Document: Tridepos tablet ENG PL change

• Tridepos tablet PL
• Tridepos tablet ENG PL

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Package leaflet: Information for the patient

Tridepos 70 mg + 500 mg/800 IU 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. 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 Trideposis and what it is used for

2. What you need to know before you take Tridepos

3. How to take Tridepos

4. Possible side effects

6. Contents of the pack and other information

Tridepos is a combination pack of two types of tablets: alendronic acid tablet (called alendronate tablet in this leaflet) and calcium/cholecalciferol (vitamin D₃) tablets (called calcium/vitamin D in this leaflet).

Alendronate tablet

Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the breakdown of bone tissue,that occurs in women in relation to menopause.

Calcium/vitamin D tablets

Calcium and vitamin D₃ are both important components in the formation of bone. Vitamin D₃ regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue.

Tridepos is used to treat osteoporosis in women who have passed the menopause and are at risk of having low levels of calcium and vitamin D. Osteoporosis is a condition that affects the bones, causing them to become weak, fragile and more likely to break.

The combination of alendronate and calcium/vitamin Dlower the risk of spine and hip fractures by increasing bone strength and restoring calcium and vitamin D levels.

Tridepos is presented in a wallet pack for one week´s treatment. Tridepos contains 1 alendronate tablet and 6 calcium/vitamin D tablets, including instructions on how to take the medicine.

Do not take Tridepos:

• If you are allergic to alendronate or calcium/vitamin D or any of the other ingredients in the medicines in this pack (listed in section 6).

• If you have certain problems with your gullet (oesophagus), such as narrowing or if food often gets stuck in your gullet because of a condition where the muscles in your gullet does not work properly (achalasia).

• If you are unable to stand or sit upright for at least 30 minutes.

• If you have severe kidney impairment or kidney stones.

• If your doctor has told you that you have:

• hypocalcaemia (a low blood calcium level),

• a disease or condition that may result in hypercalcaemia (a high blood calcium level) or hypercalciuria (a high calcium level in the urine),

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Tridepos.

Warnings and precautions

Before taking Tridepos

Talk to your doctor or pharmacist before taking Tridepos if any of the following apply to you, as they may want to change your dose or medication, or simply monitor you more closely:

• Swallowing difficulties, disease of the gullet, gastro-intestinal inflammation or ulcers.

• Major gastro-intestinal disease such as peptic ulcer, active gastro-intestinal bleeding or have had surgery on your gut.

• Barrett's oesophagus (abnormal cells in the gullet).

• You have or have had cancer.

• You are undergoing chemotherapy or radiotherapy.

• You are taking corticosteroids or glucocorticoids (e.g. prednisolone, betametasone).

• You are an active smoker (as smoking may increase the risk of dental problems).

• You have any dental problems such as toothache, loose teeth or bleeding gums, or:

• You have or have had dental disease, poor dental hygiene.

• You are wearing poorly fitted dentures.

• You recently had, or plan to have, a tooth extraction or filling.

• You have hypoparathyroidism (decreased function of the parathyroid glands with lack of parathyroid hormone or lack of effect of this hormone).

• You have a vitamin D deficiency.

• You have impaired kidney function.

• You suffer from sarcoidosis (a chronic inflammatory condition that may affect different organs in the body).

• You are an elderly patient and you are also taking medicine for heart failure or irregular heartbeat (these medicines are called cardiac glycosides or diuretics).

• You are taking other medicines that also contain vitamin D.

• You are immobilised.

Whilst taking Tridepos

• It is important to maintain good oral hygiene, attend routine dental check-ups, and report any oral symptoms such as loose teeth, toothache or swollen gums to your doctor or dentist.

• If you must undergo dental surgery, tell your dentist that you are being treated with Tridepos.

• If you experience any thigh, hip or joint pain, contact your doctor.

Children and adolescents

Tridepos is not for use in children under the age of 18 years.

