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COLECALCIFEROL 800 IU FILM-COATED TABLETS - Patient leaflet, side effects, dosage

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Patient leaflet - COLECALCIFEROL 800 IU FILM-COATED TABLETS

2. what you need to know before you

TAKE COLECALCIFEROL

FILM-COATED TABLETS

Do not take Colecalciferol Film-coated Tablets if:

  • if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6)
  • if you have high levels of calcium in your blood or urine
  • if you have kidney stones or calcium deposits in your kidneys
  • if you have severe renal impairment
  • if you are already taking additional doses of vitamin D (e.g. multivitamins or food supplements containing vitamin D).

Warnings and precautions

If any of the following applies to you, please tell your doctor:

  • You have a high tendency to kidney stone formation
  • You have cancer or any other condition that may have affected your bones
  • You have parathyroid hormone imbalance (pseudo-hypoparathyro­idism).

If you have any of the following conditions, your doctor will monitor the levels of calcium or phosphate in your blood, or the level of calcium in your urine:

  • If you are on long term treatment with this medicine
  • If you have kidney problems
  • If you suffer from “sarcoidosis”; an immune system disorder which may affect your liver, lungs, skin or lymph nodes.

Other medicines and Colecalciferol Film-coated Tablets

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

In particular, tell your doctor if you are taking any of the following medicines:

  • diuretics (water tablets) – your blood calcium

levels will be monitored regularly

  • corticosteroids (‘steroids’ e.g. prednisolone, dexamethasone) – your dose of Vitamin D may need to be increased
  • cholestyramine (a cholesterol lowering medicine) or laxatives (e.g. paraffin oil) – they reduce vitamin D absorption
  • heart medicines (cardiac glycosides) – you should be monitored by a physician and possibly your ECG and your blood calcium levels will be monitored
  • anticonvulsants (for the treatment of epilpsy), sleeping medicines (e.g. hydantoin, barbiturates) or primidone – these reduce the effect of vitamin D
  • calcitonin, etidronate, gallium nitrate, pamidronate or plicamycin – these decrease blood calcium levels
  • calcium containing products in high doses: these increase the risk of high blood calcium levels
  • magnesium containing products (e.g. antacids) -these should not be used during treatment with vitamin D

because of the risk of high magnesium levels

  • phosphorus containing products in large doses -these increase the risk of high phosphate blood levels.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, or breast-feeding, ask your doctor for advice before taking this medicine. If you are breast-feeding, your doctor will monitor the levels of calcium or phosphate in your blood, or the level of calcium in your urine.

Driving and using machines

There is no known effect on your ability to drive or use machines.

Colecalciferol Film-coated Tablets contain lactose and sucrose

If your doctor has previously told you that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. how to take colecalciferol film-coated tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets can be taken with or without food.

Dosage

The amount of Colecalciferol will depend on your vitamin D levels and on the response given to the treatment.

Prevention of vitamin D deficiency (maintenance):

  • for adults and elderly: 800–1600 IU/day or equivalent

weekly or monthly dose.

  • for adults and elderly with osteoporosis: maximum 2000 IU/day or equivalent weekly or monthly dose.

Treatment of severe vitamin D deficiency for the adults and elderly (loading dose):

  • 800–4000 IU/day or equivalent weekly or monthly dose.

Patients with kidney problems

Your doctor may arrange regular blood and/or urine tests for you.

Use in Children

Colecalciferol Film-coated Tablets are not suitable for children under 12 years.

For adolescents (12–18 years):

  • 800 IU daily depending on the severity of the disease and the patient's response to treatment. Should only be given under medical supervision.

If you take more Colecalciferol Film-coated Tablets than you should

You may develop the following symptoms: loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, confusion, having to pass more urine than usual, bone pain, kidney problems, and in severe cases, irregular heartbeat, coma or even death.

If you take too many tablets, contact your doctor

immediately or go to the emergency department of the nearest hospital. Take the packet and any remaining tablets with you.

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

4. possible side effects

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

  • Stop taking Colecalciferol Film-coated Tablets and seek immediate medicinal help if you experience symptoms of serious allergic reactions, such as: swollen face, lips, tongue or throat difficult to swallow
  • hives and difficulty breathing.

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

  • too much calcium in your blood (hypercalcaemia) – symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than usual, muscle weakness, drowsiness and confusion
  • too much calcium in your urine (hypercalciuria).

Rare side effects (may affect up to 1 in 1,000 people):

  • Pruritus, rash and urticaria.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store colecalciferol film-coated tablets

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

Blister: Store below 25°C.

Store in the original package in order to protect from light.

Tablet container: Store in the original tablet container in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Colecalciferol Film-coated Tablets contains

The active substance of the product is colecalciferol (vitamin D3).

Colecalciferol 800 IU Film-coated Tablets: Each film-coated tablet contains 8 mg colecalciferol concentrate (powder form) (equivalent to 20 pg colecalciferol = 800 IU vitamin D3).

250 film-coated tablets in plastic HDPE container with LDPE cap, in a box.

Colecalciferol 1000 IU Film-coated Tablets: Each film-coated tablet contains 10 mg colecalciferol concentrate (powder form) (equivalent to 25 pg colecalciferol = 1000 IU vitamin D3).

Colecalciferol 7000 IU Film-coated Tablets: Each film-coated tablet contains 70 mg colecalciferol concentrate (powder form) (equivalent to 175 pg colecalciferol = 7000 IU vitamin D3).

