Introduction

This information is for you if you are starting, or have already started taking a medicine called ciclosporin. This page contains important information on how to take this medication safely.

For most medicines, information is provided by the manufacturer in the medicine package. However, this medicine does not have a license to be used for ulcerative colitis in the UK. This means that the information provided by the manufacturer does not tell you everything you need to know. This leaflet has been designed to provide you with some extra information.

Unlicensed use

Some medicines have been licensed for a certain condition and then later, experience or research shows that it works well for a different condition. The manufacturer can choose whether to apply to the Government to have more recent information added to the license. This is expensive and in some situations it is not economically viable to extend the license.

Ciclosporin is an immunosuppressant made by the manufacturer to prevent organ rejection after transplant and for the treatment of rheumatoid arthritis and psoriasis. However, it is also useful in the treatment of ulcerative colitis.

What is ciclosporin and how does it work?

Ciclosporin works by suppressing the immune system, which is overactive in ulcerative colitis. When used in a severe flare of ulcerative colitis that has not responded to standard treatment for inflammatory bowel disease, including steroids, it has been demonstrated to reduce the need for surgical operations to remove the large bowel (known as a colectomy). 

Before starting treatment

Before starting treatment with ciclosporin your doctor should check if you have any allergies, if you are (or could be) pregnant, or breast feeding. Receiving treatment with ciclosporin while you are pregnant could harm your unborn baby. If you are of child-bearing potential you should ensure that you use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using the medicine, tell your doctor right away. 

Your doctor should check if you have any pre-existing medical conditions that could be complicated by treatment or if you take any medicines that may interact. 

Conditions which you should ensure your doctor is aware of include:

• Renal (kidney) or hepatic (liver) problems.
• Poorly controlled high blood pressure.
• Cancer.

What dose do I take?

The dose of ciclosporin is initially based on weight and may be adjusted according to the response and blood levels of the drug. Ciclosporin capsules are available as 10, 25, 50, or 100 mg strengths and you need to pay careful attention to the capsule strengths to achieve the correct dose. Ciclosporin is available in a liquid form if you have difficulty swallowing capsules. You should stay on the same brand of ciclosporin unless directed otherwise by your doctor.

How long will I take ciclosporin for?

Ciclosporin is usually a short-term (3-6 months) option as the risk of side effects increases with longer-term use. Most patients will be started on a medicine called a thiopurine (azathioprine or mercaptopurine) around the time of starting ciclosporin when there is evidence that symptoms are responding to ciclosporin treatment. The hope is that the thiopurine will take over from the ciclosporin and then keep the colitis in remission. You will receive information on this medicine if your consultant decides you need it. 

How should I take ciclosporin?

Some patients start ciclosporin intravenously (into the vein) when they are in hospital. If you respond well to the treatment, this is then changed to oral form (capsules or liquid) to take twice a day. Ideally the dose should be taken 12 hours apart. Capsules should be taken with water and swallowed whole. 

Grapefruit and grapefruit juice should be avoided as it can increase the ciclosporin levels in your blood.

How will I be monitored?

Regular blood tests will check the level of ciclosporin in the blood and also check that the kidneys and liver are working properly. These will be weekly initially, decreasing to fortnightly and then monthly once stable.

To measure the concentration of ciclosporin in the blood, the timing of the blood test is very important. We want to know the lowest drug level (drug trough level), which is 12 hours after your last dose, just before taking your next dose. Your ciclosporin drug level blood test should be planned for this trough level as best as possible. Your gastroenterology team at North Bristol NHS Trust will contact you if we need you to change your dose. 

Your blood pressure will be monitored regularly as ciclosporin may cause it to rise. These blood tests and blood pressure checks can be arranged with your GP surgery, and your GP will be informed of the monitoring you will need when you are on this medicine. The gastroenterology specialist pharmacists will be reviewing your blood results and will communicate any issues to you and your GP.

How will I get more prescriptions?

Ciclosporin can only be prescribed by a gastroenterology consultant or specialist registrar at North Bristol NHS Trust. 

