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CINACALCET ACCORD 60 MG FILM-COATED TABLETS

Active substance(s): CINACALCET HYDROCHLORIDE / CINACALCET HYDROCHLORIDE / CINACALCET HYDROCHLORIDE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Cinclacet

Market

UK-IE-MT

Language

English

Size

155 x 560 mm (PIL)

Min. Font Size

9

Version No.

3 (Page 1 of 2) (II03)

Date

06.01.17 (Cinclacet (ACC-UK-IE-MT) II03 - PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: Information for the
patient

Cinacalcet Accord
30 mg film-coated
tablets
Cinacalcet Accord
60 mg film-coated
tablets
Cinacalcet Accord
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 Accord is and what
it is used for
2. What you need to know before you
take Cinacalcet Accord
3. How to take Cinacalcet Accord
4. Possible side effects
5. How to store Cinacalcet Accord
6. Contents of the pack and other
information

60mm

1. What Cinacalcet
Accord is and what it
is used for
Cinacalcet Accord works by controlling
the levels of parathyroid hormone
(PTH), calcium and phosphorus 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).

In primary and secondary
hyperparathyroidism too much PTH is
produced by the parathyroids 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 Accord
Do not take Cinacalcet Accord
- 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 Accord
Before you start taking Cinacalcet
Accord, 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.

Children and adolescents
Children under the age of 18 must not
take Cinacalcet Accord.
Other medicines and Cinacalcet
Accord
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 Accord 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 Accord 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 Accord with food and
drink
Cinacalcet Accord 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 Accord
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 Accord contains 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
Accord
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 cinacalcet you must
take.
Cinacalcet Accord 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
Accord 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
Accord is 30 mg (one tablet) twice per
day.
If you take more Cinacalcet Accord
than you should
If you take more Cinacalcet Accord
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
Accord
Do not take a double dose to make up
for a forgotten dose.
If you have forgotten a dose of
Cinacalcet Accord, 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.

For additional information see section 4.

4. Possible side effects

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

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

60mm

Cinacalcet Accord 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.

Approved By
Quality Assurance

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Cinclacet

Market

UK-IE-MT

Language

English

Size

155 x 560 mm (PIL)

Min. Font Size

9

Version No.

3 (Page 2 of 2) (II03)

Date

06.01.17 (Cinclacet (ACC-UK-IE-MT) II03 - PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

cramps and seizures you should tell
you doctor immediately. These may
be signs that your calcium levels are
too low (hypocalcaemia).

Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom

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).

Manufacturer
GE Pharmaceuticals Ltd.
Industrial Zone, Chekanitza South
Area
Botevgrad, 2140
Bulgaria

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).
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 national
reporting system (see contact details
below). By reporting side effects you
can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store
Cinacalcet Accord

Marketing Authorisation Holder and
Manufacturer

S.C. Polisano Pharmaceuticals S.R.L.,
Alba Iulia Street 156, 550052 Sibiu,
Sibiu County, Romania
The medicinal product is authorized
in the Member States of the EEA
under the following names:
Name of the
Member
State
Austria
Czech
Republic
Germany
Denmark

France
Ireland
Italy

Netherlands
Portugal

Romania
Sweden
United
Kingdom
Finland
Bulgaria
Cyprus

Estonia

Croatia
Iceland

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

Lithuania

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.

Latvia

This medicinal product 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

Malta
Cinacalcet
Norway
Poland
Slovak
Republic

Name of the
medicinal product
Cinacalcet Accord
30/60/90 mg
filmtabletten
Cinacalcet Accord
30/60/90 mg
potahovaná tableta
Cinacalcet Accord
30/60/90 mg
filmtabletten
Cinacalcet Accord
30/60/90 mg
filmovertrukne
tabletter
Cinacalcet Accord
30/60/90 mg
comprimé pelliculé
Cinacalcet Accord
30/60/90 mg
film-coated tablets
Cinacalcet Accord
30/60/90 mg
compressa rivestita
con film
Cinacalcet Accord
30/60/90 mg
filmomhulde tablette
Cinacalcet Accord
30/60/90 mg
comprimidos
revestidos por película
Cinacalcet Accord
30/60/90 mg
comprimate filmate
Cinacalcet Accord
30/60/90 mg
filmdragerad tablet
Cinacalcet Accord
30/60/90 mg
film-coated tablets
Cinacalcet Accord
30/60/90 mg kalvo
päällysteiset tabletit
Cinacalcet Accord
30/60/90 mg
филмирани таблетки
Cinacalcet Accord
30/60/90 mg δισκία
επικαλυμμένα με
λεπτό υμένιο
Cinacalcet Accord
30/60/90 mg õhukese
polümeerikattega
tabletid
Sinakalcet Accord
filmom obložene
tablete
Cinacalcet Accord
filmuhúðaðar töflur
Cinacalcet Accord
plėvele dengtos
tabletės
Cinacalcet Accord
apvalkotās tablete
Accord 30/60/90 mg
film-coated tablets
Cinacalcet Accord
30/60/90 mg
filmdrasjerte tabletter
Cinacalcet Accord
30/60/90 mg tabletki
powlekane
Cinacalcet Accord
30/60/90 mg filmom
obalené tablety

This leaflet was last revised in
01/2017.

What Cinacalcet Accord contains
- The active substance is cinacalcet.
Each film-coated tablet contains
30mg, 60mg or 90mg of cinacalcet
(as hydrochloride).
- The other ingredients are lactose
monohydrate, microcrystalline
cellulose, pregelatinized starch,
crospovidone, magnesium stearate
and talc.
- The tablets are coated with
SheffCoat green (containing
hypromellose, titanium dioxide
(E171), lactose monohydrate,
triacetin, yellow iron oxide (E172)
and indigo carmine lake (E132).

Cinacalcet Accord is a light green
film-coated tablet. They are
oval-shaped and have ‘C’ marked on
one side and ‘30’, ‘60’ or ‘90’ on the
other side.
Cinacalcet Accord is available in
blisters of 30 mg, 60 mg or 90 mg
film-coated tablets. Each blister pack
contains either 14, 28 or 84 tablets in a
carton.

Material number

What Cinacalcet Accord looks like
and contents of the pack

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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