1 mg / g + 20 mg / g rectal cream fluocortolone 
pivalate, lidocaine hydrochloride (anhydrous)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Doloproct is and what it is used for 
2. What you need to know before you use Doloproct 
3. How to use Doloproct 
4. Possible side effects 
5. How to store Doloproct 
6. Contents of the packaging and other information 

1. What Doloproct is and what it is used for

Doloproct contains two different active substances: fluocortolone pivalate and lidocaine hydrochloride.

  • The active substance fluocortolone pivalate belongs to the group of corticosteroids. It reduces the production of substances that cause inflammation in the body. This relieves ailments such as swelling, itching, and burning.
  • The active substance lidocaine hydrochloride belongs to the group of local anesthetics. It numbs the area where it is applied. This relieves pain and itching in that area.

Doloproct is used in adults to relieve

  • nodular enlargement of blood vessels around the anus (hemorrhoid disease)
  • inflammation of the rectal mucosa (non-infectious proctitis )
  • inflammation of the upper skin layers around the anus with symptoms such as redness, swelling, itching, and dryness or discharge (anal eczema ).

Doloproct can not remove the causes of hemorrhoid disease, inflammation of the rectal mucosa (non-infectious proctitis ), and anus (anal eczema ).

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before using Doloproct

Do not use Doloproct

  • if you are allergic to fluocortolone pivalate, lidocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
  • if you have an infection in the skin around the anus and if you have symptoms of the following symptoms in this area:
    • skin lesions caused by syphilis or tuberculosis
    • chickenpox ( infection by the varicella-zoster virus)
    • vaccination reactions
    • genital herpes infection (genital herpes ).

Warnings and cautions

Talk to your doctor or pharmacist before using Doloproct Rectal Cream.

  • Be careful not to get Doloproct in your eyes. Wash hands thoroughly after use!
  • If latex-containing products, such as condoms, are used in the same area as Doloproct, the ingredients in Doloproct may damage the latex-containing products. This may mean that their protection against pregnancy and sexually transmitted diseases, such as HIV infection, is lacking. If you have any further questions, ask your doctor or pharmacist.
  • Contact a doctor if you experience blurred vision or other visual disturbances.

Children and young people

The use of Doloproct is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.

Other medicines and Doloproct

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

Some medicines may increase the effects of Doloproct and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

As Doloproct also contains the active substance lidocaine, you should tell your doctor or pharmacist if you are taking other medicines to treat irregular heartbeat ( arrhythmia ).

Pregnancy and breastfeeding

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.

Pregnancy

To prevent any risk to your unborn baby, avoid using Doloproct when you are pregnant, especially during the first three months.

Breast-feeding

In general, you should not use Doloproct for an extended period of time to prevent your baby from ingesting the medicine through breast milk. Only use this medicine if your doctor tells you to.

Driving and using machines

Doloproct has no or negligible effect on the ability to drive and use machines.

Doloproct rectal cream contains cetostearyl alcohol

The ingredient cetostearyl alcohol may cause local skin reactions (eg contact dermatitis ).

3. How to use Doloproct

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one fingertip unit (up to 1 g) per application. A fingertip unit is the amount of rectal cream that is pushed out of the tube and applied from the outermost fold of the skin to the fingertip of an adult’s index finger. Use Doloproct rectal cream twice a day, once in the morning and once in the evening. The first few days you use cream one, you can apply it three times daily. Later, when the symptoms have improved, once a day is often enough.

Method of administration

Use Doloproct after emptying your bowels.

If your doctor has told you to apply Doloproct rectal cream around the anus and the surrounding area, follow the instructions below:

  • Thoroughly clean the anal area before use.
  • Apply a fingertip device (up to 1 g) Doloproct rectal cream to your fingertip.
  • Gently spread the cream on the sore or itchy anal area. Use your fingertip to overcome the resistance of the sphincter.
  • Wash your hands.

If your doctor has told you to apply a little cream deeper into the anus, follow the instructions below:

  • Thoroughly clean the anal area before use.
  • Screw the applicator firmly onto the tube.
  • Insert the applicator into the anus.
  • Gently squeeze the tube so that some cream comes out of the anus. Slowly pull out the applicator.
  • Clean the outside of the applicator with a paper towel after each use. Then remove remnants of the product in the applicator with a cotton swab and clean again with a paper towel. Rinse the applicator in warm water for about 1 minute and then wipe the outside with a paper towel. Do not use the applicator if it is damaged.
  • Wash your hands.

Treatment time

Doloproct should not be used for more than two weeks.

If you use more Doloproct then you should 

There is no acute risk of poisoning if you take too much Doloproct in a single-use.

If you accidentally swallow Doloproct

  • the active substance lidocaine may alter cardiac function (for example slower heart rate or in extreme cases cardiac arrest)
  • you may develop symptoms related to the central nervous system (such as convulsions, shortness of breath, or in extreme cases impaired breathing).

The expected symptoms depend on dose one. To prevent any harmful effects after swallowing Doloproct, contact your doctor immediately.

If you forget to use Doloproct

If you forget to use Doloproct, use this medicine as soon as you find it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Doloproct

Do not stop treatment with Doloproct without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Doloproct can cause side effects, although not everybody gets them.

The following side effects may occur during treatment with Doloproct. They only apply to the skin in the anal area:

Common (may affect up to 1 in 10 people):

  • burning in the skin

Uncommon (may affect up to 1 in 100 people):

  • skin irritation (eg redness, dryness)
  • allergic reactions (eg rash)

Has been reported (occurs in an unknown number of users):

  • dimsyn

If you use Doloproct rectal cream for a longer period (more than 4 weeks ), there is a risk that you may develop local skin reactions, such as

  • thinned skin ( atrophy )
  • irregular areas on the skin that look like streaks (striae)
  • enlarged blood vessels that become visible on the skin surface (telangiectasias).

Reporting of side effects

5. How to store Doloproct

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Doloproct rectal cream can be used for 4 weeks after opening.

Do not use this medicine if you notice that the cream is not white and opaque.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Doloproct rectal cream

  • The active substances are fluocortolone pivalate and lidocaine hydrochloride (anhydrous).

Each gram of rectal cream contains

  • 1 mg fluocortolone pivalate and
  • 20 mg lidocaine hydrochloride (anhydrous).
  • The other ingredients are polysorbate 60, sorbitan stearate, cetostearyl alcohol, liquid paraffin, white soft paraffin, sodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, benzyl alcohol, and purified water. See section 2 Doloproct rectal cream contains cetostearyl alcohol

What the medicine looks like and the contents of the pack

Doloproct rectal cream is a white, opaque cream.

The cream one is in an aluminum tube; an applicator included.

There are three pack sizes:

  • 10 g
  • 15 g
  • 30 g

Not all pack sizes may be marketed.

Doloproct is also provided as a suppository.

Manufacturer

LEO Pharma Manufacturing Italy Srl

Via E. Schering 21

20090 Segrate (Milano)

Italy

This medicinal product is authorized under the European Economic Area under the names :

Germany, Denmark, Iceland, Greece, Estonia, Hungary, Latvia, Slovakia, Cyprus, Malta, Austria, Lithuania, Bulgaria, Italy, and Slovenia – Doloproct

Finland – Neoproct

Portugal – Ultraproct

Muhammad Nadeem

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