The prescriber will ensure they provide you with enough medicine to last you until your next outpatient appointment. If you are running out of medications, or your dose changes and you require different strength capsules, contact the secretary for your consultant. Your GP will be informed that you are on this medication.

What are the common side effects?

The leaflet provided by the manufacturer for ciclosporin contains a list of all the effects reported for this medicine. It is very unlikely you will experience all the listed effects, but some of the most common side effects (occurring in more than 1 in 10 patients) are listed below:

• Headache.
• Increased hair growth.
• Slightly enlarged or sore gums.
• Shakiness of hands.
• Feeling sick.
• Reduced appetite.
• Metallic taste in the mouth.
• Cramps and painful periods – some women notice their periods cease whilst taking ciclosporin.

As ciclosporin suppresses the immune system, you are potentially at more risk of infections. If you develop a sore throat, any infections or begin to feel generally unwell contact your doctor, IBD nurse or pharmacist immediately.

What happens if I forget to take a dose? 

If you forget to take a dose, take another as soon as you remember, unless it is almost time for your next dose. Do not double dose. If you take too much tell your doctor immediately. 

Does ciclosporin interfere with other medication?

Ciclosporin can interact with other medications. Always tell your doctor that you are taking an immunosuppressant when any changes are made to your medication. You should also inform your dentist when you see them. Always check with your pharmacist before buying any over-the-counter medicines, alternative medicines or herbal remedies. Do not take aspirin or anti-inflammatory pain killers e.g. ibuprofen, unless prescribed by your doctor. 

Can I have vaccinations whilst I am taking ciclosporin?

You may not be able to have certain vaccinations whilst you are taking ciclosporin. All vaccinations may be less effective but live vaccines may also increase the risk of you developing the infection it’s protecting you from therefore should be avoided. Example of live vaccines are rotavirus, shingles, varicella, MMR (or any of the separate measles, mumps or rubella vaccines), yellow fever, oral typhoid and BCG. Discuss 
with your GP or IBD nurse before having any vaccinations.

For prescription queries please contact your consultants’ secretary or the gastro pharmacists/IBD nurses.

IBD advice line: 0117 4146354

Appointments helpline: 0300 5550103

© North Bristol NHS Trust. This edition published January 2024. Review due January 2027. NBT003124.

What is hepatitis B?

Hepatitis B is a serious inflammation of the liver that is caused by a viral infection.

It is spread by contact with blood and body fluids.

If you have long-term hepatitis B infection you can infect other people with the disease, even if you are well.

Around 1 in 5 people living with long-term hepatitis B will develop scarring of the liver. This happens over 10-20 years and is known as cirrhosis.

Why are people with chronic kidney disease at more risk of hepatitis B?

People with CKD are at an increased risk of hepatitis B infection because they are exposed to blood and body fluids during haemodialysis.

Some countries outside the UK have a higher rate of hepatitis B infection, so it is particularly important to be immunised if you plan to have haemodialysis abroad.

Procedures are in place to reduce the risk of hepatitis B infection across all sites supported by the Richard Bright Renal Unit, however the risk cannot be removed completely.

The Department of Health recommend that people with CKD are immunised against the hepatitis B virus. You won't have to pay for the vaccinations.

People who will need dialysis or may have a kidney transplant in the future are all offered immunisation.

People who have had a kidney transplant need to take medicines which dampen their immune system (immunosuppressive drugs). This makes it more difficult for their body to fight infection and can increase the risk of them developing a more severe hepatitis B infection.

The vaccine is safe for people on the kidney transplant waiting list.

Vaccination also prevents the disease spreading and causing harm to other people.

How is the vaccination Given?

The treatment involves a course of injections – which will be given in your upper arm, over a number of months. A nurse at your kidney unit clinic or haemodialysis unit will give you the injections.

The vaccination that will likely be given and the doses are described below, however there are other brands of vaccination available, so this may change. They will be given over a time period of six months.

