Document: leaflet MAH BRAND_PL 42582-0014 change

• leaflet MAH BRAND_PL 42582-0014
• leaflet MAH GENERIC_PL 17740-0011
• leaflet STIRLING ANGLIAN PHARMACEUTICALS_PL 17740-0011

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Package leaflet: Information for the user

u iciv-ai"L

1000 mg / 880 IU chewable tablets

Calcium and Colecalciferol

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take TheiCal-D₃ 1000 mg / 880 IU chewable tablets carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve.

•    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.

In this leaflet:

1.    What TheiCal-D₃ 1000 mg / 880 IU chewable tablets is and what it is used for

2.    Before you take TheiCal-D₃

1000 mg / 880 IU chewable tablets

3.    How to take TheiCal-D₃

1000 mg / 880 IU chewable tablets

4.    Possible side effects

5.    How to store TheiCal-D₃

1000 mg / 880 IU chewable tablets

6.    Further information

1.    What TheiCal-D3

1000 mg / 880 IU chewable tablets is and what it is used for

TheiCal-D₃ 1000 mg / 880 IU chewable tablets is a calcium-vitamin D₃-supplement.

It is used

-    to prevent and treat a lack of calcium and vitamin D in the elderly.

-    for vitamin D- and calcium supplementation as supportive treatment of osteoporosis (brittle bones).

2.    Before you take TheiCal-D₃ 1000 mg / 880 IU chewable tablets

Do not take TheiCal-D₃

1000 mg / 880 IU chewable tablets

-    if you are allergic (hypersensitive) to calcium, vitamin D₃ or any of the other ingredients of TheiCal-D₃

1000 mg / 880 IU chewable tablets

-    if you have high levels of calcium in your blood (hypercalcaemia)

-    if you have increased excretion of calcium with your urine (hypercalciuria)

-    if you suffer from overactive parathyroid glands (hyperparathyroidism)

-    if you suffer from bone marrow cancer (myeloma)

-    if you suffer from cancer that has affected your bones (bone metastases).

-    if you have a restraint of the limbs (prolonged immobilisation) accompanied with hypercalcaemia and / or hypercalciuria

-    if you have kidney stones (nephrolithiasis)

-    if you have calcium deposits in your kidneys (nephrocalcinosis)

-    if you suffer from an excessive supply of vitamin D (hypervitaminosis D)

-    if you have severe kidney problems

Take special care with TheiCal-D₃ 1000 mg / 880 IU chewable tablets

-    during long-term treatment the levels of calcium in your blood and urine and your kidney function have to be monitored regularly. This is especially important if you have a tendency to develop kidney stones. Depending on your blood levels your doctor might reduce the dosage or discontinue the treatment.

-    if you are simultaneously being treated with cardiac glycosides or thiazide diuretics (water tablets) for heart problems the levels of calcium in your blood and urine and your kidney function have to be monitored regularly. Depending on your blood levels your doctor might reduce the dosage or discontinue the treatment.

-    if you suffer from kidney problems you have to take TheiCal-D₃ 1000 mg / 880 IU chewable tablets with special care.

Your calcium levels of the blood and urine have to be checked. If you suffer from severe kidney problems, use other forms of vitamin D than colecalciferol.

-    take additional supplementation of calcium and vitamin D only under medical supervision and your doctor will require frequent monitoring of the calcium levels in the blood and urine.

-    take special care when taking TheiCal-D₃ 1000 mg / 880 IU chewable tablets if you suffer from sarcoidosis (an immune system disorder which may affect your liver, lung, skin or lymph nodes). There is a risk that the effect of this medicinal product gets too strong which can result in an overdose of calcium in the body. The levels of calcium in the blood and urine have to be monitored.

-    if you are immobile and are suffering from osteoporosis this medicinal product has to be used with special care, as the level of calcium in your blood might increase.

TheiCal-D₃ 1000 mg / 880 IU chewable tablets are not intended for use in children and adolescents.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

-    In the case of simultaneous treatment with digitalis glycosides (cardiac glycosides derived from foxglove), cardiac arrhythmias can occur. Rigorous medical monitoring including an ECG and measurement of the blood calcium level is therefore necessary.

-    In the case of simultaneous administration of diuretics of the thiazide drug class (also called water tablets), the blood calcium level should be regularly monitored since thiazides decrease the excretion of calcium in the urine.

