The active substance in Paricalcitol is paricalcitol. Paricalcitol is a synthetic (man made) replacement for vitamin D. In healthy people, the active form of vitamin D is naturally produced by the kidneys but in kidney failure, the production of the active vitamin is reduced, which can cause low levels of calcium and high levels of parathyroid hormone in the blood. Paricalcitol is used to replace the body’s naturally produced active form of vitamin D.

Paricalcitol is used for the prevention and treatment of secondary hyperparathyroidism (high levels of parathyroid hormone which can cause bone problems) in patients undergoing haemodialysis as a result of kidney failure.

If you have secondary hyperparathyroidism you may find that:

• You feel weak or tired
• You have a decreased appetite
• You feel nauseous or you vomit
• You have bone or muscle pain
• You need to go to the toilet frequently

Do not use Paricalcitol

• if you are allergic (hypersensitive) to paricalcitol or any of the other ingredients of Paricalcitol (see section 6).

• if you have very high levels of calcium or vitamin D in your blood. Your doctor will monitor your blood levels and be able to tell you if these conditions apply to you.

Take special care with Paricalcitol

• Before the treatment begins, it is important to limit the amount of phosphorus in your diet. Examples of foods high in phosphorous include tea, soda, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereals, nuts, and grains.

• Phosphate-binding medicines, which keep phosphate from being absorbed from your food, 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.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines can affect the action of Paricalcitol or make side effects more likely. It is particularly important to tell your doctor if you are taking any of the following medicines:

• to treat fungal infections such as candida or thrush, (i.e., ketoconazole)

• to treat heart or blood pressure (e.g. digoxin and diuretics or water pills).

• that contain magnesium (e.g. some types of indigestion medicines called antacids, such as magnesium trislilicate).

• that contain aluminium (e.g. phosphate-binders, such as aluminium hydroxide).

Ask your doctor, nurse, or pharmacist for advice before taking any medicine.

Using Paricalcitol with food and drink

Paricalcitol can be used before, after or during a meal. It is very important to follow the diet recommended by your doctor to get the most benefit from the treatment and to prevent serious side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless your doctor tells you to do so.

Pregnancy and breast-feeding

If you are pregnant or thinking of becoming pregnant, tell your doctor before taking Paricalcitol.

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 if you are breast-feeding.

Your doctor will decide if this treatment is necessary for you.

Driving and using machines

Paricalcitol may make you feel dizzy or confused; your ability to drive or operate machinery may be affected. Do not drive or use machines till you know how this medicine affects you.

Important information about some of the ingredients of Paricalcitol

This medicinal product contains 11 vol % ethanol (alcohol), equivalent to 2ml beer, 1 ml wine per dose.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

The usual dose is calculated by your doctor. The dosage of Paricalcitol varies for each patient. Your doctor will use the results of your laboratory tests to decide on the correct dose for you. Once Paricalcitol is started, the dose may need to be adjusted, depending on how you respond to treatment.

Method of Administration

Paricalcitol will be administered intravenously (into the vein via a needle) by your doctor whilst you are having haemodialysis.

Paricalcitol will not be given to you more than once every other day.

Use of Paricalcitol in children

There is no information on using Paricalcitol in children under 5 years of age, and there is limited experience in children over 5 years of age.

Your doctor will decide if this treatment is necessary

If you use more Paricalcitol than you should

Too much Paricalcitol may lead to high levels of calcium in the blood that may require treatment. Symptoms which can appear soon after receiving too much Paricalcitol include:

• feeling weak and/or drowsy

• headache

• feeling sick or being sick

• dry mouth, constipation

• pain in muscles or bones

• unusual taste in the mouth

Symptoms which can develop over a longer period of receiving too much Paricalcitol include:

• loss of appetite

• drowsiness

• weight loss

• sore eyes

• runny nose

• itchy skin

• feeling hot and feverish

• loss of sex drive

• severe abdominal pain

• kidney stones

• Your blood pressure may be affected and awareness of your own heartbeat (palpitations) can occur.

Paricalcitol contains Propylene glycol as an ingredient. Cases of poisonous effects related to the high doses of Propylene glycol have only rarely been reported and would not be expected when being given to kidney patients on a kidney machine because Propylene glycol is removed from the blood during dialysis.

However, your doctor will be checking your blood levels and if you experience any of the above seek medical advice immediately.

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

Various allergic reactions have been seen with Paricalcitol. Important: Tell your doctor or nurse immediately if you notice any of the following side effects:

• Shortness of breath

• Difficulty breathing or swallowing

• Wheezing

• A rash, itchy skin, or hives

• Swelling of the face, lips, mouth, tongue or throat.

Tell your doctor or nurse if you notice any of the following side effects:

Common (affects 1 to 10 users in 100):

• headache

• unusual taste in the mouth

• itchy skin

• low levels of parathyroid hormone

• high levels of calcium (feeling sick or being sick, constipated or confused); phosphorous in the blood

(probably no symptoms but it can make bones more likely to break)

Uncommon (affects 1 to 10 users in 1,000):

• allergic reactions (such as shortness of breath, wheezing, rash, itching or swelling of the face and lips); itchy blisters

• blood infection; decreased number of red cells (anaemia – feeling weak, shortness of breath, looking pale); decreased number of white cells (more likely to get infections); swollen glands in the neck, armpit and/or groin; increased bleeding time (blood will not clot so quickly)

• heart attack; stroke; chest pain; irregular/fast heartbeat; low blood pressure; high blood pressure;

• coma (a deep state of unconsciousness during which the person cannot respond to the environment)

• unusual tiredness, weakness; dizziness; fainting

• injection site pain

• pneumonia (lung infection); fluid on the lungs; asthma (wheezing, cough, difficulty breathing);

• sore throat; cold; fever; flu-like symptoms; pink eye (itchy/crusty eyelids); increased pressure in the eye; earache; nose bleeds

• nervous twitches; confusion, which is sometimes severe (delirium); agitation (feeling jittery, anxious); nervousness; personality disorders (not feeling like yourself);

• tingling or numbness; decreased touch sensation; problems sleeping; sweating at night; muscular spasms in arms and legs, even during sleep;

• dry mouth; thirsty; nausea; difficulty swallowing; vomiting; loss of appetite; weight loss; heart burn; diarrhoea and stomach ache; constipation: bleeding from the rectum;

• difficulty having an erection; breast cancer; infections in the vagina

• breast pain; back pain; joint/muscular pain; feeling of heaviness caused by general swelling or localised swelling of the ankles, feet and legs (oedema); abnormal way of walking;

• hair loss; excessive hair growth,

• increase of a liver enzyme; high levels of parathyroid hormones; high levels of potassium in the blood; low levels of calcium in the blood.

Unknown Frequency:

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing; itchy skin (hives). Stomach bleeding. Get medical help immediately

You may not be able to tell if you have some of the side effects listed above unless you are told so by your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep Paricalcitol out of the reach and sight of children.

Do not use Paricalcitol after the expiry date which is stated on the carton and the ampoule or vial after EXP. The expiry date refers to the last day of that month.

Paricalcitol should be clear and colorless. Do not use if the solution is discolored or has particles.

This medicinal product does not require any special storage conditions.

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.