Ocaliva - patient leaflet, side effects, dosage

Patient leaflet - Ocaliva

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Ocaliva 5 mg film-coated tablets

Ocaliva 10 mg film-coated tablets

obeticholic acid

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, pharmacist or nurse.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Ocaliva is and what it is used for

Ocaliva contains the active substance obeticholic acid (farnesoid X-receptor agonist) which helps to improve how your liver works by reducing the production and build up of bile in the liver and also reducing inflammation.

This medicine is used to treat adult patients with a type of liver disease known as primary biliary cholangitis (also known as primary biliary cirrhosis), either by itself or together with another medicine, ursodeoxycholic acid.

2. What you need to know before you take Ocaliva

Do not take Ocaliva

– if you are allergic to obeticholic acid or any of the other ingredients of this medicine (listed in section 6).
– if you have a complete blockage of the biliary tract (liver, gallbladder and bile ducts).

Warnings and precautions

Talk to your doctor or pharmacist before taking Ocaliva.

Your doctor may need to adjust your dose of Ocaliva if your liver function gets worse. Your doctor will do blood tests to monitor the health of your liver when you start treatment and regularly from there on.

Itching may occur when taking Ocaliva and may sometimes become severe (intense itching or itching over much of your body). Your doctor may prescribe other medicines for treatment of itching or adjust your dose of Ocaliva. If you experience itching that is difficult to tolerate, talk to your doctor.

Children and adolescents

This medicine is not for use in children or adolescents.

Other medicines and Ocaliva

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

In particular, tell your doctor if you are taking so-called bile acid binding resins (cholestyramine, colestipol, colesevelam) used to lower blood cholesterol levels as they may lessen the effect of Ocaliva. If you take any of these medicines, take Ocaliva at least 4 to 6 hours before or 4 to 6 hours after taking bile acid binding resin, giving as much time as possible.

The levels of some medicines such as theophylline (a medicine to help breathing) or tizanidine (a medicine to relieve the stiffness and restriction of muscles) may be increased and need to be monitored by your doctor while taking Ocaliva. Your doctor may need to monitor how well your blood clots when taking medicines such as warfarin (a medicine to help your blood flow) with Ocaliva.

Pregnancy

There is no experience using Ocaliva in pregnancy. As a precautionary measure, you should not take Ocaliva if you are pregnant.

Breast-feeding

It is not known if this medicine passes into human milk. Your doctor will determine whether you should discontinue breast-feeding or discontinue/abstain from Ocaliva therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.

Driving and using machines

This medicine has no or negligible influence on your ability to drive or use machines.

Ocaliva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Ocaliva

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

The recommended starting dose is one 5 mg film-coated tablet once daily or once weekly by mouth, depending on your liver function.

Your doctor may adjust your dose depending on your liver function or if you experience itching that is difficult to tolerate.

Depending on your body’s response after 3 or 6 months, your doctor may increase your dose to 10 mg once daily or twice weekly, depending on your liver function. Your doctor will discuss any change of dose with you.

If you take more Ocaliva than you should

If you accidentally take too many tablets, you may experience itching or liver-related side effects such as yellowing of the skin. Contact a doctor or go to a hospital for advice immediately.

If you forget to take Ocaliva

Skip the missed dose and take your next dose when you would normally take it. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Ocaliva

You should continue to take Ocaliva for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.

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

4. Possible side effects

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

Tell your doctor or pharmacist if you experience itching of the skin (pruritus) or if the itch gets worse while on this medicine. In general itching of the skin is a very common (may affect more than 1 in 10 people) side effect that begins within the first month following the start of treatment with Ocaliva and usually becomes less severe over time.

Other possible side effects may be:

Very common side effects

stomach pain
feeling tired

Common side effects (may affect up to 1 in 10 people)

thyroid hormone irregularity
dizziness
fast or irregular heart beat (palpitations)
pain in the mouth and throat
constipation
itchy, dry and/or red skin (eczema)
rash
pain in your joints
swelling in the hands and feet
fever

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ocaliva

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 bottle after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

What Ocaliva contains

The active substance is obeticholic acid.
– Ocaliva 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of obeticholic

acid.

– Ocaliva 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of obeticholic