Cinacalcet Viatris

Package leaflet: Information for the patient

Cinacalcet Viatris 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets

cinacalcet
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

What this leaflet contains

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

1. What Cinacalcet Viatris is and what it is used for

Cinacalcet Viatris contains the active substance cinacalcet, which works by controlling levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat diseases caused by problems with organs called parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, which produce parathyroid hormone (PTH).
Cinacalcet Viatris is used in adults:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to remove waste products from their blood.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with parathyroid carcinoma.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with primary hyperparathyroidism when removal of the parathyroid gland is not possible.

Cinacalcet Viatris is used in children aged between 3 and 18 years:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from their blood, whose condition is not controlled with other treatments.

In both primary and secondary hyperparathyroidism, excessive amounts of parathyroid hormone (PTH) are produced by the parathyroid glands. “Primary” means that hyperparathyroidism is not caused by other conditions, and “secondary” means that hyperparathyroidism is caused by another condition, such as kidney disease. Both primary and secondary hyperparathyroidism can cause loss of calcium from bone, which may lead to bone pain and fractures, blood and heart vessel problems, kidney stones, mental disturbances, and coma.

2. What you need to know before using Cinacalcet Viatris

Do not use Cinacalcet Viatris

• if you are allergic to cinacalcet or to 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 Viatris.

Before taking Cinacalcet Viatris, inform your doctor if you have or have ever had:

• seizures (fits or convulsions). The risk of having seizures is higher if you have previously experienced seizures;
• liver problems;
• heart failure.

Cinacalcet Viatris reduces calcium levels. In adults and children treated with cinacalcet, life-threatening events that may lead to death have been reported, associated with low calcium levels in the blood (hypocalcemia).
Inform your doctor if, during treatment with Cinacalcet Viatris, you experience any of the following symptoms, which may be signs of low calcium levels in the blood: muscle spasms, twitching, or cramps, numbness or tingling in the fingers, toes, or around the mouth, seizures, confusion, or loss of consciousness.
Low calcium levels in the blood may affect heart rhythm. Inform your doctor if, while taking cinacalcet, you experience an unusually fast or pounding heartbeat, have heart rhythm problems, or are taking medicines known to cause heart rhythm disturbances.
For additional information, see section 4.
During treatment with Cinacalcet Viatris, inform your doctor:

• if you have started or stopped smoking, as this may affect the action of Cinacalcet Viatris.

Children and adolescents
Children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism must not take Cinacalcet Viatris.
If you are being treated for secondary hyperparathyroidism, your doctor must check your calcium levels before starting treatment with Cinacalcet Viatris and during treatment.
You must inform your doctor if any signs of low calcium levels occur, as described above.
It is important that you take your dose of Cinacalcet Viatris exactly as prescribed by your doctor.
Note:
For children who require doses lower than 30 mg or who are unable to swallow tablets, other dosage forms/strengths of cinacalcet may be available.

Other medicines and Cinacalcet Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially etelcalcetide or any other medicine that lowers calcium levels in the blood.
You must not take Cinacalcet Viatris together with etelcalcetide.
Inform your doctor if you are taking any of the following medicines.

Medicines that may affect the action of Cinacalcet Viatris:

• medicines used to treat skin infections or fungal infections (ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) (ritonavir);
• a medicine used to treat depression (fluvoxamine).

Cinacalcet Viatris may affect the action of the following medicines:

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine);
• medicines used to treat heart rhythm disorders (flecainide and propafenone);
• a medicine used to treat high blood pressure (metoprolol).

Cinacalcet Viatris with food and drink
Cinacalcet Viatris should be taken during or immediately after a meal.

Pregnancy, breastfeeding, and fertility
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Cinacalcet has not been studied in pregnant women. During pregnancy, your doctor may decide to change your treatment, as cinacalcet may harm the unborn baby.
It is not known whether cinacalcet is excreted in breast milk. Your doctor will discuss with you whether you need to stop breastfeeding or stop treatment with Cinacalcet Viatris.

Driving and using machines
Dizziness and seizures have been reported in patients treated with cinacalcet. If you experience these side effects, do not drive or operate machinery.

3. How to use Cinacalcet Viatris

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you are unsure, consult your doctor or pharmacist. Your doctor will tell you how much Cinacalcet Viatris to
take.
Cinacalcet Viatris should be taken orally during or immediately after meals. The tablets
should be swallowed whole and must not be chewed, crushed, or split.
Your doctor will regularly prescribe blood tests during treatment to assess your response to therapy and will adjust the dose if necessary.
If you are being treated for secondary hyperparathyroidism
The initial dose of Cinacalcet Viatris in adults is 30 mg (one tablet) once daily.
The recommended initial dose of Cinacalcet Viatris for children aged 3 to 18 years is not more than 0.20 mg/kg body weight per day.
If you are being treated for parathyroid carcinoma or primary hyperparathyroidism
The initial dose of Cinacalcet Viatris in adults is 30 mg (one tablet) twice daily.
If you take more Cinacalcet Viatris than you should
If you take more Cinacalcet Viatris than you should, contact your doctor immediately.
Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.
If you forget to take Cinacalcet Viatris
Do not take a double dose to make up for the missed dose.
If you have forgotten a dose of Cinacalcet Viatris, take your next usual dose at the regular time.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately:

• If you start to feel numbness or tingling around the mouth, muscle pain, cramps, or convulsions. These symptoms may indicate that calcium levels in your blood are too low (hypocalcemia).
• If you develop swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty 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 usually mild and short-lived.

Common: may affect up to 1 in 10 people

• dizziness
• numbness or tingling sensation (paresthesia)
• loss (anorexia) or reduced appetite
• muscle pain (myalgia)
• weakness (asthenia)
• skin reactions (rash)
• reduced levels of testosterone in the blood
• elevated levels of potassium in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• epileptic seizures (convulsions or attacks)
• low blood pressure (hypotension)
• upper respiratory tract infection
• difficulty breathing (dyspnea)
• cough
• indigestion (dyspepsia)
• diarrhea
• abdominal pain, pain in the upper abdomen
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcemia)

Not known: frequency cannot be estimated from the available data

• Hives (urticaria)
• Swelling of the face, lips, oral cavity, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema).
• Unusually fast or pounding heartbeat, which may be associated with low calcium levels in the blood (QT prolongation and ventricular arrhythmia secondary to hypocalcemia).

After administration of cinacalcet, a very small number of patients with heart failure have experienced worsening of their condition and/or low blood pressure (hypotension).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cinacalcet Viatris

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 blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cinacalcet Viatris 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 microcrystalline cellulose, anhydrous colloidal silica, povidone, crospovidone,
magnesium stearate.
The tablet coating contains hypromellose, titanium dioxide (E171), glycerol triacetate,
indigotine (E132), yellow iron oxide (E172).

Description of the appearance of Cinacalcet Viatris and contents of the pack
Cinacalcet Viatris 30 mg film-coated tablets are 10.0 mm x 6.4 mm, bevelled edge, biconvex, oval, green tablets,
with "M" engraved on one side and "CI30" on the other side.
Cinacalcet Viatris 60 mg film-coated tablets are 12.5 mm x 8.0 mm, bevelled edge, biconvex, oval, green tablets,
with "M" engraved on one side and "CI60" on the other side.
Cinacalcet Viatris 90 mg film-coated tablets are 14.3 mm x 9.0 mm, bevelled edge, biconvex, oval, green tablets,
with "M" engraved on one side and "CI90" on the other side.
Cinacalcet Viatris 30 mg, 60 mg, 90 mg film-coated tablets are available in blisters of 28 tablets and in single-dose blisters of 28 x 1, 30 x 1 and 84 x 1 tablets.
Cinacalcet Viatris 30 mg film-coated tablets are also available in plastic bottles containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1
Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva (Lithuania)
Viatris Viatris
Tél/Tel: + 32 (0)2 658 61 00 Tel: + 370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Teл.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Tel: + 372 6363 052 Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: + 421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0)2 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: + 357 2220 7700 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: + 371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu