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ACLONIA 70 MG/ 2 800 IU TABLETS

Active substance(s): ALENDRONATE SODIUM TRIHYDRATE / CHOLECALCIFEROL / COLECALCIFEROL / ALENDRONATE SODIUM TRIHYDRATE / CHOLECALCIFEROL / COLECALCIFEROL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aclonia 70 mg/2,800 IU tablets
Aclonia 70 mg/5,600 IU tablets
Alendronic acid/cholecalciferol (vitamin D3)

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.

What is in this leaflet:
1. What Aclonia is and what it is used for
2. What you need to know before you take Alendronate/
Cholecalciferol
3. How to take Aclonia
4. Possible side effects
5. How to store Aclonia
6. Contents of the pack and other information

1. WHAT Aclonia IS AND WHAT IT IS USED FOR
What is Aclonia?
Aclonia is a tablet containing the two active substances,
alendronic acid (commonly called alendronate) and
cholecalciferol known as vitamin D3.
What is alendronate?
Alendronate belongs to a group of non-hormonal
medicines called bisphosphonates. Alendronate
prevents the loss of bone that occurs in women after
they have been through the menopause, and helps
to rebuild bone. It reduces the risk of spine and hip
fractures.
What is vitamin D?
Vitamin D is an essential nutrient, required for calcium
absorption and healthy bones. The body can only absorb
calcium properly from our food if it has enough vitamin
D. Very few foods contain vitamin D. The main source
is through exposure to summer sunlight, which makes
vitamin D in our skin. As we get older our skin makes less
vitamin D. Too little vitamin D may lead to bone loss and
osteoporosis. Severe lack of vitamin D may cause muscle
weakness which can lead to falls and a greater risk of
fractures.
What is Aclonia used for?
Your doctor has prescribed Aclonia to treat your
osteoporosis and because you are at risk of too little
vitamin D. Aclonia reduces the risk of spine and hip
fractures in women after menopause.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones.
It is common in women after the menopause.
At the menopause, the ovaries stop producing the
female hormone, oestrogen, which helps to keep a
woman’s skeleton healthy. As a result, bone loss occurs
and bones become weaker. The earlier a woman reaches
the menopause, the greater the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms. If
left untreated, however, it can result in broken bones.
Although these usually hurt, breaks in the bones of the
spine may go unnoticed until they cause height loss.
Broken bones can happen during normal, everyday
activity, such as lifting, or from minor injury that would
not generally break normal bone. Broken bones usually
occur at the hip, spine, or wrist and can lead not only
to pain but also to considerable problems like stooped
posture (‘dowager’s hump’) and loss of mobility.
How can osteoporosis be treated?
As well as your treatment with Aclonia, your doctor may
suggest you make changes to your lifestyle to help your
condition, such as:
Stopping smoking
Smoking appears to increase the rate at which you lose
bone and, therefore, may increase your risk of broken
bones.
Exercise
Like muscles, bones need exercise to stay strong and
healthy. Consult your doctor before you begin any
exercise programme.
Eating a balanced diet
Your doctor can advise you about your diet or whether
you should take any dietary supplements.

2. What you need to know before you
take Aclonia
Do not take Aclonia
• if you are allergic to alendronate sodium trihydrate,
cholecalciferol or any of the other ingredients of this
medicine (listed in section 6),
• if you have certain problems with your gullet
(oesophagus - the tube that connects your mouth
with your stomach) such as narrowing or difficulty
swallowing,
• if you cannot stand or sit upright for at least 30
minutes,
• if your doctor has told you that you have low blood
calcium.
If you think any of these apply to you, do not take the
tablets. Talk to your doctor first and follow the advice
given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aclonia if:
• you suffer from kidney problems,
• you have, or have recently had, any swallowing or
digestive problems,

