Document: leaflet MAH GENERIC_PL 04416-1164 change

• leaflet MAH GENERIC_PL 04416-1162
• leaflet MAH GENERIC_PL 04416-1163
• leaflet MAH GENERIC_PL 04416-1164

---

PL 04416/1164

Sandoz Ltd. Page 1 of 9

Package leaflet: Information for the user

Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +

Effervescent Tablets

Alendronic acid+calcium/Cholecalciferol

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

• Keep this leaflet. Y ou 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 Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is and what it is used for

2.    What you need to know before you take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

3.    How to take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

4.    Possible side effects

5.    How to store Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

6.    Contents of the pack and other information

1. What Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is and what it is used for

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is used to treat osteoporosis in women after menopause who also need daily calcium and vitamin D3 supplementation. This combination medicine reduces the risk of spinal and hip fractures.

a)    Alendronate belongs to a group of medicines called bisphosphonates. It prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone.

b)    Calcium/vitamin D₃ provides the calcium and the vitamin D₃ that your body may need to harden new bone.

2. What you need to know before you take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

Do not take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets if you are/have

•    allergic to alendronate sodium trihydrate, calcium carbonate, vitamin D₃, soya, peanut or any of the other ingredients of this medicine (listed in section 6)

•    certain problems with your gullet such as narrowing or difficulty swallowing

•    cannot stand or sit upright for at least 30 minutes

•    blood calcium levels which are below or above normal

•    urine calcium levels which are above normal

•    blood vitamin D levels which are above normal

•    increased levels of calcium in the kidneys, kidney stones

Warnings and precautions

Talk to your doctor before taking this medicine if any of the following conditions apply to you:

•    you suffer from kidney problems,

•    you have 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 low blood calcium ,

•    you have sarcoidosis, a disorder mainly affecting the lungs, which causes shortness of breath and coughing,

•    you are already taking vitamin D,

•    you had or have pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a tooth,

•    you have poor dental health, gum disease or you don't receive routine dental care.

You may be advised to have a dental check-up before starting treatment.

•    you are under dental treatment or will undergo dental surgery.

Tell your dentist that you are being treated with Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets.

•    you have cancer,

•    you are undergoing chemotherapy or radiotherapy,

•    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).

It is important to maintain good oral hygiene when being treated with Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets. 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, often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing, may occur. This applies especially, if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets. These side effects may worsen if patients continue to take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets after developing these symptoms.

Children and adolescents

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets should not be given to children and adolescents.

Other medicines and Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

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

a) Medicines containing any of the following reduce the effect of Alendronate if taken at the same time:

•    calcium

•    antacids, medicines to treat heartburn

• some oral medicines, such as medicines to treat pain, inflammation or rheumatism

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

b) Calcium/vitamin D₃ is known to affect or be affected by the following medicines:

•    digitalis: a medicine to treat heart disorders

•    antibiotics with active substance names ending in “cycline”

•    medicines to reduce inflammation or prevent organ transplant rejection, such as cortisone

•    sodium fluoride: used to strengthen tooth enamel or to treat osteoporosis

•    medicines to increase water output through your kidneys with active substance names ending in “zide”

•    cholestyramine: a medicine to reduce blood fat levels

•    laxatives, such as paraffin oil

Your doctor will give you further instructions, if you take any of the above-mentioned medicines.

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets with food and drink

a)    Do not take your Alendronate tablet with food or drinks, other than plain water, to ensure that it works properly. This particularly applies to dairy products, such as milk, as they contain calcium. Food and drinks, other than plain water, may only be taken at least 30 minutes after your Alendronate tablet.

b)    Do not take the dissolved Calcium/vitamin D3 effervescent tablets with foods containing high amounts of

•    oxalic acid, such as spinach and rhubarb, or

•    phytic acid, such as whole cereals

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

Pregnancy and breast-feeding

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is only intended for use in postmenopausal women.

Do not take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets may vary (See “4. Possible side effects”.)

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets contains sodium, lactose monohydrate, sucrose and hydrogenated soya oil.

The Calcium/vitamin D₃ effervescent tablets contain lactose monohydrate and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you taking this medicinal product.

The Calcium/vitamin D₃ effervescent tablets contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

The Calcium/vitamin D₃ effervescent tablets contain 4.2 mmol (96 mg) sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

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

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is a weekly therapy of:

a)    1 Alendronate tablet and

b)    6 Calcium/vitamin D3 effervescent tablets

Usual dose per weekly cycle:

•    Day 1

1 Alendronate tablet

Choose one day of the week that best fits your schedule. This will be “Day 1” of your weekly cycle. Every week, take the Alendronate tablet on your chosen “Day 1”.

•    Days 2 to 7

1 Calcium/vitamin D₃ effervescent tablet per day for the next 6 days

Start Calcium/vitamin D₃ intake on the day after the Alendronate tablet has been taken.

Do not take the Alendronate tablet and the Calcium/vitamin D₃ effervescent tablet on the same day. Every 7 days start a new weekly cycle beginning with the Alendronate tablet on your chosen “Day 1”.

Method of use

a)    Take your Alendronate tablet whole:

It is very important to follow these instructions to help the tablet reach your stomach quickly and help reduce the chance of irritating your gullet.

•    after getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronate tablet with a full glass of water only (not less than 200 ml).

-    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 chew the tablet or allow it to dissolve in your mouth.

•    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.

•    Do not take the tablet at bedtime or before getting up for the day.

•    If you develop difficulty or pain upon swallowing, chest pain, or new or worsening    heartburn,    stop

taking Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets and contact your doctor.

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

b)    Take the Calcium/vitamin D₃ effervescent tablet after dissolving it in a glass of water.

Duration of use

This will be decided by your doctor.

If you take more Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets than you should

a)    Drink one glass of milk and inform your doctor if you have taken more Alendronate tablets than prescribed. Do not make yourself vomit, and do not lie down.

b)    Please contact your doctor if you have taken more Calcium/vitamin D₃ effervescent tablets than you should.

If you forget to take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

a)    If you have forgotten to take your Alendronate tablet on your chosen day “Day 1”:

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

2.    On the following day take your Calcium/vitamin D₃ effervescent tablet. Do not take your Alendronate tablet and the effervescent tablet on the same day.

3.    Continue taking one Calcium/vitamin D₃ effervescent tablet each day until the end of the weekly cycle.

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

b)    If you have forgotten to take a Calcium/vitamin D₃ effervescent tablet:

1.    Take it on the day you remember, but do not take two effervescent tablets on the same day. Do not take the effervescent tablet on the same day as the Alendronate tablet.

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

3.    Discard the forgotten effervescent tablet.

If you stop taking Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

If you stop treatment you may worsen your osteoporosis. Please talk to your doctor before you consider stopping treatment.

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

4. Possible side effects

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

a) Possible side effects caused by Alendronate 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

•    headache

•    dizziness

•    abdominal pain, uncomfortable feeling in the stomach or belching after eating

•    constipation, full or bloated feeling in the stomach

•    diarrhoea, flatulence

•    heartburn,

•    difficulty swallowing, pain upon swallowing

•    ulcer in the gullet which can cause chest pain, heartburn or difficulty or pain upon swallowing

•    joint swelling_

•    hair loss

•    itching

•    feeling of weakness

•    swelling in the hands or legs.

Uncommon, may affect up to 1 in 100 people

•    taste disturbance

•    nausea

•    vomiting

•    irritation or inflammation of the gullet or stomach

•    black or tarlike stools

•    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

•    blurred vision, pain or redness in the eye

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

•    narrowing of the gullet

•    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.

