ACTONEL COMBI 35 MG FILM-COATED TABLETS + 1000 MG / 880 IU EFFERVESCENT GRANULES

Active substance: RISEDRONATE SODIUM

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Package leaflet: Information for the patient

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Actonel Combi is and what it is used for
2. What you need to know before you take Actonel Combi
3. How to take Actonel Combi
4. Possible side effects
5. How to store Actonel Combi
6. Contents of the pack and other information
1. What Actonel Combi is and what it is used for
What Actonel Combi is
A combination medicine packed as weekly units each containing 1 tablet of Actonel and 6 sachets of calcium/vitamin D3.
r Actonel tablets
Actonel 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.
u Calcium/vitamin D3 sachets
The sachets contain calcium/vitamin D3 effervescent granules
which provide the calcium and the vitamin D3 that your body
may need to harden new bone.
What Actonel Combi is used for
The treatment of osteoporosis, even if severe, in postmenopausal women who also need daily calcium and vitamin
D3 supplementation as assessed by their doctor.
It reduces the risk of spinal and hip fractures.
2. What you need to know before you take
Actonel Combi
Do not take Actonel Combi
• If you are allergic to risedronate sodium, calcium carbonate, vitamin D3, peanut or soya or any of the other ingredients of
this medicine (listed in section 6)
• If your doctor has told you that you have a condition called:
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)
• If you may be pregnant, are pregnant or planning to
become pregnant
• If you are breast feeding
• If you have severe kidney problems, including kidney
stones.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Actonel Combi
• If you are unable to stay in an upright position (sitting or
standing) for at least 30 minutes.
• If you have abnormal bone and mineral metabolism (for
example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level).
• If you have or have had problems in the past with your
oesophagus (the tube that connects your mouth with your
stomach). For instance you may have or have had pain or
difficulty in swallowing food.
• If you have been told by your doctor that you have an intolerance to some sugars.
• If you have a condition called sarcoidosis (an immune system
disorder mainly affecting the lungs, which causes shortness
of breath and cough).
• If you are already taking supplements of vitamin D.
• If you have had or have pain, swelling or numbness of the
jaw or a “heavy jaw feeling” or loosening of a tooth.
• If you are under dental treatment or will undergo dental
surgery, tell your dentist that you are being treated with
Actonel Combi.
Your doctor will advise you on what to do when taking Actonel
Combi 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 Actonel Combi
r Actonel tablets

Medicines containing one of the following lessen the effect of
the Actonel tablet if taken at the same time:
• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron.
Take these medicines at least 30 minutes after your Actonel
tablet.
u Calcium/vitamin D3 sachets
Medicines containing calcium/vitamin D3 are known to interfere
with the following:
• digitalis (used to treat heart disorders)
• tetracycline antibiotics
• steroids (such as cortisone)
• sodium fluoride (used to strengthen the tooth enamel)
• thiazide diuretics (used to remove water from the body by
increasing urine production)
• cholestyramine (used to treat high blood cholesterol levels)
• laxatives (such as paraffin oil).
If you are taking any of the above-mentioned medicines, your
doctor will give you further instructions.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Actonel Combi with food and drink
r Actonel tablets

It is very important that you do NOT take your Actonel 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 Actonel Combi”).
Take food and drinks (other than plain water) at least 30
minutes after your Actonel tablet.
u Calcium/vitamin D3 sachets
Do NOT take the dissolved calcium/vitamin D3 granules 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 Actonel Combi if you are pregnant, think you
may be pregnant, or planning to have a baby (see section 2,
“Do not take Actonel Combi”). The potential risk associated
with the use of risedronate sodium (active substance in Actonel
tablets) in pregnant women is unknown.
Do NOT take Actonel Combi if you are breast-feeding (see
section 2, “Do not take Actonel Combi”).
Driving and using machines
Actonel Combi is not known to affect your ability to drive and
use machines.
Important information about some of the ingredients of Actonel Combi
The tablets contain lactose. The effervescent granules contain
sorbitol, sucrose and soya-bean oil (see section 2, “Warnings
and precautions” and “Do not take Actonel Combi”).
The calcium/vitamin D3 granules 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 Actonel Combi
Actonel Combi 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: Actonel tablet (light-orange tablet)
DAY
Take ONE Actonel tablet once a week.
Choose one day of the week that best fits your
schedule. This will be your Day 1 of the weekly
cycle. Every week, take the Actonel tablet on your chosen
Day 1.
• Days 2 to 7: Calcium/vitamin D3 sachets
DAY
DAY
(effervescent granules)
2
3
Beginning on the day after the Actonel tablet
has been taken, Take ONE sachet of calcium/
vitamin D3 granules each day for the next 6 days.
Every 7 days start a new weekly box. You should begin a new
box by taking the Actonel tablet on your chosen Day 1.
Do NOT take your Actonel tablet and the sachet on the same
day.
DAY

