Cinacalcet Mylan - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Cinacalcet Mylan 30 mg film-coated tablets

Cinacalcet Mylan 60 mg film-coated tablets

Cinacalcet Mylan 90 mg film-coated tablets cinacalcet

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 further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

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.

2. What you need to know before you take Cinacalcet Mylan

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.

3. How to take Cinacalcet Mylan

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.

4. Possible side effects

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).

5. How to store Cinacalcet Mylan

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.

6. Contents of the pack and other information

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 × 1, 30 × 1 and 84 × 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 S.A.S.

117 Allee des Parcs

69 800 Saint Priest

France

Manufacturers

Mylan Hungary Kft

H-2900 Komarom, 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in

Other sources of information

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

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