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Norsed Combi D

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Package leaflet: Information for the patient


Norsed Combi D35 mg + 1000 mg / 880 IU film‑coated tablets + effervescent granules

Risedronate sodium + calcium / colecalciferol


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


What is in this leaflet

1. What Norsed Combi D is and what it is used for

2. What you need to know before you take Norsed Combi D

3. How to take Norsed Combi D

4. Possible side effects

5. How to store Norsed Combi D

6. Contents of the pack and other information


1. What Norsed Combi D is and what it is used for


What Norsed Combi D is

A combination medicine packed as weekly units each containing 1 tablet of Norsed and 6 sachets of calcium/vitamin D3.


Norsed tablets

Norsed tablets contain risedronate sodium which belongs to a group of non-hormonal medicines called bisphosphonates. These medicines are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break.


Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.

Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain.

The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis-related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.



Calcium/vitamin D3sachets

The sachets contain calcium/vitamin D3effervescent granules which provide the calcium and the vitamin D3 that your body may need to harden new bone.


What Norsed Combi D is used for

The treatment of osteoporosis, even if severe, in postmenopausal women who also need daily calcium and vitamin D3supplementation as assessed by their doctor. It reduces the risk of spinal and hip fractures.


2. What you need to know before you take Norsed Combi D


Do not take Norsed Combi D

hypocalcaemia(a low blood calcium level),

hypercalcaemia(a high blood calcium level),

hypercalciuria (a high calcium level in the urine),

hypervitaminosis D(a high blood vitamin D level)


Warnings and precautions

Talk to your doctor or pharmacist before taking Norsed Combi D

Your doctor will advise you on what to do when taking Norsed Combi D if you have any of the above.


Children and adolescents

Risedronate sodium is not recommended for use in children below 18 due to insufficient data on safety and efficacy.


Other medicines and Norsed Combi D

Norsed tablets

Medicines containing one of the following lessen the effect of the Norsed tablet if taken at the same time:

Take these medicines at least 30 minutes after your Norsed tablet.


Calcium/vitamin D3sachets

Medicines containing calcium/vitamin D3are known to interfere with the following:

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


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


Norsed Combi D with food and drink

Norsed tablets

It is very important that you do NOT take your Norsed tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take the tablet at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Other medicines and Norsed Combi D”).

Take food and drinks (other than plain water) at least 30 minutes after your Norsed tablet.


Calcium/vitamin D3sachets

Do NOT take the dissolved calcium/vitamin D3granules at the same time as foods containing high amounts of oxalic acid (spinach and rhubarb) or phytic acid (whole cereals).

Take the dissolved granules at least 2 hours after eating such foods.


Pregnancy and breast-feeding

Do NOT take Norsed Combi D if you are pregnant, think you may be pregnant or planning to have a baby (see section 2, “Do not take Norsed Combi D”). The potential risk associated with the use of risedronate sodium (active substance in Norsed tablets) in pregnant women is unknown.

Do NOT take Norsed Combi D if you are breast‑feeding (see section 2, “Do not take Norsed Combi D”).


Driving and using machines

Norsed Combi D is not known to affect your ability to drive and use machines.


Important information about some of the ingredients of Norsed Combi D

The tablets contain lactose. The effervescent granules contain sorbitol, sucrose and soya-bean oil (see section 2, “Warnings and precautions” and “Do not take Norsed Combi D”).


The calcium/vitamin D3granules contain potassium (163 mg per sachet). This should be taken into consideration if you have a reduced kidney function or are on a controlled potassium diet.


3. How to take Norsed Combi D


Norsed Combi D is a weekly therapy presented in a box containing 1 tablet (in a blister) and 6 sachets containing effervescent granules that should be taken in a special way. Every weekly box has dosing instructions on the back.


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


Recommended dose:

Weekly cycle:

Day 1: Norsed tablet (light‑orange tablet)

Take ONE Norsed tablet once a week.

Chooseone day of the week that best fits your schedule. This will be your Day 1 of the weekly cycle. Every week, take the Norsed tablet on your chosen Day 1.


Days 2 to 7: Calcium/vitamin D3 sachets (effervescent granules)

Beginning on the day after the Norsed tablet has been taken,

Take ONE sachet of calcium/vitamin D3granules each day for the next 6 days.


Every 7 days start a new weekly box. You should begin a new box by taking the Norsed tablet on your chosen Day 1.

Do NOT take your Norsed tablet and the sachet on the same day.


WHEN to take the Norsed tablet

Take your Norsed tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.


HOW to take Norsed Combi D

Norsed tablets


Calcium/vitamin D3sachets

Pour the content of the sachet into a glass of plain water and stir. Wait until the fizzing has subsided, then drink the solution.


If you take more Norsed Combi D than you should

Norsed tablets

If you have taken more tablets than you should, or if children have been taking medicine by accident, drink one fullglass of milk and seek medical attention.


Calcium/vitamin D3sachets

If you have taken more sachetsthan you should, or if children have been taking medicine by accident, please contact your doctor.


If you forget to take Norsed Combi D

Norsed tablets

If you have forgotten to take your tablet on your chosen day (Day 1):

1. Take it on the day you remember. Do NOT take two tablets in one day to make up for the tablet you missed.

2. On the following day take your calcium/vitamin D3sachet. Do NOT take your Norsed tablet and the sachet on the same day.

3. Continue taking one sachet each day until the end of the weekly cycle.

4. Discard any remaining sachets in the box at the end of the weekly cycle.

Then start a new weekly cycle: take one Norsed tablet once a week on your chosen Day 1.


Calcium/vitamin D3sachets

If you have forgotten to take a calcium/vitamin D3sachet:

1. Take it on the day you remember. Do NOT take the sachet on the same day as the Norsed tablet. Do NOT take two sachets on the same day.

2. Continue taking one sachet each day until the end of the weekly cycle.

3. Discard any remaining sachets in the box at the end of the weekly cycle.


If you stop taking Norsed Combi D

If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.


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


Possible side effects


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


Norsed tablets


Stop taking Norsed and contact a doctor immediately if you experience any of the following:


Tell your doctor promptlyif you experience the following side effects:

Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new or worsened heartburn.

Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.


However in clinical studies the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets.


Common side effects (may affect up to 1 in 10 people)


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


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


During post-marketing experience, the following have been reported

  • Hair loss

  • Liver disorders, some cases were severe.


Rarely, at the beginning of treatment, a patient’s blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms.


Calcium/vitamin D3sachets


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

Hypercalcaemia (a high blood calcium level, with potential symptoms of excessive thirst, loss of appetite, fatigue and in severe cases irregular heart beat), hypercalciuria (a high calcium level in the urine).


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


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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Norsed Combi D


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


This medicine does not require any special storage conditions.


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 Norsed Combi D contains

Film‑coated tablets

The active substance isrisedronate sodium. Each tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.


The other ingredients are:

Tablet core: lactose monohydrate (see section 2),crospovidone A, magnesium stearate and cellulose microcrystalline.


Film coating: hypromellose, macrogol, hydroxypropylcellulose, colloidal anhydrous silica, titanium dioxide [E171], iron oxide yellow [E172], iron oxide red [E172].


Effervescent granules sachets

The active substances are calcium carbonate and colecalciferol (vitamin D3). Each sachet of effervescent granules contains 1000 mg calcium (as 2500 mg calcium carbonate) and 22 micrograms (880 International Units [IU]) of colecalciferol (vitamin D3).


The other ingredients are: citric acid anhydrous, malic acid, gluconolactone, maltodextrin, sodium cyclamate, saccharin sodium, sorbitol [E420], mannitol [E421], dextrin, acacia, natural lemon oils, natural lime flavour, rice starch, potassium carbonate, all-rac-α-tocopherol, soya-bean oil (hydrogenated), gelatin, sucrose, maize starch.


What Norsed Combi D looks like and contents of the pack

The combination pack is constituted of an outer carton pack containing weekly unit(s) (carton boxes).

Each weekly unit contains:


Pack sizes: 1, 2, 4, 12 (3x4)and 16 (4x4) weekly units.

Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

[to be completed nationally]


Manufacturer:

Warner Chilcott Deutschland GmbH,

Dr.-Otto-Röhm-Str. 2-4,

64331 Weiterstadt, Germany


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

Ireland: Optinate Plus Ca & D 35 mg film‑coated tablets + 1000 mg / 880 i.u. effervescent granules

Sweden: Norsed Combi D 35 mg + 1000 mg / 880 IE filmdragerade tabletter + brusgranulat


This leaflet was last revised in:


14 January 2016


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