•    mouth ulcers when the tablets have been chewed or sucked

•    stomach or bowel ulcers (sometimes severe or with bleeding)

• severe bone, muscle and/or joint pain

•    severe skin reactions due to an allergic reaction (toxic epidermal necrolysis, erythema multiforme), symptoms include fever, general ill feeling, itching of the skin, joint aches, multiple skin lesions or blisters, which may involve the face or lips

•    rash made worse by sunlight

•    symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

•    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.

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.

b) Possible side effects caused by Calcium/vitamin D₃ Uncommon, may affect up to 1 in 100 people

•    blood calcium levels above normal

•    Symptoms are excessive thirst, loss of appetite, fatigue and in severe cases irregular heart beat.

•    urine calcium levels above normal

Rare, may affect up to 1 in 1,000 people

•    allergic reactions

•    constipation, wind, nausea, vomiting, abdominal pain, diarrhoea

•    skin reactions such as itching, rash and hives

Very rare, may affect up to 1 in 10,000 people

• serious allergic reaction which causes difficulty in breathing or dizziness, swelling of the face or throat

Special patient group

If you suffer from kidney problems you may get high levels of phosphat in your blood, kidney stones or increased levels of calcium in the kidneys.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via yellow Card Scheme:

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 Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets

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

Do not store above 25 °C. Store in the original package in order to protect from light and moisture!

Do not throw away any medicines of via wastewater 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 Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets contains

a)    Alendronate film-coated tablets

The active substance is alendronate sodium trihydrate.

One film-coated tablet contains 70 mg alendronic acid (as 91.35 mg sodium alendronate trihydrate). The other ingredients are:

•    Tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate.

•    Film coating: microcrystalline cellulose, carrageenan, macrogol 8000.

b)    Calcium/vitamin D₃ effervescent tablets

The active substances are calcium carbonate and Cholecalciferol (vitamin D₃).

One effervescent tablet contains:

-    2500 mg calcium carbonate, equivalent to 1000 mg calcium.

-    22 microgramms (880 International Units [IU]) Cholecalciferol (vitamin D₃).

The other ingredients are: citric acid anhydrous, simeticone, gelatine, lactose monohydrate, macrogol 6000, maize starch, methylcellulose, sodium cyclamate, sodium hydrogen carbonate, povidone K25, saccharin sodium, hydrogenated soya oil, sucrose, alpha-tocopherol, orange juice flavour (PHS-133147).

What Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets looks like and contents of the pack

a)    Alendronate film-coated tablets: White, round film-coated tablet, rounded on the upper and lower side (diameter 10 mm), encoded „ALN 70“ on one side. The tablets are packed in a plastic/aluminium blister.

b)    Calcium/vitamin D₃ effervescent tablets: White, round effervescent tablets, flat on both sides (diameter 30 mm). The tablets are packed in a tube.

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets are available in packs containing

•    1 Alendronate film-coated tablet + 6 Calcium/vitamin D₃ effervescent tablets or

•    2 Alendronate film-coated tablets + 12 Calcium/vitamin D₃ effervescent tablets or

•    4 Alendronate film-coated tablets + 24 (2 x 12) Calcium/vitamin D₃ effervescent tablets or

•    3 x    [4 Alendronate    film-coated tablets +    24 (2 x 12)    Calcium/vitamin    D₃    effervescent tablets] or

•    4 x    [4 Alendronate    film-coated tablets +    24 (2 x 12)    Calcium/vitamin    D₃    effervescent tablets] or

•    6 x    [4 Alendronate    film-coated tablets +    24 (2 x 12)    Calcium/vitamin    D₃    effervescent tablets].

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Limited Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

Manufacturers

Lek Pharmaceuticals d.d.

Verovskova 57,

1526 Ljubljana Slovenia

Salutas Pharma GmbH Otto-Von-Guericke-Allee 1,

39179 Barleben Germany

This leaflet was last revised in 11/2015

PIL 1164.007d 25/11/2015 V016: SPC & PIL update KP