70 mg + 500 mg/800 IU Tablets
alendronic acid + calcium/cholecalciferol
What Tridepos is and what it is used for
Tridepos is a combination pack containing two different tablets: alendronic acid tablet (called alendronate tablet in this leaflet) and calcium/cholecalciferol (vitamin D 3 ) tablets (called calcium/vitamin D tablets in this leaflet).
Alendronate tablet
Alendronate belongs to a group of non-hormonal drugs called bisphosphonates. Alendronate prevents the breakdown of bone mass that occurs in women in connection with menopause.
Calcium/vitamin D tablets
Calcium and vitamin D 3 are both important substances for new bone formation. Vitamin D 3 regulates the absorption and metabolism of calcium, as well as the storage of calcium in the skeleton.
Tridepos is used to treat osteoporosis in postmenopausal women who are at risk of low levels of calcium and vitamin D. Osteoporosis is a condition that affects the bones so that they become thinner and weaker, increasing the risk of bone fractures.
The combination of alendronate and calcium/vitamin D reduces the risk of broken bones ( fracture ) in the vertebrae and hip by making the bones stronger and restoring the levels of calcium and vitamin D.
Tridepos is supplied in blister packs for one week’s treatment. One blister contains 1 alendronate tablet and 6 calcium/vitamin D tablets.
What you need to know before taking Tridepos
Do not take Tridepos:
- if you are allergic to alendronate or calcium/vitamin D or any of the other ingredients of this medicine (listed in section 6).
- if you have certain problems with the gullet (esophagus), e.g. stricture, or if food often gets stuck in the esophagus due to a condition where the muscles in the esophagus do not work properly (akalasia).
- if you cannot stand or sit up for at least 30 minutes.
- if you have severely impaired kidney function or kidney stones.
- if your doctor has told you that you have:
- hypocalcemia (low level of calcium in the blood),
- a disease or condition that can lead to hypercalcemia (high level of calcium in the blood) or hypercalciuria (high level of calcium in the urine),
- hypervitaminosis D (high level of vitamin D in the blood).
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 your dose or medication may need to be changed or your treatment may need to be monitored more closely:
- If you have or have recently had, problems with the gastrointestinal tract such as:
- difficulty swallowing, disease of the esophagus, inflammation or ulceration of the gastrointestinal tract
- a serious disease of the gastrointestinal tract such as peptic ulcer, active bleeding in the gastrointestinal tract, or if you have undergone intestinal surgery
- Barrett’s esophagus (cell changes in the esophagus).
- You have or have had cancer.
- You are treated with chemotherapy ( chemotherapy ) or radiation.
- You are taking corticosteroids or glucocorticoids (eg prednisolone or betamethasone).
- You smoke (as smoking can increase the risk of dental problems).
- You have problems with your teeth, e.g. toothache, loose teeth or bleeding gums, or:
- you have or have had dental disease, or poor dental hygiene.
- you have dentures that don’t fit well
- you have recently had, or plan to have, a tooth extracted or a dental filling.
- You have hypoparathyroidism (impaired function of the parathyroid glands with a lack of parathyroid hormone (parathyroid hormone) or lack of effect of this hormone ).
- You have a vitamin D deficiency.
- You have reduced kidney function.
- You have sarcoid (a chronic inflammatory condition that can affect various organs in the body).
- You are elderly and also take medicines for heart failure or irregular heartbeats (these medicines are called cardiac glycosides or diuretics ).
- You are taking other medicines that also contain vitamin D.
- You have reduced mobility (sitting in a wheelchair or bedridden).
While you are taking Tridepos
- It is important to maintain good oral hygiene, go for routine examinations at the dentist and contact a doctor or dentist if you experience any symptoms such as loose teeth, toothache, or swollen gums.
- If you are going to undergo dental surgery, you must tell the dentist that you are being treated with Tridepos.
- If you get thigh, hip, or joint pain, you should contact a doctor.
Children and young people
Tridepos should not be used by children under the age of 18.
Other medicines and Tridepos
Some medicines can affect how Tridepos works. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Alendronate tablet
Likely, calcium supplements, antacids (used for heartburn) and other medicines are taken by mouth can affect how alendronate tablets are absorbed by 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 (eg aspirin or ibuprofen ) can cause digestive problems. Therefore, you should consult a doctor before and exercise caution if these medicines are taken at the same time as Tridepos.
