Ibuprofen hwi pharma services gmbh

Patient Information Leaflet: Instructions for Use

Ibuprofen HWI pharma services GmbH, 50 mg/g, gel
Ibuprofenum
For adults and adolescents aged 14 years and older
Please read this 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 leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

Table of Contents

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-relieving and anti-inflammatory medicine (non-steroidal anti-inflammatory drug, NSAID).
Ibuprofen HWI pharma services GmbH is intended for exclusive or adjunctive
topical treatment of:

• Swellings or inflammatory conditions of soft periarticular tissues (e.g. bursae, tendons, tendon sheaths, ligaments and joint capsules),
• Traumatic injuries related to sports or accidents, such as bruises, sprains or strains.

Ibuprofen HWI pharma services GmbH is indicated for use in adults and adolescents aged 14 years and older.
If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

2. Important information before using Ibuprofen HWI pharma services GmbH

When not to use Ibuprofen HWI pharma services GmbH

• if the patient is allergic to ibuprofen, other pain-relieving or anti-rheumatic medicines, or any of the other ingredients of this medicine (listed in section 6);
• on open wounds, in cases of skin inflammation or infection, or on rashes or mucous membranes;
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Ibuprofen HWI pharma services GmbH, discuss this with your doctor or pharmacist.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Bronchospasm may occur in patients using ibuprofen who have or have previously had bronchial asthma or allergies.
Patients with asthma, hay fever, nasal mucosal swelling (so-called nasal polyps), or chronic obstructive pulmonary disease or chronic respiratory infections (especially associated with symptoms similar to hay fever) are more susceptible to asthma attacks (so-called analgesic intolerance or drug-induced asthma), local skin and mucous membrane swelling (so-called Quincke's edema), or urticaria than other patients during treatment with Ibuprofen HWI pharma services GmbH. In such patients, Ibuprofen HWI pharma services GmbH should be used only with appropriate precautions and under direct medical supervision. The same applies to patients allergic to other substances, e.g. with skin reactions, itching, or urticaria.
Precautions should be taken to ensure that children do not touch areas of skin to which the medicine has been applied.
Treatment with Ibuprofen HWI pharma services GmbH should be discontinued if a skin rash develops.
Avoid exposing the treated area to strong sources of natural and/or artificial light (e.g. sunbeds) during treatment and for one day after treatment ends, to reduce the risk of photosensitivity.
Note that even when ibuprofen is used topically, its systemic effects cannot be completely ruled out. Concurrent use of ibuprofen in gel form with other NSAIDs may lead to an increased risk of adverse effects.
Severe skin adverse reactions, 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 with ibuprofen treatment. Treatment with Ibuprofen HWI pharma services GmbH should be discontinued and immediate medical advice sought if any of the symptoms associated with these severe skin adverse reactions described in section 4 occur.

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 efficacy and safety in this age group.

Ibuprofen HWI pharma services GmbH and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
No interactions have been reported with topically applied ibuprofen when used according to instructions; therefore, interactions reported with orally administered ibuprofen are unlikely.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Ibuprofen HWI pharma services GmbH must 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 recommended by a doctor. If treatment is necessary during this period, the lowest possible dose for the shortest possible time should be used.
Oral formulations (e.g. tablets) containing ibuprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Ibuprofen HWI pharma services GmbH when applied to the skin.
No harmful effects are known with the use of this medicine during breastfeeding. However, as a precautionary measure, do not apply the gel directly to the breast if you are breastfeeding.

Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
Ibuprofen HWI pharma services GmbH has no effect on the ability to drive or operate machinery when used occasionally or for short durations.

Important information about certain ingredients of Ibuprofen HWI pharma services GmbH
This medicine contains fragrance substances including benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene/d-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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 14 years and above:
Apply Ibuprofen HWI pharma services GmbH three times daily. Depending on the size of the painful area to be treated, a gel strip between 4 and 10 cm long should be applied, corresponding to 2 to 5 g of gel (100 to 250 mg of ibuprofen). The maximum daily dose is 15 g of gel, equivalent to 750 mg of ibuprofen.
If symptoms worsen or no improvement is observed after 3 days, consult your doctor.

Method of administration:
Topical application to the skin.
Before first use, pierce the protective seal on the tube opening using the piercing device integrated into the cap.
Apply Ibuprofen HWI pharma services GmbH to the skin and gently rub in.

Skin penetration of the active substance can be enhanced by iontophoresis (a special form of electrotherapy). Ibuprofen HWI pharma services GmbH should be applied under the cathode (negative pole). Current intensity should be between 0.1 and 0.5 mA per 5 cm² of electrode surface area, with a maximum treatment duration of approximately 10 minutes.

After applying the gel to the skin, wipe hands with a paper towel and then wash them, unless the hands themselves are the treated area. Dispose of the used paper towel with mixed waste. Wait until the active substance has been absorbed before taking a shower or bath.
Do not use occlusive dressings.

Duration of treatment:
This medicine is intended for short-term use only.
The duration of treatment depends on the symptoms and underlying condition. Do not use Ibuprofen HWI pharma services GmbH for longer than 2 to 3 weeks. Therapeutic benefits beyond this period have not been demonstrated.

Use of more than the recommended dose of Ibuprofen HWI pharma services GmbH
If the recommended dose is exceeded during topical application, remove the gel (e.g. with a paper towel) and wash the area with water. Contact your doctor in case of overdose or accidental ingestion of Ibuprofen HWI pharma services GmbH.
There is no specific antidote.

Missed dose of Ibuprofen HWI pharma services GmbH
Do not apply 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with ibuprofen must be discontinued and medical advice must be sought immediately if the patient
experiences any of the following symptoms:

• red, flat, non-elevated, target-like or circular skin lesions on the trunk, often with blisters in the center, peeling skin, and ulceration in the mouth, throat, nose, genital organs, and around the eyes. These severe skin reactions 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 unknown (cannot be estimated based on available data)].
• red, scaly, widespread rash with subcutaneous nodules and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis) [frequency unknown (cannot be estimated based on available data)].

Immediately inform the doctor if the patient experiences any of the following
adverse reactions:
Common (may affect up to 1 in 10 people): local skin reactions such as redness,
itching, burning, rash, including blistering or urticaria
Uncommon (may affect up to 1 in 100 people): hypersensitivity reactions,
e.g. local allergic reactions (contact dermatitis)
Very rare (may affect up to 1 in 10,000 people): angioedema, narrowing
of the airways (bronchospasm)
Frequency unknown (cannot be estimated based on available data): skin becomes sensitive
to light

When using Ibuprofen HWI pharma services GmbH over a large skin surface area and for prolonged periods, adverse reactions affecting specific organ systems or the entire body cannot be excluded, which may occur after systemic administration of medicines containing ibuprofen.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions contributes to the further enhancement of the safety information regarding the medicine.

5. How to store Ibuprofen HWI pharma services GmbH

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and tube
after: "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
The shelf life of Ibuprofen HWI pharma services GmbH after first opening the tube is
1 year.
Medicines must 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.
50 mg of ibuprofen is contained in 1 g of gel.
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
A transparent, colourless gel.
Ibuprofen HWI pharma services GmbH is available in tubes containing 20 g, 50 g, or 100 g of gel, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dolorgiet GmbH & Co. KG
Otto-von-Guericke-Str. 1
53757 Sankt Augustin
Germany
Tel. +49 2241 3170
Email: [email protected]

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

This medicinal product is authorised in the following countries 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 geel
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