-    The absorption and thus also the effectiveness of certain antibiotics (called tetracyclines) are decreased by the simultaneous administration of TheiCal-D₃ 1000 mg / 880 IU chewable tablets. These drugs should be taken at least 2 hours before or 4-6 hours after TheiCal-D₃ 1000 mg / 880 IU chewable tablets.

-    Furthermore, other medicines such as sodium fluoride (used to strengthen the tooth enamel or to treat osteoporosis) and bisphosphonate (used to treat osteoporosis) drugs are affected by interactions. These products should therefore be taken at least 3 hours before TheiCal-D₃ 1000 mg / 880 IU chewable tablets.

-    As long an interval as possible should be left between the administration of cholestyramine (a product to lower raised cholesterol levels) or laxatives such as liquid paraffin and TheiCal-D₃ 1000 mg / 880 IU chewable tablets since otherwise vitamin D is not absorbed properly.

-    The simultaneous administration of TheiCal-D₃ 1000 mg / 880 IU chewable tablets and phenytoin (a product for the treatment of epilepsy) or barbiturates (hypnotics) can result in a reduction in the effect of vitamin D.

-    The simultaneous administration of TheiCal-D₃ 1000 mg / 880 IU chewable tablets and glucocorticoids (e.g. cortisone) can result in a reduction

in the effect of vitamin D and to a decreased calcium level in the blood.

-    The additional supplementation of calcium and vitamin D should be given only under medical supervision and will require frequent monitoring of the calcium levels in the blood and urine.

-    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 TheiCal-D₃ 1000 mg / 880 IU chewable 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 TheiCal-D₃ 1000 mg / 880 IU chewable tablets.

Taking TheiCal-D₃ 1000 mg / 880 IU chewable tablets with food and drink

You can take TheiCal-D₃ 1000 mg / 880 IU chewable tablets at any time, with or without food.

Please notice that oxalic acid (contained in spinach and rhubarb) and phytic acid (contained in wholegrain cereals) can reduce the amount of calcium you absorb in your bowel. In the 2 hours before or after eating food containing high amounts of oxalic or phytic acid patients should not take medicinal products that contain calcium.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant you may use TheiCal-D3 1000 mg / 880 IU chewable tablets in case of a calcium and vitamin D deficiency.

The daily dose of half a tablet must not be exceeded. During pregnancy the total daily amount of calcium should not be higher than 1,500 mg and the total daily amount of vitamin D₃ should not be higher than 600 IU (International Units).

Long-term overdose of calcium and vitamin D during pregnancy must be avoided since this may lead to high levels of calcium in the blood and may have a negative effect on the unborn child.

TheiCal-D₃ 1000 mg / 880 IU chewable tablets can be used during breast-feeding. As calcium and vitamin D pass into breast-milk check with your doctor first if your child receives any other products containing vitamin D.

Driving and using machines

TheiCal-D₃ 1000 mg / 880 IU chewable tablets has no influence on your ability to drive and use machines.

Important information about some of the ingredients of TheiCal-D₃ 1000 mg / 880 IU chewable tablets

This medicine contains aspartame (E951), a source of phenylalanine which may be harmful for people with phenylketonuria. This medicine also contains sorbitol (E420), isomalt (E953) and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take TheiCal-D₃

1000 mg / 880 IU chewable tablets

Always take TheiCal-D₃ 1000 mg / 880 IU chewable tablets exactly as described in this leaflet. You should check with your doctor or pharmacist if you are not sure.

Dosage

If not told otherwise by your doctor the usual dose is:

Adults and elderly take 1 chewable tablet daily (corresponding to 1,000 mg of calcium and 880 IU (International Units) of vitamin D₃).

Pregnant women take only half a chewable tablet daily (corresponding to 500 mg of calcium and 440 IU (International Units) of vitamin D₃). The daily dose of half a tablet must not be exceeded.

Method of administration

The tablet has to be chewed before it is swallowed. It should be taken at any time, with or without food.

Duration of treatment

TheiCal-D₃ 1000 mg / 880 IU chewable tablets should be taken as long-term treatment. Talk to your doctor how long you should take TheiCal-D₃ 1000 mg / 880 IU chewable tablets (see also section 2, Take special care with TheiCal-D₃ 1000 mg / 880 IU chewable tablets).

