5 mg and 10 mg film-coated tablets
obeticholic acid
What Ocaliva is and what it is used for
Ocaliva contains the active substance obeticholic acid (farnesoid X receptor agonist ) which helps to improve the function of your liver by reducing the formation and accumulation of bile in the liver and also by reducing inflammation.
This medicine is used to treat adult patients with a type of liver disease called primary biliary cholangitis (also known as primary biliary cirrhosis ), either alone or in combination with another medicine, ursodeoxycholic acid.
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 bile ducts (liver, gallbladder and bile ducts).
Warnings and cautions
Talk to your doctor or pharmacist before taking Ocaliva.
Your doctor may need to adjust your dose of Ocaliva if your liver function deteriorates. Your doctor will take blood samples to check your liver function when you start treatment and regularly thereafter.
Itching can occur during treatment with Ocaliva and it can sometimes be severe (intense itching or itching over large parts of the body). Your doctor may prescribe other medicines to treat itching or adjust your dose of Ocaliva. Talk to your doctor if you experience itching that is difficult to tolerate.
Children and young people
This medicine is not intended 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, you should tell your doctor if you are taking so-called bile acid sequestrants (cholestyramine, colestipol, colesevelam) which are used to lower blood cholesterol levels as they may reduce the effect of Ocaliva. If you are taking any of these medicines, you should take Ocaliva at least 4 to 6 hours before or
4 to 6 hours after taking a bile acid-binding resin, so that it lasts as long as possible in between.
The doses for certain drugs such as Theophylline (a medicine that facilitates breathing) or tizanidine (a medicine that relieves muscle stiffness and inhibition) may need to be raised and must be checked by your doctor while you are taking Ocaliva. Your doctor may need to check how well your blood is coagulating (clotting) when you are taking medicines such as warfarin (a medicine that facilitates blood flow) together with Ocaliva.
Pregnancy
There is no experience with the use of Ocaliva during pregnancy. As a precautionary measure, do not take Ocaliva if you are pregnant.
Breast-feeding
It is not known if this medicine is excreted in human milk. Your doctor will decide if you should stop breastfeeding or stop/discontinue treatment with Ocaliva after taking into account the benefit of breastfeeding to your baby and the benefit of treatment to the woman.
Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines.
Ocaliva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to take Ocaliva
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended starting dose is one 5 mg tablet once a day or once a week, depending on your liver function. Swallowed.
Your doctor may adjust the dose based 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 a day or twice a week, depending on your liver function. Your doctor will discuss any dose change with you.
You can take Ocliva with or without food. If you are taking bile acid-binding resins, you should take this medicine at least 4 to 6 hours before or 4 to 6 hours after the bile acid-binding resin (see section “Other medicines and Ocaliva”).
If you take more Ocaliva than you should
If you accidentally take too many tablets, you may experience itching or liver side effects, such as yellowing of the skin. Contact a doctor immediately or go to a hospital for advice.
If you forget to take Ocaliva
Skip the missed dose one 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 product, ask your doctor or pharmacist.
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 itchy skin or that the itching worsens while you are taking this medicine. Skin itching is a very common side effect (may affect more than 1 in 10 people) that usually occurs within the first month after starting treatment with Ocaliva and usually becomes less severe over time.
Other possible side effects can be:
Very common side effects are
- magont
- feeling tired
Common side effects ( may affect up to 1 in 10 people)
- thyroid hormone disorders
- dizziness
- fast or irregular heartbeat (palpitations)
- pain in the mouth and throat
- constipation
- itchy, dry and / or red skin ( eczema )
- rash
- joint pain
- swelling of hands and feet
- fever
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 expiration date is the last day of the specified month.
No special storage instructions.
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.
Contents of the pack and other information
Content declaration
- The active substance is obeticholic acid.- Ocaliva 5 mg film-coated tablets: Each film-coated tablet contains 5 mg obeticholic acid.- Ocaliva 10 mg film-coated tablets: Each film-coated tablet contains 10 mg obeticholic acid.
- Other ingredients are:- Tablet core: Microcrystalline cellulose (E 460), sodium starch glycolate (type A) (see section 2, ‘Ocaliva contains sodium’), magnesium stearate.- Film coating: Partially hydrolysed polyvinyl alcohol, (E 1203), titanium dioxide (E 171), macrogol 3350 (E1521), talc (E 553b), yellow iron oxide (E 172).
What the medicine looks like and contents of the pack
- Ocaliva 5 mg is a yellow, 8 mm round film-coated tablet marked with “INT” on one side and “5” on the other side of the film-coated tablet.
- Ocaliva 10 mg is a yellow, 8 mm x 7 mm triangular film-coated tablet marked with “INT” on one side and “10” on the other side of the film-coated tablet.
Pack sizes
1 jar of 30 or 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Intercept Pharma International Ltd.
Ormond Building
31 – 36 Ormond Quay Upper
Dublin 7
Ireland
Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co.Louth
A91 P9KD
Ireland
Almac Pharma Services
Seagoe Industrial Estate
Portadown
Craigavon
BT63 5UA
UK
Millmount Healthcare Limited
Block-7, City North Business Campus
Stamullen
Co. Meath
K32 YD60
Ireland
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