0.25, 0.5, 1 microgram capsules, soft 
Alpha-Calcidol

Read all of this leaflet carefully before you start using this medicine.

– Save this information. 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. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

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

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

What Alfacalcidol Orifarm is and what it is used for

Alfacalcidol Orifarm belongs to a group of medicines called vitamin D analogs. It is a form of D vitamin. D vitamin controls the level of the two substances in your body. These substances are calcium and phosphate. Your body needs both substances for healthy bones and teeth.

Alfacalcidol Orifarm works by increasing the amount of vitamin D in your body. This means that the level of calcium and phosphate will also increase in your body.

Alfacalcidol Orifarm is used to treat diseases where the amount of calcium in the body needs to be changed. They are used to treat:

  • Bone changes due to renal impairment (osteodystrophy).
  • Changes in your parathyroid glands. These are small glands in your neck that produce a substance called parathyroid hormone which in turn changes the calcium content in your body.
  • Too low levels of calcium in the blood caused by the glands (hypoparathyroidism).
  • Bone softening and deformation due to calcium deficiency ( rickets or osteomalacia ).

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

What you need to know before you use Alfacalcidol Orifarm

Do not use Alfacalcidol Orifarm

  • If you are allergic (hypersensitive) to alpha-calcidiol or any of the other ingredients of this medicine (listed in section 6).
  • If you know you have hypercalcaemia . This means you have high levels of calcium in your blood.

If you are not sure if any of the above applies to you, talk to your doctor before taking Alfacalcidol Orifarm.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Alfacalcidol Orifarm if you:

  • have kidney problems. This includes kidney stones .
  • have atherosclerosis
  • have calcification of the heart valve or lung tissue
  • have a disease that increases the sensitivity to vitamin D (eg sarcoidosis )

Your blood calcium or phosphate levels may become too high if you take this medicine. Please read section 4 of this leaflet so that you know the symptoms that you are experiencing. Your doctor may need to change your dose .

While you are taking Alfacalcidol Orifarm, your doctor will take regular blood tests. This is done to check the calcium and phosphate levels in the blood while you are taking your medicine.

Your doctor may prescribe another medicine – a phosphate binder taken at the same time as Alfacalcidol Orifarm. This will help you maintain the right amount of phosphate in your blood.

Other medicines and Alfacalcidol Orifarm

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

You must tell your doctor or pharmacist if you are taking any of the following medicines:

  • Anticonvulsants (antispasmodics): for epilepsy or seizures. You may need a larger dose of Alfacalcidol Orifarm.
  • Barbiturates: for epilepsy . You may need a larger dose of Alfacalcidol Orifarm.
  • Cardiac glycosides such as digoxin: for heart problems. Your blood calcium level may be too high. This can cause an abnormal heart rhythm.
  • Cholestyramine: to lower cholesterol levels, or to help stop some forms of diarrhea or itching . Your Alfacalcidol Orifarm will not be able to reach your bloodstream normally.
  • Thiazide diuretics, often called “diuretic tablets”: to increase the amount of water (urine) that your body produces. Your blood calcium level may be too high.
  • Medicines containing magnesium that bind stomach acid (so-called antacids) and laxatives containing magnesium: Your magnesium level in the blood may be too high.
  • Calcium or preparations containing calcium . Your blood calcium level may be too high.
  • Other preparations containing vitamin D or its analogues . Their effects can be additive and your calcium level in the blood can become too high.
  • Preparations that contain aluminum (eg aluminum hydroxide, sucralfate) as Alfacalcidol Orifarm may increase the concentration of aluminum in your blood.

Alfacalcidol Orifarm with food, drink and alcohol

You can take the capsules with or without food.

Pregnancy, breastfeeding and fertility

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

Alfacalcidol Orifarm should not be used during pregnancy as it may harm the fetus. Use contraception during treatment with Alfacalcidol Orifarm. Talk to your doctor.

Breast-feeding

Your doctor will decide if you should use Alfacalcidol Orifarm while breast-feeding. Talk to your doctor.

Fertility

It is not known whether Alfacalcidol Orifarm affects fertility . Precautions should be taken. Talk to your doctor.

