Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - natpar

Document Subject

Generated Narrative: MedicinalProductDefinition mpf6b0c91cf3d8d1303191f090e406eedd

identifier: http://ema.europa.eu/identifier/EU/1/15/1078/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Natpar 25 micrograms/dose powder and solvent for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f6b0c91cf3d8d1303191f090e406eedd

identifier: http://ema.europa.eu/identifier/EU/1/15/1078/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - natpar

Attesters

7. Instructions for use

What is in this leaflet

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

What is Natpar? Natpar is a hormone replacement for adults with under-active parathyroid glands, a condition known as hypoparathyroidism . Hypoparathyroidism is a disease caused by low levels of parathyroid hormone, which is produced by the parathyroid glands in the neck. This hormone controls the amount of calcium and phosphate in the blood and urine. If your levels of parathyroid hormone are too low, you can have low blood calcium. Low calcium can cause symptoms in many parts of your body, including the bones, heart, skin, muscles, kidneys, brain and nerves. For a list of symptoms of low calcium, see section 4. Natpar is a synthetic form of parathyroid hormone that helps you keep calcium and phosphate levels in your blood and urine at a normal level.

Do not use Natpar

if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed in section 6)

if you are having or have had radiation therapy to the skeleton

if you have cancer of the bones or other cancer that has spread to your bones

if you are at increased risk of developing a bone cancer called osteosarcoma (for instance, if you have Paget s disease or other bone diseases)

if a blood test shows you have unexplained increases in bone alkaline phosphatase

if you have pseudohypoparathyroidism, a rare condition where the body does not respond adequately to the parathyroid hormone produced by the body Warnings and precautions Talk to your doctor, pharmacist or nurse before using Natpar. If you are treated with Natpar, you may have side effects related to low or high levels of calcium in your blood (see section 4 for these side effects). These effects are more likely to occur:

when first starting Natpar,

if you change your Natpar dose,

if you miss one of your daily injections,

if you stop taking Natpar for a short time or altogether. You may be given medicines to treat or help prevent these side effects, or you may be asked to stop some of the medicines you are taking. These medicines include calcium or vitamin D. If your symptoms are severe, your doctor may give you additional medical treatment. Your doctor will check your calcium levels. You may need to change your Natpar dose or stop the injections for a short time. Tests and checks Your doctor will check how you respond to the treatment:

during the first 7 days of starting treatment and

if your dose is changed. This will be done using tests to measure the level of calcium in your blood or urine. Your doctor may tell you to change the amount of calcium or vitamin D you take (in any form, including foods rich in calcium). Talk to your doctor or pharmacist before using Natpar if you suffer from kidney stones. Children and adolescents Natpar should not be used in children or adolescents under 18 years old. Other medicines and Natpar Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:

digoxin, also known as digitalis, a heart medicine

medicines used to treat osteoporosis, called bisphosphonates, such as alendronic acid

medicines that can affect calcium levels in your blood such as lithium or some medicines used to increase the amount of urine (diuretics). Pregnancy, breast-feeding and fertility 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. There is limited information on the safety of Natpar in pregnant women. Natpar has been shown to pass into breast milk in rats, but it is not known if Natpar would pass into breast milk in humans. Your doctor will decide whether to start treatment with Natpar. Your doctor will also decide if you should keep taking this medicine if you become pregnant or start breast-feeding while taking it. It is not known if Natpar has any effects on fertility. Driving and using machines Natpar has no effect on your being able to drive or use machines. However, hypoparathyroidism itself may affect your ability to concentrate. If your ability to concentrate is impaired, you should not drive or use machines until your ability to concentrate is improved. Natpar 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor or nurse will train you on how to use the Natpar pen. Natpar is given as a subcutaneous (under the skin) injection every day, using a pen to help you inject your medicine. The Natpar reusable pen is called Natpar pen or pen in this leaflet. Dose The recommended starting dose of Natpar is 50 micrograms per day.

However, your doctor may start you on 25 micrograms per day based on a blood test result.

After 2 to 4 weeks, your doctor may adjust the dose. The dose of Natpar varies from person to person. People may need between 25 and100 micrograms of Natpar per day. Your doctor may tell you to take other medicines such as calcium supplements or vitamin D while you are taking Natpar. Your doctor will tell you how much you should take each day. How to use the pen Read Section 7. Instructions for use in this leaflet before you use the pen. Do not use the pen if the solution is cloudy or coloured or if it contains visible particles. Before the pen is used for the first time, the medicine has to be mixed. After you have mixed the medicine, the Natpar pen is ready for use and the medicine can be injected under the skin of your thigh. Inject in the other thigh the following day and continue to alternate between the two. It is strongly recommended that every time you receive a dose of Natpar, the name and batch number of the product are recorded in order to maintain a record of the batches used. How long to use Keep using Natpar for as long as your doctor prescribes it for you. If you use more Natpar than you should If, by mistake, you inject more than one dose of Natpar in a day, contact your doctor or pharmacist immediately. If you forget to use Natpar If you forget to use Natpar (or cannot inject it at your usual time), use your injection as soon as you can but do not inject more than one dose in the same day. Take your next dose of Natpar at the usual time the next day. You may need to take more calcium supplements if you have signs of low blood calcium; see section 4 for symptoms. Do not inject a double dose to make up for a forgotten dose. If you stop using Natpar Discuss with your doctor if you want to stop treatment with Natpar. 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. Serious side effects The following potentially serious side effects can occur when using Natpar:

