Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cinacalcet

Document Subject

Generated Narrative: MedicinalProductDefinition mp52a624241d4cc518b719672757fc515f

identifier: http://ema.europa.eu/identifier/EU/1/15/1054/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cinacalcet Mylan 30 mg film-coated tablets.

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-52a624241d4cc518b719672757fc515f

identifier: http://ema.europa.eu/identifier/EU/1/15/1054/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - cinacalcet

Attesters

What is in this leaflet

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

Cinacalcet Mylan contains the active ingredient cinacalcet, which works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body. It is used to treat problems with organs called parathyroid glands. The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).

Cinacalcet Mylan is used in adults:

to treat secondary hyperparathyroidism in adults with serious kidney disease who need dialysis to clear their blood of waste products

to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with parathyroid cancer

to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with primary hyperparathyroidism when removal of the parathyroid gland is not possible.

Cinacalcet Mylan is used in children aged 3 years to less than 18 years of age:

to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products, whose condition is not controlled with other treatments.

In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid glands. Primary means that the hyperparathyroidism is not caused by any other condition and secondary
means that the hyperparathyroidism is caused by another condition, e.g. kidney disease. Both primary and secondary hyperparathyroidism can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.

Do not take Cinacalcet Mylan

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

if you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Cinacalcet Mylan. Before you start taking Cinacalcet Mylan, tell your doctor if you have or have ever had:

seizures (fits or convulsions). The risk of having seizures is higher if you have had them before;

liver problems;

heart failure.

Cinacalcet Mylan reduces calcium levels. Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated with cinacalcet.

Please tell your doctor if you experience any of the following which may be signs of low calcium levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with Cinacalcet Mylan.

Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking Cinacalcet Mylan.

For additional information see section 4. During treatment with Cinacalcet Mylan, tell your doctor:

if you start or stop smoking, as this may affect the way Cinacalcet Mylan works.

Children and adolescents Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take Cinacalcet Mylan.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Cinacalcet Mylan and during treatment with Cinacalcet Mylan. You should inform your doctor if you experience any of the signs of low calcium levels as described above.

It is important that you take your dose of Cinacalcet Mylan as advised by your doctor.

Note: For children who require doses lower than 30 mg, or who are unable to swallow tablets, other strengths/pharmaceutical forms of cinacalcet may be available.

Other medicines and Cinacalcet Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.

You should not take Cinacalcet Mylan together with etelcalcetide.

Tell your doctor if you are taking the following medicines. Medicines such as these can affect how Cinacalcet Mylan works:

medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole)

medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin)

a medicine used to treat HIV infection and AIDS (ritonavir)

a medicine used to treat depression (fluvoxamine).

Cinacalcet Mylan may affect how medicines such as the following work:

medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine)

a medicine used to relieve cough (dextromethorphan)

medicines used to treat changes in heart rate (flecainide and propafenone)

a medicine used to treat high blood pressure (metoprolol).

Cinacalcet Mylan with food and drink Cinacalcet Mylan should be taken with or shortly after food.

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.

Cinacalcet has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as cinacalcet might harm the unborn baby.

It is not known whether cinacalcet is excreted in human milk. Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Cinacalcet Mylan.

Driving and using machines Dizziness and seizures have been reported by patients taking cinacalcet. If you experience these side effects do not drive or operate machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet Mylan you must take.

Cinacalcet Mylan must be taken orally, with or shortly after food. The tablets must be taken whole and are not to be chewed, crushed or divided.

Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.

If you are being treated for secondary hyperparathyroidism

The recommended starting dose for Cinacalcet Mylan in adults is 30 mg (one tablet) once per day.

The recommended starting dose of Cinacalcet Mylan for children aged 3 years to less than 18 years of age is no more than 0.20 mg/kg of body weight daily.

If you are being treated for parathyroid cancer or primary hyperparathyroidism

The recommended starting dose for Cinacalcet Mylan in adults is 30 mg (one tablet) twice per day.

If you take more Cinacalcet Mylan than you should If you take more Cinacalcet Mylan than you should you must contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.

If you forget to take Cinacalcet Mylan Do not take a double dose to make up for a forgotten dose.

If you have forgotten a dose of Cinacalcet Mylan, you should take your next dose as normal.

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.

Please tell your doctor immediately:

If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures. These may be signs that your calcium levels are too low (hypocalcaemia).

If you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).

Other possible side effects:

Very common: may affect more than 1 in 10 people

nausea and vomiting, these side effects are normally quite mild and do not last for long.

Common: may affect up to 1 in 10 people

dizziness

numbness or tingling sensation (paraesthesia)

loss (anorexia) or decrease of appetite

muscle pain (myalgia)

weakness (asthenia)

rash

reduced testosterone levels

high potassium levels in the blood (hyperkalaemia)

allergic reactions (hypersensitivity)

headache

seizures (convulsions or fits)

low blood pressure (hypotension)

upper respiratory infection

breathing difficulties (dyspnoea)

cough

indigestion (dyspepsia)

diarrhoea

abdominal pain, abdominal pain - upper

constipation

muscle spasms

back pain

low calcium levels in the blood (hypocalcaemia).

Not known: frequency cannot be estimated from the available data

Hives (urticaria).

Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).

Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).

After taking cinacalcet a very small number of patients with heart failure had worsening of their condition and/or low blood pressure (hypotension).

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.

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 blister, carton or bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 protect the environment.

What Cinacalcet Mylan contains The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).

The other ingredients are cellulose, microcrystalline; silica, colloidal anhydrous; povidone; crospovidone; magnesium stearate.

The tablet coating contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), iron oxide yellow (E172).

What Cinacalcet Mylan looks like and contents of the pack

Cinacalcet Mylan 30 mg film-coated tablets are 10.0 mm x 6.4 mm, green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet and CI30 on the other side.

Cinacalcet Mylan 60 mg film-coated tablets are 12.5 mm x 8.0 mm, green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet and CI60 on the other side.

Cinacalcet Mylan 90 mg film-coated tablets are 14.3 mm x 9.0 mm, green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet CI90 on the other side.

Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are available in blister packs of 28 tablets and perforated unit dose blister packs of 28 x 1, 30 x 1 and 84 x 1 tablets.

Cinacalcet Mylan 30 mg film-coated tablets are available in plastic bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Pharmaceuticals Limited Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN Ireland

Manufacturers Mylan Hungary Kft H-2900 Kom rom, Mylan utca 1 Hungary

McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin Ireland

Mylan Germany GmbH Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 Bad Homburg v. d. Hoehe Hessen, 61352,
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB Tel: + 370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: + 420 222 004 Magyarorsz g
Mylan EPD Kft. Tel.: + 36 1 465 2Danmark Viatris ApS
Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan BV Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Generics Pharma Hellas
: +30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z.o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l: + 33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 214 127 Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 Ireland Mylan Ireland Limited Tel: +353 1 8711Rom nia BGP Products SRL Tel: +40 372 579 Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd
: +357 2220 7Sverige Viatris AB Tel: + 46 (0)8 630 19 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in

Other sources of information

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