1 and 2 micrograms soft capsule
paricalcitol
What Paricalcitol Alternova is and what it is used for
Paricalcitol Alternova contains the active substance paricalcitol, which is a synthetic form of active vitamin D.
Active vitamin D is needed for many of the body’s tissues, including the parathyroid gland and skeleton, to function normally. In people who have normal kidney function, this active form of vitamin D is produced naturally in the kidney, but in renal failure, the production of active vitamin D is markedly reduced. Paricalcitol Alternova therefore actively supplies vitamin D, when the body cannot produce enough. Paricalcitol Alternova helps prevent the effects of low vitamin D levels, namely high levels of parathyroid hormone, which can cause skeletal problems. Paricalcitol Alternova is used by adult patients with stage 3, 4, and 5 kidney disease and by children from 10 to 16 years of age with stage 3 and 4 kidney disease.
Paricalcitol contained in Paricalcitol Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Paricalcitol Alternova
Do not use Paricalcitol Alternova:
- if you are allergic to paricalcitol or any of the other ingredients of this medicine (listed in section 6).
- if you have very high calcium or vitamin D levels in your blood.
Your doctor can tell you if this applies to you.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Paricalcitol Alternova.
- Before starting treatment, it is important to reduce the amount of phosphate in your diet.
- Phosphate-binding drugs may be needed to control phosphate levels. If you are taking calcium-based phosphate binders, your doctor may need to adjust the dosage.
- Your doctor will need to take blood samples to check your treatment.
- In some patients with stage 3 and 4 chronic kidney disease, an increase in creatinine has been seen in the blood. However, this increase does not mean that kidney function has deteriorated.
Other medicines and Paricalcitol Alternova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the way this medicine works or increase the risk of side effects. It is especially important to tell your doctor if you are taking any of the following medicines:
- medicines for fungal infections such as candida or cod (eg ketoconazole ),
- heart or blood pressure medicines (eg digoxin and diuretics or diuretics ),
- drugs that contain a source of phosphate (eg drugs to lower the level of calcium in the blood),
- medicines containing calcium or vitamin D, including supplements and multivitamins that can be bought without a prescription,
- medicines containing magnesium or aluminum (eg certain types of medicines for acid stomachs called antacids) and phosphate binders,
- drugs to treat elevated cholesterol levels (eg cholestyramine).
Paricalcitol Alternova with food and drink
Paricalcitol Alternova can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate data on the use of paricalcitol in pregnant women. The risk to humans is unknown and therefore paricalcitol should be used during pregnancy only when needed.
Breast-feeding
It is not known if paricalcitol passes into breast milk. Talk to your doctor before breastfeeding if you are taking Paricalcitol Alternova.
Driving and using machines
Paricalcitol Alternova should not affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Paricalcitol Alternova contains excipients
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per capsule, which may reduce or increase the effect of other medicines. This can be harmful to people who have liver disease, alcoholism, epilepsy, brain damage or disease, and pregnant or breastfeeding women and children.
How to use Paricalcitol Alternova
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Chronic kidney disease stage 3 and 4
The usual starting dose for adult patients is one capsule a day, either daily or every other day, up to three times a week.
Your doctor will use the results of your laboratory tests to determine what is the right dose for you. At the beginning of treatment with Paricalcitol Alternova, a dose may need to be adjusted according to how you respond to the treatment. Your doctor will decide on the right dose of Paricalcitol Alternova for you.
Chronic kidney disease stage 5
The usual starting dose for adult patients is one capsule every other day, up to three times a week. Your doctor will use the results of your laboratory tests to determine what is the right dose for you. At the beginning of treatment with Paricalcitol Alternova, a dose may need to be adjusted according to how you respond to the treatment. Your doctor will decide on the right dose of Paricalcitol Alternova for you.
Liver disease
If you have mild or moderate liver disease, your dose will not need to be changed. However, there is no experience in patients with severe liver disease.
Kidney transplant patients
The usual dose is one capsule a day, either every day or every other day three times a week. Your doctor will use the results of your laboratory tests to determine the correct dose for you. Once treatment with Paricalcitol Alternova has started, dose one will likely need to be changed, depending on how you respond to treatment. Your doctor will decide which dose of Paricalcitol Alternova is right for you.
Use for children and adolescents
For children aged 10 to 16 years with chronic kidney disease Stage 3 or 4, the normal starting dose is one capsule every other day up to three times a week. Your doctor will use the results of your laboratory tests to determine the right dose for you. Once treatment with Paricalcitol Alternova has started, the dose may need to be adjusted according to how you respond to treatment. Your doctor will help determine what is the right dose for you.
The effect of Paricalcitol Alternova in children with chronic stage 5 kidney disease has not been established.
There is no information on the use of Paricalcitol Alternova in children under 10 years of age.
Use for the elderly
There is limited experience with the use of paricalcitol in patients 65 years of age and older. In general, there was no difference in safety and efficacy in the treatment of elderly patients (65 years and older) and younger patients.
If you take more Paricalcitol Alternova than you should
If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor or hospital immediately for an assessment of the risk and advice.
Too much Paricalcitol Alternova can cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may occur after taking too much Paricalcitol Alternova may be feeling weak and/or drowsy, headache, nausea or vomiting, dry mouth, constipation, muscle or skeletal pain, and a metallic taste in the mouth.
Symptoms that may occur if you take too much Paricalcitol Alternova for a long period may include loss of appetite, drowsiness, weight loss, eye pain, runny nose, itchy skin, fever, impotence, and severe stomach pain (due to the inflamed pancreas ) and kidney stones. Your blood pressure may be affected and irregular heartbeat (palpitations) may occur. Results of blood and urine tests may show high levels of cholesterol, urea, nitrogen, and liver enzymes. Paricalcitol Alternova can in rare cases cause mental changes including confusion, drowsiness, insomnia, and nervousness.
If you forget to take Paricalcitol Alternova
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next capsule, do not take the capsule you forgot, but continue treatment according to your doctor’s prescription ( dose and time).
Do not take a double dose to make up for a forgotten dose.
If you stop taking Paricalcitol Alternova
Unless your doctor tells you to stop treatment, you must continue to take Paricalcitol Alternova as your doctor prescribes it.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important: Contact your doctor immediately if you get any of the following side effects:
- allergic reactions (eg shortness of breath, wheezing, rash, itching, or swelling of the face and lips)
Tell your doctor or nurse if you experience any of the following side effects:
Common (may affect up to 1 in 10 people):
- elevated levels of calcium in the blood, as well as the amount of calcium with another substance in the blood called phosphate (in patients with severe chronic kidney disease)
- levels of phosphate in the blood can also increase
Uncommon (may affect up to 1 in 100 people):
- Pneumonia
- decreased levels of parathyroid hormone
- loss of appetite
- decreased levels of calcium
- dizziness
- taste changes
- headache
- irregular heartbeat
- stomach upset or stomach pain
- constipation
- diarrhea
- dry mouth
- heartburn (reflux or indigestion)
- nausea
- vomiting
- acne
- itching
- rash
- hives
- muscle cramps
- muscle pain
- sore breasts
- feeling weak
- fatigue, feeling of discomfort
- swelling of the legs
- pain
- increased levels of creatinine
- changes in liver function results
Contact your doctor immediately if you have an allergic reaction.
How to store Paricalcitol Alternova
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
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 paricalcitol. Each soft capsule contains 1 microgram or 2 micrograms.
- The other ingredients are Medium-chain triglycerides, ethanol (alcohol) anhydrous, and butylhydroxytoluene.
- The shell of the capsule contains Gelatin; glycerol, anhydrous; titanium dioxide (E171).
1 microgram capsule: iron oxide, black (E172)
2 micrograms capsule: iron oxide, yellow (E172); iron oxide, red (E172)
What the medicine looks like and the contents of the pack
Appearance
Paricalcitol Alternova 1 microgram soft capsule is a gray, oval, soft gelatin capsule.
Paricalcitol Alternova 2 micrograms soft capsules are light brown, oval, soft gelatin capsule.
Pack sizes
Blister: 7, 28, or 30 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark
Manufacturer
GAPSA Agisilaou Str. 46, 17341 A Agios Dimitirum, Athens, Greece.
and
Reform SA, These Poussi Hantzi, 19002 Paiania, Athens, Greece.
and
Viminco A / S, Lodshusvej 11, 4230 Skælskør, Denmark.
This medicinal product is authorized under the European Economic Area under the names:
Portugal: Paricalcitol Rafarm UK
Cyprus: Rexton
Spain: Paricalcitol Aurovitas Spain 1 microgram EFG mixed capsules
Czech Republic: Rikalpa