranes,
• in the last third of pregnancy.

Warnings and precautions

Please talk to your doctor or pharmacist before using ibutop Pain Cream, - if you suffer from asthma, hay fever, nasal mucosa swelling (so-called nasal polyps) or chronic obstructive airway diseases or chronic respiratory 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 edema) or urticaria when using ibutop Pain Cream than other patients. In these patients, ibutop Pain Cream 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.

Children and adolescents

ibutop Pain Cream should not be used in children and adolescents under 14 years of age, as there are no sufficient studies for this age group. Care should be taken that children do not come into contact with the skin areas rubbed with the medicine with their hands.

Use of ibutop Pain Cream 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 when ibutop Pain Cream is used as intended.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Breastfeeding

The active ingredient 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 interruption of breastfeeding will generally not be necessary. However, a daily dose of 3 to 4 times with a cream strand of 4-10 cm each should not be exceeded and early weaning should be considered for longer use. To avoid absorption by the infant, nursing mothers should not use the medicine in the breast area.

Driving and ability to operate machinery

No special precautions are required.

ibutop Pain Cream contains propylene glycol

Propylene glycol can cause skin irritation.

3. HOW TO USE IBUTOP PAIN CREAM?

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: ibutop Pain Cream is used 3 to 4 times a day. Depending on the size of the painful area to be treated, a 4-10 cm long cream strand corresponding to 2-5 g of cream (100-250 mg ibuprofen) is required. The maximum daily total dose is 20 g of cream corresponding to 1000 mg of ibuprofen.

Type of application

For external use only. Do not ingest. ibutop Pain Cream is applied to the skin and gently rubbed in. In the case of severe bruising and sprains, the application of an airtight bandage may be beneficial at the beginning of treatment. Increased penetration of the active ingredient through the skin can be achieved by using iontophoresis (a special form of electrotherapy). ibutop Pain Cream should be applied under the cathode (negative pole). The current strength should be 0.1-0.5 mA per 5 cm2 of 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. Please talk to your doctor or pharmacist if you have the impression that the effect of ibutop Pain Cream is too strong or too weak.

If you have used more ibutop Pain Cream than you should

If the recommended dosage is exceeded when applied to the skin, the cream should be removed and washed off with water. If significantly too large amounts are used or ibutop Pain Cream is accidentally ingested, the doctor must be notified. There is no specific antidote.

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, including pustules or wheals, may occur.

Uncommon (may affect up to 1 in 100 people)

Hypersensitivity reactions or local allergic reactions (contact dermatitis) may occur.

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

Bronchospasms may occur.

If ibutop Pain Cream is applied to a large area of 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, as may occur under certain circumstances after systemic use of ibuprofen-containing medicines, cannot be ruled out. Sodium methyl-4-hydroxybenzoate can cause hypersensitivity reactions, including delayed reactions.

Reporting of side effects

If you get 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, 53175 Bonn, website: www.bfarm.de, by reporting side effects you can help to provide more information about the safety of this medicine.

5. HOW TO STORE IBUTOP PAIN CREAM?

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 container after "Use by:". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening: After opening the container, ibutop Pain Cream can be stored for 3 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ibutop Pain Cream contains
The active ingredient is: Ibuprofen. 1g ibutop Pain Cream contains 50mg ibuprofen in an oil/water emulsion. The other ingredients are: medium-chain triglycerides, glycerol monostearate 40-55, propylene glycol, macrogol stearate 5000, macrogol stearate 1500, xanthan gum, sodium methyl-4-hydroxybenzoate (Ph.Eur.), purified water.

What ibutop Pain Cream looks like and contents of the pack

Tube with smooth, white to cream-coloured, soft cream. ibutop Pain Cream is available in packs of 20 g, 40 g, 50 g, 75 g, 100 g, 130 g and 150 g cream. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

axicorp Pharma GmbH
Max-Planck-Straße 36 b
61381 Friedrichsdorf
Tel.: 0800-2940-100
Fax: 0800-2946-100
E-mail: service@axicorp.de
www.axicorp.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna

This package leaflet was last revised in October 2015.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Ibuprofen. Areas of application: For the sole or supportive external treatment of muscular rheumatism, degenerative painful joint diseases (arthrosis), inflammatory rheumatic diseases of the joints and spine, swelling or inflammation of the soft tissue near the joints (e.g. bursa, tendons, tendon sheaths, ligaments and joint capsule), frozen shoulder, lumbago, lumbago, sports and accident injuries such as bruises, sprains, strains.