Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - aclasta

Document Subject

Generated Narrative: MedicinalProductDefinition mp9dc703bc672ed093a819de38cd335ddf

identifier: http://ema.europa.eu/identifier/EU/1/05/308/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Aclasta 5 mg solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9dc703bc672ed093a819de38cd335ddf

identifier: http://ema.europa.eu/identifier/EU/1/05/308/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - aclasta

Attesters

What is in this leaflet

1. What Aclasta is and what it is used for
2. What you need to know before you are given Aclasta
3. How Aclasta is given
4. Possible side effects
5. How to store Aclasta
6. Contents of the pack and other information

Aclasta contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with corticosteroids used to treat inflammation, and Paget s disease of the bone in adults.

Osteoporosis Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men. At the menopause, a woman s ovaries stop producing the female hormone oestrogen, which helps keep bones healthy. Following the menopause bone loss occurs, bones become weaker and break more easily. Osteoporosis could also occur in men and women because of the long term use of steroids, which can affect the strength of bones. Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker. Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men. In both women and men, Aclasta strengthens the bone and therefore makes it less likely to break. Aclasta is also used in patients who have recently broken their hip in a minor trauma such as a fall and therefore are at risk of subsequent bone breaks.

Paget s disease of the bone It is normal that old bone is removed and is replaced with new bone material. This process is called remodelling. In Paget s disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal. If the disease is not treated, bones may become deformed and painful, and may break. Aclasta works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.

Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Aclasta.

You must not be given Aclasta:

• if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
• if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
• if you have severe kidney problems.
• if you are pregnant.
• if you are breast-feeding.

Warnings and precautions Talk to your doctor before you are given Aclasta:

• if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Aclasta (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
• if you have a kidney problem, or used to have one.
• if you are unable to take daily calcium supplements.
• if you have had some or all of the parathyroid glands in your neck surgically removed.
• if you have had sections of your intestine removed.

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Aclasta (zoledronic acid) for osteoporosis. ONJ can also occur after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before receiving Aclasta treatment, tell your doctor, pharmacist or nurse if

• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction;
• you do not receive routine dental care or have not had a dental check-up for a long time;
• you are a smoker (as this may increase the risk of dental problems);
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders);
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer.

Your doctor may ask you to undergo a dental examination before you start treatment with Aclasta.

While being treated with Aclasta, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Aclasta. Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Monitoring test Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Aclasta. It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Aclasta, as directed by your healthcare provider.

Children and adolescents Aclasta is not recommended for anyone under 18 years of age.

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

It is important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics ( waterpills ) that may cause dehydration.

Pregnancy and breast-feeding You must not be given Aclasta if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

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

Driving and using machines If you feel dizzy while taking Aclasta, do not drive or use machines until you feel better.

Aclasta contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml vial of Aclasta, i.e., essentially sodium free .

Follow carefully all instructions given to you by your doctor or nurse. Check with your doctor or nurse if you are not sure.

Osteoporosis The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. The infusion will take at least 15 minutes.

In case you recently broke your hip, it is recommended that Aclasta is administered two or more weeks after your hip repair surgery.

It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.

For osteoporosis, Aclasta works for one year. Your doctor will let you know when to return for your next dose.

Paget s disease For the treatment of Paget s disease, Aclasta should be prescribed only by physicians with experience in the treatment of Paget s disease of the bone.

The usual dose is 5 mg, given to you as one initial infusion into a vein by your doctor or nurse. The infusion will take at least 15 minutes. Aclasta may work for longer than one year, and your doctor will let you know if you need to be treated again.

Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Aclasta. It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion. Your doctor will inform you regarding the symptoms associated with hypocalcaemia.

Aclasta with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Aclasta, as directed by your doctor. This will help to prevent dehydration. You may eat normally on the day you are treated with Aclasta. This is especially important in patients who take diuretics ( water pills ) and in elderly patients (age 65 years or over).

If you missed a dose of Aclasta Contact your doctor or hospital as soon as possible to re-schedule your appointment.

Before stopping Aclasta therapy If you are considering stopping Aclasta treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Aclasta.

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

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

Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions. The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Aclasta. The symptoms are usually mild to moderate and go away within three days. Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects. The chance of experiencing these side effects decreases with subsequent doses of Aclasta.

Some side effects could be serious Common (may affect up to 1 in 10 people) Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Aclasta for the treatment of postmenopausal osteoporosis. It is currently unclear whether Aclasta causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Aclasta.

Uncommon (may affect up to 1 in 100 people) Swelling, redness, pain and itching to the eyes or eye sensitivity to light.

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.

Not known (frequency cannot be estimated from the available data) Pain in the mouth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, 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). Tell your doctor and dentist immediately if you experience such symptoms while being treated with Aclasta or after stopping treatment.

Kidney disorders (e.g. decreased urine output) may occur. Your doctor should do a blood test to check your kidney function before each dose of Aclasta. It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Aclasta, as directed by your healthcare provider.

If you experience any of the above side effects, you should contact your doctor immediately.

Aclasta may also cause other side effects Very common (may affect more than 1 in 10 people) Fever

Common (may affect up to 1 in 10 people) Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.

In patients with Paget s disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.

Uncommon (may affect up to 1 in 100 people) Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.

Rare (may affect up to 1 in 1,000 people) 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. Low levels of phosphate in the blood.

Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to acute phase reactions (post-dose symptoms such as fever, vomiting and diarrhoea).

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

Your doctor, pharmacist or nurse knows how to store Aclasta properly.

• 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 and bottle after EXP.
• The unopened bottle does not require any special storage conditions.
• After opening the bottle, the product should be used immediately in order to avoid microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 C 8 C. Allow the refrigerated solution to reach room temperature before administration.

What Aclasta contains

• The active substance is zoledronic acid. Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate). One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
• The other ingredients are mannitol, sodium citrate and water for injections.

What Aclasta looks like and contents of the pack Aclasta is a clear and colourless solution. It comes in 100 ml plastic bottles as a ready-to-use solution for infusion. It is supplied in packs containing one bottle as unit pack, or in multipacks comprising five packs, each containing one bottle. Not all pack sizes may be marketed.

Marketing Authorisation Holder Sandoz Pharmaceuticals d.d. Verov kova ulica 1000 Ljubljana Slovenia

Manufacturer Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

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

Belgi /Belgique/Belgien Sandoz N.V. Telecom Gardens Medialaan B-1800 Vilvoorde T l/Tel: +32 (0)2 722 97 Lietuva Sandoz Pharmaceuticals d.d Branch Office Lithuania Seimyniskiu 3A LT 09312 Vilnius Tel: +370 5 2636

Te .: +359 2 970 47 Luxembourg/Luxemburg Sandoz N.V. Telecom Gardens Medialaan B-1800 Vilvoorde T l/Tel: +32 (0)2 722 97 esk republika Sandoz s.r.o. Na Pankr ci 1724/CZ-140 00, Praha 4 Tel: +420 225 775 office.cz@ sandoz.com

Magyarorsz g Sandoz Hung ria Kft. Bart k B la t 43-H-1114 Budapest Tel: +36 1 430 2Info.hungary@sandoz.com Danmark Sandoz A/S Edvard Thomsens Vej DK-2300 K benhavn S Tlf: +45 6395 1info.danmark@sandoz.com

Malta Sandoz Pharmaceuticals d.d. Verovskova SI-1000 Ljubljana Slovenia Tel: +356 21222Deutschland Hexal AG Industriestr. D-83607 Holzkirchen Tel: +49 8024 908-0 service@hexal.com

Nederland Sandoz B.V. Veluwezoom NL-1327 AH Almere Tel: +31 (0)36 5241info.sandoz-nl@sandoz.com Eesti Sandoz d.d. Eesti filiaal P rnu mnt EE 11312 Tallinn Tel: +372 6652Norge Sandoz A/S Edvard Thomsens Vej DK-2300 K benhavn S Danmark Tlf: +45 6395 1info.norge@sandoz.com

SANDOZ HELLAS
. .
: +30 216 600 5 sterreich Sandoz GmbH Biochemiestr. A-6250 Kundl Tel: +43(0)1 86659-0

Espa a Bexal Farmac utica, S.A. Centro Empresarial Parque Norte Edificio Roble C/ Serrano Galvache, 28033 Madrid Tel: +34 900 456 Polska Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02 672 Warszawa Tel.: +48 22 209 7maintenance.pl@sandoz.com France Sandoz SAS 49, avenue Georges Pompidou F-92300 Levallois-Perret T l: +33 1 49 64 48 Portugal Sandoz Farmac utica Lda. Avenida Professor Doutor Cavaco Silva, n. 10E Taguspark P-2740 255 Porto Salvo Tel: +351 21 196 40 regaff.portugal@sandoz.com

Hrvatska Sandoz d.o.o. Maksimirska 10 000 Zagreb Tel : +385 1 235 3upit.croatia@sandoz.com

Rom nia Sandoz S.R.L. Strada Livezeni Nr. 7a 540472 T rgu Mure
Tel: +40 21 407 51 Ireland Sandoz Pharmaceuticals d.d. Verov kova ulica 1000 Ljubljana Slovenia

Slovenija Lek farmacevtska dru ba d.d. Verov kova SI-1526 Ljubljana Tel: +386 1 580 21 Info.lek@sandoz.com sland Sandoz A/S Edvard Thomsens Vej DK-2300 Kaupmaannah fn S Danm rk Tlf: +45 6395 1info.danmark@sandoz.com

Slovensk republika Sandoz d.d. - organiza n zlo ka i kova 22B 811 02 Bratislava Tel: +421 2 48 200 sk.regulatory@sandoz.com

Italia Sandoz S.p.A. Largo Umberto Boccioni, 1 I-21040 Origgio / VA Tel: +39 02 96 54 1 regaff.italy@sandoz.com Suomi/Finland Sandoz A/S Edvard Thomsens Vej DK-2300 K penhamina S Tanska Puh: + 358 010 6133 info.suomi@sandoz.com

Sandoz Pharmaceuticals d.d. Verovskova SI-1000 Ljubljana

: +357 22 69 0Sverige Sandoz A/S Edvard Thomsens Vej DK-2300 K penhamn S Danmark Tel: +45 6395 1info.sverige@sandoz.com

Latvija Sandoz d.d. Latvia fili le K.Valdem ra 33 LV-1010 R ga Tel: +371 67892United Kingdom (Northern Ireland) Sandoz Pharmaceuticals d.d. Verovskova SI-1000 Ljubljana Slovenia Tel: +43 5338 2This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: