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CINACALCET DR. REDDYS 30 MG FILM-COATED TABLETS

Active substance(s): CINACALCET HYDROCHLORIDE / CINACALCET HYDROCHLORIDE

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Package leaflet: Information for the patient
Cinacalcet 30 mg Film-Coated Tablets
Cinacalcet 60 mg Film-Coated Tablets
Cinacalcet 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.
2.
3.
4.
5.
6.

What Cinacalcet is and what it is used for
What you need to know before you take Cinacalcet
How to take Cinacalcet
Possible side effects
How to store Cinacalcet
Contents of the pack and other information

1. What Cinacalcet is and what it is used for
Cinacalcet 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 is used:
• to treat secondary hyperparathyroidism in patients 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 patients with parathyroid cancer
• to reduce high levels of calcium in the blood (hypercalcaemia)
in patients with primary hyperparathyroidism when removal of
the gland is not possible.
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
Do not take Cinacalcet:


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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking cinacalcet.
Before you start taking cinacalcet, 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.
Life threatening events and fatal outcomes associated with low
calcium levels (hypocalcaemia) have been reported in patients
treated with cinacalcet.
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.
For additional information see section 4.

During treatment with cinacalcet, tell your doctor:
• if you start or stop smoking, as this may affect the way
cinacalcet works.

Children and adolescents

Children under the age of 18 must not take cinacalcet.

Other medicines and Cinacalcet

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Tell your doctor if you are taking the following medicines.
Medicines such as these can affect how cinacalcet 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 may affect how medicines such as the following work:
• medicines used to treat depression (amitriptyline,
desipramine, nortriptyline and clomipramine)
• medicines used to treat changes in heart rate (flecainide
and propafenone)
• a medicine used to treat high blood pressure (metoprolol).

Cinacalcet with food and drink

Cinacalcet 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines
have been performed. Dizziness and seizures have been reported
by patients taking cinacalcet. If you experience these, your ability
to drive or operate machinery may be affected.

Cinacalcet tablets contain lactose

If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.

3. How to take Cinacalcet
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 you must
take.
Cinacalcet must be taken orally, with or shortly after food. The
tablets must be taken whole and are not to be 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 usual starting dose for cinacalcet is 30 mg (one tablet) once
per day.

If you are being treated for parathyroid cancer or
primary hyperparathyroidism

The usual starting dose for cinacalcet is 30 mg (one tablet) twice
per day.

If you take more Cinacalcet than you should

If you take more Cinacalcet 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.

Children and adolescents

The use of cinacalcet in children and adolescents has not been
established. A fatal outcome was reported in an adolescent
clinical trial patient with very low calcium levels in the blood
(hypocalcaemia).

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 Yellow
Card Scheme, website www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety
of this medicine.

5. How to store Cinacalcet

If you forget to take Cinacalcet

Keep this medicine out of the sight and reach of children.

Do not take a double dose to make up for a forgotten dose. If you
have forgotten a dose of Cinacalcet, you should take your next
dose as normal.

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.

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

This medicinal product does not require any special storage
conditions.

4. Possible side effects

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.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you start to get numbness or tingling around the mouth, muscle
aches or cramps and seizures you should tell you doctor
immediately. These may be signs that your calcium levels are too
low (hypocalcaemia).
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 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).

6. Contents of the pack and other information
What Cinacalcet tablets contain





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:
- starch, pre-gelatinised, Ph.Eur.
- cellulose, microcrystalline, Ph. Eur.
- povidone, Ph.Eur.
- crospovidone, Ph.Eur.
- silica, colloidal anhydrous, Ph.Eur.
- magnesium stearate (from vegetable source) Ph.Eur.
The tablets are coated with:
Opadry Green 32K510035 (containing lactose monohydrate,
HPMC2910/hypromellose (E464), titanium dioxide (E171),
triacetin, FD&C Blue #2/indigo carmine (E132) and iron oxide
yellow (E172)).

What Cinacalcet tablets look like and contents of the
pack

Cinacalcet tablets are light green film-coated tablets. They are
oval-shaped and have “30”, “60” or “90” marked on one side and
“C” on the other side.
Cinacalcet is available in blisters of 30 mg, 60 mg or 90 mg filmcoated tablets. Each blister pack contains either 14, 28 or 84 filmcoated tablets in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley,
East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 01/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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