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VALEBO 70 MG + 1 MICROGRAM TABLETS + CAPSULES SOFT

Active substance(s): ALENDRONATE MONOSODIUM MONOHYDRATE / ALFACALCIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

VALEBO 70 mg + 1 microgram TABLETS + CAPSULES, SOFT
alendronic acid and alfacalcidol
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.

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

WHAT VALEBO IS AND WHAT IT IS USED FOR
Valebo is a medicine with two individual formulations: alendronic acid tablets and alfacalcidol
capsules.
What is alendronic acid?
Alendronic acid belongs to a group of medicines known as bisphosphonates. Alendronic acid
prevents the loss of bone mass occurring in women after the menopause and helps in bone
regeneration. In this way, alendronic acid reduces the risk of bone fractures which commonly occur
in association with osteoporosis, particularly spine and hip fractures. Alendronic acid is not a
hormone preparation.
What is alfacalcidol?
Alfacalcidol belongs to a group of medicines known as “vitamin D analogues”, which regulate the
amount of calcium and phosphate in the body.

Alfacalcidol causes increased uptake of calcium and phosphate from food in the small intestine and
promotes the incorporation of minerals into bone. At the same time, alfacalcidol reduces the release
of calcium from bone and prevents bone disintegration. In some clinical studies alfacalcidol has
been shown to reduce the risk of falls in the elderly.
Valebo is used for the treatment of osteoporosis which is common in women after menopause.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALEBO
Do not take Valebo if:


you are allergic (hypersensitive) to alfacalcidol, alendronic acid, to peanut or soya or other
medicines of the bisphosphonate group or any of the other ingredients of this medicine
(listed in section 6)



you have a narrowing of the gullet, swallowing difficulties or other problems that obstruct
the passage of food from the gullet into the stomach



you are unable to stand or sit upright for at least 30 minutes. You must not lie down, as the
gullet area may otherwise become irritated when taking Valebo.



your doctor has told you that your blood magnesium levels are too high



your doctor has told you that your blood calcium levels are too low or too high



you suffer from a condition known as milk-alkali syndrome or Burnett’s syndrome. In this
condition, certain blood counts (calcium levels and the calcium phosphate product) and
blood pH values are increased (so-called alkalosis).



you are known to suffer from vitamin D hypersensitivity



you are suffering from vitamin D intoxication



you have a kidney disorder and require dialysis treatment



you have ever had kidney stones or if you have sarcoidosis (Boeck’s disease), you are at
greater risk if you take this medicine.

Valebo should not be administered to children and adolescents less than 18 years of age.
If you think that one or more of these points applies to you, do not take this medicine. Talk to your
doctor first and follow his/her advice
Warnings and precautions
Talk to your doctor or pharmacist before taking Valebo if::


you have a kidney disorder



you suffer from allergies



you have low blood calcium levels. These must firstly be corrected before you take
Valebo. Other disorders associated with calcium or phosphate imbalance within your body,
such as an underactive parathyroid, may need to be treated first and require close
monitoring whilst you are taking Valebo.



you have sarcoidosis (Boeck’s disease), leukaemia or lymphoma, you are at greater risk if
you take this medicine



you are on high calcium diet; you may be at higher risk of hypercalcaemia



you suffer from an upper gastrointestinal disorder, such as swallowing difficulties,
oesophageal (gullet) disease, inflammation of the lining of the stomach or small intestine or
ulcers, or if you have recently had (within the last year) a severe gastrointestinal disorder,
such as a peptic ulcer or active gastrointestinal bleeding, or if you have had surgery on the
upper gastrointestinal tract (other than pyloroplasty, a surgical procedure on the pylorus or
gastric outlet)



your doctor has told you that you have Barett’s oesophagus (a condition associated with
changes in the cells that line the lower oesophagus)



you have poor dental health, gum disease or you don’t receive routine dental care