Vaccination: HB VAX PRO 40®

• Dose: 40mcg/ml
• Total number of clinic visits: 3

Vaccination: ENERGIX B®

• Dose: 40mcg/ml = 2 X 20mcg/ml per dose
• Total number of clinic visits: 4

The doses of the vaccine used for people with chronic kidney disease are slightly higher than those used for people without kidney disease.

What happens when I have the vaccine?

The vaccination will encourage your body to produce antibodies to fight the hepatitis B virus – in case it  enters your blood stream. 

Your kidney doctor, pre-dialysis or dialysis nurse will arrange for you to have a blood test to measure your antibody level once you have completed the course of injections (2 months after you receive the third dose).

For your protection, it is recommended that your antibody level is greater than 100mlU/ml. 

A level between 10 & 100 mlU/ml – will still give you some protection, but your doctor/nurse may recommend a further injection of the hepatitis B vaccine (a booster).

If you are on haemodialysis your hepatitis B antibody levels will be measured every year. If you level drops below 10mlU/ml you may be advised to have a booster injection.

For the immunisation to be most effective – it is very important that you have the injections at the recommended time and complete the course. Your doctor/nurse will remind you when your injections are due. We can provide you with a hepatitis B vaccination card if you wish.

Does the vaccine have any side-effects?

As with any vaccine, you may have a reaction or experience side-effects. These may include the following:

Common (about 1 in 10 people): 

• Redness, tenderness, pain, and swelling at the injection site (this usually only lasts a few days).
• Headache. 

Uncommon (about 1 in 100 people): 

• Fever or flu-like symptoms.
• Skin rash.

Very rare (less than 1 in 10,000 people):

• Severe reaction: swelling of your face with difficulty breathing (anaphylactic reaction). 

Whoever gives you your vaccine will discuss possible side-effects with you. 

Who should not have the vaccine?

Before you have the first dose of the hepatitis B vaccine, please tell your doctor/nurse if you have had a severe reaction to any vaccine in the past.

If you have had a previous severe reaction to the hepatitis B vaccine you should not have another Hepatitis B vaccination.

If you have a high fever or severe infection when your vaccination is due, the vaccine should be given after you have recovered. If you have a minor infection like a cold – this should not be a problem with having the vaccination. You can discuss this with the nurse/doctor before you receive the jab.

There is no evidence of any risk from vaccinating pregnant or breastfeeding women against hepatitis B.

Further information 

Please speak to your kidney doctor or renal nurse if you are unsure of anything or if you have any further questions or website: Renal (Kidney) | North Bristol NHS Trust (nbt.nhs.uk)

NHS Website: Hepatitis B - NHS (www.nhs.uk)

© North Bristol NHS Trust. This edition published February 2024. Review due February 2027. NBT002096. 

GMC number: 3277304

Year & location of first qualification: 1991, Manchester University

Specialty: Dermatology

Clinical interests: Integration of Mental Health and the Skin

Secretary: Maria Mitsis

Secretary phone number: 0117 414 7594

GMC number: 7134237

Year & location of first qualification: 2011, MBChB University of Glasgow

Specialty: Stroke Medicine

Clinical interests: Stroke and Geriatric Medicine

Secretary: Janette Duggan

Secretary phone number: 0117 414 6698

GMC number: 7271871

Year & location of first qualification: Barts and the London, 2012

Specialty: Emergency Medicine, Paediatric Emergency Medicine

Clinical interests: Paediatric Emergency Medicine, Trauma, Education, Wellbeing

Secretary: Tina Allan

Secretary phone number: 0117 414 4112

GMC number: 7293875

Year & location of first qualification: 2012, Imperial College London

Specialty: Anaesthetics

Clinical interests: General, regional anaesthesia, perioperative medicine

Secretary: Anaesthetic Department Secretary team

Secretary phone number: 0117 414 0976 

James Matthams is a fellow of the Royal College of Anaesthetists and was appointed a Consultant in Anaesthetics at North Bristol NHS Trust in 2023.

He regularly delivers general anaesthesia across a broad range of surgical specialities. He has developed subspeciality interests in regional anaesthesia and perioperative medicine.

