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

Active substance(s): CALCIUM CARBONATE / CHOLECALCIFEROL / RISEDRONATE SODIUM / CALCIUM CARBONATE / CHOLECALCIFEROL / RISEDRONATE SODIUM / CALCIUM CARBONATE / CHOLECALCIFEROL / RISEDRONATE SODIUM

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Package leaflet: Information for the patient

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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. See section 4.
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. W
 hat 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.
 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.
 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. W
 hat 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 or you have previously been
told that you have Barrett’s oesophagus (a condition
associated with changes in the cells that line the lower
oesophagus).
• 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
 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.
 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
 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.
 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)
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.
•D
 ays 2 to 7: Calcium/vitamin D3 sachets
DAY
2DAY
(effervescent granules)
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.
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
 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.
 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.

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 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 take more Actonel Combi than you should
 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.
 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.

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 via:
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

If you forget to take Actonel Combi

• Keep this medicine out of the sight and reach of children.

 Actonel 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. C
 ontinue taking one sachet each day until the end of the
weekly cycle.
4. D
 iscard 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.

•D
 o 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.

 Calcium/vitamin D3 sachets
If you have forgotten to take a calcium/vitamin D3 sachet:
1. T ake 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. C
 ontinue taking one sachet each day until the end of the
weekly cycle.
3. D
 iscard any remaining sachets in the box at the end of the
weekly cycle.
If you stop taking Actonel Combi
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
 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:
•E
 ye inflammation, usually with pain, redness and light
sensitivity.
•B
 one necrosis of the jaw (osteonecrosis) associated with
delayed healing and infection, often following tooth
extraction (see section 2, “Warnings and precautions”).
•S
 ymptoms 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).
•A
 bnormal liver tests have been reported. These can only be
diagnosed from a blood test.
Very rare (may affect up to 1 in 10,000 people)
• T alk to your doctor if you have ear pain, discharge from the
ear, and/or an ear infection. These could be signs of bone
damage in the ear.
During post-marketing experience, the following have been
reported (unknown frequency);
• Hair loss
• Liver disorders, some cases were severe.

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

5. How to store Actonel Combi

• T his 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 Actonel Combi contains
 Film-coated tablets
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,
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 Actonel Combi 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:
•o
 ne 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.
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 medicine is authorised in the Member States of
the EEA under the following names:
Belgium: Actonel Combi D 35 mg + 1000 mg / 880 IE
filmomhulde tabletten + bruisgranulaat, 35 mg +
1000 mg / 880 UI comprimé pelliculé et granulés
effervescents en sachet-dose, 35 mg + 1000 mg /
880 I.E. Filmtabletten + Brausegranulat
Finland: Optinate Combi D 35 mg + 1000 mg / 880 UI
kalvopäällysteiset tabletit + porerakeet
France: Actonel combi 35 mg + 1000 mg / 880 UI
comprimé pelliculé et granulés effervescents en
sachet-dose
Germany: Actonel plus Calcium D 35 mg +1000 mg
/880 I.E. Filmtabletten + Brausegranulat
Ireland: Actonel Plus Ca & D 35 mg film-coated tablets
+1000 mg / 880 i.u. effervescent granules
Lithuania: Actonel Combi 35 mg plėvele dengtos tabletės
+ 1000 mg / 880 TV šnypščiosios granulės
Malta: Actonel P
 lus Ca & D 35 mg film-coated tablets
+1000 mg / 880 i.u. effervescent granules
The Netherlands: Actokit D 35 mg + 1000 mg/ 880 IE
filmomhulde tabletten + bruisgranulaat
Slovenia: Actonel Combi 35 mg + 1000 mg/ 880 IE
filmsko obložena tableta + šumeča zrnca
Sweden: Actonel Combi 35 mg + 1000 mg / 880 IE
filmdragerade tabletter + brusgranulat
United Kingdom: A
 ctonel Combi 35 mg film-coated
tablets + 1000 mg / 880 IU effervescent granules
This leaflet was last revised in: December 2015

AAAI5652

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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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