you are scheduled to have a tooth removed



you have cancer



you are receiving chemotherapy or radiation treatment



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 Valebo.
It is important to maintain good oral hygiene when being treated with Valebo. 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) may occur whilst taking Valebo, which may be followed by narrowing of the
gullet in rare cases. These are often associated with symptoms such as chest pain, heartburn or
swallowing difficulties/pain on swallowing and may be so serious that hospitalisation is required.
Such problems occur less often if you drink a full glass of water (at least 200 ml, not mineral
water) when taking alendronic acid tablets and/or if you avoid lying down for 30 minutes after
taking alendronic acid tablets. Please note that these side effects may get worse if you continue to
take alendronic acid tablets after such symptoms have appeared. As the risk of such side effects is
also increased if you do not take the medicine correctly, please follow the instructions in section 3
“How to take Valebo” at all times.
Other medicines and Valebo
Tell your doctor or pharmacist if you ae taking, have recently taken or might take any other
medicines.
Medicines that interfere with the effect of alendronic acid:


If taken at the same time, dietary supplements containing calcium, antacids (stomach acid
neutralisers) and some other oral medications (taken by mouth) may affect the absorption
of alendronic acid tablets into the body. It is therefore important that you follow the
instructions given in section 3 “How to take Valebo”.



Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or
ibuprofen) might cause digestive problems. Therefore, caution should be used when these
medicines are taken at the same time as Valebo.

Medicines that interfere with the effect of alfacalcidol:


Vitamin D and its derivatives must not be taken at the same time as alfacalcidol, as
alfacalcidol itself is a highly potent vitamin D derivative. Co-administration with other
vitamin D derivatives can greatly increase the risk of hypercalcaemia (high blood calcium
levels). Very high blood calcium levels can be life-threatening.



The risk of high calcium levels may be increased by preparations containing calcium,
thiazides (certain dehydrating tablets - “diuretics”) and other medicines that increase blood
calcium levels.



In patients taking digitalis medication, even a slight rise in blood calcium levels can cause
heart rhythm disorders. For this reason, patients taking digitalis and alfacalcidol capsules
must be strictly monitored.



If you are also taking any barbiturates (potent sleeping pills or medication used to treat
seizures) or any other medicines used to treat seizures (anticonvulsants), please tell your
doctor, so that he/she can adjust the amount of alfacalcidol you are taking, as appropriate.

The following group of medicines can also impair the effect of alfacalcidol:


Glucocorticoids (cortisone and related substances)



Bile acid-binding agents (cholestyramine, colestipol)



Sucralfate (a medicine used to protect the stomach lining)



Antacids (stomach acid neutralisers) with a high aluminium content. Alfacalcidol capsules
and antacids containing aluminium should therefore be taken 2 hours apart and not at the
same time.



If, due to the menopause, you are taking hormones containing oestrogen, these may
enhance the effect of alfacalcidol.

Valebo with food and drink
Food and drink (even mineral water) will probably reduce the effectiveness of alendronic
acid tablets, if consumed together. It is therefore important you follow the instructions given
in section 3 “How to take Valebo”.

Pregnancy, breast-feeding and fertility
You should not take Valebo if you are pregnant or if you think you are pregnant. Similarly, you
should not take Valebo if you are breast-feeding.
Valebo is solely intended for use in women after the menopause.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint
pain) reported with alendronic acid that may affect your ability to drive or operate machinery.
Individual responses may vary (see section ‘Possible side effects’).
Important information about some of the ingredients of Valebo
Valebo contains arachis oil (peanut oil). If you are allergic to peanut or soya, do not use this
medicinal product.
Valebo contains sorbitol. If you have been told that you have an intolerance to some sugars,
please contact your doctor before taking Valebo.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per
capsule.

3.

HOW TO TAKE VALEBO
Valebo consists of alendronic acid tablets and alfacalcidol capsules.
The alendronic acid tablet should be taken in the morning while the alfacalcidol capsules should be
taken in the evening.
Always take Valebo exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
The usual dose is:
Alendronic acid tablets
Take one tablet once a week.
Choose a day of the week that best fits in with your general timetable. Take one tablet every week
on your selected day.
Alendronic acid tablets can cause irritation of the mouth and gullet. To reduce the risk of mucous
membrane irritation, please follow the instructions below at all times when taking alendronic acid
tablets:
1.

