Solhumin gel, 50 g

Upute za korištenje Solhumin gel, 50 g

Important notes (compulsory information):

Salhumin gel 105.5 mg / g. Active substance: hydroxyethylsalicylate (pH. EUR.). Areas of application: For the external supportive treatment of pain and swelling in acute sprains, bruises and tatters in the field of extremities due to blunt injury, e.g. sports injuries. Warning: Contains propylene glycol.

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


Instructions for use: Information for users

Salhumin® gel 105.5 mg / g
Hydroxyethylsalicylate (pH. EUR.)
For use in adults and adolescents

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always use this medicine as described in this leaflet or exactly as your doctor's or pharmacist instructions.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse after 14 days, contact your doctor.

What is in this leaflet

1. What is salhumin gel and what is it used for?
2. What should you consider before using salhumin gel?
3. How is salhumin gel to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is salhumin gel to keep?
6. Content of the pack and more information

1.What is salhumin gel and what is it used for?

Hydroxyethylsalicylate, the active ingredient in salhumin gel, belongs to the group of salicyl acid derivatives. These act as an analgesic agent (analgesic) and anti-inflammatory resource (anti-reflection in anti-phlogistikum). It is used for the external supportive treatment of pain and swelling in acute sprains, bruises and trimming in the field of extremities due to stumbers injuries, e.g. Sports injuries. If you do not feel better or even worse after 14 days, contact your doctor.

2.What should you consider before using salhumin gel?

Salhumin gel must not be used,

• if they are allergic to hydroxyethylsalicylate, other salicylates, other non-steroidal antiphlogistics / analgesics, propylene glycol or one of the other ingredients of this medicine mentioned in section 6,
• with open injury, inflammation of the skin, eczema and dandruff lichen at the place of application,
• for infants and toddlers,
• in the last 3 months of pregnancy (see section "Pregnancy and breast feeding period"),
• at the lusty breast (see section "Pregnancy and lactation"),
• on mucous membranes and near the eyes.

Warnings and Precautions:
Please talk to your doctor or pharmacist before using salhumin gel.

Children and adolescents
For infants and toddlers, the use of salhumin gel is not recommended.

Warning:
In children and adolescents with existing feverish diseases, Salhumin Gel is said to be due to the possible occurrence of a Reye syndrome, which under oral administration of salicylic acid or whose descendants were observed, not be applied. It is a very rare, but life-threatening illness, for whose ongoing vomiting may be a sign and that it is absolutely immediate medical treatment. Patients with asthma, chronic bronchi-consuming respiratory diseases (obstruction), Hay fever, nasal mucosa thresholds (so-called nasal polypn) React more often than other ill on non-steroidal anti-rheumatics with asthma attacks, local skin and mucosal threshold (so-called Quincke edema) or hives (Urticaria). Patients with preheated kidney, heavy liver damage and chronic and recurring stomach and duodenary complaints can not use salhumin gel over a long time, not for a long time and after consultation with your doctor. Special monitoring by the attending physician is required with simultaneous treatment with coagulation-resistant medicines (e.g., cumarine derivatives, heparin, except low-dose heparin therapy).

Application of salhumin gel together with other medicines:
Please inform your doctor or pharmacist if you have other medicines / apply or recently taken / applied, even if it is non-prescription medicines. Salhumin gel can enhance the transmittance of the skin for other locally used drugs. Therefore, Salhumin gel should not be applied simultaneously with other externally applied medicines. The received salicylic acid can increase the effect of methotrexate and enhance the blood sugar-lowering effect of sulfonylureas. The effects of coagulation-resistant medicinal products (e.g., Cumarine derivatives and heparin).

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding or if you suspect to be pregnant, or intend to become pregnant, ask your doctor or pharmacist for advice before applying this medicine.

Pregnancy:
In the first and second thirds of pregnancy you can only use salhumin gel after consultation with your doctor. In the last pregnancy diagram, they are not allowed to use salhumin gel as an increased risk of complications for mother and child is not excluded.

Latving:
Salhumin gel must not be applied to the lusty breast. If the physician is necessary for regular treatment of large skin areas with salhumin gel, so can be removed, as risks are not excluded because of lack of detoxification in the newborn.

Driving and ability to operate machines:
There are no experience in the impairment of ability to drive and the ability to serve machines.

Salhumin gel contains propylene glycol. Propylene glycol can cause skin irritation.

3.How is salhumin gel to apply?

Always use this medicine as described in this leaflet or exactly after the arrangement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

The recommended dose is:
Apply 2 to 3 times a day up to 5 g of salhumin gel in thin layer beyond the pain zone to the skin beyond (corresponding to up to 19 cm Geltrand). The gel is distributed evenly and easily massaged; For stronger pain, add the gel carefully and without pressure. After each application, the hands are thoroughly washing.

How and when should you use salhumin gel?
For pain, salhumin gel is applied to the skin.

How long should they use salhumin gel?
The duration of the treatment should be done until the decay of the complaints, but not more than 14 days or after the doctor's instructions. Apply only externally!

If you have applied a larger amount of salhumin gel than you should:
When the recommended dosage is exceeded, the gel should be removed again and washed off with water. Excess gel may be in the clothes. When used in too large quantities or accidental ingestion, they communicate to their doctor who will orient themselves in the treatment of any physical disorders on the clinical picture.

If you forget the use of salhumin gel:
Do not turn twice the amount if you forget the previous application. Continue with the next regular application.

If you cancel the use of salhumin gel:
If you are unsure about interruption or premature termination of treatment, please talk to your doctor. If you have WEiTERE questions about the application of this medicine, contact your doctor or pharmacist.

4.What side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

Occasionally (can occur with up to 1 of 100 patients):
Local skin irritation.

Rarely (can occur with up to 1 of 1,000 patients):
Hypersensitivity reactions. They express themselves in the occurrence of redness, nodules and bubble formation, mostly with itching at the place of treatment.

Unknown (frequency based on the available data not estimable):
Serious shapes of skin reactions (Stevens-Johnson syndrome).

When Salhumin gel is applied across the skin to the skin and applied over a longer period of time, the occurrence of systemic side effects, as they are used for oral use of medicines with active ingredients from the group of salicylates or Salicylic acid can occur, possible. If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effect any side effects directly through the national reporting system (Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5.How is salhumin gel to keep?

Keep this medicine inaccessible to children. You may post the medicine after the on the outer carton and the tube "Usable until" stated expiry date no longer use. The expiry date refers to the last day of the specified month. Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6.The packing and further information

What salhumin gel contains:
The active ingredient is: hydroxyethylsalicylate. 1 g gel contains 105.5 mg of hydroxyethylsalicylate (ph. EUR.).
The other ingredients are: Carbomer 934 p, 2-propanol (pH. EUR.), Propylene glycol, glycerol, macrogol glycerolcocoate (pH. EUR.) (7), sodium hydroxide (for adjusting the pH value), purified water.

Like salhumin gel looks and content of the pack:
Salhumin gel is a colorless, clear gel. Pack sizes Tube too 50 g tube to 100 g. Not all pack sizes may be placed on the market.

Pharmaceutical entrepreneur and manufacturer:
Bastian-Werk GmbH
August-Exter-Str. 4
81245 Munich

Telephone: 089 82093-0
Fax: 089 82093-59

This leaflet was last revised in May 2013.

Source: Information of the leaflet
Status: 02/2016