• your doctor has told you that you have Barrett’s
oesophagus (a condition associated with changes in
the cells that line the lower oesophagus),
• you have been told you have trouble absorbing
minerals in your stomach or intestines (malabsorption
syndrome),
• you have poor dental health, gum disease, a planned
dental extraction or you don’t receive routine dental
care,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as
bevacizumab or thalidomide),
• you are taking corticosteroids (such as prednisone or
dexamethasone),
• you are or have been a smoker (as this may increase
the risk of dental problems).
You may be advised to have a dental check-up before
starting treatment with Aclonia.
It is important to maintain good oral hygiene when
being treated with Aclonia. You should have routine
dental check-ups throughout your treatment and you
should contact your doctor or dentist if you experience
any problems with your mouth or teeth such as loose
teeth, pain or swelling.
Irritation, inflammation or ulceration of the gullet
(oesophagus – the tube that connects your mouth
with your stomach) often with symptoms of chest pain,
heartburn, or difficulty or pain upon swallowing may
occur, especially if you do not drink a full glass of water
and/or if you lie down less than 30 minutes after taking
Aclonia. These side effects may worsen if you continue to
take Aclonia after developing these symptoms.
Children and adolescents
Aclonia should not be given to children and adolescents
less than 18 years of age.
Other medicines and Aclonia
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
It is likely that calcium supplements, antacids, and
some oral medicines will interfere with the absorption
of Aclonia if taken at the same time. Therefore, it is
important that you follow the advice given in section 3.
How to take Aclonia and wait at least 30 minutes before
taking any other oral medicines or supplements.
Certain medicines for rheumatism or long-term pain
called NSAIDs (e.g. acetylsalicylic acid or ibuprofen)
might cause digestive problems. Therefore, caution
should be used when these medicines are taken at the
same time as Aclonia.
It is likely that certain medicines or food additives
may prevent the vitamin D in Aclonia from getting
into your body, including artificial fat substitutes,
mineral oils, the weight loss medicine, orlistat, and the
cholesterol-lowering medicines, cholestyramine and
colestipol. Medicines for fits (seizures) (like phenytoin
or phenobarbital) may decrease the effectiveness of
vitamin D.
Additional vitamin D supplements may be considered on
an individual basis.
Aclonia with food and drink
It is likely that food and beverages (including mineral
water) will make Aclonia less effective if taken at the
same time. Therefore, it is important that you follow
the advice given in section 3. How to take Aclonia. You
must wait at least 30 minutes before taking any food and
beverages except water.
Pregnancy and breast-feeding
Aclonia is only intended for use in postmenopausal
women.
You should not take Aclonia if you are or think you may
be pregnant, or if you are breast-feeding.
Driving and using machines
There have been side effects (for example blurred vision,
dizziness and severe bone, muscle or joint pain) reported
with Aclonia that may affect your ability to drive or
operate machinery. (See Possible side effects.) If you
experience any of these side effects you should not drive
until you feel better.
Aclonia contains lactose 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 Aclonia
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Take one Aclonia tablet once a week.

Follow these instructions carefully.
1) Choose the day of the week that best fits your
schedule. Every week, take one Aclonia tablet on your
chosen day.
It is very important to follow instructions 2), 3), 4) and
5) to help the Aclonia tablet reach your stomach quickly
and help reduce the chance of irritating your gullet
(oesophagus - the tube that connects your mouth with
your stomach).
2) After getting up for the day and before taking any
food, drink, or other medicine, swallow your Aclonia
tablet whole with a full glass of water only (not
mineral water) (not less than 200 ml), so that Aclonia is
adequately absorbed.
• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice or milk.
Do not crush or chew the tablet or allow it to dissolve
in your mouth because of the possibility of mouth
ulceration.
3) Do not lie down — stay fully upright (sitting, standing
or walking) — for at least 30 minutes after swallowing
the tablet. Do not lie down until after your first food of
the day.
4) Do not take Aclonia at bedtime or before getting up
for the day.
5) If you develop difficulty or pain upon swallowing,
chest pain, or new or worsening heartburn, stop taking
Aclonia and contact your doctor.






black or tar-like stools,
blurred vision; pain or redness in the eye,
rash; redness of the skin,
transient flu-like symptoms, such as aching muscles,
generally feeling unwell and sometimes with fever
usually at the start of treatment,
• taste disturbance.
Rare (may affect up to 1 in 1,000 people):
• symptoms of low blood calcium levels including
muscle cramps or spasms and/or tingling sensation in
the fingers or around the mouth,
• stomach or peptic ulcers (sometimes severe or with
bleeding),
• narrowing of the gullet (oesophagus – the tube that
connects your mouth with your stomach),
• rash made worse by sunlight,
• mouth ulcers.
Very rare (may affect up to 1 in 10,000 people):
• talk 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.
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 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 Aclonia

6) After swallowing your Aclonia tablet, wait at least
30 minutes before taking your first food, drink, or
other medicine of the day, including antacids, calcium
supplements and vitamins.
Aclonia is effective only if taken when your stomach is
empty.

