Preotact 100 micrograms powder and solvent for solution forinjection

Preotact is used to treat osteoporosis in women past menopause with high risk of fractures. Osteoporosis is a disease that causes bones to become thin and fragile. It is especially common in women after the menopause. The disease progresses gradually so you may not feel any symptoms at first. But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists. It may also cause back pain, loss of height, and a curved back.

Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength.

Do not use Preotact:

• if you are allergic (hypersensitive) to parathyroid hormone or any of the other ingredients of Preotact;
• if you have had radiation therapy to the skeleton;
• if you suffer from high calcium levels and other disturbances in the calcium-phosphor metabolism;
• if you have other bone disease (including hyperparathyroidism or Paget?s disease);
• if you have high levels of alkaline phosphatase;
• if you suffer from severe kidney problems;
• if you suffer from severe liver disease;

Measuring of the calcium levels in the blood and/or urine

Your doctor will check your response to treatment at regular intervals. He or she must perform blood and/or urine tests at month 1, 3 and 6 after starting your treatment with Preotact.

Take special care with Preotact:

Preotact should be used with caution if you suffer from kidney stones or have had kidney stones.

Specific populations:

Children and adolescents

Preotact should not be used in children or adolescents.

Elderly

No special precautions.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Preotact should be used with caution if you receive heart medicine.

Taking Preotact with food and drink

Food and drink have no influence on the effect of Preotact.

Pregnancy and breast-feeding

Do not use Preotact if you are pregnant or breast-feeding.

Driving and using machines:

No studies on the ability to drive or operate machines have been performed. If you feel dizzy, do not drive or operate any machines until you feel better.

Important information about some of the ingredients of Preotact:

This medicinal product contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially ?sodium-free?.

Always use Preotact exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

The usual dose of Preotact is 100 micrograms given once a day.

Your doctor may advise you to take supplementary calcium and vitamin D. Your doctor will tell you how much you should take each day.

Method of administration

Preotact should be used with the Preotact pen.

When you place the cartridge in the Preotact pen, the solvent and the powder mix. The solution is then ready to be injected into the abdomen (under the skin). When not in use put the Preotact pen into the refrigerator.

Important information when using Preotact

• Inject yourself with Preotact shortly after you have taken the Preotact pen out of the refrigerator
• Put the Preotact pen back into the refrigerator immediately after you have used it. Never remove a cartridge in use from the pen.
• DO NOT SHAKE the Preotact pen (neither before nor after injection) as it may destroy the effect of the active substance
• Use a new injection needle for each injection and throw it away after each use.
• Never store your Preotact pen with the needle attached.
• Never share your Preotact pen with anyone.

For instructions on how to use the Preotact pen, please read the User Manual of the Preotact pen.

Duration of treatment

Keep using Preotact for as long as your doctor prescribes it for you ? normally no longer than 24 months.

If you use more Preotact than you should:

If, by accident, you inject more than one dose of Preotact in a day, contact your doctor or pharmacist.

If you forget to use Preotact:

If you forget to take Preotact (or cannot take Preotact at your usual time), take it as soon as possible on that day. Never take more than one injection in the same day. Do not take a double dose to make up for forgotten doses.

If you stop taking Preotact:

If you stop taking Preotact before finishing the treatment please inform you doctor.

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

The most common side effects (in more than 10% of patients) are: increased level of calcium in the blood, increased level of calcium in the urine, and nausea.

Common side effects (in 1 to 10% of patients) are: back pain, constipation, decreased muscle strength, diarrhoea, dizziness, erythema at injection site, fast or irregular heart beats, headache, muscle cramps, pain in extremity, stomach upset, tiredness, and vomiting.

Uncommon side effects (in 0.1% to 1% of patients) are: abdominal pain, flu, increased level of uric acid in the blood, irritation of the skin at the injection site, loss of appetite, smell disturbance, and taste disturbance.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

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

Unused cartridge

• Do not store above 25°C. Do not freeze.
• Keep the cartridges in the outer carton in order to protect them from light

Cartridge in use

• A cartridge in use (in the Preotact pen) should be stored in a refrigerator (2-8°C). Do not freeze.
• A cartridge in use will keep for 28 days in refrigerator.
• If for some reason you cannot store your Preotact pen (with the inserted cartridge) in a refrigerator for a number of days, it can be stored outside the refrigerator below 25°C - BUT ONLY FOR A TOTAL OF 7 DAYS during the 28-day use period.
• If the Preotact solution in the cartridge is more than 28 days old, or if it has not been stored correctly, throw it away, even if the cartridge is not completely empty.
• If the Preotact solution becomes cloudy or coloured throw the cartridge away.

Any unused product or waste material should be disposed of in accordance with local requirements.

What Preotact contains

Preotact is supplied in a dual-chamber cartridge. The first chamber contains the powder with the active substance and the second chamber contains the solvent.

• The active substance is parathyroid hormone. Each cartridge contains 1.61 mg parathyroid hormone. When the powder and the solvent have been mixed, the solution for injection contains parathyroid hormone at a concentration of 1.4 mg/ml.
• Other ingredients: The powder contains sodium chloride 0.4 %, mannitol, citric acid monohydrate, hydrochloric acid, and sodium hydroxide. The solvent contains metacresol and water for injections.

What Preotact looks like and contents of the pack

Preotact is a powder and solvent for solution for injection.
It is supplied in a dual-chamber cartridge which contains 1.61 mg parathyroid hormone as powder and 1.13 ml of solvent

Preotact is available in packs of 2 and 6 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde
Tlf: +45 46 77 11 11
info@nycomed.com

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Nycomed Belgium SCACVA Gentsesteenweg 615 B-1080 Bruxelles Brussel Brüssel TélTel 32 2 464 06 11 nycomed-belgiumnycomed.com Nycomed Langebjerg 1 DK-4000 Roskilde Tel 45 46 77 11 11 infonycomed.com LuxembourgLuxemburg Nycomed Belgium SCACVA Gentsesteenweg 615 B-1080 Bruxelles Brüssel Belgique Belgien TélTel 32 2 464 06 11 nycomed-belgiumnycomed.com Magyarország Nycomed Langebjerg 1 DK-4000 Roskilde Dània Tel 45 46 77 11 11 infonycomed.com

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Nycomed Langebjerg 1 DK-4000 Roskilde Tel 45 46 77 11 11 Sverige Nycomed AB Box 27264 SE-102 53 Stockholm Tel 46 8 731 28 00 infoswedennycomed.com

Latvija Nycomed East Europe Vairoga 4 LV-1039 Riga Tel 371 784 0082 nycomednycomed.lv United Kingdom Nycomed UK Ltd. Three Globeside Business Park Fieldhouse Lane SL7 1HZ Marlow Buckinghamshire Tel 44 0 1628 646400

Lietuva
Austrijos bendroves "Nycomed Osteuropa
Marketing Service GmbH" atstovybe
Seimyniskiu 3
LT-09312 Vilnius
Tel: +370 521 09 070
Infor@nycomed.lt

This leaflet was last approved in MM/YYYY