ZEMPLAR 2 MICROGRAMS CAPSULES SOFT

Active substance: PARICALCITOL

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Zemplar® 2 microgram Capsules, Soft
Paricalcitol

1000007713

Package leaflet:Information for the user

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 or pharmacist.
- 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 or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Zemplar is and what it is used for
2. What you need to know before you take Zemplar
3. How to take Zemplar
4. Possible side effects
5. How to store Zemplar
6. Contents of the pack and further information
1. What Zemplar is and what it is used for
Zemplar is a synthetic form of active vitamin D.
Active vitamin D is required for the normal function of many tissues in the body, including
the parathyroid gland and bones. In people who have normal kidney function, this active
form of vitamin D is naturally produced by the kidneys, but in kidney failure the production of
active vitamin D is markedly reduced. Zemplar therefore provides a source of active vitamin
D, when the body cannot produce enough and helps to prevent the consequences of low
levels of active vitamin D, in patients with kidney disease (Stages 3, 4 and 5) namely high
levels of parathyroid hormone which can cause bone problems.
2. What you need to know before you take Zemplar
Do not take Zemplar
- if you are allergic (hypersensitive) to paricalcitol or any of the ingredients of Zemplar
(listed in section 6).
- if you have very high levels of calcium or vitamin D in your blood.
Your doctor will be able to tell you if these conditions apply to you.
Warnings and precautions
- Before the treatment begins, it is important to limit the amount of phosphorus in your diet.
- Phosphate-binding medicines may be needed to control phosphorus levels. If you are
taking calcium-based phosphate binders, the doctor may need to adjust your dose.
- Your doctor will need to do blood tests to monitor your treatment.
- In some patients with chronic kidney disease stages 3 and 4, an increase in the blood
levels of a substance called creatinine has been observed. However, this increase does
not reflect a reduction in renal function.
Other medicines and Zemplar
Please tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can affect the action of Zemplar or make side-effects more likely. It is
particularly important to tell your doctor if you are taking ketoconazole (used to treat fungal
infections such as candida or thrush), cholestyramine (used for lowering cholesterol levels),
medicines for the heart or for blood pressure (e.g. digoxin and diuretics or water pills) or
medicines containing high calcium levels. It is also important to mention if you are taking
medicines which contain magnesium or aluminium e.g. some types of indigestion medicines
(antacids) and phosphate-binders.
Ask your doctor or pharmacist for advice before taking any medicine.
Zemplar with food and drink
Zemplar may be taken with or without food.
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 taking this medicine.
There is no adequate data on the use of paricalcitol in pregnant women. Potential risk in
human use is not known, therefore paricalcitol should not be used unless clearly necessary.
It is not known if paricalcitol passes into human breast milk. Tell your doctor before breastfeeding while taking Zemplar.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Zemplar should not affect your ability to drive or use machines.
Zemplar contains ethanol
This medicine contains a small amount of ethanol (an alcohol), less than 100mg per capsule,
which may modify or increase the effect of other medicines. This could be harmful to people
who suffer from liver disease, alcoholism, epilepsy, brain injury, or disease as well as in
pregnant or breast-feeding women and children.
3. How to take Zemplar
Always take Zemplar exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Chronic Kidney Disease Stages 3 and 4
The usual dose is one capsule every day, or every other day, up to three times a week. Your
doctor will use the results of your laboratory tests to decide the correct dose for you. Once
Zemplar is started, the dose is likely to need adjusting, depending on how you respond to
treatment. Your doctor will help determine the correct dose of Zemplar for you.
Chronic Kidney Disease Stage 5
The usual dose is one capsule every other day, up to three times a week. Your doctor will
use the results of your laboratory tests to decide the correct dose for you. Once Zemplar is
started, the dose is likely to need adjusting, depending on how you respond to treatment.
Your doctor will help determine the correct dose of Zemplar for you.
Liver disease
If you have mild to moderate liver disease, your dose will not need to be adjusted. However,
there is no experience in patients with severe liver disease.
Use in children and adolescents
There is no information on the use of Zemplar Capsules in children.
Use in elderly
There is a limited amount of experience of using Zemplar in patients aged 65 years or older.
In general no overall differences in effectiveness or safety were seen between patients aged
65 years or older and younger patients.
If you take more Zemplar than you should
Too much Zemplar can cause abnormally high levels of calcium in the blood, which can be
harmful. Symptoms which can appear soon after taking too much Zemplar may include a
feeling of weakness and/or drowsiness, headache, nausea (feeling sick) or vomiting (being
sick), a dry mouth, constipation, pains in muscles or bones and a metallic taste in the mouth.
Symptoms which can develop over a longer period of taking too much Zemplar include loss
of appetite, drowsiness, weight loss, sore eyes, a runny nose, itchy skin, feeling hot and
feverish, loss of sex drive and severe abdominal pain (due to an inflamed pancreas) and
kidney stones. Your blood pressure may be affected and heart beat irregularities (palpitations)
can occur. The results of blood and urine tests may show high cholesterol, urea, nitrogen
and raised levels of liver enzymes. Zemplar may rarely cause mental changes including
confusion, drowsiness, insomnia or nervousness.
If you take too much Zemplar, or experience any of the above, seek medical advice
immediately.
If you forget to take Zemplar
If you forget to take a dose, take it as soon as you remember. However, if it is almost time
for your next dose, do not take the dose that you have missed; simply continue to take
Zemplar as previously directed (dose and time) by your doctor.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zemplar
Unless your doctor tells you to stop your treatment, it is important to keep taking Zemplar
as your doctor has directed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Zemplar can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects:
In patients with chronic kidney disease stage 3 and 4
The most common (at least 1 in 100 patients) include: rash and stomach discomfort.
Increase in the blood levels of a substance called calcium, as well as the amount of calcium
times the amount of another substance in the blood called phosphate (in patients with
significant chronic kidney disease) may occur.

