Ibuprofen Hvi pharma services Gmbh

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the patient

Ibuprofen HWI pharma services GmbH, 50 mg/g, gel
Ibuprofenum
For adults and adolescents aged 14 and above

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should consult a doctor.

Table of contents of the leaflet

• 1. What is Ibuprofen HWI pharma services GmbH and what is it used for
• 2. Important information before using Ibuprofen HWI pharma services GmbH
• 3. How to use Ibuprofen HWI pharma services GmbH
• 4. Possible side effects
• 5. How to store Ibuprofen HWI pharma services GmbH
• 6. Contents of the pack and other information

1. What is Ibuprofen HWI pharma services GmbH and what is it used for

Ibuprofen HWI pharma services GmbH contains the active substance ibuprofen. Ibuprofen is a pain reliever and anti-inflammatory (non-steroidal anti-inflammatory drug, NSAID).
Ibuprofen HWI pharma services GmbH is intended for the exclusive or supportive treatment of external

• swellings or inflammatory conditions of the soft tissues around the joints (e.g. bursae, tendons, tendon sheaths, ligaments, and joint capsules),
• post-traumatic changes related to sports or accidents, e.g. bruises, sprains, or strains.

Ibuprofen HWI pharma services GmbH is indicated for use in adults and adolescents aged 14 and above.
If after 3 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before using Ibuprofen HWI pharma services GmbH

When not to use Ibuprofen HWI pharma services GmbH

• if you are allergic to ibuprofen, other painkillers or anti-rheumatic agents, or any of the other ingredients of this medicine (listed in section 6);
• on open wounds, in case of skin inflammation or infections, as well as on eczema or mucous membranes;
• if you are in the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with Ibuprofen HWI pharma services GmbH, you should discuss it with your doctor or pharmacist.
Side effects can be minimized by using the lowest effective dose for the shortest necessary duration to control symptoms.
Bronchospasm may occur in patients using ibuprofen, in whom asthma or allergies have occurred or previously existed.
Patients with asthma, hay fever, nasal polyps, or chronic obstructive pulmonary disease or chronic respiratory infections (especially those associated with symptoms similar to hay fever) are more likely to experience asthma attacks (so-called intolerance to painkillers or drug-induced asthma), local skin swelling and mucous membranes (so-called Quincke's edema) or urticaria than other patients during treatment with Ibuprofen HWI pharma services GmbH. In these patients, Ibuprofen HWI pharma services GmbH can only be used with certain precautions and under direct medical supervision. The same applies to patients who are also allergic to other substances, e.g. with skin reactions, itching, or urticaria.
Precautions should be taken to prevent children from touching areas of skin to which the medicine has been applied.
Use of Ibuprofen HWI pharma services GmbH should be discontinued if a skin rash occurs.
Exposure of the treated area to strong natural or artificial light sources should be avoided during treatment and for one day after the end of treatment to reduce the risk of photosensitivity.
It should be noted that even when ibuprofen is used locally, its effect on the body as a whole cannot be completely ruled out, and concurrent use of ibuprofen in gel form with other NSAIDs may lead to an increase in side effects.
Severe skin side effects, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Use of Ibuprofen HWI pharma services GmbH should be discontinued and medical attention should be sought immediately if any of the symptoms associated with these severe skin side effects occur as described in section 4.

Children and adolescents

Ibuprofen HWI pharma services GmbH should not be used in children and adolescents under 14 years of age, as there is insufficient data on its efficacy and safety in this age group.

Ibuprofen HWI pharma services GmbH and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions with ibuprofen used locally have been reported when used as directed, so the occurrence of interactions reported with ibuprofen used orally is unlikely.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Ibuprofen HWI pharma services GmbH should not be used during the last 3 months of pregnancy. Ibuprofen HWI pharma services GmbH should not be used during the first 6 months of pregnancy, unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period, the lowest possible dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of ibuprofen may cause side effects in the unborn child. It is not known whether this risk also applies to Ibuprofen HWI pharma services GmbH when applied to the skin.
No harmful effects have been reported when using this medicine during breastfeeding. However, as a precaution, do not apply the gel directly to the breast if you are breastfeeding.
Ibuprofen belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines

Ibuprofen HWI pharma services GmbH has no influence on the ability to drive and use machines when used once or for a short period.

Important information about some ingredients of Ibuprofen HWI pharma services GmbH

This medicine contains fragrances with benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene, linalool, which may cause allergic reactions.