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

WHEN to take the Actonel tablet
Take your Actonel tablet at least 30 minutes
before the first food, drink (other than plain
water) or other medicine of the day.
HOW to take Actonel Combi
r Actonel tablets

• Take the tablet whilst you are in an upright position
(you may sit or stand) to avoid heartburn.
• Swallow it with at least one glass (120 ml) of plain
water.
• Swallow it whole. Do not suck or chew it.
• Do not lie down for 30 minutes after taking your
tablet.
u Calcium/vitamin D3 sachets
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 Actonel Combi than you should
r Actonel tablets

If you have taken more tablets than you should, or if children
have been taking medicine by accident, drink one full glass
of milk and seek medical attention.
u Calcium/vitamin D3 sachets
If you have taken more sachets than you should, or if children
have been taking medicine by accident, please contact your
doctor.

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.
u Calcium/vitamin D3 sachets
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)
• Constipation, wind, nausea, abdominal pain, diarrhoea.
• Skin reactions such as itching, rash and hives.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
5. How to store Actonel Combi
• 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

If you forget to take Actonel Combi

What Actonel Combi contains

r Actonel tablets

r Film-coated 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 D3 sachet.
Do NOT take your Actonel 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 Actonel tablet once
a week on your chosen Day 1.
u Calcium/vitamin D3 sachets
If you have forgotten to take a calcium/vitamin D3 sachet:
1. Take it on the day you remember. Do NOT take the sachet
on the same day as the Actonel 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.

The active substance is risedronate 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,
silicon dioxide, titanium dioxide [E171], iron oxide yellow
[E172], iron oxide red [E172].
u 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-␣-tocopherol, soya-bean oil (hydrogenated),
gelatin, sucrose, maize starch.

If you stop taking Actonel Combi

The combination pack is constituted of an outer carton pack
containing weekly unit(s) (carton boxes).
Each weekly unit contains:
• one film-coated tablet which is an oval light-orange tablet
with the letters “RSN” on one side and “35 mg” on the other
side, packaged in a blister card.
• 6 sachets of effervescent granules of calcium and vitamin D3.
Pack sizes: 1, 2, 4, 12 (3x4) and 16 (4x4) weekly units.
Not all pack sizes may be marketed.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
r Actonel tablets
Stop taking Actonel and contact a doctor immediately
if you experience any of the following:
• Symptoms of a severe allergic reaction such as;
– Swelling of face, tongue or throat
– Difficulties in swallowing
– Hives and difficulties in breathing
• Severe skin reactions that can include blistering of the skin.
Tell your doctor promptly if you experience the following
side effects:
• Eye inflammation, usually with pain, redness and light
sensitivity.
• Bone necrosis of the jaw (osteonecrosis) associated with
delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions").
• 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)
• Indigestion, feeling sick, stomach ache, stomach cramps or
discomfort, constipation, feelings of fullness, bloating,
diarrhoea.
• Pain in your bones, muscles or joints.
• Headache.
Uncommon side effects (may affect up to 1 in 100 people)
• Inflammation or ulcer of the oesophagus (the tube that
connects your mouth with your stomach) causing difficulty
and pain in swallowing (see also section 2, “Warnings and
precautions”), inflammation of the stomach and duodenum
(bowel draining the stomach).
• Inflammation of the coloured part of the eye (iris) (red painful
eyes with a possible change in vision).
Rare side effects (may affect up to 1 in 1,000 people)
• Inflammation of the tongue (red swollen, possibly painful),
narrowing of the oesophagus (the tube that connects your
mouth with your stomach).
• Abnormal liver tests have been reported. These can only be
diagnosed from a blood test.
During post-marketing experience, the following have been
reported (unknown frequency);
• Hair loss
• Liver disorders, some cases were severe

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Warner Chilcott UK Ltd.,
Old Belfast Road,
Millbrook, Larne, County Antrim,
BT40 2SH, United Kingdom
Manufacturer:
Warner Chilcott Deutschland GmbH,
Dr.-Otto-Röhm-Str. 2–4,
64331 Weiterstadt, Germany

This leaflet was last revised in: 2012-04-13

10000325

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.

What Actonel Combi looks like and contents of the
pack

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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