500 mg / 200 IU chewable tablet is 
calcium / cholecalciferol ( vitamin D 3 )

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • 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 Calcichew-D3 Mite Lemon is and what it is used for 
2. What you need to know before you take Calcichew-D3 Mite Lemon 
3. How to use Calcichew-D3 Mite Lemon 
4. Possible side effects 
5. How to store Calcichew-D3 Mite Lemon 
6. Contents of the packaging and other information 

1. What Calcichew-D3 Mite Lemon is and what it is used for

Calcichew-D Mite Lemon is a chewable tablet that contains calcium and vitamin D 3, both of which are important substances for bone formation. Calcichew-D MiteLemon is used to prevent and treat deficiency of calcium and vitamin D, as well as as an adjunctive treatment for osteoporosis.

What you need to know before taking Calcichew-D3 Mite Lemon

Do not use Calcichew-D3 Mite Lemon

  • if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe renal impairment.
  • if you have increased levels of calcium in your blood or urine.
  • if you have kidney stones.
  • if you have increased levels of vitamin D in your blood.

Warnings and cautions

Talk to your doctor or pharmacist before taking Calcichew-D 3 Lemon

  • if you are taking Calcichew-D Mite Lemon for a long time especially if you are also taking diuretics ( diuretics for the treatment of high blood pressure and edema ) or cardiac glycosides (for the treatment of heart disease).
  • if you show signs of impaired kidney function or have a high tendency to get kidney stones .
  • if you suffer from sarcoidosis (a disease of the immune system that can increase the amount of vitamin D in the body).
  • if you have osteoporosis and at the same time have difficulty moving.
  • if you are taking other products that contain vitamin D. Additional intake of calcium and vitamin D should be done under the supervision of a doctor.

Other medicines and Calcichew-D3 Mite Lemon

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

If you are also taking tetracyclines (a type of antibiotic ), take them at least 2 hours before or 4-6 hours after taking Calcichew-D Mite Lemon. Calcium carbonate can affect the body’s uptake of tetracycline preparations if taken at the same time.

Medicines containing bisphosphonates should be taken at least one hour before Calcichew-D Mite Lemon.

Calcium may reduce the effect of levothyroxine. Therefore, levothyroxine should be taken at least four hours before or four hours after taking Calcichew-D Mite Lemon.

The effect of the antibiotics of the quinolone type can be worse if taken at the same time as calcium. Such antibiotics should be taken two hours before or six hours after taking Calcichew-D Mite Lemon.

Calcium salts can reduce the absorption of iron, zinc, and strontium ranelate. Therefore, preparations containing iron, zinc, or strontium ranelate should be taken at least two hours before or after taking Calcichew-D Mite Lemon.

Other medicines that can affect or be affected by Calcichew-D Mite Lemon are:

  • thiazide diuretics ( diuretic for the treatment of high blood pressure and edema )
  • cardiac glycosides (for the treatment of heart disease).

Orlistat (used to treat obesity) can affect the uptake of fat-soluble vitamins, such as vitamin D 3.

If you are taking any of the above medicines, your doctor will give you further instructions.

Calcichew-D3 Mite Lemon with food, drink, and alcohol

It does not matter if you take Calcichew-D Mite Lemon with food and drink.

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.

If you are pregnant, you can take Calcichew-D Mite Lemon if you are deficient in calcium and vitamin D. During pregnancy, your daily intake should not exceed 2500 mg of calcium and 4000 IU of vitamin D, as overdoses can have negative effects on the unborn baby…

Calcichew-D Mite Lemon can be used during breast-feeding. Calcium and vitamin D pass into breast milk. This should be considered when giving vitamin D supplements to the baby.

Driving and using machines

Calcichew-D Mite Lemon has no known effect on the ability to drive and use machines.

Calcichew-D3 Mite Lemon contains isomalt and sucrose

Calcichew-D Mite Lemon contains sucrose (0.4 mg) which can be harmful to the teeth. The tablet also contains isomalt (E953). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Calcichew-D Mite Lemon is almost sodium-free

This medicine contains less than 23 mg sodium per tablet, it is essentially ‘sodium-free’.

3. How to use Calcichew-D3 Mite Lemon

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

Dosage:

The recommended dose for adults is one tablet 1-3 times daily.

Use for children

The recommended dose for children is one tablet 1-2 times daily.

The tablets can be chewed or slowly melted in the mouth.

If you forget to take Calcichew-D3 Mite Lemon

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

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.

Hypersensitivity reactions have occurred (however common it can not be calculated from available information). If you experience the following symptoms, contact your doctor immediately. Swelling of the face, tongue, lips ( angioedema ) or swelling of the throat (laryngeal edema).

Uncommon side effects (may affect up to 1 in 100 people): 
Increased levels of calcium in the blood (hypercalcemia) or in the urine ( hypercalciuria ) may occur at high doses.

Rare side effects (may affect up to 1 in 1,000 people): Constipation, dyspepsia(indigestion), flatulence, nausea, abdominal pain, diarrhea

Very rare side effects (may affect up to 1 in 10,000 people): 
Itching , rash, and hives. Milk-alkali syndrome (also called Burnett’s syndrome and usually occurs only in patients who have ingested large amounts of calcium ), whose symptoms are frequent urination, headache, loss of appetite, nausea or vomiting, unusual fatigue or weakness and increased calcium levels in the blood and kidney failure.

If you have impaired kidney function, there may be a risk that you get increased levels of phosphate in the blood, that kidney stones are formed and increased levels of calcium in the kidneys.

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 Calcichew-D3 Mite Lemon

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 label after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Close the package tightly. Moisture sensitive.

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 substances in a tablet are:

– calcium carbonate 1250 mg (equivalent to 500 mg calcium )

– cholecalciferol ( vitamin D3) 200 IU (5 micrograms)


Other ingredients are:

xylitol (E967), povidone, isomalt (E953), flavor (lemon), magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids, tocopherol, sucrose, modified corn starch, medium-chain triglyceride s, sodium and anhydrous colloidal silica.

What the medicine looks like and the contents of the pack

Calcichew-D3 Mite Lemon are white round chewable tablets.

Pack sizes:

Plastic jar with HDPE screw cap: 20, 30, 50, 60, 90, 100, 120 and 180 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Takeda AS

PO Box 205

NO-1372 Asker

Norway

Muhammad Nadeem

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