Colecalciferol 30000 IU Film-coated Tablets: Each film-coated tablet contains 300 mg colecalciferol concentrate (powder form) (equivalent to 750 pg colecalciferol = 30000 IU vitamin D3).

The other ingredients:

  • Tablet core: cellactose 80 (lactose monohydrate and powdered cellulose (E460 (ii)) modified starch, maize starch, croscarmellose sodium (E468), sucrose, colloidal anhydrous silica (E551), colloidal hydrous silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium chain triglycerides, DL-alpha-tocopherol (E307).
  • Coating: Opadry II Yellow 85F 32659 consisting of polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol, talc (E553b), quinoline yellow aluminum lake (E104), yellow iron oxide (E172).

Colecalciferol 800 IU Film-coated Tablets:

Yellow coloured, round, 6.1 mm diameter film-coated tablets with smooth convex surface on both sides.

Pack sizes: 30, 60 or 90 film-coated tablets in opaque PVC/PVdC-Alu blisters and box.

250 film-coated tablets in plastic HDPE container with LDPE cap, in a box.

Colecalciferol 1000 IU Film-coated Tablets:

Yellow coloured, round, 7.2 mm diameter film-coated tablets with smooth convex surface on both sides and ‘D’ embossed on one side.

Pack sizes: 30, 60 or 90 film-coated tablets in opaque PVC/PVdC-Alu blisters and box.

Colecalciferol 7000 IU Film-coated Tablets:

Yellow coloured, round, 7.2 mm diameter film-coated tablets with smooth convex surface on both sides and ‘W’ embossed on one side.

Pack sizes: 4, 8 or 12 film-coated tablets in opaque PVC/PVdC-Alu blisters and box.

Colecalciferol 30000 IU Film-coated Tablets: Yellow coloured, round, 13.2 mm diameter film-coated tablets with smooth convex surface on both sides.

Pack sizes: 1, 2, 3, 4, 6, 8 or 12 film-coated tablets in opaque PVC/PVdC-Alu blisters and box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Consilient Health Limited

5th Floor, Beaux Lane House, Mercer Street Lower Dublin 2, Ireland

Manufacturer

Pharma Patent Kft.

Nepfurdo utca 22.

Duna torony B epulet, 10. emelet 1138 Budapest, Hungary

This leaflet was last revised in December 2018.

Consilient Health

P1191

The drug is classified in the ATC tree:

Frequently Asked Questions

What is colecalciferol and how does it work?

Colecalciferol, also known as vitamin D3, helps your body absorb calcium and phosphorus, which are essential for maintaining healthy bones and teeth.

Who should take colecalciferol 800 IU tablets?

Colecalciferol 800 IU tablets are typically recommended for individuals with low vitamin D levels, older adults, or people who have limited sun exposure.

How often should I take colecalciferol 800 IU tablets?

It's usually recommended to take one tablet daily, but always follow your healthcare provider's instructions.

Can I take colecalciferol with other medications?

Generally, colecalciferol is safe to take with most medications. However, consult your doctor or pharmacist to avoid any potential interactions.

What are the side effects of colecalciferol?

Common side effects may include nausea, constipation, or headache. Serious side effects are rare but require immediate medical attention.

Can I take colecalciferol if I am pregnant or breastfeeding?

Consult your healthcare provider before taking colecalciferol if you are pregnant or breastfeeding to ensure it is safe for you.

Will colecalciferol help me if I have osteoporosis?

Colecalciferol can help improve calcium absorption, which may benefit individuals with osteoporosis. Discuss this with your doctor.

What should I do if I miss a dose of colecalciferol?

If you miss a dose, take it as soon as you remember. If it's almost time for the next dose, skip the missed dose and continue as scheduled.

How can I tell if I need more vitamin D?

Signs of vitamin D deficiency can include bone pain and muscle weakness. A blood test can confirm your vitamin D levels.

Are there specific dietary recommendations while taking colecalciferol tablets?

Maintain a balanced diet rich in calcium and vitamin D while taking colecalciferol to support overall bone health.

Can children take colecalciferol 800 IU tablets?

Children can benefit from vitamin D supplements but should only take them under pediatric advice regarding appropriate dosages.

Is there a difference between vitamin D2 and D3?

Vitamin D2 (ergocalciferol) and D3 (colecalciferol) are different forms of vitamin D; D3 is generally considered more effective at raising vitamin D levels in the body.

How long will it take to feel the benefits of taking colecalciferol?

You may start noticing benefits within a few weeks, but it can vary based on individual health conditions and existing vitamin D levels.

Can I get enough vitamin D from sunlight instead of supplements?

While sunlight is a natural source of vitamin D, many people struggle to get enough due to factors like skin tone, geographic location, and lifestyle.

What happens if I take too much colecalciferol?

Taking too much colecalciferol can lead to toxicity symptoms like nausea, vomiting, weakness, and serious kidney problems. Always use as directed.

Does colecalciferol help with mood disorders like depression?

Some studies suggest that adequate vitamin D levels may play a role in mood regulation; however, consult your healthcare provider for personalized advice.

Can I consume alcohol while taking colecalciferol tablets?

Moderate alcohol consumption is generally considered safe; however, excessive drinking can interfere with calcium metabolism. Discuss this with your doctor.

What lifestyle changes can enhance the efficacy of colecalciferol supplements?

Incorporate regular physical activity and a diet rich in calcium and magnesium alongside your supplementation for optimal bone health.

Where should I store my colecalciferol tablets?

Store your tablets in a cool, dry place away from direct sunlight and out of reach of children to maintain their effectiveness.