Very common: high levels of calcium in your blood, which can occur more often when you start treatment with Natpar.

Very common: low levels of calcium in your blood; this can occur more often if you suddenly stop taking Natpar. Symptoms related to high or low calcium levels are included in the list below. If you experience any of these side effects, contact your doctor right away. Other side effects include: Very common (may affect more than 1 in 10 people):

headaches*,

tingling and numbness of the skin

diarrhoea*,

nausea and vomiting*
joint pain*
muscle spasms Common (may affect up to 1 in 10 people):

feeling nervous or anxious

sleep problems (feeling sleepy during the day or having trouble sleeping at night)*
fast or uneven heart beat*,

high blood pressure*
cough

stomach pain*
muscle twitching or cramping

pain in your muscles

neck pain

pain in your arms and legs

increased level of calcium in your urine*
need to pass urine often

fatigue and lack of energy*
chest pain

redness and pain at injection site

thirst*
antibodies (produced by your immune system) to Natpar

in blood tests, your doctor may see decreased levels of vitamin D and magnesium Not known (frequency cannot be estimated from the available data):

allergic reactions (hypersensitivity), such as: swelling of the face, lips, mouth, or tongue; shortness of breath; itching; rash; hives

seizures (fits) due to low levels of calcium in your blood *These side effects may be related to high level of calcium in your blood. These side effects may be related to low level of calcium in your blood. 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 cartridge and carton after EXP. The expiry date refers to the last day of that month. Before mixing

Store in a refrigerator (2 C to 8 C).

Do not freeze.

Keep the cartridge within its cartridge holder in the outer carton in order to protect from light. After mixing

Store in a refrigerator (2 C to 8 C).

Do not freeze.

Keep the pen containing a mixed cartridge tightly closed in order to protect from light.

Do not use this medicine for more than 14 days after it has been mixed.

Do not use this medicine if it has not been stored correctly.

Before attaching a new needle to your Natpar pen, check that the solution is clear and colourless. It is common to see small bubbles. Do not use this medicine if it has become cloudy, coloured, or contains visible particles. Do not throw away any medicines via household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Natpar contains The active substance is parathyroid hormone (rDNA). It is available in 4 different strengths of cartridge (each cartridge contains 14 doses): Natpar 25 micrograms Each dose contains 25 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution. Natpar 50 micrograms Each dose contains 50 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution. Natpar 75 micrograms Each dose contains 75 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution. Natpar 100 micrograms Each dose contains 100 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution. The other ingredients in the cartridge (for all strengths) are: In the powder:

sodium chloride

mannitol

citric acid monohydrate

sodium hydroxide (for pH adjustment) In the solvent:

metacresol

water for injections What Natpar looks like and contents of the pack Each cartridge of Natpar contains medicine as a powder together with a solvent to make a solution for injection. The cartridge is made of glass, with a rubber seal on top. The cartridge is contained in a plastic cartridge holder. Natpar is available in a pack with 2 cartridges inside their cartridge holders. The carton/cartridge colour shows the strength of your Natpar medicine: Natpar 25 micrograms/dose Purple cartridge. Natpar 50 micrograms/dose Red cartridge. Natpar 75 micrograms/dose Grey cartridge. Natpar 100 micrograms/dose Blue cartridge. Marketing Authorisation Holder and Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com Malta Drugsales Ltd Tel: +356 21419safety@drugsalesltd.com Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com Eesti Takeda Pharma O Tel: +372 6177 medinfoEMEA@takeda.com Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com sterreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com Espa a Takeda Farmac utica Espa a, S.A. Tel: +34 917 90 42 medinfoEMEA@takeda.com Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com France Takeda France SAS T l: + 33 1 40 67 33 medinfoEMEA@takeda.com Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

A.POTAMITIS MEDICARE LTD : +357 22583a.potamitismedicare@cytanet.com.cy Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 3333 000 medinfoEMEA@takeda.com This leaflet was last revised in This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. Detailed information on this medicine is available on the European Medicines Agency web site: