0.25 and 0.50 microgram capsules, soft 
alpha-calcidol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Alfacalcidol Alternova is and what it is used for 
2. What you need to know before you use Alfacalcidol Alternova 
3. How to use Alfacalcidol Alternova 
4. Possible side effects 
5. How to store Alfacalcidol Alternova 6. Contents of the pack 
and other information 

What Alfacalcidol Alternova is and what it is used for

Alfacalcidol is used when the body produces too little D vitamin. D vitamin is necessary for the body to absorb calcium. Alpha-calcidiol can normalize calcium levels and counteract the deficiency symptoms (fatigue, muscle weakness, itching, and depression).

Alfacalcidol contained in Alfacalcidol Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Alfacalcidol Alternova

Do not use Alfacalcidol Alternova

  • if you are allergic to alfacalcidol or any of the other ingredients of this medicine (listed in section 6).
  • if you have too high a level of calcium in your blood (hypercalcemia).

Warnings and cautions

Talk to a doctor, pharmacist, or nurse. before using Alfacalcidol Alternova.

For the following diseases, Alfacalcidol Alternova should be used with caution, therefore you should inform your doctor before treatment if you have:

  • Kidney stone
  • Arteriosclerosis
  • Calcification of heart valve or lung tissue
  • A disease that increases the sensitivity to vitamin D (eg sarcoidosis ).

During treatment with Alfacalcidol Alternova, the levels of calcium and phosphate in the blood should be checked.

For the following conditions, pay extra attention:

  • If you experience decreased appetite, fatigue, nausea and vomiting, constipation or diarrhea, large amounts of urine, sweating, headaches, strong thirst, high blood pressure, drowsiness, and dizziness, you may have elevated calcium levels in your blood. If you have these symptoms, talk to your doctor.
  • If you have high levels of calcium in your blood, caused by vitamin D intake, and at the same time use Alfacalcidol Alternova and digitalis glycosides (cardiac medicine increases the risk of affecting the heart rhythm).
  • If you suffer from incomplete or deficient bone tissue formation ( renal osteodystrophy ) or severe renal impairment, you may need to take phosphate-binding drugs and to prevent elevated phosphate levels in your blood during treatment with Alfacalcidol Alternova.

Other medicines and Alfacalcidol Alternova

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

Concomitant treatment with agents for the treatment of epilepsy ( barbiturate s, phenytoin, primidone, or carbamazepine) may cause the dose of Alfacalcidol Alternova must be increased.

Concomitant use of cholestyramine (used in cases of elevated blood lipids and diarrhea) may impair the uptake of Alfacalcidol Alternova. Alfacalcidol Alternova should therefore be taken at least 1 hour before, or 4 to 6 hours after cholestyramine.

As Alfacalcidol Alternova may increase the uptake of magnesium, magnesium-containing antacids (preparations that relieve heartburn and acid reflux should not be used during treatment, as this may lead to elevated levels of magnesium in the blood).

Concomitant use of other vitamin D-containing preparations, thiazide diuretics, or calcium-containing preparations may increase the risk of increased calcium levels in the blood.

Aluminum levels in the blood can be increased by Alfacalcidol Alternova. If you are taking aluminum-containing preparations at the same time, your aluminum levels in the blood should be checked.

Alfacalcidol Alternova with food and drink

Alfacalcidol Alternova can be taken independently of food.

Pregnancy and breastfeeding

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.

Pregnancy :

Limited experience of use during pregnancy. Alfacalcidol Alternova should not be used during pregnancy unless clearly necessary. Elevated blood calcium levels during pregnancy can cause birth defects in the baby. Caution should be exercised when treating women of childbearing potential.

Breastfeeding :

Alfacalcidol Alternova is excreted in human milk. A decision on whether to discontinue breast-feeding or whether to discontinue/discontinue treatment may be made taking into account the benefit of breast-feeding for the child and the benefit of treatment for the woman.

Newborns/infants of mothers treated with Alfacalcidol Alternova should be closely monitored for elevated blood calcium levels.

Driving and using machines

The active substance in Alfacalcidol Alternova has no direct effect on the ability to drive or use machines. As dizziness can be a side effect of the treatment, you should take this into account when driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Alfacalcidol Alternova contains sorbitol

Alfacalcidol Alternova 0.25 micrograms contains 19.2 mg sorbitol per capsule.

Alfacalcidol Alternova 0.5 micrograms contains 15.7 mg sorbitol per capsule.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Alfacalcidol Alternova 0.5 micrograms contain Allura Red AC (E129)

Alfacalcidol Alternova 0.5 micrograms also contain the dye Allura red AC (E129) which may cause allergic reactions.

How to use Alfacalcidol Alternova

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for the patient.

The usual dose for adults and for children weighing more than 20 kg

Initially 1-2 micrograms per day. Maintenance dose: 0.25–2 micrograms per day.

The usual dose for children weighing less than 20 kg

Initially 0.05 micrograms per kg and day.

The capsules should be swallowed whole with a glass of water.

If you forget to take Alfacalcidol Alternova

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Contact a doctor immediately if any of the following serious side effects occur:

(Uncommon side effects that may affect up to 1 in 100 people.)

  • Nausea, vomiting, fluid retention in the body ( edema ), decreased urine output, or inability to urinate. These symptoms may be signs of impaired kidney function.
  • Pain, often on the side and back of the lower back, possibly accompanied by blood in the urine. This may be a sign of kidney stones.

Other side effects that may occur:

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

  • Elevated calcium levels in the blood. Symptoms that can be noted in connection with elevated calcium levels in the blood are decreased appetite, fatigue, nausea and vomiting, constipation or diarrhea, large amounts of urine, sweating, headache, strong thirst, high blood pressure, drowsiness, and dizziness. If you experience any of the above symptoms, ask your doctor for a check-up.
  • Elevated calcium levels in the urine.
  • Elevated phosphate levels in the blood.
  • Stomach pain and stomach discomfort.
  • Different types of skin reactions such as skin rash and itching.

Less common side effects are (may affect up to 1 in 100):

  • Confusion.
  • Headache.
  • Diarrhea, vomiting, constipation, nausea.
  • Muscle aches.
  • Fatigue, weakness, malaise.
  • Calcium deposits in your tissues.

Rare side effects are (may affect up to 1 of 1000 users):

  • Dizziness.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Alfacalcidol Alternova

Do not store above 30 ° C.

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 blister 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is Alpha-calcidiol 0.25 micrograms and 0.5 micrograms per capsule, respectively.
  • Other ingredients are:

0.25 micrograms:

Gelatin, glycerol, titanium dioxide (dye E171), medium-chain triglycerides, sorbitol, purified water, butyl hydroxyanisole, butylhydroxytoluene.

0.5 micrograms:

Gelatin, glycerol, yellow iron oxide (dye E172), titanium dioxide (dye E171), medium-chain triglycerides, sorbitol, purified water, butyl hydroxyanisole, butylhydroxytoluene, Brilliant blue FCF (dye E133), Allura red AC (dye AC) (dye

What the medicine looks like and the contents of the pack

Appearance

Alfacalcidol Alternova 0.25 micrograms: Soft, white, oval capsule, approx. 10 mm long and approx. 7 mm wide.

Alfacalcidol Alternova 0.5 micrograms: Soft, red, oval capsule, approx. 10 mm long and approx. 7 mm wide.

Pack sizes

Blister pack: 30 and 100 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

Viminco A / S, Lodshusvej 11, 4230 Skælskør, Denmark

Or

Orifarm Generics A / S, Energivej 15, 5260 Odense S, Denmark

Muhammad Nadeem

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