What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL16189/0027.

Calcichew-D3 Forte 500 mg/400 IU Film-coated Tablets

Package leaflet: Information for the user

Calcichew-D3 Forte 500mg/400IU Film-coated Tablets

calcium / colecalciferol (vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

You must contact a doctor if your symptoms worsen or do not improve after two weeks.

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.

What is in this leaflet:

1. What Calcichew-D3 Forte Film-coated Tablets are and what they are used for
2. What you need to know before you take Calcichew-D3 Forte Film-coated Tablets
3. How to take Calcichew-D3 Forte Film-coated Tablets
4. Possible side effects
5. How to store Calcichew-D3 Forte Film-coated Tablets
6. Contents of the pack and other information

1. What Calcichew-D3 Forte Film-coated Tablets are and what they are used for

Calcichew-D3 Forte Film-coated Tablets are film-coated tablets containing calcium and vitamin D, which both are important substances in bone formation. Calcichew-D3 Forte Film-coated Tablets is used in the prevention and treatment of calcium and vitamin D deficiency in the elderly, and as a supplement to specific treatment of osteoporosis.

2. What you need to know before you take Calcichew-D3 Forte Film-coated Tablets

Do not take Calcichew-D3 Forte Film-coated Tablets if you:

  • are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6)
  • have severe kidney problems
  • have excessive amounts of calcium in the blood or in the urine
  • have kidney stones
  • have excessive amounts of vitamin D in the blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking Calcichew-D3 Forte Film-coated Tablets if you:

  • are on long-term treatment, especially if you also take diuretics (used in treatment of high blood pressure or oedema) or cardiac glycosides (used to treat heart disorders)
  • have signs of impaired renal function or high tendency of renal stone formation
  • have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body)
  • have osteoporosis and at the same time are unable to move around
  • take other products containing vitamin D. Additional doses of calcium and vitamin D should be taken under close medical supervision.

Children

Calcichew-D3 Forte Film-coated Tablets are not intended for use in children.

Other medicines and Calcichew-D3 Forte Film-coated Tablets

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

Calcium carbonate may interfere with the absorption of tetracyclines (a type of antibiotics) if taken at the same time. For this reason, tetracycline preparations should be taken at least 2 hours before or 4-6 hours after intake of Calcichew-D3 Forte Film-coated Tablets.

Medicines containing bisphosphonates (used to treat osteoporosis) should be taken at least one hour before intake of Calcichew-D3 Forte Film-coated Tablets.

Calcium can reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after Calcichew-D3 Forte Film-coated Tablets.

The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Calcichew-D3 Forte Film-coated Tablets.

Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Calcichew-D3 Forte Film-coated Tablets.

Other medicines that may influence or be influenced by Calcichew-D3 Forte Film-coated Tablets are: thiazide diuretics (used in treatment of high blood pressure and oedema) and cardiac glycosides (used to treat heart disorders).

Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, e.g. vitamin D3.

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

Calcichew-D3 Forte Film-coated Tablets with food and drink

Calcichew-D3 Forte Film-coated Tablets can be taken with or without food and drink.

Pregnancy breast-feeding 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 before taking this medicine.

Pregnancy

Calcichew-D3 Forte Film-coated Tablets can be used during pregnancy, in case of calcium and vitamin D deficiency. During pregnancy you should not take more than 2500 mg calcium and 4000 IU vitamin D per day, as overdoses may harm the unborn child.

Breast-feeding

Calcichew-D3 Forte Film-coated Tablets can be used during breastfeeding. Calcium and vitamin D pass into breast milk. This should be considered when giving additional vitamin D to the child.

Driving and using machines

Calcichew-D3 Forte Film-coated Tablets has no known influence on your ability to drive or use machines.

Calcichew-D3 Forte Film-coated Tablets contain sorbitol and sucrose

Calcichew-D3 Forte Film-coated Tablets contains sorbitol and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.

3. How to take Calcichew-D3 Forte 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.

Dosage:

The recommended dose is one tablet twice daily. The tablet may be swallowed or chewed.

Use in children

Calcichew-D3 Forte Film-coated Tablets are not intended for use in children.

