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STRIVIT-D3 800 IU CAPSULES SOFT - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - STRIVIT-D3 800 IU CAPSULES SOFT

1. what strivit-d3 is and what it is used for

STRIVIT-D3 contains the active substance Colecalciferol.

Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Often vitamin D is given in combination with calcium. STRIVIT-D3 is recommended for use when you have a normal intake of dietary calcium.

STRIVIT-D3 may be prescribed by your doctor to treat or prevent vitamin D deficiency. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant). STRIVIT-D3 may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines.

2. what you need to know before you take strivit-d3

Do not take STRIVIT-D3

  • if you are allergic (hypersensitive) to vitamin D or any of the other ingredients in the capsules (these are listed in section 6, Further information)
  • if you have high levels of vitamin Din your blood (hypervitamino­sis D)
  • if you have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria)
  • if you have kidney stones or serious kidney problems.

If any of the above applies to you, tell your doctor or pharmacist before taking STRIVIT-D3.

Warnings and precautions

  • Talk to your doctor before taking STRIVIT-D3 if you have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine.
  • if you are being treated for heart disease
  • you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)
  • if you are already taking additional doses of calcium or vitamin D. Whilst you are taking STRIVIT-D3 your doctor will monitor your blood levels of calcium to make sure they are not too high.

Other medicines and STRIVIT-D3

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

In particular the following medicines may interact with STRIVIT-D3:

  • Heart medicines (cardiac glycosides such as digoxin).Your doctor may monitor your heart with an electrocardiogram (ECG) and measure the levels of calcium in your blood.
  • Thiazide diuretics (used to treat high blood pressure) reduce the urinary excretion of calcium and can increase risk of hypercalcaemia.
  • Medicines used to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) can decrease the effects of vitamin D.
  • Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone) can decrease the effects of vitamin D.
  • Laxatives (such as paraffin oil), or a cholesterol lowering drug called colestyramine, may reduce the absorption of vitamin D.
  • Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) may interfere with the metabolism of vitamin D.

STRIVIT-D3 with food and drink

You can take STRIVIT-D3 with or without food and drink.

Pregnancy and breast-feeding

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.

Driving and using machines

STRIVIT-D3 should not affect your ability to drive or operate machinery.

3. how to take strivit-d3

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

The recommended dose is:

In severe vitamin D deficiency (for adults and the elderly)

Your doctor will usually prescribe you a dose of 1–4 capsules daily for up to12 weeks. The amount will depend on how low your vitamin D levels are and how you respond to treatment. Your doctor will then tell you to take 1–2 capsules daily to maintain your vitamin D levels.

In moderate vitamin D deficiency (for adults and the elderly) or to prevent vitamin D deficiency

Your doctor will usually prescribe 1–2 capsules daily.

In vitamin D deficiency in children over 12 years

Your doctor will usually prescribe you 1 capsule daily.

In osteoporosis (you will also be taking other medicines for this)

Your doctor will usually prescribe 1 capsule daily. You should check with your doctor or pharmacist if you are unsure.

The capsules should be swallowed whole (not chewed) with water.

STRIVIT-D3 is not suitable for children under 12 years.

If you take more STRIVIT-D3 than you should

If you accidentally take one capsule too many, nothing is likely to happen. If you accidentally take several capsules too many, tell your doctor or get other medical advice immediately. If possible, take the capsules, the box and this leaflet with you to show the doctor. If you take too many capsules, you may feel or be sick, become constipated or have stomach pains, weak muscles, tiredness, lack of appetite, kidney problems and in severe cases irregular heartbeats.

If you forget to take STRIVIT-D3

If you forget to take your capsules, take them as soon as you can. Do not take a double dose to make up for a forgotten dose. After that, take the next capsule in accordance with the instructions given to you by your doctor.

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

4. possible side effects

Like all medicines, STRIVIT-D3 can cause side effects, although not everybody gets them. Side effects with STRIVIT-D3 may include: Uncommon side effects (affecting less than 1 in 100 people)

  • Too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion.
  • Too much calcium in your urine (hypercalciuria).

Rare side effects (affecting less than 1 in 1000 people)

  • Skin rash
  • Itching
  • Hives

Not known (cannot be estimated from the available data)

  • swelling of voice box/throat (laryngeal oedema) or swelling of skin layers (angioedema)

5. how to store strivit-d3

Keep out of the reach and sight of children. This medicine does not require any special temperature storage conditions. Keep the blister in the outer carton in order to protect from light.

Do not use STRIVIT-D3 after the expiry date which is stated on the carton as “EXP”. The expiry date refers to the last day of that 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 pack and other information

What STRIVIT-D3 contains

The active ingredient (which makes the medicine work) is Colecalciferol.

Each capsule contains 800 IU Colecalciferol (equivalent to 20 micrograms Vitamin D3). The other ingredients are:

Capsule Content

Maize oil, refined

Capsule Shell

Gelatin

Glycerol (E 422)

Brilliant Blue Supra containing Brilliant blue for coloring of food (E133), sodium chloride and sodium sulphate

Purified Water

What STRIVIT-D3 looks like and contents of the pack

STRIVIT-D3 800 IU Capsule is a translucent blue capsule (size 2) and has no markings. It is available in blister packs containing 28, 30, 56, 60 or 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Strides Arcolab International Ltd. Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire WD18 9SS, United Kingdom

Manufacturer:

Strides Pharma UK Ltd.

Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire WD18 9SS, United Kingdom

This leaflet was last revised in 12/2017

9ZSZ


ezaz


Dimension – 140 × 240 mm


Font: Times New Roman 9 pt


Front Side


Dimension – 140 × 240 mm


Font: Times New Roman 9 pt


Back Side


ARTWORK DETAIL LABEL

Product

STRIVIT-D3 800 IU Capsules

Buyer/Country

Strides Pharma UK Ltd.

Component

PACK INSERT

Dimension

140 × 240 mm

Pack

New Item Code

1035437

Old Item Code

1035108

Colour Shades

BLACK

No. of Colours

1

Change Control No.

Record # 163585 Artwork Version 3.0

Design/Style

Front & Back Side printing. To be supplied in the UNFFOLDED SIZE.

Substrate

60 GSM Paper.

Special Instructions

PRINTING CLARITY TO BE CLEAR AND SHARP.

Autocartonator Requirements

Pack insert supply should be as per auto-cartonator. Refer auto-cartonator drawing for instructions.

Caution to the printer: Before processing, please ensure that the ARTWORK received for printing is exactly in line with APPROVED ARTWORK provided to you. In case of any FONTS/DESIGN are Mis-matching with the APPROVED ARTWORK, please inform PDC for further action. DO NOT MAKE ANY CHANGE TO THE ARTWORK WITHOUT WRITTEN INSTRUCTIONS FROM PDC.

RD/PD/OO3/F-O8/RO

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is STRIVIT-D3 800 IU Capsules Soft used for?

STRIVIT-D3 800 IU Capsules Soft are primarily used to prevent and treat vitamin D deficiency, which is important for maintaining healthy bones and teeth.

How does STRIVIT-D3 help with bone health?

STRIVIT-D3 helps the body absorb calcium, which is essential for strong bones and preventing conditions like osteoporosis.

Who should take STRIVIT-D3 800 IU Capsules?

Adults who may be at risk of vitamin D deficiency, including those with limited sun exposure or certain medical conditions, may benefit from taking STRIVIT-D3.

Are there any side effects of taking STRIVIT-D3?

While generally considered safe, some people may experience mild side effects such as nausea or constipation. Consult your doctor if you experience any unusual symptoms.

Can I take STRIVIT-D3 if I’m pregnant or breastfeeding?

Yes, but it’s important to consult your healthcare provider before taking any supplements during pregnancy or while breastfeeding.

How should I take STRIVIT-D3 800 IU Capsules?

Take one capsule daily with a meal to enhance absorption. Follow your doctor’s instructions for dosage.

Is it safe to take STRIVIT-D3 with other medications?

Most medications are safe to take with STRIVIT-D3, but always check with your doctor or pharmacist to avoid potential interactions.

Can children take STRIVIT-D3 800 IU Capsules?

STRIVIT-D3 is not typically recommended for children unless prescribed by a healthcare provider. Always seek medical advice before giving supplements to children.

How long should I take STRIVIT-D3 capsules?

Duration of intake should be determined by your healthcare provider based on your individual health needs and vitamin D levels.

What happens if I miss a dose of STRIVIT-D3?

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

Can I overdose on STRIVIT-D3?

Yes, taking too much vitamin D can lead to toxicity. Symptoms may include nausea, vomiting, weakness, and kidney problems. Always adhere to prescribed dosages.

What lifestyle changes can enhance the effectiveness of STRIVIT-D3?

Incorporating foods rich in calcium and vitamin D, along with regular sun exposure and exercise, can boost the effectiveness of STRIVIT-D3.

Are there dietary sources of vitamin D that can complement STRIVIT-D3?

Yes, foods such as fatty fish (like salmon), egg yolks, fortified dairy products, and mushrooms are good sources of vitamin D.

Why is sun exposure important for vitamin D levels?

Sunlight triggers the body’s production of vitamin D, making regular safe exposure vital for maintaining healthy levels alongside supplementation.

Can I take STRIVIT-D3 if I have certain health conditions?

Patients with certain health conditions like kidney disease or hyperparathyroidism should consult their doctor before taking vitamin D supplements.

How do I store STRIVIT-D3 capsules properly?

Store in a cool, dry place away from direct sunlight and moisture. Keep out of reach of children.

What should I do if my symptoms don’t improve while taking STRIVIT-D3?

If you don't notice improvement after several weeks or have concerns about your dosage, consult your healthcare provider for further evaluation.

Is it normal for my urine to change color when taking STRIVIT-D3?

Some people may notice changes in urine color due to hydration levels or dietary changes. If you have concerns about unusual urine colors or smells, speak with a doctor.

Can I use intermittent fasting while taking STRIVIT-D3?

Yes, intermittent fasting generally won’t affect the efficacy of strivit-d3; however, ensure that you’re consuming adequate nutrition during eating windows.

What are the benefits of taking vitamin D beyond bone health?

Vitamin D supports immune function and may help reduce the risk of chronic diseases such as heart disease and certain cancers. It's essential for overall well-being.