This information is for patients who have been referred by their GP for an upper abdomen ultrasound (scan). 

You must telephone the NBT Imaging department within 4 weeks of your GP referral. We will arrange an appointment at a convenient time for you at Southmead Hospital or one of our community sites. 

Our phonelines are open:

• Monday - Friday
• 08:30 - 16:00

Phone: 0117 414 8994

You should have a pen and paper ready to write down the date, time, and location of your appointment. 

If for any reason you need to change your appointment, please contact us on the number above. 

Before your abdomen scan

Please do not eat for at least 5 hours before your scan. 

You may drink clear fluids only, for example water. 

You may take your normal medication. 

If you are diabetic please contact us on 0117 4148994 as soon as possible and we can give you advice. 

If for medical reasons you need assistance with transport to and from your appointment, please contact us on 0117 4148994.

When you arrive 

If you are coming to Southmead Hospital, please follow the check-in process outlined in your appointment letter. 

If your appointment is at another community site, please book in at the Imaging or X-ray reception desk. 

The examination will be performed by a sonographer or radiologist. Each scan takes around 15-20 minutes. 

Once the scan is complete you may leave. A report will be sent to your GP, this is usually within 10 days. 

After the scan you may eat and drink normally. 

© North Bristol NHS Trust. This edition published February 2024. Review due February 2027. NBT003667.

This information is for patients who have been referred by their GP for a pelvic ultrasound (scan). 

You must telephone the NBT Imaging department within 4 weeks of your GP referral. We will arrange an appointment at a convenient time for you at Southmead Hospital or one of our community sites. 

Our phonelines are open:

• Monday - Friday
• 08:30 - 16:00

Phone: 0117 414 8994

You should have a pen and paper ready to write down the date, time, and location of your appointment. 

If for any reason you need to change your appointment, please contact us on the number above. 

Before your pelvic scan

You will need a full bladder for this examination. 

Please drink two pints of water or squash at least one hour before your appointment time and do not pass water (pee). 

Your appointment may also include an internal examination. This will be explained in detail by the staff performing the examination. 

If for medical reasons you need assistance with transport to and from your appointment, please contact us on 0117 414 8994.

When you arrive 

If you are coming to Southmead Hospital, please follow the check-in process outlined in your appointment letter. 

If your appointment is at another community site, please book in at the Imaging or X-ray reception desk. 

The examination will be performed by a sonographer or radiologist. Each scan takes around 15-20 minutes. 

Once the scan is complete you may leave. A report will be sent to your GP, this is usually within 10 days. 

© North Bristol NHS Trust. This edition published February 2024. Review due February 2027. NBT003668.

What is birth spacing or pregnancy spacing?

Pregnancy spacing is an essential part of family planning. The time between giving birth and getting pregnant again is called birth spacing, or pregnancy spacing.

This page has information about the importance of pregnancy spacing and will help you understand the factors you should consider before you conceive again. 

Following a pregnancy, a woman's body needs to rest. Pregnancy spacing is an essential part of family planning. 

Why is family planning important?

Being parents already, family planning takes on new meaning. Having another child can change your family's lives. Some questions you may want to think about:

• Are you ready to take care of a newborn again?
• How will your other child/children react to sharing your attention with a new baby?

While you and your partner might have preferences about how close in age you'd like your children to be, some research shows that how you space your pregnancies can affect the mother and baby’s health and development?  

Research shows that getting pregnant less than 12 months after a birth is associated with health risks for women of all ages. 

For most women, its best to wait at least 18 months between giving birth & getting pregnant again. 

This gives your body time to fully recover from your last pregnancy before it’s ready for your next.

What are the risks of spacing pregnancies close together? 

Research suggests beginning a pregnancy within 6 months of a previous birth, increases the risk for certain health problems for the mother and baby. 

These include the risk of: 

• Premature birth.
• Low birth weight.
• Stillbirth.
• Placenta partially or completely peeling away from the inner wall of the uterus before delivery (placental abruption).
• Congenital disorders.
• Mental health disorders.
• Maternal anaemia (anaemia for mother).

Closely spaced pregnancies might not give a mother enough time to recover from pregnancy before moving on to the next pregnancy. For example, pregnancy and breastfeeding can deplete your stores of nutrients, particularly folate. If you become pregnant before replacing those stores, it could affect you or your baby's health.  
Inflammation of the genital tract that develops during pregnancy and doesn't completely heal before the next pregnancy could also play a role.

What are the risks of spacing pregnancies far apart?

Some research also suggests that long intervals between pregnancies pose concerns for mothers and babies, such as an increased risk of pre-eclampsia in people with no history of the condition.

It's not clear why long pregnancy intervals might cause health problems. It's possible that pregnancy improves uterine capacity to promote foetal growth and support, but that over time these beneficial physiological changes disappear.

What’s the best interval between pregnancies?

To reduce the risk of pregnancy complications and other health problems, research suggests waiting 18 to 24 months, but less than five years after a live birth before attempting your next pregnancy. 

Balancing concerns about infertility, people older than 35 might consider waiting 12 months before becoming pregnant again. Choosing when to have another baby is a personal decision. When planning your next pregnancy, you and your partner might consider various factors in addition to the health risks and benefits. Until you decide about when to have another child, using a reliable method of contraception. 

If you have previously had a caesarean section, births that occurs 18 months or less apart, you have a higher risk of uterine rupture (this is an emergency, when the scar on the uterus opens prior to delivery). 

Health professionals will always support you in your choice, which will be about what is right for you and your pregnancy.

What else do I need to know about pregnancy spacing?

There is no perfect time to have another baby. Even with careful planning, you can't always control when conception happens. 

Discussing reliable contraception options until you are ready to conceive and understanding the possible risks associated with the timing of your pregnancies can help you make an informed decision about when to grow your family.

© North Bristol NHS Trust. This edition published March 2024. Review due March 2027. NBT003676.

Intrauterine contraception, known as a coil or IUD, is one of the most effective ways of preventing or delaying a further pregnancy.

It is possible to have this fitted at the time of a caesarean birth. It is inserted through the opening in the womb, after the placenta (afterbirth) has been removed.

Caesarean childbirth and coil fitting 

There are many benefits to having your contraceptive coil fitted at the time of your caesarean:

• It is very safe.
• It provides contraception immediately.
• It is painless - you will already have an anaesthetic for the operation.
• Either the hormone (LNG-IUD) or hormone free, copper coil (Copper-IUD) can be fitted.
• Both coils are safe to use while breastfeeding.

About the contraceptive coil

No contraceptive method is 100% effective, but the coil has a very low risk of failure (less than one pregnancy per 100 women over a year).

When a coil is fitted at the time of a caesarean there is a one in 1000 risk of injury to the womb (perforation) at the time of insertion and a one in 20 risk of the device falling out of the uterus afterwards.

There is a small chance of infection (one in 100) in the first few weeks following insertion, this is the same risk as if the coil was fitted later.

Types of contraceptive coil: 

Hormonal LNG-IUD

Copper IUD

Advice after your coil fitting: 

What to expect

You will need to have a follow up appointment in the hospital after your coil fit for a scan and possibly a thread trim. 

The scan is to confirm the coil remains correctly sited within the uterus once is has returned to its pre-pregnancy size. We would recommend using additional contraception until this follow up appointment has taken place.

When the coil is inserted at the time of a caesarean, there is a higher chance that the threads will not be seen in the vagina at the check-up visit. This does not affect how the coil works and most can be removed easily when required.

I think I can feel the threads, what to do?

I think my coil has come out, what to do?

When can I have sex again after having a coil inserted?

Post-partum contraception advice

If you are looking for further information or have any further questions or queries, please contact: 

Southmead Hospital if you give birth or due to give birth here: 

contraception@nbt.nhs.uk

St Michaels Hospital if you give birth or due to give birth here: 

stmikesLARC@ubhw.nhs.uk                

© North Bristol NHS Trust. This edition published March 2024. Review due March 2027. NBT003674.