Other medicines and Tridepos

Certain medicines may affect the way that Tridepos works. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Alendronate tablet

It is likely that calcium supplements, antacid(used to treat heartburn) and other medicines which are ingested orally can interfere with how the alendronate tablets is absorbed in the body, if they are taken at the same time. It is therefore important that you follow the advice in section 3. How to take Tridepos.

Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems. Therefore, the doctor should be consulted and caution used if these medicines are taken at the same time as Tridepos.

Calcium/vitamin D tablets

Special monitoring is needed during concomitant use of:

• Thiazide diuretics (e.g. hydrochlorothiazide) used to treat high blood pressure.

• Cardiac glycosides (e.g. digoxin) used to treat heart failure or irregular heartbeat.

The calcium/vitamin D tablets, can affect the way other medicines work

It is important that you allow enough time between taking these medicines and your calcium/vitamin D tablets.

• Levothyroxine (used to treat the symptoms of low thyroid activity): Leave at least a 4-hour time gap between taking each medicine.

• Iron salts (used to treat anaemia), Zinc (used to treat deficiency) or Strontium ranelate (used to treat severe osteoporosis): Leave at least a 2-hour time gap between taking any of these medicines and calcium/vitamin D tablets.

• Tetracycline preparations (used to treat a variety of bacterial infections): Leave at least 2 hours before or 4 to 6 hours after taking the calcium/vitamin D tablets.

• Quinolones (used to treat a variety of bacterial infections): Take calcium/vitamin D tablets at least 2 hours after your quinolone antibiotic. Alternatively take your quinolone antibiotic at least 6 hours after taking the calcium/vitamin D tablets.

• Alendronate (used to treat osteoporosis): Although this medicine forms part of the Tridepos treatment, it should not be taken on the same day as your calcium/vitamin D tablets since calcium can interfere with the absorption of alendronate (please see section 3. How to take Tridepos).

Certain medicines may affect the way that Trideposwork

Tell your doctor before taking Tridepos if you are taking the following medicines:

• Phenytoin (used to treat epilepsy/seizures).

• Barbiturates (a class of medicines used to treat anxiety, depression or some sleep disorders).

• Systemic corticosteroids (strong anti-inflammatory drugs that are used to treat conditions such as arthritis, asthma and inflamed colon (colitis).

• Orlistat (used to treat obesity) may possibly impair the absorption of fat-soluble vitamins (e.g. vitamin D).

• Cholestyramine (a cholesterol-lowering drug).

• Laxatives such as paraffin oil (used to treat constipation).

If you have any concerns, please speak with your doctor.

Tridepos with food and drink

Alendronate tablet

Food and drinks (including mineral water) will interfere with the way that your alendronate tablet works. Therefore, you must wait at least 30 minutes after taking alendronate before eating or drinking.

Calcium/vitamin D tablet

The calcium absorption may be inhibited by food containing oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals). You should leave at least two hours between takingthe calcium/vitamin D tablet and having a meal with high content of oxalic acid or phytic acid.

Pregnancy and breast-feeding

Tridepos is only for women after menopause. Tridepos should not be used during pregnancy or while breastfeeding. 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

Your ability to drive or operate machinery may be affected by Tridepos, for example loss of balance, dizziness and severe bone, muscle or joint pain. If you experience any of these symptoms do not drive or use machinery until you have recovered.

Tridepos contains lactose and sucrose

Each alendronate 70 mg tablet contains lactose and each calcium/vitamin D tablet contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tridepos is presented in a wallet pack for one week´s treatment and contains 1 alendronate tablet and 6 calcium/vitamin D tablets together with instructions on how to take the medicine.

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

Osteoporosis does not always have obvious symptoms and you may not notice that you have been affected by it. It is important to follow your doctor’s advice as Tridepos can help treat your osteoporosis only as long as you continue to take the tablets.

Dosing

The recommended dose is:

Take ONE alendronate tablet once a week.

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

Beginning on the day after the alendronate tablet has been taken, take ONE tablet of calcium/vitamin D each day for the next 6 days.

Every 7 days start a new weekly cycle. You should begin a new pack by taking the alendronate tablet on your chosen Day 1.

