Neozem

Neozem is a niche product, developed on request and requires cold chain infrastructure place in the market for products of its type in the treatment of anal fissure.

Neozem is manufactured to GMP standard at an MHRA approved site with QP release and batch certification. 

The product contains 2% Diltiazem Hydrochloride and has a shelf life of 18 months if unopened in a refrigerator. Once open, the shelf life reduces to 28 days. 

Package leaflet: Information for the user

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or healthcare professional
• If you notice any side effects, please tell your doctor or healthcare professional

In this leaflet:

1. What is Neozem (Diltiazem) Cream and what it is used for
2. Before you use Neozem Cream
3. How to use Neozem Cream
4. Possible side effects
5. How to store Neozem Cream
6. Further information

1.What is Neozem (Diltiazem) Cream and what it is used for

Neozem contains 2% w/w Diltiazem hydrochloride in a cream base. Neozem cream is used to treat anal fissures. Anal fissures are cuts or tears in the anal canal, which can cause severe pain, redness, irritation and even bleeding from the anus (back passage), particularly following a bowel movement.

Diltiazem belongs to a group of drugs called calcium channel blockers. It works by relaxing the muscles and blood vessels. It is often used to treat hypertension (high blood pressure), angina (chest pain) and certain heart rhythm disorders. In the treatment of anal fissures it is thought to act by relaxing the anal muscles and thereby allowing increased blood supply to the surrounding tissues.

There are other conditions that cause similar symptoms, so you should consult your doctor or healthcare professional before you use this product.

2.BEFORE YOU USE NEOZEM CREAM 

Do not use Neozem:

• If you have certain heart conditions, such as “sick sinus syndrome” or AV block (unless you have a pacemaker)
• If you have low blood pressure
• If you recently have had a heart attack
• If you are taking other medicines containing Diltiazem
• If you are allergic to Diltiazem, or any of the other ingredients in this cream
• If you are pregnant
• If you are breast feeding

If any of the above applies consult your doctor or healthcare professional before using Neozem Cream.

3. HOW TO USE NEOZEM CREAM 

Always use Neozem cream exactly as your doctor has told you. You should check with your doctor or healthcare professional if you are not sure. • Remove the plastic cap from the tube, reverse it and reapply to the tube to puncture the seal in the mouth of the tube. • Squeeze approximately 2.5 centimetres (1 inch) of the cream from the tube onto your finger • Rub the cream in and around the anus (back passage) as instructed by your doctor • Apply the cream twice per day (morning and evening) • Continue the treatment as prescribed by your doctor in this way until the fissures have healed • Once opened discard after 28 days

This product is for external use only.

Do not take orally.

Do not use for children. 

4. POSSIBLE SIDE EFFECTS 

Tell your doctor or healthcare professional about any other medicines you are taking before using Neozem cream.

All medicines may cause side effects and using Neozem cream can sometimes cause itching and soreness. If you do experience these side effects or anything unusual happens or the condition gets worse, consult your doctor or healthcare professional. 

5. HOW TO STORE NEOZEM CREAM 

Store in a refrigerator prior to, and during use. Do not freeze. Store in the original packaging.

Keep out of the reach and sight of children.

Do not use Neozem cream after the expiry date that is stated on the end of the tube and 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 healthcare professional how to dispose of medicines no longer required. These measures help to protect the environment.

6. FURTHER INFORMATION 

What Neozem 2% Cream contains 

• The cream contains 2% w/w Diltiazem hydrochloride as the active substance
• Other ingredients are: water, liquid paraffin, monopropylene glycol,cetostearyl alcohol, cremophor A6, cremophor A25 and phenoxyethano

What Neozem 2% cream looks like and contents of the pack 

Neozem is presented as a white, soft cream contained in an aluminium tube within a cardboard carton. It is available as a 30g pack.

Manufactured for NeoCeuticals Limited, The Innovation Centre, Innovation Way, Heslington, York YO10 5DG MS 20848 



This leaflet was last approved in 09/2012 NZCL01-4