Patient leaflet - Salofalk enema 2 g

1. What Mesalazine Dr Falk Pharma 2 g enemas are and what they are used for

Mesalazine Dr Falk Pharma enemas contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Mesalazine Dr Falk Pharma enemas are used for:

the treatment of mild episodes of an inflammatory disease in parts of the colon and the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis.

2. What you need to know before you use Mesalazine Dr Falk Pharma 2 g enemas

Do not use Mesalazine Dr Falk Pharma enemas

If you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g., aspirin) or any of the other ingredients of this medicine (listed in section 6).
If you have a serious liver or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine:

If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma.
If you have a history of allergy to sulphasalazine, a substance related to mesalazine.
If you suffer with problems of your liver.
If you suffer with problems of your kidney.
If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine.

Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.

Further precautions

During treatment your doctor may want to keep you under close medical supervision, and you may need to have regular blood and urine tests.

Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with mesalazine.

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Stop using mesalazine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears contact your doctor immediately.

Other medicines and Mesalazine Dr Falk Pharma enemas

Tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions):

Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders).
Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood, e.g., warfarin)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. It may still be alright for you to use this medicine and your doctor will be able to decide what is suitable for you.

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 using this medicine.

You should only use this medicine during pregnancy if your doctor tells you to.

You should also only use this medicine during breast-feeding if your doctor tells you to, as this medicine may pass into breast milk.

Driving and using machines

There are no effects on the ability to drive and use machines.

Mesalazine Dr Falk Pharma enema contains potassium metabisulphite and sodium benzoate

Potassium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm.

This medicinal product contains 60 mg sodium benzoate in each Mesalazine Dr Falk Pharma enema. Sodium benzoate may cause local irritation.

3. How to use Mesalazine Dr Falk Pharma 2 g enemas

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

Method of administration

This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take by mouth.

Dosage

Adults and elderly:

The recommended dose is one enema once a day, at bedtime.

For the best results empty your bowels before using the enema.

Shake the bottle well for at least 30 seconds before use to ensure thorough mixing.
Remove the protective cap. Hold the container upright to avoid spillage.
Lie on your left side with your left leg stretched out and your right knee bent for balance. If this is not convenient, then lie on your right side with your right leg stretched out and your left leg bent for balance to apply the enema but turn to your left side after application.
Insert the lubricated applicator deep into your rectum. Keep the bottle pointed towards your navel.
Tip the bottle slightly downwards and then squeeze it slowly and evenly.
Once the bottle is empty, slowly remove the applicator.
Lie on your left side for at least 30 minutes to enable the medicine to spread evenly through the bowel. Try to retain the enema all night.

The active substance in this product can cause staining and/or discolouration of some surfaces and fabrics. Ensure that the product does not come into contact with surfaces or fabrics during use. To prevent staining, use the product while lying on a suitable pad or cloth.

Use in children

There is little experience and only limited documentation for an effect in children.

Duration of treatment

The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you need to continue the treatment with this medicine. This will depend on your condition.

PL 10341/0008; Salofalk Enema 2g

Dr. Falk Pharma UK Ltd mock-up-leaflet eCTD 0032, Self-certification – addition of staining warning to PIL, initial, 29/06/2026 1 of 2

To obtain the maximum benefit from this medicine, you should use Mesalazine Dr Falk Pharma enemas regularly and consistently, as directed.

If you think your Mesalazine Dr Falk Pharma enemas are too strong or too weak, talk to your doctor.

If you use more Mesalazine Dr Falk Pharma enemas than you should

Contact a doctor if you are in doubt, so he or she can decide what to do.

If you use too many enemas on one occasion, just use your next dose as prescribed. Do not use a smaller amount.

If you forget to use Mesalazine Dr Falk Pharma enemas

Do not use a larger than normal dose of Mesalazine Dr Falk Pharma enema next time, but continue treatment at the prescribed dosage.

If you stop using Mesalazine Dr Falk Pharma enemas

Do not stop using this product until you have talked to 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, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms after using this medicine, you should contact your doctor and stop using Mesalazine Dr Falk Pharma enemas immediately:

General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties or a general inflammation of your large bowel (causing severe diarrhoea and abdominal pain). These reactions are very rare.
A marked reduction of your general health, especially if accompanied by fever, and/or a sore throat and mouth. These symptoms can, very rarely, be due to a fall in the number of white cells in your blood, which may make you more prone to developing a serious infection (agranulocytosis). Other cells of the blood may also be affected (e.g. platelets or red cells causing aplastic anaemia or thrombocytopenia) and cause symptoms
- Numbness and tingling in the hands and feet (peripheral neuropathy)
- Reversible decrease in semen production

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mesalazine Dr Falk Pharma 2 g enemas

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and on the carton. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Mesalazine Dr Falk Pharma enemas contain

The active substance is mesalazine and one enema contains 2g mesalazine.

The other ingredients are

Carbomer 35 000, disodium edetate, potassium acetate (E261), potassium metabisulphite (E224), purified water, sodium benzoate (E211), xanthan gum (E415). which may include unexplained bleeding, purple spots or patches under your skin, anaemia (feeling tired, weak and looking pale, especially on lips and nails). A blood test can confirm whether your symptoms are due to an effect of this medicine on your blood. These reactions are very rare.

Serious skin rashes with reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These can be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
Shortness of breath, chest pain or irregular heartbeat, or swollen limbs which may be indicative of cardiac hypersensitivity reactions. These reactions are rare.
Problems with your kidney function (can occur very rarely), e.g. a change in the colour or amount of urine produced and swollen limbs or a sudden flank pain (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)).
Strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure within your skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from the available data]).

The following side effects have also been reported by patients using mesalazine:

Common: may affect up to 1 in 10 people

Rash, itching

Rare side effects (that affect less than 1 in 1,000 patients):

Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting, constipation
Headache, dizziness
Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)

Very rare side effects (that affect less than 1 in 10,000 patients):

Severe abdominal pain because of acute inflammation of the pancreas
Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions
Muscle and joint pain
Jaundice or abdominal pain because of liver and bile flow disorders
Hair loss and the development of baldness
What Mesalazine Dr Falk Pharma enemas look like and contents of the pack
Mesalazine Dr Falk Pharma enemas are in a low-density, concertina shaped, polythene bottle with a low-density polythene application nozzle.
Mesalazine Dr Falk Pharma enemas are available in packs of 7.
Marketing Authorisation Holder
Dr Falk Pharma UK Ltd
Unit K, Bourne End Business Park, Cores End Road Bourne End, SL8 5AS
Tel: 01628 536600 e-mail: office@drfalkpharma.co.uk
Manufacturer
DR. FALK PHARMA GmbH
Leinenweberstrasse 5 79108 Freiburg
Germany
This leaflet was last revised in
Mock-up GB/06.26