Calcium/vitamin D tablets
Careful control is needed with the simultaneous use of:
- Thiazide diuretics (eg hydrochlorothiazide ) are used to treat high blood pressure.
- Cardiac glycosides (eg digoxin ) are used to treat heart failure or irregular heartbeats.
The calcium/vitamin D tablets can affect how other medicines work
You must allow enough time to pass between taking these medicines and the calcium/vitamin D tablets.
- Levothyroxine (used to treat symptoms of hypothyroidism): Leave at least 4 hours between taking each medicine.
- Iron (used to treat anemia ), zinc (used to treat deficiency), or strontium ranelate (used to treat severe osteoporosis): Leave at least 2 hours between taking any of these medicines and the calcium/vitamin D tablet.
- Tetracycline preparations (used to treat various bacterial infections): Take the medicine at least 2 hours before or 4-6 hours after taking the calcium/vitamin D tablet.
- Quinolones (used to treat various bacterial infections): Take the calcium/vitamin D tablet at least 2 hours after the quinolone antibiotic. Alternatively, take the quinolone antibiotic at least 6 hours after taking the calcium/vitamin D tablet.
- Alendronate (used to treat osteoporosis): Although this medicine is included as part of the treatment with Tridepos, it should not be taken on the same day as the calcium/vitamin D tablet because calcium can interfere with the body’s absorption of alendronate (see section 3. How to taking Tridepos).
Some other medicines can affect how Tridepos works
If you are taking any of the following medicines, tell your doctor before taking Tridepos:
- Phenytoin (used to treat epilepsy/seizures).
- Barbiturates ( a class of medicines used to treat anxiety, depression, or certain sleep disorders).
- Systemic corticosteroids ( strong anti-inflammatory medicines used to treat conditions such as joint inflammation ( arthritis ), asthma, and inflammation of the large intestine ( colitis ).
- Orlistat (used to treat obesity) may reduce the absorption of fat-soluble vitamins (eg vitamin D).
- Cholestyramine (a cholesterol-lowering medicine).
- Laxatives such as paraffin oil (used to treat constipation).
If you have any questions, talk to your doctor.
Tridepos with food and drink
Alendronate tablet
Food and drink (including mineral water) affect how the alendronate tablet works. Therefore, you must wait at least 30 minutes before eating or drinking anything after taking alendronate.
Calcium/vitamin D tablet
The absorption of calcium in the body can be inhibited by food containing oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grain products). Leave at least 2 hours between taking the calcium/vitamin D tablet and a meal with a high content of oxalic acid or phytic acid.
Pregnancy and breastfeeding
Tridepos is only intended for postmenopausal women. Tridepos should not be used during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Your ability to drive or use machines can be affected by Tridepos, through, for example, poor balance, dizziness, and severe bone, muscle, or joint pain. If you get any of these symptoms, you should wait to drive or use machines until they have disappeared.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tridepos contains lactose and sucrose
An alendronate tablet contains lactose and a calcium/vitamin D tablet contains sucrose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is almost ‘sodium-free’.
How to take Tridepos
Tridepos is supplied in blister packs for one week’s treatment and contains 1 alendronate tablet and 6 calcium/vitamin D tablets.
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Osteoporosis does not always cause clear symptoms and you may not notice this condition. You must follow your doctor’s instructions because Tridepos can only contribute to the treatment of your osteoporosis as long as you continue to take the tablets.
Dosage
The recommended dose is:
- Day 1: alendronate tablet
Take ONE alendronate tablet once a week.
Choose the day of the week that suits you best. This will be day 1 of your weekly cycle. Then take the alendronate tablet every week on the day of the week you have chosen as day 1.
- Days 2-7: calcium/vitamin D tablet
The day after you take the alendronate tablet, take ONE calcium/vitamin D tablet per day for the next six days.
Every 7 days a new weekly cycle begins. You should start a new blister by taking the alendronate tablet on the day of the week you have chosen as your day 1.
Continue to follow your weekly cycle for as long as your doctor has directed.
How to take the tablets
Alendronate should be taken once a week. Calcium/vitamin D should not be taken on the same day as alendronate, as it may reduce the body’s absorption of alendronate. Tridepos is supplied in blister packs for one week’s treatment with one tablet of alendronate and six tablets of calcium/vitamin D.
Day 1: Alendronate tablet
Follow these instructions to be sure that the alendronate tablet has the intended effect:
- Take the alendronate tablet in the morning before you have anything to eat or drink and before you take any other medicines.
- Swallow it with a glass (at least 200 ml) of plain water (mineral water or other drinks may reduce the absorption of alendronate).
- Swallow it whole. Do not crush or chew the tablet and do not allow it to dissolve in the mouth, as this may cause mouth and throat ulcers.
- Take the tablet in an upright position (you can sit or stand) to avoid problems with the gullet (esophagus).
- Do not eat or drink for at least 30 minutes after taking your tablet.
- Do not lie down earlier than 30 minutes after taking your tablet.
- The tablet should never be taken at bedtime or before you get up for the day.
Day 2-7: Calcium/vitamin D tablet
Swallow the tablet whole, crushed, or divided with water to facilitate swallowing.
For information on missed doses, see the section “If you have forgotten to take your tablets”.
If you have kidney problems
Tridepos should be used with caution if the kidneys are not working properly. The doctor may decide that the levels of calcium and phosphate in the blood should be checked. Ask your doctor or pharmacist if you are unsure. Tridepos should not be used if you have severely impaired kidney function, see section 2 Do not take Tridepos.
Older
The doctor must take into account your kidney function.
If you have taken too many tablets
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
Alendronate tablets
If you accidentally take too many alendronate tablets, drink a full glass of milk and contact your doctor immediately. Do not try to induce vomiting and do not lie down.
In case of overdose, you may experience the following symptoms:
- Low level of calcium in the blood (symptoms may include muscle cramps, spasms, twitching, and tingling in the fingers or around the mouth).
- Low levels of phosphate in the blood (symptoms may include tiredness, muscle weakness, confusion, or hallucinations).
- Upset stomach, heartburn, chest pain, sour taste in the mouth, flatulence, belching, and burning when swallowing hot drinks.
Calcium/vitamin D tablets
Contact a doctor or the Poisons Information Center immediately and do not take any more tablets.
In case of overdose, you may experience the following symptoms:
- Loss of appetite, thirst, nausea, vomiting, constipation, and abdominal pain.
- Muscle weakness, fatigue, bone pain.
- Mental problems (symptoms may include confusion or difficulty concentrating, depression or anxiety).
- Need to urinate more often (sometimes even during the night) and increased urine volume.
If you have forgotten to take your tablets
Alendronate tablets
If you forget to take a dose, take the weekly alendronate tablet in the morning of the next day according to the dosing instructions (see section 3). The alendronate tablet must be taken weekly. Calcium affects the absorption of alendronate in the body and leads to a reduced effect of alendronate. Therefore, wait at least 30 minutes before taking the daily calcium/vitamin D tablet.
Do not change your weekly cycle ie. continue to take the alendronate tablet on the day of the week you chose as day 1. If at the end of the weekly cycle you have any calcium/vitamin D tablets left, throw them away (not down the drain or with household waste, see section 5).
Calcium/vitamin D tablets
If you forget to take a calcium/vitamin D tablet, skip that dose and continue with your usual treatment with one calcium/vitamin D tablet per day. Do not take an extra calcium/vitamin D tablet on the same day to make up for a missed tablet.
If at the end of the weekly cycle you have any calcium/vitamin D tablets left, they should be thrown away (not down the drain or among household waste, see section 5).
If you stop taking Tridepos
Take this medicine for as long as your doctor has directed. Osteoporosis is a condition without clear symptoms and treatment is usually long-term.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following serious symptoms as your dose may need to be reduced or treatment stopped.
Common (may affect up to 1 in 10 users):
- New or worsening heartburn, pain/difficulty swallowing, ulcers in the esophagus that may cause chest pain.
Rare (may affect up to 1 in 1,000 users):
- The narrowed passage in the esophagus can make swallowing difficult.
- Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing ( angioedema ).
- A serious skin reaction:
- The reaction may begin with flu-like symptoms followed by a painful, red, or purple rash that spreads and blisters (called Stevens-Johnson syndrome ).
- Development of a rare skin condition that causes the outermost layer of skin to peel off. It can look like a second-degree burn and other symptoms are fever, fatigue, cough, itchy skin, muscle aches, and sore throat followed by skin ulcers (called toxic epidermal necrolysis ).
- Severe pain, swelling, redness in the jaw, or other signs of infection in the gums ( osteonecrosis of the jaw).
- Unusual femur fractures may occur in rare cases, especially in patients receiving long-term treatment for osteoporosis. Contact the doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femur fracture.
Very rare (may affect up to 1 in 10,000 users):
- Pain in the ear, discharge from the ear, and/or an ear infection. This could be a sign of a bone injury in the ear.
- Swelling of the larynx, making it difficult to breathe.
Other side effects you may experience while taking alendronate:
Very common (may affect more than 1 in 10 users):
- Pain in bones, muscles, or joints can sometimes be severe.
Common (may affect up to 1 in 10 users)
- Headache, dizziness, or impaired balance ( vertigo ).
- Stomach problems such as abdominal pain, indigestion, constipation, diarrhea, gas in the stomach, and bloating.
- Alopecia (hair loss).
- Itching.
- Swollen joints.
- Lack of energy.
- Swelling of hands and legs.
Uncommon (may affect up to 1 in 100 users)
- Changed taste experience
- Stomach problems such as nausea, vomiting, inflammation or irritation of the esophagus or stomach, and black “tar-like” stools.
- Inflamed eye.
- Rash, skin redness.
- Transient symptoms such as muscle pain, muscle weakness, or discomfort, and, in rare cases, fever, usually occur at the beginning of treatment.
Rare (may affect up to 1 in 1,000 users):
- Low calcium in the blood (symptoms include muscle cramps, spasms, twitching, and tingling in the fingers or around the mouth and are usually due to a pre-existing condition in the user).
- Ulcers in the mouth, throat, or stomach, perforation (hole in the stomach), or bleeding in the stomach.
- Skin rash is made worse by sunlight.
- Hypersensitivity reaction, swollen, pale red bumps on the skin ( hives ).
Other side effects you may experience when taking calcium/vitamin D:
Uncommon (may affect up to 1 in 100 users):
- High levels of calcium in the blood – which lead to the need to urinate more often (sometimes even during the night) and feeling thirstier than usual.
- High level of calcium in the urine – possible symptoms can be blood in the urine, and back or stomach pain.
Rare (may affect up to 1 in 1,000 users):
- Stomach problems may include constipation, flatulence (gas), nausea, abdominal pain, and diarrhea.
- Itching, rash or swollen, pale red bumps on the skin ( hives ).
Special patient groups
Patients with impaired kidney function are at risk of abnormally high levels of phosphate in the blood (usually without symptoms but can be serious), kidney stones, and increased levels of calcium in the kidneys (symptoms may include blood in the urine, back, or stomach pain).
How Tridepos should be stored
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton (after EXP). The expiration date is the last day of the specified month.
- Store at a maximum of 30°C. Store in the original packaging. Light sensitive. Moisture sensitive.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Tridepos is a combination pack containing two different tablets:
Alendronate tablets
One tablet contains sodium alendronate trihydrate corresponding to 70 mg of alendronic acid.
Other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and anhydrous colloidal silicon dioxide.
Calcium/vitamin D tablets
One tablet contains calcium carbonate corresponding to 500 mg of calcium and 800 IU (20 micrograms) of cholecalciferol (vitamin D 3 ).
Other ingredients are:
Core: maltodextrin, croscarmellose sodium, anhydrous colloidal silicon dioxide, magnesium stearate, all -rac -alpha-tocopherol, sucrose, medium-chain triglycerides, sodium starch octenyl succinate (E1450), silicon dioxide, sodium ascorbate.
Coating: hypromellose, macrogol, paraffin.
(See also section 2 ‘Tridepos contains lactose and sucrose’ and ‘Sodium content.)
Appearance and package sizes of the medicine
Tridepos is a combination pack of two different tablets supplied in blister packs for one week’s treatment. A blister contains 1 alendronate tablet and 6 calcium/vitamin D tablets.
1 alendronate tablet
A white tablet, oblong and biconvex (5.5 x 11.5 mm). The alendronate tablets are smaller than the calcium/vitamin D tablets.
6 calcium/vitamin D tablets
White to off-white film-coated tablet, dots may appear, oval, engraved with R150 (8.5 x 19 mm). The calcium/vitamin D tablets are larger than the alendronate tablets.
Package sizes:
4 blisters in a carton.
12 blisters in a carton.
Each blister contains 1 alendronate tablet and 6 calcium/vitamin D tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Meda AB
Box 906
170 09 Solna
Telephone: 08-630 1900
Manufacturer
Meda Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany
or
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1.
Come room
2900
Hungary