If you take more Calcichew-D3 Forte Film-coated Tablets than you should

If you may have taken more Calcichew-D3 Forte Film-coated Tablets than you should, talk to your doctor or pharmacist immediately.

If you forget to take Calcichew-D3 Forte Film-coated Tablets

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

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.

Hypersensitivity reactions have occurred with unknown frequency (cannot be estimated from the available data).

If you experience the following symptoms, you should immediately contact a doctor. Swelling of the face, tongue, lips (angioedema) or swelling of the throat (laryngeal oedema).

Uncommon side effects (may affect up to 1 in 100 people): Excessive amounts of calcium in the blood (hypercalcaemia) or in the urine (hypercalciuria) may occur with large doses.

Rare side effects (may affect up to 1 in 1,000 people): constipation, dyspepsia, flatulence, nausea, gastric pain, diarrhoea.

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 only seen when excessive amounts of calcium have been ingested), symptoms are frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, along with elevated levels of calcium in the blood and kidney impairment.

If you have impaired renal function, you may be at risk of increased amounts of phosphate in the blood, kidney stone formation and increased amounts of calcium in the kidneys.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in United Kingdom as Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Calcichew-D3 Forte Film-coated Tablets

Do not store above 25°C. Keep the container tightly closed in order to protect from moisture.

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. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

What Calcichew-D3 Forte Film-coated Tablets contains

The active ingredients are 500 mg calcium (as calcium carbonate) and 400 IU vitamin D3 (equivalent to 10 micrograms colecalciferol).

The other ingredients are

tablet core: sorbitol E420, mannitol, acesulfame potassium, flavouring (lemon), croscarmellose sodium, microcrystalline cellulose, magnesium stearate, maltodextrin, tocopherol-rich extract, all-rac-alpha-tocopherol, sucrose, modified maize starch, medium chain triglycerides, sodium ascorbate and anhydrous colloidal silica

film-coating: talc, hypromellose, propylene glycol.

(see also end of Section 2 “Calcichew-D3 500mg/400IU Forte Film-coated Tablets contain sorbitol and sucrose”).

What Calcichew-D3 Forte Film-coated Tablets looks like and contents of the pack

Calcichew-D3 Forte Film-coated Tablets are white/off white, oval film-coated tablets.

Pack sizes:

20, 30, 50, 60, 90, 100, 120, 180 and 250 tablets

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Takeda UK Limited
Building 3
Glory Park
Glory Park Avenue
Wooburn Green
BUCKS
HP10 0DF
UK

Manufacturer:

Takeda Pharma AS
Jaama 55B
63308 Põlva
Estonia

or

Takeda GmbH
Lehnitzstr. 70-98
DE-16515
Oranienburg
Germany

This leaflet was revised in December 2018.

Additional Information

Calcichew-D3 Forte Film-coated Tablets are a combination of calcium and vitamin D designed to keep bones healthy. Calcium is an essential component of bones while vitamin D plays an important role in the absorption of calcium from food.

Requirements for calcium increase with age and, although many people obtain enough calcium from their diet, some people may require a supplement in order that their body has all the calcium it needs to maintain healthy bones. Vitamin D is produced largely from the action of sunlight. Certain foodstuffs do contain vitamin D in reasonable amounts but it is not always possible to obtain all the vitamin D you need from your diet. People who do not get out and about, for instance those who are housebound or people living in nursing and residential homes, may not receive all the vitamin D they need.

People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium and vitamin D intake can lead to the development of osteoporosis, a condition where bones become weak to a level that minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.

Calcichew-D3 Forte Film-coated Tablets have been designed to give people whose intakes of calcium and vitamin D are low a boost to the recommended amounts.

Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and vitamin D and, for some people, advice on how to prevent falls which may lead to fracture.

For patients in the UK, the National Osteoporosis Society (NOS) is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The NOS offers support to people with osteoporosis and raises awareness of the importance of healthy bones.

If you are concerned about osteoporosis, please contact the

National Osteoporosis Society
Camerton
Bath
BA2 0PJ
Tel: 01761 471 771
Fax: 01761 471 104

or email: info@nos.org.uk.

*Registered Trademark