If you take more TheiCal-D₃ 1000 mg / 880 IU chewable tablets than you should

Overdose of TheiCal-D₃ 1000 mg / 880 IU chewable tablets may lead to symptoms such as feeling sick (nausea), vomiting, thirst or excessive thirst, increased urine output, depletion of body fluids or constipation. If an overdose is suspected, contact your doctor or pharmacist immediately.

If you forget to take TheiCal-D₃ 1000 mg / 880 IU chewable tablets

If you forget to take TheiCal-D₃ 1000 mg / 880 IU chewable tablets, take it as soon as you remember. However, do not take a double dose to make up for a forgotten tablet.

If you stop taking TheiCal-D₃ 1000 mg / 880 IU chewable tablets

If you wish to interrupt or prematurely discontinue the treatment, please consult 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, TheiCal-D₃ 1000 mg / 880 IU chewable tablets can cause side effects, although not everybody gets them. The evaluation of side effects is based on the following frequencies:

Very common: affects more than 1 user in 10

Common:    affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000 Rare:    affects 1 to 10 users in

10,000

Very rare:    affects less than 1 user in

10,000

Not known: frequency cannot be estimated from the available data

Stop taking TheiCal-D₃

1000 mg / 880 IU chewable tablets and

contact a doctor immediately if you

experience the following allergic reaction (not known as frequency cannot be estimated from the available data):

-    swelling of the face, lips, tongue or throat with sudden difficulty breathing and severe rash.

The other side effects reported are:

Rare side effects:

-    feeling sick (nausea), diarrhoea, abdominal pain, constipation, wind, bloating (abdominal distension).

-    rash, itching, hives.

Uncommon side effects:

-    high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria).

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.

5. How to store TheiCal-D₃

1000mg / 880 IU chewable tablets

Keep out of the reach and sight of children.

Do not use TheiCal-D₃ 1000 mg / 880 IU chewable tablets after the expiry date (EXP) which is stated on the carton and on the tablet container or on the laminated aluminium paper foil. The expiry date (EXP) refers to the last day of that month.

For tablet container: Keep the tablet container tightly closed in order to protect from moisture.

For strips: This medicinal product does not require any special storage conditions.

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. Further information

What TheiCal-D3 1000 mg / 880 IU chewable tablets contains

-    The active substances are calcium and colecalciferol. Each chewable tablet contains 2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium) and 8.8 mg of colecalciferol concentrate (powder form) (equivalent to 22 micrograms of colecalciferol = 880 IU of vitamin D₃).

-    The other ingredients are isomalt (E953), xylitol, sorbitol (E420), citric acid, anhydrous, sodium dihydrogen citrate, magnesium stearate, carmellose sodium, flavour orange "CPB" and flavour orange "CVT" (which both contain sorbitol (E420)), aspartame (E951), acesulfam potassium, sodium ascorbate, all-rac-alpha-tocopherol, modified (maize) starch, sucrose, triglycerides medium chain and silicon dioxide colloidal.

What TheiCal-D₃ 1000 mg / 880 IU chewable tablets looks like and contents of the pack

TheiCal-D₃ 1000 mg / 880 IU chewable tablets are round, white tablets with faultless surface and a breakmark. The tablet can be divided into equal halves.

The chewable tablets are available in polypropylene tablet containers with polyethylene stoppers containing a desiccant in the following package sizes: 20, 28, 30, 50, 56, 60, 90, 100 (bundling package 5 x 20) chewable tablets.

The chewable tablets are available in strips of laminated aluminium paper foil in the following package sizes:

20, 28, 30, 48, 56, 60, 90, 96, 100 (bundling package 5 x 20) chewable tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Stirling Anglian Pharmaceuticals Limited

Hillington Park Innovation Centre

1 Ainslie Road

Hillington Park

Glasgow

G524RU

UK

Manufacturer

Hermes Arzneimittel GmbH Georg-Kalb-Strasse 5-8 82049 Grotehesselohe / Munich Germany

This leaflet was last revised in January 2016.

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany:

theiCal-D₃ 1000 mg / 880 I.E. Kautabletten Italy:

theiCal-D₃ 1000 mg / 880 UI compresse masticabili