Less commonly (at least 1 in 1000 patients), allergic reactions (such as shortness of breath,
wheezing, rash, itching or swelling of the face and lips), itchy skin and hives may occur,
as well as constipation, dry mouth, muscle cramps, dizziness and an unusual taste in the
mouth. Changes in liver function tests may also occur.
If you experience an allergic reaction, please contact your doctor immediately.
In patients with chronic kidney disease stage 5
The most common (at least 1 in 100 patients) side effects are diarrhoea, heartburn (reflux or
indigestion), decreased appetite, dizziness, breast pain and acne. Abnormal blood calcium
levels can also occur.
The most common (at least 1 in 100 patients) side effects seen in patients during use of
paricalcitol injection are: headache, unusual taste in the mouth, itching, decreased levels
of parathyroid hormone, increased levels of calcium, and increased levels of phosphorous.
Less common (at least 1 in 1000 patients) side effects seen in patients during use of
paricalcitol injection are: irregular heartbeat, prolonged bleeding, liver function test abnormal,
weight loss, heart stops beating, very fast heartbeat, low white blood cell count, low red
blood cell count, swollen glands, stroke, mini-stroke, coma, fainting, dizziness, twitching,
feeling of pins and needles, numbness, increased pressure in the eyes, pink eye, red eyes,
earache, water in the lungs, nose bleed, shortness of breath, wheezing, cough, low blood
flow to the intestines, anal bleeding, upset stomach, difficulty swallowing, irritable bowel
syndrome, diarrhoea, constipation, heartburn, vomiting, nausea, dry mouth, stomach
discomfort, itchy rash, rash, blister, hair loss, hair growth, night sweats, injection site pain,
skin burning sensation, joint pain, muscle pain, back pain, joint stiffness, muscle twitching,
high levels of parathyroid hormone, loss of appetite, decreased appetite, blood infection,
pneumonia, flu, cold, sore throat, vaginal infection, breast cancer, low blood pressure, high
blood pressure, chest pain, abnormal walk, swelling in the legs, swelling, chest discomfort,
fever, weakness, pain, tired, not feeling well, thirsty, feeling abnormal, breast pain, allergy,
difficulty having an erection, disturbance of consciousness, confused, anxious, can not
sleep, nervous, restless.
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 (see details below).
By reporting side effects, you can help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
5. How to store Zemplar
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Zemplar after the expiry date which is stated on the carton and label after
abbreviation EXP used for expiry date. This expiry date refers to the last day of that month.
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 further information
What Zemplar contains
- The active substance is paricalcitol. Each soft capsule contains 2 micrograms of
paricalcitol.
- The other ingredients are: medium chain triglycerides, ethanol, butylhydroxytoluene.
- The capsule shell contains: gelatin, glycerol, water, titanium dioxide (E 171), iron oxide
red (E 172) and iron oxide yellow (E 172).
- The printing ink contains: propylene glycol, black iron oxide (E172), polyvinyl acetate
phthalate, Macrogol 400, ammonium hydroxide.
What Zemplar looks like and contents of the pack
Zemplar Capsules, 2 micrograms, is an oval, orange-brown soft capsule imprinted with
and ZF.
Each carton contains either 1 or 4 foil blister packs. Each pack contains 7 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder in the UK is AbbVie Ltd, Abbott House, Vanwall Business
Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK
The Product Authorisation holder in Ireland is AbbVie Limited, Block B, Liffey Valley Offi ce
Campus, Quarryvale, Co. Dublin, Ireland
Manufacturer: Aesica Queenborough Ltd., Queenborough, Kent, ME11 5EL, United Kingdom
This leaflet was last revised in May 2014

1000007713

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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