3. How to use Ibuprofen HWI pharma services GmbH

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 14 and above:
Ibuprofen HWI pharma services GmbH is applied 3 times a day. Depending on the size of the painful area to be treated, a strip of gel of 4 to 10 cm in length is applied, which corresponds to 2 to 5 g of gel (100 to 250 mg of ibuprofen). The maximum daily dose is 15 g of gel, which corresponds to 750 mg of ibuprofen.
If after 3 days the symptoms worsen or do not improve, consult a doctor.
Method of administration:
For cutaneous use.
Before the first use, pierce the protective foil at the tube opening using the puncture device attached to the cap.
Ibuprofen HWI pharma services GmbH is applied to the skin and gently rubbed in.
The penetration of the active substance through the skin can be increased by iontophoresis (a special form of electrotherapy). Ibuprofen HWI pharma services GmbH should be applied under the cathode (negative pole). The current intensity should be between 0.1 and 0.5 mA per 5 cm² of electrode surface, and the treatment time should not exceed approximately 10 minutes.
After applying the gel to the skin, wash your hands with paper towels and then with water, unless they are the treated area. The paper towel should be disposed of with mixed waste. Before showering or bathing, wait until the active substance has been absorbed.
Occlusive dressings should not be used.
Duration of treatment:
The medicine is intended for short-term use.
The duration of treatment depends on the symptoms and the underlying disease. Ibuprofen HWI pharma services GmbH should not be used for more than 2 to 3 weeks. The therapeutic benefits of using it after this period have not been proven.

Using a higher dose of Ibuprofen HWI pharma services GmbH than recommended

If the recommended dose is exceeded when applied to the skin, the gel should be removed (e.g. with a paper towel) and washed off with water. Consult a doctor if you have used too much or accidentally ingested Ibuprofen HWI pharma services GmbH.
There is no specific antidote.

Missing a dose of Ibuprofen HWI pharma services GmbH

Do not use a double dose to make up for a missed dose.
If you have any further questions 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 gets them.

Stop using ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• red, non-raised, target-like or circular spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] [very rare (may affect up to 1 in 10,000 people)].
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome) [frequency not known (cannot be estimated from the available data)].
• red, peeling, widespread rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis) [frequency not known (cannot be estimated from the available data)].

Tell your doctor immediately if you notice any of the following side effects

Common (may affect up to 1 in 10 people): local skin reactions, such as redness, itching, burning, rash, also with the formation of pustules or urticaria
Uncommon (may affect up to 1 in 100 people): allergic reactions, e.g. local allergic reactions (contact dermatitis)
Rare (may affect up to 1 in 10,000 people): angioedema, bronchospasm (bronchial constriction)
Frequency not known (cannot be estimated from the available data): skin becomes sensitive to light
In the case of using Ibuprofen HWI pharma services GmbH on a large skin surface and for a long time, it is not possible to rule out the occurrence of side effects related to a specific organ system or the whole body, which may occur after systemic administration of medicines containing ibuprofen.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen HWI pharma services GmbH

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after “EXP”. The expiry date refers to the last day of the month.
Do not store above 25°C.
The shelf life after first opening the tube of Ibuprofen HWI pharma services GmbH is 1 year.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen HWI pharma services GmbH contains

The active substance is ibuprofen.
1 g of gel contains 50 mg of ibuprofen.
The other ingredients are:
Dimethyl isosorbide, 2-propanol, poloxamer 407, medium-chain triglycerides, lavender essential oil (contains benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene, linalool), neroli essential oil (contains citral, citronellol, farnesol, geraniol, limonene/d-limonene, linalool), purified water.

What Ibuprofen HWI pharma services GmbH looks like and contents of the pack

Transparent to colorless gel.
Ibuprofen HWI pharma services GmbH is available in tubes containing 20 g, 50 g, or 100 g of gel, in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Dolorgiet GmbH & Co. KG
Otto-von-Guericke-Str. 1
53757 Sankt Augustin
tel. +49 2241 3170
email: info@ dolorgiet.de

Manufacturer

Dolorgiet GmbH & Co. KG
Otto-von-Guericke-Str. 1
53757 Sankt Augustin
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Dolgit Ibu 50 mg/g Gel
Bulgaria:
Dolgit Ibu Gel 50 mg/g
Cyprus:
Dolgit Ibu Gel 50 mg/g
Estonia:
Dolgit 50 mg/g gel
Croatia:
Dolgit 50 mg/g Gel
Hungary:
Dolgit Ibu Gél 50 mg/g
Latvia
Ibutop 50 mg/g gels
Lithuania:
ibuprofen HWI pharma services GmbH
Poland:
Ibuprofen HWI pharma services GmbH
Romania:
Dolgit 50 mg/g gel
Slovakia:
Dolgit proti bolesti

Date of last revision of the leaflet: