Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - forsteo

Document Subject

Generated Narrative: MedicinalProductDefinition mpf37dc8b0ce387c50af638cbc7ed30e60

identifier: http://ema.europa.eu/identifier/EU/1/03/247/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f37dc8b0ce387c50af638cbc7ed30e60

identifier: http://ema.europa.eu/identifier/EU/1/03/247/001-002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - forsteo

Attesters

What is in this leaflet:

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

FORSTEO contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.

FORSTEO is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.

Do not use FORSTEO

• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from high calcium levels (pre-existing hypercalcaemia).
• if you suffer from serious kidney problems.
• if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones.
• if you have certain bone diseases. If you have a bone disease, tell your doctor.
• if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor.
• if you have had radiation therapy involving your bones.
• if you are pregnant or breast-feeding.

Warnings and precautions FORSTEO may cause an increase in the amount of calcium in your blood or urine.

Talk to your doctor or pharmacist before or while using FORSTEO:

• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
• if you suffer from kidney stones or have a history of kidney stones.
• if you suffer from kidney problems (moderate renal impairment).

Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject FORSTEO where you can sit or lie down right away if you get dizzy.

The recommended treatment time of 24 months should not be exceeded.

FORSTEO should not be used in growing adults.

Children and adolescents FORSTEO should not be used in children and adolescents (less than 18 years).

Other medicines and FORSTEO Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).

Pregnancy and breast-feeding Do not use FORSTEO if you are pregnant or breast-feeding. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of FORSTEO. If you become pregnant, FORSTEO should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines Some patients may feel dizzy after injecting FORSTEO. If you feel dizzy you should not drive or use machines until you feel better.

FORSTEO contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

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

The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to take your medicine, inject it at about the same time each day.

Inject FORSTEO each day for as long as your doctor prescribes it for you. The total duration of treatment with FORSTEO should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.

FORSTEO can be injected at meal times.

Read the user manual booklet, which is included in the carton for instructions on how to use the FORSTEO pen.

Injection needles are not included with the pen. Becton, Dickinson and Company pen needles can be used.

You should take your FORSTEO injection shortly after you take the pen out of the refrigerator as described in the user manual. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use. Never store your pen with the needle attached. Never share your FORSTEO pen with others.

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

FORSTEO can be given with or without food.

If you use more FORSTEO than you should If, by mistake, you have used more FORSTEO than you should, contact your doctor or pharmacist.

The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.

If you forget or cannot take FORSTEO at your usual time, take it as soon as possible on that day. Do not take a double dose to make up for a forgotten dose. Do not take more than one injection in the same day. Do not try to make up for a missed dose.

If you stop taking FORSTEO If you are considering stopping FORSTEO treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with FORSTEO.

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

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

The most common side effects are pain in limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common). If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel better, you should call a doctor before you continue treatment. Cases of fainting have been reported in association with teriparatide use.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks. Otherwise tell your doctor as soon as possible.

Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur.

Other side effects include: Common: may affect up to 1 in 10 people

• increase in blood cholesterol levels

• depression

• neuralgic pain in the leg

• feeling faint

• irregular heart beats

• breathlessness

• increased sweating

• muscle cramps

• loss of energy

• tiredness

• chest pain

• low blood pressure

• heartburn (painful or burning sensation just below the breast bone)

• being sick(vomiting)

• a hernia of the tube that carries food to your stomach

• low haemoglobin or red blood cell count (anaemia)

Uncommon: may affect up to 1 in 100 people

• increased heart rate
• abnormal heart sound
• shortness of breath
• haemorrhoids (piles)
• accidental loss or leakage of urine
• increased need to pass water
• weight increase
• kidney stones
• pain in the muscles and pain in the joints. Some patients have experienced severe back cramps or pain which lead to hospitalisation.
• increase in blood calcium level
• increase in blood uric acid level
• increase in an enzyme called alkaline phosphatase.

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

• reduced kidney function, including renal failure
• swelling, mainly in the hands, feet and legs.

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.

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

FORSTEO should be stored in a refrigerator (2 C to 8 C) at all times. You can use FORSTEO for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2 C to 8 C).

Do not freeze FORSTEO. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use FORSTEO if it is, or has been, frozen.

Each pen should be properly disposed of after 28 days, even if it is not completely empty.

FORSTEO contains a clear and colourless solution. Do not use FORSTEO if solid particles appear or if the solution is cloudy or coloured.

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 to protect the environment.

What FORSTEO contains

• The active substance is teriparatide. Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
• The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.

What FORSTEO looks like and contents of the pack FORSTEO is a colourless and clear solution. It is supplied in a cartridge contained in a pre-filled disposable pen. Each pen contains 2.4 mL of solution enough for 28 doses. The pens are available in cartons containing one or three pens. Not all pack sizes may be available.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Manufacturer Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France.

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

Belgi /Belgique/Belgien Eli Lilly Benelux S.A./N.V. T l/Tel: + 32 (0) 2 548 84 Lietuva Eli Lilly Lietuva Tel: + 370 (5) 2649
" " . . -
: + 359 2 491 41 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. T l/Tel: + 32 (0) 2 548 84 esk republika Eli Lilly R, s.r.o. Tel: + 420 234 664 Magyarorsz g Lilly Hung ria Kft. Tel: + 36 1 328 5Danmark Eli Lilly Danmark A/S Tlf: + 45 45 26 60 Malta Charles de Giorgio Ltd. Tel: + 356 25600 Deutschland Lilly Deutschland GmbH Tel: + 49 (0) 6172 273 2Nederland Eli Lilly Nederland B.V. Tel: + 31(0) 30 6025Eesti Eli Lilly Nederland B.V.
Tel: +372 6 817 Norge Eli Lilly Norge A.S Tlf: + 47 22 88 18 a

• . . . . : + 30 210 629 4 sterreich Eli Lilly Ges. m.b.H.
  Tel: + 43 (0) 1 711 Espa a Valquifarma, S.A.U.
  Tel: + 34-91 623 1Polska Eli Lilly Polska Sp. z o.o. Tel: + 48 22 440 33 France Lilly France T l: + 33 (0) 1 55 49 34 Portugal Lilly Portugal Produtos Farmac uticos, Lda Tel: + 351 21 412 66 Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 Rom nia Eli Lilly Rom nia S.R.L. Tel: + 40 21 4023Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353 (0) 1 661 4Slovenija Eli Lilly farmacevtska dru ba, d.o.o. Tel: + 386 (0) 1 580 00 sland Icepharma hf. S mi: + 354 540 8Slovensk republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 Italia Eli Lilly Italia S.p.A. Tel: + 39 055 42Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358 (0) 9 8545
  Phadisco Ltd
  : + 357 22 715Sverige Eli Lilly Sweden AB Tel: + 46 (0) 8 7378Latvija Eli Lilly (Suisse) S.A P rst vniec ba Latvij
  Tel: + 371 67364United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4This leaflet was last revised in

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