Continue to follow your schedule for as long as your doctor has told you to.

How to take the tablets

Alendronate should be taken once a week. Calcium/vitamin D should not be taken the same day as it may decrease the body’s uptake of alendronate. Tridepos is presented in weekly packs with one alendronate tablet and six calcium/vitamin D tablets for the other days of the week.

Alendronate tablet

To make sure that the alendronate 70 mg tablets work properly, please follow these instructions:

• Take the alendronate tablet in the morning before having anything to eat or drink and before you take any other medicines.

• Swallow it with at least one glass (not less than 200 ml) of plain water (mineral water or other beverages may reduce the uptake of alendronate).

• Swallow it whole. Do not crush or chew the tablet or allow the tablet to melt in your mouth as this may cause mouth or throat ulcers.

• Take the tablet whilst you are in an upright position (you may sit or stand) to avoid problems from the oesophagus (gullet).

• Do not eat or drink for at least 30 minutes after taking your tablet.

• Do not lie down for 30 minutes after taking your tablet.

• The tablet should never be taken at bedtime or before arising for the day.

Calcium/vitamin D tablet

Swallow the tablet with water, whole, crushed or divided to facilitate swallowing.

For information regarding missed doses, see section “If you forget to take your tablets”.

If you have kidney problems

Tridepos should be used with caution if your kidneys are not working properly, and your doctor may decide to monitor your levels of calcium and phosphate in the blood. Check with your doctor or pharmacist if you are not sure. Tridepos must not be used if you have severe kidney impairment, see section 2, Do not take Tridepos.

Older people

Your doctor should consider your kidney function.

If you take more tablets than you should

If you have taken too many tablets or if, for example, a child has ingested the medicine by mistake, tell your doctor or nearest hospital casualty department so that they can assess the risk and give you advice.

Alendronate tablets

If you take too many alendronate tablets by mistake, drink a whole glass of milk and contact your doctor immediately. Do not try to induce vomiting and do not lie down.

You may experience the following symptoms after an overdose:

• Low calcium in the blood (symptoms include muscle cramps, spasms, twitching and tingling in the fingers or around the mouth).

• Low phosphate in the blood (symptoms may include tiredness, muscle weakness, confusion or hallucination).

• Upset stomach, heartburn, chest pain, acid taste in your mouth, bloating, belching and burning when swallowing hot drinks.

Calcium/vitamin D tablets

Immediately seek medical attention from your doctor or pharmacist and do not take any more tablets.

You may experience the following symptoms after an overdose:

• Loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain.

• Muscle weakness, fatigue, bone pain.

• Mental disturbances (symptoms may include confusion or inability to concentrate, depression or anxiety).

• The need to urinate more often (sometimes even during the night) and passing large volumes of urine.

If you forget to take your tablets

Alendronate tablets

If a dose is missed, the weekly alendronate tablet should be taken on the next day in the morning according to the dosing instructions (see section 3). The alendronate tablet must be taken each week. Calcium interfere with the absorption of alendronate resulting in less effect of alendronate. Therefore, wait at least 30 minutes before you take the daily calcium/vitamin D tablet.

Do not change the timing of your weekly cycle, i.e. continue to take your alendronate tablet on your chosen Day 1. The remaining calcium/vitamin D tablets at the end of a weekly cycle should be thrown away (not via wastewater or household waste, please see section 5).

Calcium/vitamin D tablets:

If a daily dose of calcium/vitamin D is missed, skip the dose and continue with the normal course of one calcium/vitamin D tablet each day. Do not take any extra calcium/vitamin D tablets on the same day to make up for the forgotten tablets. Any remaining calcium/vitamin D tablets at the end of the weekly cycle should be thrown away (not via wastewater or household waste, please see section 5).

If you stop takingTridepos

Take the medicine for as long as your doctor has told you. Osteoporosis is a condition without clear symptoms and treatment is normally long-term.

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.

If you notice any of the following serious symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped.

Common: may affect up to 1 in 10 people

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

• Narrowing or tightening of the gullet that may make it difficult to swallow.

• Swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties (angioedema).

• A severe skin reaction:

• This may begin with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters (known as Stevens‑Johnson syndrome).

• A rare skin condition may develop causing you to lose your outer layer of skin. It may look like a second-degree burn and other symptoms include fever, tiredness, cough, itchy skin, muscle aches, and sore throat followed by skin wounds (known as toxic epidermal necrolysis).

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

Other side effects you may experience when taking alendronate:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

• Headache, dizziness or loss of balance (vertigo)

• Gut problems such as abdominal pain, indigestion, constipation, diarrhoea, flatulence, bloating.

• Alopecia (loss of hair)

• Itching

• Joint swelling

• Lack of energy

• Swelling in the hands or legs

Uncommon: may affect up to 1 in 100 people

• A change in taste

• Gut problems such as nausea, vomiting, inflammation or irritation of the gullet or stomach, black "tarry" stools.

• Inflamed eye

• Rash or redness of the skin

• Short-acting symptoms such as muscle pain, muscle weakness or discomfort and rarely fever, typically experienced at the beginning of treatment.

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

• Low calcium in the blood (symptoms include muscle cramps, spasms, twitching and tingling in the fingers or around the mouth and is generally due to a condition that is already present).

• Ulcers of the mouth, throat or upper gut, perforation (torn gut) or bleeding of the upper gut.

• Skin rash which becomes more sensitive to light.

• Hypersensitivity reaction, swollen, pale red bumps on the skin (hives).

Other side effects you may experience with calcium/vitamin D:

Uncommon: may affect up to 1 in 100 people

• High calcium in the blood - resulting in the need to urinate more often (sometimes even during the night) and feeling thirstier than usual.

• High calcium in the urine - possible symptoms may include blood in the urine, back pain or abdominal pain.

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

• Stomach problems including constipation, flatulence (gas), nausea, abdominal pain, diarrhoea.

• Itching, rash or swollen, pale red bumps on the skin.

Special populations

Patients with reduced kidney function are at potential risk of developing abnormally high phosphate levels in the blood (this will generally have no symptoms but may be serious), kidney stones and increased calcium in the kidneys (symptoms may include blood in the urine, back pain or abdominal pain).

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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tridepos

• 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.

• Store below 30°C. Store in the original package in order to protect from light and moisture.

• 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 Trideposcontains

Tridepos is a combination pack of two types of tablets:

Alendronatetablets

Each tablet contains sodium alendronate trihydrate equivalent to 70 mg alendronic acid.

The other ingredients are: lactosemonohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal anhydroussilica.

Calcium/vitamin D tablets

Each tablet contains calcium carbonate equivalent to 500 mg of calcium and cholecalciferol (vitamin D₃) 800 IU (20 microgram).

The other ingredients are:

Core: Maltodextrin, croscarmellose sodium, colloidal anhydroussilica, magnesium stearate, all-rac-alpha-tocopherol, sucrose, medium chain triglycerides, starch sodium octenyl succinate (E 1450), silicon dioxide, sodium ascorbate.

Coating: hypromellose, macrogol, paraffin.

What Tridepos looks like and contents of the pack

Tridepos is a combination pack of two types of tablets, presented in a wallet pack for one week´s treatment. Tridepos contains 1 alendronate tablet and 6 calcium/vitamin D tablets together with instruction on how to take the medicine.

1 alendronate tablet

A white tablet, oblong and biconvex in shape (5.5 x 11.5 mm). Alendronate tablets are smaller than the calcium/vitamin D tablets.

6 calcium/vitamin D tablets

White to off-white film-coated tablet, dots may occur, oval in shape and engraved with R150 (8.5 x 19 mm). The calcium/vitamin D tablets are larger than the alendronate tablets.

Pack sizes are:

4 wallet packs (4 alendronate tablets and 24 calcium/cholecalciferol tablets)

12 wallet packs (12 alendronate tablets and 72 calcium/cholecalciferol tablets).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

To be completed nationally

Manufacturer:

Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

This leaflet was last revised in 2 June 2016