Indomethacin Ointment 10% (40 g)

Do not use Indomethacin ointment in case of:

• Hypersensitivity to the drug or to any of the excipients of the product;
• Hypersensitivity to non-steroidal anti-inflammatory drugs;
• Active peptic ulcer disease, leukopenia, thrombocytopenia, coagulopathy.

Please note the following when using this medicinal product:

Indomethacin ointment should not be used in children under 14 years of age due to a lack of sufficient clinical experience.

The product is not applied to open wounds, mucous membranes, oral cavity, eyes. Apply only on unaffected skin.

The use of Indomethacin ointment is not recommended in people with a history of hypersensitivity to food and medication, bronchial asthma, allergic rhinitis or other allergic conditions.

Prolonged use of the product, especially on large areas of skin, should be limited in severe liver and kidney disease.

If the treatment lasts more than 10 days, laboratory control of leukocytes and platelets is required.

Pregnancy:

• Before taking any medicine, consult your doctor or pharmacist!
• There is no clinical experience demonstrating the safety of Indomethacin ointment in pregnant or during lactation, so long muprilozhenie in these categories of persons are excludes.

Breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine. There is no clinical experience proving the safety of Indomethacin ointment in pregnant and lactating women, therefore its long-term use in these categories of persons is excluded.

Driving and using machines:

Indomethacin ointment does not affect driving or using machines.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

There are no data on adverse drug interactions with other topical products. Concomitant use with corticosteroids is not recommended due to the possibility of increased risk of ulceration. When used concomitantly with antibiotics, anticoagulants and antidiabetic agents, it is necessary to monitor the relevant laboratory parameters.

Side effects:

Like all medicines, Inodmethacin ointment has side effects. Tolerance to Indomethacin ointment is usually good. There may be manifestations of hypersensitivity of the skin – itching in the genital area and anus, redness, skin rash, burning at the site of application.

If you notice side effects, please inform your doctor or pharmacist!

INDOMETHACIN 10% ointment 40 g SOPHARMA

Package leaflet: user
information Indometacin Sopharma 10% ointment Indomethacin Sopharma 10% ointment

indomethacin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4,
• If after 10 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet

1. What Indomethacin Sopharma Ointment is and what it is used for
2. What you need to know before you use Indomethacin Sopharma Ointment
3. How to use Indomethacin Sopharma Ointment
4. Possible side effects
5. How to store Indomethacin Sopharma Ointment
6. Contents of the pack and other information

1. What Indomethacin Sopharma ointment is and what it is used for

Indomethacin Sopharma ointment contains the active substance indomethacin, which belongs to a group of medicines called antirheumatic or non-steroidal anti-inflammatory. Indomethacin relieves the symptoms of inflammation – pain and swelling. Indomethacin Sopharma ointment is intended for local symptomatic treatment of pain and edema in inflammatory and degenerative diseases and injuries of the musculoskeletal system (tendons, muscles, joints); localized forms of extraarticular rheumatism of the musculoskeletal system: tendinitis, synovitis, tendovaginitis, inflammation of the fascia and ligaments, bursitis; some forms of arthritis of the arms, legs, or spine.

2. What you need to know before you use Indomethacin Sopharma ointment

Do not use Indomethacin Sopharma ointment

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of the product.
• if you are hypersensitive to aspirin or other NSAIDs with a clinical manifestation of an asthma attack, urticaria or allergic rhinitis.

Warnings and precautions

Talk to your doctor or pharmacist before using Indomethacin Sopharma ointment. Take special care when using Indomethacin Sopharma ointment

• if you have a stomach or duodenal ulcer, cardiovascular insufficiency, kidney problems;
• if you have had hypersensitivity to food and medication;
• if you have suffered from asthma or have other allergic diseases;
• if you have shown hypersensitivity to aspirin or other antirheumatic medicines;
• ointment is applied only to healthy skin (in the absence of open wounds and injuries);
• not applied to the eyes and mucous membranes;
• in case of skin or other signs of hypersensitivity, the use of the drug should be discontinued;
• If treatment lasts more than 10 days, it is advisable to do laboratory control of leukocytes and platelets.

Other medicines and Indomethacin Sopharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Although interactions with other medicines are unlikely with topical administration, tell your doctor if you are taking aspirin or other anti-inflammatory medicines, corticosteroids, medicines to lower blood pressure.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of Indomethacin ointment is not recommended during pregnancy and during lactation.

Driving and using machines

Indomethacin ointment is a topical formulation. Has no influence on the ability to drive and use machines.

Indomethacin Sopharma ointment contains dimethyl sulfoxide and lanolin.

This medicinal product contains dimethylsulfoxide as an excipient. May cause skin irritation.
This medicinal product contains lanolin as an excipient. May cause local skin reactions (e.g. contact dermatitis).

3. How to use Indomethacin Sopharma ointment

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

It is applied topically, on the skin.

Adults and adolescents over 15 years: the ointment is applied to the affected area 3-4 times a day, carefully rubbed into the skin until its full resorption. The amount of ointment needed for one smear depends on the treated area and is about 4-5 cm. It is administered at intervals of not less than 6 hours. Duration of treatment: 7-10 days. If symptoms do not affect during this period, treatment should be reevaluated.
Children under 15 years: Use of the product in this age group is not recommended.
Check with your doctor or pharmacist if you are not sure.

If you use more Indomethacin Sopharma ointment than you should

Since the product is applied topically, an overdose is unlikely. In case of accidental ingestion of large quantities of the product or if it gets into the eyes, on mucous membranes or open, wounds, contact your doctor or contact the nearest medical institution.

If you forget to use Indomethacin Sopharma ointment

Do not take a double dose to make up for a forgotten dose of Indomethacin Sopharma ointment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With topical application, local reactions from the skin after application of the product – burning at the application site, redness, itching, rashes, flaking and dryness of the skin
Swelling and bubble formation on the skin at the site of application, allergic reactions such as wheezing, shortness of breath and swelling of the face can be most often reported.
If the described adverse reactions on the part of the skin occur, the use of the product should be discontinued.
Adverse effects such as gastrointestinal disorders (lack of appetite, nausea, vomiting, diarrhoea, pain, haemorrhages and ulcerations) may occur when applied to large skin surfaces.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Inomethacin Sopharma ointment

Keep out of the reach of children.
This medicinal product does not require any special storage conditions. Shelf life after opening the tube – 6 months.

Do not use Indomethacin Sopharma ointment after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.

6. Contents of the pack and other information

What Indomethacin Sopharma ointment contains

• The active substance is indomethacin 100 mg per 1 g of ointment.
• The other ingredients (excipients) are: lanolin, white soft paraffin, dimethylsulfoxide, yellow beeswax; colloidal anhydrous silica; lavender oil.

What Indomethacin Sopharma ointment looks like and contents of the pack

Yellow homogeneous ointment with a specific odor. 40 g ointment in membrane aluminum tubes with polyethylene caps, 1 tube per cardboard box, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria