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CINACALCET 30 MG FILM-COATED TABLETS

Active substance(s): CINACALCET HYDROCHLORIDE

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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 or pharmacist.
- 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
This medicine contains active ingredient called Cinacalcet that 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 hyper parathyroidism when removal of the
gland is not possible.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine.
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking or 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);

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

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SAME SIZE ARTWORK
Front




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 this medicine.
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.
This medicine contains lactose
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

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

2. What you need to know before you
take this medicine

3. How to take this medicine
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure. Your doctor will tell you how much medicine you must take.
This medicine 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 hyper parathyroidism
The usual starting dose for this medicine is 30 mg (one tablet)
once per day.
If you are being treated for parathyroid cancer or primary hyper
parathyroidism
The usual starting dose for this medicine is 30 mg (one tablet)
twice per day.
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Package leaflet: Information for the patient

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If you take more of this medicine than you should
If you take more of this medicine 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 this medicine
If you forget to take a dose, just take your next dose as normal.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.



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).



This medicine is available in blister packs of 14, 28 or 84
tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
After taking cinacalcet a very small number of patients with heart
failure had worsening of their condition and/or low blood pressure
(hypotension).
Children and adolescents
The use of cinacalcet in children and adolescents has not been
established. A fatal out come was reported in an adolescent clinical
trial patient with very low calcium levels in the blood (hypocalcaemia).

Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
E-mail:
info@bristol-labs.co.uk

4. Possible side effects
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).

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
at: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

Cinacalcet 30 mg film-coated tablets, PL 17907/0544
Cinacalcet 60 mg film-coated tablets, PL 17907/0545
Cinacalcet 90 mg film-coated tablets, PL 17907/0546
This leaflet was last revised in July 2016

5. How to store this medicine

Common (may affect up to 1 to 10 people)
• dizziness
• numbness or tingling sensation (paraesthesia)
• loss (anorexia) or decrease of appetite
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• reduced test osterone 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).





6. Contents of the pack and other information
What this medicine contains
• The active substance is cinacalcet. Each film-coated tablet contains
30 mg, 60 mg or 90 mg of cinacalcet.
• The other ingredients are:
Tablet core: Pregelatinised maize starch, Microcrystalline cellulose,
Croscarmellose sodium, Colloidal silica anhydrous, Magnesium
stearate.
Tablet coat: Hypromellose 15cP, Lactose monohydrate, Titanium
dioxide (E171), Triacetin, Indigo carmine aluminium lake (E132),
Iron oxide yellow (E172).
What this medicine looks like and contents of the pack
• 30mg: Green, oblong, biconvex film-coated tablets, engraved
with ‘30’on one side and plain on the other side.
• 60mg: Green, oblong, biconvex film-coated tablets, engraved
with ‘60’ on one side and plain on the other side.
• 90mg: Green, oblong, biconvex film-coated tablets, engraved
with ‘90’on one side and plain on the other side.
V3 20-07-16 D0

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SAME SIZE ARTWORK
270 x 250mm
Back

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Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated on
the label after EXP. The expiry date refers to the last day of that
month.
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.

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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)




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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.

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V1 13-05-2016 D1, V2 19-05-2016 D0, V3 20-07-2016 D0,

PL 17907/0544 / 0545 / 0546
Bristol Laboratories Ltd.

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270 mm
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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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