2 microgram / ml injection solution 
alfacalcidol

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 or pharmacist.

– 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 or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Etalpha is and what it is used for

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

Etalpha injection is used to treat too high levels of parathyroid hormone if you suffer from kidney failure and receive dialysis .

Alphacalcidol contained in Etalpha 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.

2. What you need to know before you use Etalpha

Do not use Etalpha

  • if you are allergic to alphacalcidol 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 ( hypercalcaemia ).

Warnings and cautions

Talk to your doctor or pharmacist before using Etalpha.

For the following diseases, Etalpha 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
  • Disease that increases the sensitivity to vitamin D (eg sarcoidosis ).

During treatment with Etalpha, 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. In case of these symptoms you need to 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 Etalpha and digitalis glycosides (heart 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 medicines to prevent elevated phosphate levels in your blood during treatment with Etalpha .

Other medicines and Etalpha

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 Etalpha must be increased.

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

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

Etalpha with food and drink

Etalpha 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. Etalpha 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 .

Breast-feeding

Etalpha 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.

Breastfed newborns / infants to mothers treated with Etalpha should be closely monitored for elevated blood calcium levels.

Driving and using machines

The active substance in Etalpha has no direct effect on the ability to drive and 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.

Etalpha contains ethanol, sodium and propylene glycol

This medicinal product contains up to 160 mg alcohol ( ethanol ) per dose (a dose of 2 ml equivalent to 4 micrograms alpha-calcidol), corresponding to 10% by volume. The amount in a dose of this medicine corresponds to less than 4 ml of beer or 1.7 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.

This medicine contains 415 mg propylene glycol per ml, equivalent to 20.75 mg / kg / day (equivalent to 0.1 micrograms / kg / day alphacalcidol). If your child is younger than 4 weeks, consult a doctor or pharmacist before using the medicine, especially if the child is taking other medicines that contain propylene glycol or alcohol.

3. How to use Etalpha

Initially, 1 microgram is given after each dialysis , but a maximum of 3 micrograms / week. Dose one can then be increased at 1 week intervals by 1 microgram up to a maximum dose of 12 micrograms / week, or a maximum of 4 micrograms / dialysis.

Injection one is given for 30 seconds at the end of dialysis one. Dose one is determined based on the level of calcium in the blood.

Instructions for use

The solution should be shaken well before use.

If you take more Etalpha than you should

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to take Etalpha

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 or pharmacist.

4. Possible side effects

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

The most common side effects (affects more than 1 user in 100) are various types of skin reactions such as itching and rash, elevated calcium and phosphate levels in the blood and urine, and stomach pain / discomfort.

Uncommon side effects (affects less than 1 in 100 people) are confusion, headache, diarrhea, vomiting, constipation, nausea, fatigue, weakness, malaise, muscle aches, effects on kidney function and calcification of tissues .

A rare side effect (affecting less than 1 user in 1,000) is dizziness.

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.

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. Postal address

5. How to store Etalpha

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ºC – 8 ºC).

Store in the outer carton. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton 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-calcidol 2 micrograms per ml.
  • The other ingredients are: Water for injections, citric acid monohydrate, sodium citrate, ethanol and propylene glycol.

What the medicine looks like and contents of the pack

Solution for injection

Clear, colorless solution.

Ampoule containing:

10×0.5 ml

10×1 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

LEO Pharma AB

Box 404

201 24 Malmö

Tel. 040-35 22 00

Manufacturer

Cenexi SAS, 52, rue Marcel et Jacque Gaucher, 94120 Fontenay-sous-Bois, France

Muhammad Nadeem

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