Driving and using machines

Usually, your medicine has very little effect on your 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 Orifarm contains sorbitol E420 and the color Allura Red AC (E129)

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

Alfacalcidol Orifarm 0.5 microgram capsules contain the azo dye Allura Red AC (E129). The substance may cause allergic reactions.

How to use Alfacalcidol Orifarm

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

The recommended dose is:

Adults and children weighing more than 20 kg:

The usual starting dose is 1 microgram daily. Your doctor will adjust the dose individually for you. Maintenance dose: 0.25 – 2 micrograms daily.

Children weighing less than 20 kg:

The usual starting dose is 0.05 micrograms per kilogram body weight daily. For example, a child with a body weight of 10 kg should be given a starting dose of 0.5 micrograms.

It is necessary to check the calcium and phosphorus levels in your blood through blood tests. Talk to your doctor.

If you have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 micrograms daily. Your doctor may prescribe another medicine called a calcium supplement to be taken with Alfacalcidol Orifarm. This will help maintain the right level of calcium in the blood.

Your calcium and phosphate levels in the blood may be too high. Please read section 4 of this leaflet so that you recognize the symptoms that you may experience.

If you forget to take Alfacalcidol Orifarm

If you forget to take your medicine, take it as soon as you remember. Then take the following dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Alfacalcidol Orifarm

In general, your treatment lasts for a long time. Alfacalcidol Orifarm should be taken regularly. Ask your doctor for advice if you want to stop taking the medicine.

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.

Serious side effects:

If you experience any of the following symptoms, seek medical attention immediately.

Headache, weakness, high blood pressure , loss of appetite, nausea, vomiting, diarrhea or constipation, large amounts of urine, sweating, dizziness, increased thirst ( polydipsia ), drowsiness, muscle and leg pain and metallic taste in the mouth. These symptoms can be caused by too high levels of calcium in your blood ( hypercalcaemia , may affect up to 1 in 10 people).

Low blood pressure and tendency to faint, calcification of the skin and subcutaneous tissue , as well as along the edge of the cornea. These symptoms can be caused by too high a phosphate level in the blood ( hyperphosphatemia , may occur in up to 1 in 100 users).

Calcification of ligaments and tendons (calcinosis, may occur in up to 1 in 100 users).

Other side effects:

Common side effects: may affect up to 1 in 10 people

Gastrointestinal pain and discomfort, rash, itching , increased urinary calcium ( hypercalciuria ).

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

Confusion, headache, diarrhea, vomiting, constipation, nausea, fatigue, weakness, discomfort, muscle aches and kidney stones . Renal impairment including acute renal failure .

Rare side effects are : may affect up to 1 in 1000 users

Dizziness

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alfacalcidol Orifarm

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. 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.

Alfacalcidol Orifarm 0.25 microgram capsules contain 0.25 micrograms of alfacalcidol.

Alfacalcidol Orifarm 0.5 microgram capsules contain 0.5 micrograms of alfacalcidol.

Alfacalcidol Orifarm 1 microgram capsule contains 1 microgram of alfacalcidol.

The other ingredients are: medium triglycerides; butyl hydroxyanisole (E320), butylhydroxytoluene (E321), gelatin, sorbitol, liquid (non-crystallizing) (E420), glycerol.

0.25 microgram capsules also contain titanium dioxide (E171).

0.5 microgram capsules also contain titanium dioxide (E171), yellow iron dioxide (E172), Allura Red AC (E129) and brilliant blue (E133).

1 microgram capsules also contain black iron oxide (E172) and red iron oxide (E172).

What the medicine looks like and contents of the pack

  • Alfacalcidol Orifarm 0.25 microgram capsules are oval, white opaque soft gelatin capsules.
  • Alfacalcidol Orifarm 0.5 microgram capsules are oval, red opaque soft gelatin capsules.
  • Alfacalcidol Orifarm 1 microgram capsules are oval, brown opaque, soft gelatin capsules.

Alfacalcidol Orifarm is available in blister packs of 98, 100, 98 x 1 or 100 x 1 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048,

102 17 Stockholm

info@orifarm.com

This medicinal product is authorized under the European Economic Area under the names:

Denmark Alphacalcidol Orifarm
Norway Alphacalcidol Orifarm
Finland Alphacalcidol Orifarm

Muhammad Nadeem

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