Take the alendronic acid tablet after getting up on your selected day of the week, before
having anything to eat or drink and before taking other medications. Swallow the
alendronic acid tablet and then drink a full glass of water immediately (at least 200 ml).
You must not chew the tablet or allow it to dissolve in your mouth.
- Do not take the tablet with mineral water (either carbonated or non-carbonated).
- Do not take the tablet with coffee or tea.
- Do not take the tablet with juice or milk.

2.

Do not lie down after taking the tablet; keep your upper body in an upright position
(sitting, standing or walking) for at least 30 minutes after taking the tablet. After this

time, do not lie down without having had a meal. In this way, you will prevent the tablets
from leaving the stomach and re-entering the gullet, where they cause irritation.
3.

However, wait for at least 30 minutes after taking the alendronic acid tablet until you
have your first food, drink or other medications of the day [including antacids (stomach
acid neutralisers), dietary supplements containing calcium and vitamins]. Alendronic acid
tablets are effective only if you take them on an empty stomach.

4.

Do not take alendronic acid tablets before going to bed or before getting up for the day.

5.

If you experience difficulties or pain when swallowing, chest pain, sudden heartburn or if
you notice any worsening of frequent existing heartburn, you must stop taking the
alendronic acid tablets and tell your doctor.

Alfacalcidol capsules
Take one capsule once daily.
1.

Take each alfacalcidol capsule in the evening.

2.

Swallow the capsule whole with sufficient liquid.

3.

Your doctor should regularly measure calcium levels in your blood. If there is any rise in
these levels, you may have to stop taking calcium-containing products altogether or just
temporarily stop taking the alfacalcidol capsules until your blood calcium levels have
returned to normal.

Use in children and adolescents
Valebo should not be administered to children and adolescents less than 18 years of age.
It is important that you continue to take Valebo for as long as your doctor prescribes. Valebo can
only improve your osteoporosis if you take both the tablets and capsules. The duration of treatment
depends on osteoporotic fracture risk; your doctor will decide for how long you will need to take
Valebo.
If you take more Valebo than you should
If you have taken more Valebo as prescribed, you should inform your doctor or your local poison
control center immediately.
If you take more alendronic acid tablets than you should
Drink a full glass of milk or take an antacid. Do not force yourself to be sick and do not lie down.
Inform your doctor or go to your nearest hospital immediately. The following symptoms may
occur: reduced calcium and phosphate in the blood and upper gastrointestinal adverse events, such
as upset stomach, heartburn, oesophagitis, gastritis or ulcers.
If you take more alfacalcidol capsules than you should
In the event of a long-term overdose with alfacalcidol, life-threatening hypercalcaemia (high blood
calcium levels) may sometimes occur.
Symptoms of this disorder may be gradual in onset and may be confused with malaise (generally
feeling unwell). Possible signs are:
- weakness, tiredness, exhaustion, headache
- digestive complaints such as nausea, vomiting, constipation or diarrhoea
- heartburn, dry mouth
- muscle, bone and joint pain

-

itching or palpitations.

If your kidneys are no longer able to concentrate urine, the following disorders may also occur:
increased urine output, increased thirst and drinking, night-time urinary urgency
- protein in the urine.
-

Contact your doctor if you have taken too many alfacalcidol capsules or if, based on the symptoms
above, you think that your blood calcium levels might be too high.
If you forget to take your alendronic acid tablets
If you forget an alendronic acid tablet, take one on the following morning, after you realise.
Do not take two tablets in one day. Afterwards, continue with your usual treatment schedule, taking
one alendronic acid tablet again as usual on your selected day of the week.
If you forget to take your alfacalcidol capsules
If you forget to take the alfacalcidol capsules, take them as soon as you realise. Do not take a
double dose to make up for a forgotten dose. Then simply continue taking the capsules as per your
treatment schedule.
If you stop taking Valebo
You should not decide to suspend your treatment with Valebo, or end it before you should, without
talking to your treating doctor. If you are required to suspend your treatment or end it early on
medical grounds, please follow the instructions given by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

POSSIBLE-UNDESIRABLE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you are affected by any of the side effects listed below, stop taking Valebo and consult your
doctor as soon as possible.
Possible side effects of alendronic acid tablets
Very common (may affect more than 1 in 10 people): bone, muscle and/or joint pain which is
sometimes severe.
Common (may affect up to1 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, 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.
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, 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): allergic reactions such as hives; swelling of the face,
lips, tongue and/or throat, possibly causing difficulty breathing or swallowing, 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), mouth ulcers when the

tablets have been chewed or sucked, rash made worse by sunlight, 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.
Possible side effects of alfacalcidol capsules
Rare (may affect up to 1 in 1,000 people): allergic reactions, anaphylactic shock (caused mainly by
the peanut oil which is one of the ingredients in the capsules), increases in blood phosphate levels,
hypercalcaemia (increased blood calcium concentration). The clinical symptoms of hypercalcaemia
are uncharacteristic (e.g. weakness, tiredness, feeling thirsty, gastrointestinal symptoms and
itching). If you experience such signs, you should consult your doctor, so that he/she can monitor
your blood calcium levels. Such an increase in calcium levels is particularly dangerous if you are
also taking digitalis for heart failure (for further details, see also section 2 “Taking other
medicines”).
Very rare (may affect up to 1 in 10,000 people): calcium deposits have been reported in tissue, e.g.
in the cornea of the eye or blood vessels, in patients taking alfacalcidol and have been shown to be
reversible.
For Valebo
Both components of Valebo, alendronic acid and alfacalcidol, can both affect calcium levels in
your blood: alendronic acid may reduce them, whilst alfacalcidol may increase them. Thus, the risk
of calcium imbalance is reduced.
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 the Yellow Card
Scheme at: 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 VALEBO
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and outer packaging
after EXP. The expiry date refers to the last date that month.
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
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.

CONTENTS OF THE PACK AND OTHER INFORMATION
What Valebo contains
The active substances are alendronate monosodium monohydrate and alfacalcidol.
One tablet contains 70 mg alendronic acid (as alendronate monosodium monohydrate).

One capsule, soft contains 1 microgram alfacalcidol.
The other ingredients are:
Tablets: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Capsules, soft: citric acid anhydrous, propyl gallate, all-rac-α-tocopherol (vitamin E), ethanol
anhydrous and arachis oil (peanut oil) refined.
Capsule shell: gelatine, glycerol 85%, anidrisorb 85/70 (which consists of: sorbitol, sorbitan
anhydrides, mannitol, higher polyols and water) and titanium dioxide (E171).
Printing ink: shellac and iron oxide black (E172).
What Valebo looks like and contents of the pack:
This medicinal product is presented as tablet (alendronic acid) and soft capsule (alfacalcidol).
The tablets are white to off-white, round tablets, flat on both sides and with bevelled edges. They
are stamped with “T” on one side and without marking on the other side.
The capsules are opaque, white to off-white oval capsules, soft, imprinted with “1.0” in black ink.
Each blister contains one alendronic acid tablet and seven alfacalcidol capsules.
Valebo is available in packs of:
2 blisters: 2 alendronic acid tablets and 14 alfacalcidol capsules, soft
4 blisters: 4 alendronic acid tablets and 28 alfacalcidol capsules, soft
12 blisters: 12 alendronic acid tablets and 84 alfacalcidol capsules, soft
Not all pack sizes may be marketed.
Marketing authorisation holder
TEVA Pharma B.V.
Computerweg 10, 3542DR Utrecht
The Netherlands
Manufacturer
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
OR*
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem

The Netherlands
*Only the actual site of batch release will appear on the printed version of the leaflet
This leaflet was last revised in 03/2014.
PL 14776/0091

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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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