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

If you take more Aclonia than you should
If you take too many tablets by mistake, drink a full glass
of milk and contact your doctor immediately. Do not
make yourself vomit, and do not lie down.

Store in the original blister in order to protect from
moisture and light.

If you forget to take Aclonia
If you miss a dose, just take one tablet on the morning
after you remember. Do not take two tablets on the
same day. Return to taking one tablet once a week, as
originally scheduled on your chosen day.
If you stop taking Aclonia
It is important that you take Aclonia for as long as your
doctor prescribes the medicine. Since it is not known
how long you should take Aclonia, you should discuss
the need to stay on this medicine with your doctor
periodically to determine if Aclonia is still right for you.
An Instruction Card is included in the carton for Aclonia.
It contains important information reminding you how to
take Aclonia properly.
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.
See your doctor immediately if you notice any of the
following side effects, which may be serious, and for
which you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):
• heartburn; difficulty swallowing; pain upon
swallowing; ulceration of the gullet (oesophagus - the
tube that connects your mouth with your stomach)
which can cause chest pain, heartburn or difficulty or
pain upon swallowing.
Rare (may affect up to 1 in 1,000 people):
• allergic reactions such as hives; swelling of the face,
lips, tongue and/or throat, possibly causing difficulty
breathing or swallowing; severe skin reactions,
• pain in the mouth, and/or jaw, swelling or sores inside
the mouth, numbness or a feeling of heaviness in the
jaw, or loosening of a tooth. These could be signs of
bone damage in the jaw (osteonecrosis) generally
associated with delayed healing and infection, often
following tooth extraction. Contact your doctor and
dentist if you experience such symptoms,
• 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,
• bone, muscle and/or joint pain which is severe.
Other side effects include
Very common (may affect more than 1 in 10 people):
• bone, muscle and/or joint pain which is sometimes
severe.
Common (may affect up to 1 in 10 people):
• joint swelling,
• abdominal pain; uncomfortable feeling in the stomach
or belching after eating; constipation; full or bloated
feeling in the stomach; diarrhoea; flatulence,
• hair loss; itching,
• headache; dizziness,
• tiredness; swelling in the hands or legs.

Do not use this medicine after the expiry date which
is stated on the blister and carton after EXP. The expiry
date refers to the last day of that month.

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 Aclonia contains
• The active substances are alendronic acid and
cholecalciferol (vitamin D3).
Each 70 mg/2,800 IU tablet contains 70 mg alendronic
acid as alendronate sodium trihydrate and 70
micrograms (2,800 IU) cholecalciferol (vitamin D3).
Each 70 mg/5,600 IU tablet contains 70 mg alendronic
acid as alendronate sodium trihydrate and 140
micrograms (5,600 IU) cholecalciferol (vitamin D3).
• The other ingredients for 70 mg/2,800 IU are
microcrystalline cellulose, lactose anhydrous,
croscarmellose sodium, magnesium stearate, sunflower
oil, refined, butylhydroxytoluene (BHT)-E321, gelatin
sucrose, maize starch and aluminium magnesium
silicate.
• The other ingredients for 70 mg/5,600 IU are
microcrystalline cellulose, lactose anhydrous,
croscarmellose sodium, magnesium stearate, sunflower
oil, refined, butylhydroxytoluene (BHT)-E321, gelatin
sucrose, maize starch and aluminium magnesium
silicate.
What Aclonia looks like and contents of the pack
Aclonia 70 mg/2,800 IU tablets are available as oblongshaped, white to off-white, biconvex tablets engraved
with 2,800 on one side, 12.3±0.2 mm in length and
6.5±0.2 mm in width.
Aclonia 70 mg/5,600 IU tablets are available as modified
rectangle-shaped, white to off-white tablets engraved
with 5,600 on one side, 11.4±0.2 mm in length and 7.2
± 0.2 mm in width.
The tablets are supplied in Aluminium/Aluminium (PA/
AL/PVC - Aluminium) foil blisters in cardboard box in the
following pack sizes:
For Aclonia 70 mg/2,800 IU
4, 12 tablets
For Aclonia 70 mg/5,600 IU
4, 12 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Consilient Health Ltd.,
5th floor, Beaux Lane House,
Mercer Street Lower,
Dublin 2, Ireland
Manufacturer
Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
This leaflet was last revised in 05/2017.

Uncommon (may affect up to 1 in 100 people):
• nausea; vomiting,
• irritation or inflammation of the gullet (oesophagus –
the tube that connects your mouth with your stomach)
or stomach,
P0616

Expand Transcript

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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